FDA getting tougher with refuse-to-file letters

More bad news on the big drought of new drug approvals. Not only are approvals at a 25-year low while non-approvable letters and black box warnings are on the rise. Now the RPM Report says that "refuse-to-file" letters are also spiking. Last year there were eleven refuse-to-files, compared to three in 2004 and four in 2005. Last year there were seven. And the 11 refusals, where the agency rejects an application for review, are particularly disturbing when you compare it to the 19 NCE approvals last year [1]. FDA officials say the drug developers should have seen it coming.

"There's a factor in there of inexperience and lack of regulatory savvy, but also maybe they get too invested or too wedded to their product and can't see the forest by being buried in the application," New Drugs Director John Jenkins tells RPM. "We do see cases where it's so clear to us that this isn't going to get approved."

- read the story [2] in the RPM Report

ALSO: The RPM Report is predicting--or perhaps just speculating--that the FDA is gearing up for a significant crackdown on drug investigators. Report [3]

Related Articles:
2007 FDA approvals. Report [1]
Dry spell or parched desert for NME approvals? Report [4]
New drug approval lags in 2007. Report [5]
FDA quick to reject drugs as it gets more cautious. Report [6]