2002.06.18:PDUFA Reauthorization Good for American Patients

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FOR IMMEDIATE RELEASE
Tuesday, June 18, 2002

Contact:

FDA Press Office
(301) 827-6242

PDUFA REAUTHORIZATION GOOD FOR AMERICAN PATIENTS

HHS Secretary Tommy G. Thompson today called the recently signed reauthorization of the Prescription Drug User Fee Act (PDUFA) an important law that will be good for all American patients by providing more resources for the Food and Drug Administration (FDA) to review new drug applications in a timelier manner.

"Americans deserve timely access to potentially lifesaving new drugs as soon as possible once they are proven safe and effective," Secretary Thompson said. "This law will ensure that the FDA has the expert staff and resources to promptly review applications and get safe, effective new drugs into the hands of the people who need them."

The reauthorization of PDUFA was included in the bioterrorism legislation passed last month by both houses of Congress, and was signed into law by the President on June 11th.

"PDUFA will be stronger and more effective than ever. With the additional resources and an enhanced ability to monitor safety of new drugs as they enter the marketplace we're taking a step forward in transforming FDA into an even more efficient agency, while maintaining our high standards of safety," said Deputy FDA Commissioner Dr. Lester M. Crawford.

The law's provision authorizing the third five-year extension of the Prescription Drug User Fee Act (PDUFA) of 1992 is of great significance for the FDA's drug review process. It maintains the high performance goals of PDUFA II, which included greatly reduced drug review times and increased and accelerated consultations between the FDA and the product sponsors. In addition, PDUFA III meets two major FDA goals by remedying resource shortages that have affected the program in recent years.

The law puts PDUFA III on sound financial basis by authorizing the agency to collect $1.2 billion in user fees over the next five years. This will enable the FDA to increase the staffing of the drug program by 450 full-time employees, and improve their working conditions and training. Equally important is the authorization to spend $70 million of the user fees to increase the agency's surveillance of the safety of drugs during the first two (or, for potentially dangerous medications, three) years on the market. It is during this initial period, when new medicines enter in wide use, that the agency is best able to identify and counter adverse side effects that did not appear during the clinical trials.

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