Blog | 1/16/2026

Sharp Strategy Spotlight: January 16, 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 15, 2026. The details and broad themes may have changed.

KEY HEALTH NEWS (Global)

Inside Trump's $11 billion health plan to replace "neo-colonial" USAID

  • The Trump administration is launching an unprecedented, $11 billion soft-power effort to remake foreign health assistance after its controversial decision to gut USAID.
  • Why it matters: Called the America First Global Health Strategy, the program aims to boost U.S. influence and interests in developing nations —especially those in Africa — while bypassing non-government organizations that delivered services through USAID.
  • The program would send billions of dollars directly to needy foreign governments, health care organizations and drug manufacturers over the next five years — a plan that critics worry could be a recipe for corruption and "catastrophic" failures.
  • Zoom in: So far, Secretary of State Marco Rubio has signed 15 agreements with African countries aimed at improving their health systems with an emphasis on HIV/AIDS, malaria, tuberculosis and maternal health.
    • The U.S. has committed $11.1 billion over five years to the countries, which have pledged $12.2 billion in matching funds and promised to meet performance goals.
    • The State Department aims to have agreements with 50 countries in a few months.
  • https://www.axios.com/2026/01/14/trump-foreign-aid-africa-usaid   (subscription required for full text)

US, European regulators set principles for 'good AI practice' in drug development

  • The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and responsible use of artificial intelligence in developing medicines, aiming to speed up innovation while safeguarding patients.
  • The principles, issued on Wednesday, offer broad guidance on how AI should be used to generate and monitor evidence across a drug's lifecycle, from early research and clinical trials to manufacturing and safety surveillance.
  • The move comes as regulators push to expand the use of AI in drug discovery and development to shorten timeline and reduce animal testing.
  • The FDA has a generative AI tool, Elsa, aimed at improving efficiency across its operations, including scientific reviews.
  • European guideline work is already under way, building on the EMA's 2024 AI reflection paper, and aligns with the agency's mission to promote safe and responsible use of AI.
  • The joint initiative follows an FDA–EU bilateral meeting in 2024.
  • https://www.reuters.com/business/healthcare-pharmaceuticals/us-european-regulators-set-principles-good-ai-practice-drug-development-2026-01-14/

KEY FEDERAL GOVERNMENT NEWS

Trump announces outlines of health care plan he wants Congress to consider

  • President Donald Trump on Thursday announced the outlines of a health care plan he wants Congress to take up as Republicans have faced increasing pressure to address rising health costs after lawmakers let subsidies expire.
  • The cornerstone is his proposal to send money directly to Americans for health savings accounts so they can handle insurance and health costs as they see fit. Democrats have rejected the idea as a paltry substitute for the tax credits that had helped lower monthly premiums for many people.
  • Trump’s plan also focuses on lowering drug prices and requiring insurers to be more upfront with the public about costs, revenues, rejected claims and wait times for care.
  • It was not immediately clear if any lawmakers in Congress were working to introduce the Republican president’s plan.
  • A White House official who was not authorized to speak publicly and described some details on condition of anonymity said the administration had been discussing the proposal with allies in Congress but was unable to name any lawmakers who were working to address the plan.
  • Press: https://apnews.com/article/trump-health-care-insurance-congress-savings-accounts-b7b4caae9ad14fda4646c42d3858202b
  • White House: https://www.whitehouse.gov/fact-sheets/2026/01/fact-sheet-president-donald-j-trump-calls-on-congress-to-enact-the-great-healthcare-plan/

Government approves $60 billion of enhanced Medicaid funding for hospitals, other providers

  • The federal government approved $60 billion worth of extra Medicaid funds for hospitals, doctors, nursing homes, and other medical providers in the closing months of 2025 — money that will gradually get cut under Republicans’ tax law.
  • The new approvals lock in Medicaid payment rates that are on par with the lofty prices paid by commercial insurers until 2028, when the funds will start to dissipate. That means in the near term, for many hospitals across the country, Medicaid will still not always be the dismal payer that they say it is.
  • STAT has been tracking these supplemental Medicaid funds, known as state directed payment programs, previously reporting that the Centers for Medicare and Medicaid Services approved tranches of state applications totaling $9 billion and $4 billion last year. In September, CMS projected state directed payment programs would cost $124 billion in 2025 and $145 billion this year.
  • https://www.statnews.com/2026/01/12/medicaid-approves-state-directed-payments-texas-before-trump-cuts   (subscription required for full text)

