Blog | 4/4/2025

Trump Administration Healthcare News: April 4, 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 April 3, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global & US & EOs)

WHO proposing to cut jobs and slash budget by a fifth, memo shows

  • The World Health Organization (WHO) is proposing to reduce staff numbers and the scale of its work as it slashes its budget by just over one fifth due to the impact of U.S. funding cuts, according to an internal memo seen by Reuters.
  • U.S. President Donald Trump's administration withdrew from the WHO upon taking office in January, saying the global health agency had mishandled the COVID-19 pandemic and other international health crises.
  • "The United States' announcement, combined with recent reductions in official development assistance by some countries to fund increased defense spending, has made our situation much more acute", stated the WHO memo, which was dated March 28 and signed by WHO's Director-General Tedros Adhanom Ghebreyesus.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/who-proposing-cut-jobs-slash-budget-by-fifth-memo-shows-2025-03-29/

KEY FEDERAL GOVERNMENT NEWS

Sweeping health agency cuts at FDA, CDC, CMS and more divisions begin

  • The wide-reaching job cuts, which will total approximately 10,000 workers, are affecting employees at the Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration, the Centers for Disease Control and Prevention (CDC) and more. While the full extent of the cuts are still developing, early indications suggest entire offices are now shuttered.
  •  At the FDA, the Office of Management is one of the causalities, according to one individual with knowledge of the situation who agreed to share anonymously with Fierce Healthcare under fear of retribution. This office provides services and resources to the Center for Drug Evaluation and Research, a government page explains.
  • Elsewhere, the entire Freedom of Information Act office, which helps the public understand the innerworkings of a government agency, was eliminated at the CDC and slashed dramatically at the FDA, reported media outlets. Another team focused on infertility was laid off, reported The Huffington Post, and communications offices throughout HHS faced heavy reductions. The Substance Abuse and Mental Health Services Administration was similarly affected. Other top officials at the National Institute of Allergy and Infectious Diseases, the CDC and FDA were offered a transfer to the Indian Health Services. And the Administration for Community Living, which handles aging and disability policy and handles Meals on Wheels, faced cuts of at least 40%.
  • Also eliminated is the HHS Office of Infectious Disease and HIV Policy under a reorganization of HHS.
  • And in the CDC, the deletion of a tobacco control program spells great trouble in tracking tobacco use and running prevention programs, which are not duplicative roles to tobacco product regulation at the FDA, said former CDC Director Tom Frieden in a LinkedIn post.
  • A source with ties to HHS said that CMS was largely spared from the April 1 cuts beyond the 300 individuals the department had announced would be cut in the original restructuring announcement on Thursday. The Administration for Children and Families faced deeper cuts, the source said. 
  • News reports have also outlined a slew of high-ranking officials who were let go, placed on administrative leave, pressured to leave the government or decided to do so upon being offered a diminished role at a separate office.
    • Among these names were Peter Stein, director of the FDA's Office of New Drugs; Brian King, director of the FDA's Center for Tobacco Products; Jeanne Marrazzo, M.D., director of the National Institute of Allergy and Infectious Diseases; Kayla Laserson, director of the CDC's Global Health Center; Julie Tierney, deputy director at the FDA's Center for Biologics Evaluation and Research; and Diana Bianchi, M.D., director of the NIH's National Institute of Child Health and Human Development.
    • They add to other high-profile departures from the federal health agencies in recent days, chief among which was FDA Center for Biologics Evaluation and Research Director Peter Marks, M.D.
  • On Tuesday afternoon, Senator Bill Cassidy, R-Louisiana, scheduled a hearing on April 10 for RFK Jr. to explain the cuts. Kennedy promised Cassidy he would appear quarterly before the Senate HELP Committee in exchange for Cassidy's crucial vote to confirm hearing. 
  • "This will be a painful period for HHS as we downsize from 82,000 employees to 62,000, but we are keenly focused on paring away excess administrators while increasing the number of scientists and frontline health providers so we can do a better job for the American people," Kennedy said.
  • Senator Ron Wyden, D-Oregon, and former HHS Secretary Xavier Becerra condemned the cuts in statements released the same morning.

