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FDA Completes Work on Three Drug User Fee Programs
Date:1/13/2012

SILVER SPRING, Md., Jan. 13, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.

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The programs include the fifth authorization of the Prescription Drug User Fee Act (PDUFA), and new user fee programs for human generic drugs and biosimilar biological products. Work on the proposals was concluded before the agency's mid-January deadline.

Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA's drug review activities while the FDA agrees to overall performance goals such as reviewing a certain percentage of applications within a particular time frame.

"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."

The proposed user fee programs for generic drugs and biosimilars are modeled on the successful PDUFA program "which has ensured a predictable, consistent, and streamlined premarket program for prescription drugs," Hamburg said.
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SOURCE U.S. Food and Drug Administration
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