No oversight needed?

From Scott Hensley over at the Wall Street Journal's health blog:

"The malaise in Big Pharma is deepening, as 2007 shapes up as one of the slowest in years for new drugs.

Through Oct. 31, the FDA had approved just 15 drugs classified as “new molecular entities,” the designation for medicines that represent something really different. At that pace, the agency would greenlight just 18 new drugs (not counting vaccines or additional uses for existing drugs) by year-end, Peter Loftus of Dow Jones Newswires reports.

By comparison, FDA approved 22 NMEs last year, 20 in 2005 and 36 in 2004.

Some companies pin the blame on a skittish FDA. Safety worries since Merck withdrew painkiller Vioxx three years ago have put a chill on the agency, they say. FDA concerns have delayed several expected blockbusters, including Novartis’s diabetes drug Galvus and Sanofi-Aventis’s diet drug rimonabant, sold as Acomplia in Europe.

Right.  "Skittish." 

In related news, Congress passed and the President signed the Prescription Drug User Fee Act (PDUFA) last month to re-authorize the FDA to charge drug companies fees (about $1.1 million per), re-cycling the perverse incentives and conflict-of-interest between regulator and regulatee.