FDA to Consider Approval of Botanical (not synthetic) CBD Drug

Authored by Robert Prince, Ph.D, https://www.duanemorris.com/attorneys/robertwprince.html

On Thursday April 18, 2018, at 8:00AM-12:30PM EST, an FDA advisory panel will consider whether to recommend or not recommend approval of GW Pharmaceutical’s cannabis-based drug Epidiolex ® for use in treating two rare types of epilepsy in children- Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex is an oral formulation of a purified form of cannabidiol (CBD) a component found in cannabis. CBD does not have any psychoactive effects as compared to another component of cannabis tetrahydocannabinol (THC). Epidiolex has less than 0.1 percent of THC.

If approved, Epidiolex would be the first botanical cannabis product approved in the U.S. for any indication. The FDA has approved Marinol® and Syndros® for uses in the U.S. for the treatment of anorexia associated with weight loss in AIDS patients. Both products contain dronabinol, a synthetic delta-9-tetrahydrocannabinol. Another FDA approved drug Cesamet® contains nabilone, which is a synthetic drug with a structure similar to THC that is used to treat nausea and vomiting.

The FDA released briefing documents on April 17, 2018, which did not seem to raise any major issues with Epidiolex, resulting in the share price of GW Pharmaceuticals to rise sharply- up 2.27%. The Center for Drug for Drug Evaluation and Research (CDER) indicates that it plans to provide a free of charge, live webcast of the April 19, 2018 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. Information regarding the webcast, including the web address for the webcast, will be made available at the following website: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. At the time of writing this note, the FDA has not provided any login information for the webcast.

IP Protection and the Cannabis Industry: Strategies and Trends

Protection of intellectual property is a key element in any company’s efforts to secure a competitive advantage. For companies in the cannabis space, efforts to secure intellectual property protection play out against a background of conflicting federal and state regulations. Cannabis continues to be a Schedule I drug under the Controlled Substances Act, and possession of cannabis is prohibited by federal law. However, 29 U.S. states and the District of Columbia have legalized medical cannabis, and eight U.S. states have legalized recreational cannabis. This article will address various IP strategies, including trademarks and branding, patents and trade secrets, for protection of cannabis and cannabis-related products and services. The article will also discuss trends in the industry as well as contrasting protections available on the state and federal levels.

To read the full text of this article by Duane Morris attorneys Gretchen Temeles, Christiane Campbell and Vicki Norton, please visit the Duane Morris website.

Access to Medicinal Marijuana in New Jersey Improves

In response to Executive Order No. 6, issued by New Jersey Governor Phil Murphy, the New Jersey Department of Health (the “Department”) reviewed certain elements of New Jersey’s Compassionate Use Medical Marijuana Act and the implementation of the Medical Marijuana Program (“MMP”) (Executive Order 6 Report). …

The Department’s analysis resulted in the recommendation and approval of an immediate expansion to the MMP. The first stage of the expansion includes the addition of five conditions to the existing list of diagnoses for which medicinal marijuana can be prescribed. Patients with chronic pain related to Musculoskeletal Disorders, Migraines, Anxiety, chronic pain of Visceral Origin, and Tourette’s Syndrome are now eligible to participate in the MMP.

Read the full story on the Duane Morris Health Law Blog.

 

Interview with Seth Goldberg: Is NJ About To Fire Up The East Coast Regulation Rush? And Hemp vs Cannabis

You may have read a piece by CLR on Duane Morris’ approach to the national cannabis market late last year.

They are running ahead of their competitors and continue to do so.

They are one of the few firms in the Am Law 200 to have taken up the challenge presented by this de-centralized and sometime rather chaotic corner of the American economy.

Seth Goldberg, based in Philadelphia, practices in business and litigation with a particular emphasis in highly regulated industries such as healthcare and Pharma, saw the opportunities in cannabis and hemp early on in the game and has developed a multidisciplinary cannabis practice drawing across a wealth of experience in the firm.

The practice now comprises 48 attorneys, of whom a good 30 or so are partners.

They are taking the sector seriously and here at CLR we’re surprised that more in the top echelons still aren’t doing the same. …

It’s a question we posed to Seth during our hour long conversation and he concurred that he was equally surprised at the lack of cannabis / hemp practice development at the larger firms on the eastern seaboard.

To read the full text of this article, please visit the Cannabis Law Report website.

