Medical device makers and industry lobbyists lined up in support of the tentative agreement inked with the FDA to double user fees in exchange for performance goals, but some voices in the crowd said ‘nay.’
Both Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) announced their support for the measure, which raises user fees from $295 million to $595 million over 5 years, but Cook Medical head Kem Hawkins was less enthusiastic about the bump.
The watchdog agency agreed to a number of changes in device review protocol in efforts to improve decision times and make the process more transparent and predictable, measures that industry groups lauded yesterday.
Despite the buzz, Cook’s Hawkins worried that the anticipated performance goals were 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 an email.
In return for higher fees, medical device makers charged the FDA with some new goals, including shortened time-frames for pre-market approval applications and 510(k) submissions that will consider total review time in calendar days in addition to "FDA days."
The FDA must also publish regular metrics regarding review times, withdrawal rates, clearances and other measurements of its medical device pathways, expand its pre-review discussions with the industry and enlist the help of a 3rd-party consulting agency to help identify opportunities for streamlining its processes.
"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 yesterday. "We are pleased with the careful balance struck in this agreement and will urge the Congress to grant timely approval."
Other highlights of the agreement include an initiative dubbed "leave no submission behind," which charges the FDA with reaching out to the device maker when an applications pushes past the ideal time-frame to ensure that no device languishes in regulatory purgatory.
"Boston Scientific worked with FDA, MDMA and AdvaMed to reach agreement over a deal that increases the transparency and predictability of the review process," Boston Scientific officials told The Star Tribune. "Boston Scientific supports the MDUFA III agreement, and anticipates that the agency will be accountable to performance goals that are intended to ensure timely availability of safe, effective and innovative medical devices to U.S. patients."
The measures were signed off by the FDA, 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.