The FDA Amendments Act (FDAAA) requires that the FDA hold public meetings and conduct discussions with both the regulated industry and stakeholder groups in order to develop recommendations for the next Medical Device User Fee and Modernization Act (MDUFMA) program, which will span fiscal years 2013-17. Given this mandate, the FDA periodically conducts meetings on the MDUFMA program. The current legislative authority for MDUFMA, reauthorized in 2007 by the FDAAA, will expire in September 2012. Discussions between the medical device industry and the FDA appear to revolve around the FDA’s request for increased funding, and industry’s perception that the FDA has not met performance goals to justify increased funding.
For example, minutes from the May 4, 2011, meeting in response to the FDA’s proposal package indicate the industry’s concern that “the key goal is to provide timely access to safe and effective products, and that user fees were not meant to supplant appropriations.” The industry has generally disagreed with the FDA’s assertion that its workload has increased and has asserted that the FDA has not met qualitative and quantitative performance goals.
Discussions between the FDA and the industry have continued to revolve around issues of funding and performance. Minutes from the latest meeting, scheduled for July 15, 2011, have not yet been posted.
Stay tuned for more.