Health Care Week in Review | HHS Secretary RFK Jr. Testifies Before Congressional Committees on the FY 2027 Budget; President Trump Nominates Dr. Erica Schwartz to be the Next CDC Director

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 April 15, 2026, the Food and Drug Administration (FDA) released a rule entitled, Medical Devices: Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant. FDA is classifying the manual surgical instrument for appropriate patient selection for orthopedic implant 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 classification of the manual surgical instrument for appropriate patient selection for orthopedic implant. FDA is taking this action because the agency has determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device.
• On April 15, 2026, FDA released a notice entitled, Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing. The draft document provides recommendations for next-generation sequencing (NGS)-based methods used in nonclinical studies that will likely be needed to support initiation of clinical trials of investigational human genome editing (GE) products.
• On April 15, 2026, FDA released a rule entitled, Medical Devices: Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion. FDA is classifying the transcutaneous electrical nerve stimulator for the relief of congestion into class II. The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the transcutaneous electrical nerve stimulator for the relief of congestion. FDA taking this action because they have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device.
• On April 15, 2026, FDA released a rule entitled, Physical Medicine Devices: Reclassification of Non-Invasive Bone Growth Stimulators. FDA is issuing a final order to reclassify non-invasive bone growth stimulators (product codes LOF and LPQ), postamendments class III devices, into class II, subject to premarket notification. FDA is codifying the reclassification of these devices under the new classification regulation, “non-invasive bone growth stimulator.” FDA is also establishing the special controls necessary to provide reasonable assurance of safety and effectiveness of these devices.
• On April 17, 2026, FDA released guidance entitled, Compliance Policy Regarding Premarket and Other Requirements for Certain National Institute for Occupational Safety and Health Approved Air-Purifying Respirators. This draft guidance document provides a proposed compliance policy for and information about respirators approved by the Centers for Disease Control and Prevention (CDC) National Institute for Occupational Safety and Health (NIOSH) in accordance with 42 CFR part 84, specifically: surgical N95 respirators and N95 filtering facepiece respirators (FFRs); other NIOSH approved, non-surgical respirators including powered air-purifying respirators (PAPRs), non-powered, air-purifying particulate FFRs, and reusable respirators; and FFRs for use by the general public in public health medical emergencies. This guidance, once finalized, is intended to facilitate more efficient and effective use of resources, consistent with the least burdensome policies for devices.
• On April 17, 2026, FDA released guidance entitled, Establishing Impurity Specifications for Antibiotics. The draft guidance provides recommendations regarding the establishment of specifications for organic impurities in antibiotics manufactured by fermentation and semisynthesis. This draft guidance applies to antibiotic drugs subject to approval under new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and associated type II drug substance drug master files (DMFs) referenced in antibiotic NDAs and ANDAs. This guidance also applies to nonprescription antibiotic drugs, often referred to as over-the-counter (OTC) monograph drugs. These recommendations are intended to clarify effective control strategies, support the development of high-quality antibiotic products, and promote consistency in quality standards.
• On April 17, 2026, FDA released guidance entitled, Potential New Indication for Testosterone Replacement Therapy. FDA is announcing that they have reviewed information that seems promising regarding the potential use of testosterone replacement therapy (TRT) in the treatment of low libido in men with decreased libido associated with idiopathic hypogonadism. FDA is encouraging holders of approved TRT NDAs that are interested in seeking approval for this new indication to contact FDA for further information regarding submission of a supplemental NDA, including data needed to support an approval.

