This bill amends the Federal Food, Drug, and Cosmetic Act to exempt, from specified requirements and restrictions under that Act and other laws, the provision of certain unapproved, investigational drugs to a terminally ill patient who has exhausted approved treatment options and is unable to participate in a clinical trial involving the drugs. The manufacturer or sponsor of an eligible investigational drug must publish annual summaries on any use of the drug in accordance with these provisions.

The bill limits the liability of a sponsor, manufacturer, licensed physician, clinical investigator, or hospital that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.