Blog | 1/23/2026

Sharp Strategy Spotlight: January 23, 2026

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 January 22, 2026. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

As U.S. prepares to exit WHO, it is stiffing the agency on a large bill

  • When the United States’ withdrawal from the World Health Organization goes into effect Thursday, the world’s largest economy will be leaving the global health agency with a hefty unpaid bill.
  • The U.S. has not made good on its assessed contributions for the past two years — including the final year of the Biden administration — effectively stiffing the WHO on a bill of roughly $278 million. In addition, several hundred million dollars in promised voluntary contributions for 2025 — and to a lesser extent for 2024 — have also not been delivered.
  • Voluntary contributions are earmarked funds a country provides the WHO to support work that is of particular interest to that country.
  • Under the provisions of a congressional resolution that allowed the country to join the nascent global health agency in 1948, the U.S. is supposed to pay at least some of that outstanding bill before leaving the organization. And in a WHO press conference last week, the agency’s principal legal officer, Steven Solomon, suggested its member states will study the issue to determine if the U.S. has met the requirements for leaving.
  • https://www.statnews.com/2026/01/21/trump-withdrawal-world-health-organization-leaves-unpaid-bills-behind/   (subscription required for full text)

U.S. Cuts Health Aid and Ties It to Funding Pledges by African Governments

  • The State Department is negotiating agreements with countries across the developing world to  provide billions of dollars in health aid, an effort intended to replace the system of global health assistance that had for decades been offered through the now-dismantled U.S. Agency for International Development.
  • Over the past month the U.S. has signed agreements with 16 African countries to provide more than $11 billion in health aid over the next five years, and is negotiating dozens more deals with governments in Asia and Latin America as well as Africa.
  • The new commitments represent a steep drop in the health aid that the United States contributed before President Trump ordered a review of foreign assistance on his first day in office last year. According to an analysis by the nonprofit Partners in Health, health funding under the agreements would drop by 69 percent to Rwanda, 61 percent to Madagascar, 42 percent to Liberia and 34 percent to Eswatini, where a quarter of adults live with H.I.V.
  • https://www.nytimes.com/2026/01/15/health/health-agreements-us-africa.html   (subscription required for full text)

Confusion Over ‘Cancellation’ of Controversial Hepatitis B Trial in Guinea-Bissau

  • A controversial clinical trial on the effects of the hepatitis B vaccine on babies in Guinea-Bissau has been “cancelled”, according to Dr Yap Boum of Africa Centres for Disease Control and Prevention (CDC).
  • However, this has been contested by the US Department of Health and Human Services (HHS), which is funding a Danish group to conduct the study, according to CIDRAP.
  • An HHS official told CIDRAP that researchers are still working on the study protocol, the official said, adding, “we are proceeding as planned.”
  • But Boum told a media briefing on Thursday that there were “ethical challenges” with the trial design, and Africa CDC had engaged with the health ministry of Guinea-Bissau about it.
  • “Our information is that the study has been cancelled,” said Boum, who added that while the continent needs research about vaccines, including hepatitis B, “this has to be done within the norms, so we are glad that at this point, the study has been cancelled”.
  • The US Centers for Disease Control and Prevention (CDC) awarded Bandim Health Project at the University of Southern Denmark a $1,6 million five-year grant to study the “optimal timing and delivery of monovalent hepatitis B vaccinations on newborns in Guinea-Bissau”, according to the US HHS federal register.
  • https://healthpolicy-watch.news/confusion-over-cancellation-of-controversial-hepatitis-b-trial-in-guinea-bissau/

