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FDA PDUFA V Update

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On October 24, Marcie Bough, PharmD, APhA's Senior Director of Government Affairs, testified and served as a panel member of the Health Care Professional Perspectives panel at FDA's public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA) program (76 FR 56201). FDA and manufacturers have been working on a draft agreement for the program which Congress needs to reauthorize by September 2012. The user fees help fund FDA’s drug review program and support about half of FDA’s operating budget; the other half comes from Congressional appropriations. 

APhA’s comments supported revisions outlined in the draft agreement related to: 

  • Enhancements to the program;
  • Focus on pharmacogenomics and post-market surveillance activities; and
  • Improving the risk evaluation and mitigation (REMS) program. 

APhA also expressed strong appreciation for FDA's efforts to gather public input throughout the reauthorization discussions. The testimony detailed APhA's belief that the dialogue between FDA and stakeholders at the same time FDA was meeting with industry greatly improved the reauthorization process, is reflected in the proposal, and exceeded the minimum requirements for gathering public input. APhA additionally stated its appreciation to FDA for the amount of time that FDA listened to and discussed improving REMS programs. APhA's REMS advocacy efforts are reflected in the draft proposal. 

In January, FDA will submit its PDUFA reauthorization proposal to Congress. APhA will continue to work with FDA and members of Congress throughout the reauthorization process. Pharmacists are encouraged to join APhA's Advocacy Key Contact (AAKC) Network to learn more about advocacy opportunities on this very important issue. 

PDUFA is a far reaching initiative that could impact pharmacy in a myriad of ways. Pharmacists should become aware of the provisions. For more information, read  REMS improvements proposed for PDUFA V in 2012 on pharmacist.com.

November 2, 2011

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