Tuesday, October 9, 2007

FDA To Hire More Staffers for Generic Application Processing

I just thought this was interesting. Off the AP Wire.

WASHINGTON_The Food and Drug Administration on Thursday unveiled a plan to speed up the approval of generic drugs and address a backlog of hundreds of applications.

FDA officials outlined a half dozen recent changes that it said will streamline how the agency processes applications for cheaper versions of branded drugs.

Perhaps most significantly, FDA said it would immediately begin processing applications for generic drugs that have lost patent protection. Previously these applications would sit in a queue behind applications for drugs that might still be patented for years.

FDA also said it hopes to hire additional employees beyond the 215 staffers who currently review generic drug applications. Whether FDA has funding to hire new reviewers depends on whether Congress approves the agency's budget request later this year.

Unlike makers of traditional drugs, generic drug companies do not pay user fees to help offset the cost of hiring drug reviewers. Efforts to set up generic drug user fees have been opposed by the Generic Pharmaceutical Assocation, whose members include Barr Pharmaceuticals Inc., Mylan Laboratories Inc. and Teva Pharmaceutical Industries Ltd.

The industry group reacted coolly to FDA's initiative, saying the best way to speed up generic drug approvals is to outlaw tactics which branded companies use to protect their drug patients.

"For years, the agency has tinkered around the edges with programs and initiatives designed to increase efficiency but have proven to yield little in the way of significant results," said Kathleen Jaeger, the group's president. "There are serious legislative and regulatory issues that must be addressed to yield a true increase in the number of affordable generics brought to market."

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