The FDA user fee bill, which passed a final regulatory hurdle in the Senate last night, is a 3-way win for patients, medical device makers and the FDA, industry lobby AdvaMed’s president & CEO Stephen Ubl told reporters today.
"We’re at the finish line with the Senate expected to vote this evening on the pending legislation," Ubl said. "Today’s vote caps nearly 3 years of effort on a bipartisan basis to achieve central goals: first, to ensure that patients have more timely access to safe and effective products and ensure that medical technology innovators can continue to do what they do best, which is create treatments and cure and address the most pressing unmet public health needs and to continue to be an engine of jobs creation to spur our nation’s economic recovery."
The Senate voted 89-3 last night to close debate on the latest iteration of the FDA’s Medical Device User Fee & Modernization Act, which doubles the previous amount that medical device makers pay for agency review for new products.
A final vote on the measure is expected tonight, after which the bill will head to the White House for a final signature before becoming law.
The MDUFMA bill, which is wrapped in a larger FDA user fee measure and doubles medical device user fees from $295 million over 5 years to $595 million in exchange for certain performance goals set for the FDA.
Industry stakeholders and FDA representatives came to terms on a tentative version of the agreement in February, following a series of meetings in which participants hashed out the details of the fee structure, inflation adjustment rates and a waiver system for certain laboratory-developed tests.
"Two years ago the industry faced increasing uncertainty and delays at the FDA, and some were calling for radical changes," Ubl said today. "Thanks in part to the agency’s initiatives and the user fee legislation, we’ve set the conditions for success at the agency to achieve a more timely and predictable review process."
"This user fee agreement really isn’t your father’s user fee agreement, if you will," Ubl added. "There are a number of perks in this user fee agreement. It’s the first user fee agreement to include goals that are focused on total review times from the first time of submission at the agency to when the agency makes the final decision on a PMA or 510(k). The agreement for the first time includes a provision we refer to lovingly as "no submission left behind," which requires the agency to meet with companies if the agency misses a performance goal."
Although AdvaMed has largely lauded MDUFMA III as a “game-changing” measure, stakeholders aren’t ready to stand idly by once the bill is finalized and made law.
"There’s no agreement that’s self-executing, and we stand ready to work very closely with the agency and all stakeholders to ensure that the agreement is implemented effectively," Ubl said.
Rep. Joe Pitts (R-Penn.) is also on watch, he told MassDevice.com earlier this month after the user fee bill had passed nearly unanimously in initial rounds in both houses of Congress, on a 387-5 vote in the House and on a 96-1 vote in the Senate.
"We’re going to follow up with real oversight on the FDA as to what they’ve committed," Pitts told us. "We’re going to make sure they really deliver on what they’ve promised."
