Blog | 5/30/2025

Trump Administration Healthcare News: May 30, 2025

Health Advances weekly healthcare tracker focused on top level government administration news.

NOTE: All words/analysis are those from the source noted, opinions are those of the original authors and not reflective of Health Advances in general nor any individual. All sources are non-confidential and in the public domain (but some may be behind paywalls).

This issue reflects news as of 11 AM on May 29, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

US, Argentina launching new ‘alternative’ to WHO

  • The top health authorities of the U.S. and Argentina are launching what they call an “alternative international health system” separate from the World Health Organization (WHO).
  • On the first day of his second term, President Trump signed an executive starting the yearlong process of withdrawing the U.S. from the WHO. In February, Argentinian President Javier Milei followed suit.
  • In a joint statement Tuesday, Health and Human Services Secretary Robert F. Kennedy Jr. and Argentine Minister of Health Mario Lugones remarked on the decision to withdraw from the global health authority.
  • On a post on the social platform X, Kennedy said he met with Milei to discuss the creation of an “alternative international health system based on gold-standard science and free from totalitarian impulses, corruption, and political control.”
  • Press: https://thehill.com/homenews/5320168-us-argentina-launch-alt-health-system/
  • Joint statement: https://www.hhs.gov/press-room/us-argentina-withdraw-who.html

Germany Plans Global Alternative to PubMed

  • On March 1, the world's largest database for biomedical literature -- PubMed -- went down, immediately causing a global panic that the nation's essential publishing resource was yet another casualty of the new administration's many budget cuts and executive orders.
  • Though the outage was apparently just a glitch and PubMed was back up the next day, the pause in the ability to access published research prompted the fear that PubMed could disappear, and soon.
  • Now that fear has spurred some to action, but not in the U.S.
  • ZB Med, or the German Library of Medicine, has launched an effort to create an open-source global literature infrastructure which its developers are calling a PubMed "alternative." They say there's a need to create such a service in case U.S. funding is curtailed or the quantity or quality of its 37 million citations fall victim to politicization, or a DOGE-like chain saw attack of its trained personnel, sources told MedPage Today.
  • OLSPub or Open Life Science Publication Database would create "a drop-in replacement for what the [National Library of Medicine] currently offers in the event that PubMed is no longer available," Konrad Förstner, one of OLSPub's two project managers, said during a May 14 webcast announcing the project. The session, held in German, was released on May 21 on YouTube with English subtitles.
  • The organizers have committed to an 18-month startup.
  • Press:  https://www.medpagetoday.com/special-reports/features/115790
  • German site: https://www.zbmed.de/en/research/current-projects/olspub

KEY FEDERAL GOVERNMENT NEWS

Trump administration proposes cutting FDA budget by 5.5%

  • The Trump administration is proposing a $6.8 billion budget request for the U.S. Food and Drug Administration for the 2026 fiscal year, its Commissioner Martin Makary said on Thursday, a cut of around 5.5% from its $7.2 billion budget this year.
  • The White House had on May 2 proposed reducing U.S. health spending by more than a quarter next year, with the National Institutes of Health and   facing the brunt of billions of dollars in cuts.
  • The proposed budget requested $93.8 billion for the Department of Health and Human Services - a cut of $33.3 billion, or 26.2% - from this year's budget of $127 billion, but did not mention the FDA. Makary's comments on Thursday were the first official outlining of the agency's 2026 budget request.
  • "The Trump administration is proposing a $6.8 billion budget for the FDA," Makary told the Senate Appropriations Committee's Subcommittee on Labor, Health and Human Services, Education, and Related Agencies at a hearing on the budget.
  • The FDA in 2025 had a budget of $7.2 billion, including $3.5 billion in user fees, payments made by pharmaceutical and medical device manufacturers to fund the staff resources needed to review their products quickly, conduct inspections, and ensure the safety of clinical trials.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/trump-proposing-68-bln-budget-us-fda-commissioner-says-2025-05-22/

