FDA deadlines may compromise drug safety by rushing approval

Fast-tracked medications more likely to face later regulatory action to remedy safety concerns

CAMBRIDGE, Mass. – Many medications are approved by the U.S. Food and Drug Administration on the brink of congressionally mandated deadlines, and those drugs are more likely to face later regulatory intervention than those approved with greater deliberation, researchers at Harvard University have found. Drugs fast-tracked by the FDA are more likely to eventually be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labeling changes, according to Daniel Carpenter, professor of government in Harvard’s Faculty of Arts and Sciences. The research will be published in the Mar. 27 issue of the New England Journal of Medicine.

Carpenter’s co-authors were Jerry Avorn, Professor of Medicine at Harvard Medical School/chief, Division of Pharmacoepidemiology at Brigham and Women’s Hospital and Evan James Zucker, a student at Harvard Medical School.

“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 Carpenter. “This suggests that drug safety might improve under an FDA approval protocol that is more flexible and less driven by deadline pressures and more by stable growth in FDA resources.”

The deadlines imposed on the FDA’s drug-approval process were first enacted as part of the Prescription Drug User Fee Act (PDUFA) of 1992, which mandated that the FDA must act on 90 percent of all drug candidates within 12 months of submission or face funding cuts. The timeline was tightened to 10 months as part of the 1997 Food and Drug Administration Modernization Act, a timeline extended by Congress in 2002 as part of bioterrorism legislation and renewed again in 2007.