Reasons for the tougher regulatory environment, according to Baghdadi? “First, the FDA is bringing more drugs in front of advisory panels due to changes in FDA law that require most new drugs to be reviewed by outside experts,” the article notes. “Second, stricter conflict of interest rules implemented by FDA (in the wake of the 2007 reform law) have made it more difficult for the agency to recruit experienced panel members.”
If inexperienced members without conflicts of interest are more prone to voting no, how does that explain 2007, when the current rules weren’t in place and there were still 50 percent “no” votes?
Here’s my analysis: Generally speaking, the FDA calls advisory committees for two reasons: either its staff is internally divided or uncertain of its analysis of the safety and efficacy of a particular new drug application; or, it is looking for the outside panel to ratify what is going to be a controversial decision. In the former case, one would expect votes to go about 50-50. It’s like a well designed clinical trial where the observers truly don’t know what the outcome will be. You’d expect success — or failure — about half the time.
As for “ratification” votes, I’d look to the shifting political environment for an explanation. The FDA serves two constituencies: people and organizations primarily concerned about bringing new drugs to market (industry, many clinicians and patient advocacy groups) and those primarily concerned about drug safety and overutilization. FDA decisions generate controversy whenever they alienate either side.
In the wake of the Vioxx scandal, safety advocates have recouped some ground lost during the 1990s and the first half of the last decade, when the agency became overly industry friendly. These days, I would put their influence at the FDA about on par with industry, i.e., the odds of the FDA making a controversial decision requiring advisory committee ratification are about 50-50.
The 2008 and 2009 high approval numbers marked the end of an era when advisory committees served as rubber stamps for an industry-friendly FDA. Let’s hope this year’s votes mark the beginning of a new, more scientific era.
(Hat tip to FDAWebview – subscription required – for alerting me to TheStreet.com story.)