Blog | 5/2/2025

Trump Administration Healthcare News: May 2, 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 1, 2025. The details and broad themes may have changed.

 

KEY FEDERAL GOVERNMENT NEWS

FDA

Exits continue at FDA, as more staff in drug office follow fired colleagues out the door

  • The FDA office that approves new drugs is seeing more staff leave in early retirements, following broad cuts this month that targeted almost 20% of workers at the agency.
  • The departures, many of which include senior managers with decades of experience at the FDA, combined with the sweeping staff cuts from April 1, have caused concern that there will be a loss of institutional knowledge at the regulator. Some of the latest exits were posted by departing employees on social media, while others were confirmed to Endpoints News by current and former FDA workers.
  • The FDA has yet to say how many staff members have exited the agency in the last month. Commissioner Marty Makary has said the cuts did not include medical product reviewers or inspectors. An FDA spokesperson said that drug reviews will continue.
  • https://endpts.com/more-fda-staff-leave-following-broad-firings-at-drug-agency/   (free subscription required for full-text)

FDA chief says they're looking at whether to approve COVID shots for next winter

  • The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.
  • "We're taking a look. I can't comment on any particular application. As you know, we have a bunch of applications for those booster shots," FDA Commissioner Dr. Marty Makary told CBS News chief Washington correspondent Major Garrett.
  • Last year, the FDA issued guidance on what strain should be targeted by the shots for the following winter. Updates to Moderna and Pfizer's COVID shots for the new strain were approved in August.
  • The Centers for Disease Control and Prevention is also now weighing whether to significantly narrow its recommendations for COVID-19 vaccines.
  • https://www.cbsnews.com/news/fda-covid-booster-shots-marty-makary

FDA won't reorganize medical product centers, Makary says in interview: 'I rejected that proposal'

  • The FDA plans to consolidate some administrative functions, but won’t embark on a wholesale reorganization of the review centers that oversee drugs, biologics and medical devices, FDA Commissioner Marty Makary said in an interview published Tuesday.
  • “Yes, we are consolidating travel offices, IT, and some other things that make sense for efficiency, but nothing else is planned,” Makary told Harvard physician Jeremy Faust in an interview.
  • https://endpts.com/fda-wont-reorganize-medical-product-centers-makary-says-in-interview/   (free subscription required for full-text)

NIH

RFK Jr. Bets $500 Million on Universal Vaccines in Shift From Covid-19 Funding

  • In a shift away from next-generation Covid-19 vaccines, the Trump administration is investing $500 million in a vaccine project championed by two scientists who were recently tapped to serve in senior roles within the National Institutes of Health, according to emails reviewed by The Wall Street Journal.
  • The unusually large sum comes as the nation’s health agencies are cutting budgets, shrinking staff and terminating hundreds of active research grants.
  • The project involves producing vaccines from chemically inactivated whole viruses, a throwback to how flu vaccines were made decades ago.
  • Story: https://www.wsj.com/health/healthcare/rfk-jr-bets-500-million-on-universal-vaccines-in-shift-from-covid-19-funding-0299d927   (subscription required for full-text)

NIH announces six new acting institute directors, many of them filling posts of ousted predecessors

  • The National Institutes of Health on Friday announced six acting directors to run institutes, many to fill vacancies created by the ouster of predecessors as part of the Trump administration’s unprecedented reshaping of federal scientific agencies.
  • In an email from the NIH Executive Secretariat obtained by STAT, the agency said it was naming Courtney Aklin to run the National Institute of Nursing Research; Alison Cernich to run the National Institute on Child Health and Human Development; Monica Webb Hooper to run the National Institute on Minority Health and Health Disparities; Andrea Beckel-Mitchener to run the National Institute of Mental Health; Carolyn Hutter to run the National Human Genome Research Institute; and Jeff Taubenberger to run the National Institute of Allergy and Infectious Diseases.
  • The NIH email encourages staff to “please welcome these distinguished colleagues as they begin their new roles.” But the future of some of these acting directors is uncertain. That’s because a draft Trump administration budget leaked on April 16 revealed plans to cut NIH’s spending by 40% and to reorganize the agency’s 27 institutes and centers into eight. That plan involves eliminating four centers, including NINR and NIMHD, and folding NIMH and two other institutes into a new National Institute of Behavioral Health.
  • https://www.statnews.com/2025/04/25/nih-announces-six-new-acting-institute-directors (subscription required for full-text)

