One small step for humankind

That's pequeño, chiquitito, itty bitty, teeny weeny, but it's something. You may not have noticed what with the plane landing on I-95, more OJ, the MIT student wearing a fake bomb in the airport, and MoveOn.org publishing the single most offensive, treasonous, worthy-of-the-death penalty advertisement since uh, I dunno, Swiftboat Veterans for Truth -- oh, no, sorry, that wasn't offensive at all -- but Congress finally passed a reconciled version of the FDA reform bill. The LA Times makes it sound maybe a little too good: "Congress gave final approval Thursday to legislation designed to transform the Food and Drug Administration from a passive monitor to an active detective seeking out medications that have been approved for sale but turn out to be hazardous -- a problem linked to an estimated 15,000 deaths a year."

Yeah, that's sort of the idea, but the legislation isn't going to fundamentally change the drug approval process. It does include increased resources for post-marketing surveillance, and, if the FDA has good reason to think a drug might have a safety problem, it has more effective means of making drug companies do new safety studies. Right now, it often orders the studies, but the drug companies just ignore the order and there are no consequences. The legislation also requires public disclosure of more studies, including those unfavorable to a drug, and create greater transparency in the drug approval process.

This is better than nothing, but we still have only reduced, not eliminated major conflicts of interest in the drug approval process, nor have we required real proof that a new drug is better and safer than existing alternatives before it gets approval. Furthermore, efforts to ban direct to consumer advertising within the first six months after approval of a drug were eliminated from the bill thanks to the pharma lobby, although the FDA can "review" ads somewhat more aggressively. So we'll see how much of a difference this really makes.

But, at least it isn't nothing.