The bill will now head to President Donald Trump for final approval, which will likely be the case, as the president has repeatedly supported the potential new law, most recently in his 2018 State of the Union address.
Nine months after the US Senate passed legislation which would provide patients who are terminally ill an ability to seek out experimental, unapproved therapies, Congress has voted to do the same, 250-169.
Known colloquially as the right to try, the bill will now head to President Donald Trump for final approval, which will likely be the case, as the president has repeatedly supported 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. It is time for the Congress to give these wonderful Americans the 'right to try,'" Trump said in his 2018 State of the Union address.
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 Republications, which would have limited those able to make use of it to the patients who had perhaps only months to live. However, it would have reportedly given the US Food and Drug Administration (FDA) wider perception of the use of these medicines while on their newly developed pathway.
Scott Gottlieb, MD, the FDA’s commissioner, 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. 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 in medicine, including Richard Klein, the former director of the FDA’s Patient Liaison Program, have told 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 told MD Magazine. “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,” 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.