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WASHINGTON, D.C. – Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, along with Reps. Palmer (AL-06), Carter (GA-01), Bilirakis (FL-12), and Obernolte (CA-23), penned a letter to the Executive Director of Covered California (CoveredCA), Jessica Altman, to request further information related to the potentially unauthorized transmission of sensitive personal health information involving Covered California’s website. Key Letter Excerpt: “According to public reports and agency statements, tracking technology was embedded on Covered California's website beginning in February 2024, as part of a broader digital advertising effort, and in direct contravention of the tracking platform’s user agreement, which prohibits the use of such tools on pages that collect sensitive health information. Although the tags were reportedly removed in April 2025, following external scrutiny and a vendor transition, the extended period of data exposure raises serious questions about the adequacy of safeguards that Covered California had in place. Forensic testing by investigative reporters identified the trackers in operation and confirmed that user-entered health information was being transmitted to third parties without consent. These circumstances warrant examination of Covered California’s actions under federal privacy standards.” “Ensuring the confidentiality of health information is a foundational obligation for entities operating within the health insurance ecosystem. Federal privacy protections, particularly the Health Insurance Portability and Accountability Act (HIPAA), establish expectations for how covered organizations handle sensitive data. Recent reports and public filings raised questions about whether those expectations were met in this case, and whether existing oversight mechanisms are sufficient to detect and prevent improper disclosures.” Background: Forensic testing shows Covered California —the State of California’s official health insurance marketplace—has been sending sensitive user health data to third-party websites through several online data trackers. Prior to removal of the trackers, CoveredCA had more than 60 trackers active on its website; the average number of trackers on a government website is three. Some types of information sent to such websites include: Searches for doctors in network with specific plans/specializations Demographic information, including gender, ethnicity, and marital status Length of treatment a patent received by a provider Frequency of doctor visits If the user indicated they were blind, pregnant, a victim of domestic abuse, or used prescription medications. The State of California independently operates CoveredCA. As the state’s official ACA marketplace, CoveredCA falls under the purview of Health Insurance Portability and Accountability Act (HIPAA). The disclosure of information such as pregnancy or prescription drug use without proper consent—even for “marketing purposes”—may violate HIPAA. This Congress, the Committee has sent letters to 23andMe and DeepSeek over potential data privacy concerns: The Committee also held a hearing last Congress on the Change Healthcare hack, where personal health information was also jeopardized. CLICK HERE to read Fox News coverage of the letter. CLICK HERE to view the full letter. ###

Washington, D.C. — In a new letter to Department of Health and Human Services (HHS) Inspector General Christi Grimm, House Energy and Commerce Committee Republicans requested an investigation into the strength, quality, and types of evidence-based scientific and pediatric medical literature relied on by the department to promote gender transition procedures for children.  KEY LETTER EXCERPT:  “As the agency responsible for safeguarding the health and well-being of Americans, all of HHS’s medical treatment recommendations, especially medical treatment recommendations for children, should be based on rigorous and well-established research, such as randomized controlled trials, that have definitively illustrated the long-term benefits of gender affirming care treatments.”  BACKGROUND:  Under the Biden administration, HHS has advocated for sex reassignment procedures on minors, including the use of serum puberty blockers, which have historically been used to treat children with precocious puberty (i.e., early onset puberty affecting about one percent of U.S. children) and sex offenders.   Puberty blockers, however, are known to stunt normal childhood development in children unaffected by precocious puberty.  HHS officials contend that sex reassignment procedures on minors are an unanimously accepted medical practice.  HHS Secretary Becerra testified before Congress that “every major medical association,” “medical journals,” and “scientific and medical evidence” has demonstrated the benefits of transitioning children’s biological sex.  When asked, via a Freedom of Information Act request, for the underlying scientific or medical basis for its position, HHS was only able to produce a two-page brochure that was already publicly available.  In contrast to HHS, a growing body of literature from medical experts and authorities around the world, including those in Europe, caution against performing such procedures on minors.   