FDA cracks down on unapproved ear drops

FDA cracks down on unapproved ear drops.

Agency Also to Examine Children’s Use of Cough, Cold Medications With Codeine

From the 7 July 2015 AAFP news release

On July 1, FDA officials moved to shut down the manufacture and sale of 16 unapproved prescription otic products used to relieve ear pain, inflammation and infection. Specifically, the agency notified(www.fda.gov) companies that produce and/or distribute these products that it will take enforcement action against them if they continue to make and market the ear drops.

In separate action, the agency said it also plans to scrutinize safety data pertaining to the use of codeine-containing products used to treat cough or colds in children younger than 18 years.

Prescription Ear Drops

Otic drops are frequently given to young children suffering from ear infections and other ailments that cause ear pain and swelling. A number of FDA-approved prescription otic products are available to manage these symptoms, as are legally marketed OTC ear drops. Those products are not affected by the agency’s action.

Products that have not been evaluated by the FDA for safety, quality and efficacy, on the other hand, increase patients’ risk for adverse effects, such as those due to contamination or varying dosage levels that stem from improper manufacturing practices. The unapproved products covered by this action contain the following ingredients:

• benzocaine;
• benzocaine and antipyrine;
• benzocaine, antipyrine and zinc acetate;
• benzocaine, chloroxylenol and hydrocortisone;
• chloroxylenol and pramoxine; and
• chloroxylenol, pramoxine and hydrocortisone.

Patients who are using these unapproved products (or their parents) are advised to consult with their physician regarding other treatment options.

Codeine-containing Cough-and-Cold Products

In a Drug Safety Communication(www.fda.gov) issued July 1, FDA officials announced that the agency is investigating the safety of using cough-and-cold medications that contain codeine in children younger than 18 years. The agency cited concerns about the potential for severe side effects associated with use of these products, including slowed or difficult breathing.

Children with existing respiratory problems, such as asthma or other breathing disorders, may be particularly susceptible to these adverse effects.

The FDA’s action comes on the heels of an April announcement(www.ema.europa.eu) from the European Medicines Agency (EMA), which declared that the use of codeine-containing cough-and-cold medications was contraindicated in children younger than 12 years because of the risk of side effects. The agency also noted at the time that use of these products was not recommended in children ages 12-18 who have breathing problems.

Furthermore, EMA officials warned, patients of any age who are considered “ultra-rapid metabolizers” of the drug, which is converted into morphine in the body, must not use codeine to treat cough or colds.

The FDA announcement states that the agency will continue to evaluate the safety of using codeine products to treat cough or colds in children and young teens — including reviewing the EMA’s action and the evidence on which it was based — and will release final conclusions when that investigation is completed.

In the meantime, agency officials recommend caution when prescribing these medications for young patients, and they urge both physicians and patients to report adverse effects(www.accessdata.fda.gov) linked to use of the drugs via MedWatch, the FDA’s Safety Information and Adverse Event reporting Program.

Press Announcements > FDA launches drug shortages mobile app

Press Announcements > FDA launches drug shortages mobile app.

From the 4 March 2015 announcement

Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.

The app identifies current drug shortages, resolved shortages and discontinuations of drug products.

Drugs in short supply can delay or deny needed care for patients. Drug shortages may also lead health care professionals to rely on alternative drug products, which may be less effective or associated with higher risks than the drug in shortage.

“The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” said Valerie Jensen, associate director of the Drug Shortage Staff in the FDA’s Center for Drug Evaluation and Research. “The new mobile app is an innovative tool that will offer easier and faster access to important drug shortage information.”

App users can search or browse by a drug’s generic name or active ingredient, and browse by therapeutic category. The app can also be used to report a suspected drug shortage or supply issue to the FDA.

The agency developed the drug shortages app to improve access to information about drug shortages, as part of the FDA’s efforts outlined in the Strategic Plan for Preventing and Mitigating Drug Shortages.

The app is available for free download via iTunes (for Apple devices) and theGoogle Play store (for Android devices) by searching “FDA Drug Shortages.”

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

[News] The coming revolution in much cheaper life-saving drugs | Medication Health News

The coming revolution in much cheaper life-saving drugs | Medication Health News.

From the 22 January 2015 post

Recently the FDA has approved the first “biosimilars” to be available in the United States.  In order for a drug to be considered biosimilar, the law requires that the copycat drug is “highly similar” to the reference drug, and does not have “clinically meaningful” differences. Biosimilar drugs will offer lower-cost competition as they tend to cost between 20 – 30 % less than the original branded drug. According to the Federal Trade Comission, Biosimilar products are estimated to take 8 to 10 years to develop and will cost the manufacturers up to $200 million to produce.With this new class of drugs, patients will be able to save thousands on their medications. Has your company/employer began exploring the budgetary effects of biosimilars? How will this new class of biosimilars affect health care spending in the US?

For additional information click here

Photo courtesy of [ddpavumba]  freedigitalphotos.net

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[News] New regulations proposed for off-label uses of drugs, devices — ScienceDaily

New regulations proposed for off-label uses of drugs, devices — ScienceDaily.

Excerpts

Date:January 22, 2015

Source:University of California, Los Angeles (UCLA), Health Sciences

Summary:Researchers have proposed a system for off-label drug prescriptions combining reporting, testing and enforcement regulations, and allowing interim periods of off-label use. This would give patients more treatment options while providing regulators with evidence of the drugs’ safety and efficacy.

---

 

Medicine drugs (Photo credit: Wikipedia)

Off-label use of drugs and medical devices — using approved remedies in unapproved ways — has long been a part of medicine. The practice provides public health benefits but also presents some risks.

For the most part, the U.S. Food and Drug Administration allows physicians to prescribe drugs and devices off-label in the same way they are prescribed for their approved uses. The FDA couldn’t require approval for each off-label use because the burden for approval would be so high that few off-label uses would be approved, which would deprive patients of effective treatments for which the drugs weren’t originally intended.

As a result, health care providers have had to make their own decisions about using drugs off-label, often in the face of uncertain evidence.

To address that issue, researchers from the David Geffen School of Medicine at UCLA have proposed a system combining reporting, testing and enforcement regulations, and allowing interim periods of off-label drug prescription. Their recommendations, published in the Duke Law Journal, would give patients more treatment options while providing regulators with evidence of the drugs’ safety and efficacy.

….

The authors’ proposal comprises three elements:

• Improved reporting of off-label use through disclosure of diagnostic codes in reports to the FDA, in detailing data that pharmaceutical companies obtain on physicians’ prescribing habits, and in reports to the FDA and Medicare/Medicaid reimbursement requests. This information, which would omit details that could identify individual patients, could then be shared with academics and pharmaceutical companies for use in research. • Expansion of post-market testing requirements for off-label use of drugs and medical devices. • A tiered labeling system for drugs consisting of “red box” warnings that prohibit certain off-label uses; informed consent from patients receiving prescriptions for off-label use of some drugs that currently carry “black box” warnings, which identify drugs that pose a significant risk of serious or life-threatening adverse effects; and the creation of a new “grey box” warning that blocks Medicare Part D and Medicaid reimbursements by the Centers for Medicare and Medicaid Services.

“The improved reporting, testing and enforcement regulation would work together to produce a more layered range of regulatory responses,” the authors write. “The FDA, armed with better information about the extent of off-label use and adverse effects, would be in a better position to require post-market testing and to discourage off-label use with new types of warnings if manufacturers fail to provide sufficient, timely evidence of safety and efficacy in that particular extrapolation.”

The report can be found at: http://scholarship.law.duke.edu/cgi/viewcontent.cgi?article=3785&context=dlj

 

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[Report] Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

From the summary of the December 2014 report by the Congressional Research Service

In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or
tissue, to provide information in making health care decisions. Examples of IVDs include (1)
pregnancy test kits or blood glucose tests for home use; (2) laboratory tests for infectious disease,such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and (3) tests forvarious genetic diseases or conditions. More recently, a specific type of diagnostic test—called acompanion diagnostic—has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine.

…
In June 2010, FDA announced its decision to exercise its authority over all LDTs. A provision in
the Food and Drug Administration Safety and Innovation Act of 2012 stipulates that the agency
“may not issue any draft or final guidance on the regulation” of LDTs without, “at least 60 days
prior to such issuance,” first notifying Congress “of the anticipated details of such action.” On
July 31, 2014, in fulfillment of this statutory requirement, the FDA officially notified the Senate
Committee on Health, Education, Labor and Pensions and the House Committee on Energy and
Commerce that it will issue draft guidance on the regulation of LDTs, and included the
anticipated details of that regulatory framework. On October 3, 2014, the FDA formally issued
these documents as draft guidance in the Federal Register, giving 120 days for comment.
The draft guidance identifies groups of LDTs that will be (1) exempt from regulation entirely; (2)
only required to meet notification and adverse event reporting requirements; and (3) required to
meet notification, adverse event reporting, applicable premarket review, and other regulatory
requirements. FDA will use the information obtained through the notification requirement to
classify LDTs, based on risk, using a public process involving advisory panels and public
comment. Once classification has taken place, the FDA will enforce premarket review
requirements, prioritizing the highest-risk tests. The agency anticipates the entire process of
bringing all LDTs into compliance will take nine years to complete.

 

Related articles

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[Report] Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices, Laboratory Developed Tests (LDTs), and Genetic Tests

From the summary of the December 2014 report by the Congressional Research Service

In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or
tissue, to provide information in making health care decisions. Examples of IVDs include (1)
pregnancy test kits or blood glucose tests for home use; (2) laboratory tests for infectious disease,such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and (3) tests forvarious genetic diseases or conditions. More recently, a specific type of diagnostic test—called acompanion diagnostic—has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine.

…
In June 2010, FDA announced its decision to exercise its authority over all LDTs. A provision in
the Food and Drug Administration Safety and Innovation Act of 2012 stipulates that the agency
“may not issue any draft or final guidance on the regulation” of LDTs without, “at least 60 days
prior to such issuance,” first notifying Congress “of the anticipated details of such action.” On
July 31, 2014, in fulfillment of this statutory requirement, the FDA officially notified the Senate
Committee on Health, Education, Labor and Pensions and the House Committee on Energy and
Commerce that it will issue draft guidance on the regulation of LDTs, and included the
anticipated details of that regulatory framework. On October 3, 2014, the FDA formally issued
these documents as draft guidance in the Federal Register, giving 120 days for comment.
The draft guidance identifies groups of LDTs that will be (1) exempt from regulation entirely; (2)
only required to meet notification and adverse event reporting requirements; and (3) required to
meet notification, adverse event reporting, applicable premarket review, and other regulatory
requirements. FDA will use the information obtained through the notification requirement to
classify LDTs, based on risk, using a public process involving advisory panels and public
comment. Once classification has taken place, the FDA will enforce premarket review
requirements, prioritizing the highest-risk tests. The agency anticipates the entire process of
bringing all LDTs into compliance will take nine years to complete.

From the summary of the December 2014 report by the Congressional Research Service

In vitro diagnostic (IVD) devices are used in the analysis of human samples, such as blood or
tissue, to provide information in making health care decisions. Examples of IVDs include (1)
pregnancy test kits or blood glucose tests for home use; (2) laboratory tests for infectious disease,such as HIV or hepatitis, and routine blood tests, such as cholesterol and anemia; and (3) tests forvarious genetic diseases or conditions. More recently, a specific type of diagnostic test—called acompanion diagnostic—has been developed that may be used to select the best therapy, at the right dose, at the correct time for a particular patient; this is often referred to as personalized or precision medicine.

…
In June 2010, FDA announced its decision to exercise its authority over all LDTs. A provision in
the Food and Drug Administration Safety and Innovation Act of 2012 stipulates that the agency
“may not issue any draft or final guidance on the regulation” of LDTs without, “at least 60 days
prior to such issuance,” first notifying Congress “of the anticipated details of such action.” On
July 31, 2014, in fulfillment of this statutory requirement, the FDA officially notified the Senate
Committee on Health, Education, Labor and Pensions and the House Committee on Energy and
Commerce that it will issue draft guidance on the regulation of LDTs, and included the
anticipated details of that regulatory framework. On October 3, 2014, the FDA formally issued
these documents as draft guidance in the Federal Register, giving 120 days for comment.
The draft guidance identifies groups of LDTs that will be (1) exempt from regulation entirely; (2)
only required to meet notification and adverse event reporting requirements; and (3) required to
meet notification, adverse event reporting, applicable premarket review, and other regulatory
requirements. FDA will use the information obtained through the notification requirement to
classify LDTs, based on risk, using a public process involving advisory panels and public
comment. Once classification has taken place, the FDA will enforce premarket review
requirements, prioritizing the highest-risk tests. The agency anticipates the entire process of
bringing all LDTs into compliance will take nine years to complete.

