title: Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals.
abstract: After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns. We examined whether the frequency of these safety problems has increased since 1992, when the Prescription Drug User Fee Act, legislation designed to accelerate the drug approval process at the Food and Drug Administration, was passed. We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up). We could not establish causality, however. Our findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently.
authors.affiliation: Cassie Frank (cfrank@challiance.org) is an instructor of medicine at Cambridge Health Alliance and Harvard Medical School, in Boston, Massachusetts.
authors.forename: Cassie
authors.initials: C
authors.lastname: Frank
authors.affiliation: David U. Himmelstein is a professor at the School of Public Health, City University of New York (CUNY).
authors.forename: David U
authors.initials: DU
authors.lastname: Himmelstein
authors.affiliation: Steffie Woolhandler is a professor at the School of Public Health, CUNY.
authors.forename: Steffie
authors.initials: S
authors.lastname: Woolhandler
authors.affiliation: David H. Bor is an associate professor of medicine at Cambridge Health Alliance and Harvard Medical School.
authors.forename: David H
authors.initials: DH
authors.lastname: Bor
authors.affiliation: Sidney M. Wolfe is a senior adviser at the Health Research Group, Public Citizen, in Washington, D.C.
authors.forename: Sidney M
authors.initials: SM
authors.lastname: Wolfe
authors.affiliation: Orlaith Heymann is a research assistant at Boston Medical Center and the School of Medicine, Boston University, in Massachusetts.
authors.forename: Orlaith
authors.initials: O
authors.lastname: Heymann
authors.affiliation: Leah Zallman is an instructor of medicine at Cambridge Health Alliance and Harvard Medical School.
authors.forename: Leah
authors.initials: L
authors.lastname: Zallman
authors.affiliation: Karen E. Lasser is an associate professor of medicine at Boston Medical Center and the School of Medicine, Boston University.
authors.forename: Karen E
authors.initials: KE
authors.lastname: Lasser
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007880:Legislation, Drug / Q000592:standards; D008297:Male; D061214:Patient Safety; D055553:Prescription Drugs; D057051:Product Recalls and Withdrawals; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D055553:Prescription Drugs
keywords: Pharmaceuticals; Quality Of Care