Congress passed the Right to Try Act of 2017, sending a priority bill to President Donald J. Trump for his signature.
The “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017” passed Congress on May 22, 2018.
The bill amends Federal law to allow certain unapproved, experimental drugs to be administered to terminally ill patients who have exhausted all approved treatment options and are unable to participate in clinical drug trials.
Eligible drugs must have undergone the Food and Drug Administration’s (FDA) Phase I (safety) testing.
The bill requires any manufacturer or sponsor of an eligible investigational drug to report to the FDA on any use of the drug on a “Right to Try” basis.
The FDA will post an annual summary report of “Right to Try” use on its website.