Congress has voted to pass the right-to-try bill, which will provide terminally ill patients with the ability to seek out experimental therapies not yet approved by the FDA.
In a 250-169 vote, Congress has passed legislation which will provide terminally ill patients with the ability to seek out experimental therapies not yet approved by the US Food and Drug Administration (FDA). This vote comes just 9 months after the US Senate’s vote to do the same.
Now, the right-to-try bill will be sent to President Donald Trump for final approval, which will likely be the case, as the president has repeatedly professed support for the potential new law, most recently in his State of the Union address.
"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," Trump said in his 2018 State of the Union address. “It is time for the Congress to give these wonderful Americans the 'right to try.’”
Although the legislation will allow for patients to seek out these therapies, it does not demand that pharmaceutical companies provide them to patients, nor does it prevent them from charging patients for them if they do.
The policy passed by the House on Tuesday was a slightly modified version of the bill that was constructed by House Republicans, which would have limited those able to make use of it to the patients with perhaps only months to live. However, it would have reportedly given the FDA wider perception of the use of these medicines while on their newly developed pathway.
FDA commissioner Scott Gottlieb, MD, noted last week that the version of the bill which passed yesterday would make things a little more difficult for the FDA, in both supervision and regulation. In fact, Dr. Gottlieb told STAT News last week that the original version contained aspects that would have been modifiable to allow for more patient defenses, and had, perhaps, a little more leeway for the FDA to implement the law.
The program has been the topic of much discussion, with supporters on both sides of the argument. Many physicians, including Richard Klein, the former director of the FDA’s Patient Liaison Program, have told our sister publication MD Magazine that they are in support of the incurably ill having access to unapproved therapies.
“I talked to an AIDS patient back then who was upset about the FDA not approving enough drugs for the market,” Klein said. “He told me he could take his last nickel to Vegas tomorrow, gamble it away and no one would stop him. So why shouldn’t he be able to gamble his life?”
Although, there have been criticisms of the current bill from those same physicians. Klein, along with Alison Bateman-House, PhD, MPH, MA, from the Division of Medical Ethics at NYU Langone Health, have suggested the right-to-try laws, in truth, do not “point out and try to solve” any actual problems. Klein specifically critiqued the belief of the burden of the Expanded Access program application on physicians—most he has talked with have declared they are glad to take on the task for a patient in need.
“If you think critically about the benefits of right-to-try, I don’t think it provides anything above or beyond what’s currently available. It becomes a political win—but not a win for the patients,” Dr. Klein said.
Currently, right-to-try laws exist in 40 states, with only Alaska, Delaware, Hawaii, Kansas, Massachusetts, New Jersey, New Mexico, New York, Rhode Island, and Vermont, excluded.
A previous version of this article has appeared on MDMagazine.com.