Courts and government health agencies responsible for determining child welfare have sought to limit child sex reassignment procedures.   Other countries have banned these interventions and surgeries on minors altogether.  An article published in the British Journal of Medicine found “there is great uncertainty about the effects of puberty blockers, cross-sex hormones, and surgeries in young people.”   A court in the United Kingdom noted the obvious about administering puberty blocking chemicals onto children: “[i]t is highly unlikely that a child aged 13 or under would be competent to give consent to the administration of puberty blockers. It is doubtful that a child aged 14 or 15 could understand and weigh the long-term risks and consequences of the administration of puberty blockers.”  In April 2024, the Cass Review , an independent review of gender identity services for children and young people, commissioned by the National Health Service England, found “[w]hile a considerable amount of research has been published in this field, systematic evidence reviews demonstrated the poor quality of the published studies, meaning there is not a reliable evidence base upon which to make clinical decisions, or for children and their families to make informed choices.”   The Cass Review also found that “[t]he rationale for early puberty suppression remains unclear, with weak evidence regarding the impact on gender dysphoria, mental or psychosocial health,” as well as unknown effects on cognitive and psychosexual development.  In August 2024, the American Society of Plastic Surgeons (ASPS) became the first major U.S. medical association to express caution on the use of gender surgery for gender dysphoria in adolescents. In its formal statement, the association stated: “ASPS currently understands that there is considerable uncertainty as to the long-term efficacy for the use of chest and genital surgical interventions for the treatment of adolescents with gender dysphoria, and the existing evidence base is viewed as low quality/low certainty. This patient population requires specific considerations.”   The letter was signed by Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), Rep. Dan Crenshaw (R-TX), Rep. Gus Bilirakis (R-FL), Rep. Buddy Carter (R-GA), Rep. Gary Palmer (R-AL), Rep. Neal Dunn (R-FL), Rep. Randy Weber (R-TX), Rep. Troy Balderson (R-OH), Rep. August Pfluger (R-TX), Rep. Diana Harshbarger (R-TN), and Rep. Kat Cammack (R-FL).  CLICK HERE to read the letter.

Americans deserve to have their sensitive health information protected. Energy and Commerce Republicans have been actively working since the February 21st cyberattack on Change Healthcare to understand how it happened, how it can be prevented in the future, and how to help Americans continue to access care.  THE PROBLEM Change Healthcare is one of the largest health payment processing companies in the world. It acts as a clearing house for 15 billion medical claims each year—accounting for nearly 40 percent of all claims. The cyberattack that occurred in February knocked Change Healthcare—a subsidiary of the behemoth global health company UnitedHealth—offline, which created a backlog of unpaid claims. This has left doctors’ offices and hospitals with serious cashflow problems—threatening patients’ access to care. It has since come to light that millions of Americans may have had their sensitive health information leaked onto the dark web, despite UnitedHealth paying a ransom to the cyber attackers. E&C ACTION From the outset, Members on Energy and Commerce have been working with the administration and Change Healthcare to help providers—particularly smaller and rural practices—maneuver through the new, complicated process of getting reimbursed, so they could keep their doors open and focus on caring for patients. Energy and Commerce Republicans were briefed by the Administration for Strategic Preparedness and Response, the Centers for Medicare and Medicaid Services, and Change Healthcare in the weeks following the attack. Following the briefings, bipartisan Energy and Commerce leaders wrote to UnitedHealth seeking answers about the attack. The Subcommittee on Health convened a hearing on May 17th to explore cybersecurity vulnerabilities in the health care sector and discuss possible solutions to address them. This week, the Oversight and Investigations Subcommittee called UnitedHealth CEO Sir Andrew Witty to explain to the American people what happened in the lead up to and during the attack, how the company is responding, and how it plans to prevent such an attack from happening again. WHAT WE LEARNED 1. The attack occurred because UnitedHealth wasn’t using multifactor authentication [MFA], which is an industry standard practice, to secure one of their most critical systems.  Mr. Witty:   We're continuing to investigate as to exactly why MFA was not on that particular service. It clearly was not. I can tell you I'm as frustrated as you are about having discovered that and as we've gone back and figured out how this situation occurred.    