President Donald Trump signed right-to-try legislation that will allow patients with life-threatening diseases to access investigational drugs outside of clinical trials without FDA approval.
Trump called for the legislation in his January State of the Union. The Senate passed the bill, S. 204, last year and the House of Representatives passed it last week.
Companies, physicians and patients will continue to have the option to seek FDA authorization for providing access to investigational drugs outside of clinical trials through FDA's existing expanded access process, which is unaffected by the new law.
In a statement, FDA Commissioner Scott Gottlieb said “Our implementation of the Right to Try Act will build on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, in a way that seeks to protect their autonomy, their safety, and the safety of others following in their paths.”
Gottlieb did not provide details on how FDA plans to implement the pathway.
S. 204 is also known as the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017.