The House passed its version of a “right-to-try” bill on Wednesday, but it gained little notice because it was overshadowed by the omnibus spending bill that had just become public and which President Trump signed on Friday.
The right-to-try legislation, if signed into law, will allow terminally ill patients to seek drug treatments that have passed phase one of the FDA’s approval process, but have not yet received full approval.
Terminally ill patients are not a big or vocal political constituency, but their vulnerability makes them worth listening to. Giving them the right to try experimental treatments won’t transform the healthcare sector radically, but it will stop the government obstructing those who want to take a chance to live a little longer.
The reform is common sense, and is therefore popular nationwide: Thirty-eight states, from deep-blue California to deep-red Alabama, have already established a right to try. But the question of whether FDA regulations pre-empt state laws is unclear, which makes congressional action necessary.
Thankfully, a similar right-to-try bill already passed the Senate unanimously.
There are legitimate concerns about the right to try, but the bills in Congress improve on the status quo. The FDA already has expanded access programs for some terminal patients, and between 2010 and 2015 it authorized more than 99 percent of requests. But that amounts to only 1,200 patients a year, a tiny portion of the millions who are diagnosed with or die of terminal illnesses. Too many patients who would be helped by the right to try don’t qualify for the FDA process.
Critics worry that phase one FDA approval means a drug isn’t yet safe enough for terminal patients. But phase one approval means a treatment has already passed basic safety testing and is probably ready for clinical research trials. As the libertarian Goldwater Institute says: “Fewer than 3 percent of terminally ill patients gain access to investigational treatments through clinical trials. Right to try was designed to help the other 97 percent.”
There are also safeguards in the legislation. No patient will ever be forced to take an unapproved drug. And no doctors will be forced to provide a drug they wouldn’t advise. No pharmaceutical company will be forced to give a drug if they don’t think it will help the patient. What’s more, a drug manufacturer or prescriber couldn’t be sued for providing treatment through right to try.
Right to try won’t save everyone who takes advantage of it, but if a treatment has passed basic safety testing and terminally ill patients understand the risks, the government shouldn’t stop them trying to save their own lives.
Jim Burhorn was 59 when he was diagnosed with neuroendocrine cancer. His doctors recommended a certain treatment, but Burhorn might only have been able to get it in Switzerland, because the FDA hadn’t given it final approval. But, thanks to Colorado’s right-to-try law, Burhorn was treated in America. Other patients across the country should be able to do the same.
President Trump endorsed the right to try in his first State of the Union address, saying, “We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives. People who are terminally ill should not have to go from country to country to seek a cure — I want to give them a chance right here at home. It is time for the Congress to give these wonderful Americans the ‘right to try.’”
The Senate and House should swiftly resolve the minor differences between their bills and send a right-to-try bill to Trump to sign.
