Blog | 9/19/2025

Sharp Strategy Spotlight: September 19, 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 September 18, 2025.  All words/analysis are those from the source noted; all sources are in the public domain so content may be shared with clients.  Please know that many topics remain fluid even as this email is sent.

KEY FEDERAL GOVERNMENT NEWS

Short-term government spending bill includes OTC drug user fees

  • The renewal of the FDA’s over-the-counter (OTC) drug user fee program was tucked into a stopgap spending package to fund the government through Nov. 21, according to a draft posted by the House Appropriations Committee on Tuesday.
  • The legislation, which is making its way through the House Rules Committee, specifies how to set the user fee levels for the program, known as OMUFA. Similar to the FDA’s drug and device user fee programs, OMUFA requires industry to pay fees to help support FDA’s work on OTC drugs. In exchange, the agency agrees to adhere to performance goals on timing.
  • OTC drug manufacturers currently pay about $37,000 annually to register manufacturing and processing facilities, as well as other fees that have steadily increased over the years. OMUFA is set to expire on Sept. 30.
  • The government funding bill also calls on the Comptroller General of the US to submit a report to the Senate Committee on Health, Education, Labor and Pensions, and the House Committee on Energy and Commerce in 2027 on the supply chain for OTC drugs and its stability.

CDC to issue contract to study debunked link between autism and vaccines

  • The Centers for Disease Control and Prevention plans to contract with Rensselaer Polytechnic Institute to investigate the debunked idea that vaccines cause autism, according to a notice on the federal website.
  • Why it matters: Several large studies have already disproven the connection. But Health Secretary Robert F. Kennedy Jr. has continued to promote the possibility of a link.
  • Zoom in: The CDC on Thursday evening posted a notice of intent to award a sole-source contract to the Troy, New York-based private university and asked for a response to the application by Sept. 26.
    • The notice did not specify a time frame for the project, or the amount of the contract.
    • CDC isn't asking for competitive bids, but said any responses received within 15 days of the notice from other institutions will be considered.
  • The Health and Human Services Department did not immediately respond to a request for comment.
  • https://www.axios.com/2025/09/12/cdc-autism-research-contract-vaccines

HHS abruptly cancels CDC meeting with RFK Jr., anti-vaccine activist as scrutiny mounts

  • A meeting of health secretary Robert F. Kennedy Jr., anti-vaccine campaigner David Geier, and leaders of the country’s most robust vaccine safety database was abruptly canceled Wednesday, just hours before they were likely to discuss using the database to investigate whether there is a link between autism and the national childhood vaccine schedule, according to a person who had been invited to attend.
  • Decades of research has shown that vaccines do not cause autism. Nevertheless, Kennedy hired Geier to reanalyze data that he and his father worked with in the early 2000s to try to find such a link. The duo quickly lost access to the Vaccine Safety Datalink in 2004 after managers of the database learned they were pursuing a research question different from what they had proposed and had been approved.
  • The meeting with Centers for Disease Control and Prevention officials overseeing the VSD was intended to discuss granting Geier access to more recent vaccine safety data than he previously had analyzed, the VSD official told STAT. The official asked to remain anonymous due to fears that they could lose their job.
  • https://www.statnews.com/2025/09/17/rfk-vaccines-autism-key-data-safety-meeting-canceled/   (subscription required for full text)

RFK Jr. appoints five more members to vaccine panel

  • Health Secretary Robert F. Kennedy Jr. on Monday added five members to serve on his handpicked vaccine advisory panel just days ahead of a key meeting where the group will make recommendations for who should get COVID shots.
  • Last month's firing of Centers for Disease Control and Prevention director Susan Monarez, along with the resignations of several top agency scientists and appointment of some outside experts with known anti-vaccine views, left few guardrails on Kennedy's agenda.
  • The new members are:
    • Kirk Milhoan, pediatric cardiologist and former U.S. Air Force flight surgeon based in Hawai’i
    • Catherine Stein, a professor and epidemiologist at Case Western Reserve University in Ohio
    • Hilary Blackburn, a pharmacist and director of medication access and affordability at AscensionRx in Missouri
    • Raymond Pollak, a surgeon and transplant specialist 
    • Evelyn Griffin, an OB-GYN in Baton Rouge, Louisiana
  • https://www.axios.com/2025/09/15/rfk-jr-vaccine-panel-picks