RFK Jr. appoints 2 vocal opponents of vaccine use in pregnancy to federal advisory board

HHS dismisses members of vaccine injury advisory panel

  • At least two members of a committee that advises the federal government on its vaccine injury compensation program have had their terms prematurely ended, potentially foreshadowing further changes to the federal apparatus that reviews vaccine injuries and compensates patients.
  • Veronica McNally, an attorney who is also director of trial advocacy at Michigan State University, and Wendy Lane, a clinician and researcher at the University of Maryland School of Medicine, received emails on Tuesday from Commander George Reed Grimes, director of the division of injury compensation programs at the Department of Health and Human Services, telling them they’d been removed from the Advisory Commission on Childhood Vaccinations.
  • According to both, the email read, in part: “We are grateful for the valuable contributions you and your fellow members have made.” McNally was serving a three-year term on the ACCV that was slated to end next year.
  • https://www.statnews.com/2026/01/13/hhs-dismisses-veronica-mcnally-advisory-commission-on-childhood-vaccinations/   (subscription required for full text)

Dems make health deal offer with ACA subsidies

  • Democrats sent Republicans a proposal over the weekend to renew enhanced Affordable Care Act subsidies for three years, paired with extensions of other expiring health programs, sources said.
  • Why it matters: Sunday's offer shows there's increasing bipartisan sentiment to address long-stalled priorities like overhauling pharmacy benefit manager business practices — even if prospects for the ACA subsidies are much murkier.
  • What's inside: The proposal from Democratic leadership and health committees was in response to a GOP offer last week to renew funding for community health centers, certain Medicare telehealth flexibilities and other health "extenders" ahead of a Jan. 30 deadline.
    • The underlying package being discussed largely mirrors a bipartisan health deal that was due to be included in a 2024 year-end government funding deal before it was jettisoned at the urging of Elon Musk and then-President-elect Trump, sources said.
    • That included PBM measures aimed at lowering drug costs, such as "delinking" PBM compensation from the price of a drug in Medicare Part D.
    • There is also a measure addressing Medicare hospital costs that would require hospital outpatient departments to use unique identifier numbers in a bid to crack down on what critics say is overbilling.
  • The big picture: On a separate track, a bipartisan Senate group has been discussing an ACA subsidy deal that would extend the tax credits along with new restrictions Republicans favor, such as eliminating $0 premiums that critics say fuel fraud.
    • There still are considerable hurdles, with most Republicans still opposed to any kind of ACA subsidy extension and many backing new prohibitions on using the money to pay for abortion services.
    • President Trump told reporters Sunday night that he "might" veto a subsidy extension, though he was responding to a question about the clean three-year extension, which is unlikely to get to his desk anyway.
  • https://www.axios.com/2026/01/12/democrats-health-deal-aca-subsidies-gop    (subscription required for full text)

NIH loses yet another leader as heart, lung and blood director exits

  • Gary Gibbons, M.D., is retiring as National Heart, Lung and Blood Institute (NHLBI) director, adding to the extensive churn at the top of the National Institutes of Health (NIH). The departure will mean 15 of the NIH’s 27 institutes and centers are under interim leadership.
  • Gibbons has led the NHLBI since 2012, supporting work to cure sickle cell disease and show the effect of intensive blood pressure management on cardiovascular mortality. Before joining the institute, he was founding director of the Morehouse School of Medicine's Cardiovascular Research Institute.
  • Effective Jan. 31, Gibbons will leave the post and retire from federal service. David Goff, M.D., Ph.D., will serve as acting NHLBI director while the NIH searches for a permanent replacement.
  • https://www.fiercebiotech.com/biotech/nih-loses-yet-another-leader-heart-lung-and-blood-director-exits

