H.R. 4525 — Right to FDA-Approved Medicines Act

This section defines four terms for purposes of the Act: (1) “FDA-approved medicine” as 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” as including each branch, department, agency, instrumentality, and official of the United States or a State; (3) “health care provider” as any entity or individual (including any physician, certified nurse-midwife, nurse, nurse practitioner, physician assistant, and pharmacist) licensed or otherwise authorized by a State to prescribe FDA-approved medicines; and (4) “State” as including each of the 50 States, the District of Columbia, the Commonwealth of Puerto Rico, each territory and possession of the United States, and any political subdivision thereof (e.g., a county, city, town, village, or other general purpose political subdivision).

This section states the purposes of the Act: (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 health care providers to facilitate prescribing such medicines.

This section establishes a statutory right for individuals to obtain FDA-approved medicines free from coercion and a corresponding right for health care providers to provide such medicines and related information, referrals, and services. It prohibits any limitation or requirement that singles out (1) the provision of FDA-approved medicines or related information, (2) health care providers who provide them, or (3) facilities in which they are provided, if such limitation impedes access to those medicines or information. A limitation may be defended by clear and convincing evidence that it significantly advances access to FDA-approved medicines or related information and that no less restrictive alternative exists. The section does not limit FDA authority to approve drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or biologics under section 351 of the Public Health Service Act (42 U.S.C. 262).

This section preempts all federal and state laws, rules, regulations, or similar measures—whether enacted before or after the date of enactment—that prohibit or restrict the sale, provision, use, or aiding in obtaining FDA-approved medicines (as defined in the Act), including exemptions from generally applicable laws that hinder such activities. It applies notwithstanding any other federal law, including the Religious Freedom Restoration Act, and supersedes subsequently enacted federal laws unless they explicitly exclude application of this Act; allows the Act to be raised as a defense in relevant causes of action; and takes effect immediately upon enactment. The preemption does not affect federal laws relating to coverage under group health plans, group or individual health insurance, or federal health care programs (as defined in section 1128B(f) of the Social Security Act).

This section establishes rules of construction for interpreting the Act, including (1) directing courts to liberally construe its provisions to effectuate the purposes described in section 3; (2) clarifying that the Act does not authorize any government to interfere with a health care provider's ability to provide FDA-approved medicines or related information, or a patient's ability to obtain such medicines; and (3) deeming any individual authorized by federal or state law to implement or enforce a limitation or requirement that violates section 4 to be a government official for purposes of the Act.

This section establishes enforcement mechanisms for violations of section 4, including (1) authority for the Attorney General to commence civil actions against violating states or government officials, with courts required to hold unlawful and set aside such limitations or requirements; (2) a private right of action for any adversely affected individual, entity, health care provider, or patient, with health care providers able to sue on behalf of their staff and patients; (3) authority for courts to award equitable relief, including temporary, preliminary, and permanent injunctive relief; (4) mandatory awards of litigation costs and reasonable attorney's fees to prevailing plaintiffs, with no liability for plaintiffs in nonfrivolous actions; (5) federal district court jurisdiction without exhaustion of administrative remedies; and (6) abrogation of state sovereign immunity under the Tenth and Eleventh Amendments or other sources of law.

This section establishes a severability clause, providing that if any provision of the Act, or its application to any individual, entity, government, or circumstance, is held unconstitutional, the remainder of the Act and the application of such provision to others remains unaffected.