Blog | 4/25/2025

Trump Administration Healthcare News: April 25, 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 24, 2025. The details and broad themes may have changed.

 

KEY FEDERAL GOVERNMENT NEWS

FDA

With Dr. Marty Makary in power, the FDA’s future comes slightly more into view

  • Makary’s plan for the agency — and the extent to which he’ll be influenced by HHS Secretary Robert F. Kennedy, Jr. — has yet to fully unfold. But he did hint at some of his plans in an interview with former Fox News journalist Megyn Kelly last week.
  • For one, Makary proposed rolling out a new pathway for rare disease approvals that could get drugs into the hands of patients faster.
  • If there’s a new treatment for a rare disease that makes sense physiologically — meaning the mechanism is scientifically plausible — the proposed pathway would allow patients to get on the treatment if they wanted to, even in the absence of a randomized controlled trial.
  • Makary also touched on the burgeoning anti-vaccine efforts taking shape under Kennedy’s helm, noting that “there’s been an epidemic of distrust [in the FDA] and part of it is warranted.”
  • In response to a question posed by Kelly about negative side effects from the COVID-19 vaccine, however, Makary claimed the FDA will conduct “intense, comprehensive research” on the safety and efficacy of vaccines and emphasized the use of real-world data in doing so.
  • He also said that Marks’ former position as the agency’s top vaccine regulator will be filled, and that a lot of “talented people” were applying for the job.
  • Finally, Makary announced last week that the FDA would implement a new policy that would prevent individuals employed at pharma companies from serving as official members of FDA advisory committees, all in the name of boosting transparency and reducing conflicts of interest.
  • “While the FDA should be partnering with industry to ensure a user-friendly review process, the scientific evaluation of new products should be independent,” Makary said in a statement.

Makary seeks to limit industry’s role in FDA advisory panels

  • The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the agency consults for some regulatory decisions, Martin Makary, the FDA’s new commissioner, announced Thursday.
  • Advisory committees, which the FDA typically convenes for additional input on high-profile reviews or thorny clinical and regulatory issues, regularly include an industry representative alongside a dozen or so independent experts.
  • These representatives don’t vote on questions put to the committee. They are meant to share the perspective of their industry broadly, rather than of the specific company that employs them. There are also usually patient or consumer representatives on the panels.
  • Now, when not explicitly required by statute, the FDA will restrict industry representatives from taking part as a committee member.
  • https://www.medtechdive.com/news/makary-fda-advisory-committee-industry-conflicts/745784/

FDA fires most negotiators for pharma user fee talks, sources say

  • The U.S. Food and Drug Administration's mass layoffs included senior negotiators in talks with the pharmaceutical industry over renewing the user fee programs that fund the regulator's drug review system, six sources familiar with the matter said.
  • The firings of most of the negotiators and their project managers throw into disarray the complex process of reauthorizing the agreements, overseen by Congress, under which big pharma and generic drug companies pay for the FDA's review of their products, several experts said.
  • Pharma and medical device companies build their business models on the predictability provided in the user fee agreements, in which the FDA commits to complete new drug reviews within either 10 months or 6 months depending on whether it is a standard or priority application, experts say.
  • Among the 15 people fired were the head negotiator and deputy head negotiator for one of the user fee agreements, three of the sources said. All requested anonymity to discuss internal FDA matters that have not been reported previously.
  • The U.S. Department of Health and Human Services, which has been handling media enquiries for the FDA, did not immediately respond to a request for comment.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/fda-fires-most-negotiators-pharma-user-fee-talks-sources-say-2025-04-17/

Makary Turns To EHRs Instead Of VAERS To Track Vaccine Safety

  • FDA Commissioner Marty Makary plans to overhaul the way FDA monitors vaccine safety by using Health Information Exchanges (HIEs) to access real-world complication data through electronic health records instead of relying on the agency’s long-used Vaccine Adverse Events Reporting database.
  • Makary revealed the plan in an interview with pundit Megyn Kelly.