Event Notices

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

• April 23, 2026: The National Institutes of Health (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.
• **April 23, 2026: NIH announced a meeting entitled, Increasing Access to Nonprescription Drugs. This is a hybrid meeting open to the public.
• **April 27, 2026: The Department of Health and Human Services (HHS) announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.
• April 28, 2026: NIH announced a meeting of the Office of the Secretary. This is a hybrid meeting open to the public.
• April 29, 2026: CDC announced a meeting of the Advisory Board on Radiation and Worker Health. This is a virtual meeting open to the public.
• April 30, 2026: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a hybrid meeting 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: The Assistant Secretary for Technology Policy (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 14-15, 2026: NIH announced a meeting of the Office of the Director. This is a hybrid meeting with some sessions open to the public.
• May 18, 2026: NIH announced a meeting of the National Advisory Council for Human Genome Research. 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.
• May 19, 2026: NIH announced a meeting of the Interagency Autism Coordinating Committee. This is a hybrid meeting open to the public.
• May 19, 2026: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a virtual meeting open to the public.
• **May 19-20, 2026: NIH announced a meeting of the National Institute of Dental & Craniofacial Research. This is a hybrid meeting with some sessions open to the public.
• **May 20, 2026: NIH announced a meeting of the National Institute of Neurological Disorders and Stroke. This is a virtual meeting open to the public.
• May 21, 2026: NIH announced a meeting of the National Advisory General Medical Sciences Council. This is a virtual meeting open to the public.
• **May 21-22, 2026: NIH announced a meeting of the National Center for Advancing Translational Sciences. This is a virtual meeting with some sessions open to the public.
• **May 26, 2026: NIH announced a meeting of the Sickle Cell Advisory Committee (SCDAC). This is a virtual meeting open to the public.
• **May 27, 2026: FDA announced a meeting entitled, Animal Drug User Fee Act. This is a virtual meeting open to the public.
• **May 27, 2026: FDA announced a meeting entitled, Animal Generic Drug User Fee Act. This is a virtual 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 2, 2026: the Centers for Medicare & Medicaid Services (CMS) announced the first biannual Healthcare Common Procedure Coding System (HCPCS) Level II public meeting of 2026. 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.
• June 5, 2026: CDC announced a meeting of the Subcommittee on Procedures Reviews of the Advisory Board on Radiation and Worker Health. This is a virtual meeting open to the public.
• June 8-9, 2026: FDA announced a public workshop entitled, Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop. This is a hybrid meeting open to the public.
• June 10-11, 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.
• June 12, 2026: FDA announced a public hearing related to the Commissioner’s National Priority Voucher (CNPV) Pilot Program. This is a hybrid meeting open to the public.
• **June 12, 2026: NIH announced a meeting of the NIH Clinical Center Research Hospital Board. This is a hybrid meeting open to the public.
• June 15, 2026: NIH announced a meeting of the National Institute of Environmental Health Sciences Board of Scientific Counselors. This is a hybrid meeting with some sessions open to the public.
• June 15-16, 2026: HHS announced a meeting of the Physician-Focused Payment Model Technical Advisory Committee (PTAC). This is a hybrid meeting open to the public.
• **June 23, 2026: 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.
• **June 24, 2026: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee (DMICC). This is a virtual meeting open to the public.
• **June 24, 2026: NIH announced a meeting of the National Institute of Environmental Health Sciences. This is a virtual meeting with some sessions 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.
• **June 30, 2026: NIH announced a meeting of the National Institute of Neurological Disorders and Stroke. This is a hybrid meeting with some sessions open to the public.
• July 8, 2026: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a hybrid meeting with some sessions open to the public.
• **July 23-24, 2026: FDA announced a meeting of the Pharmacy Compounding Advisory Committee. this is a hybrid meeting 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 7-8, 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.
• December 8-9, 2026: HHS announced a meeting of PTAC. This is a hybrid meeting open to the public.

