Health Care Week in Review | President Signs 2026 Spending Package to End Brief Shutdown; Trump Administration Launches TrumpRX

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 February 2, 2026, the Health Resources and Services Administration (HRSA) released a request for public comment entitled, Request for Public Comment on the Updated Criteria for Determining Maternity Care Health Professional Target Areas. The Public Health Service Act (PHSA) directs the Department of Health and Human Services (HHS) to identify maternity care target areas (MCTAs) for the purpose of assigning National Health Service Corps participants who are maternity care health professionals to health professional shortage areas (HPSAs) with a shortage of such professionals. On September 27, 2021, HRSA published a Federal Register notice soliciting feedback on proposed criteria to be used to identify MCTAs. On May 19, 2022, HRSA published a notice that summarized and responded to the comments received during the 60-day comment period and presented the final criteria which are used to identify and score MCTAs. One of the criteria selected was the Social Vulnerability Index (SVI). HRSA is now proposing to change the criteria and point scales for MCTAs by removing the criterion for SVI and reallocating one point to population-to-full-time-equivalent maternity care health professional ratio and one point to score for travel distance/time to nearest source of accessible care outside of the MCTA.
• On February 2, 2026, the National Institutes of Health (NIH) released a notice entitled, Notice of Charter Renewal. NIH is providing notice that the charter for the National Center for Advancing Translational Sciences Council (NCATSC) is being renewed for an additional two-year period on February 7, 2026. It is determined that NCATSC is in the public interest in connection with the performance of duties imposed on NIH by law, and that these duties can best be performed through the advice and counsel of this group.
• On February 4, 2026, the Food and Drug Administration (FDA) released guidance entitled, Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions. This document provides FDA’s recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends being included in premarket submissions for devices with cybersecurity risk. These recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats. This guidance also addresses FDA’s recommendations regarding section 524B of the
  Federal Food, Drug, and Cosmetic (FD&C) Actfor cyber devices. This document supersedes FDA’s guidance entitled, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issued June 27, 2025.
• On February 4, 2026, FDA released guidance entitled, Computer Software Assurance for Production and Quality Management 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 management system. This guidance describes a risk-based approach to establish confidence in the automation used for production or quality management systems, identify where additional rigor may be appropriate, and various methods and testing activities that may be applied to establish computer software assurance. FDA’s goal is to help manufacturers produce high quality medical devices while complying with the Quality Management System regulation. This document supersedes FDA guidance entitled, Computer Software Assurance for Production and Quality System Software, issued September 24, 2025.
• On February 5, 2026, FDA released a final amendment entitled, Listing of Color Additives Exempt From Certification; Beetroot Red. FDA is amending the color additive regulations to provide for the safe use of beetroot red for the coloring of human foods generally, at levels consistent with current good manufacturing practice. This does not apply to products under the jurisdiction of the Department of Agriculture (USDA), infant formula, or foods for which standards of identity have been issued under section 401 of the FD&C Act, unless the use of the added color is authorized by such standards.
• On February 5, 2026, FDA released a final amendment entitled, Listing of Color Additives Exempt from Certification; Spirulina Extract. FDA is amending the color additive regulations to provide for the expanded use of spirulina (Arthrospira platensis) extract as a color additive in human foods generally, at levels consistent with good manufacturing practice, to lower the heavy metal specifications for lead, arsenic, and mercury, and to add a specification for cadmium. This does not apply to infant formula, certain foods subject to regulation by USDA, and foods for which standards of identity have been issued under section 401 of the FD&C Act, unless the use of the added color is authorized by such standards.
• On February 5, 2026, FDA released a notice entitled, New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address. FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications (ANADAs) and conditionally approved new animal drug applications (CNADAs) during July, August, and September 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
• On February 5, 2026, FDA released a notice entitled, Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments. FDA has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register. Electronic or written comments on the notice are due by April 7, 2026.
• On February 6, 2026, the Centers for Medicare & Medicaid Services (CMS) released a notice entitled, Privacy Act of 1974; Matching Program. In accordance with the Privacy Act of 1974, as amended, CMS is providing notice of the re-establishment of a matching program between CMS and the Social Security Administration (SSA). Under this matching program, SSA will provide CMS with information for determining individuals’ eligibility for enrollment in a Qualified Health Plan (QHP), issuing certificates of exemption, and eligibility redeterminations and renewals.
• On February 6, 2026, FDA released draft guidance entitled, E22 General Considerations for Patient Preference Studies. The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). When finalized, this guidance will provide general principles for the use, design, conduct, analysis, and submission of patient preference studies (PPS) aimed at informing drug development, regulatory submission and evaluation, drug approvals, and maintenance of such approvals.

