ASHINGTON — Sen. Ron Johnson, the author of the federal “right-to-try” law signed by President Trump this week, wants to make one thing clear: His new law is meant to weaken the Food and Drug Administration.
“This law intends to diminish the FDA’s power over people’s lives, not increase it,” he wrote in a letter to Commissioner Scott Gottlieb Thursday.
The Wisconsin Republican wrote to Gottlieb to request a meeting about the implementation of the new law, which sets up a new pathway for patients with life-threatening illnesses to request access to experimental therapies the FDA has not approved.
Johnson’s comments give new credence to a longstanding criticism of the law from medical ethicists and several former FDA commissioners, who suggested that a separate pathway with less FDA oversight would undermine the agency’s ability to oversee product safety and efficacy. During the legislative process, supporters often said the legislation was about giving dying patients new hope, not about weakening any agency.
There were hints of that intent, however. The law’s main advocate was the libertarian think tank the Goldwater Institute, and Americans for Prosperity, a group backed by the conservative Koch brothers, also offered advertising and advocacy support.
In his letter, Johnson took particular issue with several comments Gottlieb made to STAT earlier this month, in which the commissioner suggested that the law would require further regulation and guidance to protect patients.
This law “is designed to work within existing FDA regulations, definitions and approval processes. 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 wrote.
It is clear Gottlieb anticipated the FDA would have to take some action to implement the law, though it isn’t clear if the implementation process he referenced in a statement after the signing ceremony would require “guidance, rules, or regulation,” as Johnson described.
“At the FDA, we stand ready to implement this legislation in a way that achieves Congress’ intent to promote access and protect patients,” he said.
Even Trump, at the signing ceremony for the bill this week, suggested that Gottlieb should get to work implementing the law.
“Scott, can you start immediately? We don’t want to start tomorrow,” he said to the FDA commissioner. “What time is it now? How about in 15 minutes?”
An FDA spokesperson said Wednesday that the FDA is convening an internal group to assess how to effectively and efficiently implement the new law and would report regularly on implementation steps.
In a separate email to staff Wednesday, Janet Woodcock, who directs the agency’s Center for Drug Evaluation and Research, told staff to direct any inquiries about the new law to drug companies.
“We believe that sponsors are in the best position to provide information on the development status of their products,” Woodcock wrote.
After the letter was published Thursday, an FDA spokesperson said the agency “will review the letter and respond directly to the senator.”
Ike Swetlitz contributed reporting.