Industry and FDA have reached an agreement on PDUFA reauthorization

The Pink Sheet and FDA News are reporting that the FDA and industry representatives from PhRMA and the BIO have reached an agreement on the reauthorization of the Prescription Drug User Fee Act (PDUFA V)--the first major milestone in the reauthorization process. According to the Pink Sheet, the PDUFA V technical agreement includes an enhanced model for reviewing new molecular entity drug applications. The molecular entity review model extends submission timelines by two months but will also improve communications and transparency by allowing for mid- and late-cycle meetings between sponsors, providing an opportunity for the agency to discuss potential issues with drug applications. Under the technical agreement, an interim assessment will be made to determine whether the changes to the molecular review program should be made permanent.

The Pink Sheet is also reporting that the technical document authorizes the allocation of industry user fees for additional enhancements to the drug review process, including:

1. Increase biomarker and pharmacogenomics teams

2. Electronic submissions/standardized electronic drug application data

3. Risk Evaluation and Mitigation Strategies standardization

4. Patient-reported outcomes and study endpoint assessment tools

5. Enhance patient and advocate views to FDA risk-benefit decision-making processes

6. Dedicated meta-analysis team

7. Increase staff for rare disease drug development efforts

8. Pilot projects to determine the feasibility of using the Sentinel Initiative to look at drug safety issues

With the technical agreement complete, the reauthorization process will now enter the public comment phase, with the first meeting planned for October, 2011.