Bipartisan Senate bill would give psilocybin and MDMA ‘right to try’

Democratic Sen. Cory Booker of New Jersey and Sen. Rand Paul, a Republican from Kentucky, introduced bipartisan legislation Wednesday to extend federal law protections to attempting the psychedelic drugs psilocybin and MDMA. Under the bill, titled the Right to Try Clarification Act, the restrictions of the federal Controlled Substances Act would not apply to Schedule I drugs that have completed a Phase 1 clinical trial. The new provisions would apply to physicians and patients with life-threatening medical conditions who use Schedule 1 controlled substances under the federal Right to Try Act.

“As a physician, I know how important the right to try is for patients who are in a life-threatening condition,” Paul said in a statement on the legislation from Booker’s office. “Unfortunately, the federal bureaucracy continues to block patients who wish to use Schedule I drugs under the right to try. I’m proud to lead this bipartisan legislation with Sen. Booker that will sidestep the government and give doctors more resources to help patients.”

The Right to Try Act allows patients diagnosed with life-threatening illnesses or conditions for which traditional therapies have not been effective to use certain treatments that have not yet been approved by the US Food and Drug Administration. In most cases, a drug is eligible to try after a Phase 1 clinical trial for that drug has been completed, but before the drug has been approved or licensed by the FDA for any use. Under the provisions of the Probationary Act, states have the option to permit or prohibit the use of the probationary right under state law.

The senators noted that two drugs, MDMA and psilocybin, show promise as treatments for a variety of mental illnesses, including depression, anxiety and PTSD. The success and safety of the drugs shown in Phase 1 and Phase 2 clinical trials has been so encouraging that the FDA has designated both compounds as “breakthrough therapies,” indicating they represent a substantial improvement over currently approved therapies exhibit.

“Recent studies suggest that MDMA and psilocybin could represent tremendous advances in mental health and psychopharmacology,” Booker said. “Unfortunately, many eligible patients in urgent need of 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 medicines.”

Accompanying measure to be introduced in-house

A bipartisan duo of House members who support federal cannabis policy have already committed to supporting Booker and Paul’s bill and will introduce accompanying legislation in the House of Representatives. Democratic Rep. Earl Blumenauer of Oregon, who has long campaigned to reform the country’s cannabis laws, and Rep. Nancy Mace, a first-term Republican who introduced a cannabis legalization bill last year, expressed their support for the change of the legislation on the right to negotiate.

“Oregon has a long history of ensuring that end-of-life patients have access to the full spectrum of treatment options to manage their condition and improve their quality of life. Patients and physicians deserve to discuss treatments — including psilocybin — that researchers have found provide immediate and lasting relief from pain, anxiety and depression for people with terminal illnesses,” Blumenauer said. “Federal restrictions have hampered access to end-of-life care for too long, this legislation will change that and ensure all patients have the right to try. I appreciate Senator Booker’s leadership, it is timely and important.”

“Advancements in science and technology are often made when we think outside the box and try new things,” Mace said. “This legislation gives patients the ability to choose alternative options such as psilocybin or MDMA when faced with a life-threatening condition. We know these chemicals have the potential to save lives, and today is an important advance in medical advances. I want to thank Senators Booker and Paul for their bipartisan work to bring these exciting new options to the general medical world.”

The Right to Try Clarification Act was introduced in the Senate just a day before Booker, Senate Majority Leader Chuck Schumer of New York, and Democratic Senator Ron Wyden of Oregon, a long-awaited bill legalizing cannabis at the federal level. Shane Pennington, an attorney with the law firm Vicente Sederberg, said he was “happy that Congress is paying attention to psychedelics issues, particularly those affecting the veteran community. Veterinarians should not have to travel to other countries to access therapies that have been shown to be safe and likely to be effective.”