119-hr4525

[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.
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