Update - On top of layoffs, HHS ordered to cut 35% of spending on contracts

  • The Trump administration is requiring the Department of Health and Human Services to cut spending on contracts by 35%, HHS spokesperson Andrew Nixon confirmed to NPR.
  • The cuts to spending on contracts applies across all divisions of HHS – which includes the Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, the Centers for Medicare and Medicaid Services and other agencies.

Update - 'We'll make mistakes' says RFK as fired US health staff asked to return

As FDA's Peter Marks resigns, industry watchers size up vaccine, cell and gene therapy hits

  • Peter Marks, M.D., Ph.D., revealed that he will relinquish his role as director of the FDA’s Center for Biologics Evaluation and Research (CBER) on April 5.
  • “It is with a heavy heart that I have decided to resign from FDA,” Marks said in a resignation letter addressed to the agency’s acting commissioner Sara Brenner.
  • In explaining his departure, Marks pointed to an “unprecedented assault on scientific truth” in the United States and called out Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. directly for promoting misinformation about the safety of FDA-approved vaccines.
  • The Wall Street Journal, citing people close to the matter, noted that an unnamed HHS official gave the director the choice to either resign from his role or face termination.
  • “If Peter Marks does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy,” the HHS told the publication.
  • Marks began his role as CBER director in 2016 and has played a key role in the evaluation and approval of vaccines, blood products and certain biologics in the U.S., including cell and gene therapies.
  • During his tenure, Marks made a name for himself as an advocate for the FDA’s accelerated approval pathway for rare diseases, especially in conjunction with gene therapies. He also had a major hand in 2020’s Operation Warp Speed effort, which saw the biopharma industry join forces with the federal government to accelerate the development of COVID-19 vaccines during the height of the pandemic.
  • “I was willing to work to address the Secretary’s concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicines,” Marks said in his letter, referring to Kennedy by his HHS title.
  • “However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies,” the outgoing CBER director continued.
  • https://www.fiercepharma.com/pharma/cber-chief-peter-marks-telegraphs-exit-fda-industry-watchers-eye-vaccine-cell-gene-hits
  • WSJ Link: https://www.wsj.com/politics/top-vaccine-official-out-at-fda-f39a5a16 (subscription required for full-text)

Day after mass FDA firings, new commissioner addresses remaining staff, focusing on 'MAHA' vision

  • New FDA Commissioner Marty Makary took to the stage at the regulator’s Maryland headquarters on Wednesday, in his first public communication to much of the agency since Tuesday’s mass firings.
  • Acknowledging the firings, which were targeted at 3,500 FDA employees — or 19% of staff — he called the changes difficult but necessary to reach the goal of “Making America Healthy Again,” referring to the slogan of new HHS Secretary Robert F. Kennedy Jr. Similar job cuts by Kennedy took place Tuesday across government health functions.
  • Two of the people said that Makary laid out a focus of the agency that closely matches Kennedy’s MAHA policies. He particularly focused on chronic diseases and bringing new viewpoints and arguments into government scientific agencies, while repeatedly emphasizing a need for humility.
  • He also spoke about the importance of gene therapies and bringing new medicines to the public, despite the reportedly forced resignation of Peter Marks, one of its biggest advocates for gene editing technology and other advanced therapies.
  • https://endpts.com/new-fda-commissioner-makary-addresses-staff-a-day-after-firings/

FDA taps insider Scott Steele to lead CBER on acting basis after Peter Marks departure

  • Agency adviser Scott Steele, Ph.D., will take over the key center for the time being, the FDA said on a post on X late Monday.
  • Steele has been a full-time adviser to CBER since late 2022, according to his LinkedIn profile. Before that, he advised the FDA's Office of Medical Policy Initiatives from June 2020 to September 2022.
  • Steele replaces Julie Tierny, who was tapped as acting CBER director amidst Marks' resignation. Tierny, along with Peter Stein, director of the Office of New Drugs, and Hilary Marston, the FDA's chief medical officer, have been put on administrative leave, Politico reports.
  • https://www.fiercepharma.com/pharma/fda-taps-scott-steele-lead-cber-acting-basis-after-marks-departure

