Jun. 01, 2012

PDUFA Reauthorization is critical to millions of Americans with chronic diseases

The Prescription Drug User Fee Act (PDUFA) authorizes the U.S. Food and Drug Administration (FDA) to collect an application fee, also known as user fees, from drug manufacturers when they submit an application for approval of a new drug.  The law designates that user fees are only for use by the Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research(CBER) for review and take action on a new drug.  PDUFA was passed by Congress in 1992 to provide the FDA with the necessary additional resources to help expedite the drug approval process, which in turns helps make new drugs available to patients in a more timely and efficient manner.  PDUFA must be renewed every five years.

At this time, the U.S. House of Representatives and the U.S. Senate have passed their versions of the PDUFA reauthorization, and they will work to reconcile their differences in the coming weeks.  Congress anticipates passing a final bill by its 4th of July recess.

Lupus Foundation of America President and CEO, Sandra C. Raymond, drafted an opinion piece published recently in The Hill newspaper, which covers the activities of Congress and the federal government.

Read Sandra Raymond’s Op Ed piece published May 21, 2012 in The Hill.


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