In a move that solidified the actions of the Senate, the US House of Representatives approved a bill this week that would allow terminally ill patients to have access to experimental drugs not yet branded with FDA approval. The proposal, known as the “Right to Try Act,” is now on its way over to President Trump for a signature. He is expected to sign the bill without issue.
“We also believe that patients with terminal conditions should have access to experimental treatments that could potentially save their lives,” Trump said earlier this year during his 2018 State of the Union address. “It is time for the Congress to give these wonderful Americans the ‘right to try.’ ”
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Although 40 states have right-to-try laws on the books, a change in federal code would allow terminally ill patients in states without those laws easier access to experimental medications. There would be no application process, nor would patients need to register on some pesky database. They would simply work with their doctor and a pharmaceutical company to obtain the drug. But there are some stipulations. The drug must be “investigational” and have cleared at least Phase 1 of clinical trials.
Marijuana fits the bill of an investigational drug. There have been a small group of studies conducted throughout the years seeking to nail down the therapeutic benefits of the plant –enough to qualify the herb under the Right to Try Act. Sadly, however, this means a person will need to be close to death before marijuana is technically legal for them to use at the federal level.
And, believe it or not, prospective Right-to-try patients will first need to fail with every approved treatment option before being given the green light to use medical marijuana. This is not as big of an issue in states with cannabis laws on the books than it is in areas of total prohibition.
As it stands, the FDA has the power to fast track experimental medications for terminally ill patients. But again, only after all approved treatment options have been exhausted.
The agency claims it approves nearly every application that crosses its path. Last year, it approved 1,831 of the 1,842 filed, according to the latest data.
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“I’m in favor of pathways that allow patients with terminal disease to get access to products that might be in development,” FDA Commissioner Dr. Scott Gottlieb said in a recent interview with CNN Chief Medical Correspondent Dr. Sanjay Gupta. “That’s why we have an expanded-access pathway.”
Interestingly, there is some opposition to right-to-try. Some say it will only give people false hope.
“The problem becomes that you have a lot of false hope as a terminal cancer patient. You want to cling to anything that’s going to sound like it’s an opportunity to live longer or have a better quality of life,” Michael Becker, a cancer patient, told NPR. “That hope can sometimes cover up the realities of some of the more sinister aspects of getting a drug, which are things go wrong. So I could take a drug that was purported to help me, and it may actually make my condition worse.
