Sen. Ron Johnson (R-WI) wants the Food and Drug Administration to get out of the way of a “right-to-try” bill signed into law by President Trump last week.
In a statement apparently taking aim at FDA Commissioner Scott Gottlieb, Johnson said in widely reported comments that his bill “intends to diminish the FDA’s power over people’s lives, not increase it.”
“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,” he said.
The bill is meant to make it easier for patients — elderly or not — to try experimental treatments for terminal conditions.
Gottlieb said in a statement said the agency was preparing to implement the legislation.
“The decisions we reach related to products that can serve as an effective treatment for a terminal illness, or that can arrest a devastating and debilitating condition, are among the most important and carefully considered judgments that we make,” he said. “We recognize the important balance between making sure patients have the assurances Congress intends, while enabling timely access to promising treatments in these devastating circumstances. And we’ll implement this new law consistent with these longstanding values.”
Elsewhere, Gottlieb was quoted as saying the agency might need to write guidance for the right-to-try program.
Though many terminally ill patients have long sought the law, the FDA has an existing program for experimental access. Opponents of the new, less strictly defined program have raised concerns about its potential to give con artists a platform for unproven methods.
Rep. Frank Pallone (D-NJ) argued that the measure will give “fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients.”