US Congress Gives Rare Pediatric Disease Voucher Program Renewal Another Try

Pfizer, Novartis, BMS, Lilly and others targeted in FDA's TV ad crackdown

  • The FDA on Tuesday released 40 letters sent to companies as part of its crackdown on pharmaceutical ads, revealing some of its criticisms on how risks and benefits of drugs are presented.
  • The untitled letters concentrated mostly on television ads from Pfizer, Novartis, Bristol Myers Squibb, AbbVie, Alnylam, Boehringer Ingelheim, Sanofi, AstraZeneca and others. Several companies received multiple letters each.
  • Bristol Myers, for example, received three untitled letters for “false or misleading” TV ads related to their blockbuster cancer drug Opdivo and their cardiomyopathy drug Camzyos. In the letter, the agency took issue with the safety explanations in each, among other concerns.
  • The new letters, signed by CDER Director George Tidmarsh, offer a glimpse at how the FDA under Commissioner Marty Makary is using new interpretations of the agency’s ad regulations, particularly around how side effects are presented. The letters, which are also expected to include some warning letters, follow the agency’s announcement of an upcoming rulemaking that could have major ripple effects.
  • https://endpoints.news/pfizer-novartis-bms-lilly-and-others-targeted-in-fdas-tv-ad-crackdown/   (subscription required for full text)

CMS launches $50 billion Rural Health Transformation Program

NIH outlines new system for awarding research grants to foreign scientists

  • Starting early next year, scientists hoping to secure funding from the National Institutes of Health to pursue projects involving research partners overseas will encounter a new system for awarding and tracking those grants. Agency officials say the changes will improve the integrity, accountability, and national security of NIH-funded research.
  • “It’s something that had been a long time coming,” Jon Lorsch, the NIH acting deputy director for extramural research, told STAT in an interview. “It was clear that we did not have good data at all for where the money was going or how it was being spent.”
  • But the policy shift is raising concerns among some scientists about who will get to participate in international research going forward and whether smaller organizations and clinics without the resources to meet new reporting requirements will be left behind.
  • https://www.statnews.com/2025/09/18/nih-research-grants-foreign-scientists/   (subscription required for full text)

FDA finalizes guidance on alternative inspection tools

  • The US Food and Drug Administration (FDA) finalized its guidance on the use of alternative tools for conducting preapproval inspections (PAI) or prelicense inspections (PLIs) in lieu of onsite inspections of drug manufacturing facilities that are named in pending applications.
  • These alternative methods can include remote regulatory assessments (RRA), which is a remote assessment of an establishment or its records, remote interactive evaluations (RIE) of facilities, or requesting information from foreign regulatory partners through mutual recognition agreements (MRA).
  • The guidance applies to new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), or a supplement to these applications. Excluded from its scope are postapproval inspections, surveillance inspections, follow-up, for-cause inspections, and bioresearch monitoring inspections.
  • https://www.raps.org/News-and-Articles/News-Articles/2025/9/FDA-finalizes-guidance-on-alternative-inspection-t

KEY REVERSALS – RESCINDED ITEMS - LAWSUITS

Trump administration cannot proceed with overhaul of US health agencies, court rules

  • A federal appeals court on Wednesday refused for now to allow U.S. President Donald Trump's administration to proceed with a planned overhaul of the U.S. Department of Health and Human Services, which would involve reorganizing several agencies and firing thousands of employees.
  • A three-judge panel of the Boston-based 1st U.S. Circuit Court of Appeals declined to lift a federal judge's injunction secured by several Democratic-led states. They had challenged a plan U.S. Health Secretary Robert F. Kennedy Jr announced in March to carry out a large-scale reorganization of the department.
  • The 1st Circuit rejected the Trump administration's claims that the states could not show they would be immediately harmed if the injunction is lifted pending an appeal. The panel noted that the lower court relied on hundreds of pages of testimony from state officials.
  • "The government does not explain how the district court clearly erred in crediting these uncontroverted facts," the court said in an unsigned order. All three judges were appointed by former President Joe Biden, a Democrat.
  • HHS did not immediately respond to a request for comment. The office of New York Attorney General Letitia James, which is spearheading the lawsuit, declined to comment.
  • https://www.reuters.com/legal/government/trump-administration-cannot-proceed-with-overhaul-us-health-agencies-court-rules-2025-09-17/

