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Washington, D.C. — In a final warning to the Food and Drug Administration (FDA), House Energy and Commerce Committee 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, threatened to issue a subpoena for documents related to risky research conducted at FDA facilities. The letter follows two previous requests for documents regarding experiments involving virus manipulation, which the FDA has acknowledged occurred in some of its research studies.   November 9, 2023  The Honorable Robert M. Califf, M.D., MACC  Commissioner  U.S. Food and Drug Administration  10903 New Hampshire Avenue  Silver Spring, MD 20903  Dr. Califf,  The Committee sent the U.S. Food and Drug Administration (FDA) a letter on March 27, 2023, regarding FDA-funded research that may pose significant biosafety or biosecurity risks. Following the FDA’s insufficient response on May 26, 2023, we sent a follow up letter on June 29, 2023. To date, the FDA has only produced 29 pages of the charter documents for the Institutional Biosafety (IBC) and the Dual Use Research of Concern (DURC) review panel, which were not sent until October 20, 2023. Having not received an adequate response to our follow-up letter, we are sending a formal document request to obtain information needed for our oversight that we requested in the June 29 letter.  Pursuant to Rules X and XI of the U.S. House of Representatives, please provide the following by November 28, 2023:  All coronavirus research studies referenced in the January 31, 2023, email. All studies that have undergone Institutional Biosafety Committee (IBC) review at the FDA since October 1, 2013, and all documents related to the IBC reviews of these studies.   All studies that have undergone Dual Use Research of Concern (DURC) review at the FDA since October 1, 2013, and all documents related to the DURC reviews of these studies.   All policies and/or procedures related to the IBC and DURC processes.   In the May 26, 2023, response letter, the FDA stated that the Center for Biologic Evaluation and Research (CBER) research studies involving coronaviruses and viral manipulation of SARS-CoV-2 “underwent applicable Institutional Biosafety Committee (IBC) review, including attestation by the principal investigator (PIs) regarding Dual Use Research of Concern (DURC) screening.” The FDA added “[n]one of these studies rose to the level of DURC review.” Please provide all documents related to these statements.  In the May 26, 2023, response letter, the FDA stated that a Center for Drug Evaluation and Research (CDER) laboratory performs studies to monitor and evaluate seasonal influenza virus resistance to clinically relevant antivirals. Please provide all documents related to these studies, including the IBC and DURC applications and approvals.   In the May 26, 2023, response letter, FDA stated that FDA requires “any research associated with hazardous biological agents and toxins (HBATs) be subject to full IBC review.” Please provide all documents since October 1, 2013, associated with HBATs, including documents related to full IBC review.  In the May 26, 2023, response letter, the FDA stated that “[s]ince September 2015, and prior to the establishment of the DRP, the FDA’s IBC application process required the attestation of all PIs concerning the nature of their work as it related to DURC policies.” Please provide a copy of the IBC application with the attestation requirement, and all documents related to the establishment of the attestation requirement.  All documents related to all extramural research that have gone through the FDA IBC and/or DURC review since September 1, 2015.    Thus, to carry out our Constitutional responsibilities of oversight, if the FDA does not produce the requested documents by November 23, 2023, it will be necessary to issue a subpoena for documents since the FDA has delayed its response and the committee has a right to obtain these materials to aid in its legislative activities and to ensure that the Executive Branch is complying with the law.  If you have any questions, please contact the Majority Committee staff at (202) 225-3641. Thank you for your attention to this request.  CLICK HERE to view the letter.  CLICK HERE to read the March 27, 2023. letter.  CLICK HERE to read the June 29, 2023, 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, sent a letter to the Substance Abuse and Mental Health Services Administration. The letter to Assistant Secretary and Administrator Delphin-Rittmon, which is the second follow up from the Committee, serves as the final notice before the Committee will be forced to issue a subpoena. KEY EXCERPTS :  “[…] SAMHSA still has not yet provided the full accounting for billions of dollars in expenditures as requested.”  […]  “Since SAMHSA apparently is not addressing our requests for expenditure information, we now request documents. The Committee’s document requests are specific and reasonable and seek to get full accountability for SAMHSA funds. Unfortunately, SAMHSA has repeatedly not provided requested information about expenditures, nor have any legal reasons been provided for not yet providing the requested information and documents.”  The Chairs requested the following documents by November 27, 2023:  The most recent copies of each state’s Payment Management System and Federal Financial Report draw-down reports for COVID supplemental funding. The most recent copies of Payment Management System and Federal Financial Report draw-down reports for each of the following programs that received COVID-19 supplemental funds: Certified Community Behavioral Health Clinics (CCBHCs); Suicide Prevention Programs; Project AWARE; Tribal Behavioral Health Grants; Substance Use Prevention, Treatment, & Recovery Services Block Grant; Community Mental Health Services Block Grant; National Childhood Traumatic Stress Network; and Community Based Substance Use Disorder Services The most recent copies of each state’s Payment Management System and Federal Financial Report draw-down reports for 9-8-8 crisis care funding.  CLICK HERE to read the full letter.  CLICK HERE to read the Chairs’ April 5, 2023, letter on Covid Spending, Suicide Hotline Rollout, Support for Treating Serious Mental Illness, and New Office of Recovery. CLICK HERE to read the Chairs’ August 10, 2023, follow up letter.

