Lowering Drug Prices by Once Again Putting Americans First

[Federal Register Volume 90, Number 74 (Friday, April 18, 2025)]

[Presidential Documents]

[Pages 16441-16444]

From the Federal Register Online via the Government Publishing Office [www.gpo.gov]

[FR Doc No: 2025-06837]

Presidential Documents

Federal Register / Vol. 90, No. 74 / Friday, April 18, 2025 /

Presidential Documents

[[Page 16441]]

Executive Order 14273 of April 15, 2025

Lowering Drug Prices by Once Again Putting

Americans First

By the authority vested in me as President by the

Constitution and the laws of the United States of

America, it is hereby ordered:

Section 1. Purpose. My first term included numerous

significant actions, including some of the most

aggressive in recent history, to deliver lower

prescription drug prices to American patients. The

message was clear: no longer would the executive branch

sit idly by as pharmaceutical manufacturers charged

patients in our Nation more than those in other

countries for the exact same prescription drugs, often

made in the exact same places.

These actions included encouraging the development of

generic and biosimilar alternatives to higher cost

brand name prescription drugs and biologics to harness

competitive forces and increase access to affordable

medicines. The United States also, for the first time,

established a pathway to expand access to lower cost

drugs imported from outside of the country. Reform

efforts ensured that Government-mandated discounts were

passed through to patients instead of being retained by

middlemen

ess to affordable

medicines. The United States also, for the first time,

established a pathway to expand access to lower cost

drugs imported from outside of the country. Reform

efforts ensured that Government-mandated discounts were

passed through to patients instead of being retained by

middlemen. New price transparency rules were

promulgated to allow patients, doctors, and employers

to see the actual cost of prescription drugs before

purchase. Insulin copayments were capped for Medicare

beneficiaries, and manufacturers, instead of patients

and taxpayers, were forced to foot the bill through the

provision of larger discounts. I also called on the

Congress to come to the table to help craft sustainable

solutions that would promote innovation and affordable

access for the long-term. When the Congress refused, I

proposed the test of an innovative new payment

mechanism that would prevent drug manufacturers from

charging our patients much higher prices than those

found abroad.

Combined, these bold actions were delivering real

savings for American patients and set the foundation to

dramatically narrow the price disparity between the

United States and foreign nations over time.

event drug manufacturers from

charging our patients much higher prices than those

found abroad.

Combined, these bold actions were delivering real

savings for American patients and set the foundation to

dramatically narrow the price disparity between the

United States and foreign nations over time.

Unsurprisingly, the Biden Administration reversed,

walked back, or neglected many of these initiatives,

undoing the progress made for American patients. The

Biden Administration then signed into law the misnamed

Inflation Reduction Act, which included the Medicare

Prescription Drug Negotiation Program. While this

program has the commendable goal of reducing the drug

prices Medicare and its beneficiaries pay, its

administratively complex and expensive regime has thus

far produced much lower savings than projected.

Further, accompanying changes to the Medicare Part D

program led to inflated premiums and diminished

coverage choices for seniors, prompting a taxpayer-

funded bailout of insurance companies offering Part D

plans. Finally, the program imposes price controls on

small molecule prescription drugs, usually in tablet or

capsule form, 4 years earlier than on large molecule

biological products. Known as the ``pill penalty,''

this discrepancy threatens to distort innovation by

pushing investment towards expensive biological

products, which are often indicated to treat rarer

diseases, and away from small molecule prescription

drugs, which are generally cheaper and treat larger

patient populations.

the ``pill penalty,''

this discrepancy threatens to distort innovation by

pushing investment towards expensive biological

products, which are often indicated to treat rarer

diseases, and away from small molecule prescription

drugs, which are generally cheaper and treat larger

patient populations.

The American people deserve better. It is time to

restore the progress our Nation made in my first term

to deliver lower prescription drug prices by putting

Americans first and making America healthy again.

[[Page 16442]]

Sec. 2. Policy. It is the policy of the United States

that Federal health care programs, intellectual

property protections, and safety regulations are

optimized to provide access to prescription drugs at

lower costs to American patients and taxpayers.

