Right-to-Try and Expanded Access to Experimental Drugs

Summary

This practice note discusses best practices for pharmaceutical companies to manage requests for access to drugs as part of right-to-try and expanded access programs. Right-to-try laws allow ill patients in the United States, who have exhausted all available treatment options and who are not otherwise eligible to participate in an ongoing clinical trial of an investigational, unapproved drug, to apply to receive an experimental drug that may save or prolong the patient's life. A majority of states have passed right-to-try laws and there is a federal pathway for requesting access to investigational drugs.