In a letter to FDA Commissioner Scott Gottlieb, MD, the Wisconsin senator expressed concern over statements from Dr. Gottlieb that suggested he would alter implementation of the law for the sake of “patient protections.”
The right to try legislation is intended to grant terminally ill patients access to drugs that have not yet received FDA approval.
Dr. Gottlieb had stated that “We felt that there were certain aspects of [the bill] that could be modified to build in additional patient protections, but if you weren’t able to do that legislatively, that there [was] a pathway by which you do that administratively and still remain consistent with the letter and the spirit of the law.”
But Mr. Johnson clarified in his letter that the intent of the law was to undermine FDA regulations and should not be altered.
“This law intends 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,” Mr. Johnson wrote in his letter. “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.”
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