FDA Posts Minutes to PDUFA V Discussion Meeting

The US Food and Drug Administration has posted on its website the minutes of the Prescription Drug User Fee Act (PDUFA) V reauthorizaton stakeholder meeting. Held in late September, the meeting focused on proposals from the agency and from stakeholders for renewing the Act. Also on the agenda were FDA’s regulatory oversight with regard to direct-to-consumer advertising and an update to the Reagan-Udall Foundation’s work.

Participants at the meeting including officials from key FDA centers, including the Center for Drug Evaluation and Research (CDER), the US Department of Health and Human Services, and various nonprofit and nongovernmental healthcare organizations.

FDA presented its proposals for improving PDUFA. The fourth version of PDUFA expires in Sept. 2012. FDA has been and will continue to hold meetings with industry and other patient and consumer groups until its final recommendations are due to Congress on Jan. 15, 2012. FDA’s proposals, according to the minutes, include the following:

1. Reduce multiple review cycles
2. Enable greater review predictability by standardizing drug application data
3. Ensure consideration of patient-focused drug development
4. Test the Sentinel project as a tool for evaluating safety signals
5. Expand capacity for scientific advice to address complex manufacturing issues
6. Ensure quality in non-inferiority and adaptive trial designs
7. Ensure quality in meta-analysis
8. Improve human subject protection by building quality into clinical trial oversight
9. Standardize and integrate risk evaluation and mitigation strategies (REMS) into the healthcare system
10. Ensure the quality of patient-reported outcomes and other endpoint assessment tools 
11. Better plan for optimal dose selection
12. Advance biomarkers and pharmacogenomics
13. Advance development of drugs for rare diseases
14. Improve the prediction of drug safety before and during development
15. Clarify small business waiver procedures
16. Issue product fees for discontinued products
17. Set expiration date for appeals for waivers, refunds, and reductions

In turn, the consumer stakeholder groups asked to be included in premarket discussions regarding REMS development and in any advisory committee planning meetings. Stakeholders expressed concern about the Sentinel Initiative’s progress. (The initiative aims to implement a system to help the agency track adverse-event reports.) Additional comments were related to the resources and/or authority FDA might need to ensure that manufacturers meet their postapproval study commitments. And patient groups proposed to continue the FDA Amendments Act of 2007 annual drug-safety user-fee funding increases throughout PDUFA V. 

In addition to discussing PDUFA’s reauthorization, meeting participants reviewed FDA’s drug-promotion oversight efforts. FDA pointed out that it places higher priority on new drugs and indications and on products that contain new safety information. Also given priority are drugs that have first-time television promotions. The agency noted that it reached agreement with industry on a user-fee program for the review of direct-to-consumer ads during last year’s PDUFA IV discussions but that Congress had decided the review funding should come from appropriated dollars instead.

Finally, as part of the meeting agenda, the executive director of the Reagan-Udall Foundation offered an updated on the Foundation’s activities. The Foundation was established as part of the FDA Amendments Act of 2007 to “aid in the discovery of new, applied scientific knowledge to evaluate products and enhance the FDA’s ability to protect and promote the health of the American public,” according to the minutes.  The Foundation’s projects include a tuberculosis program aimed at accelerating the development of treatments, harmonization of science-based food standards, and an effort to mine aggregated patient data for use in subgroup labeling and special population analyses in breast cancer trials. The Foundation, according to the minutes, has been concerned about the perceived influence of regulated industry on its and is therefore building stronger policies regarding conflicts-of-interest and transparency.

Read the full meeting minutes.

Visit the FDA PDUFA web page.