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WASHINGTON, D.C.  – Congressman Brett Guthrie (KY-02), Chairman of the Committee on Energy and Commerce, delivered the following opening statement at today’s full committee markup. Chairman Guthrie's opening statement as prepared for delivery: “Thank you all for being here today for this markup as we look to advance legislation affecting Americans in the most personal ways. From reauthorizing key programs addressing substance use disorder, to protecting Americans online from sexual exploitation, the Committee on Energy and Commerce is working to address the biggest issues facing our country and our constituents. “Every bill we are considering today is bipartisan, and in many cases members of this Committee have been working together on them over several Congresses. Every bill today either passed out of the Committee unanimously and through the House last year with strong bipartisan votes or were negotiated and agreed upon on a bipartisan, bicameral basis at the end of last year. Every single bill we are considering had bipartisan agreement last Congress, and I am hope we can pick up where we left off to move them all forward today. “Earlier this Congress, Ranking Member Pallone and I testified before the House Administration Committee to talk about our Committee budget, and I really appreciate what the Ranking Member said at that hearing about some of the legislation we are considering today. “He said, 'While we were not able to get these bipartisan bills and provisions signed into law last Congress, I know that we are committed to getting them done this Congress.' “I am glad to report that we are moving those bills forward because they make our country stronger, and we need to pass this critical legislation.  “In particular, we will advance health care legislation to lower costs for patients, support cancer research, and address substance use disorder.  “I’m thankful to all of my colleagues who have supported this legislation to increase access to care for patients and their families.  “Today, we also have an opportunity to advance multiple bills that will strengthen our communications infrastructure and better prevent attacks from our adversaries, who are continually seeking to compromise our critical infrastructure. These bills will help fortify our networks against their threats.  “While technological leadership is critically important to our national security and economic prosperity, as a father and grandfather, I am extremely concerned by the stories we are all hearing from parents about the potential unintended consequences of new technologies.   “From protecting Americans from romance scams to increasing price transparency in ticketing and lodging, today should be a chance to celebrate bipartisan wins that serve our constituents.   “I am still hopeful that we can make progress soon on some of the other bills I have discussed with my friends across the aisle, but nonetheless, we are marking up some outstanding legislation today, and I want to thank all of our sponsors for their hard work getting us to this point.  “I always say the work we do here in the House affects people in their homes. This legislation makes American homes safer, healthier, and more prosperous.   “Thank you all for your hard work, and I look forward to advancing this legislation out of Committee.” ###

WASHINGTON, D.C.  –  Today, the House Committee on Energy and Commerce, led by Chairman Brett Guthrie (KY-02), will mark up 26 bills, including H.R. 2483, the SUPPORT for Patients and Communities Reauthorization Act of 2025. This bipartisan legislation, which is co-led by Chairman Guthrie and Congresswoman Brittany Pettersen (CO-07), has received widespread support from over 160 vital substance use disorder treatment and recovery organizations. Here’s what they’re saying: “The state of behavioral health in America remains a national crisis, with millions of people across the nation experiencing an SUD and 1 in 5 Americans experiencing an MH condition each year,” said Debbie Witchey, MHA, President and CEO of Association for Behavioral Health and Wellness (ABHW). “The SUPPORT Act is critical to effectively addressing SUDs and co-occurring MH conditions. Its policies and provisions will continue to embrace prevention, treatment, and a pathway to recovery.” “Last month, the Centers for Disease Control and Prevention reported a nearly 24% decline in drug overdose deaths from September 2023 through September 2024. The number of overdose deaths during this 12-month period was the lowest since June 2020,” said Advocates for Opioid Addiction Treatment (AOAT). “Without question, the bipartisan SUPPORT Act of 2018, which expanded access to treatment and began addressing treatment workforce shortages played a critical role in reversing the tragic and deadly overdose trend and saving lives.”  “Overdose rates are beginning to drop slightly, and we firmly believe that our investment in recovery support services is a major reason why. The SUPPORT Act gave rise to the Building Communities of Recovery Program, which seeks to mobilize and connect a broad array of community-based resources for persons with substance use disorders (SUD) and co-occurring substance use and mental disorders (COD),” said Patty McCarthy, CEO of Faces & Voices of Recovery. “You have our full-throated support for the passage of this legislation, and we look forward to your continued commitment to the advancement of SUD treatment and recovery.”  Background:  H.R. 2483, the SUPPORT for Patients and Communities Reauthorization Act of 2025 reauthorizes key public health programs focused on prevention, treatment, and recovery for patients with substance use disorder that were established in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, which was signed into law in 2018. Full list of supporting organizations:  A Stepping Stone to Success Active Minds ADA Women's Center Addiction Policy Forum Addiction Professionals of North Carolina Advocates for Opioid Addiction Treatment (AOAT) Akin American Association for the Treatment of Opioid Dependence (AATOD) American Association of Addiction Nursing American College of Emergency Physicians (ACEP) American Foundation for Suicide Prevention American Jail Association American Podiatric Medical Association (APMA) Association for Behavioral Health and Wellness (ABHW) Association of Prosecuting Attorneys Barbie Girl Ink LLC Behavioral Health Foundation Beyond Addiction Boone County Drug Prevention Coalition Brain First Family Center Bridging Hope, Inc. Brightpoint Bring Light Save Life C.A.R.E CADCA California Consortium of Addiction Programs & Professionals Centerstone Center for Adolescent Behavioral Health Research, Boston Children's Hospital Chesapeake Integrated Behavioral Healthcare Children’s Hope Alliance Command Destinations Community in Connection Couve Collective Crossroads To Intervention, Inc Crosswinds Recovery Dayspring Foundation DePaul’s NCADD-RA Devin J. Norring Foundation Entertainment Industries Council, Inc. (EIC) Eating Disorders Coalition for Research, Policy, & Action (EDC) Faces & Voices of Recovery First Step Counseling & Educational Services Families Forward Michigan FASCETS Center for Neurodiversity FASD Changemakers FASD Collaborative Project FASD Network of Northern California FASD Network of Southern California FASD Strong FASD United FASDNow! Florissa Pediatric Development Center FLOW Counseling & Guidance, Pllc Formed Families Forward Foster Family Alliance of North Carolina Freund & Associates, LLC Functional Link Occupational Therapy Grant a Gift Autism Foundation Harm Reduction Research Lab, University of Arizona College of Medicine-Tucson Hawaii FASD Action Group Healthcare Leadership Council Heart & Soul Speech Hopewell HOR Community Solutions, LLC Huntington, WV QRT (Quick Response Team) Hurley House IC&RC Illuminate Colorado InforMATION, LLC Inseparable Institute for Behavior and Health, Inc. International Certification and Reciprocity Consortium (IC&RC) Iowa Harm Reduction Coalition Jenks Forensic Addictions Services JLM Research and Evaluation Kansas FASD Support Network, Inc Kasper’s FASD Life Coaching & Training Kentucky Alliance of Recovery Services Kohnlinq, Inc. Latino Ministers of New Jersey For Justice Liberation Programs Long Island Recovery Association Maddie Wright Foundation Madison County Recovery Allies Magical Manners Club for Boys & Girls Maryland Legislative Coalition Meadows Behavioral Healthcare Mental Health America Mental Health Colorado Mental Health Liaison Group (MHLG) Merakey Michigan Coalition for Fetal Alcohol Resources Education and Support Mighty Crow Milford Prevention Council Mississippi Society of Addiction Medicine Missouri Works Initiative Montgomery County Federation of Families for Children's Mental Health, Inc. NAMI Southeastern Arizona National Alliance for Comprehensive Addiction Treatment Solutions (NACATS) National Alliance on Mental Illness (NAMI) National Alliance on Mental Illness, Southeastern AZ National Association for Behavioral Healthcare (NABH) National Association for Children of Addiction National Association of Addiction Treatment Providers National Behavioral Health Association of Providers National Council for Mental Wellbeing National Council on Problem Gambling (NCPG) National Disability Rights Network (NDRN) National District Attorneys Association NCFASD Informed, Inc. Neuro.behavioral.connections New Jersey Association of Mental Health and Addiction Agencies, Inc. New Jersey Center for Empowerment and Community Development New York State Council for Community Behavioral Healthcare