Congress' biotech panel pitches FDA policy upgrades to help performance

  • As the speed of biotech innovation outpaces regulators, a new report from the National Security Commission on Emerging Biotechnology is recommending almost two dozen policy changes to help the FDA navigate the space.
  • The bipartisan NSCEB, created by Congress in 2022 to review emerging biotech advancements, is taking issue with the way the FDA is regulating certain biopharma companies and is calling on Congress to take action.
  • For instance, the NSCEB says Congress should “require that the FDA use formal notice-and-comment rulemaking” to create FDA Commissioner Marty Makary and biologics director Vinay Prasad’s new “plausible mechanism” pathway to approve certain rare disease therapies.
  • The FDA also should do a better job of matching China and Australia when it comes to initiating Phase 1 trials in a timely manner, according to the commission, chaired by Sen. Todd Young (R-IN). “Congress should direct the FDA to apply a risk-based approach to clinical holds for Phase I trials and to limit holds to cases where credible safety concerns are identified,” the report says.
  • It also calls on the agency to better leverage its vast trove of clinical data from all the applications it reviews to create a “fee-based platform that allows industry, academics, and others to access aggregated and de-identified data from product submissions.”
  • Press: https://endpoints.news/embargo-congress-biotech-panel-pitches-fda-policy-upgrades-to-help-performance/   (subscription required for full text)
  • NSCEB: https://www.biotech.senate.gov/press-releases/nsceb-aims-for-modernized-regulatory-system-to-propel-u-s-ahead-of-china-in-biotech-competition/

SAMHSA Announces $231M Funding Opportunity to Administer 988 Lifeline

  • The Substance Abuse and Mental Health Services Administration (SAMHSA), a division within the U.S. Department of Health and Human Services (HHS), announced today a $231M funding opportunity to administer the 988 Suicide & Crisis Lifeline.
  • The 988 Lifeline is comprised of a national network of more than 200 local crisis contact centers managed by a SAMHSA-funded 988 network administrator.
  • In 2025, 988 received more than 8 million contacts from help seekers via call, text, chat and ASL videophone.
  • The 988 Lifeline gives all Americans an easy way to reach a skilled, compassionate crisis counselor 24/7 for help with a mental health or substance use crisis.
    • People can call or text 988 or use chat at 988LifeLine.org for themselves or if they are worried about a loved one who may need help.
    • Individuals requesting ASL services can also directly dial 988 from a videophone through a Video Relay Service approved provider.
  • https://www.hhs.gov/press-room/samhsa-announces-231m-funding-opportunity-administer-988-lifeline.html

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

H.H.S. Reverses Decision to Cut $2 Billion for Mental Health and Addiction Services

  • Less than 24 hours after the Trump administration informed more than 2,000 addiction and mental health programs nationwide that it was immediately terminating almost $2 billion of their funding, the administration reversed course and reinstated the money.
  • An administration official confirmed Wednesday night that the money was being restored, but declined to say why.
  • The decision followed furious lobbying by lawmakers from both parties to restore the cuts and a letter to the health secretary, Robert F. Kennedy Jr., with signatures from 100 House members.
  • The cuts would have affected longstanding agency investments like drug courts that offer treatment as an alternative to incarceration, programs for pregnant and postpartum women in recovery, screening and referral services, and overdose prevention education for young people.
  • Press: https://www.nytimes.com/2026/01/14/health/samhsa-funding-cuts.html   (subscription required for full text)
  • House Appropriations statement: https://democrats-appropriations.house.gov/news/press-releases/delauro-statement-hhs-reinstating-billions-addiction-and-mental-health-grants

Hundreds of laid-off researchers at US workplace safety center are being reinstated

  • Federal officials are reinstating hundreds of U.S. health workers who were laid off last year from a small health agency that aims to protect workers.
  • In April, President Donald Trump’s administration gutted the National Institute for Occupational Safety and Health, where scientists, engineers and others conduct research and recommend ways to prevent work-related injury, illness, disability and death.
  • Government officials laid off close to 900 of NIOSH’s 1,000 employees. The layoffs were part of the Republican president’s remaking of the federal workforce led by then-adviser Elon Musk and the Department of Government Efficiency, but they drew harsh rebukes from firefighters, coal miners, medical equipment manufacturers and a range of others.
  • Some employees were brought back last year amid legal challenges and political pressure, including those who staffed a health monitoring program for miners in West Virginia. But now all the terminations have been rescinded, according to the American Federation of Government Employees, which represents workers at NIOSH and parts of the U.S. Centers for Disease Control and Prevention.
  • https://apnews.com/article/cdc-layoffs-niosh-workers-ce0d730c839521e3399dc014bb6aff2a

Lawsuit dismissed after Trump admin quietly restored tens of millions to Planned Parenthood

