At a contentious advisory committee meeting in June, the Food and Drug Administration announced it was investigating allegations of data suppression and misconduct in clinical trials of MDMA-assisted therapy.
The agency was “quite concerned” by claims included in a report from the Institute for Clinical and Economic Review think tank, agency psychiatry director Tiffany Farchione told the ad comm, and planned to complete its investigation before deciding whether to approve Lykos Therapeutics’ MDMA therapy.
Yet more than a month later, ICER chief medical officer David Rind — along with others who’ve raised concerns about Lykos’ management of the trials — told STAT they’ve yet to hear from the FDA, which is set to decide by Aug. 11 whether MDMA can be used to treat post-traumatic stress disorder. While Farchione declined to say last month whether the FDA probe was focused on the ICER allegations, Rind was surprised by the agency’s lack of outreach. The silence raises questions about how the agency is pursuing the accusations, and whether a decision on the treatment could be delayed.
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