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Natasha Sumner

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Natasha co-leads the firms’ Psychedelics and Emerging Therapies Practice Group and is also part of the product liability team. She focuses her practice on assisting clients in navigating the regulatory scheme for conducting clinical trials on psychedelics and other controlled substances and litigating product liability claims.

Natasha is well-versed in historical and current psychedelic research including recent FDA-approved studies on MDMA and psilocybin use for mental health and end-of-life issues, the legalization and decriminalization of psylocibin in numerous cities and states, and biotech and pharmaceutical research. Natasha’s interest in this area keeps her at the forefront of assisting clients in navigating regulatory uncertainty, legislative advocacy, corporate transactions, and ­­­­­­­­­­litigation in this rapidly evolving complex area. Natasha is also dedicated to insuring diversity, equity, and inclusion and recognizing and preserving indigenous knowledge.

Academic institutions, product manufacturers and commercial businesses are among the clients relying on Natasha’s broad experience. Natasha has defended clients against claims of mold, asbestos, and benzene exposure, including landlords and housing authorities in disputes regarding habitability. She has represented clients alleging violations under the Food, Drug, and Cosmetic (FD&C) Act, and counseled clients regarding California’s Proposition 65 warning requirements, among other state and federal laws.

While in law school, Natasha interned with the California Attorney General Energy Task Force, working on antitrust issues related to the state’s 2001 energy crisis. Her inside view of regulatory issues is appreciated by clients as she navigates them through various complex litigation and compliance.

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On July 3, 2024, Judge Louis Guirola, Jr. of the federal district court in Mississippi issued a nationwide preliminary injunction prohibiting the U.S. Department of Health and Human Services (HHS) from “enforcing, relying on, implementing, or otherwise acting on” the gender identity provisions of a HHS Final Rule that purported to implement Section 1557 of the Patient Protection and Affordable Care Act (ACA) and was set to go into effect on July 5, 2024. The injunction was sought by a plaintiff group comprised of fifteen individual states that alleged the Final Rule violates existing statutory and constitutional law. The breadth of the injunction includes 42 C.F.R. §§ 438.3, 438.206, 440.262, 460.98, and 460.112; 45 C.F.R. §§ 92.5, 92.6, 92.7, 92.8, 92.9, 92.10, 92.101, 92.206-211, 92.301, 92.303, and 92.304 “in so far as these regulations are intended to extend discrimination on the basis of sex to include discrimination on the basis of gender identity.” While the injunction halts the gender identity provisions of the 2024 Final Rule, the remaining provisions of the 2024 Final Rule remain in effect.

On April 29, 2024, the Food and Drug Administration (FDA) announced a Final Rule amending regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory. Under the new rule, the FDA will phase out its laboratory developed test (LDT) enforcement discretion policy over a four-year period. The phaseout policy “applies to IVDs that are manufactured and offered as LDTs by laboratories that are certified under CLIA[1] and that meet the regulatory requirements under CLIA to perform high complexity testing, and used within such laboratories, even if those IVDs do not fall within FDA’s traditional understanding of an LDT because they are not designed, manufactured, and used within a single laboratory.”

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Section 1557 of the Affordable Care Act prohibits discrimination in healthcare based on a number of characteristics including race, color, national origin, sex, age, and disability. On April 26, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that according to HHS provides clarity on Section 1557 with a goal of ensuring nondiscriminatory access to care for all, including women, people with disabilities, LGBTQI+ people, people with limited English proficiency (LEP), people of color, and people regardless of age. The first Section 1557 final rule was published in 2016 followed by a second final rule in 2020 that rescinded large sections of the 2016 rule. The 2024 Final Rule restores those provisions and enhances them.

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.

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.

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”).

On November 6, 2023, the Office of Inspector General (“OIG”) issued its long-awaited General Compliance Program Guidance (“Guidance”) “to help advance the industry’s voluntary compliance efforts in preventing fraud, waste, and abuse in the health care system.” Although the Guidance is nonbinding, it reflects the OIG’s expectation that compliance programs become increasingly sophisticated in their approach to identifying and managing compliance risks as healthcare delivery and payment models continue to evolve.

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.