Blog | 10/24/2025

Sharp Strategy Spotlight: October 24, 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 23, 2025. The details and broad themes may have changed.

KEY FEDERAL GOVERNMENT NEWS

Trump is cutting foreign aid. He’s not the only one.

  • President Donald Trump has taken an ax to global health funding and cooperation since returning to the White House in January — and what worries public health advocates is that he isn’t the only one chipping away.
  • In Europe, nine countries, including the biggest donors, are slashing foreign aid and no one is stepping up to fill the void.
  • While the Covid pandemic underscored the world’s vulnerability to contagions, it hasn’t yielded new investments many global health advocates say are needed to do better next time.
  • In fact, the opposite: Overall global health funding has dropped precipitously — to a 15-year low in 2025 — as nations focus on other priorities.
  • After a Covid spike that saw funding rise to $80 billion in 2021, overall global health funding has plummeted to just under $40 billion, according to a July report by the Seattle-based Institute for Health Metrics and Evaluation.
  • Just in the last year, America cut 67 percent of its funding, or more than $9 billion; followed by the U.K., which cut nearly 40 percent; and France, with a 33 percent cut, the same report shows.
  • Analysis: https://www.politico.com/news/2025/10/19/gobal-health-trump-rfk-who-tedros-00613700
  • Report: https://www.healthdata.org/research-analysis/library/financing-global-health-2025-cuts-aid-and-future-outlook
  • Nature press: https://www.nature.com/articles/d41586-025-03384-y

KEY FEDERAL GOVERNMENT NEWS

CMS awards 4 contracts to develop national provider directory

  • CMS has awarded four contracts for companies to help establish a national healthcare provider directory.
  • The agency granted the $1 million awards Sept. 30 to Availity, the Council for Affordable Quality Healthcare, Palantir and Gainwell Technologies for “proof of concepts for the development of the national provider directory.” The contracts expire Nov. 13.
  • “The National Provider Directory project, part of the administration’s Make Health Tech Great Again initiative, is the long-term solution to these broader data accuracy issues,” an HHS spokesperson told Becker’s.
  • https://www.beckershospitalreview.com/healthcare-information-technology/ehrs/cms-advances-national-provider-directory-with-4-1m-contracts

CMS Begins Fixing Error-Filled MA Provider Directory

US FDA Plans Move Back to More Generalist Inspectorate

  • The FDA will merge all its medical product and clinical research inspectorates as part of an effort known as "Simple Reform," HHS confirmed to the Pink Sheet.
  • The change would reverse a 2017 effort known as "program alignment," designed to ensure agency inspectors were specialized to the commodity areas they covered.
  • Experts questioned whether a return to generalist inspectors would be successful, given the very different knowledge bases needed to inspect the range of FDA commodities.
  • https://insights.citeline.com/pink-sheet/compliance/us-fda-plans-move-back-to-more-generalist-inspectorate-5V3573KXHFAJXH6LVC6NSXW37M   (subscription required for full-text)   

CMS ends shutdown-related Medicare payment holds; Telehealth claims will not be paid during shutdown w/exceptions

Three blockbusters prompt CBO to raise orphan drug expansion cost estimate to $8.8B over 10 years

  • The Congressional Budget Office on Monday almost doubled its cost estimate for new orphan drug protections granted under President Donald Trump’s recently-enacted tax package after finding that the law will impact price negotiations for three blockbusters: Merck’s Keytruda, Bristol Myers Squibb’s Opdivo and Johnson and Johnson’s Darzalex.
  • Under Trump’s July tax cuts law, any orphan or rare disease drugs, including drugs with multiple orphan indications, won’t face Medicare price negotiations under the Inflation Reduction Act. The IRA initially limited the exclusion to only drugs with one rare disease indication.
  • The CBO said Monday that it now estimates the 10-year cost of this orphan drug provision will be about $8.8 billion, up from an initial projection of $4.9 billion.
  • The office said the assessment change was made because the new law “will affect price negotiations for Darzalex, Keytruda, and Opdivo” for 2028 negotiations.
  • CMS has until Feb. 1, 2026 to select the 15 drugs for negotiations in 2028 and those three were likely to be selected prior to Trump’s law being enacted.
  • https://endpoints.news/three-drugs-push-cbo-to-raise-orphan-cost-estimate-to-8-8b-over-10-years/   (subscription required for full-text)

Congress Unlikely to Weaken Orphan Exemption to Price Negotiation Despite Higher Cost Projections

