I'm not sure this is what Nancy Reagan intended with "say No to Drugs".
As reported by John Caroll in Fierce Biotech yesterday, data from a new report by analysts at Concept Capital reveals FDA review panels are getting tougher on new drugs. The data says of 23 tries with NCEs, only 12 (52%) received the panel's recommendation. In 2008-09, that percentage was more than 75%.
New rules require review for most new therapies now. Thus more drugs are being reviewed and voted upon. Tougher-conflict of interest rules are forcing the FDA to pick less experienced reviewers -- the suggestion being they are being more cautious and thus more likley to vote negatively. One could be cyncial and say they are less cozy and less likely to rubber stamp too.
Either way, the job is getting tougher for drug makers seeking approval.
Posted by Bruce Lehr September 3rd 2010.
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