FDA Commissioner Marty Makary announces three new hires in leadership team

  • The commissioner of the Food and Drug Administration welcomed three new leaders to the agency this week, including a new deputy commissioner, according to an email to staff on Monday.
  • The new arrivals were Lowell Zeta as deputy commissioner for strategic initiatives; Timothy Schell as acting director for the Center for Veterinary Medicine; and Craig Taylor as the acting chief information officer.
  • The hires begin to fill the leadership void caused by the departures of high-level FDA officials in recent months. Some left by choice, while others were let go as part of an early April reduction in force across the Health and Human Services Department.
  • Zeta served as a senior adviser to the commissioner during the first Trump administration, when Stephen Hahn was FDA commissioner. He helped lead the FDA’s 2020 initiative to evaluate its Covid-19 response and better prepare to respond to future pandemics. He was previously a partner at the law firm Hogan Lovells, and helped current Commissioner Marty Makary start to assemble a leadership team in January.

Key FDA drug data goes missing amid DOGE cuts

  • Food and Drug Administration databases that physicians and public health experts rely on for key drug safety and manufacturing information have been neglected due to DOGE-directed layoffs, leaving health professionals flying blind on basic questions about certain drugs they're prescribing, current and former FDA officials tell Axios.
  • Why it matters: Information gaps that have become a hallmark of the workforce reductions and the sweeping reorganization of federal health agencies under Health Secretary Robert F. Kennedy Jr. are putting patient safety at risk, according to agency employees.
  • Zoom in: The FDA's drug database, which is updated when new drugs are approved, get labeling changes or are pulled from the market, has a growing amount of missing information, an FDA official who was laid off told Axios.
  • Most entries into this database since the sweeping April 1 job cuts are missing labeling information, which tells doctors what the drug is approved for, what it shouldn't be used for, dosing instructions and side effects.
  • Another repository with delayed updates due to staff cuts is the National Drug Code Directory which provides a specific code and manufacturing information for each drug, in addition to information about active ingredients and compounded drugs.
  • https://www.axios.com/2025/04/24/fda-data-missing-doge-cuts

CDC

Leaked Budget Document Confirms Axed CDC Offices

  • A leaked HHS budget document confirms that a number of CDC offices are eliminated in their entirety, as the Trump administration sets out to refocus the agency on infectious diseases.
  • It also proposes to eliminate two CDC journals: Emerging Infectious Diseases and Preventing Chronic Disease. Funding for CDC's flagship weekly journal, Morbidity and Mortality Weekly Report, however, would be preserved.
  • The administration wants to "refocus CDC on emerging and infectious disease surveillance, outbreak investigations, preparedness and response, and maintaining the Nation's public health infrastructure," according to the document, which was first shared by MedPage Today editor-in-chief Jeremy Faust, MD.
  • The National Center for Chronic Disease Prevention and Health Promotion would be eliminated, ending all programs in the center, according to the document. Funding for CDC's Global Health Center is also eliminated, according to the document.
  • Within the National Center for Viral Hepatitis, STD, and Tuberculosis Prevention, the proposed budget eliminates funding for Ending the HIV Epidemic Initiative and for CDC Domestic HIV/AIDS Prevention and Surveillance activities.
  • MedPage Today previously reported that CDC's critical STD laboratory housed within this center, was shuttered by the mass layoffs.
  • Within the National Center for Zoonotic and Emerging Infectious Diseases, funding for several programs would be discontinued, including the Lyme disease, prion disease, chronic fatigue syndrome, and the harmful algal bloom programs.
  • https://www.medpagetoday.com/special-reports/features/115174  (free registration required for full-text access)