Trump administration begins mass cuts of federal health policy researchers

  • More than half of employees at the Office of the Assistant Secretary for Planning and Evaluation and the Agency for Healthcare Research and Quality — both part of the Department of Health and Human Services — have been laid off, according to several current and former employees.
  • The two agencies operate on less than $600 million combined, or about 0.04% of what the federal government spends on health care.
  • ASPE had roughly 150 employees at the start of the year and now has fewer than 50, four former employees told Sta.
  • AHRQ started the year with over 300 employees, and Tuesday’s cuts took out 111 of them, three laid-off workers told Stat.
  • https://www.statnews.com/2025/04/02/trump-administration-begins-mass-cuts-of-federal-health-policy-researchers/  (subscription required for full-text)

State AGs file lawsuit against HHS' $11B clawback of COVID-19, public health grants

  • Twenty-three state attorneys general have filed a lawsuit to block the federal government's rescindment of billions in public health funds to states, cities and organizations.
  • The complaint, filed April 1 in the U.S. District Court for the District of Rhode Island, concerns roughly $11 billion awarded by the Department of Health and Human Services (HHS) near the end of the COVID-19 emergency related to efforts on pandemic preparedness, mental health, overdose prevention, community health programs and public health infrastructure.
  • HHS sent out the grant termination notices on March 24. At the time, an HHS spokesperson said "the COVID-19 pandemic is over, and HHS will no longer waste billions of taxpayer dollars responding to a non-existent pandemic that Americans moved on from years ago. HHS is prioritizing funding projects that will deliver on President Trump’s mandate to address our chronic disease epidemic and Make America Healthy Again."
  • The attorneys general wrote that the department decision to "abruptly and arbitrarily" pull back those funds will lead to the dissolution of programs addressing ongoing and emerging public health needs within their states, as well as widespread public health worker and contractor dismissals.
  • https://www.fiercehealthcare.com/regulatory/cdc-doge-claws-back-covid-19-grants-headed-states

Five NIH institute directors and numerous lab heads ousted in unprecedented shake-up

  • Layoffs include scientists working on sickle cell, neurological disorders, pandemic preparedness.
  • Directors of five National Institutes of Health institutes and at least two other members of senior leadership have been placed on administrative leave or offered new assignments since Monday, topping a list of hundreds of employees notified in the last 24 hours that they had lost their jobs as part of sweeping layoffs across federal health agencies.
  • The layoffs affected people across the NIH’s 27 institutes and centers, including officials who help guide how the world’s largest funder of biomedical research makes decisions about what diseases to study and what medicines to develop, as well as staff who made the organization operate day to day and communicated with the public.
  • https://www.statnews.com/2025/04/01/nih-rif-1200-layoffs-raise-concerns-health-medicine-biomedical-research/  (subscription required for full-text)

FDA planning for fewer food and drug inspections due to layoffs, officials say

  • Senior Food and Drug Administration leaders are planning for cutbacks to the number of routine food and drug inspections conducted by the agency, multiple officials say, due to steep layoffs this week in support staff.
  • Around 170 workers were cut from the FDA's Office of Inspections and Investigations, according to two federal health officials who were not authorized to speak publicly.
  • "These administrative functions are being streamlined as part of HHS' transformation initiative to make the agency more efficient and responsive. FDA inspectors were not impacted and this critical work will continue," an HHS spokesperson said in a statement.
  • The inspections and investigations office will now need to work with FDA's drug, device and food centers to reprioritize their workload for the rest of the year, one official said. That will mean trimming routine "surveillance inspections" for more urgent tasks, the official said, like inspections of firms where the agency has been alerted to a safety risk or follow-up visits to ensure that drugmakers or food producers have fixed previous violations.
  • A pilot program of unannounced foreign inspections has also been paused due to the cuts, an official said, because of the loss of staff that had been tasked with quickly securing translators around the world.
  • https://www.cbsnews.com/news/fda-food-drug-inspections-layoffs/