The Chairs’ request comes amid ongoing investigation into federal lab safety practices 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, today wrote to Food and Drug Administration Commissioner Robert Califf. The letter follows up on the FDA’s responses to the Chairs' May 24, 2023, letter and outlines concerns with how the agency has treated laboratory safety through its:  Lack of support for lab safety demonstrated by weakening the Office of Lab Safety and removing science from its mission   Noncompliance with key Occupational Safety and Health Administration (OSHA) regulations  Failure to fully address five key recommendations from the Government Accountability Office (GAO) CLICK HERE to read the full letter.  KEY EXCERPT:   “We are deeply concerned that the FDA is not meeting important federal safety requirements to protect its employees and the public while also failing to prioritize scientific data quality delivered from FDA laboratories. Finally, the response also did not address several critical questions raised in our letter. Accordingly, we are following up to outline our concerns and to submit targeted document requests that are responsive to the Committee’s oversight.” BACKGROUND ON RENAMING AND RESTRUCTURING OF OLS: Currently, the Director of OLS does not directly report to the Commissioner.   This is contrary to how the CDC prioritized this reporting relationship and to past FDA actions and commitments.  In July 2015, the External Laboratory Safety Working Group (ELSW) for laboratory safety improvements at the FDA included a recommendation that the FDA make leadership changes, including hiring a Director of Laboratory Science and Safety with a direct reporting line to the Commissioner.  According to a June 29, 2017, memorandum from then-FDA Commissioner Scott Gottlieb the FDA hired a director of laboratory science and safety in October 2015.  The FDA determined in 2016 that the OLSS director should report directly to the Commissioner.  In 2018, the FDA again realigned OLSS without any formal notice in the Federal Register during a 2018 Office of Commissioner reorganization.  This reversal was purportedly based on a McKinsey consulting report, but the FDA would not produce to the Committee any documentation from the McKinsey report to support the realignment of the OLSS office.  The FDA in 2018 reorganized OLSS and removed laboratory science from its portfolio while putting the laboratory safety office without the science portfolio in the Office of Chief Scientist.   The OLSS was renamed the Office of Laboratory Safety (OLS).  The FDA’s scoping and alignment of its laboratory office diverges from the actions of its sister agency at the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC).  BACKGROUND ON NONCOMPLIANCE WITH OSHA REGULATIONS : OSHA has several requirements that apply to FDA oversight of laboratory safety.  One regulation requires annual inspections of all laboratories, including a sufficient number of unannounced inspections.  The FDA’s responses to the Committee’s ongoing investigations indicate that the FDA is not meeting OSHA requirements and best practices.  BACKGROUND ON FDA’S FAILURE TO ADDRESS GAO LAB SAFETY RECOMMENDATIONS : In September 2020, the GAO issued a report on the FDA’s OLS and made five recommendations to provide OLS with the authority and access to facilities necessary to oversee laboratory safety.  The Department of Health and Human Services agreed with all five recommendations.  According to the GAO website, none of the five recommendations have been fully addressed.  ADDITIONAL BACKGROUND : The Committee began this Congress with an Oversight and Investigations Subcommittee hearing titled “Challenges and Opportunities to Investigating the Origins of Pandemics and Other Biological Events” that focused in part on federal biosafety practices.  The Subcommittee then held an April 27, 2023, hearing titled “Biosafety and Risky Research: Examining if Science is Outpacing Policy and Safety”  Committee Republicans sent a letter to the FDA on May 24, 2023, outlining concerns with the agency’s lab safety policies. 

