Democratic Senator Cory Booker of New Jersey and Senator Rand Paul, a Republican from Kentucky, introduced bipartisan legislation on Wednesday to extend federal Right to Try protection to the psychedelic drugs psilocybin and MDMA. Under the bill, titled the Right to Try Clarification Act, restrictions of the federal Controlled Substances Act would not apply to Schedule I Drugs for which a Phase 1 clinical trial has been completed. The new provisions would apply to doctors and patients with life-threatening medical conditions using Schedule 1 controlled substances under the federal Right to Try Act.
“As a physician, I know how important Right to Try is for patients facing a life-threatening condition,” Paul said in a statement about the legislation from Booker’s office. “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.”
The Right to Try Act allows patients who have been diagnosed with life-threatening diseases or conditions for which traditional therapies have not been effective to use certain treatments that have not yet been approved by the U.S. Food and Drug Administration. In most cases, a drug is eligible for Right to Try use after a Phase 1 clinical trial has been completed for that drug but before the drug is approved or licensed by the FDA for any use. Under the provisions of the Right to Try law, states have the option to permit or prohibit Right to Try use under state law.
The senators noted that two drugs, MDMA and psilocybin, show promise as treatment for a variety of mental health conditions, including depression, anxiety, and PTSD. The success and safety of the drugs exhibited in Phase 1 and Phase 2 clinical trials has been so encouraging that the FDA has classified both substances as “breakthrough therapies,” indicating that they show a substantial improvement over currently approved therapies.
“Recent studies suggest that MDMA and psilocybin could represent an enormous advancement in mental health and psychopharmacology,” said 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.”
Companion Measure To Be Introduced in the House
A bipartisan duo of members of the House of Representatives who support federal cannabis policy have already signed on to support Booker and Paul’s bill and will introduce companion legislation in the House. Democratic Representative Earl Blumenauer of Oregon, who has long supported reforming the nation’s cannabis laws, and Representative Nancy Mace, a first-term Republican who introduced a bill to legalize cannabis last year, expressed their support for the change to Right to Try legislation.
“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,” 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 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.”
The Right to Try Clarification Act was introduced in the Senate only one day before Booker, Senate Majority Leader Chuck Schumer of New York and Democratic Senator Ron Wyden of Oregon introduced a long-anticipated bill to legalize cannabis at the federal level. Shane Pennington, an attorney with the law firm Vicente Sederberg, said that he is “happy to see Congress paying attention to psychedelics issues, particularly those that affect the veteran community. Vets shouldn’t have to go to other countries to access therapies that evidence has shown to be safe and likely effective.”