The 3rd iteration of the FDA’s medical device user fee program rolls ever closer to finalization, as the watchdog agency and industry players move forward with a draft of the legislative language.
In a back-to-back series of 5 meetings in the first half of February, the FDA and med-tech leaders closed up some exceptions to the requirements of the Medical Device User Fee & Modernization Act, hashed out a new structure for inflation adjustments and reconciled a discretionary fee waiver for laboratory-developed tests.
The meetings followed a tentative early-February accord that would double the user fees paid over 5 years in exchange for the FDA meeting performance goals, from $295 million to $595 million.
The most recent discussions ended mid-month with a consensus to move forward with a draft commitment letter, in which the agency promised to reduce the burden on devices deemed to be low-risk, and draft legislative language for the next incarnation of the user fee measure.
Things moved smoothly in the beginning of the month, with meetings on Feb. 8 and Feb. 10 generating accord on inflation adjustments for all registration fees and industry’s proposal to close certain exceptions to the user fees.
Device makers also asked that 510(k) fees get a bump from 1.84% of pre-market approval fees to 2%, assuming that certain facilities are no longer exempt from the fees, and the group hashed out a plan for annual collection rates that would slightly over-collect in the first 2 years, with the surplus to then balance out expected under-collection in the last 3 years of the program.
But talks appeared to hit a hurdle on Valentine’s Day, when some love was lost over a proposed waiver system designed to ease the American Clinical Laboratory Assn.’s concerns about the new user fee structure and its impact on laboratory-developed tests.
The federal watchdog agency proposed that the Dept. of Health & Human Services secretary be given the discretion to waive or reduce fees on a case-by-case basis if it’s "in the interest of public health."
"If FDA is granted the proposed statutory authority to waive fees in selective instances, FDA intends to exercise that authority to ensure that no additional LDTs or laboratories would be subject to user fees during MDUFMA III due to implementation of the regulatory framework under consideration or due to other changes in policy on LDTs," according to the minutes of the Feb. 14 meeting. "FDA offered this proposal in an attempt to satisfy ACLA’s concerns and obtain their support of the final agreement."
While ACLA was pleased with the idea, med-tech representatives were less enthusiastic, and industry worried that the waivers might throw off the balance of resources to workload.
FDA reassured device makers that any adjustments to LDTs were included in the agency’s expected workload, but industry suggesting a cap on waivers and that waived applications not be subject to the same performance goals. The ACLA worried that LDT applications would get 2nd-class treatment, and med-tech decided to take the night to generate a formal response.
The payers came back to the table on Feb. 16 and hashed out the details of the waiver system, with ACLA agreeing to support MDUFMA III with the provision made by the med-tech industry.
By Feb. 17, the group had come to terms on a cap for the waiver system and exclusion from performance goals for any application not paying into the resource pool. FDA assured the ACLA that its submissions would not "go to the back of the line," but they would be reviewed "as resources permit."
The players agreed to draft legislative language for MDUFMA III and a draft Commitment Letter from the FDA, clearing the way for the agreement to head to the Dept. of Health & Human Services and the Office of Managmenet & Budget for approval.
Once through, the proposals will be subject to a 30-day public notice period before heading to Congress.
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