The FDA doesn’t appear to be buying the two year compromise on user fees that the medical device industry is floating in lieu of a full reauthorization of the fees med tech companies pay to the watchdog agency.
In a Medical Device User Fee Reauthorization or MDUFMA III stakeholder meeting with members of patient advocacy groups, FDA officials said that the medical device industry had not provided “a substantive response” to the agency’s request for more funding to increase its overall headcount.
“The underlying issues being addressed in FDA’s proposals are not addressed in a timely manner by the industry proposal for a two-year extension of the current program,” FDA officials said according to the minutes of the June 16 meeting in Washington, D.C.
In an early June negotiations meeting, members of the medical device industry said the agency had “not yet achieved” some of the qualitative and quantitative goals set when the user fee program was reauthorized in 2007 and asked the agency to maintain the current user fee levels for another two years with adjustments for inflation.
The purpose of the proposal was for the FDA to essentially clean up its act, regarding industry’s well-documented gripes about increased review times for medical devices across the board and inconsistent spending of user fee collections.
“Industry characterized FDA’s performance by asserting a lack of focused and consistent training on core competencies and training to enhance scientific expertise, a lack of analysis of training effectiveness, and not holding vendor days in 2010 and holding limited reviewer site visits,” according to minutes of the meeting.
Under the proposed compromise, industry would continue to pay user fees at current levels, allowing for a 4 percent inflationary increase each year.
The agency, on the other hand, has asked for an increase in user fees to continue 2010 levels of operations, which would amount to a roughly 17 percent increase from current levels.
However, the agency is also requesting additional funding to increase its total headcount by another 254 employees in addition to its 1,230 employees. The gulf between the two parties appears to be the agency’s contention that the total workload for the FDA has increased. Industry doesn’t believe that to be the case and maintains that workloads have remained at the same levels. Further, industry contends that the FDA has essentially doubled the user fees over the lifetime of the program and has not met performance goals.
During the June 16 meeting, patient advocacy groups expressed concern that a two year stop gap would create a scenario similar to the Medicare sustainable growth rate or SGR, which is subject to an annual one-year “doc fix” by congress, rather than address long term concerns about the program. In addition, the stakeholders voiced concern that FDA’s commitment to patient safety could be jeopardized by regulatory reform.
However, they were mostly surprised that the two parties appeared to have such a divide.
“Stakeholders noted that they perceived a divide between Industry and the FDA that is larger than they had anticipated, and expressed surprise that Industry would propose only a two year extension.”
The next meeting on MDUFMA III is set for late July.