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, sent letters to the Centers for Medicare and Medicaid Services (CMS) and Government Accountability Office (GAO) regarding changes to budget neutrality in parts of the Medicaid program.  BACKGROUND:   Section 1115 of the Social Security Act allows states to pilot distinct approaches within their Medicaid programs to address their unique population health care needs while adhering to the principle of budget neutrality. These demonstrations are intended to foster state-driven innovation and accountability in the utilization of federal funds, promoting efficiency and alignment with the broader objectives of Medicaid, which include providing essential health care services to low-income individuals and families.  A pivotal requirement for these demonstrations, grounded in the clause “must not result in increased cost to the Federal Government under part A of such title” from Section 1115 of the SSA concerning Medicaid waivers, aligns with the principle of budget neutrality.   This principle has been long interpreted and administered by CMS to mean that federal spending under a demonstration cannot exceed projected costs in the absence of the demonstration, a concept referred to as the without-waiver baseline.   If state spending under its demonstration is below the without-waiver baseline, the difference is considered a savings. The state can use any accumulated savings to finance spending on populations or services that are not otherwise covered by Medicaid, referred to as “costs not otherwise matchable” (CNOM).  This policy was first articulated by the Carter administration.   The Clinton administration was the first to issue detailed publicly available guidance on how states were to comply with the budget neutrality requirement. All subsequent administrations, except the Biden administration, have issued formal publicly available guidance on budget neutrality.  The Biden administration altered the calculation of budget neutrality during the Summer of 2022, with modifications to the Special Terms and Conditions concerning how states utilize Section 1115 demonstrations to fund health-related social needs, Designated State Health Programs, and the process of updating budget neutrality mid-demonstration, meaning that such calculations are no longer budget neutral.  KEY CMS LETTER EXCERPT:   “The Committee is concerned about the lack of transparency and consistency in how CMS, under the Biden administration, determines policy development and compliance with budget neutrality requirements.” […]   “The Committee is also concerned about the potential for fraud, waste, and abuse in the calculation and application of states’ budget neutrality limits under Section 1115 Medicaid waivers.” CLICK HERE to read the full letter to CMS Administrator Chiquita Brooks-LaSure.  KEY GAO LETTER EXCERPT:   “We write today to request that the U.S. Government Accountability Office (GAO) conduct a review of recent changes the Centers for Medicare & Medicaid Services (CMS) has made related to the budget neutrality requirement for Medicaid demonstrations. Demonstrations approved under section 1115 of the Social Security Act (‘Section 1115 Demonstrations’ or ‘demonstrations’) allow states to test new approaches in Medicaid, including spending for costs that would not otherwise be eligible for federal matching funds.”   The Chairs requested GAO conduct an analysis of the following:  1. Changes in CMS’s approach to assessing budget neutrality and setting spending limits for section 1115 demonstrations over the past ten years;  2. What is known about the implications of recent changes on federal spending; and,  3. Changes to policies and procedures for ensuring transparency around budget neutrality in section 1115 demonstration approvals.  CLICK HERE to read the full letter to GAO Comptroller General Gene Dodaro. 

Misuse of funds weakens programs for vulnerable populations 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) Inspector General (IG) Christi Grimm and Centers for Medicare and Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure regarding improper Medicaid payments, including a significant number of payments made to deceased enrollees. KEY HHS IG LETTER EXCERPT :  “Improper payments are widespread in Medicaid and have been estimated at $359.39 billion over the past five years. Such payments represent a significant misuse of funds that redirects payments away from providing essential care to our nation's most vulnerable populations.”   The Chairs requested the following information by November 13, 2023:  1. How does the HHS OIG plan to work with CMS to implement the recommendations made in the audit report [titled Virginia Made Capitation Payments to Medicaid Managed Care Organizations After Enrollees' Deaths] (A-03-22-00203)?  2. Confirm if CMS advises states to check regularly the public Death Master File (DMF) to ensure beneficiaries have not been reported.  3. Confirm if CMS advises states to check regularly the Public Assistance Reporting Information System (PARIS) to ensure that recipients of Medicaid are not receiving benefits in more than one state.  4. As discussed in the hearing on April 18, 2023, will your office commit to reviewing current CMS practices and policies for interacting with states on eligibility determination systems, as well as identifying any areas for improvement and enhancement?  CLICK HERE to read the full letter to HHS.  KEY CMS LETTER EXCERPT :  “Ensuring that Medicaid is only paying for individuals who are eligible for care should be a basic tenant of the program. However, it is clear that this simply has not been the case. A 2022 OIG audit [titled Prior Audits of Medicaid Eligibility Determinations in Four States Identified Millions of Beneficiaries Who Did Not or May Not Have Met Eligibility Requirements] (A-02-20-01018), reported that states routinely failed to document a beneficiary’s reported income, resources, citizenship, and even residency within the state from which the individual was seeking coverage from.”   