Blog | 8/29/2025

Trump Administration Healthcare News: August 29, 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 August 28, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

Global Health Workers Urge Swift Intervention To Save USAID Programs

KEY FEDERAL GOVERNMENT NEWS

White House selects Kennedy deputy Jim O'Neill as acting CDC director

  • Jim O'Neill, the deputy secretary of Health and Human Services, has been picked to lead the Centers for Disease Control and Prevention as acting director, the Washington Post first reported and Axios can confirm.
  • Why it matters: O'Neill's appointment could pave the way for Health Secretary Robert F. Kennedy Jr. to set his agenda at the CDC after a tumultuous week at the federal agency.
  •  State of play: The Trump administration's ousting of CDC director Susan Monarez has led to a wave of resignations and a walkout at the agency's global HQ in Atlanta on Thursday. Despite her firing, Monarez has refused to leave her post.
  • The biotech investor, who is close to Trump ally Peter Thiel, has been working alongside Kennedy since last November and had been tasked with implementing the "Make America Healthy Again" agenda.
  • https://www.axios.com/2025/08/28/cdc-director-rfk-jr-jim-oneill

CDC Director Susan Monarez fired by Trump administration after refusing to resign

  • The Centers for Disease Control and Prevention leadership was in stunning disarray Wednesday evening after the Trump administration fired the agency’s director hours after she refused to resign under pressure.
  • The director, Susan Monarez, said she was resisting being ousted by the nation’s top health official, Robert F. Kennedy Jr., for political reasons after about a month in office.
  • “Dr. Monarez has neither resigned nor received notification from the White House that she has been fired, and as a person of integrity and devoted to science, she will not resign,” added the attorneys, who did not reply to a request for comment.
  • The White House fired back shortly afterward, formally terminating Monarez.
  • “As her attorney’s statement makes abundantly clear, Susan Monarez is not aligned with the President’s agenda of Making America Healthy Again. Since Susan Monarez refused to resign despite informing HHS leadership of her intent to do so, the White House has terminated Monarez from her position with the CDC,” White House spokesman Kush Desai said.
  • https://www.nbcnews.com/health/health-news/cdc-director-monarez-out-confirmed-rfk-jr-rcna227620

Top CDC Officials Resigned After Trump Administration Said It Fired Susan Monarez

  • Three high-ranking officials at the Centers for Disease Control and Prevention have submitted their resignations in the wake of the Trump administration’s stated dismissal of CDC Director Susan Monarez, two agency employees with knowledge of the situation confirmed.
  • The three departing officials are Demetre Daskalakis, director of the National Center for Immunization and Respiratory Diseases; Daniel Jernigan, director of the National Center for Emerging and Zoonotic Infectious Diseases; and Debra Houry, the CDC’s chief medical officer and deputy director for program and science.
  • https://www.notus.org/health-science/cdc-officials-resign-susan-monarezs-ousting

HHS, CMS form advisory committee to improve patient care, call for nominations

FDA approves updated COVID vaccines with restrictions on their use

  • Health and Human Services (HHS) Secretary Robert Kennedy Jr. announced on Wednesday that the Emergency Use Authorizations (EUA) for all COVID-19 vaccines have been rescinded, coinciding with the approval of updated versions of the Moderna, Pfizer, and Novavax vaccines for adults over 65 and for those with underlying conditions that increase their risk for severe disease.
  • Kennedy said he has now accomplished four of his promises as HHS secretary, including to end COVID-19 vaccine mandates, to keep vaccines available to those that want them, to demand placebo-controlled trials, and to end the COVID-19 emergency.
  •  “In a series of FDA actions today we accomplished all four goals,” he wrote.
  •  “FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+),” he added. “These vaccines are available for all patients who choose them after consulting with their doctors.”
  •  As of publication, neither HHS nor the Food and Drug Administration (FDA) have issued statements regarding the vaccines or the rescission of the EUAs; however, FDA’s webpages for the three vaccines now state that their respective EUAs have been revoked as of 27 August 2025.
  • https://www.raps.org/News-and-Articles/News-Articles/2025/8/FDA-approves-updated-COVID-vaccines-with-restricti

