User Fees Increase Recalls And Warnings: Study
6 CommentsBy Ed Silverman // March 26th, 2008 // 5:08 pm
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 in The 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.”
Dan
PDUFA was clear tangible evidence of the collusion between the FDA and the pharma industry, as this Act has been revised since it’s origination to favor the pharma industry. My opinion, thier approval of meds needs to be more strict vs repeated attepts by pharma to achieve superiority at least twice over a placebo. Perhaps the FDA is under-staffed with the intent of the administration, yet the FDA was created to protect public citizens completely instead of maintaining alliances that progressively are more damaging to citizen. Clearly, this is not thier active role, the well-being of U.S. Citizens. More need to speak up on such issues. We have no one to support us, if you think about it, yet as citizens, we dictate the behavior of our government.
Lisa Van S
User Fees Increase Recalls,…. hmmm,.. Maybe because its a bad drug.
Bless The Truth
User fee is a legal “bribe” that hinder judicious evaluation of NDAS and BLAs. Big pharm use it to buy speed and action. FDA should do away with it to avoid bias.
Justice in Michigan
The study surprised me some because Dan Carpenter’s work has generally questioned the arguments over PDUFA. But stats is stats.
Bob Freeman
This is an admitedly cursory review but two red flags cause me some concern: 1) the odds ratios are not that impressive and 2) the 95 percent CIs for all odds ratios are quite large, indicating a lot of statistical noise is present in the analysis.
This does not mean the analysis is flawed; rather, this suggests the main value of the study is exploratory and not causal.
DV Jr
It’s possible that the reason these drugs came up against the deadline for approval was that FDA was concerned about their safety profile & needed more time to evaluate & debate before approving them. There’s an inherent (albeit unintentional) bias in comparing drugs that sailed through approval to drugs that required more scrutiny.