The WSJ reports that the FDA and generic-drug producers have reached a general agreement to set up a user fee program to speed the review of drug applications and also to pay for more inspections of foreign (ex-US) manufacturing plants. The initial year's funding from the drug industry is expected to reach up to $299 million.
The drug manufacturers are happy to have a possible mechanism to speed reviews and approvals as they say it can take up to 2 1/2 years now. The initial funding to kick off the program will come largely from the companies that have drug in the approval queue at present. New fees will be donated as new applications for approval are submitted. With regard to inspections, the fee system hopefully will allow the FDA to up its inspection rate of foreign facilities - currently at a low 36% of all 3700 drug facilities overseas.
It's great that the two sides can agree on a path forward that appears to serve both groups needs. Now, we only need to get Congress to endorse the program as a solution.
Posted by Bruce Lehr Aug 15th 2011.
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