Right-to-try law

Right-to-try laws are United States state laws and a federal law created with the intent to allow terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but not been approved by the Food and Drug Administration (FDA). Before right-to-try laws, patients needed FDA approval to use experimental drugs. As of 2018, 41 U.S. states had passed right to try laws. The framers of these laws argue that this allows for individualized treatments not permitted under the FDA's current regulatory scheme. The value of these laws was questioned on multiple grounds, including that pharmaceutical manufacturers would have no obligation to provide the therapies being sought. A federal right-to-try law passed in 2018. Very little data is available about the number of patients who have used the right-to-try pathway, but available sources indicate that since the law passed, only a handful of patients have used it, as most physicians and sponsors prefer the FDA-approved Expanded Access route. According to Scott Gottlieb, who served as commissioner of the FDA under President Donald Trump, before the right-to-try law, the FDA already approved 99% of patient requests for access to experimental drugs, either immediately over the phone or within a few days.