Change Healthcare came into the organization toward the end of 2022 after the timing of the declarations you just described.    Change Healthcare was a relatively older company with older technologies, which we had been working to upgrade since the acquisition. For some reason, which we continue to investigate, this particular server did not have MFA on it.   2. It’s estimated that a third of Americans had their sensitive health information leaked to the dark web as a result of the attack.  Oversight Subcommittee Chair Morgan Griffith: "Substantial proportion of the American population." What does that mean? How much are we talking? 20 percent? We talking 50 percent? We're talking 70? Tell us.   Mt. Witty:   Chairman, we continue to investigate the amount of data involved here. We do think it's going to be substantial. Because we haven't completed the process, I'm hesitant to be overly precise on that and and be wrong in the future. I wouldn't like to mislead anybody in that regard.   Chair Griffith:   Well, and I wouldn't want you to mislead us either. But when you say "substantially," at least give me some kind of a range. You can be on the bottom to high. I don't mind giving you a range. Are we talking 20 to 50?   Mr. Witty:   I think maybe a third or somewhere of that level.   3. This might not be the end of the leaks. Despite UnitedHealth paying a ransom to the criminals, it cannot guarantee that more of Americans’ sensitive information will not be leaked.  Chair Cathy McMorris Rodgers:   How were the hackers communicating with UnitedHealth to get the ransom? Did you communicate ever directly with the hackers?   Mt. Witty:   I did not. No. Chair Rodgers:   How much did you pay in ransom? And how was it paid it? In dollars? Bitcoin or other cryptocurrency?   Mr. Witty:   $22 million in Bitcoin.  Chair Rodgers:   What was the date that you paid the ransom?   Mr. Witty:   I'm sorry. I don't have that to mind. But I can certainly get back to you with that.   Chair Rodgers:   Can you affirmatively say that the hackers you paid did not make copies of protected or personal data and then, at a later date, uphold it onto the internet or the dark web.   Mr. Witty:   I cannot affirmatively say that. No. 4. UnitedHealth has resources to help individuals and providers.  Dr. Burgess:   Is there a generally available website or telephone number that a practice can call right now, if they're continuing to have a problem?  Mr. Witty: Yes. And thank you very much for the question. So [ https://support.changehealthcare.com/ ] is the best website for anybody to access, whether it being a provider or an individual.    But, also I would very much like to note the 1-800 number that's available for individuals to call if they have any questions at all about data or anything like that.    So, it's 1 (866) 262-5342. That service line is available and makes available very quickly is a very simple process. If anybody wants things like credit protection, identity theft protection, those services are all available to be enrolled on just through a simple phone call.   CLICK HERE to watch the full hearing. Check out some of the news coverage from the hearing: UnitedHealth’s handling of the situation will probably be “a case study in crisis mismanagement for decades to come,” said Rep. Cathy McMorris Rodgers (R-Wash.), chair of the House Energy and Commerce Committee.  Witty fielded heated questions from Senators on the House Energy and Commerce Committee about the company's failure to prevent the breach and contain its fallout.  Pressed for details on the data compromised, Witty said "maybe a third" of Americans' protected health information and personally identifiable information was stolen.  Members of the House Energy and Commerce Committee asked Witty why the nation's largest health care insurer did not have the basic cybersecurity safeguard in place before the attack. "Change Healthcare was a relatively older company with older technologies, which we had been working to upgrade since the acquisition," Witty said. "But for some reason, which we continue to investigate, this particular server did not have MFA on it."  Rep. Gary Palmer (R., Ala.), in an afternoon hearing held by the House Energy and Commerce Committee’s subcommittee on Oversight and Investigations, pressed Witty on how many government employees with security clearance were included in the breach. That kind of theft would be a national-security risk, he said.  Still, Rep. Earl L. “Buddy” Carter, R-Ga., railed against the company’s use of vertical integration, in which it has acquired physician practices, pharmacy benefit managers and other players in the health care system. “Let me assure you that I’m going to continue to work to bust this up,” Carter said.“This vertical integration that exists in health care in general has got to end.”  Several members also took the opportunity to chide United Healthcare’s use of prior authorization, which Witty said resumed for its Medicare Advantage plans April 15.   The company should “carefully review how that prior authorization” has affected patient outcomes, said Rep. John Joyce, R-Pa. 

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), 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.

