FDA To Speed Generic Drug Application Reviews

Main Category: Regulatory Affairs / Drug Approvals
Article Date: 08 Oct 2007 - 12:00 PDT

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FDA on Thursday announced that it is implementing a number of changes to speed the approval process for generic drugs and reduce a backlog of more than 1,000 generic drug applications, the AP/Chicago Tribune reports.

Under the plan, the agency said it immediately would begin processing applications for generic drugs that have lost patent protection, rather than put them in line behind applications for other drugs that could be patented for years. In addition, FDA will begin reviewing multiple applications for the same drug at the same time and encourage companies to submit more information using the Internet (AP/Chicago Tribune, 10/5).

Some of the other planned changes call for expediting reviews of drugs that do not already have generic alternatives; adding more generic drug reviewers to the staff of 215; developing and improving the application and document handling systems; and looking to other FDA departments and resources for assistance.

Gary Beuhler, FDA's director for generic drugs, said the plan is intended to help FDA "keep pace with the increasing number of generic applications" by using new resources so the agency "can review and approve even more high-quality generic drugs during the upcoming fiscal year than it did in 2007." FDA approved 682 generic drug applications in FY 2007 -- a 30% increase compared with FY 2006. The agency also has a backlog of more than 1,300 drug applications, up from about 780 applications in December 2005.

FDA said the agency's average application processing time is between 16 and 17 months, although federal law requires generic drug applications to be processed within six months (Cohen, Newark Star-Ledger, 10/5). Beuhler said, "These applications represent a vast scope of products -- and over half are still protected by patents. There is no way we could approve all of these applications," adding, "We had no anticipation that the number of generic applications would skyrocket as it did" in the last few years (Dixon, Reuters, 10/4).

Reaction
Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association, in a statement said the FDA plan "in name only simply will not get the job done," and the FDA instead must "address the core fundamental issues," such as the citizen petition process, scientific consults, improved communication, and better oversight, accountability and organization of the Office of Generic Drugs program.

Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies Chair Herb Kohl (D-Wis.) said, "For years, the FDA has been trying to work through a tidal wave of new generic drug applications without the resources to handle them," adding, "We reversed that by boosting their budget to hire more reviewers, and now we know that effort is paying off" (Carey, CQ HealthBeat, 10/4).

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