US consumer safety agency to stop collecting swaths of data after CDC cuts

  • The U.S. consumer product safety agency will stop collecting data on injuries from incidents like car accidents and adverse drug effects due to staff cuts at the Centers for Disease Control and Prevention, according to an agency email seen by Reuters and a source familiar with the situation.
  • The 47-year-old National Electronic Injury Surveillance System collects data from a representative sample of 100 hospital emergency departments across the country.
  • Injury is the leading cause of death for Americans under 45 years old, and data from the NEISS informs product recalls, safety standards and other public policy to prevent injuries and deaths.
  • The Consumer Product Safety Commission will stop collecting data on injuries from motor vehicle crashes, falls, alcohol, adverse drug effects, aircraft incidents, work-related injuries and other incidents through the NEISS, according to the source.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-consumer-safety-agency-stop-collecting-swaths-data-after-cdc-cuts-2025-04-16/

NIH

NIH grants plummeted $2.3 billion in Trump’s first months, as federal-academia partnership crumbles

  • The National Institutes of Health has scaled back its awards of new grants by at least $2.3 billion since the beginning of the year, with the biggest shortfalls hitting the study of infectious diseases, heart and lung ailments, and basic research into fundamental biological systems, a new STAT analysis has found.
  • This roughly 28% contraction in funding comes on top of threats to freeze billions of dollars of NIH funding to specific universities as well as abrupt terminations to hundreds of research projects on Covid-19, HIV/AIDS, health disparities, vaccine hesitancy, and other areas targeted by President Trump’s political agenda.
  • While Trump and his Republican allies have begun to use the threat of withholding NIH funding to force private universities like Columbia and Harvard to change what they say are “woke,” left-wing, and antisemitic policies, STAT’s analysis shows that the institutions hardest hit by the slowdown to new NIH awards include public universities, medical schools, and a nonprofit cancer research center. The Boston area and New York City — home to Harvard and Columbia — have experienced large declines in new grants, but so have Seattle and San Diego, where the public University of Washington and University of California, San Diego, are located.

NIH guts its first and largest study centered on women

  • The Women’s Health Initiative (WHI) has enrolled tens of thousands of participants in clinical trials of hormones and other medications and tracked the health of many thousands more over more than 3 decades. Its findings have had a major influence on health care.
  • WHI leaders announced yesterday that contracts supporting its regional centers are being terminated in September and that the study’s clinical coordinating center, based at the Fred Hutchinson Cancer Center, “will continue operations until January 2026, after which time its funding remains uncertain.”
  • Anderson says WHI currently enrolls 42,000 women, who update the researchers regularly on their health.
  • The contract cut will prevent researchers at WHI’s four sites from continuing to interact with the women in this cohort, which has enabled researchers to create the country’s largest data set on women in their 80s and 90s.

As Harvard battle escalates, HHS directs NIH not to tell universities about new grant freezes: reports

  • The National Institutes of Health (NIH) is halting new grant and contract payments to several universities, a move the agency has been instructed not to disclose to affected schools, according to several reports.
  • Disbursements have been halted to Harvard University, Brown University, Northwestern University and Cornell University, plus Weill-Cornell Medical School, according to an April 16 NIH email viewed by Science.
  • The Department of Health and Human Services (HHS) also told NIH to not communicate with the schools about “whether or why the funds are frozen,” according to an April 17 internal email from Office of Policy for Extramural Research Administration director Michelle Bulls, which was posted on X by Nature reporter Max Kozlov.
  • The HHS has not yet responded to Fierce’s questions about further specifics related to the “closed” opportunities
  • https://www.fiercebiotech.com/biotech/nih-directed-not-tell-universities-about-new-grant-freezes-harvard-battle-escalates
  • Link to X posting: https://x.com/maxdkozlov/status/1913327818873700556

NIH autism study will pull from private medical records

  • The National Institutes of Health will begin collecting Americans' private health records as part of Health and Human Services Secretary Robert F. Kennedy Jr.'s controversial plan to discover a cause and a cure for autism. NIH Director Jay Bhattacharya told a panel of experts about the plan this week.
  • The NIH plans to gather information from a wide range of private sources, including pharmacy chains, hospitals and wearable devices with health sensors, like smartwatches.
  • The NIH did not return a request for comment.
  • https://www.npr.org/2025/04/23/nx-s1-5372695/autism-nih-rfk-medical-records