Event Notices

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

• February 8-10, 2026: NIH announced a meeting of the National Institute of Environmental Sciences. This is a hybrid meeting with some sessions open to the public.
• February 9, 2026: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.
• February 9-10, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• February 9-10, 2026: NIH announced a meeting of the National Library of Medicine. This is a virtual meeting with some sessions open to the public.
• February 10, 2026: FDA announced a roundtable discussion with small tobacco product manufacturers to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products. This is a hybrid meeting open to the public.
• February 11, 2026: NIH announced a meeting of the National Advisory Neurological Disorders and Stroke Council. This is a virtual meeting open to the public.
• February 13, 2026: NIH announced a meeting of the National Advisory Eye Council. This is a virtual meeting open to the public.
• February 19, 2026: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This is a hybrid meeting open to the public.
• February 19, 2026: The Assistant Secretary for Technology Policy (ASTP) announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• February 23-24, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
• March 6, 2026: NIH announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting with some sessions open to the public.
• March 11-13, 2026: HHS announced the 2026 National Conference on Women’s Health. This conference is free and open to the public.
• March 19, 2026: NIH announced a meeting of the Board of Scientific Counselors of the National Cancer Institute. This is a hybrid meeting with some sessions open to the public.
• March 16, 2026: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
• March 18, 2026: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a hybrid meeting with some sessions open to the public.
• March 18, 2026: NIH announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting open to the public.
• March 18, 2026: NIH announced a meeting of the National Cancer Institute Clinical Trials and Translational Research Advisory Committee. This is a hybrid meeting open to the public.
• March 25, 2026: 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.
• 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.
• March 30-31, 2026: NIH announced a meeting of the National Institute on Aging. This is a hybrid meeting with some sessions open to the public.
• April 6, 2026: NIH announced a meeting of the National Advisory Allergy and Infectious Diseases Council. This is a virtual meeting with some sessions open to the public.
• April 7, 2026: NIH announced a meeting of the Advisory Committee on Research on Women’s Health. This is a hybrid meeting open to the public.
• April 9-10, 2026: NIH announced a meeting of the Sleep Disorders Research Advisory Board. This is a hybrid meeting open to the public.
• April 17, 2026: NIH announced a meeting of the National Center for Complementary & Integrative Health. This is a hybrid meeting with some sessions open to the public.
• April 23, 2026: 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.
• May 4-5, 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.
• May 5, 2026: NIH announced a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. This is a hybrid meeting with some sessions open to the public.
• May 7, 2026: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a hybrid meeting open to the public.
• May 12, 2026: 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.
• May 13, 2026: NIH announced a meeting of the National Institute on Aging. This is an in-person meeting with some sessions open to the public.
• May 13, 2026: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a hybrid meeting with some sessions open to the public.
• May 19, 2026: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a hybrid meeting open to the public.
• June 1-2, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• June 2, 2026: 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.
• 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.
• June 15-16, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
• June 29, 2026: NIH announced a meeting of the National Cancer Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 10-11, 2026: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• September 14-15, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.
• September 15-16, 2026: NIH announced a meeting of the National Advisory Council on Aging. This is a hybrid meeting with some sessions open to the public.
• September 24, 2026: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• November 5, 2026: ASTP announced a meeting of the Health Information Technology Advisory Committee. This is a virtual meeting open to the public.
• December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.

