On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions.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 This is the first FDA draft guidance that discusses designing clinical trials for psychedelic drugs.Continue Reading Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs
As a former life sciences researcher, Kimberly utilizes her ability to understand and explain complex topics to advise clients as to regulatory and legal liability issues. With a focus on litigation and discovery, she manages the discovery program for complex product liability and toxic tort cases as national counsel.
Kimberly works with the firm’s innovative and award-winning Asbestos Litigation team in helping clients manage their risk profiles and in defending large national dockets. Businesses, academic and medical research centers, premises owners, contractors, and manufacturers are among those who rely on Kimberly’s broad range of litigation and regulatory experience. As national coordinating counsel, she coordinates the discovery for thousands of cases—drafting, responding to and preparing discovery and trial support documents for complex cases throughout the nation.
Kimberly has advised clients in matters of product liability, environmental matters, and legal matters regarding Schedule I controlled substances that involve laws such as the Controlled Substances Act, healthcare and research study regulations under the California Business & Professions Code, requirements relating to DEA licensing and registration of controlled substances, CERCLA/Superfund, RCRA, California Proposition 65, and other alleged solid and liquid hazardous waste violations in response to federal and state agency inspections.
Kimberly is the co-founder and co-lead of the firm’s Psychedelic and Emerging Therapies practice group. Kimberly’s background in biotech startups as a research scientist gives her a unique perspective in emerging areas of law such as psychedelic therapeutics. Psychedelics have garnered headline news as breakthrough medicines for the treatment of psychiatric conditions, including PTSD and major depression. Kimberly keeps current on the academic and commercial research and drug discovery efforts in this rapidly developing field so as to assist clients in navigating and complying with complex regulatory issues and protecting and commercializing intellectual property.
Knowledgeable and energetic, Kimberly is known for identifying key strategies in challenging cases, then easily communicating those ideas to clients and legal teams in order to move forward with the best solutions.
Prior to her admission into the state bar, Kimberly externed with the California Attorney General's Office.
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