FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FY 2003 PERFORMANCE REPORT TO THE PRESIDENT AND THE CONGRESS

for the

Prescription Drug User Fee Act of 1992

as reauthorized and amended by the

Food and Drug Administration Modernization Act of 1997

and the

Public Health Security and Bioterrorism Preparedness and Response Act of 2002


Food and Drug Administration
Department of Health and Human Services

Commissioner's Report

I am pleased to submit the Food and Drug Administration's FY 2003 Performance Report to the President and the Congress for the Prescription Drug User Fee Act (PDUFA). This report marks the eleventh year of PDUFA, and completion of the first year of its most recent reauthorization (PDUFA III). Over the 11 years of PDUFA, the Agency has met or exceeded nearly all of the PDUFA goals, drug approval time has been cut almost in half, and the Agency has maintained its traditionally high standards for safety and effectiveness.

PDUFA I challenged the Agency with goals to speed agency review of new drug applications (NDAs) and biologics licensing applications (BLAs) without compromising safety. PDUFA II added goals to improve the speed of drug development before submission of the NDA or BLA.

PDUFA III expands on those efforts by adding new goals and initiatives to further improve the quality and efficiency of drug development, review, and risk management for newly approved products. The need for these improvements is significant. By some estimates, it costs more than $800 million and takes more than a decade to develop a new drug. After approval, drugs must be safely used and new safety findings can emerge. Adverse drug events result in an estimated 770,000 injuries and deaths each year. Elderly patients, who take more medications and have greater drug sensitivity, are particularly vulnerable to these risks.

PDUFA III initiatives can have a public health impact beyond the earlier market access for safe and effective new drugs. By improving development efficiency and patient safety, these initiatives can also help in controlling health system costs.

Many of the good ideas and process innovations pioneered in the PDUFA program have now been applied and extended to other FDA-regulated products in the FDA's Strategic Plan goal for efficient risk management: to provide timely, high quality and cost-effective processes for the review of new technologies.

Mark B. McClellan, M.D., Ph.D.
Commissioner of Food and Drugs

Table of Contents

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility

FDA Office of Planning