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FDA and the Move To Transparency

Posted by Jane Akre
Thursday, June 17, 2010 1:00 PM EST
Category: Major Medical
Tags: FDA, Vioxx, Clinical Trials, Drug Safety, Big Pharma, Pharmaceuticals, Merck


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IMAGE SOURCE:FDA logo

In an effort to become more transparent, the U.S. Food and Drug Administration (FDA) is beginning to post the results of its reviews into the safety of recently approved drugs and vaccines.

Until now the safety of drugs post-approval has only been revealed when there is a problem. This ongoing effort will publish reports coming in so doctors and patients can receive up-to-date information about the risks of new drugs.

Eighteen months after the approval of a new drug, the agency is required, under a 2007 law, to post safety information from a post-market analysis.

Despite clinical trials, often the troubling side effects of a drug will not be seen until the drug is taken by a larger population of varied patients. Also, some drugs are prescribed off-label for uses not approved which also raise safety questions.

"So that changes the whole game because you don't know if the drug is effective in that population," said Dr. Robert Boucher, director of FDA's office of drug surveillance, at a press briefing as reported by the Associated Press.

Where will the information come from? Assuming that drug companies pass on adverse events to the FDA, the data will come from the pharmaceutical company. Not to rely on that solely, information will also come from reports forwarded by patients and doctors, any new studies, overseas use of the drug and from prescription data bases, reports the Washington Post.

Drug companies and the FDA have been collecting this information for decades but have generally not shared it with the public.

Don’t look for data on every new drug to be posted. Omitted will be information about drugs that are substantially similar to the new novel chemical structures which will be posted. That could include new vaccines or old drugs approved for new uses.

So far the agency has 26 reviews on display at http://www.fda.gov and plans to post quarterly up to 100 drugs and vaccines a year as long as they were approved after September 27, 2007.

Approval of Section 915 of the Food and Drug Administration Amendment Act of 2007 followed on the heels of the 2004 Vioxx scandal. Pain reliever, Vioxx, was taken off the market five years after its approval because of its link to heart attack and strokes.

The AP reports critics say lives could have been saved if the post-approval information critics say that Merck withheld on Vioxx and the FDA had been shared with the public. #


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