Posted by Michael Wonder on 15 Nov 2018
FDA official hints at a tough road ahead for ‘right to try’
14 November 2018 - A top FDA official seemed to suggest that the new “right-to-try” law, which skirts around the FDA’s traditional authority to help patients get access to unapproved therapies, might have harmful consequences.
Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, said the agency’s experience with stem cell clinics might foreshadow its future with right to try. He pointed to some clinics that purported to treat patients for a variety of conditions and instead ended up blinding them or causing tumours.
