Blog | 10/31/2025

Sharp Strategy Spotlight: October 31, 2025

Strategic perspectives on the trends, policies, and ideas shaping healthcare.

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 October 30, 2025. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

Gates Foundation skews global health agenda after US retreat, study says

  • The World Health Organization’s agenda is being skewed by a growing reliance on the Gates Foundation as the US and other rich countries cut funding, according to new research.
  • The research published in BMJ Global Health on Tuesday said the WHO had warned it needed ‘‘fundamental changes’’ to its financing. If these warnings go unheeded, “then WHO will remain vulnerable to the influence of external donors and will struggle to address the full spectrum of contemporary global health challenges”, the report said.
  • https://www.ft.com/content/d2c6dcf9-0023-4fe1-a146-162051457002   (subscription required for full text)

KEY FEDERAL GOVERNMENT NEWS

Obamacare Prices Become Public, Highlighting Big Increases

FDA publishes NDA filing checklist to avoid application derailments

  • The US Food and Drug Administration (FDA) published the internal checklists its staff reference when reviewing drug and biologics applications to determine whether the submission is complete, or subject to a refuse-to-file (RTF) decision, in an updated manual of policies and procedures (MAPP).
  • FDA said the move is intended to boost transparency into the agency’s filing procedures and cut down on the number of incomplete submissions it receives, which “consume resources and delay promising treatments.”
  • “Drug applications should not be derailed or delayed by preventable procedural oversights,” said FDA Commissioner Marty Makary. “Making these checklists public is a common-sense step to make the FDA process easier to understand and more transparent.”
  • The checklists have been added to the latest version of the MAPP 6025.4, which outlines good review practices for FDA staff.
  • https://www.raps.org/news-and-articles/news-articles/2025/10/fda-publishes-nda-filing-checklist-to-avoid-applic

NIH Follows in FDA’s Footsteps and Adopts “Bulk Sensitive Data” Policy That Goes Beyond DOJ Rule Requirements

  • The National Institutes of Health (“NIH”) has become the latest federal agency to impose obligations that go beyond those required by the watershed U.S. Department of Justice (“DOJ”) data security program (“DSP”) with its new Policy on Enhancing Security Measures for Human Biospecimens (“NIH Policy”).
  • The NIH Policy took effect on October 24, 2025, and establishes NIH’s expectations for “ensuring the security of human biospecimens whose collection, obtainment, storage, use, or distribution are supported by NIH funds” such as grants, cooperative agreements, and other intramural support, consistent with the DSP.
  • The NIH Policy prohibits entities that hold human biospecimens of U.S. persons from directly or indirectly distributing the human biospecimens to institutions or parties located in countries of concern when those biospecimens are collected, obtained, stored, used, or distributed using ongoing or new NIH funding mechanisms. Notably, the NIH Policy does not expressly state that this restriction only applies to U.S. persons (as defined under the DSP). Rather, it makes clear that this policy applies to those entities that obtained human clinical and research biospecimens from U.S. persons—including biorepositories, institutions, and investigators.
  • This policy is also broader than the DSP because unlike the DSP’s “bulk thresholds,” even a single covered biospecimen can seemingly fall within the scope of the NIH Policy.
  • Analysis: https://www.mofo.com/resources/insights/251028-nih-adopts-bulk-sensitive-data-policy-beyond-doj-rule-requirements
  • NIH Policy: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-160.html

NIH Institute Director Abruptly Replaced

  • NIH Director Jay Bhattacharya, MD, PhD, sent an email to staff late last Friday announcing that Kyle Walsh, PhD, a neuroepidemiologist, became director of the National Institute of Environmental Health Sciences (NIEHS) the Friday prior, ScienceInsider reported.
  • NIH employees active on social media noted that Walsh was not selected through the standard process for filling a vacant position.
  • He is an associate professor at Duke University School of Medicine, and has received grants from at least two NIH institutes and the Department of Defense, according to his university profile page.
  • Walsh replaced Richard Woychik, PhD, who has helmed NIEHS since 2020 and recently was renewed for a second 5-year term with the support of Bhattacharya, ScienceInsider reported. He will be taking a senior position in Bhattacharya's office focusing on the NIH's "Make America Healthy Again" agenda.
  • https://www.medpagetoday.com/washington-watch/washington-watch/118131

Unite Us CEO Daniel Brillman named director of Medicaid, CHIP

  • The CEO and co-founder of Unite Us, a company that connects healthcare and social service providers for patient care coordination, has stepped down from his role and accepted a position with the Centers for Medicare and Medicaid Services (CMS), the agency announced Tuesday.
  • Dan Brillman will take over as the deputy administrator of CMS, where he will also serve as the director of the Center for Medicaid and Children's Health Insurance Program (CHIP) services, putting him in a leadership role to oversee the federal government’s safety net healthcare programs, which are ultimately administered by each individual state.
  • In announcing the hiring, CMS Administrator Mehmet Oz, MD, said Brillman will be tasked with "strengthening Medicaid and CHIP,” which have been subjected to eligibility changes and funding cuts as part of a massive spending package passed in July and was quickly signed by President Donald Trump.
  • The agency added that the current Acting Director of Medicaid and CHIP, Caprice Knapp, will be stepping down. A healthcare economist, she entered the role on a temporary basis in June, until the administration picked someone to fill it permanently.
  • https://healthexec.com/topics/healthcare-management/healthcare-policy/former-ceo-unite-us-tapped-cms-medicaid-and-chip-lead

