Health Care Week in Review | OMB Directs Agencies to Prepare for Reductions in Force if Government Shutdown Occurs; Trump Administration Links Autism to Tylenol Use During Pregnancy

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. 

 Regulations, Notices & Guidance

• On September 22, 2025, the Food and Drug Administration (FDA) released guidance entitled, Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency. This guidance describes the factors FDA intends to assess in deciding whether to issue an enforcement policy regarding in vitro diagnostic test manufacturers’ offering of certain unapproved in vitro diagnostic tests and unapproved uses of approved in vitro diagnostic tests during a declared emergency.
• On September 22, 2025, FDA released guidance entitled, Malaria: Developing Drugs for Treatment. The purpose of this draft guidance is to assist sponsors in the overall development program for drug and biological products for the treatment of malaria, caused by clinically relevant Plasmodium species.
• On September 23, 2025, FDA released guidance entitled, Computer Software Assurance for Production and Quality System Software. FDA is issuing this guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. FDA believes that these recommendations will help foster the adoption and use of innovative technologies that promote patient access to high-quality medical devices and help manufacturers to keep pace with the dynamic, rapidly changing technology landscape, while promoting compliance with laws and regulations implemented by FDA.
• On September 23, 2025, FDA released a notice entitled, Approval of Previously Withdrawn New Drug Application for WELLCOVORIN (leucovorin calcium) Tablets. FDA is announcing approval of the previously withdrawn new drug application (NDA) for Wellcovorin tablets, equivalent to (EQ) 5 milligrams (mg) base and EQ 25 mg base. FDA is initiating this action on the basis of new data and is required to publish notice of approval of an NDA for which FDA had previously withdrawn approval.
• On September 24, 2025, FDA released draft guidance entitled, Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products. The draft guidance document discusses methods and approaches for capturing postapproval safety and efficacy data for cellular and gene therapy (CGT) products. Given the potential for long-lasting effects of CGT products, and the generally limited number of participants treated in clinical trials, the collection of postapproval study data for CGT products is important for gathering data on product safety and effectiveness over time.
• On September 24, 2025, FDA released draft guidance entitled, Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations. The draft guidance document provides recommendations to sponsors who are planning clinical trials of CGT products intended for use in a disease or condition that affects a small population, generally one that meets the definition of a rare disease or condition under section 526(a)(2) of the Federal Food, Drug, and Cosmetic (FD&postaC) Act (21 U.S.C. 360bb(a)(2)). It describes FDA requirements and provides considerations for the use of various clinical trial designs and endpoints to generate clinical evidence to support product licensure. The recommendations are intended for sponsors developing CGTs intended for use in small populations to leverage the use of innovative trial designs to simultaneously expedite drug development and generate data necessary to demonstrate substantial evidence of effectiveness.
• On September 24, 2025, FDA released draft guidance entitled, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions. The draft guidance document provides sponsors engaged in the development of regenerative medicine therapies for serious or life-threatening diseases or conditions with FDA’s recommendations on the expedited development and review of these therapies. This draft guidance, when finalized, will supersede the final guidance of the same title dated February 2019, 2025.
• On September 26, 2025,  Administration for Strategic Preparedness and Response (ASPR) released a notice entitled, Single Source Cooperative Agreement to the National Emerging Special Pathogens Training and Education Center. ASPR intends to provide a five-year single-source Cooperative Agreement (CoAg) to the National Emerging Special Pathogens Training and Education Center (NETEC). The CoAg will enable NETEC to continue to lead special pathogen preparedness and response for currently active or emergent High Consequence Infectious Disease (HCID) threats. The total proposed cost of the single-source CoAg is $7,730,000 for Fiscal Year (FY) 2025. Supporting collaboration between the U.S. Public Health Service and public and private community health programs and agencies to respond to health emergencies is an authority provided to HHS under section 311(c) of the Public Health Service Act.

Event Notices

Please note that two asterisks (**) preceding the item indicate a new event.