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Caution: Some Over-the-Counter Medicines May Affect Your Driving

 

http://www.fda.gov/forconsumers/consumerupdates/ucm417426.htm

From the FDA Web site

Anyone who operates a vehicle of any type—car, bus, train, plane, or boat—needs to know there are over-the-counter medicines that can make you drowsy and can affect your ability to drive and operate machinery safely.

Over-the-counter medicines are also known as OTC or nonprescription medicines. All these terms mean the same thing: medicines that you can buy without a prescription from a healthcare professional. Each OTC medicine has a Drug Facts label to guide you in your choices and to help keep you safe. OTC medicines are serious medicines and their risks can increase if you don’t choose them carefully and use them exactly as directed on the label.

According to Ali Mohamadi, M.D., a medical officer at FDA, “You can feel the effects some OTC medicines can have on your driving for a short time after you take them, or their effects can last for several hours. In some cases, a medicine can cause significant ‘hangover-like’ effects and affect your driving even the next day.” If you have not had enough sleep, taking medicine with a side effect that causes drowsiness can add to the sleepiness and fatigue you may already feel. Being drowsy behind the wheel is dangerous; it can impair your driving skills.

Choosing and Using Safely

You should read all the sections of the Drug Facts label before you use an OTC medicine. But, when you know you have to drive, it’s particularly important to take these simple steps:

First, read the “active ingredients” section and compare it to all the other medicines you are using. Make sure you are not taking more than one medicine with the same active ingredient. Then make sure the “purpose” and “uses” sections of the label match or fit the condition you are trying to treat.

Next, carefully read the entire “Warnings” section. Check whether the medicine should not be used with any condition you have, or whether you should ask a health care professional whether you can use it. See if there’s a warning that says when you shouldn’t use the medicine at all, or when you should stop using it.

The “When using this product” section will tell you how the medicine might make you feel, and will include warnings about drowsiness or impaired driving.

Look for such statements as “you may get drowsy,” “marked drowsiness will occur,” “Be careful when driving a motor vehicle or operating machinery” or “Do not drive a motor vehicle or operate machinery when using this product.”

Other information you might see in the label is how the medicine reacts when taken with other products like alcohol, sedatives or tranquilizers, and other effects the OTC medicine could have on you. When you see any of these statements and you’re going to drive or operate machinery, you may want to consider choosing another medicine for your problem this time. Look for an OTC medicine that treats your condition or problem but has an active ingredient or combination of active ingredients that don’t cause drowsiness or affect your ability to drive or operate machinery.

Talk to your healthcare professional if you need help finding another medicine to treat your condition or problem. Then, check the section on “directions” and follow them carefully.

Here are some of the most common OTC medicines that can cause drowsiness or impaired driving:

• Antihistamines: These are medicines that are used to treat things like runny nose, sneezing, itching of the nose or throat, and itchy or watery eyes. Some antihistamines are marketed to relieve cough due to the common cold. Some are marketed to relieve occasional sleeplessness. Antihistamines also can be added to other active ingredients that relieve cough, reduce nasal congestion, or reduce pain and fever. Some antihistamines, such as diphenhydramine, the active ingredient in Benadryl, can make you feel drowsy, unfocused and slow to react.
• Antidiarrheals: Some antidiarrheals, medicines that treat or control symptoms of diarrhea, can cause drowsiness and affect your driving. One of these is loperamide, the active ingredient in Imodium.
• Anti-emetics: Anti-emetics, medicines that treat nausea, vomiting and dizziness associated with motion sickness, can cause drowsiness and impair driving as well.

“If you don’t read all your medicine labels and choose and use them carefully,” says Dr. Mohamadi, “you can risk your safety. If your driving is impaired, you could risk your safety, and the safety of your passengers and others.”

Please visit, Over-the-Counter Medicines and Driving, for the audio and slide presentation for more about driving and OTC medicines and with practice looking at Drug Facts labels.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

For More Information

• Driving When Using Medicine – Links to Additional Resources
• FDA Basics Webinar June 30, 2014: Over-The-Counter Medicines and Driving
• Driving When You Are Taking Medications
• Over-the-Counter Drug Facts Label – Video
• Medicines in My Home
• National Transportation Safety Board
• National Highway Traffic Safety Administration

Related Consumer Updates

• Allergy Meds Could Affect Your Driving
• Some Sleep Drugs Can Impair Driving
• Some Medications and Driving Don’t Mix[ARCHIVED]

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[Article] How Sweet It Is: All About Sugar Substitutes

How Sweet It Is: All About Sugar Substitutes.

 

From the 19 May 2014 FDA article

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Whether it’s to cut down on the number of calories they consume or any of a variety of other reasons, some people use sugar substitutes – also called high-intensity sweeteners – to sweeten and add flavor to their foods. They can be used alone to sweeten foods and beverages such as iced tea or coffee, or as an ingredient in other products. There are a number of sugar substitutes on the market from which to choose.

“Sugar substitutes are called ‘high-intensity’ because small amounts pack a large punch when it comes to sweetness,” says Captain Andrew Zajac, U.S. Public Health Service (USPHS), director of the Division of Petition Review at the Food and Drug Administration (FDA).

According to Zajac, unlike sweeteners such as sugar, honey, or molasses, high-intensity sweeteners add few or no calories to the foods they flavor. Also, high-intensity sweeteners generally do not raise blood sugar levels.

The FDA has approved a new high-intensity sweetener called advantame.

Advantame—which does not yet have a brand name (such as Sweet’N Low, a brand name for saccharin, or Equal, a brand name for aspartame)—has been approved as a new food additive for use as a sweetener and flavor enhancer in foods, except meat and poultry.

Examples of uses for which advantame has been approved include baked goods, non-alcoholic beverages (including soft drinks), chewing gum, confections and frostings, frozen desserts, gelatins and puddings, jams and jellies, processed fruits and fruit juices, toppings, and syrups.

How Do You Know It’s Safe?

FDA is required by law to review all new food additives for safety before they can go on the market. The process begins when a company submits a food additive petition to FDA seeking approval. One exception is for substances “generally recognized as safe,” or GRAS, because those substances are generally recognized by qualified experts as safe under the conditions of intended use and are exempt from the food additive approval process.

Zajac explains that the agency’s scientists thoroughly review all the scientific evidence submitted by a company to ensure the product is safe for the intended use.

“In determining the safety of advantame, FDA reviewed data from 37 animal and human studies designed to identify possible toxic (harmful) effects, including effects on the immune, reproductive and developmental, and nervous systems,” Zajac says.

Advantame is chemically related to aspartame, and certain individuals should avoid or restrict the use of aspartame. To that end, FDA evaluated whether the same individuals should avoid or restrict advantame, as well.

People who have phenylketonuria (PKU), a rare genetic disorder, have a difficult time metabolizing phenylalanine, a component of both aspartame and advantame. Newborns are tested for PKU using a common “heel-prick” test before they leave the hospital.

Foods containing aspartame must bear an information statement for people with PKU alerting them about the presence of phenylalanine. But advantame is much sweeter than aspartame, so only a very small amount needs to be used to reach the same level of sweetness. As a result, foods containing advantame do not need to bear that statement.

Five Already on the Market

The last high-intensity sweetener approved by FDA was Neotame (brand name Newtame) in 2002. The other four on the market, and are:

• Saccharin, was first discovered and used in 1879, before the current food additive approval process came into effect in 1958. Brand names include Sweet‘N Low
• Aspartame, first approved for use in 1981. Brand names include Equal
• Acesulfame potassium (Ace-K), first approved for use in 1988. Brand names include Sweet One
• Sucralose, first approved for use in 1998. Brand name is Splenda

In addition to the six high-intensity sweeteners that are FDA-approved as food additives, the agency has received and has not questioned GRAS notices for two types of plant/fruit based high-intensity sweeteners: certain steviol glycosides obtained from the leaves of the stevia plant (Stevia rebaudiana (Bertoni) Bertoni) and extracts obtained from Siraitia grosvenorii Swingle fruit, also known as Luo Han Guo or monk fruit.

While these high-intensity sweeteners are considered safe for their intended uses, certain individuals may have a particular sensitivity or adverse reaction to any food substance. Consumers should share with their health care provider any concerns they have about a negative food reaction.

In addition, FDA encourages consumers to report any adverse events through MedWatch: FDA’s safety information and adverse event reporting program.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

[Reblog] JAMA papers raise questions about FDA drug and device approval

JAMA papers raise questions about FDA drug and device approval.

JAN24 2014

Posted by Gary Schwitzer in FDA

An important series of papers was published in the Journal of the American Medical Association this week.

“Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012,” by Dr. Joseph Ross and colleagues, concluded that the quality of clinical trial evidence used by the FDA as the basis of approving new drugs varies widely.  A couple of interesting data points:

• in the seven-year period of analysis, 37% of drugs were approved on the basis of a single pivotal trial.
• trials using surrogate end points as their primary outcome formed the exclusive basis of approval for 45% of drugs approved. (See our primer, “Surrogate markers may not tell the whole story.”)

In an opinion piece,  “Opening the FDA Black Box,” Drs. Steven Goodman and Rita Redberg said the study:

“…raises a host of questions needing further exploration. Despite the FDA requirement for evidence from a minimum of 2 randomized clinical trials supporting an effect on health outcomes, 37% of product approvals were based on only 1 trial, 53% of cancer trials were nonrandomized, and an active comparator was used in only 27% of non–infectious disease trials. Surrogate end points were used in almost all approvals via the accelerated approval process and in 44% of nonaccelerated approvals. Trials were comparatively short, with most lasting less than 6 months, even those assessing chronic treatments for chronic diseases. Cancer drugs, perhaps predictably, were more often approved via the accelerated process and with weaker designs.”

Another paper looked at the reasons that FDA marketing approval for new drugs was delayed or denied.

And a fourth paper looked at FDA regulation of medical devices, “a process that has received relatively little attention,” according to Goodman and Redberg, who continued:

In USA Today, Liz Szabo wrote a good summary of the JAMA papers under the headline, “Not all FDA-approved drugs get same level of testing: Evidence behind FDA-approved drugs and devices often has major limitations.”

Read the entire article here

Related Resources

• ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human             participants conducted around the world.
When available, study results information is included in the study record under the Study Results tab. See How to Find Results of Studies for more information on finding results entered in the results database.

Results (after 2008, only those required by US federal requirements) include
–Participant data (how many started the trial, dropped out, etc)
—  Information about participants (age, gender, blood pressure readings, etc)

[Speaking of gender…]

Good to know, most drugs can affect women and men differently

    —   Outcome (results of taking the drug plus any placebo), with statistics

    –Adverse effects , serious and other (this was not required before 2008)

• Evaluating Health Information (from my personal Google site)

  • Research Articles Summarized for Us All

  • How to Read a Research Paper

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Another take on the “relaxation of standards”

• Drug Approvals Take Customized Approach Based on Disease
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[Pew Report] Fixing the Oversight of Chemicals Added to Our Food

From the 7 November 2013 report summary

Overview

From 2010 to 2013, The Pew Charitable Trusts conducted a comprehensive assessment of the federal food additives regulatory program. Relying on a transparent process that engaged stakeholders, Pew examined food additive issues in partnership with the food industry, the public interest community, and the federal government, including the U.S. Food and Drug Administration, or FDA. We held five expert workshops and published six reports in peer-reviewed journals. This report summarizes our findings and provides recommendations to address the problems that we identified.

With more than 10,000 additives allowed in food, Pew’s research found that the FDA regulatory system is plagued with systemic problems, which prevent the agency from ensuring that their use is safe. The cause of this breakdown in our food safety regulatory process is an outdated law with two significant problems:

First, the law contains an exemption intended for common food ingredients; manufacturers have used this exception to go to market without agency review on the grounds that the additive used is “generally recognized as safe,” or GRAS, in regulatory parlance. FDA has interpreted the law as imposing no obligation on firms to tell the agency of any GRAS decisions. As a result, companies have determined that an estimated 1,000 chemicals are generally recognized as safe and have used them without notifying the agency. The firms usually use their own employees, consultants, or experts whom they select and pay to make the safety decision with no disclosure or apparent efforts to minimize the inherent conflicts of interest.

