Berkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.
A Food and Drug Administration advisory panel on Tuesday declined to recommend the approval of MDMA as a treatment for post-traumatic stress disorder, a major setback for advocates who have long pushed to include psychedelics in treating mental health disorders. The two votes — one for the treatment’s efficacy and one for its safety, by the agency’s Psychopharmacologic Drugs Advisory Committee — marked the first time that FDA advisers have considered a Schedule I psychedelic for medical use.
David Millis, an FDA official who oversaw Lykos approval application, said during Tuesday’s meeting, because participants may feel the treatment is working if they know they are on the drug, or conversely not working if they are on a placebo. “We expressed continued concern about the adequacy of blinding,” he said.
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