Blog | 10/10/2025

Sharp Strategy Spotlight: October 10, 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 9, 2025. The details and broad themes may have changed.

KEY FEDERAL GOVERNMENT NEWS

Trump Excludes Generics From Big Pharma Tariff Plan

  • The Trump administration said it isn’t planning to impose tariffs on generic drugs from foreign countries, after months of wrangling over whether to impose levies on the vast majority of drugs that are dispensed in the U.S.
  • The administration has been weighing duties on a range of pharmaceutical products and ingredients, using a tariff investigation under Section 232 of the Trade Expansion Act of 1962, which covers threats to national security.
  • “The administration is not actively discussing imposing Section 232 tariffs against generic pharmaceuticals,” White House spokesman Kush Desai said in a statement.
  • https://www.wsj.com/health/pharma/trump-generic-prescription-drug-tariffs-3029e024   (subscription required for fulltext)

CDC approves updated Covid-19, chickenpox vaccine recommendations

  • A top federal health official has approved recommendations allowing anyone over the age of 6 months to receive an updated Covid-19 shot after discussing the risks and benefits with their provider. While the updated recommendation maintains insurance coverage for those who want the vaccine, it doesn’t specify whether some individuals will still need a prescription to access the shot, as approved by the Food and Drug Administration in August.
  • The acting director of the Centers for Disease Control and Prevention Jim O’Neill announced Monday that he had signed off on the recommendations issued by a panel of advisers to the agency last week. It had been around two weeks since those recommendations were initially made. He also approved a recommendation that children under the age of 4 receive the combined measles, mumps, rubella vaccine and the chickenpox shot separately, as opposed to receiving a combined shot.
  • News: https://www.statnews.com/2025/10/06/cdc-approves-covid-vaccine-recommendations/ (subscription required for fulltext)
  • HHS: https://www.hhs.gov/press-room/cdc-immunization-schedule-individual-decision-covid19-standalone-chickenpox-toddlers.html

Government shutdown rolls into its 2nd week: 4 updates

  1. Impasse continues
  2. Some health systems pause Medicare telehealth
  3. Health systems scrambled to discharge hospital-at-home patients
  4. Organ transplant network faces disruption

House speaker backs emergency care law as GOP targets immigrant medical treatment in shutdown fight

  • House Speaker Mike Johnson (R-La.) said Wednesday that Republicans don’t want to change a law requiring hospitals to provide care to any individual experiencing a medical emergency, including immigrants without legal status. His remarks capped off more than a week of comments from Republican politicians related to the idea of undocumented immigrants receiving medical care.
  • https://www.statnews.com/2025/10/08/mike-johnson-emtala-emergency-medical-care-immigrants-shutdown-fight/   (subscription required for full text)

White House says it will use tariff money to fund nutrition program amid shutdown

  • The White House said Tuesday it will use money from tariff revenue to fund a supplemental nutrition program facing a funding shortage amid the ongoing government shutdown.
  • White House press secretary Karoline Leavitt posted on the social platform X that President Trump and the White House had identified the “creative solution” to shift tariff funds to the Special Supplemental Nutrition Program for Women, Infants and Children, commonly known as WIC, which was set to run out of money in the coming days.
  • https://thehill.com/homenews/administration/5543943-government-shutdown-wic-funding-tariffs/

Gustav Chiarello Confirmed as HHS Assistant Secretary for Financial Resources

KEY BIOPHARMA NEWS

FDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturing

CBER chief Prasad hires ARPA-H doctor as one of two new acting deputies

  • Katherine Szarama, who joined ARPA-H in January, will take over as acting deputy director of CBER, Prasad wrote to staff in an email obtained by Endpoints News.
  • “She will focus on policy and government relations, but also participate more broadly at the center,” he wrote.
  • Szarama will take over for Brittany Goldberg, who will move over to chief medical officer at CBER.
  • https://endpoints.news/cber-chief-prasad-hires-arpa-h-doctor-as-one-of-two-new-acting-deputies/ (subscription required for full text)

Key Meeting on US Vaccine Recommendations Delayed From October

  • The US Centers for Disease Control and Prevention will reschedule a late October meeting of an influential vaccine panel that’s been weighing changes to long-standing advice around childhood shots.
  • The Advisory Committee of Immunization Practices, or ACIP, will no longer meet on Oct. 22 and 23, according to the panel’s website.
  • No indication was given of when a future meeting will take place or why it was moved.
  • https://www.bloomberg.com/news/articles/2025-10-08/key-meeting-on-us-vaccine-recommendations-delayed-from-october (subscription required for full text)

Trump Admin Continues HIV Domestic And Global Advisory Boards

TrumpRx: What Pharmacies and Plan Sponsors Need to Know

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

NIH Licensing Guidelines Put Life Sciences Innovation at Risk

  • Under the just-released guidelines, companies seeking exclusive licenses to NIH-funded inventions must submit detailed “access plans” describing how future products will be made available, affordable, acceptable, and sustainable.
  • NIH retains the authority to revisit those plans years later — and revoke or penalize licensees if outcomes don’t meet its evolving standards. 
  • https://www.michbio.org/news/nih-licensing-guidelines-put-life-sciences-innovation-at-risk

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

Medicare telehealth flexibilities expire: Immediate impacts and next steps

  • Because Congress did not reach an agreement on government funding prior to the expiration of these flexibilities, as of October 1, 2025, the Medicare telehealth flexibilities revert to pre-pandemic limitations:
    • Return of geographic and originating site requirement
    • Limited provider type eligibility.
    • Audio-only telehealth ends.
    • Rural health clinic/federally qualified health center flexibility as distant sites ends.
    • Waiver of the mental health visit in-person requirement.
  • https://www.mcdermottplus.com/insights/medicare-telehealth-flexibilities-expire-immediate-impacts-and-next-steps/

KEY MEDTECH NEWS

CDRH shares regulatory guidance priorities for the coming 12 months

FDA seeks input on evaluating AI-enabled medical devices

KEY ACRONYMS

  • ACA = Affordable Care Act
  • ACIP = Advisory Committee on Immunization Practices
  • ANDA = Abbreviated New Drug Application
  • ARPA-H = Advanced Research Projects Agency for Health
  • CBER = Center for Biologics Evaluation and Research
  • CDC = Centers for Disease Control and Prevention
  • CDRH = Center for Devices and Radiological Health
  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • GOP = The Republican Party, also known as the Grand Old Party
  • HHS = Department of Health and Human Services
  • MFN = most favored nation
  • NCI = National Cancer Institute
  • NIH = National Institutes of Health
  • WIC = Special Supplemental Nutrition Program for Women, Infants and Children

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