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The FDA

FDA, drug companies fail on post-approval drug studies

Monday, July 10, 2006 by: NewsTarget
Tags: the FDA, dangerous drugs, health news


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(NewsTarget) According to a new report by the inspector general at the Department of Health and Human Services, the U.S. Food and Drug Administration (FDA) does not track the status of post-approval drug studies, and is unaware of the status of many such studies promised by pharmaceutical companies.

"FDA cannot readily identify whether or how timely post-marketing study commitments are progressing toward completion," the report said.

After the FDA approves a drug, companies are supposed to submit annual reports to the agency on the progress of their promised post-approval studies. However in 2004, 35 percent of the nearly 400 annual reports due "were missing entirely or contained no information on open post-marketing study commitments." The FDA confirmed only about 30 percent of the annual reports.

The FDA reviewers interviewed for the report said "monitoring post-marketing study commitments is not generally considered a top priority." Though the FDA cannot force drug makers to complete the voluntary post-market studies, the agency says it is trying to improve monitoring and public reporting of such information. The inspector general's report recommends that the FDA upgrade its tracking systems and request that drug firms provide better information.

For years, critics of the FDA have said pharmaceutical companies frequently fail to follow through on post-approval studies, and some have even asked Congress to grant the FDA the power to discipline drug makers that do not complete the promised studies. Current behavior by the FDA and drug companies seems to follow a "approve-and-move on" mentality that fails to monitor the long term health and safety issues of drugs that are prescribed to millions.

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