We at Budding Trends have been optimistic, and then cautiously optimistic, that the legalization of psychedelics was close. This month, however, the U.S. Food and Drug Administration dealt a blow to our predictions. FDA decided not to approve Lykos Therapeutics, Inc.’s MDMA-assisted PTSD therapy at this time. Instead, FDA asked Lykos to further
Hillary Campbell
Hillary Campbell is an experienced litigator handling business and commercial litigation, as well as general litigation matters. A significant portion of Hillary’s practice is devoted to representing manufacturers in products liability litigation where she has represented manufacturers of products ranging from tires to medical devices to consumer products. Her business litigation practice is just as varied and has involved representing businesses and individuals in cases involving allegations of fraud and civil conspiracy, as well as in business tort and contract dispute matters.
MDMA DOA at FDA Advisory Committee
Avid readers know we have speculated that the legalization of psychedelics as a prescription medicine was “closer than ever.” Unfortunately, for proponents of the legalization of psychedelics like MDMA, progress is rarely a straight line.
As we previously reported, Lykos Therapeutics Inc. sponsored a new drug application for MDMA therapy. That application…
FTC Moves to Strike Most Noncompetes: Considerations for Cannabis Companies
As Bradley previously reported, the Federal Trade Commission at the beginning of last year issued a notice of proposed rulemaking to effectively ban employee noncompete provisions as an unfair method of competition in violation of Section 5 of the FTC Act. Following a 16-month administrative process that drew more than 26,000 public comments, the…
Legalizing LSD? FDA Says Mm-hmm to MM120
If you know either of us, you know neither of us would pass up a chance to say, “I told you so.” As we looked ahead to 2024 in January, we speculated that psychedelics could be legalized as a prescription medicine. Now, not even a quarter into 2024, proponents of the psychedelic industry should…
2023: A Good Trip Around the Sun for Psychedelics
2023 was a momentous year for psychedelics, and it’s not just because we at Budding Trends started writing about them. There were wins for the psychedelic industry at the local, state, and federal levels, as well as in the private sector, particularly for proponents of their potential medicinal and therapeutic uses.
The Food and…
Defending Psychedelics: Congress Includes Psychedelic Provisions in Defense Authorization Act
We told you it may be coming, though we were admittedly cynical about the ability to pass a bill funding psychedelic research given the current political landscape — a narrowly controlled Democratic Senate that is generally considered more conservative than the House and on the eve of an election year. But, it happened.
Big Brother Cancels Trip, Court Says Not So Fast My Friend
A few weeks ago, the Ninth Circuit Court of Appeals in Aggarwal v. U.S. DEA directed the U.S. Drug Enforcement Agency (DEA) to reconsider its decision not to transfer psilocybin from Schedule I to Schedule II.
Since at least 2021, Dr. Sunil Aggarwal has been working to legally obtain psilocybin for terminally ill cancer patients…
Hawaii and California, Seeking to Shed Their Dreary Public Images, Liberalize Psychedelics
As we’ve discussed, the federal government seems to be getting on board with the legal use of psychedelics. So are many states. While states across the country are moving towards expanding legal (or at least decriminalized) access to psychedelics, we doubt it will come as any surprise to those experienced in the cannabis industry that…
The Great Divide: The Feds’ Differing Approach to Psychedelics and Cannabis
Just as we did, the Food and Drug Administration has recognized the growing enthusiasm for exploring opportunities to use psychedelic medications to treat mental health disorders. In June, FDA issued for the first time draft guidance providing considerations for those developing psychedelic drugs for the treatment of medical conditions. The guidance explicitly focuses on “classic…
The Secret to Success: Protecting Your Cannabis Trade Secrets
You’ve spent the time and money to perfect your grow process and develop the genetically perfect plant. Or maybe, you’ve developed a new method of creating a cannabis extract or a fantastic customer list or whatever it is that gives you a competitive advantage.
The Budding Trends bard opened last night at Madison Square Garden…