Oversight & Investigations

Focus on Inferior Officer Appointments and Political Accountability Heightened as Transition in Administration Begins Washington, D.C. — In a new report issued by House Energy and Commerce Committee Republican staff outlined Department of Health and Human Services (HHS) Secretary Xavier Becerra’s failure to legally reappoint 14 key officials at the National Institutes of Health (NIH). “Secretary Becerra, an attorney by trade, failed to sign the basic legal documents and follow the process required by the Constitution and federal law necessary to reappoint key NIH officials, putting their jobs, the decisions they’ve made, and the billions in funding they’ve approved in legal jeopardy,” said Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Oversight and Investigations Chair Morgan Griffith (R-VA). “This report outlines those failures, the administration’s efforts to cover it up, and important considerations for the incoming administration as it seeks to restore the rule of law and restore accountability at government health institutions.”  BACKGROUND AND TIMELINE OF INVESTIGATION :  The NIH is the primary agency of the United States government responsible for biomedical and public health research. It is one of 13 subcabinet agencies within the HHS and has an annual budget of more than $40 billion.  On December 12, 2021, the five-year terms of 14 of the 27 NIH Institute and Center (IC) Directors expired, pursuant to the 21st Century Cures Act .  Given reports of Secretary Becerra’s apparent detachment from the NIH and lack of visibility during the pandemic response as well as the lack of any public announcements, Committee Republicans began to question whether Secretary Becerra upheld his Constitutional and statutory responsibility to reappoint the 14 IC Directors upon expiration of their five-year terms.  Republicans investigated for more than two years, overcoming stonewalling, obfuscation, and four different, conflicting explanations from the administration.  WHY IT MATTERS :  The appointments and reappointments of IC Directors are personnel actions that rise to the level of Constitutional responsibility further bolstered by federal statutes. The leaders of these institutes and centers are the ultimate decision-makers involving tens of billions of taxpayer-funded research dollars. These leaders also can play prominent roles in response to public health emergencies or in developing research plans. The effectiveness of biomedical research investments depends on the decision-making abilities and strategic visions of these IC Directors.  The health of the American people is deeply impacted by the appointees who lead the NIH’s institutes and centers. Because the Directors of NIH Institutes and Centers exercise significant authority as the final approving authority for research awards, they would qualify as Inferior Officers of U.S. who must be appointed by the HHS Secretary pursuant to the Appointments Clause of the U.S. Constitution along with the provisions of the 21st Century Cures Act . Greater democratic accountability requires department heads to be responsible for properly managing their agencies in the best interest of the public. Holding department heads accountable for the staffing of executive agencies improves accountability and transparency.   1. Improper appointments jeopardize good stewardship of funds  Improper appointments and reappointments potentially expose the actions of the improperly appointed IC Directors to legal challenge and jeopardizes the proper administration of research funds.   2. Improper appointments risk legal challenge to IC hiring and policies Improper appointments and reappointments potentially expose any personnel actions approved by the improperly appointed IC Directors to legal challenge.  3. Improper appointments may have led to improper payment of Title 42 special consultant salaries  During the year and a half of their lapsed reappointments, the affected IC Directors continued on the NIH payroll and received salaries even though they were serving without the legal authority to hold their positions. This situation raises the question of improper payments of salaries. In a 1976 opinion, the GAO Comptroller General concluded that the Federal Insurance Administrator was improperly appointed and that the appointment required Presidential nomination and Senate confirmation pursuant to the Appointments Clause.   In a subsequent opinion, the GAO Comptroller General found that the Federal Insurance Administrator was not legally occupying the position and thus was not entitled to receive salary and related benefits from the Department. GAO then concluded that this official was a de facto officer, performing his duties of the Office of Insurance Administrator with the knowledge and apparent acquiescence of the Secretary and the President. GAO concluded it was not necessary to take action to recover the salary. However, whether an NIH or HHS official who approved an expenditure of funds without legal authority could be held liable for the funds is an open question.  4. Secretary Becerra violated his oath by failing to carry out his Appointments Clause responsibilities.  When he was sworn in as HHS Secretary, Secretary Becerra took his oath of office swearing to support and defend the Constitution of the United States, including the Appointments Clause. By failing to reappoint the IC Directors pursuant to the Appointment Clause, Secretary Becerra failed to uphold the Appointments Clause until he was pressured by the Committee to issue signed affidavits ratifying the selections for reappointments a year and a half after the statutory deadline. During that time lapse the individuals serving as IC Directors were holding their positions without valid reappointments.  5. IC Directors serving without valid reappointments further undermined public trust in public health leadership.  