FDA approval practices under fire from new study

A new study has suggested that a significant percentage of last-minute drug approvals by the Food and Drug Administration have resulted in drugs being quickly withdrawn or given a black-box warning.

The study was conducted by Daniel Carpenter, a professor of government at Harvard University, and was published in the New England Journal of Medicine, citing the link between unsafe drugs and the FDA’s last-minute approval of them.

According to published reports, the study explained that since 1993, out of the 97 drugs that were approved near the FDA’s deadline to review the drugs, 14 percent of the drugs experienced severe safety issues soon after. Also, out of 21 withdrawals and black-box warnings for drugs approved since 1993, 14 were drugs that were approved 2 months before the deadline. Also included in the statistic are Baycol, Viozz and Rezulin, which were approved in the last three days but all were withdrawn because of such severe safety problems as muscle damage, heart attack and stroke.

This issue stems from an ongoing debate about the FDA’s rapid approval for drugs which, in effect, may do more damage to patients then good if not carefully reviewed. According to published reports, in 1992 the FDA made a deal with the drug industry stating that if the FDA would approve drug applications quicker, they would gain legal authority to collect fees from companies with business for the agency.

The FDA’s response is that its data did not match Carpenter’s and it will submit the conflicting data to the Journal, as well. The agency also stated that it is under no pressure to commit to deadlines, and will always and only approve a medicine if the review suggests that it is, in fact, safe.