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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.  – Today, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, Congressman Gus Bilirakis (FL-12), Chairman of the Subcommittee on Commerce, Manufacturing, and Trade, and Congressman Gary Palmer (AL-06), Chairman of the Subcommittee on Oversight and Investigations, sent a letter to 23andMe regarding the handling of Americans' sensitive data following the company's decision to file for bankruptcy. KEY EXCERPT: “According to 23andMe’s privacy statement, in a bankruptcy, customers’ ‘Personal Information may be accessed, sold or transferred as part of that transaction and this Privacy Statement will apply to [customer] Personal Information as transferred to the new entity.’ Additionally, a judge recently ruled 23andMe has the right to sell the sensitive medical and genetic information of its 15 million customers, which is considered to be the company’s most valuable asset. With the lack of a federal comprehensive data privacy and security law, we write to express our great concern about the safety of Americans’ most sensitive personal information.” Background: On March 23, 2025, 23andMe initiated Chapter 11 bankruptcy proceedings, which could have ramifications for the highly sensitive information of millions of Americans. While Americans’ personal health information is protected under the Health Insurance Portability and Accountability Act (HIPAA), these protections only apply if the information is collected by a HIPAA covered entity. Generally, direct-to-consumer companies, like 23andMe, are not covered by HIPAA. Customers have reported issues accessing and deleting their data from their 23andMe accounts. The Chairmen have requested answers to the following questions: If 23andMe were to sell the personal information of its customers either as a standalone asset or as part of a broader sale of the company, what post-sale data privacy and security protections would be in place for its customers’ personal information? Please describe how the representations made in 23andMe’s privacy statement will continue to apply—and be enforced—if the personal information of 23andMe’s customers is sold to a third party. Please include in this response information about what, if anything, would hold a third-party buyer to 23andMe’s privacy statement or prevent it from subsequently using, transferring, or otherwise selling, such information in the future. Does 23andMe plan to change its privacy statement at any time prior to selling any customers’ personal information? If so, please explain the change 23andMe plans to implement and when those changes will go into effect. Does 23andMe intend to vet prospective buyers to which it may sell its customers’ personal information? If so, please detail the vetting process and whether it will include the prospective buyer’s history of implementing data security protections and compliance with sectoral, state, or any other data privacy and security laws. If not, please explain why. Please detail the categories of customer information 23andMe has, and of that what 23andMe is considering selling. Has 23andMe notified its customers of the company’s bankruptcy announcement? If so, please attach the customer notification. If not, please explain why. Has 23andMe provided its customers with a guide for how to delete, or request to delete any information currently in 23andMe’s possession? If so, please provide a copy of that guide and specify when it was provided to customers. If not, please explain why, and explain whether 23andMe will contact each of its customers and provide an opportunity to delete their personal information prior to a potential sale of the company or personal information maintained by the company. Please detail the number of requests 23andMe received from its customers to delete their personal information between when 23andMe filed for bankruptcy and the date of the response to this letter. Of those requests, please provide a breakdown of how many requests were made by customers through their 23andMe online accounts and how many were made via customer service calls because customers were unable to successfully delete their information through their online accounts. Of those requests, please detail the number of fulfilled requests. Will 23andMe offer for sale any information in which a customer has requested the deletion of such information? If so, does 23andMe’s privacy policy consider selling information a legitimate purpose for retaining information past a customer's request to delete their information? Will 23andMe deidentify its customers’ personal information prior to selling it or the company? If so, please detail which information will be deidentified. If not, please explain why the company is electing not to deidentify information. CLICK HERE to read the full letter. CLICK HERE to read the story from CNBC. ###

