FDA ROUNDUP:

FDA issues important draft guidance for developers of psychedelic drugs for potential treatment of medical conditions (June 23, 2023).  Currently, there are hundreds of organizations across the world who are developing psychedelics for medical use.  Prior to the issuance of FDA’s draft guidance in June, these developers had little regulatory guidance beyond meeting with FDA on a product-by-product basis to understand how to progress their product through to FDA approval.  FDA’s June 2023 draft guidance is a relief to many Sponsors because it outlines FDA’s current thinking on nonclinical, CMC, and clinical topics for Sponsors who are developing psychedelic products.  The information on CMC is particularly helpful and outlines what is required to support an IND and an eventual NDA.  Despite popular belief, FDA’s expectation is that psychedelic drugs under investigation must be manufactured in compliance with GMP, even in Phase 1. With respect to nonclinical information, FDA’s expectation is that Sponsors will include information regarding the product’s pharmacological and toxicological properties that led the Sponsor to conclude that the product at the planned doses and treatment regimen would be safe in humans.  Further, the pharmacokinetic and/or pharmacodynamic profile of the product is expected to be adequately characterized in vitro and in vivo.  Sponsors should pay particular attention to evaluating drug-drug interactions and abuse potential.  Finally, FDA is clear that all drugs, including psychedelics, must adhere to the substantial effectiveness standard to establish the effectiveness of the product, although special design features need to be used to manage the unique nature of psychedelic drugs.  The guidance does an excellent job of describing how to handle the use of a placebo control, paired psychological support/psychotherapy, and subject, observer, and analyst bias).  If you are developing a psychedelic product for a medical use, see the guidance for more information or talk to Facet – we have worked with Sponsors and FDA to successfully progress psychedelic products through development.

FDA issues guidance on direct-to-consumer promotional labeling and advertisements (June 2023).  In this guidance, FDA provides a review of studies that have shown that comprehension of efficacy and risk-based material by consumers is more accurate and easily understood if comparisons between treatment and control groups are quantitative.  Citing one of FDA’s examples, “In a clinical trial, 78 out of 100 patients experienced a response after 12 weeks of treatment with Drug X, compared to 20 out of 100 patients on placebo.”  The guidance also summarizes how visual aids can help consumers understand quantitative efficacy and risk information and provides helpful suggestions on how to design such aids to align the information with the purpose and objective of the communication.  For more information, see FDA’s guidance here.

Important Upcoming Deadline – October 1, 2023:  All 510(k) submissions must be sent to FDA using the eSTAR template.  Currently, medical device Sponsors may submit their 510(k) using the traditional format or they may voluntarily use the eSTAR template, an interactive PDF that contains automation, content and structure that is complimentary to how FDA reviews and has guided construction for each written section.  We highly recommend all Sponsors use the eSTAR template voluntarily now because it streamlines the process and results in a more robust, complete submission.  However, all Sponsors must use the eSTAR template when submitting their medical device application starting October 1, 2023.