  • The American Civil Liberties Union on Monday dropped its lawsuit against the Trump administration over tens of millions in Title X family planning funds that federal officials had withheld from Planned Parenthood and some other health clinics since last spring, after HHS quietly released the money in December.
  • Though the Trump administration is still defending in court far bigger federal cuts to Planned Parenthood that Congress approved last summer, the release of the Title X funds gives the clinics a crucial lifeline.
  • The clinics and the groups representing them argue, however, that the restored funds will not undo all of the harm done over the many months the money was withheld.
  • Though many clinics had been saving their receipts from low-income patients who came in for birth control, testing for sexually transmitted infections and other Title X services and can submit them now for federal reimbursement, dozens of clinics have since shut down and are unlikely to reopen.
  • https://www.politico.com/news/2026/01/13/lawsuit-dismissed-after-trump-admin-quietly-restored-tens-of-millions-to-planned-parenthood-00723369

Federal judge orders HHS to restore $12m in funding to American Academy of Pediatrics

  • A federal judge late Sunday ordered the Trump administration to restore nearly $12 million in grants to the American Academy of Pediatrics (AAP), after the organization’s funding was abruptly cut last month.
  • Judge Beryl Howell of the U.S. District Court for the District of Columbia granted a preliminary injunction that will restore the grants and block the cuts from taking effect while the case proceeds. 
  • Howell concluded that the Department of Health and Human Services had a likely “retaliatory motive” for the terminations, due to the AAP’s outspoken opposition to Health Secretary Robert F. Kennedy Jr.
  • The AAP, the nation’s largest professional organization of doctors who treat children, said the canceled grants funded initiatives including preventing sudden unexpected infant death, improving early detection of developmental disabilities and birth defects, and strengthening pediatric care in rural communities.
  • https://thehill.com/policy/healthcare/5684666-aarp-lawsuit-grants-restored

HHS appears ready to pull appeal of 340B rebate pilot pause

  • The Department of Health and Human Services appears willing to take its contentious 340B Rebate Model Pilot Model back to the drawing board.
  • After a lawsuit filed by hospitals secured a last-minute halt from a district court, that was later upheld by a three-judge panel, the federal government penned a letter informing the appellate court that it is speaking with the plaintiff hospital groups about whether the fall's green light for participating drugmakers should be "reconsidered."
  • "The agency intends to resolve such proceedings promptly," the federal government wrote in response to a Jan. 12 deadline to propose an expedited schedule for its appeal. "Therefore, the parties do not believe that expediting this appeal is warranted at this time and plan to dismiss the appeal in short order."
  • The letter notes that the hospitals' legal representation agreed with the position.
  • https://www.fiercehealthcare.com/providers/hospital-groups-file-lawsuit-enjoin-pharma-supported-340b-rebate-pilot

KEY BIOPHARMA NEWS

FDA asks for removal of suicide warnings on GLP-1 drugs

  • The Food and Drug Administration on Tuesday told Eli Lilly and Novo Nordisk to remove warnings about the risk of suicidal thoughts and behavior from the labels of their blockbuster GLP-1 weight-loss drugs.
  • Why it matters: The action caps more than a year of studies into reported side effects in people taking the injectable drugs. It covers Novo Nordisk's Saxenda and Wegovy and Lilly's Zepbound.
    • Some research has focused on patients with psychiatric disorders, since certain antipsychotics or antidepressants are associated with weight gain and could make the patients possible candidates for GLP-1 treatment.
  • Driving the news: Regulators said a comprehensive review found no increased risk of suicidal ideation or behavior associated with the use of GLP-1s.
    • At the time of the original FDA approvals, the labeling for the weight-loss products included information about such risks based on reports of events observed with older medicines used or studied for weight loss.
    • Labels have said suicidal behavior or thoughts have been reported in clinical trials for other weight-loss products and recommend that doctors monitor patients for unusual changes in mood or behavior.
    • Novo Nordisk's Ozempic and other drugs approved as diabetes treatments don't include similar labeling language.
  • https://www.axios.com/2026/01/13/fda-wegovy-zepbound-suicide-warnings   (subscription required for full text)

FDA shares ‘more flexible approach’ to overseeing cell and gene therapy manufacturing

