So-called “Right-to-try” laws are state laws that allow terminally-ill patients to bypass the FDA Expanded Access Program and obtain experimental therapy (drugs, biologics, devices that have completed Phase 1 testing but have not been approved by FDA) directly from a manufacturer. Right-to-try is completely separate from the FDA Expanded Access Program and is not regulated or managed by the FDA. Because of this, there are few if any safety procedures in place to protect patients and monitor for adverse reactions to the experimental treatment. Moreover, because Right-to-try laws bypass the FDA, manufacturers are less likely to participate in them. In fact, to date, there has not been a successful use of Right-to-try to gain access to an experimental drug. By contrast, the FDA authorizes over 99% of the Expanded Access requests it receives.