About 5% of CBER and CDER left after FDA staff cuts, analysis finds

  • Nearly one out of every 20 staff in the FDA offices that oversee drugs and biologics are gone after the Trump administration cut thousands of agency roles and offered buyouts, according to an analysis by the investment bank Bernstein.
  • To conduct the review, the bank downloaded an online directory of HHS staff from April 15, and a second copy from May 15, and compared listings of workers at CDER and CBER. It identified 456 CDER or CBER employees — 4% of CDER and 6% of CBER — who no longer appeared in the directory and presumably no longer work at the centers.
  • “We believe these exits will put further strain on an FDA that has already shown signs of declining productivity,” the Bernstein analysts said, pointing to missed PDUFA dates (and subsequent approvals) for both the Novavax Covid-19 vaccine and the Nucala COPD label expansion.
  • The Bernstein analysts said the Office of New Drugs, the CDER office that signs off on all new pharmaceuticals, had the most staff departures: 80 people, or about 5%, of its nearly 1,600 employees. The FDA’s Office of Therapeutic Products, which oversees cell and gene therapies, lost about 4% of staff, while CBER’s Office of Vaccines Research and Review lost 7%.
  • https://endpoints.news/about-5-of-cber-and-cder-left-after-fda-staff-cuts-analysis-finds/

First Steps in Implementing the Trump Administration’s Price Transparency Agenda

  • Centers for Medicare & Medicaid Services (CMS) issued guidance and an RFI aimed at clarifying what specific information hospitals must provide under the previously established hospital price transparency requirements. Since January 1, 2021, hospitals have been required to make public:
    • A machine-readable file (MRF) containing a list of all standard charges for all items and services.
    • A consumer-friendly list of standard charges for 300 “shoppable” services. (A hospital that maintains an internet-based, prominently displayed, free-to-use price estimator tool is deemed to have met this requirement.)
  • The departments also issued a short statement and an RFI on the price transparency requirements for health plans.
  • Under current regs, most health plans are already required to disclose, via MRFs on a public website, information regarding in-network provider rates for covered items and services, out-of-network allowed amounts and billed charges for services, and negotiated rates and historical net prices for covered prescription drugs.
  • The departments previously issued technical implementation guidance for these MRFs in the form of schemas but have heard many access-related concerns about “file size, data integrity, and a lack of critical context that limits full transparency.”
  • The departments now state that they plan to issue a revised version of the schemas to address these issues.
  • The “schema version 2.0” will reduce file size by “requiring exclusion of duplicative data [and] reducing unnecessary data fields, and will include updates to better contextualize the data, making it more meaningful to ultimately achieve greater transparency.”
  • Press: https://www.mcdermottplus.com/blog/regs-eggs/first-steps-in-implementing-the-trump-administrations-price-transparency-agenda/
  • RFI: https://www.cms.gov/priorities/key-initiatives/hospital-price-transparency/accuracy-and-completeness-rfi

Trump administration cancels contract with Moderna to develop bird flu vaccine

  • US President Donald Trump's administration on Wednesday, May 28, canceled a $590 million contract with Moderna to develop an avian flu vaccine, the US biotech company said.
  • The contract, announced on January 17 – three days before Trump took office – was for an mRNA vaccine targeting the H5N1 influenza strain, which has been circulating in birds and cattle. Experts have warned the virus could jump to humans and spark a pandemic.
  • American pharmaceutical and biotechnology company Moderna disclosed the news as it announced positive results from an early-stage clinical trial of 300 people designed to test safety and immune response.
  • "While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program," said CEO Stephane Bancel in a statement.
  • https://www.lemonde.fr/en/united-states/article/2025/05/29/trump-administration-cancels-contract-with-moderna-to-develop-bird-flu-vaccine_6741794_133.html

FDA chief says pregnant women should decide on Covid vaccine with doctors

  • The Food and Drug Administration commissioner, Dr. Marty Makary, said Wednesday that the decision of whether a pregnant woman should get a Covid vaccine should come down to a conversation with her doctor — not a recommendation by the federal government.
  • Makary took part in Health and Human Services Secretary Robert F. Kennedy Jr.’s announcement Tuesday revoking the Centers for Disease Control and Prevention’s recommendation that Covid shots should be offered to pregnant women and healthy children.
  • “The data on the Covid vaccine booster in pregnant women is a mixed set of data,” Makary said in an interview. “Now, I think the decision should be between a doctor and a pregnant woman, but the idea that the government has to tell you what to do in this in an area where there is mixed data.”
  • That assertion — that the data is mixed — isn't supported by evidence, vaccine experts say.
  • The CDC doesn't mandate vaccination.
  • For decades its panel of independent vaccine experts, called the Advisory Committee on Immunization Practices, has recommended vaccination for certain groups of people based on data. The panel then passes recommendations to the director of the CDC to endorse
  • Tuesday’s decision skipped the usual process of consulting the CDC’s vaccine advisory committee and having the CDC director formally sign off. (The CDC currently has no director.)
  • https://www.nbcnews.com/health/health-news/fda-covid-vaccine-pregnant-women-doctor-rcna209526

