President Trump has signed the federal Right to Try Act into law, which will allow some patients to use “investigational” drugs that have not yet been approved by the FDA.
President Trump’s signing of the bill follows a 250 to 169 vote in the House of Representatives yesterday, and a unanimous vote in the Senate in August. The new law allows those with a life-threatening disease or condition to use an “eligible investigation drug” that has not received full approval from the Food and Drug Administration. The term ‘eligible investigational drug’, as defined by the new law, means a drug:
“(A) for which a Phase 1 clinical trial has been completed;
(B) that has not been approved or licensed for any use under section 505 of this Act or section 351 of the Public Health Service Act;
(C) (i) for which an application has been filed under section 505(b) of this Act or section 351(a) of the Public Health Service Act; or