Blog | 8/8/2025

Trump Administration Healthcare News: August 8, 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 7, 2025. The details and broad themes may have changed.

KEY FEDERAL GOVERNMENT NEWS

NIH

Senate committee opposes Trump’s NIH cuts, proposes $400M budget increase

  • A Senate committee has rejected President Donald Trump’s efforts to gouge funding for the National Institutes of Health (NIH), instead passing draft legislation that would increase funding for the nation’s medical research agency by $400 million for the next fiscal year.
  • The bill, approved by the U.S. Senate Committee on Appropriations in a 26-3 vote at the end of last week, also aims to keep CDC funding fairly intact after Trump announced plans to halve the center’s budget.
  • The House Committee on Appropriations is slated to review and revise its own version of the funding bill in September before sending it forward for a full House vote.
  • If finalized, the measure would provide $197 billion in overall funding under the Labor, Health and Human Services, Education, and Related Agencies Appropriations Act, with $48.7 billion of that money going to the NIH for biomedical research. The move signals the lawmakers' desire to maintain NIH’s status as the world’s largest public funder of biomedical research.
  • The act would also keep NIH’s 27 institutes and centers intact, in opposition to Trump’s consolidation plans.
  • Some of the highlights for NIH-specific funding include $3.9 billion for Alzheimer’s disease and dementia research; $2.3 billion for the National Institute of Diabetes and Digestive and Kidney Diseases; a $19 million increase from 2025’s fiscal year for rare disease research; and a $30 million increase for the Office of Research on Women’s Health.
  • https://www.fiercebiotech.com/biotech/senate-committee-oppose-trumps-nih-cuts-propose-400m-budget-increase

Trump administration violated impoundment law by canceling NIH grants, slowing new awards, GAO finds

  • In a scathing report issued Tuesday, the Government Accountability Office found that the Trump administration, by abruptly canceling National Institutes of Health grants, had violated a 1974 law blocking presidents from withholding funding Congress has approved.
  • The independent congressional watchdog said that in terminating over 1,800 NIH grants in response to President Trump’s executive orders directing agencies to cut off federal funding for equity-related activities, the administration illegally withheld funds. In addition, the GAO found that the NIH’s $8 billion shortfall in new and continuing awards between February and July amounted to an illegal withholding of obligated funds.
  • GAO findings are nonbinding but could empower Congress to push back against the Trump administration’s attempts to use NIH’s $48 billion biomedical research budget as leverage over the nation’s colleges, universities, and medical centers, as well provide ammunition to plaintiffs in the many ongoing lawsuits challenging the president’s tactics.
  • https://www.statnews.com/2025/08/05/gao-says-nih-cuts-violated-impoundment-control-act/  (subscription required for full text)

FDA

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

US FDA names Sean Keveney as chief counsel

  • The U.S. Food and Drug Administration on Monday named Sean Keveney as its new chief counsel, placing him in charge of overseeing all legal matters at the health agency.
  • Keveney most recently served as acting general counsel at the Department of Health and Human Services, where he led legal efforts to implement key administration priorities and regulatory reforms under the Make America Healthy Again agenda.
  • Before joining HHS, Keveney spent nearly 16 years at the Department of Justice's Civil Rights Division.
  • He replaces Robert Foster, who was serving in an interim capacity following the abrupt resignation of former chief counsel Hilary Perkins, just two days after her appointment was announced.
  • Perkins stepped down after Republican Senator Josh Hawley of Missouri criticized her selection, describing her as "pro-abortion" and supportive of vaccine mandates.
  • Foster, who has advised U.S. health secretary Robert F. Kennedy Jr. on vaccine regulation, will now assume the role of acting general counsel at HHS, the department confirmed.
  • Press:  https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-names-sean-keveney-chief-counsel-2025-08-04/
  • HHS Press: https://www.hhs.gov/press-room/fda-appoints-sean-keveney-chief-counsel.html

