Opinion: Adding psychotherapy to drug therapy works, but the FDA may not be able to handle it

STAT July 25, 2024
Thomas R. Insel

Many people were stunned when an FDA advisory committee voted “no” on a new drug application for MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD) earlier this summer. I was not among them.

Several things were stacked against approval: The FDA greenlights only about 50 new drugs each year. Drug development is a high-risk business with an overall success rate between 10% and 20%. Most FDA applications for new drug approval are from massive global companies with decades of experience and deep pockets, while the application for MDMA-assisted psychotherapy was based on two philanthropy-funded trials of a Schedule I compound — insider speak for a drug with no currently accepted medical use and a high potential for abuse (MDMA’s street name...

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