The Food and Drug Administration's decision not to approve Lycos Therapeutics' application to combine MDMA (the hallucinogen commonly known as ecstasy or Molly) with the treatment of post-traumatic stress disorder is not surprising, given that an advisory committee voted “against” the application in June. But if the lessons of reproductive health are any indication, I believe there is a future for psychedelics in medicine.
As executive director of the Petrie Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, I work on the law, ethics, and policy analysis surrounding psychedelics. As part of our growing Project on Psychedelic Drugs Law and Regulation, we hosted two major conferences on the topic this summer alone. The majority of participants seemed to feel that no matter how the FDA rules on Lykos' application, the potential of psychedelics is real and deserves continued careful attention from both scientists and policymakers.
But for many years prior to that, I worked on reproductive health legislation, advocating for universal access to emergency contraception (Plan B), increasing access to abortion services, and improving fertility and pregnancy care, including FDA approval of mifepristone in 2000. I worked with the Reproductive Health Technologies Project to make emergency contraception fully available without a prescription and to win approval of mifepristone in the United States.
Both psychedelics and reproductive medicine face a gap between public support and restrictive laws. I've come to think of these two semi-taboo medical fields as twins. Political debate breeds stigma and undermines rational legal, policy, and ethical analysis. The result can be a major shift toward restrictive laws and policies, as seen in President Richard Nixon's War on Drugs and the U.S. Supreme Court's Dobbs v. Jackson Women's Health Organization decision.
But even in environments with legal restrictions, these forms of care are in high demand, widely available, and readily available to those who know where to go and who to ask, especially those with sufficient resources. On the other hand, with these two types of care, those without resources and those with marginalized identities are much more vulnerable to legal restrictions and enforcement.
In either case, it is important that studies demonstrate safety and effectiveness at a level that the FDA and other medical and scientific experts can understand.
For enthusiastic advocates of psychedelic drug therapy, it seemed inevitable that a product like Lykos would be approved by the FDA. The widespread mental health crisis and need for new treatment options are strong driving forces for leaders in the field, some of whom have publicly stated that they have personally experienced or witnessed the toll of mental illness and healing experiences with psychedelic drugs. When strong emotions such as hopeful enthusiasm, resentment, and despair are combined with urgent needs and high expectations, delays and setbacks can feel like existential crises.
Those working to improve or maintain access to contraception, abortion, and pregnancy-related care have similarly felt frustrated when reproductive health care has been restricted or denied by policymakers and courts, contrary to evidence-based health imperatives.
For example, the “Plan B” emergency contraception pill was finally released after years of controversy, much of which was purely political: its rocky path from first approval as a prescription product to being approved fully over-the-counter included the FDA ignoring the recommendations of an independent advisory committee and scientific review staff, the high-profile resignation of the FDA's top women's health official, a Government Accountability Office report criticizing the decision to deny over-the-counter availability, unprecedented political intervention by a Secretary of Health and Human Services publicly supported by President Barack Obama, and, ultimately, a fight in federal court that was only resolved.
Before emergency contraception was approved, it had been in widespread use for decades. Healthcare professionals knew that taking high doses of common contraceptives a few days after unprotected sex provided the same effectiveness in reliably preventing pregnancy. Many health care professionals even pre-authorized prescriptions to their patients for this innovative off-label use of proven contraceptives. So, in reality, FDA approval came after many years of common, safe, effective, and practical use.
Similarly, mifepristone transformed the way abortion care was provided, especially after Dobbs, but the journey there took years and multiple rounds of FDA regulation. In 1988, the French government ordered the drug company that developed mifepristone, then called RU-486, to resume sales after it had been suspended due to pressure from abortion opponents. At the time, French Health Minister Claude Even told The New York Times, “From the moment the drug was approved by the government, RU 486 became the moral property of women, not the property of pharmaceutical companies.”
The power of mifepristone has been and continues to be its ability to address a significant unmet need. In retrospect, its eventual approval seems almost inevitable. But from 1996, when the FDA first considered mifepristone in the U.S., to its initial approval in 2000, and now to its increasing availability through telemedicine and mail pharmacy, enormous resources have been dedicated to proving the drug's safety and effectiveness beyond doubt.
The abortion care landscape has been transformed by advocates' tenacity, creativity, and support for community-based use by providing accurate public information about mifepristone, removing medically unnecessary access barriers, increasing funding sources for care and transportation, creating confidential help resources, and answering legal questions that arise in a changing and uncertain legal environment.
In many parts of the United States, the use of mifepristone occurs, at least in part, outside the formal health care system. Like the safe use of hallucinogens in indigenous communities and elsewhere, what has come to be called “self-managed abortion” has existed and been safe for many years. With the widespread availability of abortion drugs such as mifepristone and the continued efforts of organized advocates, today the primary concern about self-managed abortion is not safety, efficacy, or physical risks, but legal risks to those undergoing the abortion and those assisting them. Independent systems of access, information, and support allow high-quality abortion care to continue even when ideal legal regimes are not in place.
For psychedelics, numerous legal and policy considerations and complex ethical questions still lie ahead, as was the case after mifepristone was approved. Whatever the FDA decides, the path forward could include FDA approval of products still in development, which could lead to rescheduling and loosening of restrictions by the Drug Enforcement Administration, decriminalization by states, policies to protect and respect indigenous practices, and consideration of exemptions for religious or spiritual use. The recent review process for Lycos' treatment raised important issues, including under-reporting of adverse events, potential researcher bias, and how to handle functional “unblinding” of study participants who could correctly guess whether they had been administered MDMA.
Reports of ethical violations and misconduct by therapists and facilitators highlight the heightened vulnerability of participants seeking relief from mental health distress, especially while under the influence of psychedelics. The FDA has reportedly requested additional clinical trials, and future regulations are likely to entail continued post-marketing requirements and commitments to provide data on safety. Evidence-based risk assessment and mitigation strategies can also be applied to help prevent, monitor, and manage risks.
For psychedelics, as with emergency contraception and mifepristone, the goal must be to seek the highest quality evidence of safety and effectiveness. This requires embracing the science and fully and openly discussing all concerns and questions. A thorough process will also help reduce the stigma that still attaches to the use of these substances and lead to wider acceptance. An evidence-based path is always worth striving for.
Susanna Baruch, J.D., is Executive Director of the Petrie-Flom Center for Health Law, Policy, Biotechnology, and Bioethics at Harvard Law School. The Project on Psychedelic Law and Regulation is supported by the Saisei Foundation, Tim Ferriss and Matt Mullenweg, and the Gracias Family Foundation.
