Right-to-try law

Right-to-try laws are United States state laws and a federal law that were created with the intent of allowing terminally ill patients access to experimental therapies (drugs, biologics, devices) that have completed Phase I testing but have not been approved by the Food and Drug Administration (FDA). Prior to the passage of 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 that are not permitted under the FDA's current regulatory scheme.[1] The value of these laws was questioned on multiple grounds, including the fact that pharmaceutical manufacturers would have no obligation to provide the therapies being sought.[2] A federal right to try law was passed in May 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 signing of the bill only a handful of patients have used this pathway to access experimental therapies, as most physicians and sponsors prefer the more traditional, FDA approved, Expanded Access route.[3] According to Scott Gottlieb, who served as commissioner of the FDA under President Donald Trump, the FDA had already approved 99% of patient requests for access to experimental drugs, either immediately over the phone or within a few days, prior to the passage of right to try legislation.[4]

  1. ^ "Right To Try For Individualized Treatments (Right To Try 2.0)". Retrieved September 21, 2022.
  2. ^ Turkowitz, Julie (January 10, 2015). "Patients Seek 'Right to Try' New Drugs". New York Times. Retrieved August 14, 2015.
  3. ^ "Expanded Access and Right to Try: Alternative Paths to Experimental Treatments for Metastatic Breast Cancer".
  4. ^ "Fact check: Trump makes more than 20 false claims at Cincinnati rally". CNN. Retrieved August 3, 2019.