KEY FEDERAL GOVERNMENT NEWS

Health Groups Pleased With Proposed NIH Budget in Bipartisan Funding Bill

  • Health groups praised many of the provisions in the joint House-Senate bill that would fund the NIH and several other agencies under HHS for fiscal year 2026.
  • Notably, President Trump had previously proposed cutting the HHS budget by $33 billion, a 26.2% decrease. He'd also proposed decreasing the NIH budget by $18 billion.
  • The proposed legislation would provide HHS with discretionary funding of $116.8 billion, an increase of $210 million over fiscal year 2025. The bill, released Tuesday with bipartisan support, must still be passed by both houses of Congress and then signed by President Trump. The House is expected to pass it this week, with the Senate expected to follow next week after it returns from a week-long recess.
  • The American Cancer Society's Cancer Action Network (ACS CAN) praised the measure's allocation of $47.2 billion for NIH, an increase of $415 million from last year. The NIH funding includes $7.35 billion for the National Cancer Institute (NCI).
  • Other funding provisions of the bill related to NIH include:
    • A $100 million increase for Alzheimer's disease research
    • A $30 million increase for the Office of Research on Women's Health
    • A $23 million increase for the National Institute of Allergy and Infectious Diseases
    • A $15 million increase for amyotrophic lateral sclerosis research
    • A $10 million increase for diabetes research
  • Press: https://www.medpagetoday.com/washington-watch/washington-watch/119523
  • Bill: https://docs.house.gov/billsthisweek/20260119/DEF%20LHHS%20HS%20THUD%20-%20Bill%20Text%20-%201-19-2026.PDF

The Trump administration is creating clinical AI agents with a 3-year FDA approval timeline

  • The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals to develop two agentic AI assistants for clinical care. It hopes to set a novel regulatory precedent with the Food and Drug Administration (FDA) for the use of generative AI in high-risk settings.
  • To date, only predictive AI technologies have been approved by the agency. Trump’s ARPA-H is taking a big swing at creating and deploying generative AI to extend the healthcare workforce.
  • The Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE) aims to develop the first FDA-authorized agentic AI technology that can provide 24/7 specialty care. The program will select teams of innovators to create a patient-facing AI agent for cardiovascular disease, which results in 200,000 deaths per year, though treatments are inexpensive and widely available.
  • The research agency hopes the agents can supplement clinicians by scheduling appointments, adjusting medications and supporting diet and exercise. It will connect to the electronic health record, integrate with wearables and be available to patients 24/7.
  • The agent should be able to perform clinical tasks that a cardiologist could do over the phone, such as determining whether a patient is in heart failure or increasing a medication, Haider Warraich, M.D., program manager at ARPA-H, said.
  • https://www.fiercehealthcare.com/ai-and-machine-learning/trump-administration-creating-clinical-ai-agents-3-year-fda-approval

US health department to launch study on cellphone radiation

  • The U.S. Department of Health and Human Services will launch a study on cellphone radiation, a department spokesman said on Thursday, building on Secretary Robert F. Kennedy Jr's criticism linking them to neurological damage and cancer.
  • Last year, the department said 22 states had restricted cellphone use in schools to improve the mental and physical health of children under the "Make America Healthy Again" movement.
  • The U.S. Food and Drug Administration also took down old webpages saying cellphones are not dangerous.
  • "The FDA removed webpages with old conclusions about cell phone radiation while HHS undertakes a study on electromagnetic radiation and health research to identify gaps in knowledge, including on new technologies, to ensure safety and efficacy," said HHS spokesman Andrew Nixon.
  • "The study was directed by President Trump's MAHA Commission in its strategy report," Nixon added.
  • https://www.reuters.com/legal/litigation/us-health-department-launch-study-cellphone-radiation-2026-01-15/?

