'Right-to-try' law intended to weaken FDA, measure's sponsor says in blunt remarks

Sen. Ron Johnson (R-WI), the author of the "right-to-try" law, said his new law is meant to weaken FDA. "This law intends to diminish FDA's power over people's lives, not increase it," he wrote in a letter to FDA Commissioner Scott Gottlieb Thursday.

Sen. Ron Johnson (R-WI), the author of the "right-to-try" law, said his new law is meant to weaken FDA. "This law intends to diminish FDA's power over people's lives, not increase it," he wrote in a letter to FDA Commissioner Scott Gottlieb Thursday. Johnson requested a meeting with Gottlieb about the implementation of the new law, which sets up a new pathway for patients with life-threatening illnesses to request access to experimental therapies FDA has not approved. In his letter, Johnson took particular issue with several comments Gottlieb made earlier this month, in which the commissioner suggested that the law would require further regulation and guidance to protect patients. This law "is designed to work within existing FDA regulations, definitions and approval processes. It is not meant to grant FDA more power or enable FDA to write new guidance, rules, or regulations that would limit the ability of an individual facing a life-threatening disease from accessing treatments," Johnson wrote. FDA is convening an internal group to assess how to implement the new law and has indicated it will report regularly on implementation steps.