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The F.D.A. is poised to rule on the therapeutic use of the club drug Ecstasy, a potential watershed moment in the nascent field of psychedelic medicine.
More than a half century after federal regulators banned most psychedelic compounds, the Food and Drug Administration is nearing a decision on a novel treatment for post-traumatic stress disorder that pairs talk therapy with MDMA, the club drug commonly known as Ecstasy or Molly.
The decision, which is expected in the coming days, has generated a groundswell of lobbying by veterans groups, researchers and members of Congress from both parties. Eighty lawmakers signed letters to the Biden administration this week, urging the F.D.A. to approve the application by the drug company Lykos Therapeutics.
The campaign was prompted in part by an expert panel’s unanimous rejection in June of Lykos’s application, because of what participants said were flaws in the company’s clinical trials and insufficient data.
“We have a mental health crisis and a suicide epidemic, with thousands of military veterans taking their own lives every year,” said Representative Jack Bergman, Republican of Michigan and a former Marine Corps general who helped organize the letter’s 60 backers in the House. “I would just ask the F.D.A. to consider the negative ramifications of them not taking action, which means more veterans will die needlessly.”
The lobbying campaign, unusual for a prospective new drug, underscores the high stakes and intense emotions surrounding psychedelic medicine, a field that has been growing in recent years as the country’s top universities race one another to establish psychedelic research institutes.
The passions — and the millions of dollars in private investment flooding the field — have been buoyed by a growing body of data suggesting that compounds like LSD, psilocybin mushrooms and MDMA can have significant therapeutic effects on hard-to-treat mental health conditions like depression, anxiety and obsessive compulsive disorder. The federally prohibited substances are listed as Schedule I drugs that have “no currently accepted medical use and a high potential for abuse.”