The Chairs asked for responses to questions, including the following by November 13, 2023:   1. How does CMS plan to implement the recommendations made in the HHS OIG report (A-03-22-00203)? Does CMS agree or disagree with these recommendations? If CMS disagrees, what alternative approaches is the agency proposing to take to address the concerns? The recommendations are as follows:  a. Refund unallowable capitation payments made to managed care organizations (MCOs).  b. Identify and recover unallowable capitation payments made on behalf of deceased enrollees and repay the Federal share of amounts recovered.  c. Continue to pursue development and implementation of an automated matching and eligibility update process.  d. Implement additional supervisory review to ensure that State agency personnel completely and accurately update the State agency’s eligibility system based on information provided by the Department of Health’s Office of Vital Statistics.  2. What steps has CMS taken to ensure oversight of and prevent Medicaid MCOs from receiving capitation payments after beneficiaries’ deaths, given that the OIG has written at least 14 reports on this issue?  3. Does CMS advise states to check the Social Security Administration’s Death Master File (DMF)? If yes, please provide any supporting documentation.  a. If CMS is advising states to regularly check the DMF, explain why deceased beneficiaries continue to receive payments?  b. How often does CMS advise states to check the DMF?  c. If CMS is not advising states to regularly check the DMF, explain why not.  d. How is CMS working to improve the accuracy and timeliness of death data?  e. What measures are being implemented to enhance the coordination and data sharing between CMS and state agencies?  CLICK HERE to read the full letter to CMS. 

Washington, D.C. – The Biden administration recently proposed a one-size-fits-all federal nurse staffing mandate, despite overwhelming evidence that such a policy would be virtually impossible for the nation’s nursing homes to meet.   In a letter to Health and Human Services (HHS) Secretary Becerra and Centers for Medicare & Medicaid Services (CMS) Administrator Brooks-LaSure, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), House Ways and Means Committee Chairman Jason Smith (R-MO), and Senate Finance Committee Ranking Member Mike Crapo (R-ID) call on the administration to immediately withdraw the proposed rule and provide justification for its $40.6 billion unfunded mandate that could force many nursing homes to close, threatening resident access to direct care services.  From the letter:  “We write today to express our serious concerns regarding the administration’s minimum nurse staffing standards proposed rule. This one-size-fits-all, unfunded mandate will jeopardize access to care for the 1.2 million Americans living in more than 15,000 certified nursing homes nationwide — especially those who reside in rural and underserved areas. Our nation’s nursing homes have weathered an unprecedented storm over the past three years. From government spending induced inflation to pandemic provider burnout, community access to long-term care services has been strained. Since January 2020, over 400 nursing homes closed their doors and approximately 190,000 nursing home employees left the workforce […] Given this current landscape, the administration’s proposal will only serve to further undermine patient access to skilled nursing care. As such, we strongly urge you to withdraw the rule and work with us on tailored solutions addressing the severe health care workforce shortages in our states,” write Chair Rodgers, Chair Smith, and Ranking Member Crapo .    Under the Biden administration’s proposal, nursing homes would have limited flexibility to distribute direct care staff and meet individual resident needs. Nursing homes face strong competition to recruit and retain trained workers, especially in rural areas. CMS data indicates that 79 percent of nursing facilities across the country would need to hire additional nursing staff in order to comply with the Biden administration’s proposed mandate. While CMS argues that the total number of needed providers exist, many of these individuals are already practicing in another care setting or living in another geographic area.  From the letter:  “In applying a uniform, minimum staffing ratio to all facilities, regardless of size or case-mix, the proposed rule could incentivize some facilities to overstaff in order to meet arbitrary federal thresholds. This risks diverting qualified nurses away from small, rural and underserved facilities that also must hire additional employees, running counter to the stated intent of the proposal,” wrote Rodgers, Smith, and Crapo.   Even the final report, cited by the Biden administration to justify proposing the new mandate, found no specified level of staffing could guarantee improved beneficiary outcomes.  From the letter:  “The administration’s own study is clear that there is no significant correlation between any given staffing ratio and increased quality outcomes for residents,” wrote Rodgers, Smith, and Crapo. “These data call into question why the agency would place an unprecedented unfunded mandate on nursing facilities and the States while also acknowledging such a marginal expected increase in patient outcomes and quality.”   Background:    The Biden administration’s proposed mandate will affect up to 1.2 million Americans living in 15,000 Medicare-certified nursing homes.  Since January 2020, more than 400 nursing homes have closed and approximately 190,000 nursing home workers have left the workforce.  CMS projects this unfunded mandate would cost more than $40 billion.  The mandate proposes increasing staffing levels to 0.55 nurse hours per resident day and 2.45 nurse aide per resident day.  CLICK HERE to read the letter.  READ : Chair Rodgers Statement on Biden Admin’s Nursing Home Staffing Rule that will Harm Patients.