NIH to prioritize human-based research technologies

  • The National Institutes of Health (NIH) is adopting a new initiative to expand innovative, human-based science while reducing animal use in research.
  • Developing and using cutting-edge alternative nonanimal research models aligns with the U.S. Food and Drug Administration’s (FDA) recent initiativeto reduce testing in animals. While traditional animal models continue to be vital to advancing scientific knowledge, using new and emerging technologies can offer unique strengths that, when utilized correctly or in combination, can expand the toolbox for researchers to answer previously difficult or unanswerable biomedical research questions.
  • To integrate innovative human-based science, the NIH intends to establish the Office of Research Innovation, Validation, and Application (ORIVA) within NIH’s Office of the Director. The new office will coordinate NIH-wide efforts to develop, validate, and scale the use of non-animal approaches across the agency’s biomedical research portfolio and serve as a hub for interagency coordination and regulatory translation for public health protection.
  • ORIVA will expand funding and training in non-animal approaches and awareness of their value in translational success. New funding opportunities will include evaluation criteria that assess methods based on their suitability for the research question, context of use, translatability, and human relevance. Infrastructure for non-animal approaches will also be expanded to make these methods more accessible to researchers.
  • https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies

NIH cancels participation in Safe to Sleep campaign

  • The Trump administration has cancelled federal participation in Safe to Sleep, a 30-year campaign to prevent babies from dying in their sleep, STAT and the Medill News Service have learned.
  • The elimination of the National Institutes of Health’s role in the program, which helped slash infant deaths in the 2000s, comes at a time when sleep-related deaths among infants have increased. Sudden infant death rates were up nearly 12% between 2020 and 2022, according to the most recent data in a study published in JAMA Pediatrics.
  • “The elimination of this department is absolutely devastating as the rates of sudden unexpected infant death have begun to climb once again,” Alison Jacobson, the CEO of First Candle, a nonprofit organization that worked with the federal government on Safe to Sleep, said in an email.
  • https://www.statnews.com/2025/04/30/nih-ends-participation-in-safe-to-sleep-campaign-to-prevent-infant-deaths/  (subscription required for full-text)

HHS

HHS to require placebo testing of ‘all new vaccines’

  • The US Department of Health and Human Services (HHS) is planning changes to the way that new vaccines are tested, calling for all jabs to be evaluated in placebo-controlled trials. The move — described by a spokesperson as "a radical departure from past practices" — is the latest under HHS Secretary Robert F. Kennedy Jr. to focus on vaccines.
  • The department did, however, note that currently licensed influenza vaccines, which are updated annually, would be exempt from this requirement as they have "been tried and tested for more than 80 years."
  • According to HHS, the move is designed to increase transparency around vaccines. Despite this, concerns have been raised in some quarters, particularly around the ethics of withholding effective interventions in well-researched diseases, such as measles and polio, as would be required in the placebo arm of such studies planned by HHS.
  • https://firstwordpharma.com/story/5955763 (subscription required for full-text)