Public trust in the federal government’s health leadership was eroded during the response to the COVID-19 pandemic. The public trust is further damaged by the fact that some public health leaders cloaked in the authority of their titles were not legally authorized to hold those positions. Ensuring proper appointments and reappointments to these offices is yet an additional challenge to restore public trust. Secretary Becerra’s failure raises questions whether the American people can assume that public health leaders actually have competent authority to act during a public health emergency.  6. The failure to take seriously the reappointments of the IC Directors subverts the rule of law. The failure to take seriously the reappointments of the IC Directors subverts the rule of law. In this instance, the law called for precision: the HHS Secretary reappointing of IC Directors by a certain date. The action to be taken was to fulfill the Constitutional duty and the statutory requirement to reappoint Inferior Officers of the United States. HHS’s lax approach toward this matter and its evasive, frequently misleading responses to this investigation reveals a lack of diligence in upholding the rule of law and our democratic values. The cavalier attitude toward following the law and the Constitution as well as the subsequent attempts at hiding its failure to follow the law is a prime example of the Biden-Harris administration’s above-the-law attitude and approach to governing.  CLICK HERE to read the full report.

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.

Report Requested by E&C Republicans to Better Understand Obamacare Program Integrity Washington, D.C. — A new report issued by the Government Accountability Office (GAO) has found that the Centers for Medicare and Medicaid Services (CMS) does not adequately enforce Obamacare’s requirement that states fund the cost of state-mandated health insurance benefits. The report, requested by Energy and Commerce Committee Republicans, raises issues about CMS’s controls to ensure federal taxpayer dollars are not illegally subsidizing state mandates. BACKGROUND : Obamacare mandates a certain set of essential health benefits (EHBs) be covered by insurance plans within the individual health insurance market. States may choose to mandate additional benefits but are then required to cover the cost of such benefits. States are not permitted to use federal tax dollars, in the form of Advance Premium Tax Credits (APTCs), to do so. In its report, GAO found that CMS delegates oversight of this policy to the States instead of enforcing it on its own. As outlined in the report, “CMS has limited assurance that APTCs accurately exclude the costs of non-EHB mandated benefits” and that “CMS has expressed concerns about states’ compliance with this requirement,” highlighting critical concerns about the potential for improper federal spending. “This report, coupled with the immense Obamacare fraud this administration has overseen, highlights the need for Congress and the incoming administration to work swiftly to safeguard taxpayer funds at every corner of the agency. CMS should prioritize rigorous enforcement of all requirements intended to prevent improper spending,” said Committee Chair Cathy McMorris Rodgers (R-WA). “I commend GAO for its investigative efforts, which will help Congress protect taxpayer dollars by correcting government waste, fraud, and abuse.” REPORT HIGHLIGHTS : CMS is supposed to enforce this requirement on States, but defers to states to enforce this federal requirement on themselves:  “States may require marketplace plans to cover items and services in addition to EHB; we refer to such benefits as non-EHB mandated benefits. However, APTCs cannot be used to offset the costs of these additional benefits. Specifically, the Centers for Medicare & Medicaid Services (CMS)—the federal agency responsible for determining the APTC amounts—must exclude the costs of non-EHB mandated benefits from the APTC calculation. CMS delegates responsibility for identifying non-EHB mandated benefits to the states.”   Even CMS has concerns with State compliance with the Obamacare requirement that States fund the cost of their coverage mandates.  “However, CMS has expressed concerns about states’ compliance with this requirement. For example, in the 2021 Payment Notice, CMS noted state confusion regarding the identification of non-EHB mandated benefits and concerns that the premium data it uses to calculate the APTCs did not exclude their costs, resulting in improper federal payments. CMS reiterated these concerns in its 2022 and 2023 Payment Notices.”   GAO found one state that did not believe it had the responsibility to identify benefits that it must fund, contrary to CMS’s position of deference to states.  “Further, we identified one state that inappropriately placed the onus on CMS to determine whether a mandated benefit was non-EHB, rather than identify these benefits itself.”   CMS does not know if premium data appropriately excludes state-mandated benefits:  “In addition, CMS does not know whether the premium data submitted by marketplace plans and used to calculate APTCs exclude the costs of non-EHB mandated benefits.”   GAO concludes that CMS does not have assurances that federal taxpayer dollars are not improperly funding state-mandated benefits.  “CMS has limited assurance that APTCs accurately exclude the costs of non-EHB mandated benefits. This poses a risk to its oversight objective and is inconsistent with federal internal control standards. These standards state that agencies should identify, analyze, and respond to risks related to achieving agency objectives. Assessing whether its current oversight approach is sufficient to respond to identified risks and making changes as appropriate would be consistent with these standards. Such an assessment would also provide greater assurance that the APTCs accurately exclude the costs of non-EHB mandated benefits.”   CLICK HERE to read the GAO report.