HHS guts the teams that fulfill public records requests for health agencies

  • Teams that fulfilled requests for government documents lost their jobs on Tuesday as part of the Trump administration's 10,000-person staff cuts at the Department of Health and Human Services.
  • Their work, mandated by Congress since the 1960s under the Freedom of Information Act or FOIA, gives the public a view of the inner workings of federal health agencies.
  • Some public records teams were entirely cut at the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health and other agencies on Tuesday, according to multiple current and former staffers who did not want to be named because of fears of retribution.
  • A few people have been left standing on other FOIA teams within these agencies, for now.
  • https://www.npr.org/sections/shots-health-news/2025/04/03/g-s1-57888/hhs-fda-rfk-foia-public-records

Scientists sue NIH, saying politics cut their research funding

  • A group of scientists and health groups sued the National Institutes of Health on Wednesday, arguing that an “ideological purge” of research funding is illegal and threatens medical cures.
  • Since President Donald Trump took office in January, hundreds of NIH research grants have been abruptly canceled for science that mentions the words diversity, gender and vaccine hesitancy, as well as other politically charged topics.
  • That has led to grants being cut that fund studies of HIV prevention, violence prevention in children, pregnancy health disparities and Alzheimer’s disease, among others, according to the lawsuit filed in U.S. District Court in Massachusetts.
  • The suit aims to restore the money and end the terminations, arguing they violate NIH’s usual science-based review process, specific orders from Congress to tackle health equity and disparities, and federal regulations.
  • https://apnews.com/article/nih-funding-trump-dei-research-094ed2abe5ba529cdb74f7e0b429c4f3

HHS will not enforce gender and sexual orientation requirements for medical records

  • The changes to medical records hit federal systems first. In February, the Centers for Medicare and Medicaid Services removed sexual orientation and gender identity questions from enrollment forms for Medicare beneficiaries, and the U.S. DOGE Service said it had removed gender identity from the personal information pages of Veterans Health Administration patients.
  • Now, the Trump administration’s efforts to strip these demographics from patient forms have reached the private sector.
  • On March 21, a lesser-known office within the Department of Health and Human Services quietly announced it would not enforce requirements that electronic health records have fields to record and exchange patients’ sexual orientation and gender identity. The new standards, which have been in development for several years, were set to be enforced by January 1 next year.
  • https://www.statnews.com/2025/04/01/hhs-will-not-enforce-gender-sexual-orientation-data-medical-records-ehr/  (subscription required for full-text)

The Senate voted 53-45 on April 3 to confirm Mehmet Oz, MD, as CMS administrator

  • Mehmet Oz, M.D., more commonly known by his television moniker Dr. Oz, has been approved by the Senate to serve as administrator of the Centers for Medicare & Medicaid Services (CMS).
  • Senators voted 53-45 along party lines in favor of the nomination, which would place the thoracic surgeon at the head of more than 160 million Americans' health coverage. A procedural vote earlier in the day to advance his nomination was passed 50-45 along party lines.
  • He enters the role at a time of major upheaval. Congressional Republicans and the administration have outlined major reductions to federal health through, respectively, major spending cut targets within the ongoing budget reconciliation process and a slew of layoffs at the Department of Health and Human Services (HHS).
  • Within CMS—which was relatively unscathed with about 300 job cuts—those cuts reportedly included the Office for Equal Opportunity and Civil Rights, the Office of Minority Health and the Office of Program Operations and Local Engagement.
  • https://www.fiercehealthcare.com/regulatory/dr-oz-cms-administrator-confirmation-senate-vote

KEY BIOPHARMA NEWS

Chaotic tariff rollout leaves as many questions as answers for drugmakers

The health industry is starting to express alarm about RFK Jr.

