Policy considerations that support equitable access to responsible, accountable, safe, and ethical uses of psychedelic medicines
Neuropharmacology – August 13, 2022
Source: OpenAlex
Summary
Psilocybin and MDMA, combined with psychosocial support, offer profound potential for safe, rapid, and durable clinical improvements. Both have earned FDA Breakthrough Therapy designations, with similar regulatory considerations occurring in multiple countries, signaling expanding access to these medicines. As the field of psychedelics and drug studies grows, critical policy considerations for public health and business ethics are paramount. Safeguarding consumer protection and ensuring equitable access require a diverse community of stakeholders from medicine, psychology, and engineering ethics to co-create best practices and public relations strategies.
Abstract
There is mounting evidence suggesting psychedelic and entactogen medicines (namely psilocybin and 3,4-methylenedioxymethamphetamine [MDMA]), in conjunction with proper psychosocial support, hold the potential to provide safe, rapid acting, and robust clinical improvements with durable effects. In the US, both psilocybin and MDMA have been granted Breakthrough Therapy designations by the US Food and Drug Administration and may potentially receive full FDA approval with similar regulatory considerations occurring in multiple countries. At the same time, regulatory changes are poised to increase access to legal or decriminalized psychedelic use in various non-medical settings. This review provides a brief discussion on the historical use of psychedelic medicines, the status of the empirical evidence, and numerous significant policy considerations that must be thoughtfully addressed regarding standards-of-practice, consumer protection, engagement of communities, safeguarding access for all, and developing data standards, which supports the responsible, accountable, safe, and ethical uses of these medicines in clinical, faith-based, and other contexts. We provide suggestions for how public health and harm reduction can be supported through a public-private partnership that engages a community of stakeholders from various disciplines in the co-creation and dissemination of best practices and public policies.