NIH director pushes back timeline for RFK Jr.'s autism answers

  • The head of the National Institutes of Health now says it could take until next year to get preliminary results from their new studies into autism, marking the latest delay to findings that Health and Human Services Secretary Robert F. Kennedy Jr. had promised by September.
  • "We're going to get hopefully grants out the door by the end of the summer," NIH Director Dr. Jay Bhattacharya told reporters Tuesday. "And people will get to work. We'll have a major conference, with updates, within the next year."
  • Bhattacharya said it should still be considered "a very rapid study by NIH's normal standards," saying that the institute was working to "cut the red tape without cutting the rigor" in launching their new research grants.
  • https://www.cbsnews.com/news/nih-director-pushes-back-timeline-rfk-jr-autism-answers/

HHS

RFK Jr. Pledges To Restore HHS Public Records Requests Slowed By DOGE

  • Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. pledged at a press conference Tuesday to restore the production of federal records.
  • Those records, requested by members of the public, were said to be slowed by Department of Government Efficiency (DOGE) cuts.
  • Kennedy also said he will create a new website for HHS documents.
  • Kennedy said he would seek to publish a greater number of documents requested under the Freedom of Information Act (FOIA) — a 1967 law that allows members of the public to obtain government records with some limited exceptions such as information pertaining to national security and trade secrets. The new landing page could include records requested and released previously but unavailable on the HHS website.
  • HHS currently hosts an online reading room for some records, but it does not serve as a repository of every document released under a FOIA request.
  • https://dailycaller.com/2025/04/22/total-transparency-rfk-jr-pledges-to-restore-hhs-public-records-requests-slowed-by-doge/

KEY BIOPHARMA NEWS

Drugmakers stockpile inventory in the US, seeking to get ahead of Trump tariffs

  • Large pharmaceutical companies that make drugs around the world have begun to ship and stockpile products inside US borders, in an effort to blunt the impact of the Trump administration’s expected tariffs on the industry, multiple companies told Endpoints News.
  • The moves are a temporary solution that will at most provide a few quarters worth of respite, said the companies, which spoke to Endpoints on condition of anonymity. Many are also looking at longer-term plans to reorient current and future manufacturing plans, including possibly expanding manufacturing operations in the US.
  • “Everyone in every sector is executing the same strategy: Bring in as much as you can,” said a senior executive at a large multinational drugmaker who spoke to Endpoints on condition of anonymity, and whose company is building inventory in the US ahead of the tariffs.
  • https://endpts.com/drugmakers-stockpile-inventory-in-the-us-seeking-to-get-ahead-of-trump-tariffs/   (free registration required for full-text access)

CMS would absorb 340B drug discount program under leaked HHS reorganization proposal

  • The 340B drug discount program may move under the purview of CMS, according to a leaked HHS restructuring document reviewed by Endpoints News.  
  • The 64-page document, first reported on by the Washington Post and InsideMed on Wednesday, proposes to move the 340B program from the Health Resources and Services Administration to CMS. A broader Office of Pharmacy Affairs, which 340B would sit under, would move to CMS as well. The document lists HRSA as an agency being “eliminated.”
  • The proposed reorganization means a program that the pharma industry has been eager to reform will be under the purview of CMS administrator Mehmet Oz. An HHS spokesperson did not immediately respond to a request for comment about the department’s plans. The document is listed as “pre-decisional.”
  • The 340B program requires drugmakers to provide discounts to eligible healthcare centers serving low-income patients. It was established to help hospitals serving vulnerable communities conserve federal resources. But drugmakers have argued that 340B has ballooned far beyond that stated mission, and lawsuits have cropped up around the country arguing that discounts are being given to people who shouldn’t be getting them.
  • https://endpts.com/cms-would-absorb-340b-drug-discount-program-under-leaked-hhs-proposal/  (free registration required for full-text access)

