Blog | 6/20/2025

Trump Administration Healthcare News: June 20, 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 June 19, 2025. The details and broad themes may have changed.

KEY FEDERAL GOVERNMENT NEWS

FDA

Makary says he wants nimbler FDA, calls for new drug pathways and pilots

  • Marty Makary, commissioner of the US Food and Drug Administration (FDA), said he wants the agency to become nimbler in the next five years to adapt to the fast pace of medical innovation. As part of that modernization effort, he also said the agency is exploring new pathways and pilot programs.
  •  “I think in five years we'll be measured by how nimble we are, how we have adapted to the modern time, how fast we have changed the agency to adapt to the fast pace of medicine,” Makary said during a panel at the DIA Global Annual Meeting on Monday.
  •  More specifically, Makary said he wants to see the development of a universal influenza vaccine that would include strains of bird flu and would not require annual administration.
  • Makary stressed that FDA needs to question why it takes 10 years for new drugs to come to market. He said the barriers to getting new treatments to patients are often the processes, and the agency needs to be willing to challenge deeply held assumptions about legacy systems used to bring products to market.
  •  “We’re exploring newer pathways for drugs and pilot programs,” said Makary. “You’ll see us put out something on that in the not-too-distant future.”
  • https://www.raps.org/News-and-Articles/News-Articles/2025/6/Makary-says-he-wants-nimbler-FDA,-calls-for-new-dr
  • Press of BIO talk: https://www.fiercebiotech.com/biotech/fda-track-meet-all-pdufa-dates-makary-talks-doge-cuts-agency-fiefdom-and-new-priority 

Makary names Prasad as FDA’s chief medical and scientific officer

  • In an email to US Food and Drug Administration (FDA) staff on Wednesday, FDA Commissioner Martin Makary announced that Vinay Prasad, director of the Center for Biologics Evaluation and Research, will take on a new role as chief medical and scientific officer, in addition to leading the biologics center.
  •  In his new capacity, Prasad will be tasked with advising senior agency officials and representing the agency’s thinking on medical and scientific matters to external stakeholders. Prior to joining the agency, Prasad was a hematologist/oncologist and professor of epidemiology at the University of California, San Francisco, and was a frequent and vocal critic of FDA and certain COVID-19 public health mandates.
  •  In addition to leading the agency’s biologics center, as the new chief medical and scientific officer, he will advise the commissioner and other senior officials on “cross-cutting and emerging medical and scientific issues” that affect the agency’s work.
  •  Previously, the roles of chief medical officer and chief scientist have been separate positions; it is unclear whether the new position of chief medical and scientific officer will replace those roles.
  • https://www.raps.org/news-and-articles/news-articles/2025/6/makary-names-prasad-as-fda-s-chief-medical-office

US FDA’s Top Cell and Gene Therapy Regulators Forced Out

  • Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.
  • Top cell and gene therapy regulators Nicole Verdun and her deputy Rachael Anatol were forced out of the US Food and Drug Administration June 18, per multiple sources familiar with the matter.
  • A comment sent to Pink Sheet from Health and Human Services Department press secretary Andrew Nixon indicated Verdun and Anatol disagreed with Center for Biologics Evaluation and Research Director Viany Prasad.
  • https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-top-cell-and-gene-therapy-regulators-forced-out-CJPZRHPMRFBENIBFRGA7JBXKGA/   (subscription required for full text)

FDA to tighten up on use of American patients' biological material in "hostile countries"

