A bipartisan group consists of congressional legislators who filed this bill to clarify federal “Right to Try” (RTT) laws that allow seriously ill patients to access Schedule I drugs like marijuana.
The bipartisan bill would add a technical amendment in the existing law text, but the main purpose of the measure is to clarify, in the face Drug Enforcement Administration (DEA), that the RTT policy signed by then-President Donald Trump already allows patients with terminal illnesses to be able to access and use investigational drugs that have been through clinical trials.
The legislation is titled the “Right to Try Clarification Act” and was sponsored by Nancy Mace (R.S.C.) and Earl Blumenauer (D.OR).
“Patients and doctors deserve to discuss treatments–including psilocybin–that researchers find provide immediate and sustained relief from pain, anxiety, and depression for people battling terminal illness,” Blumenauer said in remarks for the Congressional Record. This legislation will end the federal restrictions that have prevented patients from accessing end-of-life care too long.
The congressman stated that “the psychedelics laws of this country are broken,” including our laws regarding patients’ access to promising end-of life care. “Right to Try laws have been passed in 41 states to give terminally ill patients access to treatment, including psilocybin. These laws are still being investigated. In clinical trials, both MDMA and psilocybin have shown remarkable care potential in their phase 1 and 2 clinical trials.
“The Drug Enforcement Agency has, however, refused to accommodate Right to Try laws, and denied terminally ill people their freedom to choose their preferred treatments. These patients should be able discuss with their doctors the treatments that provide long-lasting, significant and immediate relief from depression and anxiety for those who are suffering from terminal illnesses. The Right to Try Clarification Act was created to give patients the right to try these treatments.
Along with Mace and Blumenauer, the bill is co-sponsored by Madeline Dean (D–PA), Andy Biggs and Lou Correa.
The lawmakers had submitted a previous version of the measure that was not adopted by Congress. Sens. Senators.
If the bill is passed, it could impact an ongoing case against DEA. This was after refused to allow an oncology physician access to psilocybin in order to treat his terminally ill patients with cancer.
Psilocybin and MDMA have already made significant progress in clinical trials and were designated by FDA as a “breakthrough treatment.” Cannabis has also been subject to the required clinical trials.
Its text, which is three pages long, states that Congress’ bill contains the following: “clarify the Federal Right to Try law applies to schedule 1 substances for whom a phase I clinical study has been completed and to allow access for eligible patients to such substances pursuant to Federal Right to Try law.”
A section of the legislation includes a finding section that states that many Schedule I drugs have been through phase I trials and have received breakthrough therapy designation from FDA. It states that there is preliminary clinical evidence that these drugs are substantially better than existing therapies. However, eligible patients have not been allowed to access these drugs under the Federal Right to Try law.
The measure proposes to amend the statute to clarify what is covered in order to make the current policy clear for agencies like DEA.
Last year, bipartisan members in Congress, led by Blumenauer sent a letter requesting that DEA permit terminally ill patients to use psilocybin for investigational purposes without fear of federal prosecution.
Booker and Senator Brian Schatz (D HI) each pushed federal officials to give an update on research into the therapeutic value of psychedelics. They argued that federal prohibition continues to stymie studies.
Federal health officials recognized that federal prohibition made it more difficult to study the benefits psychedelics and required researchers to go through additional regulatory hurdles.
Activists, including Erinn Baldeschwiler (one of the plaintiffs in Right to Try), protested outside the DEA headquarters last year in Virginia, asking that the agency grant terminally ill patients access to psilocybin treatment.
DEA is being sued separately for repeated delays processing requests for public records relating to psychedelics or marijuana.
The agency also announced last year it was cancelling controversial plans to ban several psychedelic substances by placing these substances in Schedule 1 of the Controlled Substances Act.
In an effort to promote research and encourage innovation, the agency has raised production quotas for certain psychedelics such as psilocybin. However, its scheduling decisions continue to be a problem for scientists.
Read the of Right to Try bill:
The post Bipartisan Congressional Act Would Force DEA to Let Patients Use Psychedelics and Marijuana was first published on Marijuana Moment.
