The Prescription Drug and User Fee Act is regularly blamed for pushing the FDA to rush approvals and causing unanticipated safety problems. And so researchers examined outcomes for drugs approved two months prior to their PDUFA dates and those approved at other times and guess what they found? The PDUFA system led to more recalls and an increased likelihood that a drug will receive a Black Box warning, according to the study inThe New England Journal of Medicine.
You may recall that PDUFA was begun in 1992 and ushered in a new era in which drugmakers pay so-called users fees to the FDA to speed the approval process. Since then, however, the system has been widely criticized for turning the FDA into an arm of industry that focuses more attention on approval and less on safety.
The researchers tracked the timing of approvals before and after PDUFA was implemented, going back as far as 1950. And they found that after PDUFA, approvals were grouped close to deadlines set by the law. "You see all this piling ahead of the deadlines, and you have the piling of error," co-author Dan Carpenter of Harvard University tells Reuters.
The study contends that withdrawals are more than 5 times more common, Black Box warnings of serious side effects are more than 4 times more likely, and the chance that at least one dosage trength would be discontinued was more than 3 times greater when drugs are approved just before the deadline set by the user fee system.
Carpenter says the results should be understood from the perspective that "the FDA is pretty flexible already. If a drug is a cancer drug with good pretty data, or a drug for a life-threatening disease, they give it a priority rating and rocket it on through," he tells Reuters. "What you have to call into question is why Vioxx got a priority rating. Every time you give something a priority rating you're taking scarce resources away from other drugs."