Just One More | ACC on the Hill: Advocating For Patient Voice
Richard J. Kovacs, MD, MACC, recently testified on behalf of the ACC before the House Energy and Commerce Committee's Subcomittee on Health regarding reauthorization of the Medical Device User Fee Act (MDUFA) by the U.S. Food and Drug Administration (FDA).
Originally signed into law in 2002, MDUFA is a set of user fee agreements between the FDA and the medical device industry for the agency's review of medical devices. The act must be reauthorized every five years. MDUFA IV, the current authorization, will expire Sept. 30, and the new MDUFA V will need to pass to reauthorize the legislation.
Kovacs, ACC's chief medical officer and a past president, was one of the only individuals to testify in person. He stressed the importance of finding additional ways to incorporate the patient voice within the device development process and the total product life cycle. He noted the role of MDUFA IV in recognizing the "important role external stakeholders play in the device development process" but stressed the need for MDUFA V to include additional opportunities for patient input and continue to build on the FDA's committment to identifying "novel methods of obtaining data that may prove or disprove safety and efficacy."
Kovacs specifically underscored the need to expand capacity to address patient preferences and improve the ability to collect patient-generated information remotely and cited ACC's current efforts to include this information in its suite of NCDR registries.
He also called for guidance on best practices to incorporate clinical outcomes assessments in pre-market studies and how to use patient input to inform clinical trials and reduce barriers to clinical trial participation, especially among diverse populations.
Regarding the proposed legislation, Kovacs stressed the College's support for inclusion of the PATCH Act, which would implement cybersecurity protocols for manufactures applying for pre-market approval through the FDA, and the Diagnostic Device Advisory Committee Act, which would create an advisory committee specifically for diagnostic devices, in the MDUFA reauthorization.
Kovacs closed by thanking the FDA, medical device manufacturers and other stakeholders for coming together and putting forth a framework that aims to better the lives of the patients.
"We constantly strive to improve and refine our efforts to better achieve our mission of transforming cardiovascular care and improving heart health," he said. "The ACC looks forward to working with the members of this committee on the passage of the essential legislation required to implement future agreements and other important issues that are so vital to patient access and care."
Clinical Topics: Cardiovascular Care Team
Keywords: ACC Publications, Cardiology Magazine, United States Food and Drug Administration, Advisory Committees, Patient Preference, Commerce, Cardiology, Registries, Patient Reported Outcome Measures, Outcome Assessment, Health Care, Data Collection, Marketing, Computer Security, Life Cycle Stages, Hearing
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