A revolution in the use of psychedelic drugs to treat mental health issues experienced a setback in early August when the FDA declined to approve MMDA as a treatment for post-traumatic stress disorder.  

Host Stephanie Kennan provides important context to the FDA’s decision, which came as the agency has faced criticism for approving therapies without convincing evidence. She outlines the fallout, including a peer-reviewed journal’s decision to retract three papers about MMDA-assisted psychotherapy. She also looks ahead, explaining that, while this first attempt for MMDA stalled, other companies are working on their own applications.

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Name: Stephanie Kennan 

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

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Episode Highlights

[00:40] On August 9, the FDA announced it would not approve an application for MMDA-assisted psychotherapy to treat post-traumatic stress disorder.

[01:18] MMDA would have been the first psychedelic drug approved by the FDA, but the government’s rejection was not unexpected, as an advisory panel had voted not to approve earlier this summer.

[01:50] In addition to denying approval, the FDA also said it would withdraw a planned study on people who buy psychedelic drugs.

[02:16] The FDA’s decision comes at a time when it has been criticized for approving therapies without convincing evidence.

[02:25] Fallout from the FDA’s decision includes the “Journal of Psychopharmacology’s” retraction of three papers about MMDA-assisted psychotherapy due to violations of protocol.

[02:47] Meanwhile, the company that sought approval is raising concerns about the composition and conduct of the FDA’s advisory committee meeting.

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