Consumers Union, the nonprofit publisher of Consumer Reports, has voiced pointed concerns to Congress over the new user-fee agreement between the FDA and manufacturers of medical devices.
The agreement— inked Feb. 1 as the latest wrinkle on the Medical Device User Fee & Modernization Act (MDUFMA)—would have device makers doubling the dollars they pay FDA in exchange for speedier and more predictable reviews. That’s if it’s approved by Congress as “MDUFMA III” before the current fee structure expires Sept. 30.
Consumers Union (CU) testified before the House Energy & Commerce Committee during a Feb. 15 hearing on what the reauthorization of MDUFMA will mean for jobs, innovation and patients.
“The FDA and Congress have an opportunity to fix a system that is currently flawed because it allows too many unsafe medical devices to enter the market,” said Lisa Swirsky, a CU senior policy analyst, according to the proceedings of the hearing. “In the next five years, the use of medical devices ... will increase significantly more than in the past five years. Americans are counting on their representatives to strengthen the law to ensure that patient safety isn’t sacrificed in the drive to speed up the approval of new medical devices.”
Swirsky pointed out that, in the minutes from the meeting that produced the Feb. 1 agreement, the word “safety” never appears. “At a time when the device industry has seen large-scale safety failures of some of its products, it is troubling that the main focus of conversations between industry and the agency that regulates it is on speeding up review times,” she said.
The committee also heard testimony from Jim Shull of Browns Mills, N.J, who told about his experience as a patient harmed by synthetic mesh used for a hernia operation. “The mesh that was put inside of me has caused so much damage that none of the nerves can ever be repaired,” said Shull. “Surgical mesh and other medical devices should be tested for safety before they are allowed to be implanted into people like myself.”
Among the industry leaders testifying in favor of the MDUFMA III was David Perez, CEO of Terumo Medical and a board member of AdvaMed, one of the industry groups that put the fee agreement together. “Our industry is heavily skewed toward small companies—the kind of companies that begin with a doctor, an engineer and an idea to improve patient care,” he said. “Our industry’s investment in research and development is more than twice the national average. … The user-fee agreement our industry representatives just concluded with the agency is a huge step in the right direction.”
Ross A. Jaffe, MD, a managing director with venture capital firm Versant, expressed frustration on behalf of the market. “On the one hand, we live in a time of incredible opportunity for medical innovation,” he said. “On the other hand, as a venture capitalist I am forced to turn down investing in too many promising medical innovations—technologies that you and I would want access to in order to help our loved ones if they needed them—because it is difficult to predict how long and how much capital it will take to get a particular innovation approved by the FDA and into patient care.”
Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health (CDRH), sounded a note of cautious optimism that MDUFMA III can satisfy consumer groups and device makers alike.
“While we work with industry, other stakeholders and Congress in the statutory process toward the reauthorization of medical device user fees, we are also continuing to move forward with CDRH program improvements,” said Shuren. “If we are to sustain and build on our record of accomplishment, it is critical that the MDUFMA reauthorization occurs seamlessly, without any gap between the expiration of current law and the enactment of MDUFMA III. At the same time, we must remain mindful that user fees under MDUFMA III will fund about a third of the total cost of the medical device premarket review process, making it important to keep these resources focused on the performance goals identified in the [Feb. 1] MDUFMA agreement.”
The House Energy & Commerce Committee is chaired by Rep. Fred Upton (R-Mich.) and has Rep. Henry A. Waxman (D-Calif.) as its ranking member.