I 
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 Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Right to FDA-Ap-
proved Medicines Act’’. 
SEC. 2. DEFINITIONS. 
In this Act: 
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(1) FDA-APPROVED
MEDICINE.—The term 
‘‘FDA-approved medicine’’ means any drug ap-
proved 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, instru-
mentality, and official of the United States or a 
State. 
(3) HEALTH
CARE
PROVIDER.—The term 
‘‘health care provider’’ means any entity or indi-
vidual (including any physician, certified nurse-mid-
wife, nurse, nurse practitioner, physician assistant, 
and pharmacist) that is licensed or otherwise author-
ized by a State to prescribe FDA-approved medi-
cines. 
(4) STATE.—The term ‘‘State’’ includes each of 
the 50 States, the District of Columbia, the Com-
monwealth 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 sub-
division of a State. 
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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 cor-
responding right to provide FDA-approved medicines, and 
information, referrals, and services related to such medi-
cines. 
(b) LIMITATIONS OR REQUIREMENTS.—The statu-
tory rights specified in subsection (a) shall not be limited 
or otherwise infringed through any limitation or require-
ment that— 
(1) expressly, effectively, implicitly, or as-imple-
mented singles out— 
(A) the provision of FDA-approved medi-
cines, or information related to such medicines; 
(B) health care providers who provide 
FDA-approved medicines or information related 
to such medicines; or 
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(C) facilities in which FDA-approved medi-
cines 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 in-
formation related to such medicines; and 
(2) access to FDA-approved medicines and in-
formation related to such medicines or the health of 
patients cannot be advanced by a less restrictive al-
ternative measure or action. 
(d) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to limit the authority of the Sec-
retary 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 Cos-
metic Act (21 U.S.C. 355) or license a drug under section 
351 of the Public Health Service Act (42 U.S.C. 262), 
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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 sub-
section (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 be-
fore or after the date of enactment of this Act. 
(2) PROHIBITION.—Neither the Federal Gov-
ernment 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, provi-
sion, 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 medi-
cines; or 
(C) exempts any FDA-approved medicines 
from any other generally applicable law in a 
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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 Res-
toration Act of 1993 (42 U.S.C. 2000bb et seq.). 
(b) SUBSEQUENTLY ENACTED FEDERAL LEGISLA-
TION.—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 cov-
erage 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 in-
dividual or entity who is subject to a limitation or require-
ment that violates this Act, in addition to the remedies 
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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 im-
mediately 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 inter-
fere with a health care provider’s ability to provide FDA- 
approved medicines or information related to such medi-
cines or a patient’s ability to obtain such medicines. 
(c) OTHER INDIVIDUALS CONSIDERED AS GOVERN-
MENT OFFICIALS.—Any individual who, by operation of 
a provision of Federal or State law, is permitted to imple-
ment or enforce a limitation or requirement that violates 
section 4 shall be considered a government official for pur-
poses 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 gov-
ernment official (including an individual described in sec-
tion 6(c)) that implements or enforces a limitation or re-
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quirement 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, in-
cluding any health care provider or patient, ad-
versely affected by an alleged violation of this Act, 
may commence a civil action against any State that 
violates, or against any government official (includ-
ing an individual described in section 6(c)) that im-
plements or enforces a limitation or requirement 
that violates, section 4. The court shall hold unlaw-
ful 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 injunc-
tive relief. 
(d) COSTS.—In any action under this section, the 
court shall award costs of litigation, as well as reasonable 
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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 administra-
tive 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 re-
quirement 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 jurisdic-
tion 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 cir-
cumstance, is held to be unconstitutional, the remainder 
of this Act, or the application of such provision to all other 
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individuals, entities, governments, or circumstances, shall 
not be affected thereby. 
Æ 
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