The Food and Drug Administration’s decision not to approve Lykos Therapeutics’ application for MDMA (a psychedelic drug known on the street as Ecstasy or molly) plus therapy for post-traumatic stress disorder comes as no surprise, given an advisory panel’s “no” vote on the application in June. But if lessons from reproductive health are any signal, I believe there is a future for psychedelics in health care.
As executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, my work includes legal, ethical, and policy analysis surrounding psychedelic medicine. As part of our growing Project on Psychedelics Law and Regulation, we’ve hosted two major convenings on this topic this summer alone. Most participants seemed to feel that no matter how the FDA ruled on Lykos’ application, the potential for psychedelic medicine is real and requires ongoing, careful attention from scientists and policymakers alike.
But for many years before that, I worked in reproductive health law, advocating to make emergency contraception (Plan B) available to all, to increase access to abortion services, including through FDA approval of mifepristone in 2000, and to improve fertility care and pregnancy care. I worked with the Reproductive Health Technologies Project to make emergency contraception fully available without a prescription and to achieve mifepristone’s approval in the United States.
Both psychedelic medicine and reproductive health care face a gap between public support and restrictive laws. I’ve come to see these two semi-taboo areas of health care as a matched set, twins of a sort. Political controversy generates stigma and undermines rational legal, policy, and ethical analysis. The result can be massive swings toward restrictive law and policy, like President Richard Nixon’s War on Drugs or the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization.
Even in a restricted legal environment, though, these forms of care are in high demand, widely used, and are readily available to those who know where to go and who to ask, especially those with ample resources. Meanwhile, for both of these types of care, people without resources or with marginalized identities are much more affected by legal restrictions and enforcement.
In both cases, it is essential that research demonstrates safety and effectiveness in terms that the FDA and other medical and scientific experts understand.
For passionate supporters of psychedelic-assisted therapy, FDA approval for a product like Lykos’ had seemed inevitable. The epidemic of mental health crises and the need for new treatment options are strong drivers for leaders in this field, some of whom speak openly of having personally experienced or witnessed the toll of mental illness and/or the experience of healing from psychedelics. Strong emotions like hopeful enthusiasm, outrage, and despair plus urgent needs and high expectations can make delays and setbacks feel like an existential crisis.
People working to improve or preserve access to contraceptives, abortion, and pregnancy-related care have been similarly frustrated when reproductive health care has been limited or refused by policymakers and courts, contrary to evidence-based health imperatives.
For example, “Plan B” emergency contraception became available only after many years of controversy, most of which was pure politics. The bumpy path from initial approval as a prescription-only product to full over-the-counter approval included the FDA ignoring the recommendation of its independent advisory committee and scientific review staff, the high-profile resignation of the FDA’s top official in charge of women’s health, a report from the Government Accountability Office critical of the decision to deny over-the-counter access, unprecedented political interference by the Secretary of Health and Human Services that was publicly supported by President Barack Obama, and ultimately resolution, but only after a federal court battle.
Before emergency contraception was approved, it had been in widespread use for decades. Health care providers knew that a high dose of common birth control pills taken within a few days of unprotected sex achieved the same effect of ensuring that no pregnancy would begin. Many health care providers gave patients advance prescriptions for this innovative, off-label use of a tried-and-true contraceptive medication. Thus, in practice, FDA approval followed many years of common, safe, effective, and practical use.
Similarly, mifepristone transformed the provision of abortion care, particularly post-Dobbs, but it took years and multiple iterations of restrictions from the FDA to get there. In 1988, the French government ordered the drug company that developed mifepristone — then called RU-486 — to resume sales after distribution was suspended due to pressure from anti-abortion forces. At the time, France’s Minister of Health, Claude Evin, told The New York Times, “From the moment Government approval for the drug was granted, RU 486 became the moral property of women, not just the property of the drug company.”
Mifepristone’s power is, and always has been, its ability to address a critical unmet need. In retrospect, its eventual approval may seem almost inevitable. But since the FDA’s earliest look at mifepristone in the United States in 1996 to its first approval in 2000, and up to and including the current increasing availability of mifepristone through telehealth and mail-order pharmacies, enormous resources have been spent to prove beyond any doubt the drug’s safety and effectiveness.
The abortion care landscape has been transformed by proponents’ persistence, creativity, and support for community-based use by ensuring that accurate public information about mifepristone is available, working to eliminate medically unnecessary barriers to access, increasing funding streams for care and travel, creating confidential help resources, and answering legal questions that arise when the legal environment is evolving and uncertain.
In much of the U.S., some use of mifepristone is at least partially outside of the formal health care system. Just as with the safe use of psychedelics in Indigenous communities and elsewhere, what has come to be called “self-managed abortion” has been around and safe for many years. With the broader availability of abortion pills like mifepristone, and the ongoing efforts of well-organized supporters, the main concern about self-managing abortion today is not safety, effectiveness, or physical risks, but the legal risk for those having the abortion and those who support them. Free-standing systems of access, information, and support allow high-quality abortion care to continue, even without an ideal legal regime in place.
For psychedelics, numerous legal and policy considerations and complex ethical issues still await, as they did for mifepristone even after it was approved. Wherever the FDA lands, the path ahead could include FDA approval of still-emerging products, which might lead to rescheduling by the Drug Enforcement Administration and fewer restrictions, state decriminalization, policies to protect and respect Indigenous practices, and consideration of exemptions for religious or spiritual use. The recent review process for Lykos’ therapy aired key questions about the underreporting of adverse events, potential researcher bias, and how to handle functional “unblinding” of research participants who could correctly guess whether they received MDMA.
Reports of ethical violations and misconduct by therapists and facilitators highlight the increased vulnerability of participants seeking relief from mental health distress, especially while they are affected by psychedelics. The FDA has reportedly asked for additional clinical trials, and future regulation may come with ongoing post-market requirements and commitments to provide data about safety. Evidence-based Risk Evaluation and Mitigation Strategies could also be applied to help prevent, monitor, and manage the risks.
For psychedelic medicine, as with both emergency contraception and mifepristone, pursuing the highest quality evidence of safety and effectiveness must be the goal. That requires embracing science and a full and open discussion of all concerns and questions. A thorough process can also help reduce the stigma that’s still associated with use of these substances and lead to broader acceptance. The evidence-based path is always worth the work.
Susannah Baruch, J.D., is the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. The Project on Psychedelics Law and Regulation is supported by the Saisei Foundation, Tim Ferriss and Matt Mullenweg, and the Gracias Family Foundation.