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I am pleased to announce that a new plan for reauthorizing the highly successful Prescription Drug User Fee Act (PDUFA) program has been developed and is ready for consideration by Congress. This proposal was developed with the involvement of health professionals, patient groups, industry and the general public. Its adoption would not only ensure the continuation of this program, but promises to enhance its benefits in some important new ways.

The PDUFA program has transformed the United States into the world leader in the rapid development and review of new medicines. The American people now have unprecedented access to cutting edge therapies - therapies that still meet the same rigorous standards for safety and efficacy that have made Food and Drug Administration (FDA) approval the "gold standard" of the world.

Despite its overall success, this program is at risk of being seriously underfunded, due to unforeseen changes in drug submission patterns and other factors. The new proposal addresses these problems and establishes a financial structure that should put the program on a sound footing for the foreseeable future.

In addition, this proposal would provide FDA with significantly expanded resources for risk management activities related to medicines -- especially after they enter the marketplace. These risk management activities are essential for maximizing the benefits of medicines, minimizing their risks and continue to protect the health of the American people.

Reauthorization of PDUFA is a winning proposition for public health, and is crucial to ensuring that Americans will continue to enjoy access to medicines that can lengthen and improve their lives.

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