Senators Cory Booker (D-NJ) and Rand Paul (R-KY) introduced the Right to Try Act to allow dying patients access to certain tested psychedelics.
The Right to Try Clarification Act would remove any obstacle presented by the Controlled Substances Act and allow states to regulate psychedelics legalization and trials. It would permit patients diagnosed with life-threatening diseases or conditions who have exhausted all approved treatment options to access certain treatments that have not yet received final Food and Drug Administration (FDA) approval.
A drug is legally eligible for Right to Try use after a Phase 1 clinical trial has been completed but prior to it being approved by the FDA. In limited conditions involving life-threatening illness and for drugs that have been proven safe, the federal Right to Try law would remove the FDA from doctor-patient decisions and revert regulation back to the states. Under the federal Right to Try law, states would be free to permit or prohibit the Right to Try use under their laws.
In recent years, two substances currently classified as Schedule I drugs, MDMA (better known as Molly) and psilocybin (better known as magic mushrooms or psychedelics), have shown promise in treating mental health conditions including suicidal depression, anxiety, and Post Traumatic Stress Disorder (PTSD). Their Phase 1 and 2 clinical trials have been shown to be safe and effective. They are so effective that FDA has designated them “breakthrough therapies” since they demonstrate substantial improvement over currently available therapies.
Companion legislation to the psychedelics bill in the Senate will be introduced in the House by Representatives Earl Blumenauer (D-OR) and Nancy Mace (R-SC). Both have supported federal cannabis legalization efforts.
“Recent studies suggest that MDMA and psilocybin could represent an enormous advancement in mental health and psychopharmacology,” said Cory Booker. “Unfortunately, many eligible patients who urgently need care do not currently have access to these promising therapies. This legislation will put the patient first and help ensure access to life-changing and life-saving drugs.”
“As a physician, I know how important Right to Try is for patients facing a life-threatening condition,” said Paul. “Unfortunately, the federal bureaucracy continues to block patients seeking to use Schedule I drugs under Right to Try.”
“Oregon has a long legacy of ensuring that end-of-life patients have access to the full spectrum of treatment options to alleviate their condition and improve their quality of life. Patients and doctors deserve to discuss treatments, including psilocybin, that researchers find provides immediate and sustained relief from pain, anxiety, and depression for people battling terminal illness,” Blumenauer said. “Federal restrictions have obstructed access to end-of-life care for too long, this legislation will change that and ensure that all patients have the Right to Try.”
“Advances in science and technology are often made when we think outside the box and try new things,” said Mace. “This legislation gives patients the power to choose alternative options like psilocybin or MDMA when facing a life-threatening condition. We know these chemicals have the potential to save lives, and today is an important step forward in medical progress.”
“I am glad to see federal legislators clarifying that I and others dealing with the reality of advanced cancer can access promising drugs in the investigational process, even if they are on Schedule I,” said Erin Baldeschwiler, a patient who has been seeking access to psilocybin therapy for relief of debilitating anxiety and depression as she manages advanced cancer.
“I am eager to try psilocybin therapy to help gain comfort and peace with what is unfolding for me and be able to be more present for my children even in this most difficult time,” she added.
“This bill will open access to MDMA and psilocybin-assisted therapy for Veterans who are at serious risk of suicide and have exhausted all other options,” said retired Marines Lt. General and head of the Veteran Mental Health Leadership Coalition Martin Steele. “We thank Senators Paul and Booker for considering the realities on the ground for the Veteran community, where a growing number are seeking treatment outside the country or in the underground market.”
Progressive Congresswoman Alexandria Ocasio-Cortez (D-NY) has also been among those pushing for psychedelics legalization in the House of Representatives. She has been a strong supporter of cannabis legalization as well.
As tests show positive lab test results, magic mushrooms have become quite popular, with NJ Senate President Nick Scutari (D-Union) introducing a magic mushrooms legalization bill that the UFCW labor union endorsed.