Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals

Health Aff (Millwood). 2014 Aug;33(8):1453-9. doi: 10.1377/hlthaff.2014.0122.


After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns.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 We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up).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.

Keywords: Pharmaceuticals; Quality Of Care.

MeSH terms

  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Drug Approval* / legislation & jurisprudence
  • Drug Labeling*
  • Drug-Related Side Effects and Adverse Reactions*
  • Female
  • Humans
  • Legislation, Drug / standards
  • Male
  • Patient Safety
  • Prescription Drugs
  • Product Recalls and Withdrawals*
  • Time Factors
  • United States
  • United States Food and Drug Administration*


  • Prescription Drugs