Reforming Regulation to Promote Medical Use of Psychedelic Drugs

Every day, millions of Americans struggle with mental illness and opioid addiction. More than 6 percent of adults suffer from depression, and about 1 percent have been diagnosed with obsessive-compulsive disorder (OCD), a condition associated with anxiety. Meanwhile, the opioid crisis has become so pressing that President Donald J. Trump declared it a public health emergency. Psychedelic drugs may alleviate mental illness and substance abuse patients’ symptoms, according to a paper by Mason Marks, a fellow at the Information Society Project at Yale Law School. He observes that psychedelics may help because many patients do not benefit from existing treatments. But federal agencies—like the U.S. Food and Drug Administration (FDA) and the U.S. Drug Enforcement Administration (DEA)—strictly regulate psychedelics. According to Marks, these regulations block scientists and doctors from studying the drugs and bar patients from reaping whatever healing properties the drugs may have. Marks advocates for a variety of regulatory changes to stimulate research on psychedelics and allow doctors to more effectively combat mental illness and opioid addiction. Psychedelics—drugs that cause the user to hallucinate—can help patients by assisting recall of repressed troubling thoughts for purposes of coming to terms with those thoughts, according to Marks. He points to studies that indicate that certain psychedelics can boost moods, combat OCD symptoms, lower anxiety and depression, ease post-traumatic stress disorder, and treat opioid addictions. But existing research does not provide enough support for using psychedelics to treat mental illness, Marks contends. He offers recommendations for promoting further research. For example, he suggests that researchers should seek to work with FDA to study psychedelic drugs through clinical trials using procedures the FDA already has in place. Marks recognizes the obstacles to clinical trials for psychedelics, such as the trials’ length and expense. To reduce these impediments, Marks would have FDA categorize psychedelic drugs as “breakthrough therapy” drugs, a category under which FDA would allow “drugs for serious or life-threatening conditions” to go through an expedited FDA review process. This categorization would speed up clinical trials because it would recognize mental illness and addiction as a significant public health problem that requires a solution. Additionally, Marks suggests that proponents offer supplementary safety measures for using the drug to increase the likelihood of FDA approval. These measures might include providing information on the drugs’ risks in their packaging, supervising patients receiving the drug, and training those who give out the drug. In addition, Marks says that the DEA should loosen some of its regulations in order to allow research on the drugs. The DEA, empowered by federal law, categorizes many psychedelics as falling in the most dangerous drug category because they are likely to be abused and have no widely recognized medical purpose. As a result, researchers face procedural hurdles—such as permitting, restrictions on drug quantities, proper documentation, and safety techniques—to obtaining and using the drugs for study. To make the DEA’s regulations more amenable to psychedelics research, Marks says that Congress could loosen existing restrictions. Alternatively, the U.S. Attorney General could invite the U.S. Department of Health and Human Services “to open a scientific and medical review of” psychedelic drugs. Such a review could revise the DEA’s classification of how dangerous a drug is—and therefore how strictly the government regulates it. To convince federal agencies to loosen their regulations of psychedelics, research will need to show that psychedelics have some medical use. Marks urges the research community to seek “clear evidence,” based in sound methodology, that the drugs are helpful and safe. Marks notes that even if the DEA loosens its regulations, the drugs would still need FDA approval for doctors to give the drugs legally to patients as medicine. The states also have a role in promoting the effective use of psychedelic drugs, says Marks. For instance, states could fund joint psychedelics research with FDA, a partnership that would also reduce the currently steep costs of research. Marks argues further that states should regulate psychedelics closely. He suggests distributing psychedelic medicine only at “licensed centers” and requiring distributing doctors to go through training. To protect against abuse of the drugs, he proposes that states promote psychedelic medicine cautiously, limit who can receive psychedelics, and carefully document those who do receive them. Despite the urgent need for safe and effective medication to treat mental health problems, Marks admits that changing current regulations will be difficult. Regardless of this impediment, Marks stresses that the harms of the opioid crisis are too high for the government and doctors to ignore potential alternative avenues of treatment. Marks’s paper appears in the New York University Journal of Legislation and Public Policy