FDA needs to track safety of drugs on the market, watchdog group says

Posted by Sarah Showard | Aug 08, 2012 | 0 Comments

The U.S. Food and Drug Administration isn't doing a very good job of tracking drugs once they're on the market to see if they're safe, according to the Institute of Medicine, a government watchdog group.

Some drugs are put on the market despite evidence that they might have bad side effects, the IOM said, and the FDA should monitor them to make sure they're not hurting people. The IOM urged the FDA to make a comprehensive report available to consumers that includes risks that may be discovered after the drugs go on the market.

Right now, the FDA monitors drugs after 18 months on the market or after 10,000 people have used it, whichever occurs last, relying on reports from doctors, patients and the drug manufacturer. The FDA said costs of continual monitoring might be prohibitive.

In 2004 the pain reliever Vioxx, which was being taken by two million people, was abruptly taken off the market after five years when it was linked to heart attacks and strokes. The FDA was criticized for not acting quicker to protect consumers.

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Sarah Showard

Sarah Showard graduated from the University of Maryland in 1985, Magna Cum Laude with a Bachelor of Arts in English-Linguistics and a Certification in Womens Studies. She then graduated from New York University School of Law in 1988. Sarah began practice initially as an insurance defense attorne...


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