Tariff hits to generic drugs could 'blow back on everybody' without supply chain resilience, says USP chief

  • While much of the conversation around the Trump administration’s potential pharmaceutical import tariffs has leaned heavily toward branded drugmakers, generic medicines and the companies that manufacture them will be uniquely vulnerable in the event of a trade war given just how “little resilience” the industry enjoys compared to its patented counterpart.
  • That’s the take according to Ronald Piervincenzi, Ph.D., CEO of the United States Pharmacopeia (USP)—a nonprofit that publishes drug quality, purity, strength and identity standards that are enforced by the FDA and followed by manufacturers.
  • Ultimately, any disruption to the already fragile generics ecosystem could trigger manufacturing discontinuations, shortages and a multitude of other issues for off-brand drugmakers and the U.S. patients who rely on their products, Piervincenzi said in a recent interview with Fierce Pharma.
  • Piervincenzi shared his perspective shortly after the publication of a USP report that found the U.S. produces just 12% of the active pharmaceutical ingredients (API) for medicines going to U.S. patients. The rate is slightly higher for branded drugs, where 15% of API manufacturing takes place in the U.S., while the rate for generic ingredients is on par with the overall 12% figure, according to the report.
  • https://www.fiercepharma.com/manufacturing/tariff-hits-generic-drugs-could-blow-back-everybody-says-usp-chief-call-increased

Top leaders at FDA marketing overseer resign, potentially teeing up RFK Jr.’s promised drug ad ban: report

  • The two highest-ranking leaders within the FDA’s Office of Prescription Drug Promotion (OPDP) have stepped down, according to Politico’s AgencyIQ.
  • OPDP director Catherine Gray and deputy director Mark Askine told staffers on Thursday that they were leaving, and their resignations took effect Friday, AgencyIQ’s Alexander Gaffney reports, citing emails shared by sources within the office.
  • As Gaffney suggested, the current lack of leadership at OPDP could possibly pave the way for Robert F. Kennedy Jr., secretary of the Department of Health and Human Services, to ramp up his long-stated plan of banning pharmaceutical ads by pressuring FDA Commissioner Marty Makary, M.D., to fill out the vacancies with other opponents of direct-to-consumer drug marketing.
  • In response to a Fierce Pharma Marketing request for comment about the changes at OPDP and how they may align with Kennedy’s goal of a drug ad ban, an HHS official said, “The FDA and HHS are committed to developing new guidelines for the industry on how they market drug risks and side effects, so the American people can make informed choices about their health through radical transparency. Critical programs within the FDA will continue as part of HHS’ transformation to better serve the American people.”
  • https://www.fiercepharma.com/marketing/top-leaders-fda-marketing-overseer-resign-potentially-teeing-rfk-jrs-promised-drug-ad-ban

Vaccine biotechs say they’ve been told to stop next-gen Covid work under a Biden-era project

  • At least three biotech companies say they’ve received orders to stop their work related to a Biden administration initiative to advance new Covid-19 vaccines.
  • GeoVax, CastleVax and Vaxart told Endpoints News that they’ve been directed to stop their work for Project NextGen, a BARDA-funded initiative that was set to support planned 10,000-person Phase 2b trials testing their novel vaccines against currently approved vaccines. The companies said the notice came from Advanced Technology International, which partnered with BARDA to manage a program for supporting medical countermeasures.
  • https://endpts.com/vaccine-biotechs-get-stop-work-orders-for-their-next-gen-covid-studies/ (free registration required for full-text access)