WASHINGTON, D.C. – Last week, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, Congressman Gary Palmer (AL-06), Chairman of the Subcommittee on Oversight and Investigations, and Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Environment, wrote letters to eight Greenhouse Gas Reduction Fund (GGRF) grant recipients. In Case You Missed It: “SCOOP: Biden-era grant program described as ‘gold bar’ scheme by Trump EPA administrator under scrutiny” Fox News Alec Schemmel April 11, 2025 Republicans in Congress are launching a probe into a Biden-era green energy grant program that sent billions in funding to climate groups tied to Democrats and former President Joe Biden’s allies. GOP leaders on the House Energy and Commerce Committee sent letters to the eight nonprofits awarded grants from the $20 billion Greenhouse Gas Reduction Fund (GGRF), seeking answers to ensure the Biden Environmental Protection Agency (EPA) followed proper ethics and conflict of interest protocols in distributing the funds. In February, the Trump administration’s EPA announced it would take steps to get the money back, citing concerns over a lack of oversight related to how the money was being disbursed. In the announcement, new EPA administrator Lee Zeldin cited comments from a former Biden EPA political appointee, who described disbursements made through GGRF as akin to “tossing gold bars off the Titanic,” because Biden officials were allegedly trying to get money out the door before Trump took over. It was also revealed that $2 billion from GGRF went to a Stacy Abrams-linked group, Power Forward Communities, which had not been established until after the Biden administration announced the GGRF application process. Meanwhile, during Power Forward’s first few months of operations – prior to receiving the funding – the group reported just $100 in revenue. Climate United, another group that received the most money from the GGRF, roughly $7 billion, currently staffs a former Biden climate advisor who worked during the last two years of the former president’s term. The same group is also run by a CEO with ties to the Obama administration and a board member who was among those invited to Biden’s signing ceremony for his multitrillion-dollar infrastructure bill in 2021.  Several GGRF grant recipients have ties to Democrats and Biden advisors, and some were reportedly founded shortly before or after the Biden administration announced the program. Meanwhile, these groups, according to Zeldin, had sole discretion on how to use the funds. House Energy and Commerce Chairman Brett Guthrie, R-Ky., alongside fellow committee members Reps. Gary Palmer of Alabama and Morgan Griffith of Virginia, both Republicans, said in a joint statement that their investigation into the GGRF recipients will be “key” to understanding whether these funds were allocated “fairly and impartially to qualified applicants,” while also helping to determine the manner in which the money has been used. “The Committee has had concerns about the Greenhouse Gas Reduction Fund program since its creation—including concerns about the program’s unusual structure, a potential lack of due diligence in selecting award recipients, and the recipients’ ability to manage the large influx of federal dollars they received from the EPA,” the lawmakers said in their statement. “A recent Oversight and Investigations Subcommittee hearing that examined these concerns coupled with the speed with which money was pushed out the door by the Biden Administration’s EPA heightened the Committee’s concerns and raised additional questions about certain Greenhouse Gas Reduction Fund recipients.”  Several of the groups that were recipients of GGRF money sued the Trump administration in March over its attempts to rake back the funds.  Subsequently, Obama-appointed Judge Tanya Chutkan issued a temporary restraining order preventing the EPA from freezing $14 billion in GGRF funds awarded to three of the climate groups.  Background: The Inflation Reduction Act (IRA) authorized the Environmental Protection Agency (EPA) to create and implement a $27 billion GGRF program. Of this appropriation, $20 billion was awarded to just eight grant recipients; with $14 billion awarded to three grant recipients under the National Clean Investment Fund (NCIF) program and $6 billion awarded to five grant recipients under the Clean Communities Investment Accelerator (CCIA) program.   Letters:  National Clean Investment Fund Program Recipients Coalition for Green Capital Climate United Fund Power Forward Communities   Clean Communities Investment Accelerator Program Recipients Justice Climate Fund Opportunity Finance Network Inclusiv Native CDFI Network Appalachian Community Capital ###

WASHINGTON, D.C. – This week, Congressman Brett Guthrie (KY-02), Chairman of the House Committee on Energy and Commerce, Congressman Gary Palmer (AL-06), Chairman of the Subcommittee on Oversight and Investigations, and Congressman Morgan Griffith (VA-09), Chairman of the Subcommittee on Environment, wrote letters to eight Greenhouse Gas Reduction Fund (GGRF) grant recipients. “The Committee has had concerns about the GGRF program—including the program’s unusual structure and a potential lack of due diligence in selecting award recipients. A recent Oversight and Investigations Subcommittee hearing examined these issues and the speed with which money was pushed out the door by the Biden Administration’s EPA, which raised additional questions about certain GGRF recipients.” said Chairmen Guthrie, Palmer, and Griffith. “ This investigation is key to evaluating whether these funds were awarded fairly and impartially to qualified applicants and determining how the federal funds are being used.” Background:  The Inflation Reduction Act (IRA) authorized the Environmental Protection Agency (EPA) to create and implement a $27 billion GGRF program. Of this appropriation, $20 billion was awarded to just eight grant recipients; with $14 billion awarded to three grant recipients under the National Clean Investment Fund (NCIF) program and $6 billion awarded to five grant recipients under the Clean Communities Investment Accelerator (CCIA) program.    Letters: National Clean Investment Fund Program Recipients Coalition for Green Capital Climate United Fund Power Forward Communities   Clean Communities Investment Accelerator Program Recipients Justice Climate Fund Opportunity Finance Network Inclusiv Native CDFI Network Appalachian Community Capital Read the story here . ###

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 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 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.