Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee Budget Reconciliation Markups Expected to Happen Next Week

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.

Alston & Bird's multidisciplinary Executive Order, Action & Proclamation Task Force advises clients on the business and legal implications of President Trump's Executive Orders.

Week in Review Highlight of the Week:

This week, the White House issued executive orders aimed at bolstering biosecurity and strengthening domestic pharmaceutical production, while the House Ways and Means and Energy and Commerce Committees prepare for potential budget reconciliation markups in the coming week.

1. Regulations, Notices & Guidance

• On May 5, 2025, the Executive Office of the President (EOP)  released an executive order (EO) entitled, Improving the Safety and Security of Biological Research. This EO seeks to halt federally funded gain-of-function research on biological agents and pathogens while establishing stronger oversight mechanisms. It immediately ends federal funding for such research conducted in foreign countries of concern, mandates revisions to policies overseeing biotechnology and biosecurity, and enhances accountability through increased transparency and enforcement mechanisms. Additionally, the EO calls for a national strategy to track non-federally funded gain-of-function research and strengthen procurement security for synthetic nucleic acids. Institutions failing to comply with these standards risk revocation of federal funding and extended ineligibility for future grants.
• On May 5, 2025, the EOP released an EO entitled, Regulatory Relief to Promote Domestic Production of Critical Medicines. This EO aims to eliminate regulatory barriers and strengthen domestic pharmaceutical manufacturing to ensure a more resilient U.S. pharmaceutical supply chain. A key provision mandates the Food and Drug Administration (FDA) to review and remove unnecessary regulations, accelerate approval processes, and enhance data reporting enforcement to facilitate domestic production. Additionally, the EO directs FDA to increase oversight of foreign pharmaceutical manufacturers and publicly disclose inspection data. To streamline environmental reviews, the Environmental Protection Agency (EPA) will be required to update regulations to expedite the approval of pharmaceutical manufacturing facilities.
• On May 5, 2025, the Centers for Medicare & Medicaid Services (CMS) released guidance entitled, Offering of off-Exchange-only plans without “CSR loading”. This guidance aims to encourage states to allow insurers to offer plans without the added cost outside the Exchange to mitigate premium increases for unsubsidized consumers.
• On May 6, 2025, the Department of Health and Human Services (HHS) released a press release entitled, ED, HHS, and GSA Initiate Review of Anti-Semitic Activity at the University of Washington. The Department of Education, HHS, and the General Services Administration (GSA) announced a review of recent incidents of anti-Semitic violence at the University of Washington. The Task Force to Combat Anti-Semitism acknowledged the university’s condemnation of the events and law enforcement’s response but called for further action to prevent future incidents and protect Jewish students. The review follows unrest on May 5, during which demonstrators protesting the university’s ties to Boeing engaged in disruptive activities, including barricading a building, damaging property, and making threats. Officials emphasized that federally funded institutions must uphold civil rights protections and maintain campus safety, with agency leaders warning that failure to do so could impact federal support.
• On May 7, 2025, HHS released a press release entitled, NIH, CMS Partner to Advance Understanding of Autism Through Secure Access to Select Medicare and Medicaid Data. NIH and CMS announced a partnership to develop a real-world data platform for advanced medical research. The initiative will first focus on autism spectrum disorder (ASD), using CMS claims data, electronic medical records, and consumer wearables to examine diagnosis trends, treatment outcomes, and healthcare disparities. The project aims to expand research into chronic conditions while ensuring compliance with privacy laws.