Makary says he wants Prasad back at FDA, just a week after sudden exit

  • FDA Commissioner Marty Makary said he wants former CBER head Vinay Prasad to return to the FDA, and said it’s “untrue” that he was pushed out of his role, but instead chose to resign.
  • “We have encouraged him to reconsider and we’re still doing that,” Makary said of Prasad’s exit at a Monday event in Washington. Those comments echoed a July 30 interview with CNBC, the day after Prasad left, in which Makary said that he was still in touch with the former CBER head and called him “a genius.”
  • “We’re going to continue to talk to him,” Makary told CNBC.
  • https://endpoints.news/makary-has-asked-prasad-to-reconsider-departure-from-fda/(subscription required for full text)     

CDC

Major Medical Groups Pushed Out of Role Supporting CDC's Vaccine Advisors

  • Multiple healthcare organizations that have historically helped the CDC's Advisory Committee on Immunization Practices (ACIP) develop vaccine recommendations have been told they can no longer participate in ACIP work groups, leaving the organizations frustrated and worried about what will happen next.
  • According to an email sent late Thursday afternoon from the ACIP Secretariat, which is made up of CDC staff members, "Liaison organizations are special interest groups and therefore are expected to have a 'bias' towards their constituency and/or population that they represent. It is important that the ACIP workgroup activities remain free of influence from any special interest groups, so ACIP work groups will no longer include liaison organizations." It added, however, that "the ACIP charter will continue to include approved liaison organizations. Representatives will be permitted to continue to participate in the meetings that are open to the public."
  • This includes the American Pharmacists Association (APhA), one of the groups that received the notification.
  • Seven other medical organizations that also received Thursday's notice included the American Medical Association (AMA), American Academy of Pediatrics (AAP), Infectious Diseases Society of America (IDSA), American Osteopathic Association, American College of Physicians, American Geriatrics Society, and National Medical Association.
  • Asked to comment on the notice, an HHS spokesperson said in an email that "under the old ACIP, outside pressure to align with vaccine orthodoxy limited asking the hard questions. The old ACIP members were plagued by conflicts of interest, influence, and bias. We are fulfilling our promise to the American people to never again allow those conflicts to taint vaccine recommendations. Experts will continue to be included based on relevant experience and expertise, not because of what organization they are with."
  • https://www.medpagetoday.com/infectiousdisease/vaccines/116802   (subscription required for full text)

HHS

ACA premiums set to spike

  • People who buy health insurance through the Affordable Care Act (ACA) are set to see a median premium increase of 18 percent, more than double last year’s 7 percent median proposed increase, according to an analysis of preliminary filings by KFF.
  • The proposed rates are preliminary and could change before being finalized in late summer. The analysis includes proposed rate changes from 312 insurers in all 50 states and DC.
  • It’s the largest rate change insurers have requested since 2018, the last time that policy uncertainty contributed to sharp premium increases. On average, ACA marketplace insurers are raising premiums by about 20 percent in 2026, KFF found.
  • Insurers said they wanted higher premiums to cover rising health care costs, like hospitalizations and physician care, as well as prescription drug costs. Tariffs on imported goods could play a role in rising medical costs, but insurers said there was a lot of uncertainty around implementation, and not many insurers were citing tariffs as a reason for higher rates.
  • Press: https://thehill.com/homenews/5440172-aca-premiums-set-to-spike
  • KFF Analysis:  https://www.healthsystemtracker.org/brief/how-much-and-why-aca-marketplace-premiums-are-going-up-in-2026

KEY REVERSALS – RESCINDED ITEMS

CDC to restore overdose prevention funds

  • The Trump administration is restoring full funding for a Centers for Disease Control and Prevention program that provides grants to reduce and track drug overdoses, including fentanyl.
  • Grant recipients had been sounding the alarm after the administration held up money that had already been appropriated to the CDC’s Overdose Data to Action (OD2A) program. Advocacy groups on Tuesday said they had been informed the program will be fully funded.
  • CDC’s OD2A cooperative agreement provides funding to 90 health departments.
  • NPR first reported last month that the administration had delayed and might cancel about $140 million of the program’s grants. It was also first to report on the restoration of funding. 
  • The Office of Management and Budget told The Hill it was never withholding funding, and CDC had the authority to release the funds.
  • https://thehill.com/policy/healthcare/5437790-cdc-to-restore-overdose-prevention-funds/

HHS, CMS Eliminate Financial Pressure Tied to Hospital Staff Vaccination Reporting

