FDA To Speed Generic Drug Application Reviews

Armen Hareyan's picture

Generic Drug Applications

FDAon Thursday announced that it is implementing a number of changes tospeed the approval process for generic drugs and reduce a backlog ofmore than 1,000 generic drug applications, the AP/Chicago Tribune reports.

Underthe plan, the agency said it immediately would begin processingapplications for generic drugs that have lost patent protection, ratherthan put them in line behind applications for other drugs that could bepatented for years. In addition, FDA will begin reviewing multipleapplications for the same drug at the same time and encourage companiesto submit more information using the Internet (AP/Chicago Tribune, 10/5).

Someof the other planned changes call for expediting reviews of drugs thatdo not already have generic alternatives; adding more generic drugreviewers to the staff of 215; developing and improving the applicationand document handling systems; and looking to other FDA departments andresources for assistance.


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

FDAsaid the agency's average application processing time is between 16 and17 months, although federal law requires generic drug applications tobe processed within six months (Cohen, Newark Star-Ledger,10/5). Beuhler said, "These applications represent a vast scope ofproducts -- and over half are still protected by patents. There is noway we could approve all of these applications," adding, "We had noanticipation that the number of generic applications would skyrocket asit did" in the last few years (Dixon, Reuters, 10/4).


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

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

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