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Now What? Position Statement on the FDA Rejection

In light of the FDA rejection of the Lykos Therapeutics-led New Drug Application (NDA) for MDMA-assisted therapy for post-traumatic syndrome (PTSD), we issue the following position statements.


Key Points:


  • The medical model may be important for enabling insurance coverage of psychedelic-assisted interventions (PAIs) but it is not the only pathway towards accessibility. 

  • The medical model is likewise not the only means of establishing standards and evidence-based protocols.

  • A parallel system of complementary interventions, both PAI and psychedelic-adjacent interventions, already exists and provides accessible and in many cases affordable treatments.

  • That existing parallel system also offers benefits that surpass those provided in the medical model.

  • Likewise, the parallel system circumvents some of the problems inherent in the medical model.


CTAs:


  • Bolster the parallel system through increased funding for peer-reviewed studies and pilot projects.

  • Create and maintain standards for credentialing and certification.

  • Educate healthcare providers/wellness practitioners on how to safely and legally refer clients to the parallel system.

  • Educate healthcare providers/wellness practitioners on harm reduction practices for PAI.

  • Create protocols for self-guided PAI.

  • Offer pro-bono legal counsel to PAI personnel.

  • Lobby for full scale drug policy reform.

  • Create localized, community-based partnerships with law enforcement.









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