  • Less than two weeks after meeting with experts to discuss ways to help speed the development of cell and gene therapies, the FDA is moving to impose stricter oversight on clinical trials that involve exporting Americans' living cells outside the country for genetic engineering. The agency singled out destinations such as China and other "hostile countries," amid concerns that the international transfer and manipulation of the biological material may have exposed sensitive genetic data to "misuse" by foreign governments.
  • "The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants," remarked FDA Commissioner Marty Makary. "The integrity of our biomedical research enterprise is paramount. We are taking action to protect patients, restore public trust, and safeguard US biomedical leadership."
  • According to the FDA, there is mounting evidence that some of the clinical trials failed to inform participants about the destination of their cells — which after genetic engineering were subsequently infused back into the patient. The agency said it will review all new studies that involve such a process, which was made possible under a data security rule finalised by the Biden Administration in December last year and implemented in April.
  • Press: https://firstwordpharma.com/story/5974345
  • FDA Release:  https://www.fda.gov/news-events/press-announcements/fda-halts-new-clinical-trials-export-americans-cells-foreign-labs-hostile-countries-genetic

CMS

Feds greenlight $9 billion in supplemental Medicaid funds as GOP weighs new limits

  • Hospitals, physician groups, and nursing homes across 15 states will receive billions of dollars in extra Medicaid funding this year thanks to federal health care officials signing off on new agreements.
  • In almost all of the new agreements, states will pay health care providers average commercial prices to treat Medicaid patients — a boon for providers that often decry Medicaid as one of their worst-paying insurers.
  • The influx of recently approved Medicaid funds, known as state directed payment arrangements, highlights how the industry and state leaders of all political stripes have tapped a lucrative well within Medicaid. And the race is on to get more agreements across the finish line before Congress or the White House intervenes.
  • https://www.statnews.com/2025/06/13/medicaid-state-directed-payments-9-billion-supplemental-funds-hospitals-doctors-nursing-homes/  (subscription required for full text)

Doctors lose Medicare pay bump in Senate version of tax bill

  • The Medicare pay bump for doctors that was part of the House version of Republicans’ tax bill was dropped in the Senate’s version, released Monday evening.
  • The provision, which would boost doctors’ payment for treating Medicare patients by tying it to inflation, has long been a top priority for physician groups.
  • For years, doctors have contended with pay cuts from Medicare, which physician groups say have led to the consolidation and closure of medical practices. The Senate Finance Committee omitting the policy could be a hit for doctors’ groups that saw it as a starting point to increasing pay.
  • https://www.statnews.com/2025/06/17/senate-finance-trump-tax-bill-republicans-remove-medicare-pay-raises-for-doctors/     (subscription required for full text)

US Social Security, Medicare to run short of funds in 2033, trustees say

HHS

Members of Congress oppose NIH's payment cut plan, urge appeals court to maintain block

  • A group of members of the House of Representatives told a federal appeals court that the NIH’s planned cap on indirect cost reimbursements disregards Congress’ “exclusive authority to control federal spending” and threatens the discovery of treatments and cures for diseases.
  • In a Monday court filing, the 152 House legislators urged the US Court of Appeals for the First Circuit to uphold a block on the Trump administration’s 15% payment rate cap for NIH grantees. No members of the Republican leadership signed onto the filing.
  • The proposed cap “violates clear statutory limits imposed by Congress, encroaches on the constitutional separation of powers,” and “interferes with Congress’s ability to carry out its mission of funding health research according to priorities and conditions set by law,” the lawmakers said in the amicus brief.

US CDC official in charge of COVID, RSV data resigns ahead of vaccine meeting

  • A U.S. government scientist who oversees the team responsible for collecting data on COVID-19 and RSV hospitalizations used to shape national vaccine policy has resigned, citing concerns over how such data would be used by the Trump administration.
  • The scientist, Dr. Fiona Havers, told colleagues at the Centers for Disease Control and Prevention on Monday that she no longer had confidence that the COVID and RSV data would be used "objectively or evaluated with appropriate scientific rigor to make evidence-based vaccine policy decisions," according to an email seen by Reuters.
  • Havers, leader of the RESP-NET Hospitalization Surveillance Team, did not respond to requests for comment.
  • Her resignation follows moves by Health Secretary Robert Kennedy Jr. to abruptly fire all 17 members of the CDC's independent vaccine advisory panel and drop a recommendation for administering COVID shots to healthy children and pregnant women.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-cdc-official-charge-covid-rsv-data-resigns-ahead-vaccine-meeting-2025-06-16/