RFK Jr.’s top vaccine adviser says he answers to no one

  • Martin Kulldorff wants to rebuild Americans’ declining trust in vaccines even if that means limiting access to some shots in the process.
  • Kulldorff, who leads the Centers for Disease Control and Prevention’s vaccine advisory panel, spoke exclusively to POLITICO about how he sees his role and the task Health Secretary Robert F. Kennedy Jr., a longtime skeptic of vaccine safety, has given him.
  • That is, he said, to scrutinize the vaccine guidance the government gives to Americans with a skeptical eye.
  • Kulldorff said he’s an independent voice, has only met Kennedy twice and doesn’t talk to him regularly.
  • https://www.politico.com/news/2025/10/29/an-interview-with-the-chair-of-kennedys-controversial-vaccine-panel-00626463

US health agency fires official who opposed mRNA Covid shots

  • A senior biosecurity adviser at the U.S. Department of Health and Human Services, who has made several critical statements regarding mRNA COVID-19 vaccines, was fired over the weekend, an agency official told Reuters.
  • Steven Hatfill, who served as a senior adviser at the agency's Administration for Strategic Preparedness and Response, was fired on Saturday.
  • The HHS official told Reuters that Hatfill, who joined this spring, was "terminated for cause," a term typically used in cases involving performance or conduct issues.
  • The agency cited false claims of being the chief medical officer at ASPR and lack of effective cooperation with government agencies and department leadership as reasons for the ouster, according to Bloomberg News, which had reported the development earlier in the day.
  • "He (Hatfill) was senior advisor, not chief medical advisor or chief medical officer," the HHS official said, but did not immediately clarify whether this was related to his dismissal.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-fires-health-official-who-opposed-widely-used-covid-shots-bloomberg-news-2025-10-28/

Surgeon General nominee’s confirmation hearing delayed after she goes into labor

  • The nomination hearing for Casey Means, President Trump’s nominee for surgeon general, in front of the Senate Health, Education, Labor and Pensions (HELP) Committee has been postponed.
  • A spokesperson for the committee, chaired by Sen. Bill Cassidy (R-La.), a medical doctor, told The Hill Thursday that the hearing was postponed due to Means going into labor.
  • Last week, the committee said that Means would appear before it virtually, calling in from Kilauea, Hawaii.
  • CNN reported that Means was initially set to appear before the committee two days after her due date. The Hill has reached out to the committee for confirmation.
  • https://thehill.com/policy/healthcare/5580799-casey-means-surgeon-general-hearing-delay/

HHS Nixes Another USPSTF Meeting

  • HHS scrapped yet another meeting of the U.S. Preventive Services Task Force (USPSTF), sources told MedPage Today.
  • The meeting, which was supposed to take place in November, was cancelled on Wednesday, sources said. Similarly, the USPSTF meeting that was supposed to happen in July was abruptly cancelled.
  • An HHS spokeswoman, Emily Hilliard, confirmed the cancellation to MedPage Today, blaming the government shutdown. "The Trump Administration is committed to reopening the government so meetings like this one can occur," she said in an email.
  • The task force members are supposed to meet three times per year, according to its procedure manual: March, July, and November.
  • https://www.medpagetoday.com/primarycare/preventivecare/118227

FDA names Mary Thanh Hai as permanent director of Office of New Drugs

  • The FDA last week transitioned Mary Thanh Hai from acting to permanent director of the Office of New Drugs, two people with knowledge of the move told Endpoints News.
  • Thanh Hai took over as acting OND director from Peter Stein, who was pushed out of his position in April as part of a wider reduction in force. OND is responsible for approving all new drugs.
  • Stein told Endpoints on Monday that he thought Thanh Hai was “a great choice — she’s highly experienced, analytic and thorough, extremely knowledgeable.”
  • The FDA, CDER Director George Tidmarsh, and Thanh Hai did not immediately respond to requests for comment.
  • https://endpoints.news/fda-names-mary-thanh-hai-as-permanent-director-of-office-of-new-drugs/   (subscription required for full text)

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

CMS calls back furloughed employees to help with Medicare, ACA enrollment periods

  • The CMS is temporarily calling back its furloughed employees to help during the open enrollment periods for Medicare and Affordable Care Act plans, a spokesperson for the agency confirmed to Healthcare Dive.
  • They did not specify how many staffers are affected, but the return to work should encompass the roughly 3,000 employees put on furlough due to the government shutdown earlier this month, according to the agency’s plan for a lapse in funding.
  • The employees will resume work on Monday “in order to best serve the American people amid the Medicare and Marketplace open enrollment seasons,” the spokesperson said.
  • CMS plans to pay them through funding collected through user fees from sharing data with researchers.
  • https://www.medtechdive.com/news/cms-calls-back-furloughed-employees-medicare-aca-enrollment/803747/

