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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, and Congressman Earl L. “Buddy” Carter (GA-01), Chairman of the Subcommittee on Health, issued the following statement after the House passed H.R. 27, the HALT Fentanyl Act , by a vote of 312 to 108. “As Republicans work to fix the previous Administration’s border crisis and save lives from fentanyl poisoning, this legislation will serve as an important tool for law enforcement to fight against transnational crime organizations and drug smugglers,” said Chairmen Guthrie and Carter . “We are grateful for Reps. Griffith and Latta for their leadership on this legislation and will work with the Senate to see it passed and sent to President Trump’s desk.”   “Today, the House took a critical step forward to combat the fentanyl crisis by passing the HALT Fentanyl Act. For far too long, the Biden administration’s failure to secure our border allowed this deadly drug to pour into our country and kill more than 200 Americans a day. This bill permanently classifies fentanyl-related substances as Schedule I, giving law enforcement the tools needed to halt this epidemic,” said House Speaker Mike Johnson . “With this legislation and President Trump’s recent actions to secure our northern and southern borders, Republicans are taking decisive, strong, and immediate action to keep these dangerous drugs out of our communities.”   “The ongoing fentanyl crisis has been fueled in part by a rise in lethal fentanyl-related substances. We are pleased to see House passage of the HALT Fentanyl Act, which prioritizes the safety of American life and highlights our commitment to defeating the scourge of fentanyl,” said Reps. Griffith and Latta . “Accordingly, we urge swift passage of HALT Fentanyl in the Senate so we can complement President Trump’s actions to curb the flow of fentanyl into America.”   Background:   Drug traffickers are able to exploit loopholes in the criminal code by making minor changes to the chemical composition of fentanyl, creating an “analog” or fentanyl related substances (FRS). Congress granted temporary scheduling authority that allows Drug Enforcement Agency to immediately schedule FRS as a class, removing the incentive for new FRS to be created. The temporary scheduling authority, however, expires in March 2025.  H.R. 27 , the HALT Fentanyl Act , led by Reps. Morgan Griffith (R-VA) and Bob Latta (R-OH), would make the temporary class-wide scheduling order for FRS permanent. It ensures law enforcement have the tools they need to keep these extremely lethal and dangerous drugs off our streets. The bill also ensures practitioners can research fentanyl related substances so we can better understand their overall effects on people's health.  ### 

WASHINGTON, D.C. —  Law enforcement and advocacy groups are urging Congress to pass H.R. 27, the HALT Fentanyl Act, led by Committee on Energy and Congress Members Reps. Morgan Griffith (VA-09) and Bob Latta (OH-05). Here’s what they have to say: “We commend your early prioritization of this issue and your leadership in pushing this legislation forward. The opioid epidemic continues to claim the lives of hundreds of Americans every day. As this crisis escalates, every delay in addressing it only increases the toll on our communities. For the sake of public safety, it is imperative that the House pass the HALT Fentanyl Act as it stands, without changes, and move it forward to law.” CLICK HERE  to read the letter from the Association of State Criminal Investigative Agencies (ASCIA), Federal Law Enforcement Officers Association (FLEOA), Major Cities Chiefs Association (MCCA), Major County Sheriffs of America (MCSA), National Alliance of State Drug Enforcement Agencies (NASDEA), National Association of Police Organizations (NAPO), National District Attorneys Association (NDAA), National HIDTA Directors Association (NHDA), National Narcotic Officers’ Associations’ Coalition (NNOAC), National Sheriffs’ Association (NSA), Sergeants Benevolent Association NYPD (SBA). “We, the members of the Drug Enforcement Association of Federal Narcotics Agents, are writing to express our strong support for the Halt All Lethal Trafficking (HALT) Fentanyl Act. This bipartisan legislation is crucial in combating the devastating fentanyl crisis that has become the leading cause of death among young adults aged 18-45.” CLICK HERE  to read the letter from Drug Enforcement Association of Federal Narcotics Agents President Marshall Fisher. “The HALT Fentanyl Act is not just about strengthening law enforcement—it is about saving lives and protecting communities. By permanently scheduling fentanyl analogues, we are sending a strong message that the United States will not tolerate the continued destruction caused by this drug.” CLICK HERE  to read the letter from Association of Mature American Citizens Action Chairwoman Rebecca Weber. “On behalf of the National Association of Police Organizations (NAPO), representing over 241,000 sworn law enforcement officers across the United States, I am writing to you to express our strong support for the Halt All Lethal Trafficking of (HALT) Fentanyl Act.  [...] “NAPO has long fought for resources to support law enforcement’s efforts to combat fentanyl, its analogues, and similar opioids. We thank you for your efforts to help the fight against the spread of this deadly poison in our communities and look forward to working with you to pass this important legislation.” CLICK HERE  to read the letter from NAPO Executive Director William J. Johnson. CLICK HERE  to read more about the HALT Fentanyl Act.   ###

