Members of the Senate today passed the latest iteration of the FDA’s user fee act, granting the federal watchdog agency continued authority to charge medical device and drug companies for product review.
The measure passed with overwhelming bipartisan support on a 96-1 vote. Only Sen. Bernie Sanders (I-Vt.) voted against the measure. The FDA bill replaces an original fee agreement set to to expire this fall.
"This excellent bill is a shining example of what we can accomplish when we all work together," Sen. Tom Harkin (D-Iowa) said prior to the vote.
Industry lobby AdvaMed also praised the passage of the bill today, writing that the measure is "good for the FDA; it is good for industry; and most of all it is good for American patients."
"The user fee agreement reached between FDA and industry and implemented by this legislation is a potential game-changer that could help accelerate the development and approval of safe and effective treatments and diagnostics," AdvaMed president & CEO Stephen Ubl said in prepared remarks. "Through a combination of ground-breaking accountability and transparency measures and enhanced FDA resources, the user fee agreement has the potential to increase the predictability, consistency and efficiency of FDA’s decision-making, while maintaining the agency’s stringent product approval standards."
AdvaMed commends the Senate for its expeditious passage of this important piece of legislation. We believe the strong bipartisan support this measure received today reflects the acknowledgement that this legislation will benefit not only FDA and the medical technology industry, but most importantly American patients.
The White House Office of Management & Budget in March month signed off on the Medical Device User Fee & Modernization Act, which doubles the user fees med-tech makers pay for agency reviews, from $295 million over 5 years to $595 million. In return, the FDA committed to meeting a series of performance goals.
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.
Medical device makers largely lined up in support of the agreement, in which the FDA agreed to a number of changes in device review protocol in efforts to improve decision times and make the process more transparent and predictable.
"A strong and adequately resourced FDA is necessary to sustain public confidence and to achieve a more transparent, efficient and accountable regulatory approval process for the innovations we bring to patient care," Medtronic spokesman Steve Cragle wrote in an email to MassDevice in February. "We are pleased with the careful balance struck in this agreement and will urge the Congress to grant timely approval."
The measures were also signed off by the industry lobby groups AdvaMed, the Medical Device Manufacturers Assn. and the Medical Imaging & Technology Alliance as an agreement in principle for the next generation of the Medical Device User Fee & Modernization Act.
The nation’s upper house also voted on 17 amendments to the bill, most of which involved changes to regulation for pharmaceuticals.
The bill has yet to go to vote in the U.S. House of Representatives, but swift passage earlier this month through a health subcommittee was a promising omen, according to Ubl.
"Given the equally strong support in the House Energy & Commerce Committee of their version of the legislation, we are encouraged that reauthorization of FDA’s user fee programs is continuing on a timely track," Ubl said in a statement sent to MassDevice.com. "AdvaMed looks forward to working with Congress as the House and Senate work to reconcile their two versions of the legislation so that the agreement is passed promptly."
