An Executive Order is a directive issued by the President of the United States that manages operations of the federal government. It has the force of law but does not require approval from Congress. Executive Orders are typically used to:
- Implement or clarify existing laws passed by Congress.
- Direct federal agencies on how to enforce laws or carry out programs.
- Set policy priorities within the executive branch.
They cannot create new laws or appropriate funds, that power belongs to Congress, but they can significantly influence how laws are applied and enforced.
Delivering Most Favored Nation Prescription Drug Pricing to American Patients
On May 12. 2025, President Trump Issued an Executive Order titled, “Delivering Most Favored Nation Prescription Drug Pricing to American Patients.”
The Executive Order outlines two steps to attain Most Favored Nation (MFN) prices aligned with comparably developed nations.
Step 1: Officials communicate MFN price targets to pharmaceutical manufacturers to bring prices down for American patients.
Step 2: Additional levers to obtain MFN prices
- HHS rulemaking plan to impose MFN pricing
- Consider certification on importation approvals
- Attorney General or Federal Trade Commission legal enforcement actions on anticompetitive behaviors
- Department of Commerce actions to restrict exportation fueling price discrimination
- Food & Drug Administration (FDA) revaluation of existing approvals and potential withdrawal if criteria are not met
- All agencies take action to address freeloading/price discrimination
Direct-to-Patient Purchasing and TrumpRx
TrumpRx.gov was announced as a federal online portal (not a pharmacy) designed to connect patients with manufacturers offering discounted prices under this initiative. The platform is intended to allow patients to search for eligible medications and purchase directly from participating manufacturers at significant discounts. As of January 2026, the site displayed “Coming Soon,” with launch expected early in the year. Reported examples of discounts range from approximately 50% to 85%, but these figures are illustrative and may vary by manufacturer and drug
Tariffs
Additionally, President Trump threatened 100% tariffs on branded drugs (generics exempt) unless manufacturers build U.S. plants. However, tariffs are on hold while voluntary MFN pricing deals are negotiated. Notably, the U.S. made an agreement with the U.K., offering zero tariffs on pharmaceuticals for three years, tied to MFN pricing commitments.
Beyond deals with manufacturers, the Trump Administration has announced a number of regulatory models to ensure MFN drug pricing.
Deals with Manufacturers
On July 31, 2025, President Trump issued formal letters to the CEOs of 17 major pharmaceutical companies, including AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck, Novartis, Novo Nordisk, Pfizer, Regeneron, Sanofi, Boehringer Ingelheim, EMD Serono, and Genentech.
Each letter outlined a firm 60-day timeline to comply with the May 12, 2025 Executive Order implementing Most-Favored-Nation (MFN) drug pricing, which mandates that U.S. prices match or fall below those in other developed countries.
Key requirements included:
- Extend MFN pricing to all Medicaid patients for existing drugs.
- Guarantee MFN pricing for new drug launches in the U.S. under Medicaid and Medicare.
- Repatriate foreign revenue gains to lower domestic drug prices.
- Establish direct-to-consumer or direct-to-business purchase models allowing Americans access to the lowest global prices without intermediaries.
The letters concluded with a strong warning: if the companies failed to act, the Administration would “deploy every tool in our arsenal” — including tariff and regulatory measures — to protect American families from “abusive drug pricing practices”.
To date, 15 of 17 manufacturers have signed agreements. The two remaining companies are AbbVie and Regeneron.