Dems look to roll back drug pricing exemption

  • Senate Democrats are launching an effort to repeal a portion of Republicans' budget law that exempts certain "orphan drugs" from Medicare price negotiations, citing estimates that the cost of the carve-out has ballooned.
  • Why it matters: The measure targets a provision that the biotech industry argues is important for innovation, but that Democrats say is actually a costly handout to major pharmaceutical companies.
  • Driving the news: The bill, first shared with Axios, would repeal a provision Republicans passed in their reconciliation law in July that expands an existing exclusion for drugs that treat rare diseases from the price talks.
    • Sponsors Peter Welch (D-Vt.), Ron Wyden (D-Ore.) and Catherine Cortez Masto (D-Nev.) cite a new Congressional Budget Office analysis finding the widened exemption will now cost $8.8 billion over 10 years, up from $4.9 billion.
    • The new analysis takes into account that three blockbuster cancer drugs — Merck's Keytruda, Johnson & Johnson's Darzalex and Bristol Myers Squibb's Opdivo — would be cut out from price talks between manufacturers and the government, increasing the lost savings.
  • Between the lines: The Democratic bill would set up a new system where rare disease drugs are only exempted from negotiations if they account for less than $400 million in annual Medicare spending.
  • Analysis: https://www.axios.com/2025/10/21/medicare-orphan-drug-exemption  (subscription required for full-text)
  • Bill: https://www.welch.senate.gov/wp-content/uploads/2025/10/Bill-Text-No-Big-Blockbuster-Bailouts-Act-Welch-20251021.pdf

'Alternative' to CDC's Flagship Journal in the Works

  • A public health group and a top-tier journal will partner to publish an alternative to the CDC's flagship weekly publication that has been diminished under the Trump administration.
  • The Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, and NEJM Evidence, will establish a field notes-style publication, CIDRAP director Michael Osterholm, PhD, MPH, announced at the IDWeek conference in Atlanta.
  • The new open-access publication will be titled Public Health Alerts and could serve as a venue for research that isn't being published in Morbidity and Mortality Weekly Report (MMWR).
  • It's expected to come online in about a month, Osterholm said during the meeting.
  • https://www.medpagetoday.com/infectiousdisease/publichealth/118093

Trump moves to lower IVF costs with insurance guidance, drug agreement

Some of CDC’s health statistics employees are still in the dark

  • Confusion rules in one corner of the Centers for Disease Control and Prevention, where the purpose is the pursuit of certainty.
  • The National Center for Health Statistics plans and disseminates research informing public health policies on everything from food to oral health to environmental exposures.
  • It may be best known for reports that rely on the National Health and Nutrition Examination Survey, though its future is now a question mark after the people who make it happen were among the roughly 1,300 who received layoff notices on Oct. 10.
  • Nearly 600 of those reductions in force were reversed, but the small corps of planners in that division were not among them.
  • Or so it appears. They have not been able to access their work email accounts, and not just because of the federal government shutdown, sources told STAT.
  • https://www.statnews.com/2025/10/17/cdc-national-center-health-statistics-rif-layoff-impact/   (subscription required for full-text)

Medicare agency to recall thousands of staff next week

  • The Centers for Medicare and Medicaid Services plans to recall about 3,000 staff who were furloughed because of the shutdown starting on Monday, officials confirmed to Axios.
  • The big picture: CMS plans to tap fees it charges outside researchers to access its data to pay staff during the shutdown, a spokesperson said.
    • The sum would be repaid to the user fee fund when regular congressional appropriations resume.
    • CMS said it identified the payment source in coordination with the White House and Health and Human Services, and continues to abide by rules governing the shutdown.
  • Context: 47% of CMS staff have been on furlough since government funding ran out on Oct. 1, according to an HHS shutdown plan released before funding expired.
    • Medicare and Medicaid coverage has continued during the shutdown.
    • But some Medicare data releases have been delayed. CMS also has not been able to conduct public outreach and education, according to its contingency plan.
  • https://www.axios.com/2025/10/23/medicare-agency-recall-furlough-workers   (subscription required for full-text)

CDC Panel Targets Childhood Vaccine Schedule, Aluminum Adjuvants

  • A new Advisory Committee on Immunization Practices (ACIP) workgroup will review childhood and adolescent immunization schedules, a move that infectious disease experts caution could be another step in the revamped panel's upending of childhood vaccination policies.
  • The newly established Childhood and Adolescent Immunization Schedule Workgroup will zero in on five issues, according to a document on the CDC's website: vaccines' timing and order, concurrent vaccine administration, vaccine ingredients' safety, different schedules' safety and efficacy, and potential implementation issues caused by policy changes.
  • For example, the group will look into the timing of the non-live diphtheria-tetanus-acellular pertussis (DTaP) vaccine's last toddler dose, febrile seizure risks with concurrent vaccinations, and the risks of aluminum adjuvants.
  • Press: https://www.medpagetoday.com/pediatrics/vaccines/117980
  • CDC: https://www.cdc.gov/acip/downloads/child-schedule-tor-508.pdf

