On Wednesday, U.S. Senators Rand Paul (R-KY) and Cory Booker (D-NJ) and introduced legislation to clarify that the Right to Try Act should allow terminally ill patients to have access to Schedule I drugs for which a Phase 1 clinical trial has been completed. Specifically, the Right to Try Clarification Act would remove any obstacle presented by the Controlled Substances Act with respect to Schedule I substances when they are used by doctors and patients in accordance with the federal Right to Try law. Companion legislation will be introduced in the House by Representatives Earl Blumenauer (D-OR) and Nancy Mace (R-SC).
The federal Right to Try law permits patients who have been diagnosed with life-threatening diseases or conditions, and who have exhausted all approved treatment options, access to certain treatments that have not yet received final FDA approval. In general, a drug is eligible for Right to Try use after a Phase 1 clinical trial has been completed for that drug but prior to the drug being approved or licensed by the FDA for any use. In other words, in limited conditions involving life threatening illness and for drugs that have been proven to be safe, the federal Right to Try law removes the FDA out of doctor-patient decisions and reverts regulation back to the states. Under the terms of the federal Right to Try law, states remain free to permit or prohibit Right to Try use under their own laws.
In recent years, two substances currently classified as Schedule I drugs—MDMA and psilocybin—have shown exceptional promise in treating a variety of mental health conditions, including suicidal depression, anxiety, and PTSD. In Phase 1 and 2 clinical trials, these drugs have been shown to be safe and effective—so effective that FDA has designated them “breakthrough therapies,” meaning that they demonstrate substantial improvement over any currently available therapies.
“As a physician, I know how important Right to Try is for patients facing a life-threatening condition,” said Dr. Paul. “Unfortunately, the federal bureaucracy continues to block patients seeking to use Schedule I drugs under Right to Try. I’m proud to lead this bipartisan legislation with Sen. Booker that will get government out of the way and give doctors more resources to help patients.”
“Recent studies suggest that MDMA and psilocybin could represent an enormous advancement in mental health and psychopharmacology,” said Senator 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.”
“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 provide immediate and sustained relief from pain, anxiety, and depression for people battling terminal illness,” Rep. 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. I appreciate Senator Booker’s leadership, it is timely and important.”
“Advances in science and technology are often made when we think outside the box and try new things,” said Rep. 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 want to thank Senators Booker and Paul for their bipartisan work to bring these exciting new options into the mainstream medical world.”
“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 Erinn 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.”
“The Washington State Psychological Association applauds the introduction of a clarifying amendment to the federal Right to Try law, making it abundantly clear that RTT applies to investigational drugs on Schedule I of the Controlled Substances Act. WSPA hopes that terminally ill patients suffering anxiety and depression will soon be able to receive psilocybin therapy, improving the last bit of their lives,” said the Washington State Psychological Association.
“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 Martin R. Steele, a retired Lieutenant General in the United States Marine Corps., Chief Executive Officer of Reason for Hope, and head of the recently formed Veteran Mental Health Leadership Coalition. “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, which increases the risk of harm for Veterans in need of healing.”
The full text of the support letter from the Veteran coalition can be viewed here.
The full text of the legislation can be viewed here.