Still stinging from its troubles with Vioxx and approved antidepressants that raise suicidal thinking in some teens, the FDA is ready to pay more attention to post-approval drugs. The agency has decided to institute a pilot program under which it will track the way drugs work after they've been on the market for about 18 months. However, it will probably take a year before the program actually kicks off, according to Dr. Steven Galson, director of the agency's drug center. As part of the effort, the agency also plans to improve the way it announces safety concerns, and a collaboration with the Veterans Health Administration to see how patients are doing on the approved drugs that they take. Despite taking these steps on its own, the agency may come under further political pressure for change. Democratic Senator Christopher J. Dodd of Connecticut has said that he would like to reorganize the FDA, and require drug makers to disclose results of any clinical trials which have involved humans. Dodd, and and Republican colleague Charles E. Grassley, both have expressed concern that the approval process isn't transparent enough.
For more information on the FDA effort:
- check out the FDA's press release
- read the report from FierceBiotech
- read this piece from The New York Times
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