By Leslie P. Francis That’s correct: unless your prescription for misoprostol meets strict new conditions, possession of the drug is now illegal in Louisiana. In late May 2024, Louisiana governor Jeff Landry signed a bill making misoprostol and mifepristone schedule IV drugs, the most highly regulated controlled substances. Violating the law may result in jail…
By Barbara Pfeffer Billauer Legal pundits are predicting the imminent demise (or at least substantial enfeeblement) of the Chevron doctrine. Until recently, that case afforded substantial judicial deference to decisions made by administrative agencies if a statutory provision under its purview was ambiguous. Now two cases are before the Supreme Court challenging an agency interpretation…
by Victoria Litman, M.Div., J.D., LL.M. On May 21, 2024, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM) signed by Attorney General Merrick Garland in the Federal Register. This publication kicks off a 62-day comment period on a rule that would move marijuana to Schedule 3 of the Controlled Substances Act…
By Adithi Iyer In February, the news broke that the Food and Drug Administration (FDA) had approved a “first of its kind” new cancer therapy. Iovance’s AMTAGVITM, the subject of the approval, is a personalized immunotherapy for advanced melanoma. To be treated, adult patients who are ineligible for surgery or have metastatic disease provide their…
By Suzan Slijpen, Mauritz Kop & I. Glenn Cohen 1. Introduction: A Fragmented AI in Healthcare Regulatory Landscape In the past few years, we have witnessed a surge in artificial intelligence-related research and diagnostics in the medical field. It is possible that in some fields of medicine in the future AI tools used in diagnostics…
By Vincent Joralemon As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. For example, experts estimate MDMA-assisted therapy for PTSD will cost upwards of $12,000 per patient. These high costs highlight the need for comprehensive…
FDA rescheduling may provide a compelling model for efforts to decriminalize and destigmatize other substances moving forward.
Lykos’ current application is based on MDMA-assisted therapy, and FDA will almost surely require that patients take the drug in a clinical setting.
The telemedicine extension is not just for psychedelics; easing these restrictions means relaxing them for other controlled substances as well.
Not all lobbying campaigns are problematic — the goal should be for regulators to leverage industry insights while maintaining independence in decision-making.
