13 August 2018 - On May 30, 2018, President Trump signed into law the federal Right to Try Act of 2017,1 providing patients with life-threatening conditions a pathway to access investigational drugs without authorisation from the FDA.
Ethicists, physicians, and patient groups have raised concerns about this type of legislation at the state and national levels given its implications for patients and the FDA’s public health mission.
Now that “Right to Try” has become federal law, however, there is an opportunity to clarify statutory ambiguities that may help minimise the law’s potential to cause harm and advance its goal of encouraging companies to provide pre-approval access to investigational drugs.