FDA to accelerate approval of generic drugs

updated 9:15 p.m. ET Oct. 12, 2007

The Food and Drug Administration on Oct. 4 unveiled a plan to speed up the approval of generic drugs and address a backlog of more than a thousand 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.

Other changes include reviewing multiple applications for the same product at the same time and urging companies to submit more information over the Internet.

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.

Generic drug submissions to FDA have more than doubled over the last five years, and the agency approved a record 682 generics in fiscal 2007. There are 1,300 applications still awaiting review at FDA.

Whereas traditional drug makers pay user fees to help FDA offset the cost of hiring drug reviewers, generic drug makers do not.

And efforts to set up generic drug user fees have been opposed by the Generic Pharmaceutical Association, 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 patents.

"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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