Sec. 3. Improving upon the Inflation Reduction Act. (a)

Within 60 days of the date of this order, the Secretary

of Health and Human Services (Secretary), consistent

with sections 1191 to 1198 of the Social Security Act

(42 U.S.C. 1320f-1320f-7) and other applicable law,

shall propose and seek comment on guidance for the

Medicare Drug Price Negotiation Program for initial

price applicability year 2028 and manufacturer

effectuation of maximum fair price under such program

in 2026, 2027, and 2028

ocial Security Act

(42 U.S.C. 1320f-1320f-7) and other applicable law,

shall propose and seek comment on guidance for the

Medicare Drug Price Negotiation Program for initial

price applicability year 2028 and manufacturer

effectuation of maximum fair price under such program

in 2026, 2027, and 2028. The guidance shall improve the

transparency of the Medicare Drug Price Negotiation

Program, prioritize the selection of prescription drugs

with high costs to the Medicare program, and minimize

any negative impacts of the maximum fair price on

pharmaceutical innovation within the United States.

(b) Within 180 days of the date of this order, the

Assistant to the President for Domestic Policy, in

coordination with the Secretary, the Director of the

Office of Management and Budget (OMB Director), and the

Assistant to the President for Economic Policy, shall

provide recommendations to the President on how best to

stabilize and reduce Medicare Part D premiums.

(c) The Secretary shall work with the Congress to

modify the Medicare Drug Price Negotiation Program to

align the treatment of small molecule prescription

drugs with that of biological products, ending the

distortion that undermines relative investment in small

molecule prescription drugs, coupled with other reforms

to prevent any increase in overall costs to Medicare

and its beneficiaries.

ogram to

align the treatment of small molecule prescription

drugs with that of biological products, ending the

distortion that undermines relative investment in small

molecule prescription drugs, coupled with other reforms

to prevent any increase in overall costs to Medicare

and its beneficiaries.

Sec. 4. Reducing the Prices of High-Cost Drugs for

Seniors. Within 1 year of the date of this order, the

Secretary shall take appropriate steps to develop and

implement a rulemaking plan and select for testing,

consistent with 42 U.S.C. 1315a(b)(2), a payment model

to improve the ability of the Medicare program to

obtain better value for high-cost prescription drugs

and biological products covered by Medicare, including

those not subject to the Medicare Drug Price

Negotiation Program.

Sec. 5. Appropriately Accounting for Acquisition Costs

of Drugs in Medicare. Within 180 days of the date of

this order, as appropriate and consistent with

applicable law, the Secretary shall publish in the

Federal Register a plan to conduct a survey under

section 1833(t)(14)(D)(ii) of the Social Security Act

to determine the hospital acquisition cost for covered

outpatient drugs at hospital outpatient departments.

Following the conclusion of this survey, the Secretary

shall consider and propose any appropriate adjustments

that would align Medicare payment with the cost of

acquisition, consistent with the budget neutrality

requirement in section 1833(t)(9)(B) of the Social

Security Act and other legal requirements.

Following the conclusion of this survey, the Secretary

shall consider and propose any appropriate adjustments

that would align Medicare payment with the cost of

acquisition, consistent with the budget neutrality

requirement in section 1833(t)(9)(B) of the Social

Security Act and other legal requirements.

Sec. 6. Promoting Innovation, Value, and Enhanced

Oversight in Medicaid Drug Payment. Within 180 days of

the date of this order, the OMB Director, the Assistant

to the President for Domestic Policy, and the Assistant

to the President for Economic Policy, in coordination

with the Secretary, shall jointly provide

recommendations to the President on how best to ensure

that manufacturers pay accurate Medicaid drug rebates

consistent with section 1927 of the Social Security

Act, promote innovation in Medicaid drug payment

methodologies, link payments for drugs to the value

obtained, and support States in managing drug spending.

Sec. 7. Access to Affordable Life-Saving Medications.

