Blog | 9/5/2025

Sharp Strategy Spotlight: September 5, 2025

We’re excited to announce the relaunch of this newsletter—formerly known as the Trump Administration Newsletter (TAN)—under a new name: Sharp Strategy Spotlight. While TAN focused primarily on the first year of impactful (and sometimes disruptive) US policy developments, Sharp Strategy Spotlight will broaden its lens to offer strategic perspectives on the trends, policies, and ideas shaping healthcare globally, with a specific focus on their impact on biopharma, diagnostics, medtech, and digital health.

This evolution reflects our commitment to delivering timely, thoughtful insights that go beyond the headlines. Sharp Strategy will continue to feature news and editorial pieces from Health Advances thought leaders, as well as regular contributions from our Health Advances Library Services (HALS) team, ensuring a rich mix of expert analysis and curated intelligence. We will also continue to share healthcare news from the US administration and global policymakers on a regular basis.

Whether you're navigating regulatory shifts, evaluating commercial market dynamics, or exploring innovation across national or technological borders, we hope Sharp Strategy Spotlight will be a go-to source for clarity and context in a rapidly changing healthcare landscape.

This issue reflects news as of 11 AM on September 4, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

Trump cancels $4.9 billion in foreign aid, escalating spending fight with Congress

  • President Donald Trump has moved to unilaterally cancel $4.9 billion in foreign aid authorized by Congress, escalating the fight over who controls the nation's spending.
  • Trump told House of Representatives Speaker Mike Johnson that he plans to withhold funding for 15 international programs.
  • The U.S. Constitution grants funding power to Congress, which passes legislation each year to fund government operations.
  • The White House must secure Congress' approval if it does not want to spend that money. Congress did this in July when it approved the cancellation of $9 billion in foreign aid and public media funding.
  • The latest move -- known as a "pocket rescission" -- bypasses Congress entirely.
  • Trump budget director Russell Vought has argued that Trump can withhold funds for 45 days, which would run out the clock until the end of the fiscal year on September 30. The White House said the tactic was last used in 1977.
  • According to a court document filed on Friday, the money at issue was earmarked for foreign aid, United Nations peacekeeping operations, and democracy-promotion efforts overseas. Most of that had been handled by the U.S. Agency for International Development, which Trump's administration has largely dismantled.
  • Press: https://www.reuters.com/legal/government/trump-cancels-49-billion-foreign-aid-escalating-spending-fight-with-congress-2025-08-29/
  • White House press: https://www.whitehouse.gov/briefings-statements/2025/08/historic-pocket-rescission-package-eliminates-woke-weaponized-and-wasteful-spending/

KEY FEDERAL GOVERNMENT NEWS

House Republicans propose 6% budget cut to HHS for 2026 fiscal year

  • The House Appropriations Committee is proposing a 6% cut to the budget for the Department of Health and Human Services (HHS).
  • The panel released the proposed budget bill for the 2026 fiscal year that governs the HHS as well as the departments of Labor and Education, suggesting a $108 billion outlay for the HHS. That's $7 billion less than what was set aside for fiscal year 2025, according to a fact sheet.
  • In the announcement, the committee highlights that $48 billion is set for the National Institutes of Health (NIH), with emphasis on the Trump administration's focus on tackling chronic disease. It also maintains Head Start funding at $12.3 billion and Child Care and Development Block Grants at $8.7 billion.
  • In the fact sheet, the committee specifically calls out that NIH's $48 billion is "a necessary counter to China’s growing threat in basic science research." The proposal would also bar buying supplies from China for the Strategic National Stockpile and instead focus on buying from American manufacturers.
  • And, while the panel did put a focus on funding outlays to NIH, it is proposing a 19% cut to the Centers for Disease Control and Prevention. That reduction will also streamline 35 "duplicative and controversial programs" and focus the agency "on communicable diseases rather than social engineering," according to the fact sheet.
  • Press: https://www.fiercehealthcare.com/regulatory/house-republicans-propose-6-budget-hhs-fiscal-year-2026
  • Analysis: https://www.axios.com/2025/09/03/trump-house-republicans-gop-nih-funding   (subscription required for full text)

HHS Employees Call for RFK Jr. to Resign

  • Current and former HHS staff are formally calling for their boss to resign or be fired in an open letter, escalating their previous call for HHS Secretary Robert F. Kennedy Jr. to stop spreading misinformation.
  • More than a thousand people tied to CDC, FDA, NIH, and several other HHS agencies signed the letter addressed to Secretary Kennedy and members of Congress and posted it to a website called Save HHS.
  • "We warn the President, Congress, and the Public that Secretary Kennedy's actions are compromising the health of this nation, and we demand Secretary Kennedy's resignation," the letter stated. "Should he decline to resign, we call upon the President and U.S. Congress to appoint a new Secretary of Health and Human Services, one whose qualifications and experience ensure that health policy is informed by independent and unbiased peer-reviewed science."
  • Kennedy didn't respond to that letter, though HHS released a statement that accused the workers of "politicizing a tragedy."
  • https://www.medpagetoday.com/washington-watch/washington-watch/117295

