The White House Office of Management & Budget signed off on the medical device user fee proposal hashed out by the FDA and the med-tech industry last month.
Now that it has the administration’s blessing, the next generation of the Medical Device User Fee & Modernization Act will be subject to a 30-day public comment period before heading to Congress for final approval.
Industry stakeholders and FDA representatives came to terms on a tentative agreement early last month to double the user fees medical device companies pay for agency review, from $295 million over 5 years to $595 million, in exchange for the FDA meeting performance goals.
The parties headed back to the table many times in February to hash out the details of the fee structure, inflation adjustment rates and a waiver system for certain laboratory-developed tests, according to meeting minutes. By the end of the month, the players had agreed to draft language for MDUFMA III legislation and a draft Commitment Letter from the FDA, which was sent to the OMB for review.
The White House put its stamp of approval on the drafts today, pushing the agreement another step closer to realization.
"The OMB’s clearance of the industry-agency agreement is a positive step in enabling manufacturers to bring life-saving technologies to market so that patients benefit from the scientific innovation occurring today," Gail Rodriguez, executive director of the Medical Imaging & Technology Alliance, said in prepared remarks. "The agreement with FDA enhances both the predictability and transparency of the agency and the increase in resources corresponds to a more timely approval process, which will benefit patients and the manufacturers who develop these innovative technologies."
Read more of MassDevice.com’s coverage of the MDUFMA negotiations.
The early industry-agency accord won a lot of support from device makers and industry lobbyists, including positive votes from both Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX), but some voices in the crowd said ‘nay.’
Cook Medical head Kem Hawkins was less than enthusiastic about the bump, worrying that the anticipated FDA performance goals may be lighter than air.
"There is a long history of higher fees without a commensurate improvement in the time it takes to receive an FDA approval for a device that has been proven to save lives or reduce suffering," Hawkins told MassDevice in February.
With OMB approval in hand, the FDA announced a public workshop set for March 28 to allow stakeholders to present their views on the MDUFMA III recommendations as negotiations come to a close.
The federal watchdog agency must also present the draft recommendations to the Committee on Energy & Commerce of the U.S. House of Reps., publish the draft in the Federal Register, provide a 30-day public comment period and revise the draft as necessary before sending its final recommendation to Congress.
The public workshop will be held on March 28, 2012, at 9:00 a.m. at the Hubert H. Humphrey Building in Washington D.C.