• On May 8, 2025, FDA released a rule entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System. FDA is classifying the breast milk macronutrients test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the breast milk macronutrients test system’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 8, 2025, FDA released a rule entitled, Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System. FDA is classifying the voriconazole test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the voriconazole test system’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 8, 2025, FDA released a rule entitled, Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients. FDA is classifying the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the coagulation system for the measurement of whole blood viscoelastic properties in perioperative patients’ classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 8, 2025, FDA released a rule entitled, Medical Devices: Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection. FDA is classifying the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 8, 2025, FDA released a rule entitled, Medical Devices: Immunology and Microbiology Devices; Classification of the Device to Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens. FDA is classifying the device to detect and identify microbial nucleic acids by fluorescence in situ hybridization (FISH) in clinical specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial nucleic acids by FISH in clinical specimens classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 8, 2025, FDA released a rule entitled, Medical Devices: Immunology and Microbiology Devices; Classification of the Device to Detect and Measure Non-Microbial Analytes to Aid in the Detection and Identification of Localized Human Infections. FDA is classifying the device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections’ classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 8, 2025, FDA released a rule entitled, Medical Devices: Immunology and Microbiology Devices; Classification of the Device to Detect Nucleic Acids from Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s). FDA is classifying the device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s)’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 8, 2025, FDA released a rule entitled, Medical Devices: Immunology and Microbiology Devices; Classification of the DNA-Based Test to Measure Minimal Residual Disease in Hematological Malignancies. FDA is classifying the DNA-based test to measure minimal residual disease in hematological malignancies into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the DNA-based test to measure minimal residual disease in hematological malignancies classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 8, 2025, FDA released a rule entitled, Medical Devices: Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device. FDA is classifying the microbial nucleic acid storage and stabilization device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the microbial nucleic acid storage and stabilization device’s classification. FDA is taking this action because it has determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On May 8, 2025, FDA released a rule entitled, New Animal Drugs: Approval of New Animal Drug Applications, Withdrawal of Approval of New Animal Drug Application, Change of Sponsor; Technical Amendments. FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
• On May 8, 2025, FDA released a proposed rule entitled, Food Labeling: Front-of-Package Nutrition Information; Extension of Comment Period. FDA is extending the comment period for the proposed rule entitled, Food Labeling: Front-of-Package Nutrition Information that appeared in the Federal Register of January 16, 2025. FDA is taking this action in response to requests for an extension to allow interested parties additional time to submit comments.
• On May 8, 2025, HHS released a press release entitled, Joint Task Force Statement Regarding Columbia University. The Joint Task Force to Combat Anti-Semitism acknowledged Columbia University’s response to the takeover of Butler Library, praising Acting President Shipman’s leadership and law enforcement’s swift actions. The Task Force emphasized the need for stronger enforcement of civil rights laws at federally funded institutions and expressed confidence that Columbia would take appropriate disciplinary measures.
• On May 8, 2025, the Congressional Research Service (CRS) released a report entitled, The Reorganization of the U.S. Department of Health and Human Services: Selected Legal Issues. The report examines the legal framework surrounding the HHS reorganization plan announced on March 27, 2025. The plan consolidates several HHS divisions, transfers agencies, creates new administrative entities, and reduces personnel by 25 percent. It also raises legal and procedural questions, including concerns about the authority to restructure statutorily established agencies. The report discusses challenges from states and Members of Congress, who have questioned the legality of the HHS Secretary’s actions, particularly regarding personnel reductions and program consolidations.

