Health Care Week in Review | Senate HELP Committee Chair Cassidy Calls for 340B Reforms; House Republicans Launch American-Made Medicines Caucus

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

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

Week in Review Highlight of the Week:

This week, Senator Bill Cassidy released findings from an investigation into the 340B drug pricing program, and a group of House Republicans launched the American-Made Medicines Caucus in support of the domestic production of pharmaceuticals. 

1. Regulations, Notices & Guidance

• On April 22, 2025, the Federal Trade Commission (FTC) published a rule entitled, Children’s Online Privacy Protection Rule. The FTC amends the Children’s Online Privacy Protection Rule (the ‘‘Rule’’), consistent with the requirements of the Children’s Online Privacy Protection Act (COPPA). The amendments to the Rule, which are based on the FTC’s review of public comments and its enforcement experience, include one new definition and modifications to several others, as well as updates to key provisions to respond to changes in technology and online practices. The amendments are intended to strengthen protection of personal information collected from children, and, where appropriate, to clarify and streamline the Rule since it was last amended in January 2013. The final amendments to the COPPA Rule will become effective on June 23, 2025.
• On April 22, 2025, the Food and Drug Administration (FDA) released a notice entitled, Exploration of Health Level Seven Fast Healthcare Interoperability Resources for Use in Study Data Created From Real-World Data Sources for Submission to the Food and Drug Administration; Establishment of a Public Docket; Request for Comments. FDA is announcing the establishment of a docket for public comments exploring the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) for submission of data collected from real-world data (RWD) sources. In alignment with the new Department of Health and Human Services (HHS), Assistant Secretary for Technology Policy/Office of the National Coordinator for Health (ASTP/ONC) policy on health information technology (health IT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are exploring approaches to optimize the submission of structured and standardized clinical study data collected from RWD sources. FDA is seeking public comment from interested parties on specific questions. Interested parties may include regulated industry, health IT vendors, academic medical centers, and electronic data capture vendors as well as other interested parties.
• On April 23, 2025, FDA released a notice entitled, Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program. The FDA is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the second year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). CDER implemented this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with, and further refine as necessary, the prototype assessment protocol and process, to help enable consistent and meaningful assessment of participating establishments' quality management practices, and to provide useful feedback to participants. This notice announces CDER's intent to continue the voluntary QMM Prototype Assessment Protocol Evaluation Program, outlines the types of establishments CDER is seeking for participation, and describes the process for submitting a request to participate in the program.
• On April 24, 2025, the Executive office of the President (EOP) released an executive order (EO) entitled, Strengthening Probationary Periods In The Federal Service. The EO emphasizes improving the efficiency and quality of the Federal workforce by requiring agencies to use probationary and trial periods more effectively. It directs that newly hired Federal employees should not automatically receive tenure without explicit agency certification that their continued employment benefits the Federal service. The EO also establishes a new Civil Service Rule XI, replacing existing regulations to ensure agencies actively assess and approve probationary employees before finalizing their appointments.

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

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• April 30, 2025: The National Institutes of Health (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: The Health Resources and Services Administration (HRSA) announced a meeting of the National Advisory Council on Nurse Education and Practice (NACNEP). This is a hybrid meeting open to the public.
• May 14, 2025: NIH announced a meeting of the National Advisory Council on Aging. This is 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: FDA announced a public workshop entitled, Fiscal Year (FY) 2025 Generic Drug Science and Research Initiatives Workshop. This is a hybrid workshop open to the public.
• June 5, 2025: NIH announced a meeting of the National Advisory Environmental Health Sciences Council. This is a hybrid meeting with some sessions open to the public.
• June 6, 2025: NIH announced a meeting of the Board of Scientific Counselors Eunice Kennedy Shriver National Institute of Child Health and Human Development. This is a virtual meeting with some sessions open to the public.
• June 9, 2025: NIH announced a meeting of the National Advisory Child Health and Human Development Council. This is a virtual meeting with some sessions open to the public.
• June 10, 2025: NIH announced a meeting of the National Cancer Advisory Board. This is a virtual meeting with one session open to the public.
• June 13, 2025: NIH announced a meeting of the National Advisory Eye Council. This is a hybrid meeting with some sessions open to the public.
• June 17, 2025: NIH announced a meeting of the National Advisory Mental Health Council. This is a virtual meeting with some sessions open to the public.
• June 25, 2025: The Centers for Medicare & Medicaid Services (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 1, 2025: NIH announced a meeting of the National Advisory Council for Complementary and Integrative Health. This is a virtual meeting with some sessions open to the public.
• July 7, 2025: NIH announced a meeting of the Board of Scientific Counselors, National Cancer Institute. This is a virtual meeting with some sessions open to the public.
• July 23-24, 2025: CMS announced a meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. This is a hybrid meeting open to the public.
• August 6-7, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.
• August 8, 2025: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a hybrid meeting open to the public.
• September 11-12, 2025: HRSA announced a meeting of the Council on Graduate Medical Education. This is a hybrid meeting open to the public.
• December 4-5, 2025: HRSA announced a meeting of NACNEP. This is a hybrid meeting open to the public.

