WASHINGTON — A top Food and Drug Administration 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 tumors.
“We don’t learn about things until something really bad happens,” he said of the clinics, adding that there are “a whole lot of other things I can’t tell you about” that get reported to the FDA about stem cell clinics.
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