News

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.

Washington, D.C. — In a new letter to the Environmental Protection Agency (EPA), Energy and Commerce Committee Republicans are pressing for answers regarding Greenhouse Gas Reduction Fund (GGRF) awards. The letter to Administrator Regan, signed by Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), and Subcommittee on Environment, Manufacturing, and Critical Materials Chair Earl L. "Buddy" Carter (R-GA), requests an unredacted copy of all GGRF award agreements that have been finalized.  It follows up on an Oversight Subcommittee hearing from earlier this year, where Mr. Zealan Hoover, Senior Advisor to the Administrator, assured Committee Members that the award agreements that EPA entered into with recipients to receive GGRF program awards would address the concerns raised.   LETTER TEXT BELOW:   Dear Administrator Regan,  We write to you as part of the Energy and Commerce Committee’s (the Committee) continued oversight of the Environmental Protection Agency’s (EPA) Greenhouse Gas Reduction Fund (GGRF). As you know, Committee Members have many questions regarding this first-of-its-kind, $27 billion program, including those discussed at a January 30, 2024, Subcommittee on Oversight and Investigations hearing on the GGRF, with Mr. Zealan Hoover, Senior Advisor to the Administrator, testifying on behalf of the EPA. In numerous instances, Mr. Hoover assured Members that the award agreements that EPA would enter into with recipients that the EPA selected to receive GGRF program awards would address the concerns they raised.   For example, in response to a question from Committee Chair Rodgers about what conflicts of interest policies would govern funding recipients responsible for further distributing this money, Mr. Hoover responded that “they will be subject to all of the terms and conditions of their financial assistance agreement.” After Representative Guthrie pressed for more information on whether organizations with foreign ties could receive GGRF funding, Mr. Hoover stated that “one of the terms and conditions in each of the award agreements is going to be a prohibition against entering into any form of contractual relationship with a foreign entity of concern.” Mr. Hoover also replied to Representative Lesko, “[e]ach grantee is applying with a rigorous investment plan, proposed project pipeline, and timeline for a wide array of necessary activities covering their investment work, their governance, their organizational structure. All of that will be enshrined in our terms and conditions of the grant agreement.”   Members also submitted follow-up questions for the record after the hearing. Oversight and Investigations Subcommittee Chair Griffith requested more detail about performance audits, and the EPA responded, in part, “[w]e expect that the terms and conditions of GGRF grants, as provided in 2 C.F.R. § 200.208, will authorize the project officer to closely monitor recipient performance and compliance with grant requirements.” Additionally, in response to Chair Griffith’s inquiry on how the EPA could evaluate the past performance of applicants that included new organizations or coalitions, the EPA stated that it required applicants to submit risk management plans, and that awardees would have to comply with specific terms and conditions in their award agreements. In response to a question on Build America, Buy America Act (BABA) compliance, the EPA stated that it was “including terms and conditions in the award agreements to reinforce that all grants are subject to [BABA] by statute,” and that “EPA will hold selected applicants accountable to BABA requirements through the terms and conditions of the award agreements.” Finally, the EPA also responded to a question from Representative Crenshaw, saying that “EPA will include a term and condition in all award agreements to protect against federal funds flowing to entities with certain connections to the People’s Republic of China.”  In short, the EPA repeatedly sought to reassure the Committee that its award agreements with selected recipients would address the issues of concern and potential risks. The Committee seeks additional detail on how these award agreements will address the issues of concern and potential risks.    As such, please provide a complete and unredacted copy of the award agreement, including all of the attachments, appendices, and any amendments, that the EPA executes with each funding recipient under the GGRF. By no later than August 29, 2024, please provide a copy of all award agreements that have been finalized as of the date of this letter, and please provide a copy of all remaining agreements as soon as they are finalized. 

