The Law Isn't Ready For Psychedelic Medicine (scientificamerican.com) 185
Matt Lamkin reports via Scientific American: In March, the Food and Drug Administration approved esketamine, a drug that produces psychedelic effects, to treat depression -- the first psychedelic ever to clear that bar. Meanwhile the FDA has granted "breakthrough therapy" status -- a designation that enables fast-tracked research -- to study MDMA (also called "ecstasy") as a treatment for post-traumatic stress disorder and psilocybin as a treatment for major depression. While these and other psychedelic drugs show promise as treatments for specific illnesses, FDA approval means doctors could also prescribe them for other, "off-label" purposes -- including enhancing the quality of life of people who do not suffer from any disorder. Hence if MDMA gains approval as a treatment for PTSD, psychiatrists could prescribe the drug for very different purposes.
Yet while the FDA generally does not regulate physicians' prescribing practices, a federal law called the Controlled Substances Act bars them from writing prescriptions without a "legitimate medical purpose." Although this prohibition aims to prevent doctors from acting as drug traffickers, the law does not explain which purposes qualify as "legitimate," nor how to distinguish valid prescriptions from those that merely enable patients' illicit drug abuse. Would prescribing a psychedelic drug simply to promote empathy or increase "life satisfaction" fall within the scope of legitimate medicine -- or would these practices render the physician a drug dealer? To many the answer may seem obvious: to qualify as a "medical" use, a drug must be prescribed to treat an illness. But in fact, medical practice has always included interventions aimed at promoting the well-being of healthy individuals. "At a time when 'lifestyle drugs' are marketed as consumer products, it is increasingly difficult to draw a bright line that distinguishes legitimate medical practices from their illicit cousins," adds Lamkin. "If prescribing mind-altering drugs to help healthy people achieve desirable mental states falls within the bounds of legitimate medicine, what is left of the concept of recreational use?"
Yet while the FDA generally does not regulate physicians' prescribing practices, a federal law called the Controlled Substances Act bars them from writing prescriptions without a "legitimate medical purpose." Although this prohibition aims to prevent doctors from acting as drug traffickers, the law does not explain which purposes qualify as "legitimate," nor how to distinguish valid prescriptions from those that merely enable patients' illicit drug abuse. Would prescribing a psychedelic drug simply to promote empathy or increase "life satisfaction" fall within the scope of legitimate medicine -- or would these practices render the physician a drug dealer? To many the answer may seem obvious: to qualify as a "medical" use, a drug must be prescribed to treat an illness. But in fact, medical practice has always included interventions aimed at promoting the well-being of healthy individuals. "At a time when 'lifestyle drugs' are marketed as consumer products, it is increasingly difficult to draw a bright line that distinguishes legitimate medical practices from their illicit cousins," adds Lamkin. "If prescribing mind-altering drugs to help healthy people achieve desirable mental states falls within the bounds of legitimate medicine, what is left of the concept of recreational use?"
