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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

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

 

January 26, 2015 Posted by | Uncategorized | , , , , , , , , , | Leave a comment

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.

 

 

August 8, 2012 Posted by | health care | , , | Leave a comment

   

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