Medical Device Daily Washington Editor

FDA and industry have agreed in principal to a new five-year user fee agreement for medical devices, and the $595 million agreed to is more than double the amount collected under the prior user fee agreement, which netted the agency less than $290 million. However, industry will get some bang for the buck thanks to FDA's agreement to measure device reviews by total elapsed time rather than just the number of days an application is on the agency's clock.

The notion of calculating device application review times by non-FDA days was broached by industry in a policy briefing session last year during which Steve Ubl, president/CEO of the Advanced Medical Technology Association (AdvaMed; Washington) said it was “too early to tell“ whether industry could persuade FDA of the validity of the idea (Medical Device Daily, Feb. 3, 2010). The notion seems to have gained traction at the agency, which may be in part due to industry complaints that reviewers were asking for more information than was necessary to complete an application, but the additional monies will lead to a substantial increase in staffing at FDA's device branch as well.

During a Feb. 1 conference call by AdvaMed, Ubl, said, “we believe this agreement is a potential game changer“ for all parties and for patients, and thanked FDA commissioner Margaret Hamburg, MD, Jeff Shuren, MD, director of the Center for Devices and Radiological Health, and “our colleagues at MDMA (Medical Device Manufacturer's Association; Washington) and MITA,“ the Medical Imaging & Technology Alliance (Arlington, Virginia).

The agreement “lays the foundation for success for the agency in five major ways,“ Ubl said, including the use of “a total review time goal.“ He added that the new measurement for device reviews reflects “the most important measurement“ for turn-around of device applications.

Ubl also cited “significant improved performance goals“ compared to current times, including PMA applications that go to panel. “The new goal is that 90% will receive a decision in 320 days“ compared to 38% within 320 days under MDUFA II. Ubl also noted that the new goal for 510(k)s is that 95% will be reviewed within 90 days, up from 90% under MDUFA II. These, Ubl said, are “both significant improvements relative to current performance.“

The agreement provides some process improvements, Ubl remarked, including “a mid-submission review, which will ensure that we don't have a situations [in which] product sponsors learn of issues“ FDA has with an application “late in the review process.“ This new process will allow firms “to have appropriate time to respond to those requests,“ he explained.

Ubl said FDA has agreed to a program that will go by the moniker of “no submission left behind,“ which requires FDA “to address a situation where an application has missed a goal.“ The idea here is “for the agency to identify those applications and to reach out“ to the sponsor “and develop a plan for addressing that situation.“ The explanation was that this is for applications for which FDA is having difficulty meeting its agreed-upon goals, and another member of the AdvaMed staff remarked, “in the past there's been a tendency to put those at the bottom of the pile.“

The agreement also focuses on pre-submission interactions, which Ubl said will include “a more structured process“ and “binding agreements . . . that should create more predictability in the review process.“ The handshake also imposes “greater accountability“ on FDA, Ubl said including quarterly and annual calculations for performance indicators, but FDA would also be required to track withdrawals, the rate of 510(k)s that are deemed not substantially equivalent, the average number of review cycles, and the number of times reviewers request additional information from applicants. He added that the agreement stipulates “a new outside independent management review“ that will be followed by a corrective action plan for any signs of regulatory snags.

FDA also published notes from its Jan.31 user fee meeting with industry on Feb. 1, a document stating that the agency had proposed the sum of $595 million over five years for the third iteration of the Medical Device User Fee Agreement (MDUFA III), a substantial increase over the $500 million proposed on Jan. 5 by industry. That proposal was, in turn, a response to FDA's prior suggestion of a minimum of more than $600 million, but the original gap between the two sides was the difference between $447 million and $730 million.

FDA's notes from the Jan. 31 meeting indicate that much of the increased user fees will go toward new hires, which will total more than 200 by the end of the five-year agreement. The notes indicate that FDA will bring in 65 full-time equivalent (FTE) employees in fiscal 2013 and another 66 the following year. The notes also state that the user fee levels are subject to an inflation index using “a three-year average of payroll and Consumer Price Index-Urban . . . for the Washington, DC area,“ which would not exceed 4% in any year.

The agency's notes for Jan. 31 indicate that FDA will seek “statutory authority for streamlined hiring,“ and that “the overwhelming majority“ of the new hires would go to the Office of Device Evaluation, which will get nearly 130 employees under the plan, and the Office of In Vitro Diagnostics – which now includes the radiological devices branch – will take in 52 new FTEs.

According to FDA, the American Clinical Laboratory Association (ACLA; Washington) indicated it could not go along with the agreement in the absence of an assurance that lab-developed tests would be exempt from user fees, but the agency did not indicate whether it made any commitment on this point.

Mark Leahey, president/CEO of MDMA, said in a Feb. 1 statement that the association “is pleased that these discussions have resulted in proposed enhancements to the program that will lead to greater accountability, predictability and transparency.“ Leahey said the higher funding and improved processes at FDA “will allow FDA to fulfill its mission to promote patient care and innovation in the coming years.“

In a Feb. 1 statement, Lindsay Morris, acting executive director of MITA, said the agreement “enhances both the predictability and transparency of the agency.“ She said the agreement “enables industry to bring innovative, life-saving technologies to market faster, so that patients receive the care they need,“ and that a more timely approval process “will benefit patients and the manufacturers who develop these innovative technologies,“ she said.

Published: February 2, 2012