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

HHS says it can still fire workers despite judge’s order pausing shutdown layoffs

  • The HHS is arguing it can go ahead with firing almost 1,000 employees, despite a judge pausing the layoffs of federal workers during the government shutdown.
  • The 982 HHS employees who received reduction-in-force notices are not represented by the unions that filed the court cause seeking to halt the layoffs, Thomas Nagy, the HHS’ head of personnel, said in a court filing Friday.
  • Therefore, the temporary restraining order granted by a California Northern District judge on Wednesday doesn’t apply, Nagy argued.
  • In her order, Judge Susan Illston said the case brought by the American Federation of Government Employees and the American Federation of State, County and Municipal Employees was likely to succeed given the Trump administration’s actions appear politically motivated and illegal.
  • “HHS and its operating and staff divisions have no AFSCME representation. Although CDC did previously have AFGE bargaining units, HHS terminated the relevant collective bargaining agreements on August 26, 2025, pursuant to Executive Order 14251,” officials wrote. CDC no longer has (and did not have, at the time of the RIF notices referenced in this paragraph) any bargaining unit employees represented by plaintiffs … thus HHS has not issued any RIF notices implicated by the court’s TRO.”
  • Illston clarified that those types of employees are, in fact, covered by the order and cannot be included in the administration’s shutdown-related firings.
  • Initial press: https://www.medtechdive.com/news/hhs-shutdown-layoffs-on-despite-judge-temporary-pause/803246/
  • Judge clarification: https://federalnewsnetwork.com/government-shutdown/2025/10/court-extends-restraining-order-to-shield-more-feds-from-shutdown-rifs/

KEY BIOPHARMA NEWS

FDA review of drugs is slowing while application delays are growing, analysis finds

  • The upheaval at the Food and Drug Administration appears to be taking a toll on the pharmaceutical industry, according to a new analysis of key agency metrics.
  • There was a significant drop in drug approvals in the recently ended third quarter, more marketing applications were rejected than in previous months, and the agency delayed more reviews of those applications, the analysis by RBC Capital Markets analysts found.
  • To wit, the rate of drug approvals was 73%, which was down from an average of 87% in the six previous quarters. The analysts also found the rate of rejected marketing applications reached 15%, up from what they termed an “historical average” of 10%. And the delay rate in meeting deadlines for completing application reviews hit 11%, up from an average of 4%.
  • https://www.statnews.com/pharmalot/2025/10/20/fda-drug-approvals-slowing-rejections-rising/   (subscription required for full-text)

FDA unveils drugs to receive expedited review in support of ‘national priorities’

Trump admin readies 'imminent' probe into other nations' drug pricing, raising new tariff threat

FDA’s drug and biologics centers report steep drop in headcount in FY 2025

  • The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) recently released net hiring data that shows steep job losses at both centers in FY 2025.
  • During the previous fiscal year, CDER experienced a loss of 1,093 employees, contrasting with a net gain of 259 staff in FY 2024.
  • Similarly, CBER reported a net loss in staff; by the end of FY 2025, it had lost 224 employees, after recording a net gain of 105 employees in FY 2024.
  • https://www.raps.org/news-and-articles/news-articles/2025/10/fda-s-drug-and-biologics-centers-report-steep-drop

Mark Cuban's online pharmacy to partner with White House's TrumpRx

  • Billionaire entrepreneur Mark Cuban and his heavily discounted, mostly generic drug online pharmacy will link up with President Donald Trump’s incoming online marketplace TrumpRx, aiming to connect more patients with better drug prices.
  • Cuban announced the partnership on Sunday at the HLTH conference in Las Vegas, and called on the administration to go further on drug pricing reform, particularly around pharmacy benefit managers.
  • The Trump-Cuban partnership follows pledges from Pfizer, Amgen and AstraZeneca to offer discounted brand-name drugs via their own direct-to-consumer websites.
  • The White House previously said TrumpRx, which is set to be operational in January 2026, will direct patients to companies’ own DTC sites.
  • https://endpoints.news/cubans-cost-plus-links-with-white-houses-trumprx-site/   (subscription required for full-text)

Senate Aging Committee Proposes Fed Buyer’s Market To Improve Generic Supply Chain

KEY MEDTECH NEWS

Major Medtech Industry Groups Call for Tariff, Section 232 Exemptions

KEY ACRONYMS

  • ACA = Affordable Care Act
  • ACIP = Advisory Committee on Immunization Practices
  • 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
  • CIDRP = 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
  • MA = Medicare Advantage
  • MACs = Medicare Administrative Contractors
  • MFN = most favored nation
  • MMWR = Morbidity and Mortality Weekly Report
  • NCHS = National Center for Health Statistics
  • NIH = National Institutes of Health

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