Prescription Drug User Fee Act

For nearly 20 years, the mission of the Prescription Drug User Fee Act has been to advance public health, safeguard patient safety and give patients more timely access to new, life-saving medicines. The program was created in response to a perilous regulatory bottleneck that slowed patient access to the medicines.

PDUFA has been reauthorized and amended on a bipartisan basis three times since its 1992 enactment. Tens of millions of Americans who rely on innovative medicines to improve and extend their lives have benefited from the transformation of the Food and Drug Administration into a more effective, efficient regulatory agency during the PDUFA years.

Under PDUFA, America’s biopharmaceutical research companies pay user fees to help fund the FDA, providing crucial resources to significantly increase the number of highly qualified staffers who monitor drug safety and review new drugs and biologics. In an era of scarce resources, this influx of funding has given patients timely access to more than 1,100 new medicines and cutting-edge biologic therapies.

Despite its considerable progress, the FDA has suffered recent setbacks. By its own admission, the agency has struggled to make new medicines available to patients efficiently and to give physicians additional tools in the fight against serious and life-threatening diseases. FDA missed user-fee goals for nearly 40 percent of certain priority drug and biologics applications it reviewed in fiscal year 2008.

It is essential to return to the original mission of PDUFA: New drug reviews must be accomplished in a way that is efficient, predictable and well-coordinated within FDA.

All drugs have benefits as well as risks. It is critical that the FDA appropriately balance its approach to new drug reviews, making regulatory decisions through a consistent, transparent and science-based process that protects and promotes public health and safety.

For this reason, PhRMA is encouraged by recent remarks by FDA Commissioner Margaret Hamburg, who, according to press accounts, stressed the need to strengthen the integration of benefit and risk assessment throughout the review of medicines. Creating an independent, post-market office on drug safety, as some have advocated, “would be a mistake,” Hamburg was quoted as saying. She said that approach would further separate safety and efficacy.

For additional information on the FDA, please visit the FDA section of the PhRMA web site. And, to learn more about the U.S. drug oversight process, please visit the “Drug Safety” page of our site.

News

PhRMA's Views On PDUFA Reauthorization
Dr. David E. Wheadon, PhRMA's senior vice president for science and regulatory affairs, testifying to the FDA: PDUFA "can play a critical role in making more life-saving medicines available to patients in a timely manner, strengthening the scientific base of the FDA and providing a steady, reliable stream of resources for agency scientists."

Resources

PDUFA Annual Reports And Plans
The FDA must submit annual performance and financial reports on PDUFA to Congress and the president each fiscal year. The agency publishes those reports online here.