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FDA Deadlines Threaten Drug Safety

April 7, 2008 | A version of this story appeared in Volume 86, Issue 14

Credit: shutterstock
Credit: shutterstock

FDA rushes to approve many drugs to meet congressionally imposed deadlines, and those medicines are more likely to be recalled or relabeled than those approved with greater deliberation, according to researchers at Harvard University. "We found that while these deadlines speed up the approval process, many drugs are approved right up against the deadline, which might lead to unintended consequences with regard to drug safety," says Daniel Carpenter, professor of government in Harvard University's Faculty of Arts & Sciences. "This suggests that drug safety might improve under an FDA approval protocol that is more flexible and less driven by deadline pressures." The deadlines were first enacted as part of the Prescription Drug User Fee Act of 1992, which required FDA to act on 90% of all drug candidates within a year of submission or face funding cuts. The timeline was tightened to 10 months in 1997. The study says that drugs rushed to approval just before the deadline are two to three times more likely to be eventually pulled off shelves because of safety concerns, two to seven times more likely to receive added label warnings known as "black box revisions," and two times as likely to experience changes in manufacture.


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