User Fee programs help the Food and Drug Administration (FDA) to ensure timely review and support the development of innovative therapeutics.
Alliance’s Bens Offers Testimony on MDUFA before House Committee
Published March 28, 2017
Washington, D.C., March 28, 2017 – Today, the Alliance for Aging Research’s (Alliance) Vice President of Public Policy Cynthia Bens testified before the U.S. House of Representatives’ Energy and Commerce Committee, Subcommittee on Health, in regard to reauthorization of the Medical Device User Fee Act (MDUFA).
The MDUFA program is due to be reauthorized by Congress in 2017. The original act, which was passed in 2002 as the Medical Device User Fee and Modernization Act, authorized the U.S. Food and Drug Administration to collect fees from the medical device industry to support its review activities. In turn, the FDA agreed to specific performance goals that would result in more timely access to medical devices for patients.
In her testimony, Bens offered the Alliance’s perspectives on the benefits of the MDUFA IV agreement for FDA, patients, and industry.
“The Alliance for Aging Research supports the continuation of the medical device user fee program through the negotiated MDUFA IV agreement,” she told the committee. “The Alliance advocates for increased overall funding of the FDA with strong emphasis on finding the right balance between user fees and appropriated funding. We think that the size of the proposed fees within the MDUFA IV agreement is necessary to increase the efficiency of regulatory processes, reduce the time it takes to bring safe and effective medical devices market, and put patients at the heart of medical product development.”
Bens added that the Alliance has played a key role in the reauthorization process, advocating for greater patient input and the increased use of real-world evidence in the FDA’s medical device review process.
Read the complete testimony here.
About the Alliance for Aging Research
The Alliance for Aging Research is the leading nonprofit organization dedicated to accelerating the pace of scientific discoveries and their application in order to vastly improve the universal human experience of aging and health. The Alliance was founded in 1986 in Washington, D.C., and has since become a valued advocacy organization and a respected influential voice with policymakers. Visit agingresearch.org for more information.
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