Have Faster FDA Drug Approvals Caused More Safety Problems?

by Cassie Frank,David U. Himmelstein, Steffie Woolhandler, David H. Bor, Sidney M. Wolfe, Orlaith Heymann, Leah Zallman and
Karen E. Lasser,

A new study indicates that may be a fact.

After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns.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 We found that drugs approved after the act’s passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up).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

Put another way, for every 100 drugs arriving in pharmacies, there were 34 withdrawals or Black Box warnings during that time period. Half of the new warnings appeared within 12 years after a drug was launched and half of the withdrawals occurred within five years.

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