Chairs signal intent to subpoena if FDA continues stonewalling crucial request 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 Griffth (R-VA), on behalf of the Health and Oversight Republicans, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf. The letter follows up on a previous request for information related to the agency’s foreign drug inspection program and comes amid the Committee’s work to address drug shortages . To date, the FDA has not provided any response to the Committee.  KEY LETTER EXCERPT :  “The U.S. cannot afford additional disruptions to the drug supply chain that reduce the availability of essential medications and force doctors and patients to make difficult treatment decisions. Members of this Committee have repeatedly expressed concern regarding the effectiveness of the FDA’s foreign drug inspection program, including at two separate hearings this Congress before the Subcommittee on Oversight and Investigations and the Subcommittee on Health. Addressing drug shortages remains a top priority for the Committee.”  BACKGROUND :  Since the Committee’s July letter to the FDA, there have been additional drug recalls from Indian manufacturers and plant closures in the United States.   In August, Indian drug manufacturers, Alembic and Aurobindo Pharma, issued voluntary drug recalls citing quality and manufacturing deficiencies, respectively.   Alembic recalled over 80,000 bottles of tobramycin, used to treat bacterial eye infections, due to “failed impurities/degradation specifications.”  Aurobindo recalled rufinamide tablets used to treat seizure disorders.  Both companies have a history of drug recalls and quality control failures.   Last year, the FDA issued Alembic a Form 483, which cited its manufacturing plant in Panelav, Gujarat with four observations following a 10-day inspection.  It has come to light that the FDA ended its unannounced foreign inspection program out because the agency believed it was an obstacle to deeper collaboration with India.   The reporting also alleges that the FDA undermined a Department of Defense initiative to independently test the quality of imported drugs used by the military out of fear that it would undermine the FDA’s credibility.   In addition, a newly published study has confirmed that FDA foreign inspections in 2022 were down 79 percent compared to 2019 while at the same time the number of “citations rose dramatically, despite all establishments being given advance notice of inspections.”   ADDITIONAL BACKGROUND :  Domestic production of vital medicines continues to be under stress.   In early August, Pfizer announced it would limit the distribution of injectable drugs manufactured at its North Carolina plant after the facility suffered damage in the aftermath of a tornado.   In September, autoinjector maker Aktiv Pharma Group (“AktiVax, Inc.”), which produces autoinjectors to treat life threating conditions, announced the closure of three manufacturing facilities.   Just last year, the company w as awarded over $45 million to supply a nerve agent antidote to the Strategic National Stockpile. While shortages of cancer drugs appear to have eased slightly in recent months, demand continues to outstrip supply .  The Chairs are prepared to issue a subpoena if the FDA does not produce the requested documents January 5, 2024. CLICK HERE to read the letter.

Letter comes ahead of Director Cohen’s testimony before Oversight Subcommittee 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 Centers for Disease Control and Prevention Director Mandy Cohen, who is slated to testify before the Oversight Subcommittee tommorrow, November 30. KEY LETTER EXCERPTS :  “ The Centers for Disease Control and Protection’s (CDC) failure to communicate accurate information in real-time during the COVID-19 pandemic has undermined public trust in the agency. If the CDC is to regain credibility with the American people, it must be transparent and forthcoming with the information it has on public health threats facing our nation. “It is widely known that China thwarted international efforts, including efforts by the CDC, to respond to the burgeoning COVID-19 crisis as it began to unfold in China. Even the World Health Organization (WHO), which has long been criticized for being overly accommodating to the Chinese Communist Party (CCP), has called China’s decision to withhold information from the early days of the COVID-19 pandemic ‘simply inexcusable.’ “The WHO has now called on China to provide epidemiologic and clinical information, as well as laboratory results, on the reported pneumonia clusters among children, in addition to information on recent trends of known pathogen circulation. It would be an abdication of the CDC’s duty to the American people if it allows China to repeat its misdeeds from the COVID-19 pandemic. The American people should not have to rely on the unaccountable and untrustworthy WHO to communicate information about Chinese public health threats. Further, we cannot allow the CCP to block the CDC from accessing the information it needs to protect Americans and assist in appropriate public health response efforts.”  The Chairs requested bi-weekly briefings and answers to the following questions by December 13, 2023:  Has the CDC engaged with or interacted with its Chinese counterparts with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  If yes, when did the CDC and its Chinese counterparts first interact with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Who initiated this interaction?  At any point did the CDC’s Chinese counterparts withhold information or fail to respond to the CDC in a timely manner with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Please detail each instance and the topic of inquiry that prompted such failure to respond in a timely manner. What specific information, if any, has the CDC sought from China with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? What specific information, if any, has the CDC received from China with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia? Please detail the length of time it took China to respond to each inquiry for information. What specific response efforts, if any, has the CDC offered to take part in with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  What specific response efforts, if any, has the CDC taken part in, is actively taking part in, or plans to take part in with respect to the increased incidence of respiratory diseases and undiagnosed pneumonia?  Has specific information on the outbreak been communicated to relevant federal agencies and/or key stakeholders, including:  The Administration for Strategic Preparedness and Response (ASPR);  The U.S. Food and Drug Administration (FDA);  The National Institutes of Health (NIH); The Surgeon General; Department of Defense; Other Federal entities; and/or  State and local public health officials CLICK HERE to read the letter.

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.