  • HHS and CMS have eliminated a federal policy that tied hospital reimbursement to staff COVID-19 vaccination reporting, officials announced this week.
  • HHS Robert F. Kennedy Jr. said the incentive program — originally enacted under the Biden administration — was coercive and conflicted with principles of informed consent.
  • “Medical decisions should be made based on one thing: the wellbeing of the person — never on a financial bonus or a government mandate,” Mr. Kennedy said in an Aug. 1 statement. “Doctors deserve the freedom to use their training, follow the science, and speak the truth — without fear of punishment.”
  • The reporting policy was part of CMS’ inpatient payment rule and required hospitals to submit staff vaccination data through the CDC’s national healthcare safety network.
  • Press: https://www.beckershospitalreview.com/finance/cms-scraps-financial-incentives-tied-to-hospital-vaccine-reporting/
  • HHA Press: https://www.hhs.gov/press-room/hhs-cms-end-vaccine-reporting-incentives.html

KEY LAWSUITS

2 more cases challenging Medicare negotiation rejected in federal courts

  • Federal judges in Texas and Connecticut on Thursday ruled against arguments challenging the constitutionality of the Medicare Drug Price Negotiation Program, delivering two more blows to the pharmaceutical industry this week after an appeals court upheld the dismissal of a similar case.
  • These decisions come just one day after a federal judge upheld a ruling to dismiss a similar challenge to Medicare negotiations brought forward by the U.S. Chamber of Commerce. The courts found that several of the plaintiffs attached to the case lacked standing to sue.
  • https://thehill.com/policy/healthcare/5442026-two-more-cases-challenging-medicare-negotiation-rejected-federal-courts/

16 states sue to end Trump administration's pressure campaign on gender-affirming care providers

  • More than a dozen states filed a lawsuit Friday against the Trump administration over what they describe as an unlawful intimidation campaign against hospitals and other providers of gender-affirming care.
  • Citing executive agency guidances, demands for data and threats of civil and criminal prosecution, the complaint calls out several examples over the past few months in which pediatric hospitals and health systems said they would no longer provide some or all gender-affirming care services to young patients due to federal scrutiny.
  • Earlier this year, a Supreme Court ruling upheld a Tennessee law banning the provision of gender-affirming care for minors. More than two dozen states have similar laws in place.
  • Gender-affirming care comprises a range of social, behavioral and medical services that may include hormone therapy and, rarely, surgical procedures, the latter of which is most vigorously targeted by those opposing the treatments.
  • https://www.fiercehealthcare.com/providers/16-states-sue-end-trump-administrations-pressure-campaign-gender-affirming-care-providers

KEY BIOPHARMA NEWS

Trump, pharma industry discuss boosting medicine spending abroad to cut US prices, sources say

  • The Trump administration has been talking to drugmakers about ways to raise prices of medicines in Europe and elsewhere in order to cut drug costs in the United States, according to a White House official and three pharmaceutical industry sources.
  • U.S. officials told drug companies it would support their international negotiations with governments if they adopt "most favored nation" pricing under which U.S. drug costs match the lower rates offered to other wealthy countries, the White House official said.
  • The U.S. is currently negotiating bilateral trade deals and setting tariff rates on the sector.
  • The Trump administration has asked some companies for ideas on raising prices abroad, two of the sources said, describing multiple meetings over several months aimed at lowering U.S. prices without triggering cuts to research and development spending drugmakers insist would result.
  • The White House official called the effort collaborative, saying both sides were seeking advice from each other.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/trump-pharma-industry-discuss-boosting-medicine-spending-abroad-cut-us-prices-2025-08-07/

US FDA announces new program to boost domestic drug manufacturing

  • The U.S. Food and Drug Administration on Thursday announced a new program to strengthen the domestic pharmaceutical supply chain by facilitating construction of manufacturing sites.
  • The program, called FDA PreCheck, aims to “streamline review of domestic pharmaceutical manufacturing and eliminate unnecessary regulatory requirements”, the FDA said.
    • The program also introduces a two-phase approach to facilitate new U.S. drug manufacturing facilities.
    • The initial phase would provide for more frequent communication with the FDA, including for facility design, construction and pre-production.
    • The second phase would facilitate pre-application meetings and early feedback to help streamline the development of manufacturing and quality control processes, the agency said.
  • "The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America's reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply," FDA Commissioner Marty Makary said in a statement.
  • The FDA plans to hold a public meeting on September 30 to discuss the new program.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-announces-new-program-boost-domestic-drug-manufacturing-2025-08-07/