Inaccurate data may have led to policy decisions—like mask mandates and school closures—that were harmful to children 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 Republicans, wrote to Centers for Disease Control and Prevention (CDC) Director Mandy Cohen. The letter requests documents and information related to the CDC’s continued dissemination and reliance on COVID tracker data, which may contain inaccurate numbers. KEY EXCERPT :  “The CDC’s responses are consistent with concerns reported in the British Medical Journal (BMJ) and raised by other analysts. On March 15, 2022, the CDC removed 72,277 deaths, including those of 416 children, from its COVID-19 Data Tracker after the overestimates were attributed to ‘coding logic errors’ The inaccuracies were detected by Kelly Krohnert, a former IT programmer from Atlanta, Georgia, on February 23, 2022. She tweeted: ‘It appears [CDC’s COVID] Data Tracker has major issues when it comes to pediatric death reporting. We deserve accurate data when so much is on the line for our kids!’ Krohnert and another mother had been writing to the CDC since May 2020 about these concerns. The overcounting also raises questions about whether CDC used inaccurate data that led to decisions harmful to children .” BACKGROUND : The CDC has provided the House Energy and Commerce Committee with inconsistent data regarding deaths in children ages 0-17 due to COVID.  On August 7, 2023, CDC told the Committee that 2,292 children had died of COVID-19 based on COVID tracker data—no longer used since the end of the COVID public health emergency in May.  In response to a follow up question regarding the number of child deaths were in the National Vital Statistics System, the CDC replied that 1,696 children have died from COVID-19 in a timeframe that was two months longer. The NVSS data based on death certificates is considered by CDC to be more authoritative.  Overcounting child deaths by at least 35 percent is a massive discrepancy in reporting. The Chairs requested the following by November 7, 2023. All documents related to CDC assessments of the accuracy of COVID tracker data since January 1, 2020.  All documents related to the CDC’s decision to disseminate COVID tracker data for COVID mortality data after the public health emergency was ended, given CDC’s admission that NVSS provides “the most complete and accurate information on all deaths in the United States.”  All documents related to CDC assessments of the accuracy of NVSS data since January 1, 2020.  All documents related to CDC analyses of child COVID deaths since January 1, 2020.   All documents related to CDC decisions that relied on child COVID death data from the COVID Data Tracker. All documents related to CDC plans to improve data quality since August 1, 2022.  CLICK HERE to read the full letter. 

Investigation into supercharged virus experiment questions what types of risky research taxpayer-funded agencies are willing to green light 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, today wrote to National Institutes of Health (NIH) Acting Director Lawrence Tabak. The letter makes a final request for the following documents by October 31 or a subpoena will be issued: All proposals and progress reports discussing the mpox gene transfer experiments.  All documents related to the consideration of any mpox gene transfer research. All documents related to the reviews of the mpox gene transfer research by the Institutional Biosafety Committee.  All documents related to Federal Select Agent inspections related to the Moss laboratory’s possession of Clade 1 mpox viruses.  All documents related to the Science magazine articles published on September 15, 2022, and October 19, 2022, including communications between NIH and American Association for the Advancement of Science (AAAS) or Science magazine.  A copy of the document used by Dr. Tabak in response to a question on mpox research at the hearing on February 8, 2023, held jointly by the Subcommittee on Health and the Subcommittee on Oversight and Investigations.  BACKGROUND : November 2022 : Energy and Commerce Republicans opened an investigation into NIH experiments using more lethal mpox viruses after Dr. Bernard Moss, the leading pox researcher at NIH’s National Institute of Allergies and Infectious Diseases, gave an interview to Science magazine discussing a specific mpox project that swapped genes between a more lethal version and a more transmissible version of mpox:  Moss has been trying for years to figure out the crucial difference between two variants of monkeypox virus: clade 2, which until recently was found only in West Africa and is now causing the global outbreak, and clade 1, believed to be much deadlier, which has caused outbreaks in the Democratic Republic of Congo for many decades. He’s found that clade 1 virus can kill a mouse at levels 1000 times lower than those needed with clade 2. To find out why, Moss and his colleagues swapped dozens of clade 2 genes, one at a time, into clade 1 virus, hoping to see it become less deadly, but with no luck so far. Now, they are planning to try the opposite, endowing clade 2 virus with genes from its deadlier relative .   