Reports, Studies & Analyses

• On April 15, 2026, the Government Accountability Office (GAO) released a report entitled, Combating Fraud: Challenges in Managing Fraud Risks in Federally Funded, State-Administered Programs.  In April 2026, GAO testified before House Subcommittee on Government Operations regarding fraud risks in federally funded, state‑administered programs. GAO reported that all federal programs are inherently susceptible to fraud, including health-related programs that provide medical services or nutrition assistance. Programs administered by states—such as Medicaid, the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), the Supplemental Nutrition Assistance Program (SNAP), and the Temporary Assistance for Needy Families (TANF) block grant—are particularly exposed due to decentralized delivery models. In these arrangements, states make eligibility, payment, and oversight decisions while relying on federal funding, which increases the volume and complexity of transactions and limits centralized visibility. Medicaid was identified as one of the largest programs affected by these risks, given its scale and the tens of millions of beneficiaries it serves nationwide. GAO noted that when eligibility determinations and payments are made outside of federal agencies, opportunities for misrepresentation, improper payments, and organized fraud increase. It also estimated that the federal government loses between $233 billion and $521 billion annually to fraud, based on fiscal year 2018 through 2022 data, which includes pandemic-related spending. GAO concluded that while fraud cannot be eliminated entirely, managing fraud risk in federally funded, state‑administered health programs requires continuous attention to program design, data integration, oversight capacity, and preventive controls. As of April 2026, GAO had made over 200 recommendations to improve fraud risk management across federal programs, including health and human services programs, many which remain unresolved.
• On 2026, KFF released a report entitled, What are the recent trends in employer-based health coverage? KFF reported that employer‑sponsored insurance (ESI) remains the largest source of health coverage for people under age 65, covering 165.6 million people in March 2025, but found that access to this coverage is uneven. KFF found that not all workers have access to ESI because some employers do not offer coverage, some workers are not eligible for coverage that is offered, and some eligible workers choose not to enroll. According to KFF, coverage rates vary sharply by income, with ESI covering just 22.5 percent of people under 65 with incomes below 200 percent of the federal poverty level, compared with 82.5 percent of those with incomes at or above 400 percent of poverty. KFF also reported that access to ESI depends on both the availability and affordability of coverage through a worker or family member’s job: while 80.4 percent of non‑elderly adult workers were employed by firms that offered ESI to at least some employees and 74.6 percent were eligible for coverage in March 2025, eligibility was lower among low‑income workers, younger workers, people working part time, non‑citizens, and certain racial and ethnic groups, including Hispanic people and non‑Hispanic American Indian or Alaska Native people. KFF found that among workers who were eligible for ESI but did not enroll, most cited having other coverage (63.0 percent) or the cost of coverage (30.2 percent) as the primary reasons, with affordability concerns particularly pronounced for workers at small firms facing high contributions for family coverage.

Hearings & Markups

• On April 14, 2026, the House Committee on Ways and Means Subcommittee on Health held a hearing entitled, Field Hearing on Modernized Health Care in Practice: Empowering Americans to Live Healthier Lives. Witnesses present included: Dr. Mark Kauffman, Dean of Academic Affairs, Lake Erie College of Osteopathic Medicine; Dr. Christopher Davis, Founder, Reveal Vitality and Longevity Institute; Dr. Stelios Rekkas, Medical Director, Manatee Surgical Alliance; Dr. Patrick Hwu, President and CEO, Moffitt Cancer Center; and Mr. Scott Darius, Executive Director, Florida Voices for Health.
• On April 15, 2026, the House Committee on Oversight and Government Reform held a hearing entitled, Fraud Prevention: Understanding Fraud in Federally Funded Programs Run by the States. Witnesses present included: Dr. O.J. Oleka, Chief Executive Officer, State Financial Officers Foundation; Ms. Allison Ball, Auditor of Public Accounts, Commonwealth of Kentucky; Mr. Seto Bagdoyan, Director of Forensic Audits and Investigative Services, GAO; and Mr. Robert A. Westbrooks, Former Federal Inspector General.
• On April 15, 2026, the House Committee on Energy and Commerce Health Subcommittee held a hearing entitled, Healthier America: Legislative Proposals to Improve Public Health. Witnesses present included: Mr. Jamie Ulmer, President and Chief Executive Officer, Healthcare Network; Dr. Rachel F. Brem, Co‑Founder and Chief Medical Officer, Brem Foundation to Defeat Breast Cancer, and Professor and Vice‑Chair Emeritus, The George Washington University; Ms. Holly Ahern, Associate Professor of Microbiology, State University of New York Adirondack; Ms. Amy L. Ronneberg, Chief Executive Officer, National Marrow Donor Program; Mr. Brian Wallach and Ms. Sandra Abrevaya, Co‑Founders, I AM ALS; and Ms. René Quashie, Vice President, Digital Health, Consumer Technology Association.
• On April 16, 2026, the House Committee on Ways and Means held a hearing entitled, Full Committee Hearing with Health and Human Services Secretary Robert F. Kennedy, Jr. HHS Secretary Robert F. Kennedy Jr. served as the sole witness. 
• On April 16, 2026, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, Making Medicines More Affordable: How Competition Can Lower Drug Prices. Witnesses present included: Witnesses present included: Dr. Brian J. Miller, Associate Professor of Medicine, The Johns Hopkins University School of Medicine, and Visiting Fellow, Hoover Institution; Mr. Ryan Long, Director of Congressional Relations and Senior Research Fellow, Paragon Health Institute, and Nonresident Senior Scholar, USC Schaeffer Institute; and Mr. Robert Weissman, Co‑President, Public Citizen.
• On April 16, 2026, the House Appropriations Committee held a hearing entitled, Budget Hearing - Department of Health and Human Services. HHS Secretary Robert F. Kennedy Jr. served as the sole witness. 
• On April 17, 2026, House Education and Workforce held a hearing entitled, Examining the Policies and Priorities of the Department of Health and Human Services. HHS Secretary Robert F. Kennedy Jr. served as the sole witness.

