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Increasing Access, Limiting Authority

The sponsor of the "right-to-try" bill signed into law earlier this week by President Donald Trump says its aim is to limit the authority of the US Food and Drug Administration, Stat News reports.

The law allows terminally ill patients access to unapproved, experimental treatments without having to get the OK from the FDA, and NPR has noted that the law has divided patients, as some welcome access to possibly life-saving treatments, but others worry that unapproved therapies could shorten patients' lives.

Additionally, critics have said that "right-to-try" laws could undermine both the clinical trial process as well as the authority of the FDA.

Indeed, in a letter to FDA Commissioner Scott Gottlieb yesterday, Senator Ron Johnson (R-Wisc.), who sponsored the bill, says the point of the law is to weaken the agency's oversight, according to Stat News. "This law intends to diminish the FDA's power over people's lives, not increase it," he wrote, adding, "[i]t 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."

An FDA spokesperson tells Stat News that it is reviewing the letter and will respond to the senator.