Second, the law does not give FDA the authority it needs to efficiently obtain the information necessary to identify chemicals of concern that are already on the market; set priorities to reassess these chemicals; and then complete a review of their safety. Moreover, the agency has not been given the resources it needs to effectively implement the original 1958 law. As a result, FDA has not reevaluated the safety of many chemicals originally approved decades ago, generally rechecking safety only when requested by a company to do so, or when presented with allegations of serious adverse health effects.

---

What FDA says today about the safety of additives

“It’s perhaps a time to look at what the legal framework looks like and what opportunities there are now to ask and answer questions in new ways because of advances in science and technology.”

— FDA Commissioner Margaret Hamburg, (Reuters, May 2013)

“We’re not driven by a sense that there is a pressing public health emergency. But there are decisions being made based on data that we don’t have access to, and that creates a question about the basis on which those decisions are made.”

— FDA Deputy Commissioner for Foods Michael Taylor, (Associated Press, March 2013)

“FDA plans to issue guidance to industry on meeting the GRAS criteria established under the Act.”

— FDA spokeswoman Theresa Eisenman, (USA Today, August 2013)

---

To remedy these problems, Pew’s report recommends that Congress update the Food Additives Amendment of 1958 to ensure that FDA:

• Approves the first use of all new chemicals added to food.
• Reviews new uses or changes to existing uses of previously approved additives.
• Streamlines its decision-making process so it is timely and efficient.
• Upgrades its science to determine safety.
• Uses the scientific tools and data it needs to set priorities to reassess the safety of chemicals already allowed in food and to take action where necessary.

– See more at: http://www.pewhealth.org/reports-analysis/reports/fixing-the-oversight-of-chemicals-added-to-our-food-85899518122#sthash.cQHyqL0p.dpuf

Related articles

• FDA’s trans fat decision: An opening for regulating salt, sugar? – Los Angeles Times (latimes.com)
• Not all chemicals in your food are labeled – or tested (examiner.com)

 

[Magazine Article] The Trans-Fat Ban as a Model of Slow Health Policy

Poster from New York City’s board of health encouraging consumers to limit trans fat consumption (Photo credit: Wikipedia)

 

From the 8th November 2013 article in The Atlantic

 

..Taking trans fats off the GRAS list won’t remove them from the food supply. Manufacturers can still petition the FDA for exceptions. But it goes a long way toward getting them out.

…

what the announcement really shows is how public health works: slowly, based on mounting scientific evidence, against constant and mounting headwinds of public ridicule and, much more important, industry lobbying and advertising.

..Companies seldom change unless they have to, which they say means unless consumers ask them to. If you don’t want trans fats or gluten or genetically modified organisms, fine with us! Just tell us with your food dollars! This is of course a way of saying that they don’t want government telling them what to do, and gives them a chance to shape the public opinion they say they simply obey, with millions of dollars in ad campaigns and lobbying.

..

The lesson, though, is not that the public shouldn’t trust science, because one year’s saturated-fats-are-evil message will eventually become next year’s hey-butter-is-great-when-you-look-at-Crisco. The road to strong public recommendations isn’t clear, as scientific research is slow and zigzags. Both food makers and scientists can be guilty of jumping the gun, depending on what they think they can sell or who they can get to fund big studies and endowed chairs.

..

The analogy I’m building toward is, of course, sugar-sweetened drinks. Scientific consensus has built to practically the bursting point that sodas make kids fat. Soda makers deride the officials who try to do something about it, and work as hard as they can to cast doubt on science. Mayor Bloomberg, though fairly trim, was their fattest target, in the Mrs. Doubtfire costume they dressed him up in when he tried to impost a portion limit on sodas in restaurants and movie theaters. Now that he’s leaving, they’ll find another target.

But opinion will change, national bodies start to fall into line as they did on trans fats and are doing with sugary drinks. The most outspoken enemies of sugar, like Robert Lustig, are trying to take it off the GRAS list–something that CSPI petitioned the FDA to do last February, asking it to study and determine safe levels of high-fructose corn syrup. The chance of an FDA announcement of that in six years seems pretty unlikely now. But soda makers already have more than dozens of low-sugar and sugar-free drinks: they have scores and scores of them. They’ve quietly been working to solve the problem, while spending (often literally) untold sums not to risk their core products. The advocates against trans fats who seemed so crazy even six years ago, when the New York trans fat ban went into effect, are seeming a lot less crazy today.

…

 

Read the entire article here

 

 

 

 

 

Related articles

• NYC’s Bloomberg led the way on trans fats ban (miamiherald.com)
• Trans fat doesn’t stir much ‘nanny state’ debate (fngnutrition.ca)
• FDA’s Proposed Trans Fat Ban: An Attack on Freedom (heritage.org)
• No more trans fat: FDA banning the artery-clogger (webpronews.com)
• No more trans fat: FDA banning the artery-clogger (conservativeread.com)
• FDA to ban trans fats (cbs6albany.com)
• Trans Fat Ban?; Bullying and Bonding; Ask an Astronaut (wnyc.org)
• FDA To Ban Trans Fats (nycfitfoodfashion.com)

 

[FDA Consumer Update] Pain Medicines for Pets: Know the Risks

From the 5 November 2013 FDA Consumer Update

Pain Medicines for Pets: Know the Risks

 

Your 9-year-old German Shepherd is limping, and you think that arthritis may be setting in. A trip to the veterinarian proves that you’re right—it’s osteoarthritis, a degeneration of the cartilage and bone that affects joints. The veterinarian prescribes a non-steroidal anti-inflammatory drug (NSAID).

NSAIDs are a class of drugs extensively used in both human and veterinary medicine for their anti-fever, anti-inflammatory and pain-relieving properties, and they are the most commonly prescribed pain relievers for animals. Inflammation—the body’s response to irritation or injury—is characterized by redness, warmth, swelling, and pain. NSAIDs work by blocking the production of chemicals produced by the body that play a role in inflammation.

“Scientists consider NSAIDs the cornerstone of osteoarthritis therapy in dogs,” says Melanie McLean, D.V.M., a veterinarian at the Food and Drug Administration (FDA). Some NSAIDS are also used to manage pain after surgery in both dogs and cats. No NSAID has been approved for long-term use in cats.

NSAIDs carry risks as well as benefits, however, and all dogs and cats should undergo a thorough physical examination by a veterinarian—including a discussion of the pet’s medical history— before beginning NSAID therapy. McLean notes that it’s also important that you talk to your veterinarian about possible side effects, including those that could signal danger.

Risks and Side Effects

NSAIDS are associated with gastrointestinal ulcers/perforations, kidney, and liver toxicity (damage done by exposure to medications or chemicals) and must be used cautiously in animals with pre-existing kidney or liver problems.

Because most liver-associated toxicities occur during the first three weeks, it’s especially important to closely monitor the results of blood tests during the early stages of long-term NSAID treatment in dogs. Also, before starting long-term treatment with NSAIDs in dogs, blood tests should be conducted to establish baseline data and then repeated on a regular basis. McLean recommends that you talk with your veterinarian about how often this blood work should be done.

Some of the most common side effects of NSAIDS in animals reported to FDA are:

• vomiting
• decreased to no appetite
• decreased activity level
• diarrhea

While your animal is taking NSAIDs, continuously monitor the pet for these side effects as well as looking for blood in the feces, tar-like stools, yellowing of the whites of the eyes, or yellowing of the gums. If you see these, call your veterinarian immediately, McLean says. Other reported side effects include stomach and intestinal ulcers, intestinal perforation (a hole in the wall of the intestine), kidney failure, liver failure and death.

Giving two NSAIDs at the same time, or giving an NSAID with a steroid, such as prednisone, can significantly increase the risk and severity of side effects, especially gastrointestinal toxicity.

Risks associated with NSAIDs are detailed on the package inserts and the client information sheets that accompany all FDA-approved veterinary oral NSAIDs.

Are OTC Meds for People Safe for Pets?

McLean says that it’s not unusual for pet owners to want to give their animals NSAIDs or acetaminophen (Tylenol and other brands, which are not NSAIDs) straight from their own medicine cabinets. “Many people don’t realize that a medicine that’s safe for people may not be safe for dogs or cats, or that a dose that is safe for people may not be safe for their pets,” she notes.

In fact, some over-the-counter (OTC) human pain relievers can be toxic, or even deadly, in pets. McLean suggests that you check with your veterinarian first if you want to give your animal OTC human drugs.

“You should always check with your veterinarian first before giving your animal any kind of medication, prescription or over-the-counter,” she notes. Similarly, pet owners should not assume that a medicine that is safe for one animal is necessarily safe for another.

Communication with your veterinarian is essential. Before giving your animal an NSAID:

• Make sure you know what the medication is being prescribed for, how much to give and how long to give it.
• Discuss possible side effects and symptoms, especially those that require an immediate call to the vet.
• Tell your veterinarian if the pet has a history of gastrointestinal problems, such as stomach ulcers, or surgery on the stomach or intestines.
• Tell your veterinarian if your pet is on any other medications or supplements.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Nov. 5, 2013

For More Information

• Treating Pain in Your Dog
• Medications for Your Pet … Questions for Your Vet
• FDA Basics Webinar on Advice to Dog Owners Whose Pets Take NSAIDS

Related Consumer Updates

• Medication Errors Happen to Pets, Too
• Medications for Your Pet: 10 Questions to Ask Your Vet [ARCHIVED]
• Purchasing Pet Drugs Online: Buyer Beware

Related articles

• [FDA Press Release] Why Are Jerky Treats Making Pets Sick? – FDA asking consumers to report illnesses (jflahiff.wordpress.com)

 

[FDA program aimed at health care providers] Truthful Prescription Drug Advertising and Promotion

This page is geared towards health care providers, but it may be of interest to others.

From the US FDA (Food and Drug Administration) Web page 

FDA’s Bad Ad program is an outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.

The Bad Ad Program is administered by the agency’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research. The program’s goal is to help raise awareness among healthcare providers about misleading prescription drug promotion and provide them with an easy way to report this activity to the agency: e-mail BadAd@fda.gov or call 855-RX-BADAD.

Continuing Medical Education Video itself is free for anyone to view (http://www.sigmatech.com/BadAd/courses/index.htm)It covers what is legal/illegal for pharmaceutical companies and their representatives when advertising their products at different venues

Prescription drug advertising must:

• Be accurate
• Balance the risk and benefit information
• Be consistent with the prescribing information approved by FDA
• Only include information that is supported by strong evidence

What types of promotion does OPDP regulate?

• TV and radio advertisements
• All written or printed prescription drug promotional materials
• Speaker program presentations
• Sales representative presentations

OPDP does not regulate promotion of:

• Over-the-Counter Drugs
• Dietary Supplements
• Medical Devices

Common Violations:

• Omitting or downplaying of risk
• Overstating the effectiveness
• Promoting Uses Not Addressed in Approved Labeling

• Misleading drug comparisons

 Examples of Violations

Example of Omission of Risk

You attend a speaker program which features a slide show that presents efficacy information about Drug X, but no risk information.

This presentation would be misleading because it fails to include a fair balance of benefit and risk information for Drug X.

Example of Uses Not Addressed in Approved Labeling
You are in a commercial exhibit hall and a company representative tells you that a drug is effective for a use that is not in the FDA-approved product labeling.

This presentation would be illegal because it promotes an unapproved use.

Example of Overstating the Effectiveness

“Doctor Smith, Drug X delivers rapid results in as little as 3 days.”

This presentation is misleading because the majority of patients studied in the clinical trials for Drug X showed results at 12 weeks, with only very few showing results in 3 days.

Frequently Asked Questions

1. Can I report anonymously?

Yes, anonymous complaints often alert FDA to potential problems.  However, complaints accompanied by names and contact information are helpful in cases for which FDA needs to follow-up for more information.

2. Will OPDP be able to stop the misleading promotion?

In many cases, yes, especially if the appropriate evidence is provided.  Evidence can include the actual promotional materials or documentation of oral statements made by company representatives.

3. What will happen to my complaint once I have contacted OPDP?

The information you provide will be sent to the Regulatory Review Officer in OPDP responsible for this class of drugs.  The reviewer will evaluate it and determine if it may serve as the basis for a potential enforcement action or as valuable information for our ongoing surveillance activities.

4. How do I learn more?

To learn more about OPDP in-service training for large medical group/hospitals call 301-796-1200.