WASHINGTON, D.C. – In a new opinion piece penned in the Washington Examiner , House Committee on Energy and Commerce members Reps. Morgan Griffith (VA-09) and Bob Latta (OH-05), along with House Republican Conference Chairwoman Lisa McClain (MI-09), laid out the case for passing H.R. 27, the HALT Fentanyl Act , to give law enforcement the tools needed to fight against fentanyl-related substances flowing into our nation. The fentanyl crisis in America is an unnecessary story of anguish and despair, one that elicits pain and stifles hope. The story of 23-year-old college student Zach Cullen, who was preparing for life beyond college, is one of those stories of anguish. He spent four years delivering pizzas from Papa Johns and was interested in developing a technology company. Nine days after Cullen’s birthday, his parents got painful news. They were informed by police that their son, the youngest of their three boys, died from fentanyl-related poisoning. Cullen’s parents later testified before a House Energy and Commerce Committee roundtable demanding change. House Republicans then committed to preventing future tragedies such as Cullen’s. We put pen to paper and worked on a bill to save lives and crack down on the fentanyl crisis: the HALT Fentanyl Act. CLICK HERE to read the full piece. CLICK HERE to read more about the HALT Fentanyl Act.  ###

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, wrote to National Institutes of Health (NIH) Director Monica Bertagnolli. In the letter, the Chairs ask the NIH to confirm by May 14, 2024, whether the agency has complied with White House guidance to stop funding projects led by researchers and entities in Russia.  BACKGROUND :  On June 11, 2022, the White House Office of Science and Technology Policy (OSTP) issued guidance stating such projects and programs that commenced and/or were funded prior to Russia’s further invasion of Ukraine in February 2022 may be concluded, but new projects in affected subject areas will not be initiated.   The OSTP advised applicable departments and agencies to curtail interaction with the leadership of Russian government-affiliated universities and research institutions, as well as those who have publicly expressed support for the invasion of Ukraine.  In a statement in an April 9, 2023, article in The Washington Times , the NIH’s Office of Extramural Research claimed that “NIH currently does not fund any research in Russia.”  However, the Data Abyss tracker for the OSTP Russia guidance on federal funding agencies indicates that, as of April 5, 2024, the NIH has potentially 240 instances of problematic research collaborations since June 2022 that do not comply with the guidance. CLICK HERE to read the letter.

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight Subcommittee Republicans, wrote to Department of Health and Human Services (HHS) Secretary Xavier Becerra.  The letter outlines concerns with the role HHS Office of Civil Rights (OCR) plays—or fails to play—in investigating instances of sexual harassment that occurs at research institutions which receive grants from the National Institutes of Health (NIH).  KEY EXCERPTS :  “There have been several public reports of sexual harassment occurring on NIH-funded research or NIH-supported activities over the last decade, and it raises concerns about what, if any, actions the NIH has taken to resolve these issues. The NIH’s own statistics show a significant problem with more than 300 cases related to sexual or gender harassment since 2018—with about a third of those allegations being substantiated. This also represents hundreds of men and women who may be forced to operate in a hostile or unsafe research environment.”  [...]  “According to the HHS website, OCR does investigate and resolve complaints of sexual harassment in the education and health programs of recipients of grants or other federal financial assistance from HHS—including the NIH. Moreover, HHS OCR is required to conduct periodic compliance reviews of institutional Title IX programs to ensure compliance with the law—including examining the way in which complaints are handled by the institution.”  The Chairs have requested answers to questions about HHS OCR’s role by April 30, 2024.  BACKGROUND :  Based on a recommendation from the U.S. Government Accountability Office (GAO), HHS OCR and the NIH adopted a memorandum of understanding (MOU) to facilitate communication between the two components of HHS as it relates to sexual harassment.   This MOU was intended to clarify procedures on how the enforcement arm of HHS and the grant-making arm share valuable information with one another in an effort to respond appropriately to complaints of sexual harassment and prevent federal grant money from going to those with a history of sexual misconduct.   TIMELINE OF INVESTIGATION :  August 10, 2021 : E&C Republican Leaders Question NIH’s Handling of Sexual Harassment Complaints  August 11, 2022 : E&C Republican Leaders follow up with NIH on Insufficient Response to its Letter on the NIH’s handling of Sexual Harassment  November 30, 2022 : E&C Republicans to NIH: Turn Over Previously Requested Information Ahead of New Congress  March 14, 2023 : E&C Republicans Press NIH for Information on Handling of Sexual Harassment Complaints  October 6, 2023 : E&C Republicans Signal Intent to Issue Subpoenas to Obtain Information on NIH’s Handling of Sexual Harassment if Questions Go Unanswered  January 26, 2024 : Chair Rogers notifies NIH of Imminent Subpoena  February 5, 2024 : Chair Rodgers Subpoenas NIH for Documents Related to Investigation into Sexual Harassment at NIH and NIH Grantee Institutions February 20, 2024: HHS Responds on behalf of NIH to offer a rolling in camera document review to the Committee. Documents produced in the review have been highly redacted, including the redaction of the names of individuals convicted of criminal offenses, public news articles about individuals who have been found guilty of harassment, and redaction of the names of the institutions where the abuse occurred—effectively preventing the Committee from understanding if NIH continues to fund work performed by substantiated abusers at other institutions—a practice known as “pass the harasser.”

