Lowering Drug Prices by Once Again Putting Americans First
Directs HHS and other federal agencies to pursue more than a dozen specific steps to lower prescription drug prices, including reforming Medicare negotiation guidance, streamlining drug importation, and conditioning community health center grants on affordable insulin and injectable epinephrine access for low-income patients.
Establishes a broad drug-pricing agenda targeting Medicare Part D premiums, the so-called 'pill penalty' favoring biologics, pharmacy benefit manager fees, hospital site-of-care cost disparities, and anti-competitive manufacturer behavior — primarily through required reports, recommendations, and proposed rules rather than immediate price changes.
What this order does
What it orders
The order directs the Secretary of Health and Human Services to propose updated Medicare Drug Price Negotiation Program guidance within 60 days, develop a new high-cost drug payment model within one year, condition future community health center grants on affordable insulin and injectable epinephrine pricing within 90 days, and streamline the state drug importation program within 90 days. It also directs the Secretary of Labor to propose new regulations improving employer health plan transparency into pharmacy benefit manager compensation, and calls for multiple reports and presidential recommendations covering Medicare Part D premiums, Medicaid drug rebates, generic and biosimilar approval acceleration, hospital outpatient cost shifts, and anti-competitive manufacturer conduct.
The order itself does not change any drug prices, regulations, or laws directly. Nearly every major directive calls on agencies to study, recommend, survey, or propose rules — meaning actual impact on drug prices depends on subsequent rulemaking, congressional action, or further executive decisions. Standard severability and no-private-right-of-action clauses apply throughout.
Who it affects
Medicare and Medicaid beneficiaries, low-income patients seeking insulin or injectable epinephrine at community health centers, employers and workers enrolled in private health plans, pharmaceutical manufacturers, pharmacy benefit managers, and states seeking to run drug importation programs.
Why it matters
Low-income patients at federally funded health centers could gain access to insulin and epinephrine at near-cost prices within 90 days. Employers and Medicare beneficiaries may eventually see lower premiums and more transparent drug costs if the required rulemakings and recommendations lead to finalized changes.
What must happen and when
How the order is supposed to work
The order choreographs parallel workstreams on different clocks: a 60-day guidance proposal for Medicare drug negotiations, multiple 90-day actions on importation and grant conditions, a cluster of 180-day recommendation and rulemaking deadlines, and a one-year window to develop a new Medicare payment model. Most deliverables are reports, recommendations to the President, or proposed rules — each requiring further review before taking effect. Actual policy changes depend on completed rulemakings, appropriations, or congressional cooperation, particularly for the "pill penalty" fix and Medicaid reforms. No enforcement mechanism for missed deadlines is specified in the order.
Actions and deadlines
- Propose and seek public comment on updated Medicare Drug Price Negotiation Program guidance for 2028
- Condition future 340B health center grants on affordable insulin and injectable epinephrine pricing for low-income patients
- Streamline the state drug importation program to ease approval while maintaining safety standards
- Provide recommendations on reforming the pharmaceutical supply chain to lower drug prices for Americans
- Provide recommendations to the President on stabilizing and reducing Medicare Part D premiums
- Publish a plan to survey hospital acquisition costs for covered outpatient drugs under Medicare
- Provide recommendations to the President on improving Medicaid drug rebates and value-based payment methodologies
- Issue FDA report with recommendations to accelerate approval of generics, biosimilars, and OTC drug reclassification
- Evaluate and potentially propose regulations addressing Medicare payment disparities favoring costly hospital outpatient settings
- Propose ERISA regulations requiring greater employer health plan transparency into pharmacy benefit manager fees
- Conduct joint listening sessions and issue report on anti-competitive conduct by pharmaceutical manufacturers
- Develop a rulemaking plan and select a Medicare payment model for high-cost drugs and biologics
- Work with Congress to eliminate the 'pill penalty' by aligning small molecule and biologic negotiation timelines