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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 . ###

WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, and Congressman Gus Bilirakis (FL-12), Chairman of the Subcommittee on Commerce, Manufacturing, and Trade, announced a hearing titled The World Wild Web: Examining Harms Online . “Our increasingly digital world continually presents new threats and challenges, especially to our children. Congress must continue to address risks facing the most vulnerable and take steps to help ensure they are not being exploited by bad actors online,” said Chairmen Guthrie and Bilirakis. “We are looking forward to this important discussion and hope this leads to bipartisan consensus around legislation to protect Americans, including our children, from threats in the online world.”     Subcommittee on Commerce, Manufacturing, and Trade hearing titled The World Wild Web: Examining Harms Online     WHAT : Subcommittee on Commerce, Manufacturing, and Trade hearing on online dangers to children.     DATE : Wednesday, March 26, 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 livestreamed online at energycommerce.house.gov . If you have any questions concerning this hearing, please contact Alex Khlopin at Alex.Khlopin@mail.house.gov . If you have any press-related questions, please contact Daniel Kelly at Daniel.Kelly@mail.house.gov .  ### 

WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, and Congressman Bob Latta (OH-05), Chairman of the Subcommittee on Energy, announced a hearing titled Keeping the Lights On: Examining the State of Regional Grid Reliability . “The continued safety and reliability of our electric grid is essential to supporting small businesses, manufacturing processes, the agriculture industry, hospitals, and homes across the United States. Numerous electric-generating facilities have been prematurely retired in recent years, making it critical that we look for solutions to once again harness and expand the baseload power our communities rely on as new and emerging technologies increase the need,” said Chairmen Guthrie and Latta. “During this hearing, we will have the opportunity to hear from our nation’s regional grid operators and to discuss how we can meet the growing demand for power, the need to secure it, and address the reliability challenges confronting our electric industry.”  Subcommittee on Energy hearing titled Keeping the Lights On: Examining the State of Regional Grid Reliability.   WHAT : Subcommittee on Energy hearing examining how the nation’s regional grid operators plan to address grid reliability challenges, as demand for power increases across the nation. DATE : Tuesday, March 25, 2025        TIME : 10:15 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 livestreamed online at energycommerce.house.gov . If you have any questions concerning this hearing, please contact Calvin Huggins at Calvin.Huggins1@mail.house.gov . If you have any press-related questions, please contact Ben Mullany at Ben.Mullany@mail.house.gov .   ###

WASHINGTON, D.C.  – Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Environment, delivered the following opening statement at today’s hearing titled  Maximizing Opportunities for Redeveloping Brownfields Sites: Assessing the Potential for New American Innovation. Subcommittee Chairman Griffith's opening statement as prepared for delivery: "Today, this Subcommittee will examine the implementation of the Environmental Protection Agency’s Brownfields grant program.  "Brownfields are generally described as properties that contain or may contain a hazardous substance, pollutant, or contaminant, which in turn complicates efforts to expand, redevelop, or reuse the site.  "Often, these contaminated sites are not redeveloped, because prospective new owners are worried about becoming responsible for potential liability as the original company that is liable for the contamination no longer exists. "Through this program, EPA provides grant funding to states, Tribes, economic development agencies, and other entities who are then able to study the extent of contamination, clean up the site, and find a way to redevelop it. "Since 1993, EPA has administered efforts to clean up these sites. Congress first formally established the Brownfields program in the Small Business Liability Relief and Brownfields Revitalization Act of 2002, and codified it under the Comprehensive, Environmental Response, Compensation, and Liability Act. "The brownfields program has traditionally enjoyed bipartisan support, and the last statutory authorization expired last September, at the end of Fiscal Year 2023.  "Reauthorizing this program will provide us with an opportunity to examine the program and find out what aspects are working well and what aspects need improvement. I believe taking testimony from our witnesses today will help us to inform our efforts.  "Additionally, the Infrastructure Investment and Jobs Act provided an unprecedented supplemental appropriation of $1.5 billion for brownfields. The awards funded under the Infrastructure Investment and Jobs Act were exempted from some of the traditional statutory limitations, such as certain maximum grant amounts and state and local cost share requirements. We will need to examine these changes and understand their advantages and disadvantages. "EPA estimates there are more than 450,000 brownfields properties in the United States. This amounts to a lot of unused or underutilized land with economic potential. "Broadly we also know that we will need additional infrastructure and facilities to support our growing economy and process the materials and components needed for new innovative technologies.  "The Brownfields program may also be a good tool to help secure American leadership in emerging industries and traditional manufacturing.  "For example, ABI Research, an industry analysis firm, estimates that by the end of 2025, there will be over 6,000 data centers built worldwide as artificial intelligence continues to take off. "Over the next five years, our country’s electricity demand is expected to grow by almost 16 percent. This growing demand will entail construction of additional energy resources. "So, today we will examine opportunities to bring those industries to Brownfields sites in our communities and explore existing barriers to putting these sites to good use. "In my district in Southwest Virginia, counties, state agencies, regional organizations, and public-private partnerships have already been hard at work revitalizing former mine land for economic development. "I hope we can learn more today about how the Brownfields Program can support these endeavors and similar ones around the country.  "Thank you to our witnesses for being here and contributing to these efforts.  "First, we have the Honorable Jim Connaughton, Chief Executive Officer of James L. ConnaughtonStrategies where he works on sustainable technology innovation and public policy.  "Mr. Connaughton recently served as CEO of Nautilus Data Technologies, a company producing data center components with minimal environmental impacts. He also served as Chairman of the White House Counsel on Environmental Quality under President Bush.  "As you all know, this Committee has been engaged in robust discussion over the past few years on ways to improve the permitting process generally, so we welcome his extensive experience in this area. "We also welcome back Mayor Christian Bollwagefrom the City of Elizabeth, New Jersey.  "The Committee greatly appreciates him lending his knowledge and expertise to our efforts to reauthorize the Brownfields Program. "We will also hear from Christa Stoneham, President and CEO of the Houston Land Bank. Thank you for being here to share your insights on the program and efforts to revitalize the areas your organization serves.  "Last but not least, I am excited to welcome my constituent Duane Miller, Executive Director of the LENOWISCO Planning District Commission. My staff and I have had the privilege of working with the Commission for years. They’ve played an integral role in attracting emerging industries to our region, creating jobs, and cleaning up abandoned sites in Southwest Virginia. "Thank you all for being here, and I look forward to a good discussion. I now recognize the Ranking Member of the Subcommittee, Mr. Tonko, for his opening statement."  ###