Related articles

• FDA providing education on bad drug ads (medicationhealthnews.wordpress.com)
• FDA “Bad Ads” – Now for CME Credit… (cooleyhealthbeat.com)

[Press release] FDA issues proposed rule to help ensure the safety of food for animals

From the FDA press release

FDA issues proposed rule to help ensure the safety of food for animals

The U.S. Food and Drug Administration today issued a proposed rule under the FDA Food Safety Modernization Act (FSMA) aimed at improving the safety of food for animals. This proposed regulation would help prevent foodborne illness in both animals and people and is open for public comments for 120 days. The proposal is part of the Food Safety Modernization Act’s larger effort to modernize the food safety system for the 21st century and focus public and private efforts on preventing food safety problems, rather than relying primarily on responding to problems after the fact.

The proposed rule would require makers of animal feed and pet food to be sold in the U.S.to develop a formal plan and put into place procedures to prevent foodborne illness. The rule would also require them to have plans for correcting any problems that arise.  The proposed rule would also require animal food facilities to, for the first time, follow proposed current good manufacturing practices that address areas such as sanitation.

“The FDA continues to take steps to meet the challenge of ensuring a safe food supply,” said FDA Commissioner Margaret A. Hamburg, M.D. “Today’s announcement addresses a critical part of the food system, and we will continue to work with our national and international industry, consumer and government partners as we work to prevent foodborne illness.”

The proposed rule would help ensure the safety of food for animals and prevent the transmission of agents in food for animals that could cause foodborne illness in both animals and people. People can get sick by handling contaminated food, such as pet food.

“This proposed rule on animal food complements proposed rules published in January 2013 for produce safety and facilities that manufacture food for humans to set modern, prevention-based standards for food safety,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor. “They also work in concert with standards proposed in July 2013 to help ensure that imported foods are as safe as those produced domestically.”

The FDA will hold three public meetings on the Proposed Rule for Preventive Controls for Animal Food Facilities. The first meeting will be held on November 21, 2013 at the FDA Center for Food Safety and Applied Nutrition in College Park, MD. The second meeting will be on November 25, 2013 at the Ralph H. Metcalfe Federal Building in Chicago. The third meeting will be held on December 6, 2013 at the John E. Moss Federal Building in Sacramento, CA. For more information, visit http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247568.htm.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

And from http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm371395.htm

….The proposed rule has been published in the Federal Register, with a 120-day public-comment period. The rule is filed in FDA’s official docket at www.regulations.gov and can also be accessed at www.fda.gov/fsma

 

And from http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm371395.htm

For the first time, the Food and Drug Administration (FDA) is proposing preventive measures to protect all animal foods from disease-causing bacteria, chemicals and other contaminants.

This includes the food that pet owners give their dogs, cats and other companion animals, and the feed that farmers give their livestock.

Preventive Controls for Food for Animals is the fifth rule that FDA has proposed this year as part of the food-safety framework envisioned by the 2011 FDA Food Safety Modernization Act that focuses on preventing foodborne illnesses.

Daniel McChesney, Ph.D., director of the Office of Surveillance and Compliance at FDA’s Center for Veterinary Medicine (CVM), explains that this rule proposes establishing a whole new set of protections for animal foods. Currently, the agency primarily gets involved when there is evidence of contaminated animal food on the market.

“Unlike safeguards already in place to protect human foods, there are currently no regulations governing the safe production of most animal foods. There is no type of hazard analysis. This rule would change all that,” says McChesney.

McChesney notes that human and animal health are intertwined. People can get sick when pet food is contaminated by disease-causing bacteria like Salmonella. When such food is handled by pet owners and placed on kitchen surfaces, the bacteria can spread to foods consumed by their family.

And if an animal has eaten feed contaminated with a chemical like dioxin and then enters the food supply, consumers could likewise absorb the chemical, putting their health at risk.

By helping to prevent the contamination of animal foods, the proposed rule protects pets and people alike, he says.

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Requiring a Safety Plan

This proposed rule would create regulations that address the manufacturing, processing, packing and holding of animal food. Good manufacturing practices would be established for buildings, facilities and personnel, and would include cleaning and maintenance, pest control, and the personal hygiene of people who work there.

It would also require facilities to have a food safety plan, perform an analysis of potential hazards, and implement controls to minimize those risks. Those controls would have to be monitored and corrected as needed.

While this rule is similar in many ways to the Preventive Controls for Human Food rule that FDA proposed in January 2013, McChesney explains that it is different in a number of ways because animals face different hazards.

For example, he says, the proposed animal rule doesn’t address allergens—substances that could cause an allergic reaction. That’s because animals don’t get the kind of life-threatening allergic reactions that people do. They might get a skin reaction but not the kind of physical shock that a food allergen could trigger in a person.

On the other hand, contaminants that endanger animals are sometimes tolerated better by people and were not as great a concern in crafting protections for human food. For example, some animals are much more vulnerable to aflatoxin, a toxin caused by mold, and could die after consuming food containing the toxin.

The animal rule is also designed to prevent nutrient imbalances in animal foods. Unlike people, who get their foods from many sources, an animal’s food is meant to be a complete and balanced diet, explains McChesney. If a food doesn’t have enough of a particular nutrient, the animal has no way to make it up. For example, cats need thiamine (also known as Vitamin B1) but their bodies don’t produce it. If they don’t get enough in their food, they can suffer severe neurological problems.

The proposed rule has been published in the Federal Register, with a 120-day public-comment period. The rule is filed in FDA’s official docket at www.regulations.gov and can also be accessed at www.fda.gov/fsma.

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Import Rules Add Safeguards

The proposed animal rule would work in concert with two rules proposed in July 2013 to help ensure that foods exported to the United States are held to the same FDA food safety standards applied to foods produced in the United States. Together, the three rules would help ensure the same level of safety for domestic and imported foods for animals.

In one of the most infamous examples of pet food contamination, dogs and cats across the country were sickened and killed in 2007 when melamine, a chemical used to make plastic, was added to pet food ingredients imported from China. McChesney noted that FDA received about 18,000 calls from anxious pet owners at the time.

The requirements proposed in both the animal and import rules are designed to help prevent that from happening again, he says.

Overall, McChesney says that the animal food supply is very safe. However, with the marketplace becoming more global and more diverse, more protections are needed. When you buy food for your animals, those ingredients could come from anywhere in the world, so animal food producers and their suppliers, no matter where they are based, have to be held to the same high standards, he says.

“Whether in the home or on the farm, people take the safety of their animals very seriously, and so do we,” says McChesney.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Oct. 25, 2013

Related articles

• FDA Looks to Finally Regulate Pet Food (onegreenplanet.org)
• FDA proposes strict new safety rules for animal food (nbcnews.com)
• FDA proposes rule to control animal food manufacture (examiner.com)
• FDA wants to make pet food safer (cnn.com)
• FDA Proposes Stringent Guidelines on Animal Food After Wave of Deaths (guardianlv.com)
• Pet Foods Face First-Ever FDA Rule 6 Years After Dog Treat Scare – Bloomberg (bloomberg.com)
• FDA Proposes Pet Food Safety Rules After Jerky Treats Sicken 3,600 Dogs And Cats (medicaldaily.com)
• FDA Proposes New Pet Food Regulations (webpronews.com)

[FDA Press Release] Why Are Jerky Treats Making Pets Sick? – FDA asking consumers to report illnesses

From the 22 October 2013 FDA press release

If you have a dog or cat that became ill after eating jerky pet treats, the Food and Drug Administration (FDA) would like to hear from you or your veterinarian.

The agency has repeatedly issued alerts to consumers about reports it has received concerning jerky pet treat-related illnesses involving 3,600 dogs and 10 cats in the U.S. since 2007. Approximately 580 of those pets have died.

To date, FDA’s Center for Veterinary Medicine (CVM) has conducted more than 1,200 tests, visited jerky pet treat manufacturers in China and collaborated with colleagues in academia, industry, state labs and foreign governments. Yet the exact cause of the illnesses remains elusive.

To gather even more information, FDA is reaching out to licensed veterinarians and pet owners across the country. “This is one of the most elusive and mysterious outbreaks we’ve encountered,” says CVM Director Bernadette Dunham, DVM, Ph.D. “Our beloved four-legged companions deserve our best effort, and we are giving it.”

In a letter addressing U.S. licensed veterinarians, FDA lists what information is needed for labs testing treats and investigating illness and death associated with the treats. In some cases, veterinarians will be asked to provide blood, urine and tissue samples from their patients for further analysis. FDA will request written permission from pet owners and will cover the costs, including shipping, of any tests it requests.

Meanwhile, a consumer fact sheet will accompany the letter to veterinarians so they can alert consumers to the problem and remind them that treats are not essential to a balanced diet. The fact sheet also explains to consumers how they can help FDA’s investigation by reporting potential jerky pet treat-related illnesses online or by calling the FDA Consumer Complaint Coordinator for their state.

 

What to Look Out For

Within hours of eating treats sold as jerky tenders or strips made of chicken, duck, sweet potatoes and/or dried fruit, some pets have exhibited decreased appetite, decreased activity, vomiting, diarrhea (sometimes with blood or mucus), increased water consumption, and/or increased urination.

Severe cases have involved kidney failure, gastrointestinal bleeding, and a rare kidney disorder. About 60 percent of cases involved gastrointestinal illness, and about 30 percent involved kidney and urinary systems.

The remaining cases reported various symptoms, such as collapse, convulsions or skin issues.

Most of the jerky treats implicated have been made in China. Manufacturers of pet foods are not required by U.S. law to state the country of origin for each ingredient in their products.

A number of jerky pet treat products were removed from the market in January 2013 after a New York State lab reported finding evidence of up to six drugs in certain jerky pet treats made in China. While the levels of these drugs were very low and it’s unlikely that they caused the illnesses, FDA noted a decrease in reports of jerky-suspected illnesses after the products were removed from the market. FDA believes that the number of reports may have declined simply because fewer jerky treats were available.

Meanwhile, the agency urges pet owners to be cautious about providing jerky treats. If you do provide them and your pet becomes sick, stop the treats immediately, consider seeing your veterinarian, and save any remaining treats and the packaging for possible testing.

 

What FDA Is Doing

More than 1,200 jerky pet treat samples have been tested since 2011 for a variety of chemical and microbiological contaminants, from antibiotics to metals, pesticides and Salmonella. DNA testing has also been conducted, along with tests for nutritional composition.

In addition to continuing to test jerky pet treat samples within FDA labs, the agency is working with the Veterinary Laboratory Investigation and Response Network (Vet-LIRN), an FDA-coordinated network of government and veterinary diagnostic laboratories across the U.S. and Canada. (A summary of the tests is available on Vet-LIRN’s webpage.)

Inspections of the facilities in China that manufacture jerky products associated with some of the highest numbers of pet illness reports did not identify the cause of illness. However, they did identify additional paths of investigation, such as the supply chain of some ingredients in the treats. Although FDA inspectors have found no evidence identifying the cause of the spate of illnesses, they did find that one firm used falsified receiving documents for glycerin, a jerky ingredient. Chinese authorities informed FDA that they had seized products at the firm and suspended its exports.

To identify the root cause of this problem, FDA is meeting regularly with regulators in China to share findings. The agency also plans to host Chinese scientists at its veterinary research facility to increase scientific cooperation.

FDA has also reached out to U.S. pet food firms seeking further collaboration on scientific issues and data sharing, and has contracted with diagnostic labs.

“Our fervent hope as animal lovers,” says Dunham, “is that we will soon find the cause of—and put a stop to—these illnesses.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Oct. 22, 2013

 

For More Information

• Animal & Veterinary
• Veterinary Laboratory Investigation and Response Network
• Pet Food
• Jerky Pet Treats
• FDA Facts: Jerky Pet Treats (PDF – 216KB)
• FDA Voice Blog: Help Us Find Out Why Jerky Treats Are Making Pets Sick

Related Consumer Updates

• Caution to Dog Owners About Chicken Jerky Products
• Dog Treats May Present Health Hazard [ARCHIVED]
• No Bones About It: Bones Are Unsafe for Your Dog

Related articles

• Hundreds Of Dogs Dead From Eating Jerky Treats; FDA Isn’t Exactly Sure Why (huffingtonpost.com)
• Help Us Find Out Why Jerky Treats Are Making Pets Sick (scienceblog.com)
• Jerky treat mystery: Nearly 600 pets dead; still no source, FDA says (nbcnews.com)

 

[Reblog] Quality and Safety Concerns for Medical Apps

From the 18 September 2013 post by Michelle Kraft at the Krafty Librarian 

I just read a brief perspective article in the journal Evidence Based Medicine, “Medical apps for smartphones: lack evidence undermines quality and safety.”  It is a quick little read and it brings up some very real and interesting points which I will try to summarize.