Other Health Policy News

• On April 16, 2026, the House Committee on Ways and Means held a full committee hearing with HHS Secretary Kennedy to examine the Trump Administration’s fiscal year (FY) 2027 Budget Request and the Administration’s broader health policy priorities. The hearing offered an early look at how the Administration intends to advance its Make America Healthy Again (MAHA) agenda while implementing significant budget reductions and a sweeping reorganization of HHS. Secretary Kennedy framed the FY 2027 budget as a generational reset for federal health policy, arguing that the nation’s rising rates of chronic disease reflect decades of “misaligned incentives” that prioritize treatment over prevention. According to the Secretary, the budget is designed to redirect federal resources toward prevention, nutrition, and primary care while cracking down on waste, fraud, and abuse across federal health programs. The HHS Budget-in-Brief proposes $111.1 billion in discretionary budget authority for FY 2027, a decrease of $15.8 billion, or 12.5 percent. The FY 2027 HHS budget proposal reflects an overall reduction in discretionary spending across the Department, consistent with the Trump Administration’s broader effort to reduce non-defense spending. Secretary Kennedy emphasized that, despite these reductions, the budget prioritizes investments aligned with the MAHA agenda, including chronic disease prevention, rural health access, maternal and child health, mental health and substance use treatment, and food safety.

  Members from both parties focused on rural health care access, with Secretary Kennedy highlighting the Administration’s $50 billion Rural Health Transformation Program (RHTP), which he described as the largest federal investment in rural health to date, along with more than $135 million for rural residency programs, nutrition services, and community health centers. Lawmakers also raised concerns about rural hospital closures, reimbursement disparities between rural and urban providers, and the need for reforms to Medicare’s wage index and site-neutral payment policies, while Kennedy defended an HHS reorganization intended to reduce duplication and prioritize prevention, prompting Democratic concerns about staffing reductions and leadership vacancies weakening public health preparedness.

  There was bipartisan agreement on strengthening oversight and combating fraud, as HHS shifts toward pre‑payment review, expanded use of artificial intelligence, and heightened enforcement targeting Medicare hospice fraud, durable medical equipment schemes, and Medicaid abuses, though sharp partisan divisions emerged over proposed funding reductions affecting public health agencies and vaccine policy, among other issues. During the hearing, Secretary Kennedy also said the Administration is reforming the U.S. Preventive Services Task Force (USPSTF), the panel that determines which preventive services must be covered without cost‑sharing under the Affordable Care Act (ACA), calling the group “lackadaisical and negligent” and indicating that new members are being brought on amid ongoing work on recommendations related to autism screening, breast cancer risk assessment, and early allergen introduction for infants.

