The drug pricing regulatory and legislative landscape continues to evolve rapidly at both federal and state levels. Below, we highlight significant changes that occurred between May 22, 2025, and August 21, 2025. Download the full Q3 2025 Regulatory and Legislative Activity Update .
Federal regulatory activity
Medicare
- Medicare Part D Bids: On July 28, 2025, CMS released preliminary 2026 Medicare Part D bid information, with substantial increases in the National Average Monthly Bid Amount and direct subsidies noted.
- Medicare Physician Fee Schedule: Released on July 14, 2025, CMS proposes changes in the methodology for calculating average sales price and clarifying inclusion in drug price negotiations.
General drug updates
- Strategic Active Pharmaceutical Ingredients Reserve: On August 13, 2025, an Executive Order directed the establishment of a reserve to ensure supply of critical drugs.
- Most Favored Nation (MFN) Drug Prices: On July 31, 2025, President Trump sent letters to manufacturers outlining actions to lower U.S. prescription drug prices to align with MFN prices. Failure to comply may result in enforced measures.
Vaccine updates
- HHS Task Force on Safer Childhood Vaccines: Announced on August 14, 2025, HHS is reinstating the Task Force to enhance vaccine safety and oversight, with a report to Congress due in two years.
- Thimerosal in Influenza Vaccines: HHS Secretary approved CDC’s recommendation on July 23, 2025, to eliminate thimerosal from all influenza vaccines without disrupting supplies.
- Advisory Committee on Immunization Practices (ACIP) Members: On June 9, 2025, all 17 ACIP members were dismissed to address concerns of conflicts of interest. New members were appointed on June 11, 2025. Additionally, on July 31, 2025, the CDC restricted external groups from participating in ACIP work groups to prevent potential biases, allowing access only to open plenary meetings.
Congressional activity
Senate initiatives
- The Remedy Act: Reintroduced on July 31, 2025, focusing on curbing evergreening practices by brand-name drug manufacturers to delay generic competition.
- The ETHIC Act: Reintroduced on July 15, 2025, aimed at streamlining patent litigation to enhance competition.
House of Representatives
- PBM Reform Act: Introduced on July 10, 2025, to ban spread pricing arrangements in Medicaid and enhance transparency and reporting requirements.
- Fair Pharmacies for Federal Employees Act: Introduced on July 15, 2025, to restrict Federal Employee Health Benefits Program contract entities from owning pharmacies.
State legislative activity
- Multiple State Actions: Numerous states, including California, New Jersey, Louisiana, Ohio, and Tennessee, introduced legislation regulating PBM activities, with Arkansas’s recent prohibition on PBM ownership of pharmacies facing federal legal challenges.
Enacted State Legislation Under Legal Challenge
- Arkansas: A preliminary injunction was issued on July 28, 2025, against Act 624, halting enforcement due to constitutional concerns.
- Iowa: Legal actions are underway challenging S.F. 383’s compatibility with federal law.
Conclusion
We hope you found this summary of federal and state legislative and regulatory activity useful. While the topics that legislators and regulators are focusing on are constantly evolving, this summary captures many of the issues that are in review. The information in this report is current as of August 25, 2025.
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