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On December 9, 2025, the Food and Drug Administration (FDA) released final guidance on promotional labeling and advertising for prescription biological reference products, biosimilar products, and interchangeable biosimilar products (Final Guidance).
On December 4 and 5, 2025, the Advisory Committee on Immunization Practices (ACIP) met to discuss and vote on the committee’s recommendations for the hepatitis B birth dose and the childhood and adolescent vaccination schedule.
On November 25, 2025, the Centers for Medicare & Medicaid Services (CMS) released the maximum fair price (MFP) for each of the 15 selected drugs for IPAY 2027, which will go into effect beginning January 1, 2027. These negotiated prices reflect a marked increase in savings compared to the initial 2026 cohort, influenced by newer drugs and expanded pricing benchmarks.
On November 18, 2025, the Food and Drug Administration (FDA) published a final guidance entitled “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments” (Final Guidance).
On November 6, 2025, the Centers for Medicare & Medicaid Services (CMS) released the GENEROUS Model (Generating Cost Reductions for U.S. Medicaid Model). The model aims to achieve Most Favored Nation (MFN) international pricing for Covered Outpatient Drugs (CODs) while maintaining or improving the quality of care for Medicaid beneficiaries.
On October 31, 2025, the Centers for Medicare and Medicaid Services (CMS) issued the Physician Fee Schedule final rule (Final Rule) to be published in the Federal Register on November 5, 2025.
On September 30, 2025, the Centers for Medicare and Medicaid Services (CMS) issued final guidance for the third cycle of the Medicare Drug Price Negotiation Program for Initial Price Applicability Year (IPAY) 2028. Negotiations for the Maximum Fair Prices (MFP) on up to 15 additional negotiation-eligible Part D and/or Part B drugs will occur in 2026, with the MFP effective in IPAY 2028.
On September 30, 2025, the White House announced a deal with Pfizer to lower drug costs in line with most-favored nation (MFN) pricing. While specific terms of the agreement have not been disclosed, both Pfizer and the White House issued statements providing a broad outline of the agreement.
On September 22, 2025, President Trump claimed that acetaminophen, the active ingredient in Tylenol, taken during pregnancy increases the risk of autism. Acetaminophen has long been considered one of the few safe options for treating pain or fever during pregnancy.
On Sept 18 and Sept 19, 2025, the Advisory Committee on Immunization Practices (ACIP) met to review data and vote on vaccine recommendations.
On September 9, 2025, the Make America Healthy Again Commission (MAHA Commission) issued a strategy report titled, Make our Children Health Again (MOCHA Strategy Report).
On August 20, 2025, the U.S. Department of Health and Human Services (HHS) issued updates (the Interim Final Rule) which amends the final rule titled “Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard,” (the December 2024 Final Rule).
