On April 15, 2025, President Donald Trump signed an Executive Order (EO) titled, “Lowering Drug Prices by Once Again Putting Americans First,” building on drug pricing related actions from his first term, President Biden era actions and legislative proposals in Congress, all aimed at reducing the cost of prescription drugs for American patients. Issuance of the EO was not unexpected given President Trump's focus on drug pricing issues during his first four years in office. The EO, lays out a dozen new directives, ranging from development of regulations to reports, with specific deadlines for the Department of Health and Human Services (HHS), including the Centers for Medicare & Medicaid Services (CMS) and Food and Drug Administration (FDA), as well as the Department of Labor and Federal Trade Commission (FTC) over the next year. These directives set the stage for a sustained focus on drug pricing by the new administration. Stakeholders will be closely watching for additional details as the Trump administration implements the EO and advances its policy work on drug pricing fronts given the far-reaching implications across the health care and life sciences ecosystems.
Key areas of focus in the EO include:
- Improving transparency—and minimizing negative impacts of negotiated prices on innovation—under the Medicare Drug Price Negotiation Program (MDPNP) established by the Inflation Reduction Act (IRA) (P.L 117-169).
- Streamlining the FDA processes for generics and biosimilar products and improving the process through which prescription drugs can be reclassified as over-the-counter medications to expand competition and choice for patients.
- Working with Congress to modify the differential treatment of small molecule drugs, known as the “pill penalty,” under the IRA’s drug pricing provisions.
- Addressing the role of so-called middlemen and pharmacy benefit managers (PBMs) as well as resiliency in the prescription drug supply chain.
- Proposing and considering changes to federal health programs to reduce cost-sharing for, and enhance access to, insulin and EpiPens.
- Evaluating paying hospitals for Part B drugs on a site-neutral basis by which they would receive reimbursement at the same rate as physician offices when administering these drugs to Medicare beneficiaries.
The table below outlines the timeline for each of the EO’s deliverables, providing insight as to when to anticipate further details on the areas of focus under the EO. Stakeholders will be closely watching for each of these follow-on actions and further details as the Trump administration continues to advance its drug pricing priorities and navigates implementing a post-IRA drug pricing landscape in its second term.
