No official summary available for this bill.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4525 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 4525
To protect an individuals ability to access medicines approved by the
Food and Drug Administration to protect a health care providers ability
to provide such medicines, and information related to such medicines.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 17, 2025
Ms. Ross (for herself, Ms. Schrier, Ms. Castor of Florida, Mrs. Trahan,
and Mrs. Fletcher) introduced the following bill; which was referred to
the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To protect an individuals ability to access medicines approved by the
Food and Drug Administration to protect a health care providers ability
to provide such medicines, and information related to such medicines.
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 ``Right to FDA-Approved Medicines
Act''.
SEC. 2. DEFINITIONS.
In this Act:
(1) FDA-approved medicine.--The term ``FDA-approved
medicine'' means any drug approved under section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
licensed under section 351 of the Public Health Service Act (42
U.S.C. 262).
(2) Government.--The term ``government'' includes each
branch, department, agency, instrumentality, and official of
the United States or a State.
(3) Health care provider.--The term ``health care
provider'' means any entity or individual (including any
physician, certified nurse-midwife, nurse, nurse practitioner,
physician assistant, and pharmacist) that is licensed or
otherwise authorized by a State to prescribe FDA-approved
medicines.
(4) State.--The term ``State'' includes each of the 50
States, the District of Columbia, the Commonwealth of Puerto
Rico, and each territory and possession of the United States,
and any political subdivision of any of the foregoing,
including any unit of local government, such as a county, city,
town, village, or other general purpose political subdivision
of a State.
SEC. 3. PURPOSES.
The purposes of this Act are--
(1) to provide a clear and comprehensive right to FDA-
approved medicines; and
(2) to permit individuals to seek and obtain FDA-approved
medicines and to permit health care providers to facilitate
prescribing such medicines.
SEC. 4. PERMITTED SERVICES.
(a) In General.--An individual has a statutory right under this Act
to obtain FDA-approved medicines free from coercion, and a health care
provider has a corresponding right to provide FDA-approved medicines,
and information, referrals, and services related to such medicines.
(b) Limitations or Requirements.--The statutory rights specified in
subsection (a) shall not be limited or otherwise infringed through any
limitation or requirement that--
(1) expressly, effectively, implicitly, or as-implemented
singles out--
(A) the provision of FDA-approved medicines, or
information related to such medicines;
(B) health care providers who provide FDA-approved
medicines or information related to such medicines; or
(C) facilities in which FDA-approved medicines or
information related to such medicines; and
(2) impedes access to FDA-approved medicines or information
related to such medicines.
(c) Exception.--To defend against a claim that a limitation or
requirement violates a health care provider's or individual's statutory
rights under subsection (b), a party must establish, by clear and
convincing evidence, that--
(1) the limitation or requirement significantly advances
access to FDA-approved medicines, and information related to
such medicines; and
(2) access to FDA-approved medicines and information
related to such medicines or the health of patients cannot be
advanced by a less restrictive alternative measure or action.
(d) Rule of Construction.--Nothing in this section shall be
construed to limit the authority of the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs, to approve
a drug under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) or license a drug under section 351 of the Public
Health Service Act (42 U.S.C. 262), or for the Federal Government to
enforce such approval or licensure.
SEC. 5. APPLICABILITY AND PREEMPTION.
(a) General Application.--
(1) In general.--Except as provided in subsection (c), this
Act supersedes and applies to the law of the Federal Government
and each State, and the implementation of such law, whether
statutory, common law, or otherwise, and whether adopted before
or after the date of enactment of this Act.
(2) Prohibition.--Neither the Federal Government nor any
State may administer, implement, or enforce any law, rule,
regulation, standard, or other provision having the force and
effect of law in a manner that--
(A) prohibits or restricts the sale, provision, or
use of any FDA-approved medicines (as defined in
section 2(2));
(B) prohibits or restricts any individual from
aiding another individual in voluntarily obtaining or
using any FDA-approved medicines; or
(C) exempts any FDA-approved medicines from any
other generally applicable law in a way that would make
it more difficult to sell, provide, obtain, or use such
medicines.