Trump teases stepwise tariff plan for pharma

  • President Trump plans to levy a stepwise series of pharmaceutical tariffs that could reach 150% within a year and a half, then rise to 250%, he said in a wide-ranging interview on CNBC Tuesday.
  • It's the highest tariff rate the president has threatened the industry with to date while he also presses major manufacturers to commit to a "most-favored nation" pricing policy.
  • Trump previously threatened tariffs of up to 200%.
  • "On pharmaceuticals, we'll be putting an initially small tariff," Trump told CNBC. "But within one year, one-and-a-half years maximum, it's going to go to 150%, and then it's going to go to 250% because we want pharmaceuticals made in our country," he said.
  • An announcement is planned for as soon as this week, he said.
  • A number of drugmakers, including Eli Lilly, AstraZeneca, Johnson & Johnson and Roche, have made commitments to build up more U.S. manufacturing capability. But experts say it can take years to build new plants and shift product lines.
  • A PhRMA spokesperson wouldn't comment on Trump's latest remarks, but the group has said tariffs on medicines would be "counterproductive."
  • https://www.axios.com/2025/08/06/trump-tariff-plan-drugs-pharma

RFK Jr. cuts $500 million in mRNA vaccine contracts (BARDA)

  • The Trump administration is terminating 22 contracts focused on developing mRNA vaccines and winding down additional federal investments in mRNA technology, Health and Human Services Secretary Robert F. Kennedy Jr. announced Tuesday.
  • Many scientists and infectious disease experts swiftly denounced the move as a broadside on an area of research seen as particularly promising after its use in rapidly developing Covid vaccines.
  • The projects that are being axed were funded by the Biomedical Advanced Research and Development Authority (BARDA), a Department of Health and Human Services program that works with the pharmaceutical industry to develop vaccines and other countermeasures for public health emergencies.
  • "After reviewing the science and consulting top experts at NIH and FDA, HHS has determined that mRNA technology poses more risks than benefits for these respiratory viruses," Kennedy said in a video announcement on X.
  • Press: https://www.nbcnews.com/health/health-news/rfk-jr-cuts-500-million-mrna-vaccine-contracts-dealing-major-blow-prom-rcna223281
  • HHS Press: https://www.hhs.gov/press-room/hhs-winds-down-mrna-development-under-barda.html

HHS Unveils 340B Drug Rebate Pilot Program

  • On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases.
  • Under the program, drug manufacturers will be allowed to require safety-net hospitals and clinics to purchase select 340B drugs at full price and then submit claims data to receive manufacturer rebates after dispensation.
  • The pilot program is limited to drugs listed on the Centers for Medicare and Medicaid Services (CMS) Medicare Drug Price Negotiation Selected Drug List and is subject to proposed safeguards and requirements.
  • Covered entities, drug manufacturers, contract pharmacies, and the public can comment on the proposal on or before September 2, 2025.
  • Analysis: https://www.huschblackwell.com/newsandinsights/hhs-unveils-340b-drug-rebate-pilot-program
  • HHA Press: https://www.hrsa.gov/about/news/press-releases/rebate-model-pilot-program

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

HHS locks in health IT rule to advance electronic prior auth, real-time prescription benefit checks

KEY ACRONYMS

  • ACA = Affordable Care Act
  • BARDA = Biomedical Advanced Research and Development Authority
  • BsUFA = Biosimilar User Fee Act
  • CDC = Centers for Disease Control and Prevention
  • CBER = Center for Biologics Evaluation and Research
  • CDER = Center for Drug Evaluation and Research
  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • GAO = Government Accountability Office
  • GDUFA = Generic Drug User Fee Amendments
  • HHS = Department of Health and Human Services
  • NIH = National Institutes of Health
  • OD2A = Overdose Data to Action
  • PDUFA = Prescription Drug User Fee Act

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