HHS Secretary Kathleen Sebelius on Wednesday called on the medical device industry to work with the Food and Drug Administration on a plan for additional resources—specifically, user fees—to help make the review process more effective.
Sebelius urges industry to work with FDA to improve review process
Addressing attendees on the last day of the AdvaMed Med-Tech Conference, Sebelius cited the work of the White House Office of Science and Technology Policy, which she said is working to assemble a team of entrepreneurs to place in residence at the FDA. These experts in developing medical devices will work with FDA leadership to develop in the next three to six months the Innovation Pathway, a streamlined regulatory pathway for medical devices. Sebelius also said the FDA is working with the Medicare and Medicaid programs to establish a process for pre-market evaluations that reduce the time and uncertainty for coverage decisions for these programs, which she said are as essential as getting the products to market.
“So there's plenty of room for improvement, and we are committed to working on new ways to make the review process as consistent and effective as possible,” Sebelius said. “But ultimately, we can't make real progress through changes in policies and processes alone. It will take additional resources, and that means user fees.”
Sebelius said this work has already been done with the prescription drug-user fee program, which has cut approval times by 50%. “The agreement between the medical device industry and the FDA is under discussion right now—the so-called MDUFMA, which will be negotiated and then presented to Congress,” Sebelius told Modern Healthcare after delivering her speech. “I think both in the discussions I've had with CEOs and others—they fully believe in a fully resourced FDA,” she continued. “I mean, they understand that we need the personnel to be able to move things quickly through the pipeline, and so user-fees are a part of that discussion,” she said, adding that the drug industry pays about 60% of the drug-approval process, while the device industry pays about 20%.
Current legislative authority for MDUFMA expires in September 2012. On Monday, AdvaMed President and CEO Stephen Ubl told attendees that tripling the FDA's user fees and the doubling of its budget in recent years has not resulted in a faster approval process.
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