FDA has completed programs for rapid review of generic drugs

Generic drugThe Food and Drug Administration (FDA) has completed its three user fee programs that would collect hundreds of millions of dollars as fees from pharmaceutical companies. This program will help to speed up the review of generic drugs under an agreement as reported by FDA Commissioner Margaret A. Hamburg, M.D. today.

Kathleen Sebelius, Health and Human Services Secretary, have transmitted the recommendations to the Congress today.

The programs are composed of fifth authorization of the Prescription Drug User Fee Act (PDUFA) as well as novel user fee programs for human generic drugs and related biological products. The proposals will be completed by the mid-January.

Under this program, the industries agreed to help fund a portion of the FDA’s drug review and the FDA permits to perform certain operations and achieve goals within a specific time frame. According to Generic Pharmaceutical Association, most new drugs are reviewed in 10 months; typically it takes 30 months to review a generic drug. Moreover, FDA has an accumulation of 2000 generic drugs to be reviewed. Annually, FDA gets 800-900 new generic-drug-related applications.

“These final recommendations offer a great example of what can be achieved when the FDA, industry and other stakeholders work together on the same goal,” Hamburg said. “At a time of greater budgetary constraint, user fees provide a critical way for leveraging appropriated dollars, ensuring that FDA has the resources needed to conduct reviews in a timely fashion.”

Said Hamburg: “Human drug user fees have revolutionized the drug review process in the United States since they were adopted 20 years ago, allowing the FDA to speed the application review process without compromising the agency’s high standards.”

According to Hamburg, U.S. will lead the world in first introduction of novel drugs as a result of investment of PDUFA resources.

“These agreements are important because they are a substantial resource that lets the agency carry out its mission of protecting patients and ensuring important products come to market in a timely way,” said Allan Coukell, director of the Pew Charitable Trusts’ health advocacy group. “For the first time we will also have funding directed at increasing FDA’s inspection of foreign manufacturing facilities.”

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