Health and Medical News and Resources

General interest items edited by Janice Flahiff

[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

ID-10057221Recently 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

January 26, 2015 Posted by | health care | , , , , , , , | Leave a comment

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Ritalin

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

May 9, 2012 Posted by | Medical and Health Research News | , , , , , | Leave a comment

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.

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

Safety Information includes

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

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

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Track medication safety from your iPhone

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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.

December 29, 2011 Posted by | Consumer Health, Consumer Safety, Finding Aids/Directories | , , , , , , , , , , | Leave a comment

   

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