Manufacturers & Deal Summaries
(List out in a table all of the manufactures that have made deals and a small summary of the deal)
| Pfizer | Participates in MFN deals with standard terms, including TrumpRx, Medicaid MFN, launch price commitments, repatriation, and investment commitments. |
| EMD Serono | Agreed to reduce IVF drug costs by ~73%, with some prices dropping from $242 to $10 for eligible Americans. Received an FDA CNPV voucher and committed to MFN pricing for all future drugs, alongside plans to repatriate manufacturing. |
| AstraZeneca | Committed to MFN pricing for certain drugs in Medicaid and launched the TrumpRx direct-to-consumer platform. Announced major investments: $50B in U.S. manufacturing and R&D by 2030, including $6.5B for a new facility in Charlottesville, VA. |
| Lilly | MFN deal includes Medicare Part D expansion and significant price reductions: e.g., weight-loss drugs (Zepbound, Orforglipron) dropping from $1,086/month to $346. Additional discounts on Emgality ($299/pen) and Trulicity ($389/month), plus participation in CNPV and CMMI’s GENEROUS model. |
| Novo Nordisk | MFN deal includes Medicare Part D expansion and major price cuts: Ozempic and Wegovy reduced to $350/month; Novolog and Tresiba at $35/month. Committed to U.S.-based manufacturing for Wegovy and participation in CNPV and CMMI’s GENEROUS model. |
| Boehringer Ingelheim | Reduce price of Jentadeuto from $525 to $55 via TrumpRx |
| GSK | Offer majority of inhaled respiratory portfolio and other products on DTP platform Contribute 98.8kg of albuterol to the SAPIR |
| Novartis | Offer Mayzent, Rydapt, Tabrecta via DTP and TrumpRx Apply to participate in the GENEROUS Model |
| Merk | Offer Januvia, Janumet, and Janumet via DTP program, with intent to offer Enlicitide Decanoate following FDA approval Contribute 3.5T of ertapenem to the SAPIR |
| Amgen | Expand DTP Program, AmgenNow, to include Aimovig and Amjevita at $299 Offer discounted Aimovig, Amjevita, and Repatha on TrumpRx |
| Sanofi | Reduce prices by an average of 61% for certain medications through Medicaid, and 70% via TrumpRx and other DTP platforms |
| Genentech | Make Zofluza available at $50 DTP and via TrumpRx, representing a ~70% price reduction |
| Gilead | Provide Medicaid discounts on certain existing medications to treat HIV, Hep C, Hep B, and COVID Offer Epclusa via DTP and TrumpRx |
| Bristol Myers Squibb | Make Eliquis available to Medicaid for free and contribute 6.5T of API to the SAPIR Enable DTP for Sotyktu, Zeposid, Reyataz, Baraclude, and Orencia |
| Johnson & Johnson | Secure exemption from U.S. pharmaceutical tariffs by reducing prices for key drugs under Medicaid and TrumpRx Commit to build a new cell therapy facility in Pennsylvania and a drug-product manufacturing plant in North Carolina as part of the pricing deal |
Direct-to-Consumer Prescription Drug Advertising
On September 9, 2025, President Trump issued a Presidential Memorandum directing the Department of Health and Human Services and the Food and Drug Administration to strengthen oversight of prescription drug advertising aimed directly at consumers. The memorandum called for:
- Greater transparency and accuracy in advertisements, requiring fuller disclosure of drug risks and ensuring ads are truthful and not misleading.
- Closing the “adequate provision” framework that has allowed broadcast ads to provide only a brief risk statement and refer viewers to external sources for full safety details. The administration announced plans to return to pre-1997 standards by requiring comprehensive safety disclosures within the ads themselves. (This is an announced rulemaking, not yet finalized.)
- Expanded enforcement, including thousands of warning letters and approximately 100 cease-and-desist letters to companies violating regulations, and increased scrutiny of digital platforms such as social media influencers and online advertising.
340B Rebate Model Pilot Program
The 340B Drug Pricing Program enables covered entities to purchase outpatient prescription drugs at a discounted price from pharmaceutical manufacturers.
340B Rebate Model Pilot Program
The 340B Rebate Model Pilot Program, announced by HRSA’s Office of Pharmacy Affairs, begins January 1, 2026 (with Novartis’ Entresto starting April 1). It tests replacing upfront 340B discounts with post-sale rebates for a limited set of drugs. The pilot applies to 10 drugs selected under CMS’s Medicare Drug Price Negotiation Program (IPAY 2026), including Eliquis, Enbrel, Entresto, Farxiga, Imbruvica, Januvia, Jardiance, NovoLog/Fiasp products, Stelara, and Xarelto.
- Note: Implementation has been temporarily halted by a court order issued on December 29, 2025, when the U.S. District Court for the District of Maine granted a nationwide preliminary injunction blocking the Pilot effective January 1, 2026.
- The Court found that HRSA likely violated the Administrative Procedure Act (APA) by rolling out the Pilot with a “threadbare administrative record” that failed to assess the financial and operational burdens on 340B-covered entities and by inadequately responding to public comments.
- Additionally, the Court determined that the Pilot would cause irreparable harm to safety-net providers who rely on upfront discounts and that the balance of equities and public interest supported the injunction.
- Most Recent Update (January 12, 2026):
- The Trump administration has signaled that it intends to drop its appeal of the court order blocking the 340B Rebate Model Pilot Program. In a January 12 filing, the Department of Justice informed the U.S. Court of Appeals for the First Circuit that the parties, including HHS and the American Hospital Association, are in discussions to return the challenged rebate approvals to HHS for reconsideration, and the administration anticipates dismissing the appeal shortly.
- Hospital Outpatient Prospective Payment System (HOPPS)
- 340B Acquisition Cost Survey: CMS will conduct a survey of the acquisition costs for each separately payable drug acquired by all hospitals paid under the Hospital Outpatient Prospective Payment System (OPPS), including specified covered outpatient drugs (SCODs) such as those acquired under the 340B program. CMS indicated that this survey would be open starting at the end of CY 2025 to early CY 2026. CMS intends for the survey to be completed in time for the results to be used to inform policymaking beginning with the CY 2027 OPPS/ASC proposed rule.