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PDUFA V Can Help Patients and the FDA

June 30, 2011   |   Alliance for Aging Research Team   |   FDA & Regulatory Policy

On June 26, 2011 I was interviewed by BioCentury This Week to share the Alliance for Aging Research’s impressions on the fifth reauthorization of the Food and Drug Administration’s Prescription Drug User Fee program. Thanks to Congress, we and other active patient groups were able to lend an early voice in helping to shape how user fees might be used to help speed the delivery of better treatments and cures to patient in need of relief from Alzheimer’s, Cancer, Parkinson’s and many more diseases.

As you’ll see from the segments below, we believe that the FDA heard the calls from the patient community loud and clear. Many elements that are slated to receive support from user fees can have a meaningful impact on the future availability of beneficial therapies for unserved patient populations. However, some other groups involved in the reauthorization process do not feel their voices resonated as much. They will take their cases to Congress in hopes that their agendas will become a part of the bill required to renew this program. In evaluating these policy agendas we urge members of Congress to contemplate why these agendas were not incorporated along with that of patients in the reauthorization process already. In doing so we hope that Congress will recognize the real purpose of the user fee program-it is to ensure the timely review of products submitted to the FDA. Remembering this will not only enable FDA to do its job more effectively, but it will also benefit patients.

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