No More ODs, Inc. Objective Recovery, Inc. Ohio Mental Health and Addiction Services Oregon Council for Behavioral Health PACID: Parent Advocates for Adult Children with IDD Power Forward, Inc. Prevention Action Alliance RASE Project ReBuilding Bridges Consulting, LLC Recovery Revolutionists Rockland Recovery Homes, Inc. Sacred Hearts Psychiatry and Addiction Medicine Sage Advice Therapy LLC Salisbury Elks #699 SC FASD COLLABORATIVE SEIU Local 500 Serenity Now - Nar-Anon Chapter Shatterproof Skyland Trail South Florida Wellness Network St. Joseph's Behavioral Health Center Supporting Community in Recovery Fund/Yakima Valley Community Foundation TASC, Inc. (Treatment Alternatives for Safe Communities) Teton County Health Department - Prevention Texas FASD Network The BROCK Foundation The Florida Center The Florida Center for Early Childhood The Kennedy Forum The Ohio Council of Behavioral Health and Family Services Providers The Papillion Center Kentucky The Sanctuary Foster Care Services Thrive Family Recovery Resources Treatment Communities of America Tyler's Redemption Place University of Washington UT Tyler School of Medicine Valley Court Diversion Programs Village Collaboration Station, PC Wake Up Nevada LLC WeKonnect LLC Westcare White Flint Family Pharmacy WV Drug Intervention Institute Wyoming County Special Needs Association 101 Ways 21-14 CAF Click here to for full bill text of H.R. 2483. ###

WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, Congressman Gus Bilirakis (FL-12), Chairman of the Subcommittee on Commerce, Manufacturing, and Trade, and Congressman Richard Hudson (NC-09), Chairman of the Subcommittee on Communications and Technology, issued the following statement after President Trump delayed enforcement of the TikTok divestiture requirement in response to progress towards a deal: “We are glad to hear about significant progress towards separating TikTok from entities connected to the Chinese Communist Party. While there are remaining details that must be worked out, any deal must finally end China’s ability to surveil and potentially manipulate the American people through this app,” said Chairmen Guthrie, Bilirakis, and Hudson. “Our Committee will remain vigilant in protecting our national security and standing up for American interests across the board.” ###

WASHINGTON, D.C. – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, and Congressman Earl L. “Buddy” Carter, Chairman of the Subcommittee on Health, issued the following statement after Dr. Mehmet Oz was confirmed by the Senate to serve as Administrator of the Centers for Medicare and Medicaid Services (CMS). “CMS plays an integral role in ensuring Americans can access health care, particularly for seniors, pregnant women, children, and individuals with disabilities,” said Chairmen Guthrie and Carter . “Dr. Oz is an accomplished physician, an innovator, and a world-class communicator, who will help modernize the agency by utilizing new cutting-edge technology that empowers health care providers to better serve the American people. We look forward to partnering with him to improve health outcomes for Americans.” ###

WASHINGTON, D.C. – Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, Congressman John Joyce (PA-13), Congressman Jay Obernolte (CA-23), and Congressman John James (MI-10), along with Members of the House Committee on Energy and Commerce, California Republicans, and Conference Chairwoman Lisa McClain, introduced three Congressional Review Act resolutions that would undo harmful rules created under President Biden’s EPA. These three Congressional Review Act resolutions would reverse radical regulations that established a de facto ban on the use of gas-powered vehicles, heavy trucks, and diesel engines over the next decade. “The American people should choose what vehicle is right for them, not California bureaucrats. By submitting the three California waivers to Congress, Administrator Zeldin is ensuring that Congress has oversight of these major rules that impact every American,” said Chairman Guthrie . “The Committee has been committed to addressing this issue since California first attempted to create a de facto EV mandate. Energy and Commerce Republicans will continue to fight against far-left policies that would harm consumers and will now work to ensure that the Congressional Review Act process finally puts these issues to rest. Thank you to Congressman Joyce, Congressman Obernolte, and Congressman James for your work to ensure that families and businesses can continue to choose the vehicles they need.” “Since arriving in Washington, I have fought to protect consumer freedom and allow American families to choose the vehicle that best fits their budget and needs,” said Vice Chairman John Joyce, M.D. “The introduction of this resolution to overturn