Seriously, Congress? Our country is in financial turmoil, and you're worried about whether the Food and Drug Administration followed procedures about whether to allow an expert onto an advisory panel?
Congress is investigating whether the FDA was right to pull Dr. Sanjay Kaul off of the advisory panel for Eli Lilly's (NYSE:LLY) blood thinner prasugrel. Eli Lilly apparently suggested that the agency pull him off the panel because his publications and media interviews criticized the drug's safety. When the FDA calls an advisory panel, it's looking for opinions on whether it should approve the drug; it doesn't want panel members with an "intellectual bias."
But whether the FDA was right or wrong to pull Kaul off the advisory panel doesn't seem to really matter. The panel voted nine to zero to recommend approval of the drug, so Kaul's vote wasn't going to change the outcome. And besides, the panel's role is to advise the agency; the FDA ultimately makes the decision. And the agency had to read Kaul's opinion in order to determine that he had an intellectual bias, so his voice was actually heard.
Hopefully for Eli Lilly, this investigation won't further delay the approval of prasugrel. The company has been waiting for a decision since last June, and it should be given the chance to compete against Sanofi-Aventis (NYSE:SNY) and Bristol-Myers Squibb's (NYSE:BMY) blockbuster Plavix.
As far as I can tell, Congress needs to keep its nose out of scientific discussions. Nothing major seems to have come from investigations that Merck (NYSE:MRK) and Schering-Plough (NYSE:SGP) delayed the release of negative data on Vytorin, and I doubt much will come from their investigation of Advisory-Panelgate.
On second thought, the investigations aren't costing nearly as much as its other attempts at "helping," so maybe we should just let Congress keep on probing.
