Unlikely duo leads bipartisan Senate bill to expand Right to Try into MDMA and psilocybin

22 Jul 2022
endpts.com
Sens. Cory Booker (D-NJ) and Rand Paul (R-KY) likely don’t share much in common when it comes to policy views, but that didn’t stop the pair from introducing a new bill this week that would alter the controversial Right to Try Act to allow terminally ill patients to access Schedule I drugs after a Phase I trial has been completed . Building off its predecessor, the bill would skirt around the FDA’s expanded access program and the DEA’s regulations around controlled substances, and allow patients to potentially access Schedule I drugs — like MDMA and psilocybin — much more easily, as the senators say these drugs “have shown exceptional promise in treating a variety of mental health conditions, including suicidal depression, anxiety, and PTSD.” But as with Right to Try, the FDA is not the barrier that many assume it to be when it comes to accessing investigational drugs. The agency signs off on more than 99% of all expanded access requests it receives. It also remains unclear how many have attempted and failed to gain access to Schedule I substances outside of clinical trials or FDA’s expanded access program. Alison Bateman-House, assistant professor at New York University and an expert on expanded access, explained to Endpoints News how this bill builds on other state expansions of RTT legislation, even as any doctor with the appropriate licensing can prescribe controlled substances. “This is not an attack on the FDA, but just on regulations in general, as they don’t care who’s regulating when it comes to barriers to access,” Bateman-House said. But she said she has heard that there’s been a lot of interest from patients around clinical trials testing MDMA and psilocybin, although some of the larger players in this space already have expanded access programs set up. The Wisconsin-based Usona Institute, for instance, provides cGMP psilocybin for clinical studies and has a process set up whereby eligible academic researchers can access the supplies to advance scientific and medical understanding of psychedelics. “Recent studies suggest that MDMA and psilocybin could represent an enormous advancement in mental health and psychopharmacology,” Booker said in a statement. “Unfortunately, many eligible patients who urgently need care do not currently have access to these promising therapies.” Companion legislation will be introduced in the House by Reps. Earl Blumenauer (D-OR) and Nancy Mace (R-SC).
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