Arguments over medical-device user fee reflects FDA’S record
Debate over device user-fee act reflects FDA’S record
The third reauthorization of the medical device user-fee program is serving as a reminder of the Food and Drug Administration’s track record on safety and efficiency over the past five years.
In the last year alone, the device industry has argued that the unpredictability of device-review pathways has slowed innovation in the U.S.; advocacy groups have said that the agency is not protecting patients in some instances; and the Institute of Medicine recommended scrapping the FDA’S 510(k) review process, an expedited review pathway used by nearly 90% of the device submissions received by the FDA.
The current Medical Device User Fee Act, which requires manufacturers to pay user fees to the FDA in exchange for agreed-upon performance goals, is set to expire on Sept. 30.
Representatives of the device industry, including the Advanced Medical Technology Association, the Medical Device Manufacturers Association and the Medical Imaging & Technology Alliance, and the FDA missed a January deadline to submit the user-fee recommendations to Congress.
When an agreement in principle was reached the following month, the terms included doubling the user fees paid by industry to $595 million over the next five years, which would require the FDA to hire more than 200 full-time employees, including 140 device reviewers, and hire a thirdparty organization to audit the agency’s premarket approval review process.
“I am pleased to be able to report that after extensive negotiations, the user-fee agreement between FDA and industry has been reached and is now awaiting your action,” said David Nexon, Advamed’s senior executive vice president, in his testimony during a Senate committee hearing last week. “We believe this agreement has the potential to help achieve meaningful change in FDA performance through groundbreaking accountability and transparency measures and enhanced FDA resources.”
At the same hearing, Sen. Mike Enzi (RWyo.) described the negotiations as “contentious.”
However, Janet Trunzo, Advamed’s executive vice president of technology and regulatory affairs and the lead negotiator on the user-fee agreement, said Enzi was likely comparing the device user-fee negotiations with the drug program.
“We had a lot of changes to identify,” she said. “It took us longer to reach agreement.”
The Office of Management and Budget signed off on the agreement last month and, following a public comment period that ends in mid-april, the recommendations are expected to be sent to Congress.
Several lawmakers expressed concern at the hearing about the layoffs that would occur if Congress does not approve the agreement.
Lingering concerns about the FDA’S performance goals under the current user-fee program led Sen. Richard Burr (R-N.C.) to request that the Government Accountability Office look at the issue.
At another hearing, House lawmakers questioned why the agency’s user fees should be doubled if approval times have increased.
The GAO report, which was released last week, found that the time it takes for the FDA to issue final decisions has increased, for both the 510(k) and the more stringent pre-market approval review pathways.
It also reported that the agency inconsistently met performance goals for pre-market approval submissions.
“Questions have been raised as to whether FDA is sufficiently meeting the performance goals and whether devices are reaching the market in a timely manner,” the GAO wrote.
Other organizations say the industry isn’t paying enough.
The Safe Patient Project, an initiative developed by Consumers Union, is calling for stronger oversight of medical devices, as well as an increase in the amount of user fees that the device industry has agreed to pay.
“This money is really needed to keep up with the industry’s growth,” said Lisa Mcgiffert, director of the Safe Patient Project. “We’re concerned it’s not adequate to fund what FDA needs in the next five years.”