Right to FDA-Approved Medicines Act (H.R. 4525)

Right to FDA-Approved Medicines Act

This bill sets out statutory protections for an individual's right to access and a health care provider's right to provide medicines (i.e., drugs and biological products) approved by the Food and Drug Administration (FDA).

Generally, the bill prohibits measures that single out and impede access to FDA-approved medicines and related information. However, a party may defend against a claim that a measure violates the bill's prohibitions by demonstrating, through clear and convincing evidence, that the measure significantly advances access to FDA-approved medicines and such access cannot be advanced through less restrictive means. The bill also specifies that the prohibition preempts inconsistent state and local laws and applies in spite of other federal laws, including the Religious Freedom Restoration Act of 1993.

The Department of Justice, individuals, or health care providers may bring a lawsuit to enforce this bill, and states are not immune from suits for violations.