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What Now? 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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