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WASHINGTON, D.C. – Yesterday, Congressman Gary Palmer (AL-06), Chairman of the Subcommittee on Oversight and Investigations, led a hearing titled Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices .  “The health care sector is one of 16 critical infrastructure sectors in the U.S. and has become a significant target for cyberattacks. To ensure our hospitals are secure and patients safely receive the treatment they need, we must reduce the vulnerabilities found in legacy medical devices,” said Chairman Palmer. “Yesterday’s hearing helped us better understand the risks of these devices and how to navigate them.”   Watch the full hearing here .  Below are key excerpts from yesterday’s hearing :  Congressman Gary Palmer (AL-06): “Are there updated estimates on how many legacy medical devices are currently in-use across the U.S. health care system?” Mr. Decker: “The problem is actually sort of unknown, as far as how many devices exist, especially when we start talking about the concept of what is legacy versus what is non-legacy devices… We can estimate how many devices we think exist. So, if you look inside any typical hospital, you have for any bed 8-15 some devices connected to it. There are stats that show there’s about 913,000 beds in the United States, so extrapolating that, you get to about easily 10,000,000 devices that exist.”   Congressman Brett Guthrie (KY-02): “We’re talking about backdoor medical devices and what that means in the discovery and what vulnerabilities that has and how it’s concerning. So, Mr. Decker and Ms. Jump, how often do we find this type of thing?” Mr. Decker: “Within medical devices, specifically, it’s unknown. You know, there was that report that came out about the Contec Chinese device and in your opening comments, you mentioned there’s two potential opportunities for that to occur. We know that certain nation-state adversaries are prepositioning themselves into critical infrastructure and other critical infrastructure have been targeted for this, so it’s certainly within the realm of possibility that that’s occurring within health care.” Ms. Jump: “I would say that, as a risk management expert, I think that with the increased enforcement of risk management efforts, penetration testing, and threat modeling that FDA has placed on manufacturers, not only for new devices, but also for any devices going in for a significant change of modification, (so older devices do still go through this process) - that manufacturers are being forced to actually look critically at their devices across the whole spectrum - the entire threat landscape of that device. Therefore, I think that we are going to find more and more of these. Certainly, with my clients, we do threat modeling. We do penetration testing. We help those manufacturers find those issues before they become problems and start causing issues within the health care industry.”   Congressman Rus Fulcher (ID-01): “Mr. Garcia, during your verbal testimony, you made a statement that surprised me a little bit and it was that the medical device security in the medical industry, if I understood you correctly, was the most targeted for cyberattacks. Did I get that right?” Mr. Garcia: “The entire health care ecosystem, not just medical devices.” Mr. Fulcher: “Okay, so why health care? I mean, we hear about the banking, right? And power grids. What is it about the health care industry that creates that target?” Mr. Garcia: “Yeah, I came from financial services before this and, at that time 15 years ago, banking was the biggest target because that’s where the money is. But then they started outspending the criminals. The problem with health care is, first off, it is a widely distributed, multifaceted ecosystem that has a lot of touch points, a lot of vulnerabilities. Secondly, there is less money to spend against cyber threats. And thirdly, it’s easy money. When you have a ransomware attack, if you are a hacker and you ransom a hospital, you are forcing the decision on the hospital: should I pay the ransom and continue to treat patients or should I not and run the risk of not treating patients and/or going out of business. That’s why.”   ###

WASHINGTON, D.C. – Yesterday, Congressman Earl L. “Buddy” Carter (GA-01), Chairman of the Subcommittee on Health, led a hearing titled Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs .  “Over-the-counter (OTC) medications help Americans live longer, healthier, and more comfortable lives. This hearing was critical to understanding the vital role that safe, reliable, and affordable OTC medications play in our nation’s overall health,” said Chairman Carter. “I look forward to working in a bipartisan manner to reauthorize the Over-the-Counter Monograph Drug User Fee Program so that we can continue to support FDA’s work to bring pharmaceutical manufacturing back to America and increase patient access to OTC medications.”   Watch the full hearing here .  Below are key excerpts from yesterday’s hearing : Congressman John Joyce (PA-13): “The United States is home to world leading medical innovation. In fact, I often talk about innovation being the cornerstone of American medicine, being the cornerstone of how I practice medicine. Unfortunately, the FDA’s inaction has prevented this innovation, allowing the rest of the world to access new active sunscreen ingredients that are unavailable to Americans. Can you expand upon some of the barriers that are hindering the great innovation by not utilizing the information that our friends and allies have access to?” Mr. D’Ruiz: “People don’t die from using sunscreen. They die from not using sunscreen, number one. And I think there is a large body of evidence worldwide indicating that the news of young sunscreen filters, which have been developed over the last 10 years, are much more efficient – you use less, there is less exposure, and they are much more effective in reducing the harmful effects of both UVA and B. And three, they are more sustainable in terms of environmental impact.” Congresswoman Kat Cammack (FL-13): “You have companies that are already doing things the right way. We don’t want to punish them by putting additional burdens on them to try to capture those companies that are not in compliance. How can we handle that?” Mr. Menzel: “I think that it’s an incredibly important point that we don’t need more regulation as it relates to this, so there needs to be predictability. The OMUFA program allows predictability. The monograph program allows predictability, allows for innovation, allows for speed.”   Congressman Bob Latta (OH-05): “The Over-the-Counter Monograph Drug User Fee Program (OMUFA) at the Food and Drug Administration has produced more than 100,000 safe and effective over-the-counter drugs, giving consumers access to manage their own care in a safe and affordable manner. The OMUFA program has also reduced the number of visits consumers need to make to a doctor to obtain a prescription for a simple treatment, reducing the burden on our health care systems. The OMUFA program has also increased access and choice for consumers. Could you provide examples of how this is beneficial to the public within the United States?” Mr. Menzel: “Yeah , absolutely, I think, in terms of the benefit to the US consumer, one of the items that I think continually needs to be reinforced is for every $1 spent in this space on over-the-counter medicines, it saves the United States health care system $7 in terms of doctor visit cost savings. Pharmaceutical alternatives to pharmaceutical cost savings, the other thing that system does is it allows for a shrinking of these healthcare deserts, where access would be limited, not just in rural areas, but also urban areas that are limited by access to health care.” ###

WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, announced a full committee hearing titled Converting Energy into Intelligence: the Future of AI Technology, Human Discovery, and American Global Competitiveness . “American innovators have imagined and built many of the most impactful technologies of the last 250 years. By turning energy into intelligence, AI represents our next chance to lead the world and create a generation of growth and prosperity. In order to meet this moment, it’s critical that we invest in the right infrastructure needed to meet AI’s demands, including producing more baseload electricity, building advanced networks, and producing next generation semiconductors. We also need to understand how the federal government can facilitate further developments in computing power and AI modeling, all while ensuring we have the right guardrails in place to protect consumers,” said Chairman Guthrie. “This flagship hearing will highlight some of the most influential voices in the industry, as we work to make sure the United States is prepared to seize this once-in-a-generation opportunity.” Full Committee on Energy and Commerce hearing titled Converting Energy into Intelligence: the Future of AI Technology, Human Discovery, and American Global Competitiveness WHAT: Full Committee hearing on AI and American Global Competitiveness DATE: Wednesday, April 9, 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 online at energycommerce.house.gov . If you have any questions concerning the hearing, please contact Kaitlyn Peterson with the Committee staff at Kaitlyn.Peterson@mail.house.gov. If you have any press-related questions, please contact Matthew VanHyfte at Matthew.VanHyfte@mail.house.gov. ###

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 Gus Bilirakis (FL-12), Chairman of the Subcommittee on Commerce, Manufacturing, and Trade, led a hearing titled The World Wild Web: Examining Harms Online . “Our increasingly digital world continually presents new threats and challenges, especially to our children. I remain focused on addressing the clear risks facing the most vulnerable and want to ensure they are not being exploited by bad actors online,” said Chairman Bilirakis. “Today, we held an important discussion that I hope will be an important beginning to developing bipartisan consensus around legislation to protect Americans, including our children, from threats in the online world. I look forward to working with my colleagues to get this urgent priority across the finish line.” Watch the full hearing here . Below are key excerpts from today’s hearing : Congressman Rus Fulcher (ID-01): “Mr. Chairman, I have to admit I might be a little bit confused if I’m in the right committee hearing. We’ve somehow seemed to have got sidetracked into a presidential branch personnel discussions and food prices, so I do have some questions, but they have to do with kids online safety and, uh, and, and that subject matter. Am I in the right place? Do I have that subject matter correct?” Chairman Bilirakis: “Correct.” Congresswoman Kat Cammack (FL-03): “Today’s hearing, the ‘World Wild Web, Examining Harms Online’ could not be more timely. From exploitation to manipulation, we know that the internet has become a breeding ground for serious threats, especially to those most vulnerable – our kids. I want to begin by personally apologizing to the parents and the guests here in the committee room today for the behavior of some of my colleagues. We’re here to focus on kids and the issue at hand, not play liberal catchphrase, talk about food prices, or talk about billionaires. Anything that deviates from that is politically motivated and it is disgusting. And I am so sorry that you are in this room, championing this issue because you have had an experienced tragedy in your family. I am so very sorry.” Congressman Russell Fry (SC-07): “There is a reason why Democrats are viewed by the American people at an all-time low. It’s because they can’t keep the main thing, the main thing. We are here today, to be clear, 100%. Everyone knew the assignment when we got into this hearing room ahead of time. We are here to talk about children’s safety online. And all I hear from the other side is rantings and ravings about the FTC. If you want to talk about the FTC, go do a one-minute speech on the House floor. You want to talk about the FTC, have a press conference. Here, we are here to talk about children. But they can’t seem to get it, and that’s why they’re viewed deeply unpopular by the American people right now. In fact, the witness from the FTC spent 4 of her 5 minutes talking about how she was fired and not the actual subject why we’re here. So that’s frustrating to me, that there’s broad bipartisan consensus on a lot of this stuff, and we’re here to examine that on ways that we can advance sensible policy.” ###

WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, and Congressman Gary Palmer (AL-06), Chairman of the Subcommittee on Oversight and Investigations, announced a hearing titled Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices .  “Medical devices are critically important and broadly used to diagnose, monitor, and treat patients throughout health care delivery systems. Some medical devices, however, contain cybersecurity vulnerabilities. It is imperative we defend against cyber threats to protect patients and safeguard our national security,” said Chairmen Guthrie and Palmer. “This hearing will provide us with an opportunity to examine concerns regarding vulnerabilities in legacy medical devices, their impact on patient safety and health operations, and strategies to enhance cyber resilience.”    Subcommittee on Oversight and Investigations hearing titled Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices     WHAT : Subcommittee on Oversight and Investigations hearing on cybersecurity vulnerabilities in legacy medical devices. DATE : Tuesday, April 1, 2025 TIME : 10:30 AM ET LOCATION : 2322 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 livestreamed online at energycommerce.house.gov . If you have any questions concerning this hearing, please contact Emma Schultheis at Emma.Schultheis@mail.house.gov . If you have any press-related questions, please contact Kaley Stidham at Kaley.Stidham@mail.house.gov .   ###

WASHINGTON, D.C. – Today, Congressman Bob Latta (OH-05), Chairman of the Subcommittee on Energy, led a hearing titled Keeping the Lights On: Examining the State of Regional Grid Reliability . “Today’s grid operators made it clear that America needs more energy to be produced to keep up with our growing needs not just for consumers, but for the many small businesses, manufacturers, agriculture industry, and medical facilities that employ them,” said Chairman Latta. “Too many electric-generating facilities have been retired in recent years while new and emerging technologies are increasing the need. It is critical that we meet the growing demand for power, the need to secure it, and address the reliability challenges confronting our electric industry.” Watch the full hearing here . Below are key excerpts from today’s hearing : Congressman Troy Balderson (OH-12): “ Last year, PJM, ERCOT, SPP, and MISO jointly filed an amicus brief with the DC Circuit Court against the Biden EPA’s Clean Power Plan 2.0. I’m extremely grateful that just a few weeks ago, Administrator Zeldin announced the EPA will be reconsidering the Clean Power Plan 2.0, along with dozens of other Biden era rules and regulations. If the Clean Power Plan 2.0 were to remain in effect, would your service territory see an increased risk of rolling brownouts and blackouts?” Mr. Pablo Vegas: “ Yes, that plan had risked more than 14,000 megawatts of existing coal plants that are serving the grid today, they would be at risk and that would be a significant reliability concern.” Congresswoman Mariannette Miller-Meeks (IA-01): “In the 2024 long-term reliability assessment report, NERC recommends that to maintain demand and supply balance, dispatchable generators including carbon-based fuel generators must be available and capable of following changing electricity demand. And for the past two years when I was on this committee, we’ve hammered on this to ensure reliability. What measures are you taking to discourage premature retirement of carbon-based fuels, fuel generators such as the Clean Power Plan 2.0 rule? How are we able to maintain dispatchable or energy uh when we’re retiring, uh, carbon-based, uh, fuel generators prematurely?” Mr. Manu Asthana: “Part of it is sending the right market price signal to induce them to stay. Part of it is through, is working with our states and federal regulators to try to ensure that we don’t have rules that force these generators offline prematurely.” Congresswoman Diana Harshbarger (TN-01): “ In this scenario, let’s say that you experienced a wind drought that lasts 40 consecutive hours. How do you make up for that?” Ms. Jennifer Curran: “Thank you. Another familiar scenario that did happen to us. The way you make up for it is with resources that do have fuels that are available on demand. So, in MISO, that would be coal and gas generation that is able to run for that duration.” ###

WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, and Congressman Earl L. “Buddy” Carter (GA-01), Chairman of the Subcommittee on Health, announced a hearing titled Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs .  “From providing relief to headaches, to alleviating symptoms of the common cold, over-the-counter drugs play an important part in helping Americans live healthier lives,” said Chairmen Guthrie and Carter. “This hearing will give Members an opportunity to hear from experts and stakeholders and how the FDA’s Over-The-Counter Monograph Drug User Fee Program is working and what challenges may persist.”   Subcommittee on Health hearing titled Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs   WHAT : Subcommittee on Health hearing to discuss how the Food and Drug Administration regulates over-the-counter drugs.   DATE : Tuesday, April 1, 2025   TIME : 10:15 AM ET   LOCATION : 2123 Rayburn House Office Building   This notice is at the direction of the Chairmen. The hearing will be open to the public and press and will be live streamed online at energycommerce.house.gov . If you have any questions concerning the hearing, please contact Emma Schultheis with the Committee staff at Emma.Schultheis@mail.house.gov . If you have any press-related questions, please contact Matthew VanHyfte at Matthew.VanHyfte@mail.house.gov . ###