Reports, Studies & Analyses

• On February 3, 2026, the Government Accountability Office (GAO) released a report entitled, FDA: Oversight Responsibilities and Funding from Fiscal Years 2008 through 2024.  Prior to 2020, GAO reported that FDA faced challenges that could affect the agency’s ability to perform its oversight responsibilities. GAO undertook this review to provide the Congress with contextual information on FDA’s capacity to meet its oversight responsibilities. The report found that from 2008 through 2024, FDA’s funding increased, driven largely by user fees paid by the manufacturers it regulates. During the same period, the agency’s oversight responsibilities expanded to encompass new product areas, such as tobacco. However, FDA faced staffing challenges related to recruiting, retaining, and training staff, which presented challenges for the agency’s food and drug inspections. GAO has previously issued several recommendations to address the challenges discussed in this report and FDA has agreed with those recommendations. While FDA is taking steps in response, as of December 2025, it had not fully implemented most of GAO’s recommendations.
• On February 4, 2026, GAO released a report entitled, Rare Diseases: Funding for Rare Neurodegenerative Disease Research and Access to ALS Investigational Drugs. NIH and FDA awarded approximately $276 million from fiscal years (FY) 2022 through 2025 for implementation of the Accelerating Access to Critical Therapies for ALS (ACT for ALS) Act. According to the report, agency officials took steps to address some of the challenges to implementing the ACT for ALS Act. For example, because appropriations were not available until midway through FY 2022, applicants had limited time to apply for NIH grants. In subsequent years, NIH addressed this issue by posting requests for grant applications prior to appropriations being enacted. However, other challenges remained that were outside the agencies’ control. For example, according to agency officials, FDA did not receive direct appropriations to support its priorities for other rare neurodegenerative diseases for the public-private partnership. Stakeholder interviews, available literature, and NIH data indicated benefits of NIH and FDA funding, such as increases in the number and geographic diversity of clinic sites providing access to ALS investigational drugs. However, most of the research funded by the agencies are ongoing and the full impacts are not yet known. Anticipated benefits include increased data on ALS and addressing research gaps for ALS and other rare neurodegenerative diseases.

Hearings & Markups

• On February 3, 2026, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing entitled, Modernizing the National Institutes of Health: Faster Discoveries, More Cures. Witnesses included: The Honorable Jayanta Bhattacharya, MD, PhD, Director, NIH.
• On February 3, 2026, the House of Representatives Energy and Commerce Committee Oversight and Investigations Subcommittee held a hearing entitled, Common Schemes, Real Harm: Examining Fraud in Medicare and Medicaid. Witnesses included: Jessica Gay, CPC, AHFI, CFE, Vice President and Co-Founder, Integrity Advantage; Kaye Lynn Wootton, JD, President, National Association of State Medicaid Fraud Control Units; Stephen Nuckolls, Chief Executive Officer, Coastal Carolina Health Care, and Treasurer and former Board Chair, National Association of Accountable Care Organizations (NAACOs); and Jessica Tillipman, JD, Government Contracts Advisory Council Distinguished Professorial Lecturer in Government Contracts Law, Practice & Policy, George Washington University Law School.
• On February 4, 2026, the Senate Judiciary Committee Federal Courts, Oversight, Agency Action, and Federal Rights Subcommittee held a hearing entitled, Somali Scammers: Fighting Fraud in Minnesota and Beyond. Witnesses included: David Hoch, Independent Investigative Journalist; The Honorable Kristin Robbins, Chair of the Fraud Prevention Committee, Minnesota House of Representatives; and Robert Weissman, Co-President, Public Citizen.

Other Health Policy News

• On February 3, 2026, President Trump signed the Consolidated Appropriations Act, 2026, enacting five appropriations bills and providing a two-week Continuing Resolution (CR) for the Department of Homeland Security (DHS), ending a brief partial government shutdown. Earlier that day, the House of Representatives passed the bill by a vote of 217-214. The Senate passed the bill last week by a vote of 71-29.
  