  Next week, the Secretary is scheduled to appear before the House Committee on Energy and Commerce, the Senate Appropriations Labor-HHS Subcommittee, the Senate HELP Committee, and the Senate Committee on Finance. 

  More information on this hearing can be found here. More information on the President’s Budget Proposal can be found here.

• On April 16, 2026, President Trump nominated Dr. Erica Schwartz to serve as the next Director of the CDC. Dr. Schwartz previously served as Deputy Surgeon General during President Trump’s first term and is a retired Rear Admiral and board‑certified preventive medicine physician. The nomination comes as the CDC has operated for all but one month of the President’s second term without a Senate‑confirmed leader and amid continued turbulence following staffing, budget, and program reductions.

  The CDC is currently led on an acting basis by Dr. Jay Bhattacharya, who is also Director of the NIH and is expected to remain in that role during the Senate confirmation process for Dr. Schwartz, which could take several months.

  Dr. Schwartz’s background has drawn bipartisan support from public health leaders and former administration officials, who highlight her experience as former Chief Medical Officer of the U.S. Coast Guard, her service during the COVID‑19 response, and her academic training, which includes a medical degree from Brown University, a law degree from the University of Maryland, and a master’s in public health from the Uniformed Services University. If confirmed, Dr. Schwartz would work under HHS Secretary Kennedy and inherit an agency facing morale challenges and internal restructuring, with CDC staff expressing cautious optimism that a seasoned leadership team could bring greater stability and direction.

• On April 16, 2026, the Senate HELP Committee held a hearing entitled, Making Medicines More Affordable: How Competition Can Lower Drug Prices. The hearing examined bipartisan and partisan proposals to reduce prescription drug costs through increased competition, regulatory reform, and price controls. Lawmakers and witnesses broadly agreed that rising drug prices continue to strain American families, though sharp disagreements emerged over the appropriate role of government regulation, intellectual property protections, and executive action. Chairman Bill Cassidy (R-LA) emphasized the success of generic drugs, which account for roughly 90 percent of prescriptions filled in the U.S. while delivering hundreds of billions of dollars in annual savings. He argued that the U.S. should try to create the same kind of competition and savings for more complex drugs (biologics) by using more lower-cost alternatives known as biosimilars. Chairman Cassidy and other Republicans stressed the need to preserve patent protections and incentives for innovation while streamlining FDA regulatory pathways, including by reducing pre-market study requirements, reforming the citizen petition process, expanding over-the-counter and behind-the-counter access, and addressing pharmacy benefit manager (PBM) practices that discourage lower-cost alternatives.
  
  Democratic members, led by Ranking Member Bernie Sanders (I-VT), countered that the U.S. continues to pay the highest drug prices in the world and argued that market-based competition alone is insufficient to curb pharmaceutical monopolies. Ranking Member Sanders and other Democrats pointed to data showing widespread prescription rationing and sharply rising launch prices for new medicines, and advocated for policies that would cap U.S. drug prices at levels paid in peer countries, expand Medicare’s authority to negotiate drug prices, increase transparency, and curb patent and rebate practices that delay generic competition.
  
  Expert witnesses broadly emphasized that increasing competition through faster generic and biosimilar entry, streamlined FDA pathways, and reforms to pharmacy benefit manager incentives could help lower drug prices, while consumer advocates argued that structural market failures and weak price oversight continue to allow manufacturers to maintain high costs. Lawmakers also debated the role of PBM rebates, the expansion of the 340B program, authorized generics, and patent-related delays, alongside concerns that tariffs and potential reductions in Medicaid and ACA coverage could further increase patient out-of-pocket spending, underscoring persistent divisions over whether competition alone is sufficient to deliver lasting prescription drug savings.
  
  More information can be found here.

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