During a conference call with investors yesterday, Cardiome's President and Chief Business Officer, Doug Janzen, had some interesting thoughts on the slow approval process at the FDA:
"The FDA has actually come out and said it will be missing (PDUFA) dates... I think everyone is in a brand new environment... actually, some of the old-timers in the industry are talking about we're back in the old environment where the FDA just doesn't deal with timelines. They're missing PDUFA dates, they're missing type-C meetings, they're missing meetings to discuss protocol..."
Janzen's comments stem from the approval delay of Cardiome's intravenous drug vernakalant for atrial fibrillation. Despite being approved by an expert committee, the company has been awaiting FDA approval since the drug January 19th PDUFA date. His observations highlight the ongoing problems at the FDA. The agency is struggling to meet PDUFA dates, ensure food and drug safety, and maintain enough staff to deal with it's ever-growing list of responsibilities.
On the subject of PDUFA dates, however, it seems that an approval delay may be preferable to a hastily-made decision. Just yesterday a Harvard analysis found that that drugs approved in the two months leading up to the deadline are four to five times more likely to be withdrawn or require serious safety warnings. So is it better for the FDA to scramble to meet deadlines--and possibly miss safety problems--or miss the approval date that companies pay hefty fees for the FDA to meet?
- read the Motley Fool piece
- check out Cardiome's financial results
ALSO: Speaking of that study, the FDA says that it can't replicate the Harvard study's numbers. The agency is sending a detailed letter disputing the results to the New England Journal of Medicine, which published the research. Report