  • After the firing of thousands of Department of Health and Human Services employees on Tuesday, industry trade groups that have mostly sought to curry favor with the new administration began to express alarm.
    • “While we support improving FDA efficiency to deliver more affordable generic and biosimilar medicines to patients faster, many of the reported cuts appear to do the opposite,” said John Murphy, CEO of the Association for Accessible Medicines, which represents generic drugmakers.
  • The Pharmaceutical Research and Manufacturers of America, the powerful lobbying arm of the brand-name drug industry, also questioned the wisdom of the large cuts at the agency.
    • “We recognize the need to find efficiencies, but it’s critical the FDA has the expertise and capacity it needs to maintain its gold standard regulatory review,” PhRMA spokesperson Alex Schriver said. “The rapid and substantial changes at FDA this week raise questions about the agency’s ability to fulfill its mission to bring new innovative medicines to patients.”
  • Because the FDA relies in part on user fees paid by the companies it regulates to supplement appropriations from Congress, some industry officials had thought the agency might be shielded from layoffs. Instead, it was the hardest hit of HHS divisions.
  • https://www.politico.com/news/2025/04/01/the-health-industry-is-starting-to-express-alarm-about-rfk-jr-00265159

Amid FDA tumult, agency misses decision deadline on Novavax's COVID shot

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

  • A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry.
  • Judge Sean Jordan, for the U.S. District Court for the Eastern District of Texas, vacated the FDA’s final rule in its entirety. The court remanded the matter to newly confirmed Health and Human Services Secretary Robert F. Kennedy Jr.
  • The American Clinical Laboratory Association, which brought the case against the FDA, said the rule and its associated compliance deadlines are no longer in effect as a result of the court’s decision.
  • The first stage of the new FDA rule was set to take effect May 6, requiring compliance with medical device reporting, correction and removal, and maintenance of complaint files. The rule would then phase in over the next four years.
  • News: https://www.medtechdive.com/news/Court-vacates-FDA-LDT-lab-developed-test-final-rule/744082/
  • Rule:  https://www.thefdalawblog.com/wp-content/uploads/2025/03/LDT-FINAL-JUDGMENT.pdf

KEY MEDTECH NEWS

Trump tariff plan and FDA layoffs: The medtech industry is concerned

  • The medical device industry has spoken out against tariffs throughout the early days of the Trump administration, calling for exemptions for the industry.
  • On Wednesday, Scott Whitaker, the President and CEO of AdvaMed, the Medtech Association, again expressed his disappointment and called for an exemption.
  • Media reports say the FDA is reducing its staff by 3,500, including regulators in the FDA’s Center for Devices and Radiological Health (CDRH). The Wall Street Journal reports that Michelle Tarver, M.D., Ph.D, CDHR’s leader, is one of the few senior leaders still in place at the FDA.
  • De novo device clearances: So far in 2025 only three novel, or de novo, devices have been cleared by the FDA, compared to 13 during the same period in 2024.
  • Premarket approval: Four original devices have received approval in 2025, compared to eight in the same period in 2024.
  • https://www.medicaleconomics.com/view/trump-tariff-plan-and-fda-layoffs-the-medtech-industry-is-concerned
  • WSJ article: https://www.wsj.com/health/healthcare/health-department-begins-sweeping-job-cuts-84fee104 (subscription required for full-text)

Cybersecurity Threats Remain a Problem for Older Medical Devices, House Members Say

CURRENT APPOINTEE STATUS

 https://ourpublicservice.org/performance-measures/political-appointee-tracker/

Updated April 3 at 11 AM EST.

KEY ACRONYMS

  • AHRQ = Agency for Healthcare Research and Quality
  • ASPE = Assistant Secretary for Planning and Evaluation
  • ASPR = Administration for Strategic Preparedness and Response
  • ATSDR = Agency for Toxic Substances and Disease
  • CBER = Center for Biologics Evaluation and Research
  • CDC = Centers for Disease Control and Prevention
  • CDRH = Center for Devices and Radiological Health
  • CMS = Center for Medicare & Medicaid Services
  • EO = Executive Order
  • FDA = Food and Drug Administration
  • FOIA = Freedom of Information Act
  • HHS = Department of Health and Human Services
  • HRSA = Health Resources and Services Administration
  • LDTs = Lab Developed Tests
  • MAHA = Making America Healthy Again
  • NIH = National Institutes of Health
  • NIOSH = National Institute for Occupational Safety and Health
  • OASH = Office of the Assistant Secretary for Health
  • SAMHSA = Substance Abuse and Mental Health Services Administration
  • WHO = World Health Organization​​​

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