Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals
- Cassie Frank ( [email protected] ) is an instructor of medicine at Cambridge Health Alliance and Harvard Medical School, in Boston, Massachusetts.
- David U. Himmelstein is a professor at the School of Public Health, City University of New York (CUNY).
- Steffie Woolhandler is a professor at the School of Public Health, CUNY.
- David H. Bor is an associate professor of medicine at Cambridge Health Alliance and Harvard Medical School.
- Sidney M. Wolfe is a senior adviser at the Health Research Group, Public Citizen, in Washington, D.C.
- Orlaith Heymann is a research assistant at Boston Medical Center and the School of Medicine, Boston University, in Massachusetts.
- Leah Zallman is an instructor of medicine at Cambridge Health Alliance and Harvard Medical School.
- Karen E. Lasser is an associate professor of medicine at Boston Medical Center and the School of Medicine, Boston University.
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After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns.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 We found that drugs approved after the act’s passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up).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.
