White House Announces the Great Healthcare Plan

On January 15, 2026, the White House announced the Great Healthcare Plan. The plan calls on Congress to enact a comprehensive legislative package directed to lowering drug prices and insurance premiums.

White House announcement:

• President Trump Unveils The Great Healthcare Plan to Lower Costs and Deliver Money Directly to the People – The White House
• The Great Healthcare Plan – The White House

Fact sheet:

• The-Great-Healthcare-Plan.pdf

CMS Publishes Proposed Medicare MFN Models

On December 23, 2025, CMS published notices of proposed rulemaking for the GLOBE (Medicare Part B) and GUARD (Medicare Part D) most-favored nation drug pricing models.

Federal Register announcements:

• Federal Register :: Global Benchmark for Efficient Drug Pricing (GLOBE) Model
• Federal Register :: Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model

CMS announcements:

• GLOBE (Global Benchmark for Efficient Drug Pricing) Model | CMS
• GUARD (Guarding U.S. Medicare Against Rising Drug Costs) Model | CMS

Comments are due by February 23, 2026.

BIOSECURE Act Becomes Law

On December 18, 2025, President Trump signed the BIOSECURE Act as part of the National Defense Authorization Act. The BIOSECURE Act provides that federal agencies may not contract with an entity that, in its performance of federal contracts, uses “biotechnology equipment or services” from a “biotechnology company of concern.”

A company is considered a “biotechnology company of concern” if it appears on the annual 1260H list of Chinese military companies or is designated by the Office of Management and Budget (OMB) based on its ownership or control by the government of a foreign adversary and national security risk to the United States. OMB must issue its list of designated companies and implementation guidance by December 2026.

CMS Announces IRA Prices for IPAY2027

On November 25, 2025, CMS announced the “maximum fair prices” for the second year of Medicare price controls under the Inflation Reduction Act. The prices will take effect on January 1, 2027.

New Study Confirms IRA’s Impact on R&D

A recent study by the National Pharmaceutical Council examining the impact of the Inflation Reduction Act on oncology R&D found that the number of industry-sponsored, post-approval small molecule trials dropped by 45.3% and the number of biologic trials dropped by 32.5% after the IRA entered into force.  The study reinforces how the IRA disincentivizes innovation and has a disproportionate impact on small-molecule R&D.  

The Ensuring Pathways to Innovative Cures (EPIC) Act, which seeks to eliminate this “pill penalty” and harmonize the selection timelines for small-molecule drugs and biologics, is currently pending in the House.

Source: Hanke Zheng et al., Early impact of the Inflation Reduction Act on small molecule vs biologic post-approval oncology trials, Health Affairs Scholar, Volume 3, Issue 8, August 2025, qxaf152, https://doi.org/10.1093/haschl/qxaf152.