• September 29, 2025: The National Institutes of Health (NIH) announced a meeting of the Novel and Exceptional Technology and Research Advisory Committee. This is a virtual meeting open to the public.
• September 30, 2025: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a virtual meeting open to the public.
• September 30, 2025: FDA announced a meeting entitled, Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments. This is a hybrid meeting open to the public.
• October 3, 2025: NIH announced a meeting of the National Eye Institute. This is a virtual meeting with some sessions open to the public.
• October 7, 2025: NIH announced a meeting of the Office of the Director. This is a virtual meeting open to the public.
• October 8, 2025: FDA announced a meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• October 8-9, 2025: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• October 9, 2025: FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. This is a virtual meeting open to the public.
• October 14, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
• October 15, 2025: NIH announced a meeting of the National Cancer Advisory Board Ad hoc Working Group on Extramural Research Concepts and Programs. This is a virtual meeting open to the public.
• October 15-16, 2025: NIH announced a meeting of the National Library of Medicine Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
• October 17, 2025: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• **October 21-22: The Department of Veterans’ Affairs (VA) announced a meeting of the Advisory Committee on the Readjustment of Veterans. This is an in-person meeting with some sessions open to the public.
• October 27-28, 2025: NIH announced a meeting of the Board of Regents of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
• October 27-29, 2025: NIH announced a meeting of the Board of Scientific Counselors of the National Institute on Aging. This is a hybrid meeting with some sessions open to the public.
• October 29, 2025: NIH announced a meeting of the National Heart, Lung, and Blood Advisory Council. This is a hybrid meeting with some sessions open to the public.
• **October 29, 2025: VA announced a meeting of the Veterans Rural Health Advisory Committee. This is a hybrid meeting open to the public.
• November 6, 2025: FDA announced a meeting of the Digital Health Advisory Committee. This is a virtual meeting open to the public.
• November 16-18, 2025: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting with some sessions open to the public.
• **December 1, 2025: NIH announced a peer review meeting of the draft National Toxicology Program (NTP) Developmental and Reproductive Toxicity Technical Report on 2-Hydroxy-4-methoxybenzophenone. This is a hybrid meeting open to the public.
• December 1-2, 2025: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• December 4, 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 hybrid meeting with some sessions open to the public.
• December 4-5, 2025: The Health Resources and Services Administration (HRSA) announced a meeting of National Advisory Council on Nurse Education and Practice. This is a hybrid meeting open to the public.
• December 5, 2025: NIH announced a meeting of the Board of Scientific a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.
• December 10, 2025: The Centers for Medicare & Medicaid Services (CMS) announced a town hall meeting on FY 2027 applications for new technology add-on payments. This is a virtual meeting open to the public.
• December 10, 2025: FDA announced a workshop entitled, Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development -- Leveraging Rare Disease Frameworks. This is a hybrid meeting open to the public.
• **January 23, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a virtual meeting open to the public.
• **January 26-27, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a virtual meeting with some sessions open to the public.
• March 30-31, 2026: NIH announced a meeting of the National Institute of Diabetes and Digestive and Kidney Diseases. This is a hybrid meeting with some sessions open to the public.
• **May 4, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting open to the public.
• June 5, 2026: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health & Human Development. This is a hybrid meeting with some sessions open to the public.

