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FDA Failing to Obtain Follow-Up Studies on Some Medications

Janice Simmons, for HealthLeaders Media, October 29, 2009

The Food and Drug Administration (FDA) has been lax in permitting numerous drugs designed to treat life-altering illnesses—such as HIV/AIDS or cancer—to remain on the market without their manufacturers providing required follow-up studies to show their effectiveness, according to a new Government Accountability Office (GAO) study.

Between 1992 and 2008, the Food and Drug Administration (FDA) approved 90 applications for drugs using an accelerated approval process to quickly get to market drugs aimed at treating serious or life-altering illnesses. However, weaknesses in FDA's monitoring and enforcement process have hampered its ability to effectively oversee post-marketing studies of many of those drugs, GAO said.

In efforts to expedite approval of these drugs, FDA began in 1992 to use a process based on "surrogate endpoints," which required that "drug sponsors complete post-marketing studies to confirm the drug's clinical benefit." These endpoints can include laboratory measures, such as blood pressure—instead of more direct clinical evidence, such as preventing strokes.

"Once those drugs are on the market, the FDA needs to monitor the outcomes," said Sen. Charles Grassley (R-IA), the ranking minority member of the Senate Finance Committee, who had requested the study. "The report should serve as an impetus for the FDA to improve the post market surveillance of these drugs, giving patients and their doctors' meaningful information and necessary safeguards."

FDA had required drug sponsors to conduct 144 post-marketing  studies associated with the 90 applications. By the end of 2008, two-thirds of the applications were classified as closed—meaning that drug sponsors had met FDA's requirements for these studies. However, a third of the remaining studies have been classified by FDA as "open" for an extended period.

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