Prasad's return to FDA comes with fewer titles and a seemingly lower profile

  • Vinay Prasad, who briefly left his role as head of the FDA’s Center for Biologics Evaluation and Research, has come back to the agency without his former additional titles of chief medical and scientific officer.
  • FDA Commissioner Marty Makary originally gave him the expansive roles to help lead on “cross-cutting and emerging medical and scientific issues impacting regulatory science and public health.”
  • HHS didn’t respond to a question on why Prasad no longer holds those titles, but it confirmed that his updated FDA profile is accurate. Prasad didn’t respond to a request for comment.
  • https://endpoints.news/vinay-prasad-drops-two-of-his-titles-in-return-to-fda/   (subscription required for full text)

NCI axes funding for pediatric brain cancer trial consortium, shifts focus to broader oncology group

  • The National Cancer Institute (NCI) is ending its support for a 26-year-old push to advance clinical trials for children with brain tumors.
  • Founded in 1999, the Pediatric Brain Tumor Consortium (PBTC) brings together 15 academic centers and children’s hospitals in the U.S. and Canada to run phase 1 and 2 trials. The consortium has led studies of new therapies, treatment delivery technologies and radiation treatment strategies and worked with the Children’s Oncology Group to move programs into larger trials.
  • That work is now coming to an end, at least at the PBTC. In an update first reported by Endpoints News, the NCI said the PBTC will not be able to apply for another five-year award to continue its funding beyond March 2026. A Department of Health and Human Services spokesperson confirmed and explained the decision to Fierce Biotech.
  • “Over time the fields of pediatric drug development and brain tumor research have evolved considerably,” the HHS spokesperson said via email. “After reviewing this changing landscape, NCI has concluded that its resources can be used most effectively by expanding support for the Children’s Oncology Group Pediatric Early Phase Clinical Trials Network (PEP-CTN).”
  • Press: https://www.fiercebiotech.com/biotech/nci-axes-funding-pediatric-brain-cancer-trial-consortium-shifts-focus-broader-oncology

FDA To Publish Drug-Related Adverse Event Reports Daily

  • The FDA Adverse Event Reporting System, which Commissioner Marty Makary called “clunky,” previously published updates on a quarterly basis.
  • The FDA has started publishing drug-related adverse events detected by the FDA Adverse Event Reporting System daily, a move that Commissioner Marty Makary said will help boost the agency’s transparency.
  • “Adverse event reporting should be fast, seamless and transparent,” Makary said in a prepared statement on Friday, in which he called the government’s toxicity reporting system for side effects “clunky.” People using the system “should not have to wait months” before safety information regarding the medicines become public. Before Friday, the FDA updated the FAERS quarterly.
  • The FAERS is the agency’s main repository of adverse events related to drugs and biologics, as well as “serious medication errors” and quality complaints. It collects reports from doctors, manufacturers and consumers. The public can access these reports through an interactive dashboard, which gives the users “more ways of searching for and organizing data” on adverse events of drugs and biologics.
  • Press: https://www.biospace.com/fda/fda-to-publish-drug-related-adverse-event-reports-daily
  • FDA: https://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data

Blue States That Sued Kept Most CDC Grants, While Red States Feel Brunt of Trump Clawbacks

  • The Trump administration’s cuts to Centers for Disease Control and Prevention funding for state and local health departments had vastly uneven effects depending on the political leanings of a state, according to a KFF Health News analysis. Democratic-led states and select blue-leaning cities fought back in court and saw money for public health efforts restored — while GOP-led states sustained big losses.
  • The Department of Health and Human Services in late March canceled nearly 700 Centers for Disease Control and Prevention grants nationwide — together worth about $11 billion.
  • Initially, grant cancellations hit blue and red states roughly evenly.
  • But after attorneys general and governors from about two dozen blue states sued in federal court and won an injunction, the balance flipped.
  • In blue states, nearly 80% of the CDC grant cuts have been restored, compared with fewer than 5% in red states, according to the KFF Health News analysis.
  • https://kffhealthnews.org/news/article/cdc-grant-trump-clawbacks-blue-red-state-comparison/