  Of note, the Consolidated Appropriations Act, 2026 includes a total of $116 billion in discretionary spending for HHS. The bill allocates $4.1 billion for CMS, $8.9 billion for HRSA, $9.2 billion for CDC, and $48.7 billion for NIH. It also includes several bipartisan health care policies, including reforms for pharmacy benefit managers (PBMs) and a directive to state Medicaid programs to streamline out-of-state provider enrollment for pediatric providers. The bill would also require separate unique health identifiers services furnished by a hospital off-campus outpatient department. Other notable provisions include an increase in funding for community health centers (CHCs) to $4.6 billion for FY 2026 and a provision that would allow Medicare coverage for multi-cancer early detection screening tests.
  
  The full bill text and summaries can be found here.
• On February 2, 2026, HHS announced that the Substance Abuse and Mental Health Services Administration (SAMHSA) had distributed $794 million in block grant funding for community mental health services and substance abuse treatment and prevention. This includes $319 million for the Community Mental Health Services Block Grant (MHBG), which supports comprehensive services for adults with serious mental illness and children with serious emotional disturbance, and $475 million for the Substance Use Prevention, Treatment, and Recovery Services Block Grant (SUBG) program. This represents the first allocation of the FY 2026 annual block grant awards.
  
  The HHS press release can be found here.
• On February 3, 2026, the Senate HELP Committee held a hearing entitled, Modernizing the National Institutes of Health: Faster Discoveries, More Cures. The hearing examined NIH Director Dr. Jay Bhattacharya’s leadership amid heightened scrutiny over grant disruptions, shifting research priorities, and public trust in science. Senators from both parties pressed the NIH on urgent issues, including the management of Alzheimer’s research, ongoing debates over the origins of COVID‑19 and the Trump Administration’s new restrictions on gain‑of‑function research, and concerns that recent policy changes could worsen long‑standing gaps in women’s health research and maternal health outcomes. Several Democratic senators criticized widespread grant pauses, vaccine policy changes, and political appointee influence. Dr. Bhattacharya defended the Trump Administration’s reforms as efforts to depoliticize science, strengthen research oversight, and rebuild public trust. Many Senators, however, raised broader concerns about clinical trial stability, the biomedical workforce, scientific independence, and the effects of rapid changes to research portfolios and public health policy.
  
  More information on this hearing can be found here.
• On February 4, 2026, Senate Finance Committee Ranking Member Ron Wyden (D-OR), alongside Senators Catherine Cortez Masto (D-NV), Peter Welch (D-VT), and Ruben Gallego (D-AZ), announced a policy framework for lowering drug prices. The policy framework aims to deliver on three main goals, including: (1) lowering the prices manufacturers charge for drugs; (2) reducing out-of-pocket drug costs; and (3) restoring and bolstering American innovation.
  
  Specifically, the memo states that Democratic Senate Finance Committee staff will develop policies to enable Medicare to negotiate more drugs more quickly, and to incorporate international pricing into the Medicare drug price negotiation framework, including approaches that would allow the HHS Secretary to consider international prices as a factor in negotiations. Senate Finance Committee staff will also craft policies to ensure that patient cost sharing for brand name drugs better reflects the actual costs paid by plans and PBMs, while establishing new incentives to support innovation and drug development within the Committee’s jurisdiction. The memo also notes that more details on their suggested policies will be released in the coming weeks and months.
  
  The Dear Colleague letter can be found here.
• On February 5, 2026, the Trump Administration announced the launch of TrumpRx, a website that displays discount prices for certain prescription drugs and provides purchase options offered by manufacturers or pharmacies. As of the launch, 40 branded medicines are available for purchase through the website. The website features drugs made by the first five manufacturers to reach most-favored-nation (MFN) pricing deals with the Trump Administration: AstraZeneca, Eli Lilly, EMD Serono, Novo Nordisk, and Pfizer. The Trump Administration noted that additional drugs from other companies that have signed MFN pricing agreements will be added to the website in the coming months.
  
  A White House fact sheet can be found here.

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