1. There is no official vetting system for medical apps – Some apps are blatantly wrong and dangerous, some are out of date therefore also dangerous.
2. Lack of information and clinical involvement in the creation of the apps – There is a paucity of information regarding the creator of the app. Some apps have no physician involvement.
3. Companies (authors specifically mention Pharma) creating apps could create conflicts of interest and ethical issues – Pharma apps could produce drug guides or clinical decision tools that subtlety push their own products.

The FDA will regulate some apps but not all.  The FDA will regulate apps that control a medical device or displays, stores, analyzes patient data (example: electrocardiogram).  They will also regulate apps that use formulas or algorithms to give patient specific results such as diagnosis, treatment, recommendation or differential diagnosis.  Finally they will regulate apps that transform a mobile device into a medical device (example: apps that use attachments or sensors to allow the smartphone to measure blood glucose).

That still leaves a ton of medical apps hanging out there in the app stores which are largely unregulated.  The article states, “Until now, there has been no reported harm to a patient caused by a recalled app. However, without app safety standards, it is only a matter of time before medical errors will be made and unintended harm to patient will occur.”  Basically it is the Wild West in the medical app arena.

There are two groups that are trying to evaluate medical apps.  iMedicalApps.com and the Medical App Journal review various apps directed toward medical professionals.  I take issue with the article authors who state these sites are a “good starting point for peer-reviewing apps, the current assessment criteria do not address the scientific evidence for their content, but rather matters of usability, design, and content control.”  While I don’t use the Medical App Journal as often,  I use iMedicalApps.com quite often and they do more than just assess the usability and design. I have read reviews where they question the medical correctness of apps, intended audience, and have even pushed for more information regarding authorship/responsibility.  Several of their reviews questioned an app’s update schedule and updated content.  They have also investigated, questioned, and reported instances of fraud and plagiarism with medical apps.  I think iMedicalApps does a very good job in a very flooded market, but there are areas for improvement.  As with any website that relies on a large number of reporters/reviewers, there is some variance in the quality based on the reviewer.  I haven’t found any reviews that are bad, just some are better and more thorough than others.  Perhaps a little more explanation or transparency regarding how they determine the accuracy or validity of medical app might be helpful, or a standardized checklist about the things they look at.  I realize evaluating the latest UpToDate app is different compared to an app on EKGs.  UpToDate already has an established proven product where as there is more to investigate and validate with an app that isn’t a version of an already established product.

The authors believe the medical community needs to be more involved with regulating medical apps.  They suggest:

1. Official certification marks guaranteeing quality
2. Peer review system implemented by physicians’ associations or patient organizations
3. Making high quality apps more findable by adding them to hospital or library collections

1.  I like the idea of having an official certification indicating quality, but there are two things that must be addressed prior to that.

First you have to get the organizations to actually take responsibility for looking at apps that are in their area of expertise. The field is already cumbersome, I am not sure many organizations are able to handle that. Although I have found that several journals have now included app reviews.  While they can’t come close to scratching the surface of medical apps, these journals often have MDs, RNs, MPTs writing reviews and evaluating the content.  Specifically I have found some good reviews in the physical therapy and nursing journals.

Second, there is growing problem with fake certifications. If an app is created by a company or people who already don’t care about its accuracy or is a plagiarizing a product, they probably have no qualms about lifting the image of the certification and posting it on their website.  They could create their own certifications to fake (but legit sounding) orgs and post those on their app’s site too.  Official certification is a good idea and I like it but there needs to be more to it to make sure it truly represents quality.

2. I personally believe the writers at iMedicalApps.com are on their way to something of a peer review system.  Right now they only have one person review an app.  While that completely makes sense from a writing perspective, perhaps they can implement some sort of peer review process where more than just one person is reviewing the app, yet still retain the one voice post for ease of reading.  Perhaps they could  reach out to a few medical professionals who are leaders in their field to review specific apps.  Thus giving the reviewed app a little bit more weight.  This along with astandardized check list or illustrating how they review the medical accuracy of an app would make the information on their site even more important and provide an excellent way of separating the wheat from the chaff.

3. An online repository of approved apps would be great.  Some hospital IT departments that have mobile device policies have this, but they seem to be only hospital type apps like Citrix or database subscription apps like LexiComp, PubMed, UpToDate, etc.  While these apps are important, there is little worry about apps like LexiComp, UpToDate, or PubMed because they were well established medical information products before their app.  Their app is just an extension of their verified product.  I don’t see a lot of  IT departments that have investigated having a pool of apps that aren’t hospital specific or from database subscriptions.  Additionally, IT would either need to rely on an outside sources like iMedicalApps or content experts within the field in that hospital to build the app pool.  IT would have no way of verifying the authenticity and validity of an app on pediatric emergency medicine.

Finally, getting hospitals to buy bulk licenses to apps is tricky at best.  With exception of a few places like Epocrates, Unbound Medicine, Inkling, and Skyscape (many of those companies dealt with institutional subscriptions before app stores….remember PDAs?) there are very few places that sell or license apps to a group of people.  The purchasing of apps was created as an individual service.  Now academic medical centers may have a foot in the door with iTunes U, but I have heard that discussions with Apple and their app store and hospitals is an “interesting” process.  The same principle applies to library repositories.  Instead of IT aggregating the apps, the library would do that.  There are a lot of library’s that already have great lists suggesting various medical apps.   But the vast majority of medical libraries have app resources guides, suggesting apps that the individual must buy.  Also just like with an IT repository of apps, the librarian must rely on sites like iMedicalApps.com or their own physician suggestions to ensure they are listing quality apps.

Like I said it is the Wild West when it comes to medical apps.  That is because the whole app industry is a new frontier.  There are quality and accuracy problems with other apps in the app stores. A pedometer app with errors is not going to kill somebody, but an inaccurate medical app can.  Yes, the medical community needs to get involved in evaluating apps, but so does Apple and Google.   Right now Apple’s iTunes store feedback and ranking system while good for games, is not adequate for medical apps and can easily be subject to fraud.  Additionally, Apple is extremely tight lipped about its app store rules and regulations.  Some apps have extreme difficulty getting approved, while others fly through approval process only to be mysteriously removed later.  There is no transparency to the Apple App Store.  For example, there is no information about the app Critical APPraisal which was determined to be a plagiarized version of Doctor’s Guide to Critical Appraisal.  The app was available in the App Store July 2011.  However, if you searched today for the app, you wouldn’t be able to find it in the App Store, it simply disappeared.  Unless you happen to read the article in BMJ, iMedicalApps.com, or a few other British publications, you would have no clue as to why the app was removed.  When it comes to dangerous apps, disappearing them from the App Store is not good enough. You must have transparency when it comes to medicine.

**Update**

According to an updated BMJ article, the doctors accused of plagiarizing The Doctor’s Guide to Critical Appraisal to use in their app Critical APPraisal, have been cleared of plagiarism by the Medical Practitioners Tribunal Service.

“A regulatory panel rejected charges by the General Medical Council (GMC) that Afroze Khan, Shahnawaz Khan, and Zishan Sheikh acted dishonestly in knowingly copying structure, contents, and material from a book, The Doctor’s Guide to Critical Appraisal, when developing their Critical APPraisal app, representing it as their own work, and seeking to make a gain from the material.”

Shahnawaz Khan and Afroze Khan were also accused of dishonestly posting positive reviews of the app on the Apple iTunes Store without disclosing that they were co-developers and had a financial interest in the app.  The GMC found that Shahnawaz Khan  no evidence that he knew that the app, which was initiallly free, would later sold for a fee. His case was concluded without any findings.  However, the GMC panel found that “Afroze Khan’s conduct in posting the review was misleading and dishonest.” Yet they considered this type of dishonesty to be “below the level that would constitute impairment of this fitness to practise.”  The GMC panel said it was an isolated incident and did not believe it would be repeated in which they “considered his good character and testimonials attesting to his general probity and honesty and decided not to issue a formal warning.”

Related Resources

Health Apps (Free and Low Cost)

Free and low cost Health Apps in this section include:   Health and Wellness Information Apps for locating information for personal health and wellness Health and Fitness Tracking Apps to help you enter and store your personal health and fitness information quickly   And these may be helpful when selecting health apps   How to Choose A Better Health App (by LEXANDER V. PROKHOROV, MD, PHD  at KevinMD.com on August 8, 2011) contains advice in the following areas Set realistic expectations Avoid apps that promise too much Research the developers Choose apps that use techniques you’ve heard of See what other users say Test apps before committing  iMedical apps has mobile medical app reviews and commentary by medical professionals. Most apps are about  apps geared toward professionals and are not free.          The iMedical app forum now includes a medical librarian corner, with some patient/consumer apps

Related articles

• FDA plans to approve some medical apps (wwlp.com)
• Evaluating mobile weight loss apps on use of evidence-based behavioral strategies (eurekalert.org)

 

Dietary Supplements: Structure/Function Claims Fail To Meet Federal Requirements

 

Dietary supplements (Photo credit: Andrei Z)

 

From the 2 October 2012 report by the Office of the Inspector General, US Department of Health and Human Services

 

Summary

WHY WE DID THIS STUDY

The Government Accountability Office and public interest groups have raised concerns about a specific type of claim-called a structure/function claim-that manufacturers may use on dietary supplement labels. Manufacturers have used these claims to promote health benefits of their products. Stakeholders have urged FDA to strengthen oversight of these claims because they are potentially misleading and may lack scientific support. FDA lacks authority to review or approve these claims before products enter the market. Manufacturers must have competent and reliable scientific evidence to show that claims are truthful and not misleading, but they do not have to submit the substantiation to FDA, and FDA has only voluntary standards for it. A manufacturer must notify FDA when it uses structure/function claims, and a product label must include a disclaimer stating that FDA has not reviewed the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.

HOW WE DID THIS STUDY

We analyzed structure/function claims for a purposive sample of 127 dietary supplements marketed for weight loss or immune system support. We reviewed the claims to determine the extent to which they complied with FDA regulations. We reviewed substantiation provided by manufacturers to describe the quantity and nature of the evidence. We also assessed the accuracy and completeness of notification letters that manufacturers must submit to FDA for their structure/function claims.

WHAT WE FOUND

Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence. FDA could not readily determine whether manufacturers had submitted the required notification for their claims. Seven percent of the supplements lacked the required disclaimer, and 20 percent included prohibited disease claims on their labels. These results raise questions about the extent to which structure/function claims are truthful and not misleading.

WHAT WE RECOMMEND

We recommend that FDA seek explicit statutory authority to review substantiation for structure/function claims to determine whether they are truthful and not misleading. We recommend that FDA improve the notification system for these claims to make it more organized, complete, and accurate. We also recommend that FDA expand market surveillance to enforce the use of disclaimers for structure/function claims and to detect disease claims. In its comments on the draft report, FDA did not explicitly concur with our first recommendation, but said it would consider it. FDA concurred with our second and third recommendations.

 

Related articles

• CRN Responds To Today’s Dietary Supplement Reports From Health And Human Services (sacbee.com)
• Report: Some dietary supplements illegally labeled (seattlepi.com)
• Feds: Many dietary supplements illegally labeled (cbsnews.com)
• Report: Some Dietary Supplements Illegally Labeled (sanfrancisco.cbslocal.com)

 

Off-Label Drug Use Common, but Patients May Not Know They’re Taking Them

 

From the 6 August 2012 article at Science News Daily

Many people have probably heard of off-label drug use, but they may not know when that applies to prescriptions they are taking, a Mayo Clinic analysis found. Off-label drug use occurs when a physician prescribes medication to treat a condition before that use has been approved by the Food and Drug Administration.

In a newly published article in Mayo Clinic Proceedings, researchers pose and answer 10 questions about off-label drug use.

“Since the Food and Drug Administration does not regulate the practice of medicine, off-label drug use has become very common,” says lead author Christopher Wittich, M.D., internal medicine physician at Mayo Clinic. “Health care providers and patients should educate themselves about off-label drugs to weigh the risks and benefits before a physician prescribes one or a patient takes one.”

Some highlights from the article:

* Off-label drug use is common. Within a group of commonly used medications, roughly 1 in 5 prescriptions were for an off-label use, a 2006 report found. Another study found that about 79 percent of children discharged from pediatric hospitals were taking at least one off-label medication.

* Patients may not know when drugs they have been prescribed are being used off-label. No court decision has required that physicians must disclose, through informed consent, the off-label use of a drug, the authors say. The FDA makes clear that it doesn’t regulate the practice of medicine and that the federal Food, Drug, and Cosmetic Act of 1938 doesn’t make physicians liable for off-label drug use, they note.

