U.S. Dept. of Health & Human Services Secretary Kathleen Sebelius told medical device makers Wednesday that the improvements they seek in the regulatory process will come partially as a result of agreeing to a new user fee agreement.
“There is plenty of room for improvement, and we continue to look for new ways to make the review process as effective and consistent as possible,” Sebelius said. “But ultimately, we cannot make real progress through changes in policies and processes alone. It will also take additional resources, and that means user fees.”
Sebelius, in remarks at the annual Advanced Medical Technology Conference in Washington, D.C., used the pharmaceutical arena as a prime example of an industry which benefited from higher user fees in the past.
“Before the prescription drug user fee program, the drug industry argued that the U.S. lagged behind Europe in getting medicines to market. They called it the drug lag,” she said. “Now, with additional resources, we are frequently the first country to approve drugs. The initial program cut review times in half. And additional user fees 10 years ago cut approval times by another 50 percent. We can do the same for medical devices. And I encourage you to work with the FDA to come together around a plan for additional resources that also holds us accountable for the improvements we’ve promised.”
The secretary’s comments come as the industry is locked in negotiations with the FDA over the reauthorization of the medical device user fees, or MDUFMA III.
The current medical device user fee act is set to expire in 2012. The agency first won the authority to collect user fees under the 2002 Medical Device User Fee and Modernization Act. The program was reauthorized in 2007 under MDUFMA II. The user fees are supposed to make up for the FDA’s resource shortfall to help it review device applications more quickly and, ultimately, speed devices to market. In return for receiving industry funding, the FDA was tasked with meeting performance goals under MDUFMA, which set benchmarks for measuring improvements in the agency’s review times.
While representatives from both sides have met several times over the year in order to hammer out an agreement, there has been significant tension in trying to come to an arrangement that will please both sides.
For example, the agency has asked for an increase in user fees to continue 2010 levels of operations, which would amount to a roughly 17 percent increase from current levels. The FDA is also requesting more funding to increase its total headcount by another 254 employees in addition to its 1,230 employees. The gulf between the two parties appears to be the agency’s contention that the total workload for the FDA has increased.
The med-tech industry doesn’t believe that to be the case and maintains that workloads have remained at the same levels. Further, industry contends that the FDA has essentially doubled the user fees over the lifetime of the program and has not met performance goals. During an early June meeting, industry proposed a two year stay at current levels (adjusted for inflation) because the agency had “not yet achieved” some of the qualitative and quantitative goals set when the user fee program was reauthorized in 2007.