CMS demands data from hospitals providing pediatric transgender care

  • The Centers for Medicare and Medicaid Services (CMS) sent letters Wednesday to hospitals that provide transgender care services to children, demanding data on their quality standards and finances.
  • CMS Administrator Mehmet Oz sent letters to “select hospitals,” giving them 30 days to provide specific information on “medical interventions for gender dysphoria in children.”
  • In Wednesday’s letters, Oz cited the Trump administration’s unsigned report issued this month that questioned the evidence in support of gender-affirming care for children and adolescents. It advocated for a greater reliance on psychotherapy to treat gender dysphoria.
  • Oz requested that the hospitals provide information on their policies and procedures regarding informed consent for minors determining making life-changing decisions; any changes they plan to make in response to the Trump administration’s report; and any adverse events related to gender dysphoria procedures.
  • Press: https://thehill.com/policy/healthcare/5322553-cms-pediatric-transgender-care-hospital-data/
  • CMS Statement: https://www.cms.gov/newsroom/press-releases/cms-launches-oversight-initiative-hospitals-performing-experimental-sex-trait-modification

HHS letter tells health care providers to disregard treatment protocols for trans people, adhere to report by unnamed authors

  • The US Department of Health and Human Services said Wednesday that Secretary Robert F. Kennedy Jr. sent a letter urging health care providers and medical boards to update treatment protocols for youth with gender dysphoria based on a controversial HHS review of scientific literature that was released earlier this month.
  • The HHS report, released May 1, says it is “not a clinical practice guideline,” but Kennedy’s letter warns providers against relying on science-based professional guidelines and urges them to use the government document to inform their practice instead.
  • The letter also said that HHS is committed to protecting whistleblowers and may soon create new policies and oversight actions to “hold providers that harm children accountable.”
  • Press: https://www.cnn.com/2025/05/28/health/transgender-care-letter-kennedy
  • Letter on X: https://x.com/HHSGov/status/1927791449476567043

CMS outlines tweaks to ACO REACH for 2026 performance year

  • The Centers for Medicare & Medicaid Services (CMS) revealed several updates to the ACO REACH program in 2026, though the model's long-term future remains unclear.
  • The CMS said it is making changes to the model based on preliminary data on 2023 performance, which found that standard accountable care organizations saved $197.5 million in aggregate that year. New entrant ACOs, meanwhile, generated $36.8 million in aggregate savings, reducing gross spending at higher rates that standard organizations.
  • In addition, high-needs ACOs reduced spending by $2.3 million in the aggregate, according to the preliminary report. The CMS is set to release full data on ACO REACH later this year.
  • Based on the preliminary savings results, the CMS said it will implement an additional 3% cap on risk score growth from 2019 to 2026 for standard ACOs, with the goal of controlling risk score increases compared to the model's launch window. It will also boost the coding intensity factor ceiling for high-needs ACOs from 1% to 2%, according to a post on its website.
  • Press: https://www.fiercehealthcare.com/regulatory/cms-outlines-tweaks-aco-reach-2026-performance-year
  • CMS Announcement: https://www.cms.gov/aco-reach-model-performance-year-2026-model-update-quick-reference

KEY REVERSALS – RESCINDED ITEMS

Federal judge extends order blocking RFK Jr. from reorganizing HHS

  • The Trump administration has been barred from carrying out its sweeping plan to restructure and downsize the Department of Health and Human Services, following a court order that also applies to about 20 other federal agencies.
  • The late Thursday decision by a California judge extends an order halting HHS Secretary Robert F. Kennedy Jr.’s plan, which called for consolidating the health agency from 28 divisions into 15, and firing about 10,000 full-time employees. That effort has led to mass departures at the FDA and has sparked concern that the changes could cause delays and other disruptions with drug regulation.
  • The preliminary injunction granted by District Judge Susan Illston applies to HHS and other agencies across the federal government. It blocks them from “further implementing” reduction in force and reorganization plans to the extent that they would execute directives from the White House or the Office of Management and Budget and Office of Personnel Management.
  • https://endpoints.news/federal-judge-blocks-rfk-jr-from-reorganizing-hhs/