U.S. Government Cracks Down on Organ Transplant System

  • Organ donation groups accused of safety lapses are facing multiple investigations, and new policies are underway to protect patients.
  • The federal government is cracking down on the U.S. organ transplant system, investigating donation groups accused of safety lapses and overhauling policies meant to protect donors and recipients.
  • The efforts come after congressional scrutiny and reporting in The New York Times revealed troubling problems in the system, including at organ procurement organizations, the nonprofit groups in each state that arrange transplants. A federal investigation recently found that the organization in Kentucky had ignored signs of growing alertness in critically ill patients being prepared for organ donation.
  • The U.S. Department of Health and Human Services has begun investigating other nonprofits over similar accusations, as well as reining in others that flout fairness rules by sending organs to patients who are not near the top of waiting lists.
  • The initiatives were described in an interview with Dr. Raymond Lynch, the transplant chief at the Health Resources and Services Administration, an agency within H.H.S. that oversees the system. “We want to make sure that people continue to have faith in the public good that is organ procurement and transplant,” he said. “We will make it safe and reliable.”
  • Press: https://www.nytimes.com/2025/08/28/us/federal-crackdown-organ-donations.html   (subscription required for full text)
  • HHS: https://www.hhs.gov/press-room/hrsa-organ-allocation-dashboard.html

KEY REVERSALS – RESCINDED ITEMS

Courts press pause on key elements of Trump administration's ACA rule

  • A federal judge has blocked multiple provisions of the Trump administration's Affordable Care Act (ACA) overhaul from taking effect Monday as scheduled.
  • The plaintiffs, including multiple large cities like Baltimore and Columbus, Ohio, as well as organizations like the Main Street Alliance, sued in an attempt to block the regulations in early July, arguing they could lead 1.8 million or more people to lose coverage and drive up premiums and out-of-pocket costs.
  • The lawsuit challenges the rule as a violation of the Administrative Procedure Act.
  • Given that high likelihood of success, Hurson granted an injunction Friday that bars these elements from taking effect until the case can be heard. That includes a $5 premium penalty on auto-enrollments as well as a policy that would disqualify individuals from advanced subsidies if they didn't file income taxes or did not reconcile their tax credits in previous years.
  • The ruling also pauses the rollout of new calculations around plan tiers and requirements for pre-enrollment eligibility checks for the special enrollment periods.
  • https://www.fiercehealthcare.com/regulatory/courts-press-pause-key-elements-trump-administrations-aca-rule

KEY BIOPHARMA NEWS

White House officials link pharma tariffs with ‘most favored nation’ pricing program

  • One of the main questions facing the Trump administration as it seeks to lower prescription drug prices through executive order is: How?
  • Tuesday’s cabinet meeting seemed to provide an answer.
  • For the first time, top members of the administration publicly linked the Commerce Department’s 232 investigation into pharmaceutical products — and tariffs that are expected to follow — with President Donald Trump’s “most favored nation” plan to get drugmakers to reduce prices in the US.
  • Commerce Secretary Howard Lutnick told the president that the combination of the 232 investigation and the most favored nation program, which is being led in part by HHS Secretary Robert F. Kennedy Jr., “really gives Bobby the tools to go execute your plan.”
  • Kennedy, who was also at the cabinet meeting, praised Lutnick, and said that “he’s going to help us get across the finish line with the leverage that we have from tariffs.”
  • https://endpoints.news/us-officials-link-tariffs-with-drug-pricing-talks/   (subscription required for full text)

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

RFK Jr.: Americans will see health records on phones

KEY ACRONYMS

  • ACA = Affordable Care Act
  • CDC = Centers for Disease Control and Prevention
  • CMS = Centers for Medicare & Medicaid Services
  • EUA = Emergency Use Authorizations
  • FAERS = FDA Adverse Event Reporting System
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • MAHA = Make America Healthy Again
  • MFN = most favored nation
  • NCI = National Cancer Institute
  • NIH = National Institutes of Health
  • PBCT = Pediatric Brain Tumor Consortium
  • PEP-CTN = Pediatric Early Phase Clinical Trials Network
  • USAID = U.S. Agency for International Development

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