Can terminally ill patients bypass the FDA to access experimental therapies?

Countries & Cities · Published 12 October 2026 Swipe more like this →

In short: Under current regulations, patients typically require full FDA approval to use experimental drugs. However, Right-to-Try laws offer a different path, allowing seriously ill individuals to seek unapproved treatments. This mechanism bypasses traditional regulatory hurdles, shifting the decision-making power from federal agencies to patients and their physicians.

The Right-to-Try Act, signed into law on May 30, 2018, created a uniform federal system for terminally ill patients seeking access to investigational treatments. This federal law followed a wave of state-level initiatives, beginning with Colorado on May 17, 2014. While the federal law focuses on terminally ill patients, some states have moved toward 'Right-to-Try 2.0' models. These expanded laws, passed in 17 states, allow individuals with non-terminal, rare, or degenerative conditions to access individualized experimental therapies that may not have even completed Phase I testing.

The regulatory landscape under this Act is distinct from standard FDA protocols. Notably, the FDA does not review or approve individual Right-to-Try requests; its role is limited to receiving and posting annual summaries of use. Furthermore, while Institutional Review Boards (IRBs) do not need to approve individual requests, the investigational drugs used must meet specific criteria. Importantly, the legislation does not mandate that sponsors supply qualifying medication to patients, regardless of whether they fulfill every criterion.

The process places significant responsibility on medical professionals. Physicians must obtain written informed consent from the patient or a legally authorized representative. Additionally, the drug cannot be used if its Investigational New Drug (IND) application is under a clinical hold. Manufacturers and sponsors are required to submit annual reports to the FDA by March 31, detailing the drug name, IND number, number of doses supplied, number of patients treated, the condition being treated, and any serious adverse events.

General information, not professional advice. Spotted an error? Flag the card or see corrections and complaints.

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