Analysts at the Washington Research Group recently dissected the decisions of the FDA's influential expert panels to see which ones were the toughest. Overall, according to a piece in the Wall Street Journal's Health Blog, 70 percent of the new apps that came the experts' way were endorsed by the committees. But once you break it down by category, the track records vary considerably.
At the top of the toughest critics list you'll find the oncologic drugs committee, which recommended only 12 of 22 apps, slightly more than half. Then there's the peripheral and central nervous system drug advisory committee, which is seven for seven in favor. The anti-viral panel registered an 80 percent thumbs up score with the lightly used gastrointestinal and reproductive health panels each scoring 60 percent positive. The endocrinologic and metabolic drugs panel--seven yeas and one nay over four years--now faces a relatively grueling schedule for a slate of new obesity drugs up for an approval.
One of the authors, Ramsey Baghdadi, told the blog that the panels appear to make their decisions on a simple, case-by-case basis, with no indication that they're more heavily influenced by either safety or efficacy.
- here's the story from the Wall Street Journal