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I am pleased to present the Food and Drug Administration's (FDA's) fiscal year (FY) 2004 Performance Report to the President and the Congress for the Prescription Drug User Fee Act (PDUFA). This report marks the twelfth year of PDUFA, and completion of the second year of its most recent reauthorization (PDUFA III). Over the 12 years of PDUFA, the Agency has met or exceeded nearly all 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, it is important to ensure that drugs are used safely. Even with the best available data, drugs sometimes have side effects that were not predictable or detectable in studies conducted before their approval. 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 to safe and effective new drugs. By improving development efficiency and patient safety, these initiatives can also help in controlling health care costs.
The Agency has applied and extended many of the good ideas and process innovations pioneered in the PDUFA program to other FDA-regulated products. FDA's Strategic Plan goal for efficient risk management asserts that providing timely, high-quality, and cost-effective processes for the review of new technologies remains a high priority for the Agency.
Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of Food and Drugs