US FDA's PDUFA reauthorization gets backing from PhRMA and AAR

The US Food and Drug Administration held a public meeting on April 12, to discuss the reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA IV, currently set to expire in September 2012, authorizes the FDA to collect user fees from companies wishing to submit their products for agency review. The intention is that the fees would be used to provide an additional revenue stream for the agency to hire more staff, improve systems and establish a better managed drug review process to speed up the delivery of needed therapies to the public.

Testifying at the hearing, Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president for scientific and regulatory affairs David Wheadon stated: 'The FDA is a cornerstone in our country's efforts to improve the health of all Americans. One of the agency's most important functions is to protect the public health by assuring the safety, efficacy and security of human drugs and biologic products. Another key function is to promote the public health by ensuring that innovative medicines are brought to patients without unnecessary delay. For nearly 20 years, PDUFA has helped the FDA fulfill this dual mission.

PDUFA has been a success for patients and for the public health, he said. In an era of scarce resources, PDUFA user fees have provided the Agency with critical resources necessary to bring needed medicines to patients. While we have been heartened that FDA leadership has embraced the need to advocate for an empowered Agency that is fully funded through enhanced Congressional appropriations, we support a reauthorization of PDUFA in 2012 to bolster these resources.