Event Notices—NOTE: Due to an HHS communications freeze, many of these meetings may be cancelled or postponed. We are continuing to monitor.

 ** - New addition

• May 13, 2025: NIH announced a meeting of the National Advisory Council on Drug Abuse. This is a virtual meeting with some sessions open to the public.
• **May 13-14, 2025: NIH announced a meeting of the National Institute on Alcohol Abuse and Alcoholism. This is a virtual meeting with one session open to the public.
• May 14, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
• May 14, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is a virtual meeting with one session open to the public.
• May 14-15, 2025: NIH announced a meeting of the National Institute of Neurological Disorders and Stroke. This is a virtual meeting with some sessions open to the public.
• May 20, 2025: NIH announced a meeting of the National Institute of Nursing Research. This is a virtual meeting with some sessions open to the public.
• May 22, 2025: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting with some sessions open to the public.
• May 23, 2025: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• May 28, 2025: NIH announced a meeting of the National Advisory Dental and Craniofacial Research Council. This is a virtual meeting with some sessions open to the public.
• June 2, 2025:  NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a hybrid meeting with some sessions open to the public.
• June 2-3, 2025: CDC announced a meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding. This is a hybrid meeting open to the public.
• June 3, 2025: NIH announced a meeting of the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This is a hybrid meeting with some sessions open to the public.
• **June 3, 2025: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• June 3-4, 2025: FDA announced a public workshop entitled, Fiscal Year (FY) 2025 Generic Drug Science and Research Initiatives Workshop. This is a hybrid workshop open to the public.
• June 5, 2025: NIH announced a meeting of the National Advisory Environmental Health Sciences Council. This is a hybrid meeting with some sessions open to the public.
• June 6, 2025: NIH announced a meeting of the Board of Scientific Counselors Eunice Kennedy Shriver National Institute of Child Health and Human Development. This is a virtual meeting with some sessions open to the public.
• June 9, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting with some sessions open to the public.
• June 10, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a virtual meeting with one session open to the public.
• June 13, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• June 17, 2025: NIH announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting with some sessions open to the public.
• June 25, 2025: CMS announced a meeting of the Medicare Evidence Development and Coverage Advisory Committee. This is a virtual meeting open to the public.
• June 27, 2025: CMS announced a meeting regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year (CY) 2026. This is a hybrid meeting open to the public.
• July 1, 2025: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. This is a virtual meeting with some sessions open to the public.
• July 7, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Cancer Institute. This is a virtual meeting with some sessions open to the public.
• July 23-24, 2025: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting open to the public.
• August 6-7, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.
• August 8, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a hybrid meeting open to the public.
• September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education. This is a hybrid meeting open to the public.
• December 4-5, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.

2. Reports, Studies, & Analyses

• On May 6, 2025, the RAND Corporation released a report entitled, A Policy and Regulatory Framework to Promote Care Delivery Redesign and Production Efficiency In Health Care Markets. The report examines how antitrust enforcement in healthcare has historically prioritized predicting post-merger market share rather than assessing the effects of mergers and acquisitions on production efficiency and care quality. It highlights the concept of care delivery redesign, which encompasses innovations in healthcare organization and delivery that could improve efficiency and patient outcomes. The report outlines the need for regulators and policymakers to establish empirical measures to track changes in healthcare production and consolidation. The report also emphasizes opportunities for improving data collection and reporting, such as enhancing hospital and insurer transaction price transparency, expanding access to all-payer claims databases, refining Medicare cost reporting, and standardizing quality metrics. Additionally, the report stresses the importance of longitudinal tracking of healthcare organizations and their affiliated entities, particularly as mergers and ownership structures—including those involving private equity—continue to reshape the industry across markets and state boundaries.
• On May 7, 2025, the Congressional Budget Office (CBO) released a letter with the subject, Estimates for Medicaid Policy Options and State Responses. CBO wrote the letter in response to a request made by Senator Ron Wyden (D-OR), Ranking Member of the Senate Committee on Finance, and Representative Frank Pallone (D-NJ-06), Ranking Member of the House Committee on Energy & Commerce, to examine the effects on the federal deficit and Medicaid enrollment of five Medicaid policy proposals. These five proposals are said to be among those being considered for inclusion in Republicans’ budget reconciliation package.
• The first policy, an FMAP reduction for Medicaid expansion, is expected to reduce the federal deficit by $710 billion while also eliminating Medicaid coverage for 5.5 million individuals and causing a 2.4 million increase in the number of uninsured individuals. The second policy, which limits state provider taxes, is estimated to reduce the deficit by $668 billion while eliminating Medicaid coverage for 8.6 million enrollees and increasing the uninsured population by 3.9 million. The third policy, which applies per capita spending caps to all eligibility groups, is expected to reduce the deficit by $682 billion, cut Medicaid coverage for 5.8 million people, and increase the uninsured population by 2.9 million. The fourth policy sets similar caps but only for the expansion population, and is estimated to lower the deficit by $225 billion, eliminate Medicaid coverage for 3.3 million individuals, and raise the uninsured count by 1.5 million. The fifth policy, repealing the Eligibility and Enrollment Final Rule issued by the Biden Administration in 2023 and 2024, would reduce the deficit by $162 billion, reduce the Medicaid population by 2.3 million, and increase the uninsured population by 0.6 million.
• On May 7, 2025, the Bipartisan Policy Center (BPC) released a report entitled, Sustaining Rural Hospital Access: Adjustments to Medicare Rural Hospital Designations. The report discusses the financial challenges facing rural hospitals, particularly as key Medicare rural designation programs approach their 2025 expiration. It highlights the importance of making these programs permanent to ensure long-term stability for small, geographically isolated facilities. Additionally, it examines the financial strain of Medicare Advantage (MA) reimbursement rates, which BPC states are often lower than traditional Medicare, making it difficult for rural hospitals to sustain operations. The report also calls for reforms to payment policies, expanded hospital participation, and new funding models to support essential services like emergency care, maternal health, and behavioral health treatment. The report underscores the urgency of updating Medicare ambulance and emergency medical services (EMS) reimbursement policies to preserve healthcare access in rural communities.

