Right-to-Try Author Says Law's Intent Is to Diminish FDA's Power
(Bloomberg) -- Senator Ron Johnson, the chief sponsor of a new law giving terminally ill patients easier access to experimental drugs, said the aim of the measure is to weaken the U.S. Food and Drug Administration.
In a letter to FDA Commissioner Scott Gottlieb on Thursday, the Wisconsin Republican said the goal is to “diminish the FDA’s power over people’s lives, not increase it.”
Gottlieb told the news outlet Stat this month that the FDA may need to propose new regulations to ensure that patients are protected. The agency has a program to approve patient requests for access to experimental drugs if they aren’t eligible for a clinical trial. The “right-to-try” law allows patients to get the unproven medications without FDA permission.
“This legislation is fundamentally about empowering patients to make decisions in cooperation with their doctors and the developers of potentially life-saving therapies,” Johnson wrote. “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.”
Johnson also stressed that the law aims to help those with a terminal illness, specifically a deadly form of childhood muscular dystrophy, not just those with immediately life-threatening diseases, as the FDA originally suggested. He also emphasized that the FDA cannot use adverse outcomes patients may experience taking the experimental treatments when the agency reviews the drug for approval, unless it is critical to determining safety.
“This language is not intended to enable the FDA to expand the scope of existing safety determinations about investigational drugs,” Johnson wrote.
The law was backed by the Goldwater Institute, a libertarian think tank, and Americans for Prosperity, which is affiliated with the conservative Koch brothers.
The FDA will respond directly to Johnson, spokeswoman Sandy Walsh said in an email.
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