Sen. Ron Johnson warned the Food and Drug Administration not to interfere with a new law that lets terminally ill patients try experimental treatments.
The Wisconsin Republican wrote to FDA Commissioner Scott Gottlieb Thursday in response to comments Gottlieb made recently about the need for regulations to balance patient protections with the law that President Trump signed Tuesday.
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“This law intends to diminish the FDA’s power over people’s lives, not increase it,” Johnson wrote in the letter. “It is designed to work within existing FDA regulations, definitions, and approval processes. It is not meant to grant the 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 was a co-sponsor of the bill that lets terminally ill patients try an experimental drug that has gone through the first of three clinical trials the FDA requires for approval. The first clinical trial focuses on whether a drug is safe and not if it is effective.
The FDA already has a program called compassionate use that lets terminally ill patients apply to receive drugs that have cleared the first clinical trial. The new law would create a pathway for terminally ill patients to bypass the compassionate use program and apply to get such experimental treatments.
However, neither compassionate use nor the new law require drugmakers to provide the drug.
