HR4525-119

What This Bill Does

The Right to FDA-Approved Medicines Act defines FDA-approved medicine as a drug approved under section 505 of the Food, Drug, and Cosmetic Act or licensed under Public Health Service Act section 351. It creates a statutory right for individuals to obtain FDA-approved medicines free from coercion and for licensed health care providers to provide FDA-approved medicines plus related information, referrals, and services. Restrictions that single out FDA-approved medicines, providers, or facilities and impede access are barred unless the defending party proves by clear and convincing evidence that the restriction significantly advances access and that no less restrictive alternative can advance access or patient health. The Act supersedes federal and state law except for specified coverage provisions, applies notwithstanding RFRA and later federal law unless that law expressly excludes this Act, may be raised as a defense, and is liberally construed. The Attorney General may sue states or government officials that violate the Act, and adversely affected individuals, entities, providers, or patients may also sue. Courts must set aside unlawful restrictions and may award equitable relief, with litigation costs and reasonable attorney fees to prevailing plaintiffs and no fee liability for nonfrivolous plaintiffs. The Act takes effect immediately and includes severability.

Who Benefits and How

Patients seeking FDA-approved medicines benefit from a statutory right to obtain covered drugs and biologics free from coercion. Licensed health care providers benefit from a corresponding right to provide FDA-approved medicines, information, referrals, and services. Patients challenging state restrictions benefit from federal preemption, defense rights, equitable relief, and fee-shifting. The Attorney General benefits from explicit authority to sue states or government officials over covered restrictions.

Who Bears the Burden and How

States restricting FDA-approved medicines must defend limits under a clear-and-convincing-evidence standard and risk injunctions. Government officials enforcing covered restrictions may face federal or private civil actions. Courts must apply the Act without requiring exhaustion of administrative remedies and must set aside unlawful limits. Health insurance programs are not required to provide specific benefits even though access restrictions are preempted.

Key Provisions

• Creates a statutory right for individuals to obtain FDA-approved medicines free from coercion.
• Creates a corresponding provider right to provide medicines, information, referrals, and related services.
• Preempts federal and state restrictions that single out FDA-approved medicines or providers and impede access unless strict statutory defenses are met.
• Authorizes Attorney General enforcement and private civil actions with equitable relief, costs, and attorney fees for prevailing plaintiffs.
• Applies immediately and preserves specified health coverage rules while allowing severability.