  • The FDA is taking steps to ease some manufacturing requirements for cell and gene therapies in an effort to expedite their development.
  • Traditionally, the FDA’s Center for Biologics Evaluation and Research has used the same chemistry, manufacturing and control requirements for all different types of therapies, but cell and gene therapy products are more complicated to make and are often individualized for patients, the FDA said Sunday.
  • The agency said it recognizes that since the patient populations for CGTs are smaller compared to other drugs, companies can’t show large batch numbers when submitting a CGT product for approval. As a result, the FDA said it will be more flexible in its product release specifications for new CGTs.
  • The agency also said that if a CGT product is in preclinical or Phase 1 trials, manufacturers won’t be required to comply with good manufacturing practices for finished drugs, unlike other therapies. And as a drug moves from Phase 1 to later stages, CBER will allow “minor changes” in the manufacturing process, supported by data, but without requiring “overly stringent and onerous” comparability studies.
  • Finally, the FDA has removed the need for three rounds of Process Performance Qualification before commercialization in certain cases and also noted quality specifications can be revised after approval. PPQs are used to prove that commercial manufacturing of a drug can be done at scale at a consistent quality.
  • Press: https://endpoints.news/fda-shares-eased-manufacturing-rules-for-cell-and-gene-therapies/   (subscription required for full text)       
  • FDA: https://www.fda.gov/news-events/press-announcements/fda-increases-flexibility-requirements-cell-and-gene-therapies-advance-innovation?utm_medium=email&utm_source=govdelivery

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

Labs lobby Congress over Medicare cuts

  • Clinical laboratories that run everything from basic blood tests to genomic screening are lobbying Congress to avert steep Medicare payment cuts that they say could result in less access to lab tests for consumers.
  • The debate over how Medicare pays for lab tests has been going on since 2014, when Congress passed the Protecting Access to Medicare Act.
  • The bill aimed to bring Medicare payments for lab tests in line with what private insurers spent on the same diagnostics.
  • But the implementation of the law has been rocky. That’s partly because the effort to collect data about what labs are paid by private insurers relied on the lab companies to voluntarily self-report the data. Labs say that when data was reported for 2016, fewer than 1 percent of laboratories across the country submitted rates.
  • https://www.politico.com/newsletters/prescription-pulse/2026/01/13/labs-lobby-congress-over-medicare-cuts-00723673   (subscription required for full text)

KEY MEDTECH NEWS

ARPA-H to revolutionize cardiovascular disease management with clinical agentic AI

  • The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new research and development funding opportunity through its Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE) program.
  • This program aims to develop the first FDA-authorized, agentic artificial intelligence (AI) technology that can provide 24/7 specialty care for the deadliest chronic disease in the United States.
  • This technology could serve as a clinician extender that patients engage with at all times, keeps a close eye on their heart health, and provides access to personalized information and actions, all of which can help them live long and well with advanced heart disease.  
  • The ADVOCATE program seeks to develop agentic AI technology that connects to patient records, assists in scheduling appointments, provides diet and physical therapy recommendations, writes and modifies prescriptions, supports diagnoses, and recommends when a human healthcare provider should step in. The program is focused on patients with heart failure and those who have had heart attacks. ADVOCATE will also develop a ‘supervisory agent’ that will ensure that all clinical AI agents being used in clinical practice provide safe and effective clinical recommendations to patients. The goal of ADVOCATE is for these technologies to be FDA-authorized, and ARPA-H will work closely with HHS partners to overcome blockers to innovation. If successful, ADVOCATE could pave the way for authorizing clinical agentic AI for more conditions. 
  • https://origin.arpa-h.gov/news-and-events/arpa-h-revolutionize-cardiovascular-disease-management-clinical-agentic-ai

KEY ACRONYMS

  • AAP = American Academy of Pediatrics
  • ACA = Affordable Care Act
  • ACIP = Advisory Committee on Immunization Practices
  • ADVOCATE = Agentic AI-Enabled Cardiovascular Care Transformation
  • ARPA-H = Advanced Research Projects Agency for Health
  • CDC = Centers for Disease Control and Prevention
  • CGTs = cell and gene therapies
  • CMS = Centers for Medicare & Medicaid Services
  • EMA = European Medicines Agency
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • HRSA = Health Resources and Services Administration
  • NHLBI = National Heart, Lung and Blood Institute
  • NIH = National Institutes of Health
  • NIOSH = National Institute for Occupational Safety and Health,
  • NSCEB = National Security Commission on Emerging Biotechnology
  • PPQs = Process Performance Qualifications
  • SAMHSA = Substance Abuse and Mental Health Services Administration
  • USAID = U.S. Agency for International Development

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