After a year of negotiations, the medical device industry and the FDA signed off on a tentative agreement for the next 5 years of med-tech user fees, nearly doubling the industry’s expected buy-in and setting some "game-changing" expectations for the agency.
The deal raises user fees to $595 million over 5 years, just about halfway between the FDA’s initial request and the industry’s rebuttal. The FDA had asked for an increase from the $295 million agreed to in the last series of negotiations, to $730 million to $805 million over the next 5 years. The industry balked at that number, proposing to pay $447 million instead.
"There were compromises, obviously, on both sides of the agreement and we reached a place that I think is a potential game-changer for the agency and for the industry," Stephen Ubl, president & CEO of industry lobby AdvaMed, said in a conference call today.
"It strikes a careful balance between what industry agreed to pay and what the FDA can accomplish with the amount of funding proposed," according to an FDA press release.
In return for higher fees, medical device makers charged the agency with some new goals, including 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."
"FDA days" measure how many working days the agency has spent on a particular application, but do not include periods when the agency has "stopped the clock" by, for example, putting the ball back in the device maker’s court by asking for more information on an application.
"By having a total-time goal that works in concert with an FDA-day goal we will, for the first time, be measuring – and performance will be tracked on – a total-time basis," Ubl said. "We think that will have the net effect of reducing total review time, which is the most important measurement you can make."
The new deal includes total-time goals for pre-market approval bids and 510(k) applications that will ramp up over the 5-year span of the deal.
The industry wants to see an average total review time of 385 calendar days for PMAs and 124 calendar days for 510(k) applications by the final year of the deal, AdvaMed officials said during the call.
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.
"In the past, there has been a tendency to put those on the bottom of the pile," Ubl said.
Under the terms of the new agreement, the FDA is required to reach out to the product maker to begin discussions on a plan to move the application forward.
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.
The tentative agreement also got the green light from the Medical Device Manufacturers Assn., the Medical Imaging & Technology Alliance and Medtronic (NYSE:MDT), who says it was one of the original advocates for the device user fee program in 2002.
"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. "We are pleased with the careful balance struck in this agreement and will urge the Congress to grant timely approval."
"In a time of tremendous advances in imaging and radiation therapy technologies, the agreement enables the industry to bring innovative, life-saving technologies to market faster, so that patients receive the care they need," MITA wrote in a press release. "The increase in resources to the agency under this agreement corresponds to a more timely approval process, which will benefit patients and the manufacturers who develop these innovative technologies."