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Subcommittee on Health Chair Brett Guthrie (R-KY) announced a subcommittee hearing titled "Legislative Proposals to Support Patient Access to Telehealth Services." “The pandemic opened our eyes to the many benefits telehealth services provide to patients, especially those in rural areas or who are homebound. Similarly, previous investments have demonstrated success as telehealth is playing a key role in addressing the mental health crisis in America,” said Chairs Rodgers and Guthrie. “We want to ensure patients continue to have the choice whether to go to a doctor in person or use telehealth when appropriate and more convenient for them. At the same time, we must also be vigilant that technological innovations provide value for both patients and the Medicare program as a whole. This hearing will give Members the opportunity to discuss legislation aimed at accomplishing all of these goals.”  Subcommittee on Health hearing titled "Legislative Proposals to Support Patient Access to Telehealth Services."   WHAT : A hearing to discuss legislative proposals that will support patients’ access to telehealth services.   DATE : Wednesday, April 10, 2024     TIME : 10:00 AM ET LOCATION : 2123 Rayburn House Office Building     WITNESSES : Witnesses will be announced and are by invitation only.  LEGISLATIVE PROPOSALS TO BE CONSIDERED :  H.R. 134 , To amend title XVIII of the Social Security Act to remove geographic requirements and expand originating sites for telehealth services (Reps. Vern Buchanan and Michelle Steel)   H.R. 1110 , KEEP Telehealth Options Act of 2023 (Reps. Troy Balderson, Susie Lee, Ashley Hinson, and Joe Neguse)   H.R. 3432 , Telemental Health Care Access Act (Rep. Doris Matsui)  H.R. 3875 , Expanded Telehealth Access Act (Reps. Mikie Sherrill, Diana Harshbarger, Lisa Blunt Rochester, Andre Carson, David Valadao, Jennifer Kiggans, Mark Pocan, Glenn Thompson, Tracey Mann, Chellie Pingree, Salud Carbajal, Marc Veasey, Marie Gluesenkamp Perez, Susan Wild, Greg Stanton, Don Bacon, Colin Allred, and Josh Gottheimer)  H.R. 4189 , CONNECT for Health Act of 2023 (Reps. Mike Thompson, David Schweikert, Doris Matsui)  H.R. 5541 , Temporary Reciprocity to Ensure Access to Treatment (TREAT) Act (Reps. Robert Latta and Debbie Dingell)  H.R. 5611 , Helping Ensure Access to Local TeleHealth (HEALTH) Act of 2023 (Reps. Glenn Thompson and Ann Kuster)  H.R. 6033 , Supporting Patient Education And Knowledge (SPEAK) Act of 2023 (Reps. Michelle Steel, Jimmy Gomez, Juan Ciscomani, Adriano Espaillat, Tony Cardenas, Monica De La Cruz, Young Kim, Henry Cuellar, Judy Chu, Jimmy Panetta, David Valadao, Juan Vargas, Salud Carbajal, Susie Lee, and Terri Sewell)  H.R. 7149 , Equal Access to Specialty Care Everywhere (EASE) Act of 2024 (Reps. Michelle Steel, Susie Lee, Mike Kelly, Darrin LaHood, Donald Davis, Yadira Caraveo, Lori Chavez-DeRemer, Don Bacon, Monica De La Cruz, Andrea Salinas, and David Valadao)  H.R. 7623 , The Telehealth Modernization Act of 2024 (Reps. Earl “Buddy” Carter, Lisa Blunt Rochester, Gregory Steube, Terri Sewell, Miller-Meeks, Debbie Dingell, Jefferson Van Drew, and Joseph Morelle)  H.R. 7711 , To amend title XVIII of the Social Security Act to make permanent certain telehealth flexibilities under the Medicare program (Reps. Debbie Dingell, and Jack Bergman)  H.R. 7858 , Telehealth Enhancement for Mental Health Act of 2024 (Reps. John James, Donald Davis, and David Schweikert)  H.R. 7856 , The PREVENT DIABETES Act (Reps. Diana DeGette, Gus Bilirakis, and Jason Crow)  H.R. 7863 , To require the Secretary of Health and Human Services to issue guidance on furnishing behavioral health services via telehealth to individuals with limited English proficiency under Medicare program (Reps. Michelle Steel, Gus Bilirakis and Susie Lee)  H.R. ____ , Hospital Inpatient Services Modernization Act (Reps. Brad Wenstrup and Earl Blumenauer)  This notice is at the direction of the Chair. The hearing will be open to the public and press and will be live streamed online at https://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 Christopher Krepich at Christopher.Krepich@mail.house.gov . 

