EO 14297 directs HHS to communicate MFN drug-price targets

On 12 May 2025 President Donald J. Trump signed Executive Order 14297, “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” at a White House signing.¹ The order directs the Secretary of Health and Human Services (RFK Jr.) to communicate, within 30 days of signing, “most-favored- nation price targets” to pharmaceutical manufacturers; relies on the Center for Medicare and Medicaid Innovation payment-model- testing authority at § 1115A of the Social Security Act, 42 U.S.C. § 1315a; directs the Secretary of the Treasury to report within 180 days on importation and manufacturer practices; and instructs HHS to solicit voluntary manufacturer commitments before any MFN rulemaking is proposed.¹² EO 14297 follows Executive Order 14273 of 15 April 2025 (“Lowering Drug Prices by Once Again Putting Americans First”) and revives an MFN reference-pricing approach the Trump administration first attempted in 2020 — CMS interim final rule CMS-9912-IFC, 85 Fed. Reg. 76180 (Nov. 27, 2020), which was preliminarily enjoined on Administrative Procedure Act grounds in Association of Community Cancer Centers v. Azar, No. 8:20-cv-03531 (D. Md. Dec. 23, 2020), and rescinded by CMS in December 2021.³⁴⁵ Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) opposed the order in same-day statements.⁶⁷

1. Operative price changes require either voluntary manufacturer compliance or a final HHS rule promulgated through notice and comment under the Administrative Procedure Act, 5 U.S.C. § 553.⁸ The 30-day window is the deadline for HHS to communicate MFN targets; the substantive rulemaking timeline runs separately.

2. The Inflation Reduction Act of 2022, Pub. L. 117-169 §§ 11001-11002, establishes the Medicare Drug Price Negotiation Program at Part E of Title XI of the Social Security Act, codified at 42 U.S.C. §§ 1320f-1320f-7, with the “maximum fair price” mechanism for selected high-cost drugs.⁹ CMS would have to specify in rulemaking the relationship between a CMMI MFN payment model under § 1315a and the IRA “maximum fair price” regime.

3. The order’s reference to FDA approval review introduces a regulatory lever distinct from CMS payment authority. Under § 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355, FDA approval is reviewed on safety and efficacy grounds.¹⁰ FDA’s § 804 prescription-drug importation programme requires a Secretary’s finding that the imported drugs pose no additional risk to public health and “result in a significant reduction in the cost” of covered products.¹¹