KEY BIOPHARMA NEWS

FDA Moves to Eliminate Expert Advisory Panels for Individual Drug Reviews Under Trump Administration

  • The FDA under President Trump is abandoning its decades-old policy of convening outside expert panels to review individual drug applications, with officials claiming these meetings are redundant and time-consuming.
  • George Tidmarsh, head of the FDA's Center for Drug Evaluation and Research, stated the agency "would like to get away" from assembling expert panels because "I don't think they're needed" for specific drug evaluations.
  • The FDA has already reduced advisory committee meetings from 22 in the same period last year to only seven since Trump's return, while beginning to publish complete response letters as an alternative transparency measure.
  • https://trial.medpath.com/news/fdccea7db059f210/fda-moves-to-eliminate-expert-advisory-panels-for-individual-drug-reviews-under-trump-administration

Drugmakers submit plans to join 340B rebate model pilot program

  • All eligible drugmakers have applied to participate in the government’s pilot program testing a rebate model for certain 340B drug discounts, an HHS spokesperson said.
  • Novartis and Bristol Myers Squibb confirmed to Endpoints News that they submitted their plans for the program to the Health Resources and Services Administration, following a Monday deadline to do so. Johnson & Johnson and AstraZeneca also told Endpoints they intend to participate in the pilot.
  • The pilot could change how the federal drug discount program has operated for decades. A rebate model would require health centers to purchase certain 340B-eligible drugs at market price and then recoup the discounts via rebates, as opposed to upfront. Several pharma companies have been fighting HRSA in court over proposals to implement their own rebate models to address what they claim is fraud and abuse of the program.
  • For now, only drugs subject to the first round of Medicare negotiations are eligible for the pilot.
  • https://endpoints.news/drugmakers-submit-plans-to-join-340b-rebate-model-pilot-program/   (subscription required for full text)

Hill staff gets briefed on implications of Trump’s drug pricing plan

  • Congress is again discussing the Trump administration’s plan to force drug companies to lower their U.S. prices, at least behind the scenes.
  • Congressional staffers and health policy experts from major think tanks held a closed-door meeting to discuss policy options that would peg U.S. prices for drugs to what other countries pay, called most-favored nation pricing. The discussions are the latest example of growing interest among Republicans in more aggressive measures to lower drug prices, including the most-favored nation plan that has been a top priority for President Trump.
  • Most of the staffers present were from Republican offices, according to Richard Frank, a panelist at the event who works at the left-leaning Brookings Institution. And the leader of the Senate health panel, Sen. Bill Cassidy (R-La.), has circulated proposed legislation for an MFN policy.
  • https://www.statnews.com/2025/09/15/trump-drug-prices-most-favored-nation-behind-the-scenes/    (subscription required for full text)

KEY DIAGNOSTICS – LIFE SCIENCE RESEARCH NEWS

Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices

  • The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification.
  • FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.
  • Absent the special controls identified in this final order, general controls applicable to these device types are insufficient to provide reasonable assurance of the safety and effectiveness of these devices.
  • FDA expects that the reclassification of these devices will enable more manufacturers to develop these types of devices such that patients will benefit from increased access to safe and effective diagnostics.
  • https://www.federalregister.gov/documents/2025/09/18/2025-18082/microbiology-devices-reclassification-of-antigen-antibody-and-nucleic-acid-based-hepatitis-b-virus

KEY HEALTH INFORMATION TECHNOLOGY (HIT) NEWS

FDA to Convene Advisory Committee Meeting on GenAI Mental Health Devices (Date Set)

KEY ACRONYMS

  • ANDA = abbreviated new drug application
  • BLA = biologics license application
  • 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
  • CMS = Centers for Medicare & Medicaid Services
  • DHAC = Digital Health Advisory Committee
  • FDA = Food and Drug Administration
  • HHS = Department of Health and Human Services
  • MAHA = Make America Healthy Again
  • NDA = new drug application
  • NIH = National Institutes of Health
  • OMUFA = Over-The-Counter Monograph Drug User Fee Program
  • OTC = Over the Counter
  • PAI = preapproval inspection
  • PLI = prelicense inspection
  • RRA = remote regulatory assessments
  • VSD = Vaccine Safety Datalink

 

 

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