Summary: Tom Angell writes for Forbes blog about the “Right to Try Act,” a new bill proposal circulating through Congress that may allow terminally ill patients access to medications not yet approved by the U.S. Food and Drug Administration, potentially including medical marijuana. “Thanks to research being funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), cannabis seems to fit the bill,” says Angell. MAPS Director of Strategic Communications Brad Burge speaks with Forbes about MAPS’ ongoing clinical trial researching the efficacy of marijuana to treat symptoms of PTSD, and the newly proposed Right to Try Act. “Making medical marijuana available for terminally ill patients would certainly be a significant step forward for federal policy. If MAPS’s current Phase 2 clinical trial of marijuana for symptoms of PTSD in military veterans qualifies marijuana for use under the proposed Right to Try Act, then the trial will already have helped a lot of people,” explains Burge. “Still, only making marijuana available for those on the verge of dying isn’t nearly enough, and the best thing the federal government can do for patients is to end the federal monopoly on marijuana for research currently being upheld by Jeff Sessions.”
Originally appearing here.
A Republican-backed bill working its way through Congress could have the unintended consequence of allowing seriously ill patients to use medical marijuana.
Under legislation set to be voted on by the House of Representatives on Tuesday, patients with terminal diseases would be able to access drugs that have not yet been approved by the Food and Drug Administration.
The proposal, known as the “Right to Try Act,” lays out certain criteria for what can be considered an “eligible investigational drug,” all of which marijuana appears to meet.
In order to qualify, a drug has to have completed a phase 1 clinical trial, be under active development and not yet have been approved or licensed for any legal use by the federal government. An eligible medicine also needs to be the subject of an active investigational new drug application and under investigation in a clinical trial intended to form the basis of a claim of effectiveness in support of approval or licensure by the FDA.
Thanks to research being funded by the Multidisciplinary Association for Psychedelic Studies (MAPS), cannabis seems to fit the bill.
The organization, which began its quest for investigational new drug status for marijuana in 2010, is currently in the middle of Phase 2 clinical trials on the use of cannabis by military veterans with post-traumatic stress disorder. The goal is to turn whole-plant marijuana into a legal, FDA-approved prescription medicine.
In the meantime, while the congressional bill appears to open the door to legal access to marijuana, only the most gravely ill patients would qualify.
To access cannabis, they would need to be in “a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death.”
They would also need to have “exhausted approved treatment options” and not be eligible to otherwise participate in ongoing clinical trials on the drug because they don’t meet inclusion criteria or live within geographic proximity of where the study is taking place.
“Making medical marijuana available for terminally ill patients would certainly be a significant step forward for federal policy. If MAPS’s current Phase 2 clinical trial of marijuana for symptoms of PTSD in military veterans qualifies marijuana for use under the proposed Right to Try Act, then the trial will already have helped a lot of people,” Brad Burge, MAPS’s director of strategic communications, said in an interview. “Still, only making marijuana available for those on the verge of dying isn’t nearly enough, and the best thing the federal government can do for patients is to end the federal monopoly on marijuana for research currently being upheld by Jeff Sessions.”
Under longstanding U.S. policy, all marijuana used in scientific research is grown at a University of Mississippi farm licensed by the National Institute on Drug Abuse. Researchers have long complained that it is difficult to obtain cannabis from the government-sponsored lab and that the product is often of low quality. In 2016, the Obama administration moved to allow more cultivation facilities, but the Department of Justice under U.S. Attorney General Jeff Sessions has reportedly blocked the Drug Enforcement Administration from acting on any of the license applications it has so far received.
Because the Right to Try bill is being brought forth on an expedited basis known as “suspension of the rules,” it needs support from two-thirds of House members present and voting, with a roll call expected to take place Tuesday evening. A similar bill was approved by the Senate last August.
If the House passes the legislation, the two chambers will work to reconcile the versions into a single proposal to be sent to President Trump, who pledged his support during his State of the Union address in January.
Republican and Democratic staffers for the House Energy and Commerce Committee, which has jurisdiction over food and drug safety, did not respond to a request for comment.
State-based legislation that explicitly outlines a right to try cannabis for terminally ill patients has advanced this year in Utah and Missouri.
UPDATE: The bill fell just short of getting the necessary two-thirds support it needed to pass the House under suspension of the rules on Tuesday evening.