3. Hearings & Markups

• On May 6, 2025, the Senate Committee on Finance held a hearing entitled, Hearing to Consider the Nominations of James O'Neill, of California, to be Deputy Secretary of Health and Human Services, vice Andrea Joan Palm, resigned and Gary Andres, of Virginia, to be an Assistant Secretary of Health and Human Services, vice Melanie Anne Egorin, resigned. Witnesses included: James O’Neill, Nominee for Deputy Secretary of Health and Human Services, and Gary Andres, Nominee for Assistant Secretary for Legislation.
• On May 8, 2025, the Senate Health, Education, Labor & Pensions Committee held a hearing entitled, Nomination of James O’Neill to serve as Deputy Secretary of Health and Human Services. Witnesses included: James O’Neill, Nominee for Deputy Secretary of Health and Human Services, and Hon. Thomas (Tommy) Thompson, former HHS Secretary and Governor of Wisconsin.

4. Other Health Policy News

• On May 5, 2025, Senators Josh Hawley (R-MO) and Peter Welch (D-VT) introduced bipartisan legislation to prohibit pharmaceutical companies from charging U.S. consumers higher prices than the international average. Though distinct from the GOP’s budgetary proposals, the bill highlights ongoing bipartisan interest in curbing drug costs. Senator Hawley has positioned the legislation as a continuation of former President Donald Trump’s efforts to tie U.S. drug prices to international benchmarks, while Senator Welch has emphasized the need to prevent price gouging by pharmaceutical companies. CBO previously estimated that an international reference pricing system could lower average drug prices by over five percent by 2031. Read the press release on legislation to reduce prescription drug prices here.
• On May 6, 2025, the Senate Committee on Finance held a hearing entitled, Hearing to Consider the Nominations of James O'Neill, of California, to be Deputy Secretary of Health and Human Services, vice Andrea Joan Palm, resigned and Gary Andres, of Virginia, to be an Assistant Secretary of Health and Human Services, vice Melanie Anne Egorin, resigned. The hearing examined the nominations of James O’Neill for Deputy Secretary of HHS and Gary Andres for the Department’s Assistant Secretary for Legislation (ASL). Members from both parties voiced concerns about the nominees, citing HHS Secretary Robert F. Kennedy, Jr.’s troubling record during his brief tenure. Senators criticized Mr. O’Neill and Mr. Andres for evading direct questions with vague responses. Democratic senators raised alarms about the Administration’s disregard for science-backed treatments, warning of risks to public health, especially amid a measles outbreak that has already claimed two children’s lives.
• On May 7, 2025, President Donald Trump announced Dr. Casey Means as his new nominee for U.S. Surgeon General. The decision comes one day before the scheduled confirmation hearing for his initial choice, Dr. Janette Nesheiwat, whose nomination was withdrawn. Dr. Means, a Stanford-trained physician, left traditional medical practice to focus on preventative health, co-founding the health app Levels and co-authoring the book Good Energy with her brother, Calley Means, a top adviser to HHS Secretary Robert F. Kennedy Jr. The withdrawal of Dr. Nesheiwat’s nomination follows scrutiny over her academic credentials and pressure from conservative influencer Laura Loomer, who urged President Trump to reconsider. President Trump stated that Dr. Nesheiwat would still serve in a senior role at HHS.

5. Additional Alston & Bird Publications

• We maintain an online tracker for all executive orders issued by the Trump Administration, which is updated regularly and can be found here.

View our Health Care Legislative & Public Policy team.

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