Health Care Week in Review | President Trump Announces Actions to Lower Drug Prices; Trump Administration Initiates Section 232 Investigation on Pharmaceuticals

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.

Week in Review Highlight of the Week:

This week, President Trump signed an executive order directing HHS to take steps to lower prescription drug prices, and the U.S. Department of Commerce announced an investigation into the impact of pharmaceuticals and pharmaceutical ingredients on U.S. national security.

1. Regulations, Notices & Guidance

• On April 14, 2025, the Department of Commerce’s Bureau of Industry and Security (BIS) released a request for information entitled, Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients. The Secretary of Commerce has initiated an investigation to determine the effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients, including finished drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients, and key starting materials, and derivative products of those items. This investigation has been initiated under section 232 of the Trade Expansion Act of 1962, as amended. Interested parties are invited to submit written comments, data, analyses, or other information pertinent to the investigation to BIS, Office of Strategic Industries and Economic Security. Comments may be submitted at any time but must be received by May 7, 2025.
• On April 15, 2025, the Executive Office of the President (EOP) published Executive Order (EO) 14273 entitled, Lowering Drug Prices By Once Again Putting Americans First. This EO directs the Department of Health and Human Services (HHS) to take steps to significantly reduce drug prices for American patients by enhancing the Medicare drug pricing programs, aligning payments with hospital acquisition costs, and standardizing payments for certain treatments. It calls on HHS to introduce significant discounts for low-income patients, including reduced costs for insulin and injectable epinephrine. The order also facilitates importation programs and improves transparency in prescription drug markets.
• On April 15, 2025, EOP published EO 14275 entitled, Restoring Common Sense to Federal Procurement. The EO mandates revisions to the Federal Acquisition Regulation (FAR) within 180 days, ensuring it includes only essential provisions for efficiency, usability, and security. Within 15 days, agencies must appoint senior procurement officials to collaborate on FAR reform and suggest supplemental regulations. Within 20 days, the Office of Management and Budget (OMB) must issue guidance on implementation.
• On April 15, 2025, EOP published a memorandum entitled, Preventing Illegal Aliens From Obtaining Social Security Act Benefits. This memorandum directs the Secretary of Labor, the HHS Secretary, and the Commissioner of Social Security, in consultation with the Secretary of Homeland Security as necessary, to take measures to prevent ineligible individuals from receiving Social Security benefits. It mandates the expansion of fraud-prosecutor programs in the Social Security Administration (SSA) and the Centers for Medicare & Medicaid Services (CMS), requiring Special Assistant U.S. Attorneys to focus on fraud and identity theft. It also calls for prioritization of fraud efforts in areas with large populations of undocumented individuals and calls for specific audits and investigations, including referrals for earnings anomalies among centenarians. The SSA Commissioner must assess whether to resume civil monetary penalties and act accordingly.
• On April 16, the Substance Abuse and Mental Health Services Administration (SAMHSA) released a noticed entitled, Fiscal Year 2025 Notice of Supplemental Funding Opportunity. This notice is to inform the public that SAMSHA is supporting a supplement (in scope of the parent award) for the Cooperative Agreement for National Suicide Prevention Lifeline and Disaster Distress Helpline recipient, Mental Health Association of New York City, Inc. (DBA Vibrant Emotional Health), funded in FY 2021 under Notice of Funding Opportunity (NOFO) SM 21-005. The recipient may receive up to $100,000,000 and has a project end date of September 2026. The supplemental funding will be used to maintain 988 operations and services, both at local levels and across all subnetwork services, to ensure continuation of all 988 services and supports.
• On April 16, 2025, EOP published EO 14271 entitled, Ensuring Commercial, Cost-Effective Solutions In Federal Contracts. This EO mandates that federal agencies prioritize procuring commercially available products and services whenever possible, in line with the Federal Acquisition Streamlining Act of 1994 (FASA). It requires agencies to review all non-commercial procurement requests within 60 days, consolidate them into a formal application, and submit them for approval. The approval authority then has 30 days to assess compliance with FASA and recommend alternatives if commercial options could fulfill procurement needs. Agencies must provide reports on their adherence to FASA and progress in implementing this policy.
• On April 18, 2025, the Health Resources and Services Administration (HRSA) published a notice entitled, National Vaccine Injury Compensation Program List of Petitions Received. HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

