Publications
Alliance President Makes Remarks at a Hearing on Prescription Drug User Fee Act Reauthorization
| Type: | Document, Testimony |
| Date: | November 2011 |
| Related Topics: | Drug Development, Federal Funding, Policy |
On October 24th, Alliance President & CEO Daniel Perry presented remarks at a public meeting on the fifth reauthorization of 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 allowed for patient groups to engage in monthly consultations with FDA representatives to enable all stakeholders to have an early voice in shaping the PDUFA V agreement.
In his remarks, Mr. Perry 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 by increasing their capacity to qualify biomarkers and other endpoints for use in development, and to continue assessing the benefits and risks of new therapies post-approval so as not to delay treatments for patients who may benefit from them.