Since the US government passed the Prescription Drug User Fee Act in 1992, new drug approvals have occurred twice as fast as previously, and there has been a significant increase in black-box warnings and withdrawals of drugs from the market for safety reasons, according to research published in Health Affairs.
A team of Cambridge Health Alliance, Harvard Medical School, Boston University and Public Citizen researchers examined all drugs that had been approved between 1992 and 2010 and compared the findings to earlier research. “We found that drugs approved after the act’s passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100.0 drugs versus 21.2 per 100.0 drugs at up to sixteen years of follow-up).”
The researchers could not establish causality; however, they wrote that, “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.”
Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals (Frank, Cassie et al. HealthAffairs. doi: 10.1377/hlthaff.2014.0122 Health Aff August 2014 vol. 33 no. 8 1453-1459)