FDA: Hyper-cautious or simply vigilant?

Two weeks ago, an FDA advisory panel voted against expanding Genentech's blockbuster Avastin for use against breast cancer. According to trial data, the drug hasn't been as effective in that disease as it has for colon and lung cancer, and it comes with some well known risks, such as bleeding, heart attack, and stroke. But based on the same data, European regulators gave their blessing to the treatment. What gives?

Though each drug approval is its own special case, some in the industry say decisions such as this one on Avastin show that the FDA has gone gun-shy. After much-publicized recalls and warnings--need we mention Vioxx, Bextra, Avandia, Trasylol, and the like?--the agency is afraid to approve because it fears possible backlash. Or so the theory goes. When the FDA held Novartis' new diabetes drug Galvus off the market, for instance, at least one analyst blamed the agency, not the med. "I think it has more to do with a cautious FDA," he said. "In other times, I don't think the FDA would have taken this step." And it's true that FDA approvals are way down this year. Through October 31, only 15 entirely new drugs got the FDA nod. Twenty-two were approved in 2006, and 36 in 2004.

Pharma execs aren't amused. "It just indicates to you that when bureaucrats come under pressure, they tend to choose the path of asking for more data, as opposed to approving the drug," Schering-Plough's CEO Fred Hassan told the Wall Street Journal.

The flip side of this coin is that the FDA has come under extreme fire in recent months as Chinese import scandals unfolded, implicating not only food oversight, but drug oversight, too. Its own science committee recently said that the FDA can't guarantee drug safety without some serious additional cash. And one of the reasons the FDA hasn't approved so many novel meds is that pharma hasn't filed as many new drug apps.

- read our special report on the top warnings and recalls of 2007