This bill, titled the "Right to FDA-Approved Medicines Act," establishes a clear and comprehensive statutory right for individuals to obtain medicines approved by the Food and Drug Administration (FDA) without coercion. It also protects the corresponding right of health care providers to offer these FDA-approved medicines, as well as related information, referrals, and services. The Act defines "FDA-approved medicine" as any drug approved or licensed under specific federal acts, and broadly defines "government" to include both federal and state entities. The legislation prohibits federal and state governments from imposing limitations or requirements that expressly or effectively single out the provision of FDA-approved medicines or impede access to them. Any such limitation is presumed unlawful unless the government can prove, by clear and convincing evidence, that it significantly advances access and no less restrictive alternative exists. This ensures that access to approved medications is not unduly restricted by governmental actions. The Act broadly supersedes and applies to all federal and state laws, whether statutory or common law, adopted before or after its enactment, including the Religious Freedom Restoration Act of 1993. It explicitly prohibits governments from restricting the sale, provision, or use of FDA-approved medicines or aiding others in obtaining them. However, the Act does not affect federal laws related to coverage under group health plans, health insurance, or federal health care programs. To ensure compliance, the bill provides robust enforcement mechanisms. The Attorney General may initiate civil actions against states or government officials who violate the Act. Additionally, any individual or entity, including health care providers and patients, adversely affected by a violation has a private right of action to sue. Courts are empowered to award equitable relief, including injunctive relief, and prevailing plaintiffs are entitled to litigation costs and reasonable attorney's fees. Furthermore, the Act abrogates state immunity under the Tenth and Eleventh Amendments for such actions.
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in House
Referred to the House Committee on Energy and Commerce.
Introduced in House
Referred to the House Committee on Energy and Commerce.
Health
Right to FDA-Approved Medicines Act
USA119th CongressHR-4525| House
| Updated: 7/17/2025
This bill, titled the "Right to FDA-Approved Medicines Act," establishes a clear and comprehensive statutory right for individuals to obtain medicines approved by the Food and Drug Administration (FDA) without coercion. It also protects the corresponding right of health care providers to offer these FDA-approved medicines, as well as related information, referrals, and services. The Act defines "FDA-approved medicine" as any drug approved or licensed under specific federal acts, and broadly defines "government" to include both federal and state entities. The legislation prohibits federal and state governments from imposing limitations or requirements that expressly or effectively single out the provision of FDA-approved medicines or impede access to them. Any such limitation is presumed unlawful unless the government can prove, by clear and convincing evidence, that it significantly advances access and no less restrictive alternative exists. This ensures that access to approved medications is not unduly restricted by governmental actions. The Act broadly supersedes and applies to all federal and state laws, whether statutory or common law, adopted before or after its enactment, including the Religious Freedom Restoration Act of 1993. It explicitly prohibits governments from restricting the sale, provision, or use of FDA-approved medicines or aiding others in obtaining them. However, the Act does not affect federal laws related to coverage under group health plans, health insurance, or federal health care programs. To ensure compliance, the bill provides robust enforcement mechanisms. The Attorney General may initiate civil actions against states or government officials who violate the Act. Additionally, any individual or entity, including health care providers and patients, adversely affected by a violation has a private right of action to sue. Courts are empowered to award equitable relief, including injunctive relief, and prevailing plaintiffs are entitled to litigation costs and reasonable attorney's fees. Furthermore, the Act abrogates state immunity under the Tenth and Eleventh Amendments for such actions.