KEY BIOPHARMA NEWS

FDA, aiming to lower drug costs, moves to speed approval of biosimilars

  • The Food and Drug Administration wants to speed the development of biosimilars, announcing new guidance on Wednesday that would no longer require the makers of copycat biologics to run human trials showing their products are as effective and safe as their branded counterparts.
  • The FDA agency said the policy shift should make biosimilar development faster and cheaper, estimating that companies could now save $100 million in development costs per product.
  • At a press conference, Commissioner Martin Makary said the move could help create “more competition [and] more choices” for people who need biologic medicines.
  • Wednesday’s announcement builds on previous FDA initiatives to ease the development and review of biosimilars. In 2024, the agency proposed dropping studies analyzing the effects of “switching” between branded products and biosimilars. That move was designed to make it easier for biosimilars to gain “interchangeability” status, which allows pharmacists to substitute them for a biologic without a doctor’s prescription.
  • Press: https://www.biopharmadive.com/news/fda-biosimilars-guidance-speed-development-comparative-efficacy-studies/804164/
  • FDA Announcement: https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs

FDA official issues warning about looming biosimilar void

  • The US Food and Drug Administration’s (FDA) top biosimilar regulator said that a recent report that found lacking biosimilar development to many of the biological products that will soon lose patent protection is a warning sign for the future of drug affordability in the US.
  • Sarah Yim, director of the FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB) within the Center for Drug Evaluation and Research (CDER), indicated that her office is looking to streamline reviews of biosimilars, so they are more like those for generic drugs, during a presentation at the Association of Accessible Medicines (AAM) GRx+Biosim meeting on 28 October.
  • Yim stated that the division aims to update and streamline the biosimilar review process to align it more closely with the review processes for generic drugs.
  • https://www.raps.org/news-and-articles/news-articles/2025/10/fda-official-issues-warning-about-looming-biosimil

Stakeholders Advocate for FDA Modernization In Senate Biotech Hearing

KEY MEDTECH NEWS

Trade Deal Leapfrogs Medical Devices Into Malaysia Market

  • The Malaysia-US reciprocal trade agreement creates an express lane for local registration of medicines and medical devices manufactured in the US, as Malaysia must accept US FDA certs and prior marketing authorisations as sufficient for local requirements.
  • A trade agreement between Malaysia and the United States expedites the entry of American-made pharmaceuticals and medical devices into the Malaysian market by cutting regulatory red tape.
  • The Malaysia-US Agreement on Reciprocal Trade (ART) – which was signed by Malaysia Prime Minister Anwar Ibrahim and US president Donald Trump last Sunday during a bilateral meeting on the sidelines of the 47th Asean Summit here – breaks down non-tariff barriers for US industrial exports.
  • This includes Malaysia “accepting US Food and Drug Administration (FDA) certificates and prior marketing authorisations for medical devices and pharmaceuticals,” according to a fact sheet by the Office of the United States Trade Representative (USTR).
  • Section 2 of Annex III of the legally binding Malaysia-US trade agreement, published by the White House last Sunday, addresses non-tariff barriers in Malaysia, including medical devices and pharmaceuticals under Article 2.4.
  • On medical devices, ART requires Malaysia to accept a prior approval or clearance issued by the US FDA as “sufficient evidence that a medical device manufactured in the United States meets Malaysia’s requirements for marketing authorisation”. Malaysia also shall not require market authorisation for low-risk medical devices where marketing authorisation is not required by the FDA.
  • “For greater certainty, this paragraph does not preclude Malaysia from maintaining registration requirements. Malaysia shall ensure that any registration requirement does not impose any additional conformity assessment procedures or other evaluation of marketing authorisation.”
  • ART requires Malaysia to recognise audits and certificates of device manufacturers’ quality management systems that are in accordance with the requirements established by the Medical Device Single Audit Program (MDSAP) and conducted by auditing organisations authorised by the regulatory authorities participating in MDSAP to audit under the MDSAP requirements, “and shall not impose additional regulatory requirements beyond those required for MDSAP”.
  • https://codeblue.galencentre.org/2025/10/trade-deal-leapfrogs-us-drugs-medical-devices-into-malaysia-market/

KEY ACRONYMS

  • AAM = Association of Accessible Medicines
  • ACA = Affordable Care Act
  • ART = Agreement on Reciprocal Trade
  • ASPR = Administration for Strategic Preparedness and Response
  • CBO = Congressional Budget Office
  • CDC = Centers for Disease Control and Prevention
  • CDER = Center for Drug Evaluation and Research
  • CHIP = Children's Health Insurance Program
  • CMS = Centers for Medicare & Medicaid Services
  • DOJ = Department of Justice
  • DSP = data security program
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • MAPP = manual of policies and procedures
  • MDSAP = Medical Device Single Audit Program
  • NIEHS = National Institute of Environmental Health Sciences
  • NIH = National Institutes of Health
  • OND = Office of New Drugs
  • OTBB = Office of Therapeutic Biologics and Biosimilars
  • RTF = refuse-to-file
  • USPSTF = U.S. Preventive Services Task Force
  • USTR = United States Trade Representative
  • WHO = World Health Organization

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