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.

House Republicans scrutinize government grant funding recipients that fail to protect individuals from antisemitism Washington, D.C. — In a new letter to J. David Gladstone Institutes President Dr. Deepak Srivastava, the House Committee on Energy and Commerce (E&C) and House Committee on Education and the Workforce (E&W) have requested information about ongoing and pervasive acts of antisemitic harassment and intimidation at Gladstone and its leadership’s insufficient response to these acts. The letter is signed by E&C Chair Cathy McMorris Rodgers (R-WA), E&C Subcommittee on Health Chair Brett Guthrie (R-KY), E&C Oversight and Investigations Subcommittee Chair Morgan Griffith (R-VA), E&W Chair Virginia Foxx (R-NC), and E&W Subcommittee on Higher Education and Workforce Development Chair Burgess Owens (R-UT).  KEY LETTER EXCERPTS: “The Gladstone Institutes, an independent biomedical research organization, claims that it takes an active stance against serious issues like discrimination and harassment and aims to ‘ensure all community members at Gladstone feel included’ and that the Institutes will aim to ‘implement accountability measures and reinforce Gladstone’s commitment to having an environment free of harassment.’ However, these values do not seem to be reflected in the actions of leadership in response to recent concerns of antisemitic harassment and discrimination within the Institutes.” [...] “The reports of antisemitic harassment at Gladstone coupled with the inadequate response by leadership is concerning to the Committees. Failing to act decisively to ensure a safe environment for all trainees, faculty, and staff is a grave dereliction of your responsibilities as President of Gladstone.” “Failing to comply with basic safety protections for members of Gladstone or failure to respond appropriately to and prevent harassment and discrimination, no matter the cause, may be grounds to withhold federal funds from the university. Congress has an obligation to exercise oversight of recipients of federal funds when blatant and ongoing Title VI violations appear to be happening. If Congress determines an institution of higher education/research is blatantly ignoring its legal responsibilities, we may consider rescinding research and development funds previously appropriated.” BACKGROUND ON TAXPAYER FUNDING: Gladstone received more than $41 million in funding from the NIH in Fiscal Year 2023, not including potential taxpayer funding that individual faculty may have received through their affiliation with the University of California, San Francisco (UCSF) or any other affiliated universities.   According to the NIH’s Grant Policy Statement, any institution receiving federal funds must assure work environments are free of discriminatory harassment and are safe and conducive to high-quality work.  Institutions receiving federal taxpayer financial assistance—such as NIH grants—are prohibited from discriminating based on a variety of categories, including national origin.   These laws also protect members of the institution who are or are perceived to be members of a group with shared ancestry, such as students/trainees of Jewish heritage. BACKGROUND ON INSTANCES OF ANTISEMITISM : Two days after the October 7, 2023, Hamas terrorist attack, a graduate student working in a lab within Gladstone sent an antisemitic email to all Gladstone faculty, trainees, and staff falsely stating that the attack on innocent Israeli civilians was “the resistance in Gaza launch[ing] a surprise attack against Israel, taking occupation soldiers hostage, taking over Israeli military vehicles, and gain[ing] control over illegal Israeli settlements.”  The email goes on to claim that all casualties resulting from Palestinian actions are the responsibility of Israel.  Immediately following this mass email, members of the Gladstone faculty began contacting the Gladstone Institutes’ President and other leadership, appalled by the language of the email, concerned for their safety and worried that the email could be seen as an incitement to violence.  Jewish members of the Institutes also expressed their deep, personal pain following the Hamas attack, as some members had family or friends reported killed or missing directly after the attack.  These fears—including fears of being attacked in the lab by the author of this cruel and antagonistic email—were shared directly with President Srivastava.  Despite this, Gladstone leadership did not issue a public statement or position against antisemitism to quell fears of Jewish faculty and trainees.  In May 2024, the Center for Combatting Antisemitism sent President Srivastava a letter requesting administrative action to address the hostile environment and disparate treatment of Jewish members at Gladstone.  