Trump Orders FDA Review of Psychedelic Therapies
President Donald Trump signed an executive order Saturday that he said directs the FDA to expedite their review of certain psychedelics already designated as breakthrough therapy drugs.
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In a new blog post, Dr. Jeffrey Singer says “Even if the president’s executive order eliminates much of the red tape clinical researchers face when conducting clinical trials, we shouldn’t be overly optimistic that patients will have access to these drugs for psychedelic-assisted psychotherapy anytime soon. Under the current framework, the FDA must first determine that a psychedelic is safe and effective for a specific therapeutic use before clinicians can prescribe it—a process that can take 10 to 12 years. The DEA must then reschedule it from Schedule I to a less restrictive category.
Decades of prohibition-era messaging may also shape how FDA reviewers evaluate these substances. Even if the agency approves them, it remains unclear whether it will allow meaningful patient access—or what constraints it will impose.
Even after that, access will remain tightly controlled. The FDA is likely to require that patients obtain the drug through a licensed clinician—typically a physician or nurse practitioner—and may impose a Risk Evaluation and Mitigation Strategy (REMS) that specifies who may administer it and under what protocols.
In other words, the very agencies that kept these therapies out of reach for decades will now control how—and by whom—they are delivered.”
More can be read here: Trump’s Psychedelic Order Speeds Research—but Not Access.
To speak with Dr. Singer, please reach out to Emily at esalamon@cato.org.
Source: https://www.cato.org/news-releases/trump-orders-fda-review-psychedelic-therapies
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