Medical device user fees would rise to $134.5 million, representing a modest increase over the $128.4 million requested by President Barack Obama in his fiscal year 2016 proposed budget, as part of recommendations being considered by the House Appropriations Committee.
In a yet-unnumbered bill, the committee has proposed $424.1 million in appropriations for the U.S. FDA’s Center for Devices and Radiological Health and the related field activities of its Office of Regulatory Affairs. That was more than the $327.8 million the president had been seeking.
Overall, the bill would give the FDA almost $2.6 billion in discretionary funding, representing an increase of $30 million over the FY 2015.
The bill was released two weeks ago and sent to the subcommittee that oversees the FDA, which approved it in a June 18 voice vote. Last Tuesday, the committee released a report detailing how fees should be applied. A subsequent markup session of the bill was postponed.
The House committee tasks the FDA with wrapping up a couple of long-term projects. For example, in 2011, the agency’s National Mammography Quality Assurance Advisory Committee approved a change to the mammogram patient and physician reports to include information on individuals’ breast density. The FDA has yet to complete this process, and the committee is pushing the agency to implement it in an “expedited manner” and report on progress made no more than 60 days after the act goes into effect, according to the report. The committee made the same request in last year’s funding proposal.
The committee also chides the agency for not taking action on guidance issued in December 2011 on responding to unsolicited requests for off-label information on devices. The guidance’s comment period closed March 27, 2012, and the agency subsequently responded to two citizens petitions asking for clarification of the regulations.
The committee instructs the agency to address this issue comprehensively and provide strategies for how the medical device industry can communicate this information to interested parties. Again, the committee gives the agency 60 days to complete the guidelines.