This letter noted that Gladstone refused to acknowledge Jewish American Heritage Month, Passover, or Holocaust Remembrance Day, despite sending official celebratory emails and holding events for other religious, ethnic, or national holidays, including Black History Month, International Women’s Day, and Ramadan.  The Center followed up with Gladstone several times, but never received a response.  Jewish faculty and trainees have conveyed to leadership within Gladstone instances of antisemitic harassment and discrimination, which faculty and trainees believe were not taken seriously, making some feel uneasy about speaking out.  For example, per a publicly available Fair Employment and Housing Act complaint to the California Civil Rights Division, a Jewish faculty member openly discussed fellow faculty using racial stereotypes, including comments about a “Jewish nose.”  When these comments were brought to human resources, no investigation occurred.  Instead, the complainant was subsequently targeted with an investigation ultimately deemed to be unwarranted.  Then, following the complainant’s post-October 7th advocacy on behalf of Jewish faculty and trainees, the complainant was threatened repeatedly with career-ending termination, allegedly in an attempt to extort a resignation.  When the threats did not have their desired effect, Gladstone placed the complainant on administrative leave and removed the complainant’s electronic access to email and files but also physical access to the complainant’s lab, removing all ability to conduct work on an NIH-funded grant.  Gladstone ultimately paid an undisclosed sum to settle the matter and avoid litigation.  To elevate concerns regarding widespread, ongoing discrimination, Jewish faculty and trainees requested permission to bring in a speaker related to antisemitism.  Other minority groups had previously been given permission to bring in similar anti-racism speakers.  However, while leadership stated it would look into the idea, ultimately no speaker was brought, and no program was launched regarding antisemitism. BACKGROUND ON AFFILIATIONS WITH OTHER INSTITUTIONS UNDER INVESTIGATION : Gladstone Institutes is affiliated with other institutions under congressional investigation.  For example, Gladstone is an affiliate of the UCSF, which is undergoing congressional investigation for reports of antisemitism within the university, medical school, and medical centers.  Most of Gladstone’s principal investigators are also faculty at UCSF, and the Institutes provide research positions and opportunities for graduate students from UCSF.  Moreover, there is a joint institute—the Gladstone-UCSF Institute of Genomic Immunology—further linking the two institutions.  Gladstone is also affiliated with the University of California, Berkeley and Stanford University, both of which are also under investigation for concerns related to antisemitism. CLICK HERE to read the full letter.

Washington, D.C. — In a new letter to Government Accountability Office Comptroller General Gene Dodaro, House Energy and Commerce Committee Republicans have requested an examination of the structure of laboratory safety programs at the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH).  The letter was signed by 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).  KEY LETTER EXCERPT :  This committee remains concerned about the effectiveness of the oversight HHS and its agencies provide to the laboratories they own and operate. In addition to numerous GAO recommendations that remain unimplemented by the FDA, both the CDC and the FDA recently announced organizational reforms to their laboratory safety and security functions, and it is not clear whether these changes will strengthen oversight or create new undue risk. The FDA has, for example, reorganized several of its laboratories such that they now fall within the Office of the Chief Scientist. This raises potential independence concerns, as the FDA’s laboratory safety and security functions report to the same office.  BACKGROUND :  The mission of the U.S. Department of Health and Human Services (HHS) is to enhance the health and well-being of all Americans.   As such, HHS is most directly involved in leading public health preparedness and response efforts, as well as associated research.   However, past safety lapses involving the CDC, the FDA, and the NIH have been the result of multiple breakdowns in compliance with established policies coupled with inadequate oversight.   For example, in July 2014, boxes containing decades-old vials of smallpox and other hazardous biological agents were found in a storage space of an FDA laboratory on the NIH’s campus. GAO and other reviews resulted in numerous findings and recommendations to strengthen laboratory safety and security, which led to changes to the way HHS and its agencies oversee their laboratories.   Likewise, GAO and other reviews have highlighted the importance of laboratory science and security in the handling of federal select agents and other dangerous pathogens in research.  CLICK HERE to read the full letter.