Tariffs

Tariffs drive some health plans to hike premiums

  • Health insurers are starting to notify states that tariffs will drive up the premiums they plan to charge individual and small group market enrollees next year.
  • Why it matters: The Trump administration's trade policy is adding another layer of uncertainty for health costs as Congress considers Medicaid cuts and is expected to sunset enhanced subsidies for Affordable Care Act coverage.
  • The big picture: Health insurers calculate monthly premiums in advance of each year based on the expected price of goods and services and projected demand for them.
  • Tariffs announced by President Trump are expected to drive up the cost of prescription drugs, medical devices and other medical products and services. Some of that difference ultimately would be passed down to enrollees.
  • Where it stands: A handful of health insurers administering individual and small group plans have already explicitly told state regulators that tariffs are forcing plans to raise enrollee premiums more than they otherwise would next year, KFF policy analyst Matt McGough wrote in an analysis published Monday.
    • Independent Health Benefits Corporation told New York regulators in a filing last month that it plans to raise premiums for its individual market enrollees 38.4% next year.
    • About 3% of that is directly due to tariffs, based on projections of how much they'll increase drug prices and the use of imported drugs, Frank Sava, a spokesperson for Independent Health, told Axios.
    • Similarly, UnitedHealthcare of Oregon said in a filing that nearly 3% of its planned 19.8% premium increase for small group enrollees next year is due to uncertainty around tariffs, particularly on how they'll affect pharmaceutical prices.
  • https://www.axios.com/2025/06/18/tariffs-health-insurance-premium-hikes

KEY REVERSALS – RESCINDED ITEMS

Judge orders NIH to restore hundreds of grants cut under Trump

  • A federal judge in Boston has ruled that the U.S. National Institutes of Health (NIH) must immediately restore approximately 800 grants touching on politically sensitive topics that it abruptly canceled earlier this year.
  • In his ruling today after a morning hearing, U.S. District Court for the District of Massachusetts William Young said the agency’s decision to terminate grants in areas such as racial health disparities and transgender health were arbitrary and capricious, meaning there was no legally valid process behind its reasoning.
  • Young also said the terminations were rooted in discrimination against racial, sexual, and gender minority groups. “I would be blind not to call it out. My duty is to call it out,” he said.
  • Andrew Nixon, director of communications for the Department of Health and Human Services, NIH’s parent agency, responded that, “HHS stands by its decision to end funding for research that prioritized ideological agendas over scientific rigor and meaningful outcomes for the American people.”
  • The department “is exploring all legal options,” he said, including filing an appeal and a motion to stay the order.
  • The case—a partial consolidation of two separate lawsuits—centers on NIH’s claims that the grant revocations reflect a shift in agency policies under President Donald Trump’s administration to deprioritize research on topics that the agency considers to be “unscientific” or supporting discrimination that is “harm[ful to] the health of Americans.”
  • https://www.science.org/content/article/judge-orders-nih-restore-hundreds-grants-cut-under-trump

Patient Safety Network Papers Restored Amid Lawsuit From Doctors

  • Papers removed from a government patient safety website earlier this year have been restored.
  • The reappearance of the papers comes amid a lawsuit challenging their removal from the Patient Safety Network (PSNet), which has existed as part of the Agency for Healthcare Research and Quality (AHRQ) under HHS.
  • The papers had been removed from the website for containing terms like "transgender," "gender identity," "non-gender-conforming," or "LGBTQ" in the wake of a memorandum from the Trump administration's Office of Personnel Management entitled, "Initial Guidance Regarding President Trump's Executive Order Defending Women."
  • Following the removal, Gordon Schiff, MD, and Celeste Royce, MD, physicians from Harvard Medical School whose papers were among those removed, filed a lawsuit against federal agencies to have their work republished.
  • However, missing from the restorations is a paper discussing implicit bias, the ACLU and Romano noted. Other content without named authors, such as brief summaries of published papers that were previously sent in weekly issues to some 41,000 subscribers, also have not been restored, Romano added.
  • https://www.medpagetoday.com/special-reports/features/116123

