Sen. Ron Johnson (R-Wis.) requested a meeting with FDA Commissioner Scott Gottlieb to clear up “misconceptions” about the agency’s role in implementing the newly signed right-to-try legislation.
Rather than add to the FDA’s authority, the law’s intent is “to diminish the FDA’s power over people’s lives, not increase it. It is designed to work within existing FDA regulations, definitions, and approval processes,” Johnson said, in a letter to Gottlieb. “It is not meant to grant FDA more power or enable the FDA to write new guidance, rules, or regulations that would limit the ability of an individual facing a life-threatening disease from accessing treatments.”
The bill’s lead sponsor, Johnson quotes Gottlieb as saying before the law’s passage that it would benefit from additional patient protections, but if such provisions did not make it into the final bill they could be passed “administratively” without compromising the intent of the law.