PDUFA renewed for five years

August 1, 2002

Pharmaceutical Representative

The Prescription Drug User Fee Act has been reauthorized for another five years.

The Prescription Drug User Fee Act, which was passed in combination with the "Public Health Security and Bioterrorism Preparedness and Response Act," has been reauthorized for another five years.

The law, known as PDUFA III, authorizes the Food and Drug Administration 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. The agency is also authorized to spend $70 million of the user fees to increase the surveillance of the safety of drugs during the first two or three years on the market to identify and counter adverse side effects that did not appear during clinical trials.

"PDUFA will be stronger and more effective than ever," said Deputy FDA Commissioner Lester M. Crawford. "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 the FDA into an even more efficient agency, while maintaining our high standards of safety."

Pharma, biotech companies approve

The reauthorization of the PDUFA has been praised by the Biotech Industry Organization and the Pharmaceutical Research and Manufacturers of America, both based in Washington.

"The five-year PDUFA renewal will ultimately help transform the promise of the Human Genome Project into direct medical benefits for patients suffering disorders such as Alzheimer's and Parkinson's disease, various genetic diseases, cancer, and autoimmune diseases," said BIO President Carl B. Feldbaum. "BIO fully supports passage of this legislation."

"The reauthorization of PDUFA is a major victory for patients," said Alan F. Holmer, president of PhRMA. "It will enable the FDA to build on the great progress it has already made under the user-fee law during the past decade in reducing drug-review times while fully preserving the highest safety standards of any drug-regulatory agency in the world." PR

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