Subcommittees

WASHINGTON, D.C.  – Congressman Earl L. "Buddy" Carter (GA-01), Chairman of the Subcommittee on Health, delivered the following opening statement at today’s hearing titled  Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs. Subcommittee Chairman Carter's opening statement as prepared for delivery: “I want to welcome everyone to today’s hearing on the Over-the-Counter Monograph Drug User Fee Program, referred to as “OMUFA.” I'm especially pleased that we're talking about the reauthorization of this program as almost 5 years to the date, the initial bill – sponsored by my good friend from Ohio, Representative Latta, as well as one of Georgia's finest, Senator Johnny Isakson – was signed into law by President Trump in March 2020. “The enactment of this program reformed and modernized the regulation of OTC monograph drugs and authorized the FDA to assess and collect user fees dedicated to OTC monograph drug activities. Industry and public health stakeholders supported these reforms, which have provided FDA with additional resources and tools to streamline the monograph process to increase access to quality commonly used drugs and self-care products for the American consumer. This program is designed to improve innovation, while maintaining the FDA ‘gold-standard’ of safety. “The current legislative authority for OMUFA expires September 30th, 2025 – at which point, new legislation will be required to reauthorize the Over-the-Counter Monograph User Fee program for another five-year term. “Over-the-counter medications are widely used to treat common ailments such as colds, headaches, and seasonal allergies. In fact, nearly 9 out of every 10 Americans use OTC medications regularly and trust these affordable remedies to get well and stay healthy. Safe, reliable, and affordable OTC drugs allow consumers to treat common ailments at home, usually without visiting a health care provider, saving the health care system billions annually. “Of particular note is a company called Symrise. They own and operate a manufacturing plant in Georgia’s First Congressional District. Symrise manufactures aroma molecules and fragrance ingredients, which are used in various consumer products across a number of product categories. They also manufacture two of the key UV filters that are commonly used in many OTC sunscreens on the market today.  “Sadly, Symrise’s Colonel’s Island plant experienced a serious fire in 2022. Symrise made the strategic decision to re-invest in the site and restore its capacity in my community, at a time when other companies were leaving. They successfully completed renovations and today, the plant is again fully operational, back at its pre-fire capacity. This is a real success story, and we are grateful for their commitment to Georgia. “We are also fortunate to have Mr. Kevin Menzel before our Committee today. Mr. Menzel is President of Focus Consumer Healthcare, which is a wholly owned subsidiary of Kobayashi Healthcare. Kobayashi was founded as a family company in 1886 in Japan. They established a presence in the United States in 1998, and maintain manufacturing and operations in Dalton, Georgia - employing 270 people with products ranging from OTC medicines and supplements, to recreational products like Hot Hands Hand Warmers. Georgia’s pro-business climate and infrastructure make it an ideal location for companies such as Kobayashi. In fact, just recently, Kobayashi began expanding its U.S. manufacturing footprint even further, with a significant announced investment in Georgia — doubling capacity to support ongoing growth and expand employment. “Success stories such as Symrise and Kobayashi highlight why it is critical for this Subcommittee to reauthorize the Over-the-Counter Monograph Drug User Fee Program in a timely manner. This program demonstrated the ability to bring more jobs back to America, while increasing access to safe, reliable, and affordable OTC drugs. “I look forward to hearing from our witnesses today and working with my colleagues on both sides of the aisle to reauthorize this program on time and through regular order.” ###

