It will be another two to three months before the FDA releases guidance or information for drug manufacturers about the nation’s new right-to-try law, Scott Gottlieb, head of the agency, said.
President Donald Trump signed the right-to-try legislation, S. 204, May 30. The measure is designed to give desperate patients access to unapproved treatments. Lawmakers and patient advocacy groups have hailed the law as one that may provide life-saving treatments to people who need it. But critics, including Public Citizen, a consumer group, say patients could be endangered by using treatments that have not been thoroughly vetted.