US court blocks Trump from imposing the bulk of his tariffs

  • A federal court on Wednesday ruled that President Donald Trump overstepped his authority to impose sweeping tariffs that have raised the cost of imports for everyone from giant businesses to everyday Americans.
  • But the administration immediately appealed the decision on Wednesday night, leaving the situation uncertain for consumers and companies and potentially prolonging the battle over whether Trump’s import duties will stand – and possibly reshape the global economy.
  • A three-judge panel at the US Court of International Trade, a relatively low-profile court in Manhattan, stopped Trump’s global tariffs that he imposed citing emergency economic powers, including the “Liberation Day” tariffs he announced on April 2. It also prevents Trump from enforcing his tariffs placed earlier this year against China, Mexico and Canada, designed to combat fentanyl coming into the United States.
  • The order halts Trump’s 30% tariffs on China, his 25% tariffs on some goods imported from Mexico and Canada, and the 10% universal tariffs on most goods coming into the United States. It does not, however, affect the 25% tariffs on autos, auto parts, steel or aluminum, which were subject to Section 232 of the Trade Expansion Act – a different law than the one Trump cited for his broader trade actions.
  • https://www.cnn.com/2025/05/28/business/us-court-blocks-trumps-tariffs
  • HALS NOTE: this impacts pharmaceuticals, devices, diagnostics, hospital supplies, and drug delivery devices

KEY LAWSUITS

States sue over Trump cuts to research funding, STEM diversity efforts

  • A group of U.S. states filed a lawsuit on Wednesday seeking to block the administration of President Donald Trump from making massive cuts to federal funding for scientific research and projects focused on increasing diversity in science, technology, engineering, and math fields.
  • The attorneys general of 16 states, including New York, California, Illinois, and New Jersey, say the Trump administration lacks the power to cap research funding and eliminate diversity programs provided by the National Science Foundation that were mandated by Congress.
  • The lawsuit was filed in Manhattan federal court.
  • Earlier this month, 13 major U.S. universities sued over NSF's decision to cap reimbursement for indirect research costs such as lab space and equipment at 15%, which mirrored funding cuts at the National Institutes of Health and U.S. Department of Energy that judges have temporarily blocked.
  • Wednesday's lawsuit also challenges the cap at NSF along with the elimination of programs designed to boost the participation of women, minorities and people with disabilities in STEM fields. The states say both efforts could cause the U.S. to lose its position as a global leader in STEM research.
  • https://www.reuters.com/world/us/states-sue-over-trump-cuts-research-funding-stem-diversity-efforts-2025-05-28/

KEY BIOPHARMA NEWS

FDA leadership preps for summer biopharma listening tour across six cities

  • FDA Commissioner Marty Makary, newly minted CBER chief Vinay Prasad and Principal Deputy Commissioner Sara Brenner are visiting six US cities in June and July to meet with biotech and pharma executives to discuss how the FDA can “modernize its regulatory framework to better support innovation and patient access to safe and effective therapies,” the agency announced on Friday.
  • Companies seeking to attend must have at least one active application (drug, biologic or clinical trial) on file with the FDA, and CEO participation is preferred, although registration is also open to companies’ chief medical officers or heads of R&D.
  • The six tour dates and cities, according to the request for attendance from the FDA, include:
    • FDA’s campus in Silver Spring, MD — June 5
    • San Francisco, CA — June 12
    • San Diego, CA — June 13
    • Boston, MA — June 17
    • New York, NY — July 30
    • Atlanta, GA — TBD
  • “These CEO Forums are a chance for the FDA to listen and gather feedback from those at the front lines of discovery,” Makary said in a statement.
  • https://endpoints.news/fda-leadership-preps-for-summer-biopharma-listening-tour-across-six-cities/

KEY MEDTECH NEWS

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

KEY ACRONYMS

  • ACO = Accountable Care Organization
  • CBER = Center for Biologics Evaluation and Research
  • CDC = Centers for Disease Control and Prevention
  • CDER = Center for Drug Evaluation and Research
  • CMS = Centers for Medicare & Medicaid Services
  • eSTAR = electronic Submission Template and Resource
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • MRF = machine-readable file
  • NLM = National Library of Medicine
  • NSF = National Science Foundation
  • OLSPub = Open Life Science Publication Database
  • PDUFA = Prescription Drug User Fee Act
  • WHO = World Health Organization

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