FDA Releases PDUFA V Agreement

On September 1, FDA released a draft agreement between itself and the drug industry on the Prescription Drug User Fee Act (PDUFA V) reauthorization. PDUFA authorizes the FDA to collect fees from manufacturers producing certain human drug and biological products to help fund the drug application review process. Congress must reauthorize the Act every five years and PDUFA IV (P.L. 110-85) is set to expire September, 2012. The commitment letter serves as a framework for FDA to gather public input and then present its proposal to Congress in January, 2012. 

Of interest to pharmacy, the new agreement:

  • Increases industry paid user fees to the FDA for prescription drug reviews by approximately 6%;
  • Extends by 60 days, the timeframe by which FDA must approve or reject new drugs;
  • Requires FDA to develop a five-year plan to further standardize its drug risk-benefit process;
  • Provide for increased standardization and earlier consideration of risk evaluation and mitigation strategies (REMS) in the drug review process; and
  • Improve FDA programs for post-market surveillance and adverse events tracking (e.g. Sentinel Initiative).

APhA Government Affairs staff will continue to monitor PDUFA V developments. For more information, visit the FDA website. See also the minutes of meetings between FDA and stakeholder groups.

September 7, 2011