* Off-label drug use can become the predominant treatment for a condition. For example, some antidepressants are not approved by the FDA as a treatment for neuropathic pain, yet some drugs in this class are considered a first-line treatment option.

* Examples of widely practiced off-label drug use include morphine, used extensively to treat pain in hospitalized pediatric patients. Many inhaled bronchodilators, antimicrobials, anticonvulsants, and proton pump inhibitors also are used in children without formal FDA approval.

* Obtaining new FDA approval for a medication can be costly and time-consuming. To add additional indications for an already approved medication requires a supplemental drug application; if eventually approved, revenue from it may not offset the expense and effort for obtaining approval.

* Generic medications may not have the requisite funding resources needed to pursue FDA-approval studies. For these financial reasons, drug proprietors may never seek FDA approval for a new drug indication.

* Pharmaceutical manufacturers are not allowed to promote off-label uses of medications. However, they can respond to unsolicited questions from health care providers and distribute peer-reviewed publications about off-label use. Just this year, GlaxoSmithKline agreed to pay a record $3 billion to settle a Justice Department case involving alleged off-label drug use marketing, and Merck Sharp & Dohme was fined $322 million over its alleged promotion of the painkiller Vioxx for an off-label use.

 

Related articles

• Disclosure Not Necessary For Off-Label Drug Use; Patients May Not Know They’re Taking Them (medicalnewstoday.com)
• Many People Not Aware Of Their Off-Label Drug Use (medicalnewstoday.com)
• Off-label drug use common, but patients may not know they’re taking them, Mayo finds (eurekalert.org)
• Off-label drug use common, but patients may not know they’re taking them, study finds (medicalxpress.com)
• Off-Label Drug Disclosure Inadequate (the-scientist.com)
• Doctors Petition F.D.A. for Painkiller Limits (nytimes.com)
• Off-Label Use of Rx Drugs Legal, Controversial (blogs.lawyers.com)
• OxyContin: Painkillers for Kids (zen-haven.dk)

 

Move for Food Freedom!

RELATED ARTICLES

• How food safety regulations do not necessarily lead to greater food safety(thebovine.wordpress.com)
• The FDA’s powers are increasing and farmers should be worried(EndtheLie.com)
• The Sickening Nature of Many Food-Safety Regulations (txwclp.org)
• The Food Safety Modernization Act (foodservicewarehouse.com)

One Mover's Blog

“Food Safety Now!”

Who wouldn’t rally behind such a cause?

This has been the battle cry of those in the uppermost echelons of our food regulatory bodies and public health departments for years now. With each widely-publicized food-borne disease outbreak comes more proposed controls on who, where, when, why and how we can put food on our tables. With such names as The Food Safety Modernization Act, it’s hard to argue against the proposals…at least until you peel away the layers.

The vast majority of these bills are simply means to control the food supply; and thereby control the citizenry. Sure there are some well-intentioned, pure-hearted advocates of food safety out there. You’ll always see some grieving mother who’s child fell victim to a tainted chicken finger but the legislation seldom addresses the source of the problem. The majority of the food-related regulations that are proposed (these bills are chock…

View original post 396 more words

Database Is One-Stop Resource on Kids’ Medications

From an FDA Consumer Update

When adults are advised by their health care professional to use a medication, they expect to receive information—backed up by data from studies—on the correct and safe dose to take. For drugs used in children, this information may not be available because historically not all products are studied in children.

To fix this situation, Congress passed legislation to increase pediatric studies and incorporate the resulting information in labeling. This is a key point because medicines often affect children differently from the way they work in adults.

The Food and Drug Administration (FDA) has been working hard on this project. To make it easier for parents and health care professionals to find information on pediatric medications, the FDA created a database that covers medical products studied in children under recent pediatric legislation.

The Pediatric Labeling Information Database is a one-stop resource. You can search for information by the product’s commercial or chemical name, or by the condition for which it was studied. FDA’s Office of Pediatric Therapeutics (OPT), which focuses on safety, scientific, and ethical issues that arise in pediatric clinical trials or after products are approved for use in children, developed the tool in collaboration with another branch of the agency, the Center for Drug Evaluation and Research.

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ritalin (Photo credit: Wikipedia)

From the summary at Full Text Reports (May 5, 2012)

Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Source:  Institute of Medicine
In any given month, an estimated 48 percent of Americans take at least one prescription drug. Prescription drugs are crucial for preventing and treating diseases and improving the public’s health, but they can also have unintended harmful effects. Often, their benefits and risks cannot be fully identified until after a drug has been used by a large, diverse group of patients over time, mainly because clinical trials conducted before approval may be too small or too short to detect all possible risks. The passage of the Food and Drug Administration Act in 2007 provides the Food and Drug Administration (FDA) with additional postmarketing regulatory tools to better protect the health of the public, including the authority to require manufacturers to continue studying drugs that are being marketed.
To help determine when it is appropriate to require a postmarketing study, which types of studies to require, how to best protect the rights and interests of patients who participate in research, and how to use research in making regulatory decisions, the FDA asked the IOM to evaluate the scientific and ethical aspects of conducting safety studies for approved drugs. The IOM concludes that the FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle. Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision-making process more predictable, transparent, and proactive. These changes could allow the FDA to better anticipate post-approval research needs and improve drug safety for all Americans.

The free full text report is at http://www.iom.edu/Reports/2012/Ethical-and-Scientific-Issues-in-Studying-the-Safety-of-Approved-Drugs.aspx

Related articles

• Ethical and Scientific Issues in Studying the Safety of Approved Drugs (bespacific.com)
• IOM report concludes that the FDA is not doing its job (madinamerica.com)
• IOM report recommends US expand drug safety monitoring after approval (eurekalert.org)
• IOM report recommends US expand drug safety monitoring after approval (medicalxpress.com)
• How Do Docs Prescribe Kids’ Meds? Guess (abcnews.go.com)
• IOM Addresses Drug Safety (lawprofessors.typepad.com)

Fatal Attraction: Cosmetics and Chemicals

This item came to me this morning by Jenica Rhee (Twitter – @jenicarhee), who has emailed me links in the past few months to infographics she created (How Bikes can Save Us and Soda’s Evil Twin).
A quick glance at the references shows a great selection of resources from reputable organizations.

It is heartening to see a cosmetology school take a strong stand on regulating chemicals in cosmetics.

Chemicals in Cosmetics and on Your Face

Click here to see the graphic!

Scientists are talking about it; angry people are talking about it. The United States Food and Drug Administration is the government regulator of things like vaccines and pharmaceutical drugs, but when it comes to cosmetics (the topical stuff you put on your body like lotions, deodorant, and make-up) there seems to be a disconnect. The FDA only regulates the labeling of cosmetics, but the public safety of the chemicals in those products is assessed by the  ”Cosmetic Ingredient Review” — which is funded by the industry. Go figure.

The graphic outlines various studies that have cropped up over time regarding potential connections between hazardous chemicals and contamination of Americans, whose cosmetic regulatory polices lag far behind places like Europe and Canada. Take a look at some of the stuff that’s hiding in your daily routine — you might never shampoo your hair ever again.

• Scientists are talking about it; angry people are talking about it. The United States Food and Drug Administration is the government regulator of things like vaccines and pharmaceutical drugs, but when it comes to cosmetics (the topical stuff you put on your body like lotions, deodorant, and make-up) there seems to be a disconnect. The FDA only regulates the labeling of cosmetics, but the public safety of the chemicals in those products is assessed by the  ”Cosmetic Ingredient Review” — which is funded by the industry. Go figure.The graphic outlines various studies that have cropped up over time regarding potential connections between hazardous chemicals and contamination of Americans, whose cosmetic regulatory polices lag far behind places like Europe and Canada. Take a look at some of the stuff that’s hiding in your daily routine — you might never shampoo your hair ever again.

From the link at  Chemicals in Cosmetics and on Your Face

Scientists are talking about it; angry people are talking about it. The United States Food and Drug Administration is the government regulator of things like vaccines and pharmaceutical drugs, but when it comes to cosmetics (the topical stuff you put on your body like lotions, deodorant, and make-up) there seems to be a disconnect. The FDA only regulates the labeling of cosmetics, but the public safety of the chemicals in those products is assessed by the  ”Cosmetic Ingredient Review” — which is funded by the industry. Go figure.

The graphic outlines various studies that have cropped up over time regarding potential connections between hazardous chemicals and contamination of Americans, whose cosmetic regulatory polices lag far behind places like Europe and Canada. Take a look at some of the stuff that’s hiding in your daily routine — you might never shampoo your hair ever again.

Related articles

• Fatal Attraction: Cosmetics and Chemicals (simplegreenorganichappy.com)
• Do You Worry About Chemicals in Your Makeup? (bellasugar.com)
• Cracking Down on Toxic Makeup (ecocentric.blogs.time.com)
• Toxic Cosmetics: Is More Regulation Needed? (abcnews.go.com)
• What You Need To Know About Beauty Product Safety (self.com)
• Cosmetics Bill Seeks Full Ingredient Disclosure, FDA Oversight (greenbiz.com)
• Beauty Byte: Cosmetics Labels Are About to Bug Out (bellasugar.com)
• The FDA Is Cracking Down on Cosmetics Claims (bellasugar.com)
• Beauty Byte: Consumer Group Questions Carcinogenic Chemicals in Johnson & Johnson Products (bellasugar.com)
• Cosmetics and Contraversy (drerindenil.wordpress.com)
• Fatal Attraction (hartlove.wordpress.com)

Warning! Ads and popups at inspiredm.com, still…the listings of infographics is a good find…so use your judgement before clicking on the link below

• Infographics of the Week #22 (inspiredm.com)

Communicating Health Risk Is A Risky Task For FDA

 

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Communicating Health Risk Is A Risky Task For FDA

From the 23 January Medical News Today article

The impact of efforts by the U.S. Food and Drug Administration to notify the general public and health care providers about unanticipated risks from approved medications has been “varied and unpredictable,” according to a systematic review of published studies about FDA warnings and alerts over the last 20 years.

Although some communication efforts had a strong and immediate effect, many had little or no impact on drug use or health behaviors and several had unintended consequences, researchers report in the journal Medical Care. …

…The FDA has several standard tools to disseminate new evidence about drug safety. These include “Dear Healthcare Provider” letters to prescribers*, “public health advisories” and “Safety Alerts” targeting the general public, and “black box warnings”** added to a label when a drug’s risks may be particularly severe or affect a large population. Despite numerous studies examining single alerts, advisories and label changes, no prior study has systematically examined the effect of these risk communications….

[Article summarizes the effectiveness of 4 categories of communication]

…Part of the problem, the authors emphasize, is the challenge of communicating complex risk messages to a large, diverse audience. “The most effective communications were the simplest, those that were specific, where alternatives were available, and where the messaging was reinforced over time,” said Stacie Dusetzina, PhD, lead author from Harvard Medical School.

 

Read the entire Medical News Today article

*No direct links to “Dear Healthcare Provider” letters at http://www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/default.htm
However, individual letters can be found through using search engines, as a recent one for the drug Promacta

**Recent black box warnings are listed at Drug Safety Communications . If a drug has a black box warning, it will be part of its label. Drug information by name of drug is located at Drugs@FDA.

Related articles

• Beauty Byte: FDA Orders “Black Box” Warning For Botox (bellasugar.com)
• Risk Strategy Requirement Change For Low Platelet Counts Drugs, Nplate And Promacta – FDA (medicalnewstoday.com)
• FDA favors more risk info on birth control pills (goerie.com)
• Regulation and drug safety (blacktriangle.org)
• FDA favors more risk info on birth control pills (sfgate.com)

MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Concerned about the safety of your drugs or medical advices? Wish to report a serious medical product problem online?
The US Food and Drug Agency (FDA) can help.

Medwatch is the FDA gateway for clinically important safety information and reporting serious problems with human medical products.

Safety Information includes

• DailyMed (National Library of Medicine)
  Current Drug Prescribing Information
• Medication Guides
• Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)
• Postmarketing Drug and Biologic Safety Evaluations
  Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.
• Current Drug Shortages
  
• Recalls and Alerts
  • MedWatch Safety Alerts for Human Medical Products
  • FDA Patient Safety News Video Broadcasts
  • FDA Drug Safety Newsletter

Medwatch also encourages anyone to report serious problems with human medical products

• Report a Serious Medical Product Problem Online
• Reporting Unlawful Sales of Medical Products on the Internet
  

Want to stay informed with MedWatch updates? Here are some options…

Stay Informed

• Subscribe to MedWatch Safety Alerts
• Join the MedWatch E-list
• About the MedWatch E-list
• Follow MedWatch on Twitter
• MedWatch Safety Alerts RSS Feed
• RSS News Feed Help

Related Resource

Track medication safety from your iPhone

Now available for free in the iTunes store!