FDA Pulls RFK Jr. Critic Off Its Vaccine Advisory Panel

  • Pediatric vaccine expert Paul Offit, MD, a longtime critic of HHS Secretary Robert F. Kennedy Jr., has been removed from the FDA's influential vaccine panel.
  • Offit had already served two 4-year terms on the Vaccines and Related Biological Products Advisory Committee (VRBPAC), from 2017 to January 2025. He agreed to another 2-year term that was slated to end Jan. 31, 2027. But the paperwork to keep him on the FDA panel wasn't approved by HHS, and he was notified last week that it meant he was off the committee.
  • The FDA told MedPage Today in an e-mail that it had "issued notifications to certain advisory committee members whose Special Government Employee (SGE) terms have expired and therefore can no longer participate in Advisory Committee work."
  • VRBPAC is made up of a group of independent experts who evaluate the safety and effectiveness data on vaccines and related biological products and make recommendations to the FDA commissioner.
  • https://www.medpagetoday.com/infectiousdisease/vaccines/117281

HHS to expand eligibility for catastrophic plans

  • The Trump administration is expanding individuals' ability to purchase catastrophic health insurance during Affordable Care Act enrollment if they qualify for a hardship exemption based on their household income, officials tell Axios first.
  • Why it matters: The coverage could be a less costly alternative to protect individuals against high medical costs in the event of serious illness or injury.
  • But it could expose customers to possibly high out-of-pocket costs until they reach a deductible.
  • Driving the news: The new guidance from the Health and Human Services Department will kick in at the start of ACA enrollment on Nov. 1 and streamline access for individuals who are ineligible for ACA subsidies or cost-sharing reductions.
    • Eligibility would be based on projected annual household income.
    • The plans comply with ACA coverage requirements for essential health benefits, including preventive services without cost-sharing, while offering lower premiums, HHS said.
    • Officials didn't provide more details.
  • Analysis: https://www.axios.com/2025/09/04/trump-hhs-expand-catastrophic-plan-eligibility   (subscription required for full text)
  • HHS Press: https://www.hhs.gov/press-room/hhs-expands-access-affordable-catastrophic-health-coverage.html

Republicans tout CBO analysis that found 2.3M misstated income to secure ACA subsidies

  • Legislators asked the CBO to dig further into the potential coverage impacts of the One Big Beautiful Bill Act, a massive and far-reaching reconciliation package that includes significant overhauls in healthcare. The analysis found that 2.3 million individuals received premium tax credits improperly by misstating their income.
  • That grew from 1.3 million people who did the same in 2023, according to the CBO.
  • It also estimates that if income verification requirements, which were established as part of a recently finalized regulation, had been in place previously, about 500,000 fewer people would have received enhanced premium subsidies on the exchanges.
  • The CBO also said the bill could lead to a 0.6% decrease in premiums on the exchanges in 2034.
  • The OBBBA also restricts immigrants' access to ACA marketplace coverage, and the CBO estimates that this will lead to about 900,000 people losing coverage by 2034. Policy changes to prevent immigrants from receiving enhanced premium tax credits, or EPTCs, would lead to a further 300,000 coverage losses, the report shows.
  • Press: https://www.fiercehealthcare.com/regulatory/republicans-tout-cbo-analysis-found-23m-misstated-income-secure-aca-subsidies
  • CBO Report: https://d1dth6e84htgma.cloudfront.net/08_25_2025_Letter_CBO_Response_to_07_29_2025_ACA_Letter_5b33c15fef.pdf

KEY LAWSUITS

Trump admin agrees to restore public health webpages

  • The Trump administration agreed to restore scores of health agency webpages and datasets that went dark to comply with executive orders on diversity, equity and inclusion and gender identity, under a court settlement announced on Tuesday.
  • Why it matters: The information blackout shocked health providers and centered on issues like contraception and transgender health that President Trump and Republicans have repeatedly targeted. It also swept up information about HIV, at-risk youths and women's health.
  • The action prompted a lawsuit from nine medical groups who alleged the administration's actions were arbitrary, illegal and threatened public health.
  • Driving the news: Under the agreement, the Health and Human Services Department will reinstate the webpages in question to reflect how they appeared online as of Jan. 29, 2025.
  • Once that happens, the case will then be dismissed, according to AcademyHealth, one of the plaintiffs in the lawsuit.
  • Yes, but: It's unclear if agencies like the Centers for Disease Control and Prevention will have the resources to update the data.
  • Analysis: https://www.axios.com/2025/09/02/tpublic-health-webpages-restored   (subscription required for full text)
  • Lawsuit Press: https://www.medpagetoday.com/washington-watch/washington-watch/117294

