[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. 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.
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 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. 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.
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.
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]]
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
(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.
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.
(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