On April 12th, Alliance President & CEO Daniel Perry presented remarks at a public meeting on the reauthorization process for the Prescription Drug User Fee Act (PDUFA). PDUFA IV, currently set to expire in September of 2012, authorizes the Food and Drug Administration (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 FDA 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.
The PDUFA reauthorization process has historically been conducted through negotiations between the Agency and regulated industries, however the current round of negotiations are open to broader participation and transparency. The FDA will be seeking feedback from patient and consumer groups as well as the general public before entering into formal negotiations with industry and also before submitting its recommendations to Congress. This meeting was the first opportunity the patient community had to comment on how it views the performance of PDUFA and what elements should be reconsidered in the PDUFA V reauthorization.
In his remarks, Mr. Perry stressed the importance of FDA increasing stakeholder involvement in the regulatory process to address any barriers that slow patient access to new therapies. He also emphasized the need for FDA to have the ability to play a more significant role in encouraging the development of new therapies for diseases like Alzheimer’s disease, by providing guidance on streamlining clinical trial designs, the qualifying biomarker for use in development, and assessing the benefits and risks of new therapies post-approval so as not to delay treatments for patients who may benefit from them. Lastly, Mr. Perry highlighted the fact that user fees cannot be the sole source of support for the FDA; they must be balanced with Congressional appropriations. The full text of Mr. Perry’s remarks can be downloaded from the link on this page.