RFK Jr.’s HHS Orders Lab Studying Deadly Infectious Diseases to Stop Research

  • A research facility within the US National Institutes of Health that is tasked with studying Ebola and other deadly infectious diseases has been instructed by the Trump administration’s Department of Health and Human Services (HHS) to stop research activities.
  • According to an email viewed by WIRED, the Integrated Research Facility in Frederick, Maryland, was told to stop all experimental work by April 29 at 5 pm.
  • The facility is part of the National Institute of Allergy and Infectious Diseases (NIAID) and is located at the US Army base Fort Detrick. It conducts research on the treatment and prevention of infectious diseases that are deemed “high consequence”—those that pose significant risks to public health. It has 168 employees, including federal workers and contractors.
  • The facility’s director, Connie Schmaljohn, has also been placed on administrative leave, according to the email.
  • In an emailed statement provided to WIRED, Bradley Moss, communication director for the office of research services at NIH, confirmed the halt in research activity.
  • “NIH has implemented a research pause—referred to as a safety stand-down—at the Integrated Research Facility at Fort Detrick. This decision follows identification and documentation of personnel issues involving contract staff that compromised the facility’s safety culture, prompting this research pause. During the stand-down, no research will be conducted, and access will be limited to essential personnel only, to safeguard the facility and its resources.”
  • https://www.wired.com/story/hhs-niaid-irf-ebola-disease-research-stop/?utm_source=substack&utm_medium=email

HHS, RFK Jr. sued again over $11B infectious disease grant cuts as measles threat rises

  • The Department of Health and Human Services (HHS) and Secretary Robert F. Kennedy Jr. are being sued again for eliminating $11 billion in grants for disease outbreak prevention programs, this time with a newfound surge in measles cases as the backdrop.
  • Labor union American Federation of State, County and Municipal Employees (AFL-CIO); Harris County, Texas; and the cities of Nashville, Tennessee; Columbus, Ohio; and Kansas City, Missouri are asking the federal judge to vacate the COVID-19-related grant program eliminations and require HHS to follow federal law and its own regulations to continue administering the program permanently.
  • Terminating these grants has led to layoffs at AFL-CIO and in public health departments across the country and has dealt a “massive blow” in preventing public health outbreaks from spreading, said the plaintiffs.
  • https://www.fiercehealthcare.com/regulatory/hhs-rfk-jr-sued-over-11b-grant-cuts-measles-threat-rises

KEY REVERSALS – RESCINDED ITEMS

HHS rolls back reports of a national autism registry

  • The Department of Health & Human Services is reportedly not creating a national autism registry, which seemingly contradicts statements made by the director of the National Institute of Health last week.
  • While HHS is not creating a new registry of Americans with autism, the agency is launching a $50 million research effort to understand the causes of autism spectrum disorder and improve treatments, an official told STAT on Thursday.
  • "We are not creating an autism registry. The real-world data platform will link existing datasets to support research into causes of autism and insights into improved treatment strategies," an official for the department told CBS News.
  • Last week, National Institutes of Health Director Jay Bhattacharya announced the NIH would launch an initiative to integrate patient medical record data for researchers to study the factors influencing autism.
  • Data would come from pharmacies, health organizations, clinical data, claims and billing, environmental, and sensors and wearables. The NIH site indicates the protection of patient confidentiality within researcher access.
  • CBS News reported that the NIH would amass private medical records from federal and commercial databases to give to HHS Secretary Robert F. Kennedy Jr.
  • The use of private electronic health records and other data that could expose personally identifiable information created a backlash.
  • https://www.healthcarefinancenews.com/news/hhs-rolls-back-reports-national-autism-registry   (subscription required for full-text)

