WASHINGTON — A key Republican lawmaker released a new version of so-called “right to try” legislation around midnight Friday, a pivotal next step in the effort to help dying patients get access to experimental therapies.
The legislation, from House Energy and Commerce Committee Chairman Greg Walden (R-Ore.), is more limited than an earlier measure championed by Sen. Ron Johnson (R-Wis.) that passed the Senate last fall. Walden’s version would ensure that the Food and Drug Administration has more oversight of the process. Like the Senate bill, it includes liability protections for drug companies and providers who decide to use the process. Walden’s bill also limits the process to patients who are likely to die “within a matter of months” or “severely premature.”
In a statement, Walden and health subcommittee chairman Michael Burgess (R-Tex.) said they believe the legislation is now ready for a vote in the House of Representatives.
“This updated ‘Right to Try’ bill is the direct result of conversations with our colleagues, the administration, and stakeholders on all sides of the issue,” the pair said. “This is a complicated issue with passionate advocates on both sides and it was imperative we got the policy right. After months of thoughtful discussions, we believe this legislation is ready for a vote in the House.”
They said they had specifically worked to address concerns of FDA Commissioner Scott Gottlieb, who testified in October that the Senate-passed legislation was too broad.
It’s not yet clear, however, whether the champions of earlier right-to-try bills will believe this new legislation goes far enough. They have argued that the FDA, which has an existing process for helping patients get access to unapproved therapies, is too slow to respond to requests and too cumbersome. Some, including representatives of groups backed by the Koch brothers, like Freedom Partners, had told STAT they would not accept legislation that is less robust than the Senate bill.
If the House passes Walden’s bill, the Senate would have to take up the issue anew, since the legislation differs from Johnson’s bill.
Starlee Coleman, a senior policy adviser for the Goldwater Institute, a central backer of the effort to pass right-to-try laws in states and at the federal level, called the bill “a terrific development.”
“This bill will provide millions of terminally ill Americans an additional pathway to access promising investigational treatments before it’s too late,” she said in an email.
“We’re grateful for the efforts of Chairman Walden and his team to craft a bill that reflects the spirit and intent of the Right to Try movement, and respects much of the work done by Senators Johnson and Donnelley in the Senate. We are hopeful this bill will pass quickly so we can get it back through the Senate and to the President’s desk.”
Critics of past right-to-try bills have pushed back against the changes, saying the new pathway could leave desperate and dying patients open to exploitation and “false hope.” They say past versions of the bills have too aggressively carved the FDA out of the drug approval process.
The overall movement has the broad support of Vice President Mike Pence and President Trump, who touted it in his State of the Union address in January.