HHS watchdog finds $19B in waste, fraud and savings

  • The government's health care watchdog identified more than $19 billion in wasteful or fraudulent federal payments and possible cost savings during a span that included the first nine months of President Trump's second term, a report provided exclusively to Axios shows.
  • Why it matters: The Trump administration often cites rampant waste, fraud and abuse as justification for deep program cuts.
    • The semiannual report from the Department of Health and Human Services' inspector general backs up that point, identifying questionable spending like a more than sixfold year-over-year increase in Medicare payments for high-tech bandages.
  • Where it stands: The savings identified in fiscal 2025 dwarf the $7 billion identified through investigative and audit work in 2024.
    • But much of the final figure for each semiannual reporting period depends on when certain civil settlements or criminal judgements are finalized, the IG's office told Axios.
  • Zoom in: OIG this year identified a 640% increase in Medicare payment for high-tech skin substitutes. Medicare administrators in the fall announced a new cap on what the program will pay for the bioengineered grafts — a change that's expected to save more than $9 billion.
    • The office will continue looking into skin substitutes next year, Ann Maxwell, deputy inspector general for evaluation and inspections, told Axios.
    • "We want to make sure that the fix sticks and that we are protecting Medicare and beneficiaries from this," she said.
  • https://www.axios.com/2026/01/21/hhs-watchdog-waste-fraud-savings   (subscription required for full text)

Makary cites higher FDA user fees as one key to counter China biotech

  • As China sees increased biotech investments, licensing deals and faster early-phase clinical trial starts, FDA Commissioner Marty Makary said his agency is reworking Phase 1 trial regulations to speed that entry process and tweaking user fees to encourage R&D in the US.
  • “We can come up with some protection strategies, but ultimately, what we need to do is be more competitive with what’s going on with Phase 1s” and investigational new drug applications, Makary told the “All-In Podcast” in a nearly 90-minute interview, referring to the way China has increasingly sped up the activation of new early-phase trials.
  • Makary also said he’s going to help incentivize US-based drug development by charging companies higher fees if they develop their drugs outside of the country.
  • “I’d like to see those user fees go much higher if your Phase 1 is done overseas, and if it’s done in the United States, it’s going to be a lower user fee,” he said. That echoes what the agency has laid out in early negotiations for the next five-year round of pharma company user fees.
  • https://endpoints.news/makary-talks-fdas-plans-to-combat-chinas-biotech-growth/   (subscription required for full text)

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

Public health groups sue over CDC vaccine recommendations

  • A coalition of medical groups have expanded an ongoing lawsuit against Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. to now challenge and reverse the reductions made to the childhood vaccine schedule.
  • A group of plaintiffs including the American Academy of Pediatrics (AAP), the American College of Physicians (ACP) and the American Public Health Association (APHA) and others sued HHS under Kennedy in July 2025 to undo updated COVID-19 vaccine guidance that no longer included pregnant women and healthy children in the recommended demographics.
  • In its fourth amended complaint, the lawsuit now additionally challenges the decision by the Centers for Disease Control and Prevention (CDC) earlier this month to reduce the number of recommended childhood vaccines from 17 to 11, bringing the country in line with that of Denmark, a nation Kennedy frequently points to when expounding on vaccine guidance.
  • The plaintiffs called this decision the “most egregious, reckless, and dangerous of the actions Defendants have taken to date” in their amended complaint filed on Monday. They further called for an upcoming meeting of the CDC’s Advisory Committee on Immunization Practices to be blocked from being held.
  • https://thehill.com/policy/healthcare/5697104-public-health-groups-cdc-vaccine-recommendations-lawsuit/

Supreme Court agrees to review ‘skinny labeling’ and generic drug access

  • The Supreme Court has agreed to review a controversy over so-called skinny labels for medicines, a decision that will be closely watched for its implications for the availability of generic medicines.
  • Skinny labeling refers to moves by generic companies that seek regulatory approval to market a medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.
  • This tactic has been a linchpin for generic companies ever since the Hatch-Waxman Act went into effect about four decades ago. The federal law established the mechanisms by which generic drugs can more readily enter the marketplace. And skinny labeling, which amounts to a carve-out, is one way that Congress attempted to foster more competition to benefit consumers.
  • Press: https://www.statnews.com/pharmalot/2026/01/16/scotus-generics-patents-supreme-court-amarin-hikma/   (subscription required for full text)
  • Analysis: https://www.mofo.com/resources/insights/260120-supreme-court-takes-up-hikma-v-amarin