HHS reverses course, says long-running women’s health study will retain funding

  • Days after the Women’s Health Initiative (WHI), one of the largest and longest-running women’s health studies in the world, announced that the Department of Health and Human Services was terminating some of the initiative’s funding, the agency has reversed course.
  • “These studies represent critical contributions to our better understanding of women’s health. While NIH initially exceeded its internal targets for contract reductions, we are now working to fully restore funding to these essential research efforts,” an HHS spokesperson told Fierce Biotech in an email. “NIH remains deeply committed to advancing public health through rigorous gold standard research and we are taking immediate steps to ensure the continuity of these studies.”
  • On the social media platform X, HHS Secretary Robert F. Kennedy Jr. said that reports of cuts to the WHI were “fake news.”
  • “We are not terminating this study,” Kennedy wrote. “We all recognize that this project is mission-critical for women’s health.”
  • However, the WHI has not yet received official confirmation that the funding will be restored, Garnet Anderson, Ph.D., a biostatistician and the principal investigator of the WHI’s Clinical Coordinating Center at Fred Hutchinson Cancer Center in Seattle, told Fierce Biotech in an email.
  • https://www.fiercebiotech.com/research/hhs-reverses-course-says-long-running-womens-health-study-will-retain-funding

KEY BIOPHARMA NEWS

Trump warns of a 'tariff wall' for pharmaceutical companies

Exclusive-US pharma tariffs would raise US drug costs by $51 billion annually, report finds

  • The analysis, conducted by Ernst & Young, found the United States imported $203 billion in pharmaceutical products in 2023, with 73% coming from Europe -- primarily Ireland, Germany and Switzerland. Total U.S. sales of finished pharmaceuticals that year were $393 billion.
  • The report, dated April 22 and not made public, was commissioned by the main U.S. pharmaceutical lobby, the Pharmaceutical Research and Manufacturers of America, whose members include Amgen, Bristol Myers Squibb, Eli Lilly, and Pfizer, among others.
  • PhRMA did not immediately respond to a request for comment. The group has argued tariffs would undermine efforts to boost domestic manufacturing, a goal of U.S. President Donald Trump.
  • https://ca.finance.yahoo.com/news/exclusive-us-pharma-tariffs-raise-135301386.html

RFK Jr. touts CMS program testing new ways to pay for sickle cell disease treatment

  • HHS Secretary Robert F. Kennedy Jr. said Friday that 35 states had signed up to participate in a new payment model meant to improve access to and lower costs for gene therapies for sickle cell disease.
  • The level of participation in the voluntary model is “unprecedented” and represents a “real win-win” for states and patients with Medicaid, Kennedy said during a short speech at the National Council of Insurance Legislators’ spring meeting in Charleston, SC.
  • The program “illustrates a broader principle that I want to realize throughout HHS. People assume that budget cuts translate into worse service for beneficiaries, and I don’t think it has to be that way,” he said.
  • The Biden administration first announced the payment model, called the Cell and Gene Therapy Access Model, in February 2023, and sickle cell disease was chosen as the first focus a year later.
  • The model, born out of the CMS Innovation Center, tests tying drugmakers’ payments for cell and gene therapies to whether they improve outcomes for Medicaid patients. In December, CMS said it had negotiated agreements with Vertex Pharmaceuticals, the maker of sickle cell treatment Casgevy, and bluebird bio, the maker of Lyfgenia, as part of the program.
  • Kennedy said the 35 states participating cover about 84% of Medicaid beneficiaries with sickle cell disease. HHS will work on onboarding all of those states by the end of year, and one is already onboarded, he said.
  • https://endpts.com/rfk-jr-touts-program-testing-ways-to-pay-for-sickle-cell-care/  (free subscription required for full-text)

FDA delays PDUFA date for small biotech, raising questions about impact of agency cuts

  • The fate of a small, privately-held biotech’s new drug has been delayed, in what appears to be a sign that broad cuts to the FDA by the Trump administration may be affecting key regulatory decisions.
  • Stealth BioTherapeutics said the FDA would not meet its Tuesday deadline for approving or rejecting the company’s drug, elamipretide.
  • Asked about possible FDA delays, an HHS spokesperson said that “the FDA is on track to reach its PDUFA targets. Just for clarity, they are not deadlines as some has reported, they are targets. Scientists have at times said that individual targets will or won’t be met due to the complexity of certain product applications. FDA would rather have a sound decision and it’s been a long-standing practice that some fraction of product decisions are made after the PDUFA target date. FDA is confident they will be met.”
  • Typically, the FDA does not miss PDUFA dates unless it requests more data or raises safety or manufacturing concerns. Those sorts of delays are usually communicated to the companies with new decision dates.
  • https://endpts.com/fda-delays-small-biotechs-decision-date-seemingly-due-to-agency-cuts/   (free subscription required for full-text)

