Full Text
Official text as published. Use Ctrl+F / Cmd+F to search within the document.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4355 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
2d Session
S. 4355
To require the Department of Health and Human Services to release
documents, communications, and other information relating to most
favored nation pricing agreements and other private or confidential
drug pricing deals struck with manufacturers, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 21, 2026
Mr. Wyden (for himself, Mr. Welch, Ms. Warren, Mr. Gallego, Mr.
Merkley, Mr. Lujan, Ms. Baldwin, Mr. Whitehouse, Mr. Kelly, Mr.
Sanders, Mr. Warner, Ms. Smith, Ms. Hassan, Ms. Cortez Masto, Mr.
Bennet, Mr. Warnock, Ms. Hirono, and Ms. Cantwell) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To require the Department of Health and Human Services to release
documents, communications, and other information relating to most
favored nation pricing agreements and other private or confidential
drug pricing deals struck with manufacturers, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Drug Deal Disclosure Act''.
SEC. 2. RELEASE OF INFORMATION RELATING TO MOST-FAVORED-NATION PRICING
AGREEMENTS.
(a) Public Release of Information.--
(1) In general.--Not later than 30 days after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this Act as the ``Secretary''),
subject to subsections (b) and (c), shall make publicly
available in a centralized, searchable, and downloadable format
all records, documents, communications, meeting notes,
memoranda, directives, logs, metadata, contracts, and
agreements as provided by the Department of Health and Human
Services, or any other Federal department, agency, or office
that possesses such information to which the Secretary does not
have direct access, that relate to any agreement, including any
agreement described in paragraph (2) or (3), between an
Executive Office of the President, the Department of Health and
Human Services, the Department of Commerce, or another Federal
department, agency, or office and any drug manufacturer entered
into on or after January 20, 2025, that includes any of the
following provisions:
(A) That the manufacturer or any of its
subsidiaries shall offer reduced prices on any of its
drugs to levels that make reference to the prices paid
for drugs in nations other than the United States,
including under the Medicare program under title XVIII
of the Social Security Act (42 U.S.C. 1395 et seq.) and
the Medicaid program under title XIX of such Act (42
U.S.C. 1396 et seq.).
(B) That the manufacturer or any of its
subsidiaries shall offer or expand its offerings of
direct-to-consumer drug sales or discounts on its drugs
through the website of such manufacturer or subsidiary,
partnerships with other entities, or any government-
sponsored platform, including TrumpRx.
(C) That goods imported or produced by the
manufacturer or any of its subsidiaries shall be
excluded or exempt from any duties or other import
restrictions.
(D) That the manufacturer or any of its
subsidiaries shall further invest money or resources
into the United States or repatriate revenue made in
nations other than the United States.
(E) That the manufacturer or any of its
subsidiaries shall receive special treatment, such as
an exemption from, or specialized predetermined
conditions of participation for, any demonstration
project proposed or implemented by the Center for
Medicare and Medicaid Innovation, including the Global
Benchmark for Efficient Drug Pricing ``GLOBE'' Model,
and the Guarding U.S. Medicare Against Rising Drug
Costs ``GUARD'' Model.
(F) That the manufacturer or any of its
subsidiaries shall contribute to, or be guaranteed
purchasing agreement for, the Strategic National
Stockpile established under section 319F-2 of the
Public Health Service Act (42 U.S.C. 247d-6b).
(G) That the manufacturer or any of its
subsidiaries shall receive a Commissioner's National
Priority Review Voucher through the pilot program of
the Food and Drug Administration.
(2) Agreements.--The agreements described in this
paragraph, and for which public disclosure is required under
paragraph (1), include the agreements publicly announced by an
Executive Office of the President or the applicable drug
manufacturer, as follows:
(A) AbbVie Inc. on January 12, 2026.
(B) Amgen Inc. on December 19, 2025.
(C) AstraZeneca plc. on October 10, 2025.
