Unlikely duo lead bipartisan Senate bill to expand right to try MDMA and psilocybin – Endpoints News

The senses. Cory Booker (D-NJ) and Rand Paul (R-KY) probably don’t have much in common when it comes to political views, but that hasn’t stopped the pair from introducing a new bill this week that would change the controversy Right to Try Act allow terminally ill patients to access Schedule I drugs after the end of a Phase I trial.

Building on its predecessor, the bill would bypass the FDA’s Expanded Access Program and DEA controlled substance regulations, and allow patients to potentially access Schedule I drugs – like MDMA and psilocybin – much easier, 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 many assume it is when it comes to accessing experimental drugs. The agency disconnects over 99% of all expanded access requests it receives. It’s also unclear how many have tried and failed to access Schedule I substances outside of clinical trials or the FDA’s expanded access program.

Alison Bateman-House

Alison Bateman-House, an assistant professor at New York University and a specialist in expanded access, told Terminal News how this bill builds on other state extensions of RTT legislation, even though any doctor with the proper license can prescribe controlled substances.

“This is not an attack on the FDA, but just on regulations in general, because they don’t care who regulates when it comes to barriers to access,” Bateman-House said.

But she said she has heard that patients are showing great interest in clinical trials testing MDMA and psilocybin, although some of the biggest players in this space have already established expanded access programs.

The Wisconsin-based Usona Institute, for example, provides cGMP psilocybin for clinical studies and has established a process through which eligible university researchers can access the supplies to advance the scientific and medical understanding of psychedelics.

“Recent studies suggest that MDMA and psilocybin could represent a huge advance in mental health and psychopharmacology,” Booker said in a statement. “Unfortunately, many eligible patients who are in urgent need of care do not currently have access to these promising therapies.”

Complementary legislation will be introduced in the House by Representatives Earl Blumenauer (D-OR) and Nancy Mace (R-SC).

Norman D. Briggs