Reports, Studies & Analyses

• On September 22, 2025, the Government Accountability Office (GAO) released a report entitled, Health Care Consolidation: Published Estimates of the Extent and Effects of Physician Consolidation. GAO found that physicians have become increasingly consolidated as the share of physicians in practices owned by other entities has increased over time. Studies indicate that physician consolidation with hospital systems can lead to increased spending and prices. For example, several studies found increased Medicare spending due to services being provided in more expensive hospital-based settings and increases to prices paid by commercial insurers following hospital-physician consolidation. In contrast, GAO found that this type of consolidation generally resulted in no changes in the quality of care. Studies examining the effects of physician consolidation involving private equity firms were limited, but provided some evidence of price increases for commercial insurance.
• On September 22, 2025, the HHS Office of Inspector General (OIG) released a report entitled, Deficiencies With Incorporating Required Cybersecurity Language in HHS Contracts and Timeliness of Contractor Incident Reporting. OIG did this audit to determine whether the contracts that three HHS agencies had with 14 selected information and communications technology (ICT) service contractors included required language about reporting cybersecurity incidents to HHS and whether the contractors followed HHS requirements to timely report cybersecurity incidents. OIG found that four of the 14 HHS ICT service contractors reviewed reported a total of 10 cybersecurity incidents to HHS; however, two of those contractors each failed to report an incident to HHS within the 1-hour timeframe stipulated by their contracts. Eight of the 14 HHS ICT service contracts reviewed did not include required security language regarding the reporting of all suspected or confirmed cybersecurity incidents and breaches. The remaining six contracts included the required security language. OIG recommended implementing a step in the procurement process to confirm that ICT service contracts contain all required security language before they are awarded.
• On September 23, 2025, OIG released a report entitled, Hospitals Charged CMS for Trauma Team Activations That Did Not Comply With Federal Requirements. OIG found that CMS made Medicare payments to trauma centers for trauma team activations that did not comply with Federal requirements. Specifically, 107 of 125 sampled claims with trauma team activations did not meet Medicare requirements—100 sampled claims had unallowable trauma team activation charges that totaled $728,468, and 7 sampled claims had coding errors that did not have any impact on payment or charges associated with the trauma team activation. OIG estimated that approximately 77 percent of all claims submitted to Medicare with trauma team activations did not comply with Federal requirements. Additionally, OIG estimated that hospitals also billed approximately $2.4 billion in unallowable charges for trauma team activations that did not meet Medicare requirements from January 1, 2020, through June 30, 2022. OIG made four recommendations, including that CMS take the necessary steps to address the estimated $2.4 billion in unallowable trauma team activation charges reported on hospitals’ cost reports and the resulting incorrect outlier payments to improve the accuracy of data used to establish future prospective payment system payment rates. However, CMS did not concur with this recommendation, stating that the OIG’s understanding of trauma team activation billing requirements exceeded CMS requirements.
• On September 24, 2025, the Congressional Research Service (CRS) released a report entitled, Expiring Health Provisions of the 119^th Congress. The report provides information on selected health provisions that have expired or are scheduled to expire during the 119^th Congress. The expiring provisions included in this report are any identified provisions related to Medicare, Medicaid, the State Children's Health Insurance Program (CHIP), or private health insurance programs and activities. The report also includes any identified expiring public health and other health care-related provisions. Of note, expiring provisions included in the report include the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, the advance alternative payment model (APM) bonus, and the temporary payment increase under the Medicare Physician Fee Schedule (PFS) to account for exceptional circumstances.

Other Health Policy News

• The federal government is currently operating under a continuing resolution (CR) passed in March 2025 that funds the government through September 30, 2025. Unless Congress passes an annual appropriations act or an interim CR by that date, the government will shut down on October 1, 2025.
  
  On September 19, 2025, the Senate rejected a CR entitled, the Continuing Appropriations and Extensions Act of 2026, by a vote of 48-44. The CR, which was introduced by House Republicans, was passed by the House of Representatives earlier in the day by a vote of 217-212. The bill would extend current funding levels through November 21, 2025, and includes an extension of several public health provisions, known as “health extenders,” that are set to expire on September 30, 2025, without congressional action. These provisions include an extension of Medicare telehealth flexibilities and funding for community health centers, the National Health Service Corps, and the Teaching Health Center Graduate Medical Education (THCGME) program. The Trump Administration has expressed full support for the bill. The House-passed CR can be found here. A summary of the bill can be found here.
  
  The Senate also rejected an alternative CR released by Democratic leadership of the Senate and House Appropriations Committees by a vote of 47-45. The CR, entitled, the Continuing Appropriations and Extensions and Other Matters Act, 2026, would extend funding through October 31, 2025. While the Democratic CR includes an extension of the same public health provisions as the version released by House Republicans, it also includes a permanent extension of enhanced premium tax credits (EPTCs), which are set to expire on December 31, 2025. The bill would also repeal the health care provisions within the One Big Beautiful Bill Act. The CR released by the Democratic leadership of the Senate and House Appropriations Committees can be found here. A summary of the bill can be found here.
  