Trump administration blocked from cutting local health funding for four municipalities

  • A federal court has temporarily blocked the Trump administration from clawing back millions in public health funding from four Democrat-led municipalities in GOP-governed states.
  • It’s the second such federal ruling to reinstate public health funding for several states.
  • U.S. District Judge Christopher Cooper in Washington, D.C., issued a preliminary injunction Tuesday sought by district attorneys in Harris County, Texas, home to Houston, and three cities: Columbus, Ohio, Nashville, Tennessee, and Kansas City, Missouri.
  • The decision means the federal government must reinstate funding to the four municipalities until the case is fully litigated.
  • https://apnews.com/article/public-health-money-trump-lawsuit-houston-harris-county-424ec5cc43d0eadd98c05d9efb0ae039

KEY POLLS – SURVEYS – STUDIES

Medicaid cuts could result in more than 16,000 preventable deaths annually

  • Key health care provisions in the One Big Beautiful Bill Act, especially the proposed Medicaid cuts and Affordable Care Act marketplace reforms, would lead to 16,642 preventable deaths every year if implemented, according to a new analysis published Monday in Annals of Internal Medicine.
  • The proposed changes would also result in 7.6 million people losing insurance coverage, according to the analysis, which relied on data from a recent Congressional Budget Office analysis as well as data from at least four peer-reviewed studies of previous Medicaid expansions and cutbacks.
  • The authors, who characterized their estimates as conservative, said they excluded the impact of other provisions in the bill, such as lowering payments to health care providers, as well as possible state actions in response to shortfalls in federal Medicaid funding. They urged lawmakers to “weigh the likely health and financial harms to patients and providers of reducing Medicaid expenditures against the desirability of tax reductions, which would accrue mostly to wealthy Americans.”
  • Press:  https://www.statnews.com/2025/06/16/medicaid-cuts-new-analysis-16-thousand-deaths-millions-uninsured-from-big-beautiful-bill/   (subscription required for full text)
  • Article:  https://www.acpjournals.org/doi/10.7326/ANNALS-25-00716

KEY BIOPHARMA NEWS

FDA announces new voucher program for drugs tied to national priorities

  • This year, an unspecified number of drug developers will be eligible to take part in a pilot of the new US Food and Drug Administration (FDA) Commissioner’s National Priority Voucher (CNPV) program, the agency announced on Tuesday.
  •  Recipients of these non-transferrable vouchers are promised a dramatically shorter review of a specific investigational new drug and better access to agency officials, plus products may also be eligible for accelerated approval. The agency also said it will apply a voucher to a specific investigational product or grant an “undesignated voucher” to a company to use at its discretion, so long as its use is consistent with the program.
  • According to FDA, vouchers will be awarded to companies that align with the program’s stated priorities, including addressing a national health crisis, delivering more innovative cures, addressing unmet public health needs, or increasing domestic drug manufacturing as a national security issue.
  • As part of the new program, sponsors would submit most application materials early, such as chemistry, manufacturing and controls (CMC) and draft labeling, 60 days before final clinical trial results are available. Vouchers would expire after two years of receipt, though the agency has the option of extending priority review timelines.
  • Press: https://www.raps.org/news-and-articles/news-articles/2025/6/fda-announces-new-voucher-program-for-drugs-tied-t
  • FDA press: https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests

Trump administration demands pharma companies begin drug price negotiations, a day after key deadline

  • The Trump administration is pushing pharmaceutical companies to begin negotiations to bring their drug prices in line with what other countries pay — usually far less than Americans.
  • “Under President Trump’s direction, HHS is demanding that pharmaceutical companies end their obstruction and come to the table—just as they already do with nearly every other economically comparable nation—to negotiate fair, transparent pricing for Americans,” an agency spokesperson said in a statement to STAT, adding that the companies were “prevent[ing] progress of lowering prices for the American people.”
  • The spokesperson did not immediately clarify how companies were preventing that progress. The administration’s statement comes after pharmaceutical executives said they were expecting more details about the kinds of drugs that would be up for negotiations and the price targets for them.
  • https://www.statnews.com/2025/06/12/trump-administration-demands-drug-companies-start-negotiating-prices/    (subscription required for full text)

