The FDA missed a 2nd deadline for submitting a proposal to the U.S. Congress detailing the user fees it will charge medical device makers to review their products.
The device industry and the federal watchdog agency have been haggling for months over the fees mandated by the Medical Device User Fee & Modernization Act, which is slated to be renewed this year.
The “robust exchange” over the MDUFMA re-authorization was to have resulted in a proposal for legislators by Jan. 15. With the Health sub-committee of the House’s Energy & Commerce Committee slated to hold a hearing Feb. 15 over the fees, it’s not clear whether the parties can agree on a proposal by then.
The industry ponied up $295 million in user fees over 5 years, according to BusinessWeek, and he FDA wants to raise that to between $730-$805 million. Med-tech balked at that number, proposing to pay $447 million instead, according to minutes from a Dec. 6 meeting. Minutes from 2 more recent meetings held Dec. 13 and Jan. 5 meetings won’t be released until they’re approved by both sides, FDA spokeswoman Karen Riley told the magazine.
The industry believes its $447 million offer would cover about 26% of the agency’s medical device review budget for fiscal 2017, according to the minutes of the 45-minute Dec. 6 meeting.
“Industry believes that these additional resources would allow FDA to achieve the goals outlined in the commitment letter,” according to the minutes. “FDA noted that industry and the agency remain far apart regarding an appropriate level of resources to support the draft commitment letter. … Both sides expressed concern with how long it is taking to reach agreement on appropriate funding levels but pledged to continue to look for ways to close the gap.”