WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today held a hearing examining four bills consistent with the committee’s bipartisan efforts to support the review and regulation of medical devices as part of the FDA user fee reauthorization process.
Last month, bipartisan leaders of the Energy and Commerce Committee, along with bipartisan leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a discussion draft of the Food and Drug Administration (FDA) Reauthorization Act of 2017, reauthorizing FDA’s user fee agreements. The draft followed hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA), and the Medical Device User Fee Amendments (MDUFA).
Today’s hearing examined potential bills to be added to the user fees.
Chairman Burgess delivers his opening remarks.
After gaveling-in the hearing, #SubHealth Chairman Burgess vowed to improve the regulation of medical technologies as part of the user fee process. Chairman Burgess stated, “It is my top priority to build upon this committee’s work in the 21st Century Cures Act to get safe and effective treatments to patients and providers without unnecessary delay.”
Full committee Chairman Greg Walden (R-OR) reiterated Chairman Burgess’ comments about the user fee process and reiterated the committee’s commitment to a timely reauthorization of the user fees. “The good news is that we are well on our way,” said Chairman Walden.
Dr. Jeff Shuren, Director, FDA, Center for Devices and Radiological Health, echoed these sentiments, thanking the subcommittee for its “support for timely reauthorization of the Medical Device User Fee Amendments.”
Speaking in support of H.R. 1652, the Over-the-Counter Hearing Aid Act of 2017, Dr. Frank Lin, Associate Professor of Otolaryngology at Johns Hopkins University, Head and Neck Surgery, Geriatric Medicine, Mental Health, and Epidemiology, highlighted recent reports about hearing loss and some of the possible side effects they have a greater chance of experiencing. Dr. Lin testified, “These research studies also clearly suggest that hearing loss treatments such as using hearing aids and other forms of amplification could potentially decrease these risks and lead to real and tangible benefits for individuals, families, and society. And yet, presently, less than 20 percent of the nearly 38 million Americans with a significant hearing loss currently has access to hearing aids.”
Dr. Thomas Powers, Powers Consulting, LLC, acknowledged how H.R. 1652 could possibly deliver on increased access and affordability, but encouraged the bill be revised to only allow over-the-counter hearing aid sales for individuals with mild hearing loss.
Mr. Joe Robinson, Senior Vice President, Phillips North America, Health Systems Solutions, spoke in support of H.R. 2009, the Fostering Innovation in Medical Imaging Act of 2017 and H.R. 2118, the Medical Device Servicing and Accountability Act. In speaking to H.R. 2009, Mr. Robinson stated, “Removing impediments to technological advancements in medical imaging will encourage innovation and allow physicians to better diagnose and treat patients in the United States in a manner that is consistent with practice internationally.” He also stressed that H.R. 2118 would “protect patients and ensure effective device performance through increased visibility and accountability for medical device servicers.”
Mr. Robert Kerwin, General Counsel, International Association of Medical Equipment Remarketers and Servicers, questioned the need for H.R. 2118, saying, “there has been no evidence to support a systemic problem.”
Ms. Patricia Shrader, Vice President, Global Regulatory Affairs, Medtronic, spoke on behalf of AdvaMed in support of H.R. 1736, to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications, stating, H.R. 1736 will “improve the device inspections process to increase predictability and transparency of FDA routine inspections, and to ensure that both FDA and industry resources are best targeted to public health needs.”
For more information on today’s hearing, including a background memo, witness testimony, and archived webcast, click HERE.