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After approval, many prescription medications that patients rely on subsequently receive new black-box warnings or are withdrawn from the market because of safety concerns.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 We found that drugs approved after the act's passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up).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

Evaluation of technologies approved for supplemental payments in the United States

“…The studies supporting NTAP approval of new technologies often lacked features of high quality research design and were prone to bias. Although higher quality studies are possible, they are often not done in order to minimise time and expense to the manufacturer, creating potential patient safety concerns 35. This problem exists internationally.…”

Healing an ailing pharmaceutical system: prescription for reform for United States and Canada

“…Canadian and US regulatory agencies too often allow unsafe drugs to reach the market73747576 and inadequately monitor them after approval 777879. Both agencies’ independence has been eroded by their reliance, starting in the 1990s, on funding from fees paid by drug companies.…”

Existing FDA Pathways Have Potential To Ensure Early Access To, And Appropriate Use Of, Specialty Drugs

“…24 The agency could, as some drug safety experts have suggested, add special symbols to the labeling of specialty drugs to indicate their newness to the market and the limited evidence of their efficacy. 25 In the European Union, a black triangle is placed on the labels of new medications for their first five years on the market, signaling that the drug will be subject to intense regulatory monitoring. The black triangle encourages European physicians and patients to become active partners in learning about recently approved drugs by reminding them to report adverse drug reactions.…”