WASHINGTON, D.C.  – Congressman Gary Palmer (AL-06), Chairman of the Subcommittee on Oversight & Investigations, delivered the following opening statement at today’s hearing titled  Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities In Legacy Medical Devices. Subcommittee Chairman Palmer's opening statement as prepared for delivery: “Good morning, and welcome to today’s hearing entitled 'Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices.' “Legacy medical devices are medical devices that cannot be reasonably protected against current cybersecurity threats. In some instances, these are older devices that were made before existing cybersecurity requirements were established, but they can also be newer devices that have outdated software and lack the necessary cybersecurity protections required to defend against current threats.  “There is a broad range of medical devices that can be vulnerable to cybersecurity threats, but examples include patient monitors, infusion pumps, and imaging systems. With over 6,000 hospitals in the U.S., each housing a range of rooms and beds and an average of 10 to 15 connected devices per bed, it is clear how integral medical devices are to delivering health care in the U.S. “One challenge with these devices is that the hardware can last 10 to 30 years, but the software becomes obsolete much sooner. Patching and updating software are common ways to address cybersecurity vulnerabilities, but it is unlikely that such vulnerabilities can be sufficiently mitigated through these approaches due to outdated technology and compatibility issues.  “Moreover, merely replacing devices comes with financial and logistical challenges which leads many hospitals to retain these legacy medical devices well beyond their life expectancies – often without the software support to handle modern cybersecurity risks. This is particularly true in small, rural, or under-resourced facilities, making it crucial to find practical solutions. “It is also important to recognize that the health care sector is one of 16 critical infrastructure sectors in the U.S., and it has become a significant target for cyberattacks. For example, in 2017, the global WannaCry ransomware attack severely impacted the health care sector. In the U.S., medical device manufacturers rushed to patch affected devices after WannaCry showed that malware could jump from PCs to embedded medical devices. This attack demonstrated how unpatched, older Windows-based systems in medical devices can be immobilized by ransomware. “Additionally, the risk of harm to patients is a big concern because if a medical device’s vulnerability is exploited, the ability for a device to help monitor, diagnose, or treat a patient can be compromised.  “There are also national security concerns. On January 30th, the Cybersecurity and Infrastructure Security Agency and the Food and Drug Administration (FDA) released an alert about a Chinese-made patient monitor that had a hidden backdoor that could enable remote control and data exfiltration. While the vulnerability may have been unintentional, it raised concerns and highlighted the risk of nation-state actors pre-positioning destructive malware in our health care sector as part of a potential, large-scale cyberattack to disrupt one of our nation’s critical infrastructure sectors. “Progress was made to address legacy medical device issues in 2022, with the enactment of the PATCH Act which increased FDA's authority over medical device cybersecurity. The law now requires manufacturers to submit cybersecurity plans for new devices. Legacy medical devices that were on the market before this law took effect, however, still pose a significant risk. “Therefore, addressing cybersecurity threats in legacy medical devices is critical. Fortunately, thanks to the ongoing work of the experts represented by our witnesses today, we have valuable partnerships and coordinated efforts to help address these risks and threats. “I thank our witnesses for joining us today and sharing their expertise to guide the efforts in addressing these challenges, and I look forward to their testimony.  “I now recognize the Ranking Member of the Subcommittee, Ms. Clarke, for her opening statement.” ###

WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, announced a Full Committee Markup of 26 bills. WHAT : Full Committee Markup of 26 Bills DATE : Wednesday, April 2, 2025 TIME : 10:00 AM ET LOCATION : 2123 Rayburn House Office Building This notice is at the direction of the Chairman. The hearing will be open to the public and press and will be live streamed at energycommerce.house.gov . If you have any questions concerning the hearing, please contact Alex Khlopin with the Committee staff at Alex.Khlopin@mail.house.gov . If you have any press-related questions, please contact Matthew VanHyfte at Matthew.VanHyfte@mail.house.gov . Items to be considered: H.R. 1442 , Youth Poisoning Protection Act H.R. 973 , Setting Consumer Standards for Lithium-Ion Batteries Act H.R. 633 , Tools to Address Known Exploitation by Immobilizing Technological Deepfakes On Websites and Networks (TAKE IT DOWN) Act   H.R. 1664 , Deploying American Blockchains Act of 2025   H.R. 2444 , Promoting Resilient Supply Chains Act of 2025   H.R. 2480 , Securing Semiconductor Supply Chains Act   H.R. 1402 , Transparency In Charges for Key Events Ticketing (TICKET) Act   H.R. 1479 , Hotel Fees Transparency Act of 2025   H.R. 859 , Informing Consumers About Smart Devices Act  H.R. 2481 , Romance Scam Prevention Act   H.R. 617 , American Music Tourism Act of 2025  H. R. 2269 , Wastewater Infrastructure Pollution Prevention and Environmental Safety (WIPPES) Act   H.R. 906 , Foreign Adversary Communications Transparency (FACT) Act  H.R. 2449 , Future Uses of Technology Upholding Reliable and Enhanced (FUTURE) Networks Act   H.R. 2458 , Secure Space Act   H.R. 866 , Removing Our Unsecure Technologies to Ensure Reliability and Security (ROUTERS) Act   H.R. 2482 , National Telecommunications and Information Administration (NTIA) Reauthorization Act of 2025   H.R. 2399 , Rural Broadband Protection Act of 2025   H.R. 2037 , OpenRAN Outreach Act   H.R. 1717 , Communications Security Act H.R. 2483, SUPPORT for Patients and Communities Reauthorization Act of 2025   H.R. 2483 , SUPPORT for Patients and Communities Reauthorization Act of 2025 H.R. 1520 , Charlotte Woodward Organ Transplant Discrimination Prevention Act   H.R. 2319 , Women and Lung Cancer Research and Preventive Services Act of 2025   H.R. 1669 , To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program.   H.R. 1082 , Shandra Eisenga Human Cell and Tissue Product Safety Act  H.R. 2484 , Seniors’ Access to Critical Medications Act ###