In my capacity as President and under the authority granted by the Constitution and the laws of our great nation, I hereby issue the following directive:
Section 1. Purpose
During my first term, I undertook several pivotal actions aimed at reducing prescription drug prices for American citizens. The underlying message was unequivocal: the executive branch would no longer remain passive while pharmaceutical companies charged our citizens exorbitantly for the same medications available at significantly lower prices abroad, often manufactured in identical facilities.
These initiatives included promoting the development of generic and biosimilar alternatives to high-cost brand-name drugs, thereby leveraging competitive dynamics to enhance access to affordable medications. For the first time, we established a framework for importing lower-cost drugs from other countries. Our reform measures ensured that government-mandated discounts were actually passed on to patients rather than pocketed by intermediaries. Additionally, we introduced new transparency regulations enabling patients, healthcare providers, and employers to understand the real costs of prescription medications prior to purchase. We capped insulin copayments for Medicare beneficiaries and mandated that manufacturers shoulder the financial burden through greater discounts. I also urged Congress to collaborate on crafting sustainable solutions for long-term innovation and access, but when they declined, I proposed a groundbreaking payment mechanism to prevent manufacturers from imposing inflated prices on our patients compared to international markets.
These bold actions yielded tangible savings for American patients and laid the groundwork for progressively narrowing the price gap between the United States and other nations. Yet, predictably, the Biden Administration reversed or neglected many of these initiatives, effectively erasing the progress achieved for American patients. The administration subsequently enacted the aptly named Inflation Reduction Act, which includes the Medicare Prescription Drug Negotiation Program. Although this program aims to lower drug prices for Medicare and its recipients, its convoluted and costly framework has thus far delivered savings far below expectations. Moreover, modifications to the Medicare Part D program have resulted in inflated premiums and fewer coverage options for seniors, necessitating a taxpayer-funded rescue for insurance companies offering Part D plans. The program imposes price controls on small molecule drugs—usually in tablet or capsule form—four years ahead of similar measures for large molecule biological products, creating a “pill penalty” that could skew investment towards pricier biological treatments for rare diseases, rather than affordable small molecules that benefit larger patient populations.
The American public deserves superior healthcare policies. It is time to reinstate the progress achieved during my first term, prioritizing the health of Americans and reviving our commitment to accessible healthcare.
Sec. 2. Policy
It is the policy of the United States to optimize federal healthcare programs, intellectual property protections, and safety regulations to ensure American patients and taxpayers have access to prescription drugs at lower costs.
Sec. 3. Improving upon the Inflation Reduction Act
(a) Within 60 days of this order, the Secretary of Health and Human Services (Secretary) shall propose and solicit input on guidance for the Medicare Drug Price Negotiation Program, focusing on the initial price applicability for 2028 and the implementation of maximum fair prices for 2026, 2027, and 2028. This guidance will enhance transparency within the Medicare Drug Price Negotiation Program, prioritize high-cost prescription drugs, and mitigate any adverse effects on pharmaceutical innovation in the United States.
(b) Within 180 days, the Assistant to the President for Domestic Policy, in collaboration with the Secretary, the Office of Management and Budget Director, and the Assistant to the President for Economic Policy, shall present recommendations to the President on stabilizing and reducing Medicare Part D premiums.
(c) The Secretary will collaborate with Congress to amend the Medicare Drug Price Negotiation Program to ensure equitable treatment of small molecule drugs relative to biological products, eliminating distortions that hinder investment in small molecule treatments, alongside other reforms aimed at preventing increased overall costs for Medicare and its beneficiaries.
Sec. 4. Reducing the Prices of High-Cost Drugs for Seniors
Within one year of this order, the Secretary shall develop and implement a plan for rulemaking and select for testing, in accordance with 42 U.S.C. 1315a(b)(2), a payment model that enhances the Medicare program’s capability to procure better value for high-cost prescription drugs and biological products, including those not covered under the Medicare Drug Price Negotiation Program.