Stay up to date with the latest news and government safety alerts for the prescription medicines you take. Submit any side effects you experience to the US Food and Drug Administration (FDA) to make drugs safer for everyone.

MedWatcher is a mobile tool for both healthcare professionals and the general public.

Related articles

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• An important FDA advisory update (in my dreams) (medcitynews.com)
• FDA: Do not use ShoulderFlex Massagers (gloucestercitynews.net)
• FDA Warns of Celexa Heart Risk (webmd.com)
• Pradaxa Benefit Outweighs Bleeding Risk – ABC News (abcnews.go.com)
• HCG Weight Loss Products Removed from the Market (fdarecalls.wordpress.com)
• Product Recall: Nostrilla Nasal Spray (habwwe.wordpress.com)
• FDA: Celexa May Damage Heart at High Doses (earlsview.com)
• Nostrilla Nasal Decongestant Recalled – Oct 2011 (wholefoodandmore.net)
• Risk Strategy Requirement Change For Low Platelet Counts Drugs, Nplate And Promacta – FDA (medicalnewstoday.com)

A Better FDA? Why Not? « GxP Perspectives

 

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A Better FDA? Why Not?  [From the December 2011 GxP Perspectives Blog]

Is FDA necessary? Most people I know would say yes. We need a strong, independent, effective FDA. Does FDA need improvements? Again, most people I know can point to numerous issues that FDA could handle better. Today, in the Business Section of the New York Times, there is an article on why we need government and the benefits of better government. Yes, the article by Robert H. Frank is about the Tompkins County New York Department of Moter Vehicles, but he outlines some basic principles for better government. Like better use of technology to make government more efficient. FDA is making similar efforts regarding technology. That’s great and I encourage the development. Here are three other areas that I think that FDA can improve:

1. Consistent training for field investigators….

Click here to read the entire blog item

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• Santa Claus Would be the FDA’s Public Enemy #1 if He Were Real, Says Former FDA Regulatory Counsel (prweb.com)
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Fish Hazards and Controls: More Than a Fish Story

From the FDA Web page

The Hazards Guide is a roadmap for commercial fishermen and processors to follow to ensure that consumers don’t become ill from parasites, pathogens (bacteria, viruses, fungi), or natural toxins (poisonous substances produced by living organisms) in the seafood they eat.

In April 2011, FDA released the fourth edition of the Hazards Guide and posted on the FDA website an introductory video to the guide for the seafood industry.

The Hazards Guide gives fishermen and seafood processors the latest scientific information on contaminants that can be present in their products and where they need controls to eliminate them.

For example, research conducted by FDA gave the agency new insights on what was needed to control scombrotoxin in the processing of tuna and mahi-mahi. Scombrotoxin is one of the most common causes of fish-related “food poisoning” in the U.S….

Related Resources

• Fresh and Frozen Seafood: Selecting and Serving it Safely
• Fish and Fishery Products Hazards and Controls Guidance
• Cooperative Program Ensures Safe Shellfish (slideshow)
• Cooperative Program Ensures Safe Shellfish (Consumer Update)

Related articles

• “Seafood Processors, Importers Face FDA Scrutiny” and related posts (foodsafetynews.com)
• [Food Warning] Fish Often Mislabeled In U.S. (inquisitr.com)
• US FDA finally releases new Fish and Fishery Products Hazards and Controls Guidance (fishconsultancy.wordpress.com)
• NYT: Something fishy about seafood labels (msnbc.msn.com)
• Tests Reveal Mislabeling of Fish (nytimes.com)

Drug Information Product DailyMed Mobile Version Launched

DailyMed Mobile Version Launched

From the National Library of Medicine (NLM)  March 4 announcement

NLM® released DailyMed® Mobile on January 31, 2011. DailyMed provides access to over 20,000 structured product labels (SPL) from the Food and Drug Administration. DailyMed mobile features a simplified design enabling easy search, retrieval and display of SPLs from any Web-enabled mobile device (see Figure 1). Users can also e-mail SPLs to themselves or colleagues for later viewing on other platforms.

Editor Flahiff’s note:  You also cannot go wrong with these nonmobile(at least for now!)  resources (via a Consumer Health Library Guide

Dietary Supplements Labels Database

Information about ingredients in more than three thousand selected brands of dietary supplements. It enables users to determine what ingredients are in specific brands and to compare ingredients in different brands. Information is also provided on the health benefits claimed by manufacturers. These claims by manufacturers have not been evaluated by the Food and Drug Administration. Check out the Help section for tips on how to browse and search this site.

Drug Digest

This noncommercial consumer health and drug information site provides information about drugs and treatment options to be discussed with your primary health care provider or a pharmacist.  Information about over 1,500 drugsas well as common herbs and supplements. The check interactions tab (potential interactions between drugs)  and conditions/treatments area provide easy-to-read overviews. Information provided by Drawing pharmacy experts, licensed doctors of pharmacy, and physicians. From ExpressScripts.

Drugs and Supplements (sponsored by the Mayo Clinic)

Somewhat lengthy drug and over-the-counter medicationinformation with these sections: description, before using, proper use, precautions and side effects. From Micromedex, a trusted source of healthcare information for health professionals. 

Herb and supplement information includes information on uses based on scientific evidence as well as safety and potential interactions with drugs, herbs, and supplements. From Natural Standard, an independent group of researchers and clinicians.

Drug Information Portal

A good central source of drug information by the US government (the National Institutes of Health). It links you to information on over 12,000 drugs from trusted consumer drug information sources, the US Food and Drug Information, and LactMed*** (summary of effects on breastfeeding i), It also gives any summaries from medical and toxicological articles (however, some whole articles may not be for free on the Internet).

PillBox Beta

Aids  in the identification of unknown solid dosage pharmaceuticals using images to identify pills (color, shape, etc) as well as a separate advanced search (imprint, drug manufacture, ingredients, etc)

Related Articles

			Announcements Beware of Fraudulent Weight Loss “Dietary Supplements” The Food and Drug Administration warns that false claims and tainted products can cause serious harm to consumers. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246742.htm Consumer Update: Dietary Supplements The Food and Drug Administration has found nearly 300 fraudulent products—promoted mainly for weight loss, sexual enhancement, and bodybuilding—that contain hidden or deceptively labeled ingredients. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246744.htm

• Drug Information Product DailyMed Mobile Version Launched (jflahiff.wordpress.com)
• PubMed Health Provides Disease and Treatment Information for Consumers (jflahiff.wordpress.com)

***As of July 2011…The National Library of Medicine Drugs and Lactation Database (LactMed)
has added complementary and alternative medicine (CAM) products. CAM
products generally consist of dietary supplements derived from botanicals
(herbals), “nutraceuticals” (natural and synthetic nonherbals, such as
coenzyme Q10), and related products.
http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Evidence lacking for widespread use of costly antipsychotic drugs, says Stanford researcher

Evidence lacking for widespread use of costly antipsychotic drugs, says Stanford researcher
[This editor blogged a related item on December 6, 2010, Nursing homes are seeking to end the stupor]

From a January 7, 2011 Eureka news alert

STANFORD, Calif. — Many prescriptions for the top-selling class of drugs, known as atypical antipsychotic medications, lack strong evidence that the drugs will actually help, a study by researchers at the Stanford University School of Medicine and University of Chicago has found. Yet, drugs in this class may cause such serious effects as weight gain, diabetes and heart disease, and cost Americans billions of dollars.

“Because these drugs have safety issues, physicians should prescribe them only when they are sure patients will get substantial benefits,” said Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center, who is senior author of the study to be published online Jan. 7 in Pharmacoepidemiology and Drug Safety.*** “These are commonly used and very expensive drugs.”

Prescriptions for these drugs have risen steadily since they first came on the U.S. market in 1989, largely replacing the first generation of antipsychotics, which were mainly used to treat schizophrenia. The U.S. government’s original stamp of approval for the new drugs was for treating schizophrenia, but they’re used more today for other conditions, including other psychoses, autism, bipolar disorder, delirium, dementia, depression and personality disorders. And while some of these uses have recently been approved by the U.S. Food and Drug Administration, many have not….

…These new drugs accounted for more than $10 billion in retail pharmacy U.S. prescription drug costs in 2008, representing the largest expenditure for any single drug class — nearly 5 percent of all drug spending, surpassing even blockbusters like statin cholesterol medications. According to a 2004 study, a quarter of all residents of U.S. nursing homes had taken them. Among the drugs are quetiapine, aripoprazole (brand name, Abilify), olanzapine (Zyprexa) and risperidone (Risperdal), each with annual U.S. sales exceeding $1 billion.

Stafford’s new study adds to concerns about the drugs, which have been the focus of thousands of lawsuits, and as a class make up the single largest target of litigation filed under the federal False Claims Act. All major companies selling new-generation antipsychotics have either recently settled cases for hundreds of millions of dollars or are currently under investigation for skewing results or using questionable marketing tactics.

In 2005, the FDA issued its strongest type of caution, the “black box” warning, for use of new-generation antipsychotics, because of increased risk of death for dementia patients.

“Most people think, ‘If my doctor prescribed this, the FDA must have evaluated whether this drug was safe and effective for this use.’ That’s not true,” said Stafford. When doctors prescribe drugs for purposes other than those approved by the FDA, it’s called “off-label” use. Though it’s riskier for patients, there’s nothing illegal about it, and can make sense medically in some instances, Stafford said, especially if there are no approved treatments or if a patient has not responded to approved drugs.

Previous studies had shown that antipsychotic drug use is ballooning. Stafford’s new study not only corroborated and updated these findings but also identified the fraction of off-label use that is based on uncertain evidence.

The researchers’ first step was to analyze the results of a physicians’ survey conducted by health-care information company IMS Health. The IMS Health National Disease and Therapeutic Index survey gives a snapshot of the conditions doctors treated and drugs they prescribed. About 1,800 physicians participate each calendar quarter and each is randomly assigned two days per quarter to provide data.

After identifying which antipsychotics were being used, and for what, the researchers assessed the strength of the evidence supporting those that lacked FDA approval, using efficacy ratings from the widely used drug compendium, Drugdex.

Lead author Caleb Alexander, MD, assistant professor of medicine at the University of Chicago, and colleagues conducted the analysis. Stafford supervised the project and with Alexander interpreted the data. Stanford clinical assistant professor of psychiatry Anthony Mascola, MD, provided expertise on the treatment of psychiatric conditions.

Among their findings:

Antipsychotic treatment prescribed during the surveyed doctors’ visits nearly tripled from 6.2 million in 1995 to 16.7 million in 2008, the most recent year for which they had data. During this period, prescriptions for first-generation antipsychotics decreased from 5.2 million to 1 million.
Antipsychotic use for indications that lacked FDA approval by the end of 2008 increased from 4.4 million prescriptions during surveyed doctors’ visits in 1995 to 9 million in 2008.
In 2008, more than half — 54 percent — of the surveyed prescriptions for the new-generation antipsychotics had uncertain evidence.
An estimated $6 billion was spent in 2008 on off-label use of antipsychotic medication nationwide, of which $5.4 billion was for uses with uncertain evidence.
Prescriptions for antipsychotics began dropping slightly in 2006, shortly after the FDA issued a warning about their safety.
Stafford suggests the upswing in prescriptions for antipsychotics despite the absence of good evidence for their value in many instances is the result of marketing — whether legal or illegal — and ingrained cultural tendencies. “Physicians want to prescribe and use the latest therapies — and even when those latest therapies doesn’t necessarily offer a big advantage, there’s still a tendency to think that the newest drugs must be better,” he said.

Physicians could benefit from more feedback on what percentage of their prescriptions is for off-label uses, said Stafford. “In many cases, physicians don’t realize they’re prescribing off-label,” he said.

In fact, in a previous survey of physicians, Alexander found that the average respondent accurately identified the FDA-approval status of drugs for a given condition just over half the time.

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Related news article

Short Time on Antipsychotics May Up Heart Disease

Using the nutrition facts label – A FDA guide for older adults

The US Food and Drug Administration (FDA) has published a nutrition facts label guide in PDF format.

It includes information on how to read the labels and also provides guidance in other nutrition areas as calories, daily values of nutrients, and importance of select nutrients as fat, fiber, cholesterol, and calcium.

The FDA Website has a Web page devoted to food safety, regulations, and other FDA related topics. It includes links to recall information, information on dietary supplements, food ingredients, and more.