Washington, D.C. — In a new letter to Environmental Protection Agency (EPA) Administrator Michael Reagan, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-VA), and Subcommittee on Environment, Manufacturing, and Critical Materials Chair Buddy Carter (R-GA), on behalf of the Oversight and Environment Subcommittee Republicans, are pressing for answers about the recently-awarded Greenhouse Gas Reduction Fund (GGRF) grants.  KEY LETTER EXCERPTS :  “As you know, the Committee has questioned how the Environmental Protection Agency (EPA) planned to distribute the $20 billion available to selected recipients under the new GGRF program, including the $14 billion for the National Clean Investment Fund (NCIF). Specifically, the Committee cited warnings that the EPA could use these large awards to subsidize favored organizations. At a January 30, 2024, Subcommittee on Oversight and Investigations hearing, Committee Chair Cathy McMorris Rodgers highlighted examples of former Biden administration officials and Democratic campaign staff in leadership roles of organizations vying for NCIF funding. Predictably, the EPA’s April 4, 2024, announcement of NCIF recipients confirmed our fears that this program would funnel taxpayer dollars to political allies.” [...] “Other individuals with ties to Democratic politics also lead organizations partnering with these recipients. While the EPA insists it had ethics rules and a fair competition policy in place, doling out billions of dollars to organizations led by politically connected individuals undermines public trust in the legitimacy of the federal financial awards process. It also furthers the concern that this program was created as an excuse to hand out funding to political allies.” The Chairs cited more than a dozen examples of politically connected leaders of organizations to which EPA plans to distribute billions of taxpayer dollars, and have requested a list of all of the nearly two dozen stakeholder meetings the EPA held in designing the program, including the dates, names of the individuals and organizations participating as well as any related minutes or memoranda by May 28, 2024. CLICK HERE to read the full 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 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 Oversight and Investigations Chair Morgan Griffith (R-VA), and Subcommittee on Environment, Manufacturing, & Critical Materials Chair Buddy Carter (R-GA) wrote to Environmental Protection Agency (EPA) Administrator Michael Regan regarding the agency’s Clean School Bus Program. KEY EXCERPT:   “Alarming information about this program continues to emerge. In particular, the EPA’s Office of the Inspector General (OIG) has flagged serious shortcomings in the program that create significant vulnerabilities to waste, fraud, and abuse. The EPA’s own reporting on the program reveals that numerous award recipients encountered difficulty utilizing the funding they were awarded. Additionally, the EPA continues to administer the program in a manner that favors the use of electric school buses over other types of buses that are eligible for funding under the program.”  CHALLENGES TO IMPLEMENT:   Of almost 400 selectees under the 2022 Clean School Bus Rebate program 46 selectees withdrew from the program.  The most common reasons provided for withdrawal were school boards voting against the projects for reasons including difficulties coordinating with electric utilities, potentially lengthy and costly electric infrastructure upgrades required to install electric vehicle supply equipment, and hesitancy about maintenance and range issues associated with electric buses.  The OIG concluded in a December 2023 audit that “the agency may be unable to effectively manage and achieve the program mission unless local utility companies can meet increasing power and supply demands for electric buses.”  The OIG noted that establishing charging stations and connecting them to power lines could take approximately twelve to twenty-four months.   Stakeholders reported that infrastructure to support 25 buses or more demands a more complex electrical setup, which can take a year to construct.  POTENTIAL FOR WASTE, FRAUD, AND ABUSE:   In December 2023, the OIG issued a Management Implication Report that highlighted serious problems with the Clean School Bus Program.   The OIG “identified concerns regarding the EPA’s lack of robust verification mechanisms within the Clean School Bus rebate and grant application process, which led to third parties submitting applications on behalf of unwitting school districts, applicants not being forthright or transparent, entities self-certifying applications without having corroborating supporting documentation, and entities being awarded funds and violating program requirements.”  The OIG further stated, “Our initial investigation of its protocols found that the Clean School Bus Program is rife with potentially inaccurate information” and that “the EPA uses few mechanisms to verify the accuracy of application contents and relies on the applicant’s self-certification of all aspects of the application,” including the applicant’s eligibility for the program, satisfaction of vehicle-use requirements, and the identity of the school district the replacement buses funded by the program will serve.  The OIG also found that an administrative entity with zero students was selected to receive a rebate, despite it seeking funding for buses that were ineligible for the program.   Some recipients selected to receive rebates under the 2022 Clean School Bus Rebate program later declined the funding.   These withdrawals accounted for $38 million of awards, which the OIG stated lengthened program timetables and created confusion.  EPA PICKING WINNERS AND LOSERS:   The Infrastructure Investment and Jobs Act (IIJA) directed the EPA to award grants, rebates, and contracts to replace existing school buses with both zero-emission buses and clean school buses.  The IIJA defines clean school buses as school buses that reduce emissions and operate partly or entirely using an alternative fuel, or zero-emission buses.   The Committee has previously voiced concerns about the EPA's bias towards electric buses while ignoring the benefits of other clean school buses, concerns that persist today.   According to information provided by the agency, “As of January 2024, the EPA has awarded approximately $1.84 billion to fund 5,103 clean school buses—96 percent of which are electric—and related charging infrastructure at 642 school districts in most states and territories, and at schools operated by federally recognized Tribes.”   Under the 2023 Clean School Bus Rebates program, the EPA continues to offer maximum awards for fully electric school buses that are several times larger than the maximum award amount for other types of clean school buses.  Additionally, under the Clean School Bus program, the EPA continues to fund charging infrastructure for electric vehicles but not propane or compressed natural gas fueling infrastructure.  Under the 2022 Clean School Bus Rebate program, the maximum bus funding amount for a class 7+ zero-emission bus was $375,000, and the maximum amount for a propane class 7+ propane bus was $30,000.  The EPA reported, “The majority of awarded electric school buses cost at or near $375,000, while many awarded propane buses cost around $150,000.”  In other words, the maximum rebate amount seemingly covered the entire cost of an electric bus but covered only a fraction of a propane bus.  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 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.