2. Reports, Studies, & Analyses

• On April 21, 2025, the Urban Institute, in an effort funded by the Robert Wood Johnson Foundation (RWJF) , released a report entitled, Analyzing the Effect of Per Capita Caps on the Medicaid Expansion Population. The report found that a per capita cap on the Medicaid expansion population would result in a reduction in federal contributions over 10 years of between $230 billion and $276 billion. The policies would represent a 3.1 to 3.7 percent reduction in federal spending; relative to federal spending on the expansion population, these would be cuts ranging from 14.8 to 17.8 percent. States would have to increase state spending on Medicaid by 5.2 to 6.2 percent to maintain the programs as currently structured. These increases in spending would represent increases of between 133 and 160 percent relative to current spending on the Medicaid expansion. The report also found that states with lower per capita incomes that expanded Medicaid, including three which have constitutional amendments requiring Medicaid expansion, would face the largest percentage increases in their state spending to maintain their programs.
• On April 24, 2025, Senator Bill Cassidy (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a report entitled, Congress Must Act To Bring Needed Reforms To The 340B Drug Pricing Program. The report details Senator Cassidy’s investigation into how covered entities use and generate revenue from the 340B Drug Pricing Program (340B Program) and raises concerns about transparency and oversight. As part of the investigation, Senator Cassidy requested information from covered entities, pharmacies, and manufacturers and reports that (1) hospitals do not pass the discounts received from the 340B Program directly to their patients, (2) federally qualified health centers (FQHC) generate significant revenue from the 340B Program though they differ in how they offer discounts to patients, (3)  major pharmacies impose escalating fees on covered entities that detract from the 340B Program’s mission to benefit patients, and (4) drug manufacturers report increased 340B Program sales and claim that they face challenges in ensuring program integrity due to unlawful diversions and duplicate discounts. In light of these findings, Senator Cassidy proposed reforms to increase transparency, improve access, and lower costs for patients.

3. Other Health Policy News

• On April 22, 2025, Attorney General Pam Bondi issued an internal memo with the subject, “Preventing the Mutilation of American Children.” In the memo, Attorney General Bondi states that it is the position of the Department of Justice (DOJ) that gender-affirming care for minors consisting of surgical interventions constitutes genital mutilation and directs all U.S. attorneys to investigate and prosecute all violations of existing female genital mutilation laws to “the fullest extent possible.” Attorney General Bondi also directed the Consumer Protection Branch and Fraud Branch of the DOJ’s Civil Division to pursue possible violations of the Food, Drug, and Cosmetic Act’s mislabeling provisions for hormone blocking pharmaceuticals, as well as violations of the False Claims Act for claims falsely submitted to federal health plans for gender-affirming care procedures under the guise of “legitimate purposes.” Additionally, Attorney General Bondi indicated that the DOJ would be supporting state efforts to enforce their laws against gender-affirming care, developing proposed legislation to create a private right of action for children and parents to sue physicians who provided children with certain forms of gender-affirming care, and supporting whistleblowers who wished to report instances of gender-affirming care for DOJ to investigate.
• The full memo can be viewed here.
• On April 23, 2025, the HHS Office for Civil Rights (OCR) announced a settlement with PIH Health, Inc. (PIH), a California health care network following a 2019 phishing attach that exposed 189,763 individuals’ electronic protected health information (ePHI). OCR’s investigation found potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), including failure to conduct a thorough risk analysis and timely notification of affected parties. As part of the agreement, PIH must implement a two-year corrective action plan to strengthen HIPAA compliance.
• The full press release from HHS can be viewed here, and the resolution agreement and corrective action plan is available here.
• On April 24, 2025, a group of House Republicans launched the American-Made Medicines Caucus, which is focused on onshoring and “friendshoring” pharmaceutical manufacturing and reducing reliance on adversarial countries (e.g., China) for essential medications. The Caucus will be led by Reps. Buddy Carter (R-GA), Claudia Tenney (R-NY), and Gus Bilirakis (R-FL).
• President Trump has repeatedly emphasized the need to increase domestic production of pharmaceuticals, which he plans to achieve through tariffs. To begin that process, on April 16, 2025, the Department of Commerce began an investigation under section 232 of the Trade Expansion Act of 1962 on how the country’s reliance on imports for pharmaceuticals could impact national security. The investigation’s findings, due by December 27, 2025, are a potential precursor to imposing tariffs on pharmaceuticals.
• The press release can be found here.
• On Apil 22, 2025, the U.S. Department of Health and Human Services (HHS) released a press release entitled, “HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply.” HHS and the U.S. Food and Drug Administration (FDA) have announced new measures to gradually eliminate petroleum-based synthetic dyes from the nation’s food supply. As part of this initiative, the FDA is issuing guidance and offering regulatory flexibilities to help industries adapt. Key actions include authorizing four new natural color additives and establishing a national standard with a clear timeline for transitioning to natural alternatives.
• The full press release can be viewed here.

4. Additional Alston & Bird Publications

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

View our Health Care Legislative & Public Policy team.

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