Last Wednesday, President Trump signed into law the Right to Try Act of 2017, which will allow terminally ill patients who have exhausted approved treatment options and are unable to participate in a clinical trial the ability to try certain investigational drugs that have not received FDA approval.
Despite passing in the Senate in August 2017, the legislation stalled in the House until a 250-169 vote for passage on May 22. The delay was due to the Senate and House having different versions of the legislation and opposition from patient advocacy groups and Democrats, who expressed concern that without sufficient FDA oversight, bad actors would take advantage of vulnerable patients. FDA Commissioner Scott Gottlieb originally criticized the bill, but ultimately expressed support, indicating that the FDA would implement the legislation “to promote access and protect patients” while building on the FDA’s “longstanding commitment to these important goals.” Last Thursday, the FDA indicated that guidance on the new law would be published soon.