  While the Senate is expected to reconsider the House-passed CR on Monday, September 29, 2025, it remains unclear whether seven Democratic Senators will lend their support to meet the 60-vote threshold required to proceed to a vote. A government shutdown remains a strong possibility given the current stalemate between Democrats and Republicans.
• On September 19, 2025, President Trump issue a proclamation introducing significant changes to the H-1B nonimmigrant visa program, effective 12:01 am ET on September 21, 2025. Under this proclamation, employers must include a $100,000 payment for all new H-1B petitions to be considered. Following some initial confusion about the scope of this new restriction, the Administration clarified that this does not apply to any previously issued H-1B visas nor petitions submitted prior to September 21, 2025. The U.S. Citizenship and Immigration Services later posted a H-1B FAQ, stating that this does not change “any payments or fees required to be submitted in connection with any H-1B renewals. The fee is a one-time fee on submission of a new H-1B petition. [It] does not prevent any holder of a current H-1B visa from traveling in and out of the United States.” The proclamation does allow for exemptions, and White House staff have indicated this could include physicians and medical residents, but additional details are not yet available. An Advisory from Alston & Bird’s immigration team is available here.
• On September 24, 2025, the Office of Management and Budget (OMB) issued a memo directing federal agencies to prepare reduction in force (RIF) plans to lay off employees during a possible government shutdown. OMB instructed agencies to identify discretionary programs, projects, and activities set to expire on October 1, 2025, that have no alternative funding source, and draft RIF plans that would go beyond standard furloughs. During previous government shutdowns, only employees deemed essential continued working, while others were prohibited from working and did not receive pay, but did keep their positions and receive retroactive pay once government funding was restored. In the event of a shutdown, OMB’s directive may permanently eliminate jobs in programs not consistent with the Trump Administration’s priorities. The OMB memo also notes that the RIF plans will not be necessary if Congress successfully passes a CR. The memo can be found here.
• On September 18 and 19, 2025, the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) held a meeting to review recommendations for the COVID-19, hepatitis B, and measles, mumps, rubella, and varicella (MMRV) vaccines. ACIP voted to recommend COVID-19 vaccination based on individual decision-making for all individuals age six months and older. The recommendation emphasizes that for individuals under age 65, the risk-benefit of vaccination is “most favorable for those who are at an increased risk for severe COVID-19 and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors.” Additionally, ACIP requested that CDC consider adding new safety warning language to COVID-19 vaccine materials. A proposal to recommend that state and local jurisdictions require prescriptions for COVID-19 vaccines was defeated in a 6-6 tie, with the deciding vote cast by ACIP Chair Martin Kulldorff, who opposed the measure. ACIP also voted to recommend that all pregnant women be tested for hepatitis B. Finally, ACIP recommended that toddlers up to age three be immunized for varicella (chickenpox) by standalone vaccination administered alongside the measles, mumps, and rubella (MMR) vaccine, rather than the combination MMRV vaccine.A press release on the ACIP meeting can be found here.
• On September 22, 2025, the White House held a press conference during which President Trump, alongside HHS officials, suggested a link between autism and the use of acetaminophen (Tylenol) during pregnancy. The Administration recommended that women limit Tylenol use during pregnancy unless medically necessary.
  
  The press conference included announcements from the FDA that it would update labeling to reflect this guidance. Specifically, FDA issued a physician notice and announced plans to update safety labeling for acetaminophen to suggest a link between prenatal use and autism. FDA also plans to relabel Leucovorin as a treatment for cerebral folate deficiency, which the Trump Administration claims is associated with autism. FDA officials noted that the labeling change would enable coverage of Leucovorin through Medicaid and CHIP, and states would be required to collect data on its utilization. Furthermore, the NIH launched the Autism Data Science Initiative, a $50 million initiative funding 13 projects to integrate large-scale biological, clinical, and behavioral data in autism research. An HHS press release can be found here.

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