Pfizer CEO Bourla suggests pharma tariffs will focus on US adversaries, not allies

  • With the Trump administration’s planned pharma tariffs on the horizon, Pfizer CEO Albert Bourla gave an optimistic read on Tuesday when asked how he thought the trade levies might be implemented.
  • Speaking during the company’s quarterly earnings call, Bourla said he was “cautiously optimistic” that any findings from the White House’s ongoing Section 232 investigation into pharmaceutical products would focus on imports from countries that are an actual national security risk, as opposed to allies. His read comes from conversations with the White House and associated staff, he told investors.
  • https://endpts.com/pfizers-bourla-projects-confidence-that-tariffs-will-focus-on-us-adversaries/  (free subscription required for full-text)

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

Health systems in limbo as HHS stays quiet on nondiscrimination rules for AI, algorithms

  • It’s been a year since the federal government clarified that technology tools used in health care shouldn’t discriminate against patients based on protected traits such as age, sex, race, and disability. A lot has changed in that time, including a new president in the White House. But as the May 1 deadline approaches this week, health systems face significant clinical and political uncertainty over how to comply with the rule.
  • The lack of clarity is further delaying and potentially disrupting an already complex effort by health systems and technology vendors to avoid discrimination from artificial intelligence and other clinical tools used in making decisions about patient care.
  • The nondiscrimination provision of the Affordable Care Act, called Section 1557, has always prohibited discrimination on the basis of traits like race, sex, age, and disability. But last year the Biden administration issued a final rule clarifying that patient care decision support tools, including artificial intelligence algorithms, fall under that banner. As of May 1, federally-funded health systems will have to show they’ve worked to identify tools that use protected traits — and to mitigate the risk of discrimination from their use.
  • https://www.statnews.com/2025/04/30/hhs-stays-quiet-on-section-1557-nondiscrimination-rules-for-ai-algorithms/   (subscription required for full-text)

KEY MEDTECH NEWS

Hospitals begin to grapple with tariff fallout

  • Hospitals across the country are starting to reckon with the effects President Trump's tariffs are having on medical supplies like syringes and PPE, and in some cases freezing spending and making other contingencies.
  • "Tariffs have the potential to add a layer of complication to [hospitals'] ability to get all of those medical goods, the drugs and the devices that they need to deliver care," said Akin Demehin, the American Hospital Association's vice president of quality and patient safety policy.
  • Reality check: Many hospitals may still be insulated from the worst effects because of long-term purchasing contracts.
  • What to watch: Hospitals are among trade groups lobbying for tariff exemptions for critical medical supplies, including drugs. One question is whether pharmaceutical manufacturers can limit their exposure by "reshoring" more intellectual property in order to pay more U.S. taxes, Leerink Partners wrote in an investor note on Wednesday.
  • https://www.axios.com/2025/05/01/hospitals-struggle-tariff-impacts