(3) Relationship with other laws.--This Act applies
notwithstanding any other provision of Federal law, including
the Religious Freedom Restoration Act of 1993 (42 U.S.C. 2000bb
et seq.).
(b) Subsequently Enacted Federal Legislation.--Federal law enacted
after the date of enactment of this Act is subject to this Act, unless
such law explicitly excludes such application by reference to this Act.
(c) Limitations.--The provisions of this Act shall not supersede or
otherwise affect any provision of Federal law relating to coverage
under (and shall not be construed as requiring the provision of
specific benefits under) group health plans or group or individual
health insurance coverage or coverage under a Federal health care
program (as defined in section 1128B(f) of the Social Security Act (42
U.S.C. 1320a-7b(f))), including coverage provided under section
1905(a)(4)(C) of the Social Security Act (42 U.S.C. 1396d(a)(4)(C)) and
section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13).
(d) Defense.--In any cause of action against an individual or
entity who is subject to a limitation or requirement that violates this
Act, in addition to the remedies specified in section 7, this Act shall
also apply to, and may be raised as a defense by, such an individual or
entity.
(e) Effective Date.--This Act shall take effect immediately upon
the date of enactment of this Act.
SEC. 6. RULES OF CONSTRUCTION.
(a) In General.--In interpreting the provisions of this Act, a
court shall liberally construe such provisions to effectuate the
purposes described in section 3.
(b) Rule of Construction.--Nothing in this Act shall be construed
to authorize any government to interfere with a health care provider's
ability to provide FDA-approved medicines or information related to
such medicines or a patient's ability to obtain such medicines.
(c) Other Individuals Considered as Government Officials.--Any
individual who, by operation of a provision of Federal or State law, is
permitted to implement or enforce a limitation or requirement that
violates section 4 shall be considered a government official for
purposes of this Act.
SEC. 7. ENFORCEMENT.
(a) Attorney General.--The Attorney General may commence a civil
action on behalf of the United States against any State that violates,
or against any government official (including an individual described
in section 6(c)) that implements or enforces a limitation or
requirement that violates, section 4. The court shall hold unlawful and
set aside the limitation or requirement if it is in violation of this
Act.
(b) Private Right of Action.--
(1) In general.--Any individual or entity, including any
health care provider or patient, adversely affected by an
alleged violation of this Act, may commence a civil action
against any State that violates, or against any government
official (including an individual described in section 6(c))
that implements or enforces a limitation or requirement that
violates, section 4. The court shall hold unlawful and set
aside the limitation or requirement if it is in violation of
this Act.
(2) Health care provider.--A health care provider may
commence an action for relief on its own behalf, on behalf of
the provider's staff, and on behalf of the provider's patients
who are or may be adversely affected by an alleged violation of
this Act.
(c) Equitable Relief.--In any action under this section, the court
may award appropriate equitable relief, including temporary,
preliminary, and permanent injunctive relief.
(d) Costs.--In any action under this section, the court shall award
costs of litigation, as well as reasonable attorney's fees, to any
prevailing plaintiff. A plaintiff shall not be liable to a defendant
for costs or attorney's fees in any nonfrivolous action under this
section.
(e) Jurisdiction.--The district courts of the United States shall
have jurisdiction over proceedings under this Act and shall exercise
the same without regard to whether the party aggrieved shall have
exhausted any administrative or other remedies that may be provided for
by law.
(f) Abrogation of State Immunity.--Neither a State that enforces or
maintains, nor a government official (including an individual described
in section 6(c)) who is permitted to implement or enforce any
limitation or requirement that violates section 4 shall be immune under
the Tenth Amendment to the Constitution of the United States, the
Eleventh Amendment to the Constitution of the United States, or any
other source of law, from an action in a Federal or State court of
competent jurisdiction challenging that limitation or requirement.
SEC. 8. SEVERABILITY.
If any provision of this Act, or the application of such provision
to any individual, entity, government, or circumstance, is held to be
unconstitutional, the remainder of this Act, or the application of such
provision to all other individuals, entities, governments, or
circumstances, shall not be affected thereby.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
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