FDA deadlines may compromise drug safety by rushing approval

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 Drugs fast-tracked by the FDA are more likely to eventually be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labeling changes, according to Daniel Carpenter, professor of government in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...

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