In setback for biopharma, Senate version of Trump's tax bill drops Orphan Cures Act

  • The Senate version of the One Big Beautiful Bill Act, unveiled Monday, has dropped what’s known as the Orphan Cures Act.
  • The bipartisan Orphan Cures Act would allow drugs with multiple rare disease indications to be exempt from Medicare’s drug price negotiations under the IRA. As it stands, the IRA applies such exclusions only to drugs treating a single rare disease.
  • In addition, while a drug is typically up for price negotiations either nine years or 13 years after its initial FDA approval, the Orphan Cures Act would start the countdown to eligibility for rare disease therapies only when the drug branches out beyond orphan indications, according to the House version of the Big Beautiful Bill Act passed in May.
  • Monday’s release of the proposed legislation represented the Senate’s first crack at Trump’s sweeping tax-cut and spending bill.
  • https://www.fiercepharma.com/pharma/orphan-drug-fix-ira-dropped-senate-version-big-beautiful-bill-setback-biopharma

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

Makary: EHRs Could Be Used For Patient Matching, Faster Approvals

  • FDA Commissioner Marty Makary touted the benefits of using electronic health records (EHRs) for both premarket research and post-market surveillance, saying at a conference Monday (June 17) the records could be used for patient matching and to immediately monitor drugs when they hit the market, potentially allowing for faster approvals with lower initial evidence thresholds.
  • https://insidehealthpolicy.com/daily-news/makary-ehrs-could-be-used-patient-matching-faster-approvals   (subscription required for full text)

KEY MEDTECH NEWS

MedTech Europe calls for medtech tariff and export restriction exemptions

  • MedTech Europe has issued a statement calling on European policymakers to exempt medical technologies from any trade tariffs or export restrictions.
  • The trade body’s overall request was that medical technologies be included and prioritised in a “zero for zero” tariff agreement on industrial goods or as part of any negotiated settlement that seeks to eliminate tariffs on both sides of the Atlantic.
  • Trump has since threatened to raise tariffs on the EU to 50% if no deal is reached by the end of the pause period on 9 July.
  • According to reports by German newspaper Handelsblatt, the EU was willing to accept a flat fee of 10% tariffs. However, in a statement shared with Reuters, the EC dismissed the claims, stating: “Negotiations are ongoing, and no agreement has been reached at this stage. The EU has from the start objected to unjustified and illegal US tariffs.”
  • In concluding remarks, MedTech Europe stated: “Patients must not become collateral damage in a trade dispute. Safeguarding their access to the technologies they depend on must remain a shared priority.”
  • https://www.medicaldevice-network.com/news/medtech-europe-calls-for-medtech-tariff-and-export-restriction-exemptions/?cf-view

KEY ACRONYMS

  • ACA = Affordable Care Act
  • AHRQ = Agency for Healthcare Research and Quality
  • CBER = Center for Biologics Evaluation and Research
  • CDC = Centers for Disease Control and Prevention
  • CMC = chemistry, manufacturing and controls
  • CMS = Centers for Medicare & Medicaid Services
  • CNPV = Commissioner’s National Priority Voucher
  • DNA = deoxyribonucleic acid
  • DMD = Duchenne muscular dystrophy
  • DOGE = Department of Government Efficiency
  • EC = European Commission
  • EU = European Union
  • HER = electronic health records
  • FDA = Food and Drug Administration
  • GOP= Grand Old Party (Republican)
  • HHS = Department of Health and Human Services
  • IRA = Inflation Reduction Act
  • MAHA = Make America Healthy Again
  • NIH = National Institutes of Health
  • PSNet = Patient Safety Network
  • RSV = Respiratory Syncytial Virus

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