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) today announced a Full Committee markup. The Committee will consider legislation from the Energy, Climate, and Grid Security; Environment, Manufacturing, and Critical Materials; Health; and Communications and Technology subcommittees.  Chair Rodgers released the following statements:  On the Energy and Environment bills:  “The Energy and Commerce Committee has a rich history of enacting solutions that improve people’s livelihoods and freedom, all while maintaining America’s global energy and environmental leadership. We look forward to building on this legacy with solutions that modernize our pipeline infrastructure, enhance air quality standards and public health, and ensure Americans are free to choose the home appliances that work best for their lives.”  On the Health bills: “Americans are counting on us to deliver on bipartisan solutions that will help improve their health and wellbeing. We’re proud of the hard work that Members both on and off the Energy and Commerce Committee have done to bring forth these proposals to support patients and caregivers across America.”  On the Communications and Technology bills:  “In order to win the future, it is vital that our communications networks are secure. Continuing to rely on technology sourced from foreign adversaries jeopardizes people’s homes, schools, hospitals, our financial system, and the military. That is why Energy and Commerce Republicans are leading on solutions to remove dangerous equipment from our communications infrastructure and help cement America's technological and economic leadership for generations to come.”   WHAT: A Full Committee Markup of 28 bills.  DATE: Wednesday, March 20, 2024   TIME: 10:00 AM ET  LOCATION: 2123 Rayburn House Office Building   Legislation to be considered :  H.R. 7655 , Pipeline Safety, Modernization, and Expansion Act of 2024 (Rep. Duncan)  H.R. 7673 , Liberty in Laundry Act (Rep. Ogles)  H.R. 7645 , Clothes Dryers Reliability Act (Rep. Ezell)   H.R. 7637 , Refrigerator Freedom Act (Rep. Miller-Meeks)   H.R. 7626 , Affordable Air Conditioning Act (Rep. Crenshaw)   H.R. 7700 , Stop Unaffordable Dishwasher Standards (SUDS) Act (Rep. Langworthy) H.R. 7650 , Air Quality Standards Implementation Act of 2024 (Rep. Carter) H.R. 619 , NAPA Reauthorization Act (Rep. Tonko) H.R. 620 , Alzheimer’s Accountability and Investment Act (Rep. C. Smith)  H.R. 7218 , Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer's Act of 2024 (Rep. Guthrie)  H.R. 4581 , Maternal and Child Health Stillbirth Prevention Act of 2024 (Rep. Hinson)    H.R. 2706 , Charlotte Woodward Organ Transplant Discrimination Prevention Act (Rep. Cammack)   H.R. 4646 , SIREN Reauthorization Act (Rep. D. Joyce)  H.R. 6160 , To amend the Public Health Service Act to reauthorize a lifespan respite care program (Rep. Molinaro)  H.R. 6960 , Emergency Medical Services for Children Reauthorization Act of 2024 (Rep. Carter)    H.R. 7153 , Dr. Lorna Breen Health Care Provider Protection Reauthorization Act (Rep. Wild)  H.R. 7251 , Poison Control Centers Reauthorization Act of 2024 (Rep. Chavez-DeRemer)  H.R. 7224 , To amend the Public Health Service Act to reauthorize the Stop, Observe, Ask, and Respond to Health and Wellness Training Program (Rep. Cohen)  H.R. 7208 , Dennis John Beningo Traumatic Brain Injury Program Reauthorization Act of 2024 (Rep. Pascrell)   H.R. 6829 , Cardiomyopathy Health Education, Awareness, and Research, and AED Training in the Schools (HEARTS) Act of 2024 (Rep. Pallone)    H.R. 7189 , Congenital Heart Futures Reauthorization Act of 2024 (Rep. Bilirakis)  H.R. 7406 , DeOndra Dixon INCLUDE Project Act of 2024 (Rep. McMorris Rodgers)  H.R. 3916 , SCREENS for Cancer Act of 2024 (Rep. Morelle)    H.R. 5074 , Kidney PATIENT Act (Rep. Carter)  H.R. 2864 , Countering CCP Drones Act (Rep. Stefanik)  H.R. 820 , Foreign Adversary Communications Transparency Act (Rep. Stefanik)  H.R. 1513 , Future Uses of Technology Upholding Reliable and Enhancing (FUTURE) Networks Act (Rep. Matsui)  H.R. 7589 , Removing Our Unsecure Technologies to Ensure Reliability and Security (ROUTERS) Act (Rep. Latta)  This notice is at the direction of the Chair. The hearing will be open to the public and press and will be live streamed online at https://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 Sean Kelly at Sean.Kelly@mail.house.gov and Christopher Krepich at Christopher.Krepich@mail.house.gov . 

Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), on behalf of the Health and Oversight subcommittee Republicans, wrote to Food and Drug Administration (FDA) Commissioner Robert Califf regarding how the agency handles internal scientific disagreements. Of particular concern to the Committee is whether FDA scientists face possible retaliation for expressing differing scientific views. In the letter, the Chairs note they are prepared to pursue compulsory measures should the FDA fail to respond in a timely, good-faith manner. KEY LETTER EXCERPTS : “ [I]n August 2021, the FDA announced two top vaccine regulators were leaving the agency. One reason cited for the departures was that they were upset about the Biden administration’s announcement that adults should get a coronavirus booster vaccination eight months after they received their second shot. Neither reportedly believed there was enough data to justify offering booster shots yet, and both viewed the announcement by President Biden as pressure on the FDA to authorize the shots quickly. It is unknown whether the FDA dispute resolution process was used, and if not, why not. We are concerned that the FDA may have retaliated against career FDA regulators who were viewed as insufficiently cooperative with the Biden administration’s agenda. ” […] “Given the renewed interest in updated scientific integrity policy, the Committee seeks information on the adequacy of the FDA’s existing policies for handling scientific disagreements, and whether FDA leadership has taken retaliatory actions against dissenting FDA officials." BACKGROUND : A September 2023 Government Accountability Office (GAO) report highlighted the Department of Health and Human Services’ (HHS) interest in developing processes for differing scientific opinions. The GAO also noted that the FDA has existing dispute resolution policies and may continue to use them when the updated scientific integrity policy is finalized. In addition, the GAO has issued two other recent reports that are pertinent to the FDA’s handling of internal scientific disagreements. In June 2012, the HHS Office of Inspector General (OIG) issued a study, Scientific Disagreements Regarding Medical Device Regulatory Decisions . The OIG found that accountability for the completeness of administrative files related to scientific disagreements was unclear as Not all Center for Devices and Radiological Health (CDRH) managers and reviewers received training on the new procedures CDRH faced broader challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion Further, the OIG recommended that the FDA: (1) define more clearly its requirements for documenting and resolving scientific disagreements (2) train all reviewers and managers on the new policies and procedures for resolving scientific disagreements (3) more clearly assign accountability for the contents of the administrative files of all submissions The FDA concurred with all three recommendations. The Chairs requested a response with the following information by January 17, 2024:  Copies of the administrative files related to all internal scientific disagreements at the FDA since January 1, 2018, documenting whether and/or how the resolution was reached and the basis, including any joint memoranda. All documents since January 1, 2018, related to the Office of Chief Scientist handling of appeals of internal scientific disagreements at the FDA. All documents related to the scientific disagreement within the FDA over coronavirus booster vaccination during summer 2021. If the internal process was not used, please provide all documents related to any changes in decision-making authority on the coronavirus booster vaccination during summer 2021 (e.g., authority removed from the director and deputy director of the Center for Biologics Evaluation and Research (CBER) vaccines office and reassigned to the CBER director). All documents since January 1, 2018, related to all instances where decision-making authority was removed from FDA officials involved in regulatory decisions. CLICK HERE to view the full letter.