A version of this Health Alert appeared at Forbes.
The media gave some attention to a new study, which suggests that the Food and Drug Administration (FDA) recklessly allows unsafe new prescription drugs onto the market. The research supports a longstanding suspicion that the Prescription Drug User Fee Act (PDUFA), first passed in 1992 and renewed every five years, has caused the FDA to view the research-based pharmaceutical industry as a “partner” and source of revenue, rather than a regulated industry.
Before PDUFA, the FDA was funded by general appropriations. PDUFA has allowed the FDA to increase its revenue by user fees, which drug-makers agree to pay for new drug approvals or facilities inspections. PDUFA was last renewed in 2012. At the time, I endorsed the renewal because there was no likelihood of Congress reducing the FDA’s power: PDUFA was the best way to ensure drug approvals kept moving at the FDA.
These researchers think that’s a bad thing. According to the lead author, Cassie Frank, a physician at Harvard Medical School: “The FDA is under constant pressure to rush new drugs through the pipeline to approval. In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through. By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal.”
This conclusion is sensationalist, to put it mildly.
The authors examined drugs approved from 1975 through 2009 and found that drugs approved after PDUFA’s passage were more likely to receive a new black-box warning or be withdrawn than drugs approved before its passage (26.7 per 100 drugs versus 21.2 per 100 drugs at up to sixteen years of follow-up).
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