The federal Right to Try Act (2018) and parallel state laws allow terminally ill patients to request access to investigational drugs that have completed Phase I clinical trials but have not received full FDA approval. The law operates outside the FDA's pre-existing Expanded Access ("compassionate use") program.
Supporters frame these laws as restoring patient autonomy in life-or-death situations. Critics argue the laws bypass safety review, may give false hope, and do little that Expanded Access did not already do — while shielding drug companies from liability.
In practice, manufacturers retain discretion over whether to provide the drugs, so access remains limited. The debate continues over whether right-to-try expanded real access or primarily served symbolic and political ends.