KEY BIOPHARMA NEWS

CBER updates two guides for staff on reviewing INDs and handling clinical holds

  • The US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) has updated two internal policy guides for its staff. The first guide outlines the procedures for processing and reviewing investigational new drug applications (INDs), while the second details the procedures for handling clinical holds for INDs.
  • Both updates provide additional details on the processing and review of INDs that reference a drug master file (MF); the guides went into effect on 14 January 2026.
  • The first guide, Standard Operating Policy and Procedures (SOPP) 8217, version 6, addresses the administrative processing of INDs, including those for expanded access, except for emergency use requests. This latest version includes additional information in the policy section regarding the procedures for reviewing a drug master file (MF) in an IND submission.
  • https://www.raps.org/news-and-articles/news-articles/2026/cber-updates-two-guides-for-staff-on-reviewing-ind

FDA outlines draft policy on MRD, complete response for accelerated approvals in multiple myeloma

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

Telehealth, hospital-at-home set to receive multiyear extensions in recent funding proposal

  • Medicare telehealth flexibilities and the Acute Hospital Care at Home (AHCaH) program are teed up to receive multiyear extensions from Congress in its recently released funding package for the Department of Health and Human Services (HHS).
  • The extensions would provide more certainty for the industry than it’s had since the end of 2022, when Congress extended Medicare telehealth and hospital-at-home for two years. Since the end of 2024—and President Donald Trump's election—providers and hospitals have faced a series of monthslong virtual care extensions as Congress struggled to find a bipartisan solution to fund the government.
  • Tuesday, the House appropriations committee unveiled a funding package that includes a slew of healthcare reforms as well as funds HHS through the 2026 fiscal year.
  • The Medicare telehealth waivers get a two-year extension in the bill—through Dec. 31, 2027—allowing providers and patients to continue virtual visits as they have since the beginning of the COVID-19 pandemic.
  • The telehealth provisions in the bill include removing Medicare’s geographic requirements for telehealth and expanding the types of practitioners able to furnish telehealth services for the government health program.
  • If passed, the bill would also allow federally qualified health centers (FQHCs) and rural health clinics (RHCs) to continue furnishing telehealth services, including mental health visits. The bill would continue to delay the in-person visit requirement for all mental health visits until on or after Jan. 1, 2028.
  • Press: https://www.fiercehealthcare.com/regulatory/telehealth-hospital-home-set-receive-multi-year-extensions-recent-funding-proposal
  • Funding Package: https://democrats-appropriations.house.gov/news/press-releases/appropriations-committees-release-three-bill-fy26-funding-package-labor-hhs

KEY ACRONYMS

  • ACA = Affordable Care Act
  • ACIP = Advisory Committee on Immunization Practices
  • ADVOCATE = Agentic AI-Enabled Cardiovascular Care Transformation
  • AHCaH = Acute Hospital Care at Home
  • ARPA-H = Advanced Research Projects Agency for Health
  • CBER = Center for Biologics Evaluation and Research
  • CDC = Centers for Disease Control and Prevention
  • CIDRAP = Center for Infectious Disease Research and Policy
  • CMS = Centers for Medicare & Medicaid Services
  • FDA = Food and Drug Administration
  • FQHC = federally qualified health center
  • HHS = Department of Health and Human Services
  • HRSA = Health Resources and Services Administration
  • MAHA = Make America Healthy Again
  • NCI = National Cancer Institute
  • NIAID = National Institute of Allergy and Infectious Diseases
  • NIH = National Institutes of Health
  • NIOSH = National Institute for Occupational Safety and Health
  • ODAC = Oncologic Drugs Advisory Committee
  • OIG = Office of Inspector General
  • RHC = rural health clinic
  • USAID = U.S. Agency for International Development
  • WHO = World Health Organization

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