(D) Boehringer Ingelheim Pharmaceuticals, Inc. on
December 19, 2025.
(E) Bristol Myers Squibb on December 19, 2025.
(F) Eli Lilly & Company on November 6, 2025.
(G) EMD Serono Inc. on October 16, 2025.
(H) Genentech, Inc. on December 19, 2025.
(I) Gilead Sciences, Inc. on December 19, 2025.
(J) GSK plc. on December 19, 2025.
(K) Johnson & Johnson, Inc. on January 8, 2026.
(L) Merck & Co., Inc. on December 19, 2025.
(M) Novartis AG on December 19, 2025.
(N) Novo Nordisk Inc. on November 6, 2025.
(O) Pfizer Inc. on September 30, 2025.
(P) Sanofi S.A. on December 19, 2025.
(3) Subsequent agreements.--If, after the date of enactment
of this Act, an Executive Office of the President or any other
Federal department, agency, or office enters into an agreement
with a drug manufacturer or any of its subsidiaries that meets
the criteria described in paragraph (1), or modifies or amends
an agreement listed in paragraph (2), not later than 30 days
after the date of ratification of such new agreement, the
Secretary shall disclose information about such agreement as
described in paragraph (1).
(b) Prohibited Grounds for Withholding.--No record shall be
withheld, delayed, or redacted on the basis of reputational harm or
political sensitivity, including to any government official, public
figure, or manufacturer.
(c) Permitted Withholdings.--The Secretary may withhold or redact
the segregable portions of agreements required to be disclosed under
subsection (a)(1) that include proprietary pricing information, pricing
information that manufacturers are legally prohibited from disclosing
based on the law of a nation other than the United States or as part of
a settlement agreement or court directive, or information that is
protected from disclosure under other applicable law, provided that the
Secretary--
(1) discloses whether the Secretary has been provided
access to confidential pricing information by each individual
manufacturer; and
(2) includes with any such redaction or withholding a
written justification, and ensures that such written
justification is published in the Federal Register and
submitted to Congress.
SEC. 3. REPORT TO CONGRESS.
Not later than 15 days after the completion of the release of
agreements listed under section 2(a)(2), the Secretary shall submit to
the Committee on Finance and the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy and Commerce,
the Committee on Education and Workforce, and the Committee on Ways and
Means of the House of Representatives a report listing--
(1) all documents and information released and withheld;
and
(2) a summary of redactions and withholdings made,
including legal basis for such redactions and withholdings.
SEC. 4. CONGRESSIONAL BUDGET OFFICE AND GOVERNMENT ACCOUNTABILITY
OFFICE ANALYSIS.
Not later than 90 days after the completion of the release of
agreements listed under section 2(a)(2), the Director of the
Congressional Budget Office and the Comptroller General of the United
States, jointly, shall publish a report on the economic and budgetary
effects of all agreements disclosed under section 2, including--
(1) the expected economic and budgetary consequences of
each such agreement;
(2) an analysis of direct cost savings that individuals in
the United States have received and can expect to receive, by
insurance status, including uninsured individuals, as a
consequence of the agreements;
(3) a budget analysis of the impacts of the agreements on
the Medicare program under title XVIII of the Social Security
Act (42 U.S.C. 1395 et seq.), the Medicaid program under title
XIX of such Act (42 U.S.C. 1396 et seq.), and qualified health
plans offered through the American Health Benefit Exchanges
established under section 1311 or 1321 of the Patient
Protection and Affordable Care Act (42 U.S.C. 18031; 18041);
and
(4) any impact, or expected impact, on--
(A) drug price competition (such as through shifts
from the use of generic drugs to brand name drugs);
(B) section 1128B of the Social Security Act
(commonly referred to as the ``Federal Anti-Kickback
Statute'' (42 U.S.C. 1320a-7b)); and
(C) health plan formulary design (such as cost
shifting, adverse events for health plans, and spending
acceleration).
<all>