March 2023 : After being informed by NIH that the Committee would need to resubmit oversight requests from the previous Congress, Energy and Commerce Republicans renewed the request. May 2023 : Upon receiving a response from NIH that lacked any explanation and noted simply that the proposal did not go forward, Energy and Commerce Republicans requested a videotaped, transcribed interview with Dr. Moss.  July 2023 : Following a letter response, purportedly written by Dr. Moss, that raised more questions and inconsistencies, Energy and Commerce Republicans re-upped their request for a sit-down with Dr. Moss.  October 2023 : Energy and Commerce Republicans are now sending a final request after determining information provided by the NIH is still insufficient for compliance with legitimate oversight requests. The NIH’s written responses did not adequately address the Members’ questions, and NIH limited Majority Committee staff to only 20 minutes of questioning during a brief in-person briefing.

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) recently sent letters to Department of Health and Human Services (HHS) Secretary Xavier Becerra and the Acting Director of the National Institutes of Health (NIH) Lawrence Tabak. In the letters, the members outline requests for documents and information that have gone unfulfilled by the administration. In a rare move from the Energy and Commerce Committee, which has seldomly had to use compulsory measures, the Chairs note that these are the final warnings before the Committee is forced to issue subpoenas.  1) Letter to Dr. Tabak regarding documents signed by former NIH Director Francis Collins related to reappointment of NIH Institute and Center Directors. KEY EXCERPT :  “This failure to respond is part of a larger pattern from HHS and the National Institutes of Health (NIH) since March 2022 to make assertions that appointments or reappointments of NIH institute and center directors have been lawful, without producing substantiating evidence on which to evaluate this claim.”  CLICK HERE to read the letter.  Previous requests include:  March 14th, 2022 April 21st, 2023 July 7th, 2023 August 9, 2023   2) Letter to Secretary Becerra regarding documents related to the appointment of Jeanne Marrazzo to serve as Director of NIH’s National Institute of Allergy and Infectious Diseases.   KEY EXCERPT :  “We sent you a request letter on August 9, 2023, requesting this document, but HHS has failed to respond to this request. This failure to respond is part of a larger pattern from HHS and the National Institutes of Health (NIH) since March 2022 to make assertions that appointments or reappointments of NIH institute and center directors have been lawful, without producing substantiating evidence on which to evaluate this claim.”  CLICK HERE to read the letter.  Previous requests include:  March 14th, 2022   April 21st, 2023   July 7th, 2023 August 9, 2023 3) Letter to Dr. Tabak regarding documents related to early SARS-CoV-2 sequences and data from early cases.   KEY EXCERPT :  “Nearly three months later, with no meaningful evidence that the NIH is responding to this request, we sent a follow-up letter on August 9, 2023, requesting that the NIH provide responsive documents by no later than August 31, 2023. We alerted you that in the event the NIH did not provide documents by that date, the committee would consider compulsory process to secure production of the requested documents. NIH continues to not be responsive in a meaningful way.    “Over the last four months, the NIH has failed, and continues to fail, to engage with the committee, and provide requested documents. NIH’s disregard of this oversight request undermines the norms of interbranch cooperation and accommodation.”  CLICK HERE to read the letter. Previous requests include:  May 3, 2023   August 9, 2023   4) Letter to Dr. Tabak regarding documents related to NIH-supported risky research, such as virus mutation or manipulation in experiments involving SARS, MERS, or SARS CoV-2.   KEY EXCERPT :  “After more than three months with no meaningful evidence that the NIH was responding to this request, we sent a follow-up letter on August 9, 2023, requesting that the NIH provide responsive documents by no later than August 31, 2023. We alerted you that in the event the NIH did not provide documents by that date, the Committee would be forced to consider compulsory process to secure production of the requested documents.  Unfortunately, NIH continues to not be responsive in a meaningful way." CLICK HERE to read letter.  Previous requests below:  May 1, 2023   August 9, 2023