What shows up once the story must survive the terms
At the outset of life sciences transactions, there is usually a strong sense of alignment. Founders and investors tend to agree on the importance of discipline, focus, capital efficiency, and long-term value. That was evident throughout JPM Healthcare Week and in conversations around RESI 2026, where many of the same themes surfaced across different rooms and discussions.
In my November 2025 blog post, I discussed the uncertainty surrounding the DEA’s then-pending telemedicine rule and its implications for ketamine clinics. At that time, the future of pandemic-era telehealth prescribing flexibilities was unclear, and clinics across the country were bracing for the possibility of a significant regulatory shift at the end of 2025.
The legal and regulatory landscape for ketamine clinics is shifting once again, as the Drug Enforcement Administration (DEA) prepares to release its “Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” While the full text of this rule is not yet public, its very existence signals that the DEA may continue the pandemic-era telehealth flexibilities that have proven vital for many clinics and patients. For owners and operators of ketamine clinics, understanding what’s at stake and how to prepare is more important than ever.
Audit preparedness is essential for every clinical research site. By operationalizing compliance in your daily procedures, you can effectively mitigate risk and ensure smooth inspections. Start by thoroughly educating key personnel on current regulations and any changes, and involve them in risk identification and mitigation strategies. Foster a culture of shared responsibility through ongoing training and open communication. Keep detailed documentation of the reasoning behind your procedures and policies, and store all standard operating procedures (SOPs) in a central, easily accessible location. Finally, implement a robust system for managing data and documents to ensure that all necessary information is readily available for internal and external monitors, as well as regulatory agencies.
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to market. CRAs, which govern the conduct of clinical trials, are essential for detailing which party will comply with the regulatory requirements while facilitating the commercialization of new drugs, devices, and digital health solutions.
In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning interpretations of ambiguous laws, as long as those interpretations were reasonable. This doctrine has been a cornerstone of administrative law, significantly impacting
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.
Last month, The Economist published a call to action titled, “There is a worrying amount of fraud in medical research: And a worrying unwillingness to do anything about it.”[1] The article is the latest in a sequence of alarms that some clinical researchers might not be as squeaky clean as we would hope them to be. Senior DOJ officials have in turn emphasized in public remarks that investigating clinical research shortcomings is now a Justice Department priority, with the whistleblower bar following suit.
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”).