AHA sounds the alarm on rising hospital costs

  • The American Hospital Association released a report on Wednesday warning that cost growth, inadequate reimbursement and potential policy changes in Washington threaten to coalesce into a financial “perfect storm” for hospitals.
  • The lobbying group said that, while hospitals continue to see supply and labor expenses rise, they’re also being underpaid by payers. Hospitals absorbed $130 billion in underpayments from Medicare and Medicaid in 2023, with the shortfall worsening 14% annually between 2019 and 2023, according to the report.
  • The collective pressures are “jeopardizing the ability of hospitals to deliver high-quality, timely care to their communities,” AHA President and CEO Rick Pollack said in a press release.
  • Top of mind for hospital administrators is how much tariffs will impact their finances. The Trump administration has flip-flopped on its trade policy, reconsidering which countries to tariff, how high to set rates, when policies might go into effect and what goods could be subject to import taxes.
  • Still, the final impact could be large. Nearly 70% of medical devices marketed in the U.S. are manufactured overseas, and last year, the country imported over $75 billion worth of devices and supplies, including syringes, needles and IV saline bags, according to the report.
  • “Tariffs on these critical goods could exacerbate shortages, disrupt patient care and raise costs for hospitals,” the report said.
  • Story: https://www.healthcaredive.com/news/american-hospital-association-aha-sounds-alarm-rising-hospital-costs/746836/
  • Report: https://www.aha.org/press-releases/2025-04-30-new-aha-report-hospitals-and-health-systems-squeezed-persistent-economic-challenges

Tariffs are hitting surgical robots and pacemakers, but device companies aren’t sweating it, yet

  • President Trump’s tariffs are adding hundreds of millions of dollars in costs to individual medical device firms and diagnostic companies. The biggest manufacturers are relatively unbothered by it.
  • Boston Scientific, which makes a wide range of medical devices, expects to fully offset $200 million of tariffs this year through higher sales and cost cuts. The stock price of Intuitive Surgical, which makes the da Vinci surgical robot system used in hospitals, soared last week after executives said its products made in Mexico would avoid tariffs. Intuitive Surgical’s total tariff hit for this year: $165 million, or 1.7% of its annual revenue — better than what investors feared.
  • Some companies don’t expect to get dragged down at all from the tariffs. Resmed just announced its sleep apnea machines will continue to be tariff-free thanks to a little-known exemption from the U.S. Customs and Border Protection.
  • https://www.statnews.com/2025/04/28/trump-tariffs-china-medical-device-surgical-robots-lobbying-exemptions/  (subscription required for full-text)

AI Health Law & Policy: Health Tech Investment Act would create AI-enabled device Medicare payment pathway

  • U.S. Senate Artificial Intelligence Caucus co-chairs Mike Rounds (R-SD) and Martin Heinrich (D-NM) recently introduced S. 1399, the “Health Tech Investment Act,” which would establish a Medicare reimbursement pathway for novel "algorithm-based healthcare services" that have been cleared or approved by the U.S. Food and Drug Administration (FDA).
  • Yet, a predictable reimbursement pathway for AI-enabled medical devices remains a challenge for developers of innovative health technology, who need to identify an appropriate code to utilize as a path to Medicare reimbursement and payment. FDA has authorized more than 600 AI-enabled medical devices. While some of these codes do qualify for Medicare reimbursement, the Center for Medicare & Medicaid Services (CMS) lacks standard or consistent methods for reimbursing and paying for these medical products.
  • Aiming to remedy this concern for sponsors of AI-enabled devices, the Health Tech Investment Act would provide certainty and a 5-year runaway for new technology ambulatory payment classifications (APCs) for FDA-authorized medical devices that rely on AI and machine learning (ML), which are called “Algorithm-Based Healthcare Services (ABHS).”
  • https://www.hoganlovells.com/en/publications/ai-health-law-policy-health-tech-investment-act

CURRENT APPOINTEE STATUS

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

Updated May 1 at 11 AM EST.

KEY ACRONYMS

  • ABHS = Algorithm-Based Healthcare Services
  • BARDA = Biomedical Advanced Research and Development Authority
  • CMS = Center for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • NIAID = National Institute of Allergy and Infectious Diseases
  • NIH = National Institutes of Health
  • NIMH = National Institute Of Mental Health
  • NIMHD = National Institute on Minority Health and Health Disparities
  • NINR = National Institute of Nursing Research
  • ORIVA = Office of Research Innovation, Validation, and Application
  • PhRMA = Pharmaceutical Research and Manufacturers of America

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