Sec. 5. Appropriately Accounting for Acquisition Costs of Drugs in Medicare
Within 180 days, the Secretary shall publish a plan in the Federal Register to conduct a survey under section 1833(t)(14)(D)(ii) of the Social Security Act to assess hospital acquisition costs for outpatient drugs. Following this survey, the Secretary will consider adjustments to align Medicare payments with acquisition costs in compliance with budget neutrality requirements.
Sec. 6. Promoting Innovation, Value, and Enhanced Oversight in Medicaid Drug Payment
Within 180 days, the OMB Director, the Assistant to the President for Domestic Policy, and the Assistant to the President for Economic Policy, in conjunction with the Secretary, will provide recommendations to the President aimed at ensuring manufacturers deliver accurate Medicaid drug rebates, driving innovation in Medicaid drug payment methodologies, linking payments to the value delivered, and assisting States in managing drug expenditures.
Sec. 7. Access to Affordable Life-Saving Medications
Within 90 days, the Secretary shall take measures to ensure that future grants under section 330(e) of the Public Health Service Act are contingent upon health centers implementing practices to provide insulin and injectable epinephrine at or below the discounted rates afforded to health center grantees or sub-grantees under the 340B Prescription Drug Program, plus a minimal administrative fee, to individuals with low incomes facing high cost-sharing for these medications or lacking healthcare insurance.
Sec. 8. Reevaluating the Role of Middlemen
Within 90 days, the Assistant to the President for Domestic Policy, in partnership with the Secretary, the OMB Director, and the Assistant to the President for Economic Policy, shall provide recommendations to promote a more competitive, efficient, transparent, and resilient pharmaceutical value chain that delivers lower drug prices for Americans.
Sec. 9. Accelerating Competition for High-Cost Prescription Drugs
Within 180 days, the Secretary, via the Commissioner of Food and Drugs, shall release a report outlining administrative and legislative recommendations to expedite the approval of generics, biosimilars, combination products, and second-in-class brand-name medications. This report will also include strategies for reclassifying prescription drugs as over-the-counter medications, identifying which can be safely transitioned to OTC status.
Sec. 10. Increasing Prescription Drug Importation to Lower Prices
Within 90 days, the Secretary, through the Commissioner of Food and Drugs, shall work to streamline and enhance the Importation Program under section 804 of the Federal Food, Drug, and Cosmetic Act, facilitating state approvals while maintaining safety and quality standards.
Sec. 11. Reducing Costly Care for Seniors
Within 180 days, the Secretary shall assess and, where appropriate and in compliance with applicable law, propose regulations to ensure that Medicare payment structures do not incentivize a shift in drug administration from cost-effective physician office settings to more expensive hospital outpatient departments.
Sec. 12. Improving Transparency into Pharmacy Benefit Manager Fee Disclosure
Within 180 days, the Secretary of Labor shall propose regulations under section 408(b)(2)(B) of the Employee Retirement Income Security Act of 1974 to enhance transparency for employers regarding the direct and indirect compensation received by pharmacy benefit managers.
Sec. 13. Combating Anti-Competitive Behavior by Prescription Drug Manufacturers
Within 180 days, the Secretary or a designated representative will conduct public listening sessions alongside personnel from the Department of Justice, the Department of Commerce, and the Federal Trade Commission, culminating in a report with recommendations aimed at curbing anti-competitive practices among pharmaceutical manufacturers.
Sec. 14. General Provisions
(a) Nothing in this order shall be interpreted to impair or otherwise affect:
(i.) the authority granted by law to any executive department or agency, or the head thereof; or
(ii.) the functions of the Director of the Office of Management and Budget pertaining to budgetary, administrative, or legislative proposals.
(b) This order shall be executed in compliance with applicable law and subject to available appropriations.
(c) This order does not intend to, nor does it create, any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other individual.
DONALD J. TRUMP
THE WHITE HOUSE,
April 15, 2025.
