White House is reviewing FDA guidance for clinical research on cannabis.
Way back in mid-2020, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research published a draft document called “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry.”
This guidance was published in the Federal Register after it went through review at the White House Office of Management and Budget. And up until Nov 2020, sixty comments came in from entities ranging from GW Pharmaceuticals, which made the only FDA-approved product derived directly from cannabis plants, Epidiolex, to the National Center for Natural Products Research (Ole Miss), which was until recently the only entity with federal approval to grow cannabis for research.
But then, as Trump handed off to Biden, nothing. Until now.
The final guidance is now, according to the OMB site, “pending review.”
Once that review is finished, the final guidance will be published to the Federal Register. It will likely cover the same scope as the draft guidance, which is to go over “FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds … that may be used in drug manufacturing include botanical raw materials, extracts, and highly purified substances of botanical origin.”
Charlotte’s Web gets acne patent.
This week, the United States Patent and Trademark Office awarded the CBD-focused company a patent for “Composition For The Treatment Of Acne.”
Is is “a composition for treating acne in a human in need thereof consisting essentially of therapeutically effective amounts of isolated cannabigerol, isolated cannabidiol, spruce resin, xanthan gum, salicyclic acid, ethyl linoleate and black cumin seed oil.”
The latest on the CAURD licensing lawsuit.
First, the context: As Cannabis Wire previously reported, a lawsuit challenging the CAURD application process (Variscite NY One, Inc. v State of New York; New York State Office of Cannabis Management; and Chris Alexander) has blocked the state from awarding these licenses in five regions: Finger Lakes, Central New York, Western New York, Mid-Hudson, and Brooklyn.
The United States District Court for the Northern District of New York granted Variscite a preliminary injunction, or, in other words, sided with them.
On Nov 22, the state pushed back. In a memorandum in support of a motion to modify the preliminary injunction, Amanda Kuryluk, an Assistant Attorney General in the New York State Attorney General’s office, argued that the scope of the preliminary injunction should be limited to the Finger Lakes region, Variscite’s first choice, and that the preliminary injunction should be “stayed pending appeal,” as the applicant did not score high enough for a license anyway. On Nov 30, the state added to its argument.
This week, Variscite responded. There is a lot to unpack in their response, but this is what Variscite had to say about the “stay pending appeal.”
“Defendants are not seeking a stay of the Preliminary Injunction, they are seeking a backdoor denial of the Motion for Preliminary Injunction that the Court already granted. If the Court stays the Preliminary Injunction, Defendants will issue all the available CAURD Licenses for the State. When the Circuit later affirms the Preliminary Injunction, Defendants will argue that it is too late as a matter of equity to recall the licenses. Thus, Plaintiff will not be able to obtain injunctive relief. Defendants have already argued that Plaintiff cannot obtain damages because of Eleventh Amendment immunity. Thus, Plaintiff will be left without a remedy if the Court stays the Preliminary Injunction and allows Defendants to issue the CAURD Licenses.”
