Right to Try Act 2018 and state right-to-try laws

United States, federal statute and state statutes. The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act was signed on 30 May 2018 (Public Law 115-176) after Colorado passed the first state right-to-try law in 2014 and around forty states followed. Primary text: the Congress.gov record of S.204; the FDA maintains a plain-language page.

What it changed: an eligible patient (life-threatening disease, treatment options exhausted, unable to join a trial, physician certification) may receive an investigational drug that has completed a phase 1 trial and is in active development, without FDA review of the individual request and without the safety data counting against the drug except in limited circumstances. The manufacturer is under no obligation to supply, may charge direct costs, and gains liability protection. Sponsors must report annual use to the FDA, which publishes a summary.

The arguments: supporters, led by the Goldwater Institute, framed it as freeing dying patients from bureaucracy; the FDA and most oncologists replied that the agency already authorises about 99 percent of expanded access requests, usually within days, while adding a safety review and dosing advice that right to try removes. Reported use of the federal law has been small, and companies including several with cancer drugs said they would continue to route requests through expanded access. The law sits on ground the courts had already surveyed: the D.C. Circuit's Abigail Alliance ruling in 2007 held that there is no constitutional right to unapproved drugs.