Within 90 days of the date of this order, as

appropriate and consistent with applicable law, the

Secretary shall take action to ensure future grants

available under section 330(e) of the Public Health

Service Act, as amended, 42 U.S.C. 254b(e), are

conditioned upon health centers establishing practices

to make insulin and injectable epinephrine available at

or below the discounted price paid by the health center

grantee or sub-grantee under the 340B Prescription

[[Page 16443]]

ction 330(e) of the Public Health

Service Act, as amended, 42 U.S.C. 254b(e), are

conditioned upon health centers establishing practices

to make insulin and injectable epinephrine available at

or below the discounted price paid by the health center

grantee or sub-grantee under the 340B Prescription

[[Page 16443]]

Drug Program (plus a minimal administration fee) to

individuals with low incomes, as determined by the

Secretary, who:

(a) have a high cost-sharing requirement for either

insulin or injectable epinephrine;

(b) have a high unmet deductible; or

(c) have no healthcare insurance.

Sec. 8. Reevaluating the Role of Middlemen. Within 90

days of the date of this order, the Assistant to the

President for Domestic Policy, in coordination with the

Secretary, the OMB Director, and the Assistant to the

President for Economic Policy, shall provide

recommendations to the President on how best 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 of the date of this

order, the Secretary, through the Commissioner of Food

and Drugs, shall issue a report providing

administrative and legislative recommendations to:

(a) accelerate approval of generics, biosimilars,

combination products, and second-in-class brand name

medications; and

0 days of the date of this

order, the Secretary, through the Commissioner of Food

and Drugs, shall issue a report providing

administrative and legislative recommendations to:

(a) accelerate approval of generics, biosimilars,

combination products, and second-in-class brand name

medications; and

(b) improve the process through which prescription

drugs can be reclassified as over-the-counter

medications, including recommendations to optimally

identify prescription drugs that can be safely provided

to patients over the counter.

Sec. 10. Increasing Prescription Drug Importation to

Lower Prices. Within 90 days of the date of this order,

the Secretary, through the Commissioner of Food and

Drugs, shall take steps to streamline and improve the

Importation Program under section 804 of the Federal

Food, Drug, and Cosmetic Act to make it easier for

States to obtain approval without sacrificing safety or

quality.

Sec. 11. Reducing Costly Care for Seniors. Within 180

days of the date of this order, the Secretary shall

evaluate and, if appropriate and consistent with

applicable law, propose regulations to ensure that

payment within the Medicare program is not encouraging

a shift in drug administration volume away from less

costly physician office settings to more expensive

hospital outpatient departments.

shall

evaluate and, if appropriate and consistent with

applicable law, propose regulations to ensure that

payment within the Medicare program is not encouraging

a shift in drug administration volume away from less

costly physician office settings to more expensive

hospital outpatient departments.

Sec. 12. Improving Transparency into Pharmacy Benefit

Manager Fee Disclosure. Within 180 days of the date of

this order, the Secretary of Labor shall propose

regulations pursuant to section 408(b)(2)(B) of the

Employee Retirement Income Security Act of 1974 to

improve employer health plan fiduciary transparency

into the direct and indirect compensation received by

pharmacy benefit managers.

Sec. 13. Combating Anti-Competitive Behavior by

Prescription Drug Manufacturers. Within 180 days of the

date of this order, the Secretary or his designee shall

conduct joint public listening sessions with the

appropriate personnel from the Department of Justice,

the Department of Commerce, and the Federal Trade

Commission and issue a report with recommendations to

reduce anti-competitive behavior from pharmaceutical

manufacturers.

Sec. 14. General Provisions. (a) Nothing in this order

shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or

the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget

relating to budgetary, administrative, or legislative proposals.

manufacturers.

Sec. 14. General Provisions. (a) Nothing in this order

shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or

the head thereof; or

(ii) the functions of the Director of the Office of Management and Budget

relating to budgetary, administrative, or legislative proposals.

(b) This order shall be implemented consistent with

applicable law and subject to the availability of

appropriations.

(c) This order is not intended to, and does not,

create any right or benefit, substantive or procedural,

enforceable at law or in equity by any party

[[Page 16444]]

against the United States, its departments, agencies,

or entities, its officers, employees, or agents, or any

other person.

(Presidential Sig.)

THE WHITE HOUSE,

April 15, 2025.

[FR Doc. 2025-06837

Filed 4-17-25; 8:45 am]

Billing code 3395-F4-P