Related Web Sites of Note

Nutrition (MedlinePlus) provides links to overviews, health check tools, videos, patient handouts, and related issues

Diet and Nutrition (Netwellness) gives links to general nutrition information, symptoms & tests, how to stay healthy tips, and treatment (as the DASH diet)

One may Ask-An-Expert, and receive a reply within a few days. There is a link to previously answered questions.

Food and Nutrition (FamilyDoctor.org) has links to general nutrition Web pages, nutrition for weight loss, kids & nutrition, and special diets (as the Mediterranean diet)

 

Herbs at a Glance: A Quick Guide to Herbal Supplements

 

 

Herbs at a glance: a quick guide to herbal supplements is a 100 page indexed PDF document which gives the basics on the most common herbs in dietary supplements – historical uses, what they are used for now, scientific evidence on effectiveness, and potential side effects.

It is published by the US National Center for Complementary and Alternative Medicine (NCAAM).
The NCAAM Web site includes links to information under titles as

• Health Topics A-Z with Evidence-based information on treatments and conditions
• Information for Consumers with numerous fact sheets to help you decide if complementary/alternative medicine is right for you. (Don’t forget to consult with your health care providers! These fact sheets can be great discussion starters)
• A good introductory page on What is Complementary and Alternative Medicine?
• News and Events
• Ways to get updates bv email, newsfeed (RSS), Twitter, Facebook, and Youtube

A few related Web sites

• Complementary and Alternative Medicine (MedlinePlus)has links to overviews, specific conditions, tutorials, videos, research, and more
• Herbal Medicine (MedlinePlus) has links to overviews, specific conditions, research, and more
• Complementary Medicine (NetWellness) has links to general information,treatment, and Ask-An-Expert answered questions. One can ask a question at this site, and receive a reply within a few days.
• Alternative Medicine (NIH) contains links to information at US government sites
• Drug Information Portal (NIH) provides a wealth of information for consumers and professionals.
• US Office of Dietary Supplements contains fact sheets, news items, decision making guidance, consumer protection information, nutrient recommendations, and more

and a related news item…

From the December 16, 2010 Health Day news item U.S. Spending Millions to See if Herbs Truly Work

THURSDAY, Dec. 16 (HealthDay News) — People have been using herbal supplements for centuries to cure all manner of ills and improve their health. But for all the folk wisdom promoting the use of such plants as St. John’s wort and black cohosh, much about their effect on human health remains unknown.

But the federal government is spending millions of dollars to support research dedicated to separating the wheat from the chaff when it comes to herbal supplements.

“A lot of these products are widely used by the consumer, and we don’t have evidence one way or the other whether they are safe and effective,” said Marguerite Klein, director of the Botanical Research Centers Program at the U.S. National Institutes of Health. “We have a long way to go. It’s a big job.”

In August, the U.S. National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements awarded about $37 million in grants to five interdisciplinary and collaborative dietary supplement centers across the nation. The grants were part of a decade-long initiative that so far has awarded more than $250 million toward research to look into the safety and efficacy of health products made from the stems, seeds, leaves, bark and flowers of plants.

Reliance on botanical supplements faded in the mid-20th century as doctors began to rely more and more on scientifically tested pharmaceutical drugs to treat their patients, said William Obermeyer, vice president of research for ConsumerLab.com, which tests supplement brands for quality.

But today, herbal remedies and supplements are coming back in a big way. People in the United States spent more than $5 billion on herbal and botanical dietary supplements in 2009, up 22 percent from a decade before, according to the American Botanical Council, a nonprofit research and education organization.

The increase has prompted some concern from doctors and health researchers. There are worries regarding the purity and consistency of supplements, which are not regulated as strictly as pharmaceutical drugs.

“One out of four of the dietary supplements we’ve quality-tested over the last 11 years failed,” Obermeyer said. The failure rate increases to 55 percent, he said, when considering botanical products alone.

Some products contain less than the promoted amount of the supplement in question — such as a 400-milligram capsule of echinacea containing just 250 milligrams of the herb. Other products are tainted by pesticides or heavy metals.

The U.S. Food and Drug Administration warned supplement makers on Dec. 15 that any company marketing tainted products could face criminal prosecution. The agency was specifically targeting products to promote weight loss, enhance sexual prowess or aid in body building, which it said were “masquerading as dietary supplements” and in some cases were laced with the same active ingredients as approved drugs or were close copies of those drugs or contained synthetic synthetic steroids that don’t qualify as dietary ingredients.

But even when someone takes a valid herbal supplement, it may not be as effective when taken as a pill or capsule rather than used in the manner of a folk remedy. For example, an herb normally ground into paste as part of a ceremony might lose its effectiveness if prepared using modern manufacturing methods, Obermeyer said.

“You move away from the traditional use out of convenience, and you may not have the same effect,” he said.

Researchers also are concerned that there just isn’t a lot of evidence to support the health benefits said to be gained from herbal supplements. People may be misusing them, which can lead to poor health and potential interactions with prescription drugs.

“Consumers often are taking them without telling their doctor, or taking them in lieu of going to the doctor,” Klein said……

 

 

Generic Drug Roundup: December 2010

From the US Food and Drug Administration Web Page

Each year, the Food and Drug Administration (FDA) approves many generic drugs that treat a wide variety of conditions and help consumers save money.

Significant FDA approvals of generic medications are listed below.

Be aware that the notes included with the description of each drug listed below do not include all warnings, side effects, or use instructions associated with these products. You should read the medication guide, when available, and speak with a health care professional regarding any medication you are taking, have been prescribed, or are considering taking

• Anastrozole Tablets
• Venlafaxine Hydrochloride extended-release capsules
• Aztreonam (for Injection)
• Enoxaparin Sodium Injection
• Losartan Potassium Tablets
• Generic Drugs: Vital Facts
  • Generic drugs are identical to their brand-name equivalents in dosage, safety, strength, quality, performance characteristics, intended use, and the way they’re administered to patients.
  • On average, the cost of a generic drug is 80 to 85 percent lower than the brand-name product.
  • New drugs are patented to protect the investments of the manufacturers that develop them. As patents or other periods of exclusivity on new drugs expire, manufacturers—including firms that did not develop the drugs—can seek FDA approval to sell generic versions.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-
regulated products.

For More Information

• Facts and Myths about Generic Drugs
• Understanding Generic Drugs
• Drug Approval Reports by Month

 

 

 

FDA Tobbaco Products : Information Resources

FDA Tobacco Products provides information resources on tobacco products for consumers and healthcare professionals.

Resources include

• News and Events (updates, press releases, meetings,etc)
• Guidance, Compliance & Regulatory Information with links on legal, regulatory, and policy issues related to tobacco products.
• Protecting Kids from Tobacco with information on related regulations
• Resources for you with links to information on how to quit, tobacco prevention in youth, and information for health care providers

The Tools and Alerts section on the home page includes options for email alerts and Twitter. Contact information by phone and fax is also provided.

FDA Warning Letters issued to four makers of caffeinated alcoholic beverages

 

From a Nov 17, 2010 US Food and Drug Administration press release

For Immediate Release: Nov. 17, 2010
Media Inquiries: Michael Herndon, 301-796-4673, michael.herndon@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Warning Letters issued to four makers of caffeinated alcoholic beverages
These beverages present a public health concern

The U.S. Food and Drug Administration today warned four companies that the caffeine added to their malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of their products, is possible under federal law.

The companies receiving Warning Letters and their products are:

• Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
• New Century Brewing Co., LLC: Moonshot
• Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
• United Brands Company Inc.: Joose and Max

FDA’s action follows a scientific review by the Agency.  FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers.  FDA also performed its own independent laboratory analysis of these products.

“FDA does not find support for the claim that the addition of caffeine to these  alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner.  “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication.  The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.

The agency said the products named in the Warning Letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the FFDCA). Each Warning Letter requests that the recipient inform the FDA in writing within 15 days of the specific steps that will be taken to remedy the violation and prevent its recurrence. If a company does not believe its products are in violation of the FFDCA, it may present its reasoning and any supporting information as well.

If the FDA believes that the violation continues to exist, the agency may pursue an enforcement action that could include seizure of the products or an injunction to prevent the firm from continuing to produce the product until the violation has been corrected.

FDA’s action today follows a November 2009 request to manufacturers to provide information on the safety of adding caffeine to their products.

FDA is aware that on November 16, Phusion Projects, LLC, the maker of Four Loko, announced its intention to remove caffeine and other stimulants from its drinks.  FDA views this announcement as a positive step. FDA has not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product.  FDA intends to work with Phusion Projects, LLC and the other manufacturers to assure their products meet safety standards.

For More Information:

• Caffeinated Alcoholic Beverages — FDA Web Page
• Caffeinated Alcoholic Beverages — Consumer Update
• Caffeinated Alcoholic Beverages – Warning Letters:
  • Charge Beverages Corp.: Core High Gravity HG Green, Core High Gravity HG Orange, and Lemon Lime Core Spiked
  • New Century Brewing Co., LLC: Moonshot
  • Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
  • United Brands Company Inc.: Joose and Max
• Qs & As on Caffeine in Alcoholic Beverages
• Caffeinated Alcoholic Beverages — FDA Page on Flickr
• Caffeinated Alcoholic Beverages — CDC Fact Sheet
• FTC Sends Warning Letters to Marketers of Caffeinated Alcohol Drinks

 

FDA reclassifies certain digital mammography devices

From a November 4, 2010 US Food and Drug Information (FDA) news release

 

For Immediate Release: November 4, 2010

Media Inquiries: Dick Thompson, 301-796-7566, dick.thompson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA reclassifies certain digital mammography devices

Devices capturing digital image of breasts to be Class II

The U.S. Food and Drug Administration today announced that it is easing the pathway to market for mammography systems that produce computerized X-ray images of the entire breast.

These systems, known as Full Field Digital Mammography Systems, are an alternative to mammography systems that produce X-ray film.

When first approved by FDA in 2000, digital mammography systems were categorized as a high risk or Class III device, because they were then considered novel systems for screening and diagnosing breast cancer.

Since then, digital mammography has been well-validated in scientific studies involving tens of thousands of patients. The benefits and risks of digital versus film mammography have also been well -described to physicians. As a result, the FDA has decided to reclassify digital mammography from Class III devices to Class II or medium risk devices…….

…

For more information:

Federal Register Notice

Mammography

Special Controls Guidance

#

Visit the FDA on Facebook and Flickr

RSS Feed for FDA News Releases [what is RSS?]

 

 

Click here for the FDA newsroom Web page

 

 

 

FDA Issues Regulatory Science Report

Excerpts from a US Food and Drug Adminstration (FDA) Oct 6 press announcement

The U.S. Food and Drug Administration today unveiled a report outlining the agency’s plans to advance regulatory science through its Regulatory Science Initiative.

Regulatory science is the science of developing new tools, standards and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products.

The report provides examples of current FDA activities in regulatory science and also considers how advancements in the field can help deliver better, safer, more innovative products to Americans in seven different public health areas.

Copies of the report will be released at the National Press Club in Washington, D.C., when FDA Commissioner Margaret A. Hamburg M.D. speaks to a club luncheon.

Her address will begin at 1 p.m. and will be broadcast live by C-SPAN.

For more information:

• Advancing Regulatory Science for Public Health

 

 

Risks of Presymptomatic Direct-to-Consumer Genetic Testing

At home genetic testing kits have been available online for some time.  However geneticists have long warned about the dangers of consumers self testing without clinical guidance in self testing and self diagnosing.

The Food and Drug Administration has sent warning letters to at least 20 companies planning on selling these kits as over the counter items. The letters state  direct-to-c0nsumer  genetic testing may require FDA approval. At least one company has since postponed selling the kits in their stores.

Excerpts from a recent New England Journal of Medicine perspective on home genetic tests

When population screening for medical conditions is independent of any defined individual risk, the screening program should adhere to established principles in order to avoid undue harm and expense: there must be a suitable and acceptable test addressing an important health problem that has a recognizable latent or early symptomatic state, a well-understood natural history, and an accepted and available treatment or intervention.^4,5 Most genetic screening currently cannot meet such expectations. More important, DTC genetic screening may place a substantial burden on the health care system without providing demonstrable benefit.

….

The potential harms of DTC genetic testing include the loss of protections for patients offered by established health care delivery systems (e.g., doctor–patient confidentiality and beneficence), invalid analytic or clinical results from medical devices, and population screening without consensus on interpretation and follow-up. These risks must be balanced against the potential benefits of innovation. The government’s role in this arena should include both regulation and the funding of collaborative research that enables the optimal use of genetic information.