I’m not sure why we needed a study to prove it—but we’ve got one. Published in the New England Journal of Medicine is a Harvard study proving that, when the FDA approves a drug right before its deadline, there’s a four to five-fold chance it’ll be taken off the market or relabeled with stern health safety warnings.
As if the FDA wasn’t already tucked comfortably in Big Pharma’s back pocket, in 1992, Congress passed a law that would allow drug makers to pony up a few extra million dollars to get their drugs pushed through faster—an approval or rejection within 12 months.
In 1997 that deadline was squeezed down to 10 months. And sometimes as little as six months for cutting edge drugs considered to be of the highest priority.
So as not to sound like an outright bribe, the FDA—who’re forever crying poverty—are supposed to use the additional money to hire more reviewers so that all of the necessary diligence could be performed within the allotted period of time.
The caveat being, if the FDA misses a deadline, they lose out on that cash as well.
So it’s really no wonder that a significant number of drugs, approved in the last two months before deadline—arthritis drugs Vioxx and Bextra, diabetes drugs Rezulin and Avandia, and the cholesterol-lowering drug Baycol among them—are later recalled outright, or relabeled with stern safety warnings.
As opposed to drugs approved after the user-fee deadlines or those considered to be “slam dunks” that are approved almost immediately.
In the FDA’s defense, drug chief, Dr. Janet Woodcock said, “[The] FDA won’t approve a drug if we are not ready. And we have the option of denying approval altogether if there is any question about safety.”
And Janet is absolutely right. The problem lies in the fact that they don’t exercise that option with nearly as much discretion as they should.