Medical Groups Sue RFK Jr. Over AHRQ Grant Shutdown

  • Doctors filed yet another lawsuit against HHS Secretary Robert F. Kennedy Jr., this one alleging he has effectively "shut down" the Agency for Healthcare Research and Quality's (AHRQ) extramural grant-making by illegally impounding funds.
  • The plaintiffs are the Society of General Internal Medicine (SGIM), a 3,200-member group of internal medicine academic practitioners and researchers, and the North American Primary Care Research Group, which includes 1,000 members involved in primary care research in the U.S. and Canada.
  • The lawsuit asks the U.S. District Court of Maryland to compel AHRQ to conduct the peer review assessments and award grants as it's supposed to. It also asks the court to order the agency to extend the spending deadline beyond the fiscal year's end.
  • Press: https://www.medpagetoday.com/washington-watch/washington-watch/117219
  • Lawsuit: https://www.documentcloud.org/documents/26077306-1-ahrq-complaint-final/

KEY BIOPHARMA NEWS

FDA proposes new approval pathway for rare diseases

Prasad spells out new thinking on vaccine development in Covid-19 memos

  • CBER Director Vinay Prasad is quietly dropping hints on how he may alter the way vaccines win approval, including larger immunogenicity trials as well as expanding the use of randomized trials for co-administered vaccines.
  • In recent FDA decisional memos on the Covid-19 vaccine changes for Pfizer, Moderna and Novavax, Prasad outlined his thinking on what could be required for pre-approval trials and post-marketing commitments. They offer potential insight into how the agency’s standards are changing under Prasad, FDA Commissioner Marty Makary, and HHS Secretary Robert F. Kennedy Jr.
  • For example, in a nine-page memo on Pfizer’s Covid-19 vaccine Comirnaty — building off other memos released last week — Prasad wrote that CBER “has a new evidence-based philosophy for allowing the sponsor to make claims about concurrent administration of vaccines.”
  • While noting that concurrent vaccine administration “offers the theoretical benefit of increasing compliance with annual respiratory pathogen vaccination,” he also said that “the potential downside is that multiple vaccines administered together may interfere with efficacy” or could come with “new or higher rates of safety signals that would not have occurred with sequential vaccination.”
  • https://endpoints.news/prasad-spells-out-new-thinking-on-vaccine-development-in-covid-19-memos/   (subscription required for full text)

Trump tells drugmakers to ‘justify the success’ of Covid meds after FDA limits vaccine approval

  • President Donald Trump on Monday called on pharmaceutical companies to “justify the success” of their Covid drugs days after the Food and Drug Administration set new limits on who can receive vaccines for the virus.
  • “It is very important that the Drug Companies justify the success of their various Covid Drugs. Many people think they are a miracle that saved Millions of lives. Others disagree!” Trump wrote in a Truth Social post.
  • The FDA on Wednesday approved the latest round of Covid vaccines, but only for people at higher risk of severe illness.
  • https://www.cnbc.com/2025/09/01/trump-covid-vaccines-cdc-rfk.html

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

HHS to step up enforcement of information blocking rules amid interoperability push

  • The Department of Health and Human Services’ (HHS') investigation unit and health IT offices are stepping up enforcement of information blocking committed by providers, health IT developers and health information exchanges, the department announced Wednesday.
  • The news comes as President Donald Trump’s HHS is trying to improve the flow of patient health information by securing voluntary commitments by 60 major healthcare and tech companies to advance interoperability.
  • A press release from the department says Secretary Robert F. Kennedy Jr. has “directed increased resources” to investigate and enforce information blocking rules.
  • The Office of the Assistant Secretary for Technology Policy (ASTP/ONC) has already begun to review reports of information blocking and provide technical assistance to the HHS’ Office of Inspector General (OIG) to assist its investigations, Assistant Secretary Thomas Keane, M.D., said in a statement.
  • Certified health IT developers and health information networks could face penalties of up to $1 million per violation or have their certifications terminated. Medicare and Medicaid providers could be subject to disincentives under those programs, the HHS wrote.
  • Press: https://www.fiercehealthcare.com/regulatory/hhs-step-enforcement-information-blocking-amidst-interoperability-push
  • HHS Press: https://www.hhs.gov/press-room/hhs-crackdown-health-data-blocking.html

KEY ACRONYMS

  • ACA = Affordable Care Act
  • AHRQ = Agency for Healthcare Research and Quality
  • ASTP/ONC = Assistant Secretary for Technology Policy/Office of the National Coordinator
  • CBER = Center for Biologics Evaluation and Research
  • CBO = Congressional Budget Office
  • CDC = Centers for Disease Control and Prevention
  • CDER = Center for Drug Evaluation and Research
  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • MAHA = Make America Healthy Again
  • NIH = National Institutes of Health
  • OBBA = One Big Beautiful Bill Act
  • OIG = Office of Inspector General
  • RDEP = Rare Disease Evidence Principles
  • USAID = U.S. Agency for International Development
  • VRBPAC = Vaccines and Related Biological Products Advisory Committee

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