Dirty Politicians Pressured the FDA to Approve Something Unsafe? Say It Ain't So.

The New York Times reported that the FDA is investigating one of its past approval decisions, publicly questioning for the first time whether or not political pressure unduly influenced an outcome.

Wait, what?

This is the first time the agency has publicly questioned if politics played a role in its decision-making? I’m not surprised it happened; I’m surprised this is the first time they’re admitting it.

The FDA is no stranger to heavy-handed politicking. Remember that little Plan B emergency contraception fiasco a few years back? The one where the agency’s scientists wanted to approve the drug over-the-counter for 17-year-olds and the Bush administration appointees delayed a decision for three years, acting only when forced by Congress, and then set the age-limit at 18?

That black cloud is still hanging over the agency’s head. Earlier this year, a judge ordered the age-limit lowered to 17 and said the FDA’s actions had been driven by politics rather than science.

And then there was the controversy around Dendreon’s prostate cancer vaccine Provenge (sipuleucel-T), where some of the FDA-appointed advisory committee members tasked with providing recommendations about approval had financial conflicts of interest, and there were rumors of a turf war between CDER and CBER. Remember that little gem?

This time around the story is that Menaflex, a knee surgery device made by ReGen Biologics, failed its clinical trial and was heading toward FDA rejection. But then ReGen donated $26,000 to Senators Robert Menendez and Frank Lautenberg and Representatives Frank Pallone Jr. and Steven Rothman, who put “extreme” and “unusual” pressure on the FDA until it issued an approval.

So $26,000 is the going rate to buy approval of an undeserving product these days, huh? Makes you wonder how often politics play a role behind the scenes but it doesn’t make the papers.

FDA Badge photo by Flickr user larryzou@, CC.