WASHINGTON, D.C. – The Association for Prescription Psychedelics (APP) responded to a Request for Information (RFI) by the Congressional Psychedelics Advancing Therapies (PATH) Caucus on the implementation of programs and policies that expand patient access to prescription psychedelic medicine.  

“APP, the leading voice for prescription psychedelic medicine, believes that the U.S. Food and Drug Administration’s (FDA) New Drug Application (NDA) approval pathway is the only appropriate mechanism that ensures American patients can safely and effectively access these treatments,” the response states. “Rigorous, peer-reviewed scientific research and clinical trials demonstrate that these treatments hold the potential to help tens of millions of Americans who suffer from serious health conditions.” 

The letter continues: “APP encourages the PATH Caucus and Members of Congress to consider three key policy improvements to help expand access to safe and effective prescription psychedelic medicine.” 

1. Streamline FDA/DEA Coordination: To ensure safe and effective access, the DEA and FDA should begin communication at the time of an NDA submission. This is particularly critical for products that have received Breakthrough Therapy Designation (BTD), highlighting the urgency to get these potentially life-saving medicines to patients in need. 

2. Coordinated Review Processes: The creation of a coordinated review process between the FDA and the U.S. Drug Enforcement Agency (DEA) would improve efficiency and organization in the approval process, benefiting both the patients awaiting treatment and the agencies reviewing them.  

3. Application Enhancements: Reducing redundancies in application requirements will create a more productive environment for treatments. Eliminating the need for sponsors to resubmit identical safety and efficacy data to both the FDA and DEA would significantly streamline the process. 

The letter concludes: “The development and implementation of prescription psychedelic medicine presents a historic opportunity to address our nation’s mental health crisis with innovative treatments. As research advances and clinical trials demonstrate promising results, it is essential that our regulatory framework evolves to facilitate the safe, effective, and timely delivery of these therapies to patients in need.” 

See here for the full letter.  

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About the Association for Prescription Psychedelics 

The Association for Prescription Psychedelics (APP) works to educate and advocate for the development and accessibility of safe and effective prescription psychedelic medicines for patients. We serve as the trusted and recognized industry voice – at the national and state levels – on prescription psychedelic medicine and its integration into the healthcare system. Our education efforts help policymakers, regulators, and other key stakeholders learn about psychedelics and entactogens/empathogens and the associated medical conditions each compound may be able to treat. Our advocacy efforts help advance responsible legislative and regulatory policies that drive innovation, increase funding for research, and enhance access and coverage for prescription psychedelic medicine. Learn more at psychedelicsRX.org.