California’s ban on gas-powered vehicles is long overdue. Thank you to Chairman Guthrie and Chairman Capito for their leadership on this issue, and I look forward to seeing this legislation swiftly pass through Congress so President Trump can permanently protect the freedom of the open road for all Americans.” “As a representative of California, I’ve seen firsthand how burdensome regulations from the California Air Resources Board have hurt businesses and hardworking Americans by imposing costly mandates instead of allowing the market to drive innovation,” said Congressman Obernolte. “Congress must exercise its oversight authority to ensure these policies do not become the national standard. It is critical we protect jobs, supply chains, and the ability of consumers to choose what is best for them and their families.” “The Biden administration left behind comply-or-die Green New Deal mandates that threaten to crush our trucking industry and drive up costs for hardworking Americans,” said Congressman James. “I know — my family has a trucking company. Republicans are working hard to implement President Trump’s America First agenda, and the first step is repealing the rules and waivers that contributed to Bideninflation!”  “During the Biden administration, the Environmental Protection Agency (EPA) allowed a series of stringent, environmentally charged regulations on vehicles that would effectively overhaul the marketplace and steer consumers toward purchasing electric vehicles,” said Congressman Fulcher. “I am honored to join my colleagues in introducing a legislative package to repeal these overreaching federal mandates and preserve consumer freedom and choice in the automotive and heavy-duty truck markets,”  “California’s sweeping and unachievable emissions mandates are a direct assault on everyone who lives, works, or does business in our state,” said Congressman LaMalfa . “These regulations drive up costs, limit consumer choice, and force trucking and automotive industries into an impossible transition timeline. Californians are already paying some of the highest fuel and energy costs in the country. These rules are causing the cost of new and used cars and trucks to increase for everyone. If you want to buy an electric vehicle, buy one, but everybody else shouldn’t be forced into this mandate. The Federal Government cannot allow one state to destroy the American car and truck market. Instead of making life even more expensive, we should focus on what consumers want. I’m pleased to support this effort to stop California’s insanity and protect drivers and consumers across my state and the country.”  “The Newsom Administration’s irrational plan to ban gas-powered cars and trucks is an affront to the freedom of Californians and an economic burden to the whole country,” said Congressman Kiley. “ The Biden Administration aided and abetted this insanity with special waivers. With the Congressional Review Act resolutions introduced today, we have an opportunity to return to economic reality and restore common sense.”  “Biden’s EPA waivers effectively allowed one state’s woke agenda to dictate national policy. It’s not the government’s role to decide what vehicle Americans must drive,” said Chairwoman McClain. “These waivers bypass Congress and ignore millions of Americans who rely on affordable, reliable transportation. Instead, we should have a little more faith in the American people to choose what’s best for them. It’s time we end this regulatory overreach.”  Background:  Making these changes at a time when the United States is unprepared for a full transition to electric vehicles would have massive consequences for American communities. With states making up more than 40% of the auto market following California’s emissions standards, implementing Californias EV mandate would result in a nation-wide shift in the vehicles that are available for purchase, and in fact could lead to a shortage of the vehicles consumers need.   H.J. Res. 88 , introduced by Congressman Joyce (PA-13), would reverse the EPA’s decision to approve a waiver granted to California allowing the State to ban the sale of gas-powered vehicles by 2035. H.J. Res. 89 , introduced by Congressman Obernolte (CA-23), would put an end to the EPA’s decision to allow California to implement its most recent nitrogen oxide (NOx) engine emission standards, which create burdensome and unworkable standards for heavy-duty on-road engines. H.J. Res. 87 , introduced by Congressman James (MI-10), would reverse the EPA’s decision to approve a waiver granted to California allowing the State to mandate the sale of zero-emission trucks. ###

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. – 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.  – 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.” ###