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Kimberly is a seasoned professional with a rich background in biotech research, leveraging her extensive experience to guide clients through the intricate landscape of clinical trials and academic research compliance. As the co-founder and co-lead of the firm’s Psychedelic and Emerging Therapies practice group, Kimberly is particularly inspired by the potential of psychedelic therapeutics to address mental health conditions like PTSD. She skillfully navigates the legal intricacies surrounding these therapies, providing guidance through the clinical trial process at both state and federal levels.

Research into psychedelic-assisted therapy receives funding in the National Defense Authorization Act for Fiscal Year 2024.

In an epoch marked by rapid innovation in mental health treatments, a paradigm shift is on the horizon for the well-being of our armed forces personnel. Psychedelic-assisted therapy has surfaced as an innovative intervention for ailments such as depression, traumatic brain injury (TBI), and—perhaps most widely applicable to military personnel—post-traumatic stress disorder (PTSD). Combat veterans are significantly susceptible to PTSD, and the debilitating impact of PTSD can last a long time.Continue Reading Advancing Military Mental Health

Psychedelics have the potential to treat chronic conditions such as post-traumatic stress disorder (PTSD), depression, obsessive-compulsive disorder (OCD), fibromyalgia, and various behavioral health conditions, yet psychedelics are not like traditional pharmaceuticals. The mode of administration often involves a psychotherapy component, necessitating a closer patient-physician relationship and making risk management crucial. In this post, we delve into the critical legal factors that researchers and practitioners must consider before embarking on psychedelic clinical trials. From the intricacies of Food and Drug Administration (FDA) approval for Investigational New Drug (IND) applications to the imperative Drug Enforcement Administration (DEA) registration, site selection criteria, harnessing digital health technologies, and the ongoing and essential nature of informed consent, each factor plays a pivotal role in ensuring the ethical, legal, and safe exploration of psychedelics in the clinical realm. Let’s unravel these legal considerations that pave the way for responsible and groundbreaking advancements in psychedelic medicine.Continue Reading Psychedelic Breakthroughs: Key Considerations for Clinical Trials

Amid the growing interest in psychedelic-assisted psychotherapy, especially with substances like MDMA, psilocybin, and ketamine, it becomes imperative to navigate the intricate landscape of legal considerations associated with this burgeoning field. While the therapeutic benefits are promising, each substance brings along its own set of risks, responsibilities, and legal complexities for providers. In this context, the establishment of ketamine clinics demands a comprehensive understanding of the legal framework. Five major legal areas should be examined when considering opening a ketamine clinic, ensuring compliance, and fostering a secure and ethically sound environment. These considerations span corporate formation, physician-psychotherapist agreements, the development of employee handbooks, insurance coverage, and the crucial distinction between independent contractors and employees. Let’s delve into these key legal facets that make for responsible and legally compliant practices within the realm of psychedelic medicine.Continue Reading Ketamine Clinics: Five Legal Considerations for Psychedelic-Assisted Psychotherapists

On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (“MAPS PBC”) announced it has submitted a new drug application (“NDA”) to the FDA for the use of 3,4-Methylenedioxymethamphetamine (“MDMA”) for the treatment of post-traumatic stress disorder (“PTSD”).Continue Reading The First Leap to Receive Approval for a Novel Approach to PTSD Treatment

On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions. The guidance document applies to clinical trials that will be conducted under investigational new drug applications, including clinical trials that are not intended to support marketing applications. Notably, the use of the term “psychedelic” in the guidance document is intended to encompass “classic psychedelics” that are understood to be 5-HT2 agonists (e.g., psilocybin and lysergic acid diethylamide (LSD)) as well as entactogens or empathogens (e.g., methylenedioxymethamphetamine (MDMA)). This is the first FDA draft guidance that discusses designing clinical trials for psychedelic drugs.Continue Reading Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

On October 14, 2022, President Joe Biden signed Executive Order 14036, directing the Department of Health and Human Services (“HHS”) to consider innovative actions to drive down certain single-source prescription drug costs as the Biden-Harris Administration works to implement the Inflation Reduction Act of 2022 (the “Act”).Continue Reading Inflation Reduction Act Imposes Prescription Drug Pricing Reforms

DEA waivers regarding the Ryan Haight Act could play a major role in telehealth’s future.

In the first decade of the 21st century, deaths attributable to overdoses of prescription drugs saw an alarming spike in volume, led higher by a tripling of deaths due to opioid use. Amid this surge, Congress enacted the Ryan Haight Online Pharmacy Consumer Protection Act in 2008 as part of an attempt to rein in the burgeoning online marketplace for prescription drugs—particularly those involving controlled substances—which had largely evaded prior enforcement actions.Continue Reading Telehealth’s Post-Pandemic Growth Trajectory