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

• April 21, 2025: NIH announced a meeting of the Council of Councils. This is a hybrid meeting with some sessions open to the public.
• April 21, 2025: NIH announced a meeting of the National Arthritis and Musculoskeletal and Skin Diseases Advisory Council. This is a virtual meeting with some sessions open to the public.
• April 22, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is a virtual meeting with some sessions open to the public.
• April 23, 2025: NIH announced a meeting of the National Advisory Council for Nursing Research. This is a virtual meeting with some sessions open to the public.
• April 24, 2025: NIH announced a meeting of the National Diabetes and Digestive and Kidney Diseases Advisory Council. This is a virtual meeting with one session open to the public.
• April 30, 2025: NIH announced a meeting of the Fogarty International Center Advisory Board. This is a hybrid meeting with some sessions open to the public.
• April 30, 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.
• May 5, 2025: FDA announced a meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. This is a hybrid meeting open to the public.
• May 5-6, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Institute Environmental Health. This is a hybrid meeting with some sessions open to the public.
• May 5, 2025: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a virtual meeting with some sessions open to the public.
• May 5, 2025: NIH announced a meeting of the National Advisory Board on Medical Rehabilitation Research. This is a hybrid meeting open to the public.
• May 6, 2025: NIH announced a meeting of the National Advisory Council on Minority Health and Health Disparities. This is a virtual meeting with some sessions open to the public.
• May 8, 2025: NIH announced a meeting of the National Deafness and Other Communication Disorders Advisory Council. This is a virtual meeting open to the public.
• 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 14, 2025: 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 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 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 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 3-4, 2025: The Food and Drug Administration (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.
• 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.
• 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 2026. This is a hybrid meeting 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 COGME. 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 April 16, 2025, the Kaiser Family Foundation (KFF) released a report entitled, 10 Things to Know About Rural Hospitals. The report outlines essential facts about rural hospitals, with a keen focus on persistent challenges in access, sustainability, and equity. KFF found that, between 2017 and 2023, rural hospital closures significantly outpaced openings, with a net loss of 52 facilities, particularly in states that have not expanded Medicaid. KFF stated that financial vulnerability is a major concern. Specifically, in 2023, about half of rural hospitals in non-expansion states operated with negative margins. KFF found that many hospitals also reduced key services over time; for example, the share offering obstetrics care dropped from 57 percent in 2010 to 48 percent in 2022, raising alarms about access to time-sensitive care. KFF asserted that these closures and service cuts have ripple effects across communities, contributing to unemployment and economic decline.
• On April 17, 2025, the Government Accountability Office (GAO) released a report entitled Students’ Health Coverage Rates Have Improved, but Barriers to Coverage Remain for Some. The report found that health coverage rates among college students rose from 81 percent in 2010 to 92 percent in 2022 after the enactment of the Patient Protection and Affordable Care Act (ACA). Despite this progress, GAO found that about 1.6 million students remained uninsured in 2022, with disparities affecting students from historically disadvantaged groups, non-working students, and those in Medicaid non-expansion states. Colleges approach health coverage in various ways, with some requiring coverage and offering student health plans, while others do not, citing cost or low demand. HHS and the Department of Education have taken steps to help colleges support students in navigating coverage options and increase enrollment in health plans, including publishing webpages that guide students through the process and hosting webinars. However, GAO found that the cost of coverage, student deprioritization of obtaining health coverage, and disenrollment from Medicaid following the COVID-19 public health emergency all contributed to keeping student coverage at 92 percent.

3. Other Health Policy News

• On April 15, 2025, President Trump issued an EO entitled, “Lowering Drug Prices by Once Again Putting Americans First.” In the EO, President Trump directs various agency heads to begin making recommendations on policies that could reduce prescription drug prices. These include:
  • Limiting Medicare reimbursements to hospitals for outpatient drugs to the hospital’s acquisition costs for the drug;
  • Reducing the share of the drug administration volume in the Medicare program provided in hospital outpatient departments (HOPDs) compared to physician’s offices;
  • Increasing transparency among pharmacy benefit managers (PBMs);
  • Improving transparency and savings in the Medicare Drug Price Negotiation Program, while eliminating the “pill penalty” that requires small molecule drugs to be entered into the negotiation program four years earlier than biologics;
  • Mandating that federally qualified health centers (FQHCs) pass along 340B Program savings directly to patients; and
  • Streamlining states’ ability to import prescription drugs from Canada.
• Much of this EO is not self-executing, meaning that it will likely require coordination with Congress and new legislation to effectuate many of the policies proposed. What the Administration will try to implement through rulemaking remains to be seen, although the EO specifically refers to rulemaking or new regulations in the sections pertaining to a new payment model to lower drug prices, lowering drug administration volume at HOPDs, and PBM fee transparency.
• The full EO can be found here, and a fact sheet from the White House can be found here.
• On April 14, 2025, HHS introduced new guidance and launched a new online portal for whistleblowers to submit tips or complaints regarding gender-affirming medical intervention for minors. The initiative aims to bolster protections for healthcare professionals who raise ethical or religious concerns about such interventions.
• On the same day, the HHS Office for Civil Rights (OCR) also initiated an investigation into a major pediatric teaching hospital over allegations of wrongful termination. The inquiry will assess whether the hospital violated federal law—specifically the Church Amendments—by dismissing a nurse after she requested a religious accommodation to avoid administering puberty blockers and cross-sex hormones to minors. The nurse claimed the interventions did not align with her religious beliefs due to concerns over sterilization effects. Acting HHS OCR Director Anthony Archeval reinforced HHS’s commitment to enforcing legal protections for whistleblowers, “including laws that protect health care professionals from being forced to violate their religious beliefs or moral convictions.”
• A press release with more information is available here.

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