Roche seeks US tariff relief in direct talks with Trump administration

  • Swiss drugmaker Roche is petitioning the U.S. government in direct talks for import tariff exemptions, arguing the products it ships into the United States are offset by its exports of U.S.-made drugs and diagnostics.
  • "As long as we produce the same amount in the U.S. as we import ... we would not be impacted by tariffs. That's kind of the discussion we are trying to have with the U.S. government," CEO Thomas Schinecker said in a media call after the release of first-quarter sales figures.
  • He added that Roche was in touch with various levels of President Donald Trump's administration, arguing that a U.S. drive for all goods used in the country to be produced there would inflate manufacturing costs.
  • "For diagnostics, when you have 10,000 products, you cannot produce 10,000 products in every country," said Schinecker.
  • He said Roche was arguing it would "produce as much in volume as you use in the U.S., because some of that you may export".
  • Switzerland is potentially facing 31% U.S. tariffs, which have been put on hold by Trump for 90 days along with sweeping tariffs on almost all goods from dozens of other countries.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/roche-seeks-us-tariff-relief-direct-talks-with-trump-administration-2025-04-24/

GOP Launches Caucus to Promote Medicine Production in America

  • A congressional caucus [the American-Made Medicines Caucus] focused on bringing pharmaceutical manufacturing to US shores will launch Thursday as Republicans seek to further the Trump administration’s goals of boosting medicine production in America.
  • The group of lawmakers will focus on ways to bring the pharmaceutical supply chain to the US and be less dependent on nations like China for pharmaceutical products.
  • https://news.bloomberglaw.com/pharma-and-life-sciences/gop-launches-caucus-to-promote-medicine-production-in-america?   (subscription required for full-text access)

KEY MEDTECH, DIAGNOSTICS and HEALTH INFORMATION TECHNOLOGY NEWS

AdvaMed: AI medtech companies facing more risk with uncertainties at FDA

  • Medtech companies developing artificial intelligence (AI) products are taking on more risk as the Trump administration’s actions at the US Food and Drug Administration (FDA) have halted new AI-related guidances from being published, according to the lobby group AdvaMed.
  • Over the past several months, the Trump Administration has taken steps that have frozen guidance development at FDA, including issuing an executive order requiring 10 regulations, rules, or guidances be withdrawn before a new one can be published. The administration also recently fired staff who were critical to developing new guidances as part of its reduction-in-force (RIF) initiatives.
  • Members of AdvaMed’s Digital Health Tech Division discussed an AI policy roadmap during the press conference that they have presented to congressional lawmakers. It includes recommendations to allow for more data protection flexibility, especially regarding Health Insurance Portability and Accountability Act (HIPAA) requirements.
  • Press:  https://www.raps.org/News-and-Articles/News-Articles/2025/4/AdvaMed-AI-medtech-companies-facing-more-risk-with
  • AI Roadmap: https://www.advamed.org/member-center/resource-library/ai-policy-roadmap/

Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

  • The US Centers for Medicare and Medicaid Services (CMS) has scheduled three public meetings for this June and July, with the first set to address clinical trials of tremor treatment devices while the other two focus on test codes and payment rates for clinical diagnostic laboratory tests.

KEY ACRONYMS

  • AI = artificial intelligence
  • BARDA = Biomedical Advanced Research and Development Authority
  • CDC = Centers for Disease Control and Prevention
  • CMS = Center for Medicare & Medicaid Services
  • CPSC = Consumer Product Safety Commission
  • DOGE = Department of Government Efficiency
  • EHRs = electronic health records
  • EO = Executive Order
  • FDA = Food and Drug Administration
  • FOIA = Freedom of Information Act
  • HHS = Department of Health and Human Services
  • HIEs = Health Information Exchanges
  • HIPAA: Health Insurance Portability and Accountability Act
  • NEISS = National Electronic Injury Surveillance System
  • NIH = National Institutes of Health
  • OPDP = Office of Prescription Drug Promotion
  • PBMs = Pharmacy Benefit Managers
  • RIF = reduction-in-force
  • USP = United States Pharmacopeia
  • VAERS = Vaccine Adverse Events Reporting
  • WHI = Women’s Health Initiative

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