Pennsylvania Medical Marijuana Program to Begin Phase II Permitting

Seth Goldberg
Seth A. Goldberg

On April 5, 2018, Phase 2 of the PA Department of Health’s permitting for commercial medical marijuana cultivation and dispensary operations will begin.

13 Grower/Processor permits will be available, two in each of the six DOH regions, and the 13th going to the highest scorer.  23 Dispensary permits will be available, nine in Region 1, three in Regions 2 and 3, two in Regions 4 and 6, and four in Region 5.  Applications will be available online at www.medicalmarijuana.pa.gov  on April 5, and the submission deadline will be May 17.

In June 2017, 12 Grower/Processor and 27 Dispensary permits were granted.    According to April Hutcheson of DOH:

  • 25,573 patients have registered to participate in the PA program;
  • 9,020 patient certifications have issued;
  • 7,000 of those patients have purchased their ID cards;
  • 6,683 patients have bought medical marijuana in a PA dispensary;
  • 866 physicians have been registered to participate in the program; and
  • 473 of the registered physicians have been approved.

Given the very real possibility that PA will approve the use of dry flower products, i.e., smoking and edibles, this summer, the PA market is positioned for strong performance over the next few years.

NJ Governor Murphy Projects Adult Use Cannabis Legalization by January 2019

In his first budget address, New Jersey Governor Phil Murphy today reaffirmed his commitment to promptly expand the state’s currently moribund medical marijuana program, and the full legalization of adult use marijuana by January 1, 2019.

In his address, Governor Murphy explained:

We must also make sure we are investing not just in individuals, but also in entire communities – particularly our long-overlooked urban neighborhoods. We must recommit to opening the doors to economic opportunity for the thousands of young men and women – especially young men and women of color – jailed for non-violent drug-related offenses. Our current system has failed them, and put a mark on them that they will carry for their entire lives, preventing them from furthering their educations or getting jobs.

It’s the principal reason I advocate for legalizing adult-use marijuana. According to research, New Jersey spends upwards of $140 million per year adjudicating low-level marijuana possession offenses. And, marijuana-related arrest rates are tilted three-to-one against African-Americans, even though rates of marijuana use are similar among races.

These resources must have a better use, whether to tackle the trafficking of illegal guns, provide stronger community policing, or to crack the back of our opioid epidemic, which was devastating our urban centers long before it made headlines.

I greatly respect those in this chamber who have proposed decriminalizing possession of small amounts of marijuana, and I thank them for recognizing the importance of doing what’s right and just for those who carry criminal records for past possession arrests. But decriminalization alone will not put the corner dealer out of business, it will not help us protect our kids, and it will not end the racial disparities we see.

If these are our goals – as they must be – then the only sensible option is the careful legalization, regulation, and taxation of marijuana sales to adults.

Legalization will allow us to reinvest directly in our communities – especially the urban neighborhoods hardest hit by the misguided War on Drugs – in their economic development, in health care and housing, child care and after-school programs, and other critical areas. These investments will pay dividends far greater than the cost of mass incarceration.

I did not come to this overnight, myself. After all, we are the parents of four children under the age of 21. But from the standpoint of social justice, and from the standpoint of protecting our kids and lifting up our communities, I could not arrive at any other conclusion.

In the Budget in Brief submitted to the Legislature today, the Administration stated that it “plans to legalize adult-use marijuana by January 1, 2019. The State will also move forward with expanding access to medical marijuana to alleviate patient suffering.”

The Budget projects $80 million in new revenue from legalizing marijuana, without specifying tax rates or the number of dispensaries the Governor anticipates.  This is part of $2 billion in new revenues to meet the $37.5 billion budget that also includes a millionaires tax ($765 million), restoring the sales tax rate to 7% ($581 million) and business tax modernization ($110 million).

Next on the Governor’s agenda: the anticipated release of substantially revised regulations governing New Jersey’s medical marijuana program that currently consists of only 6 vertically-integrated, nonprofit dispensaries serving less than 15,000 patients.  The Governor has promised rules by March 24 designed to increase the qualifying conditions for which marijuana may be prescribed and to increase patient access to medical marijuana.

Medical marijuana expansion can be largely accomplished by the Governor without legislation, though it is anticipated the  Legislature is expected to consider changes beyond the Governor’s regulatory authority, including clear authorization to dispense edible products to medical marijuana patients.

 

 

 

Sessions Draws Lines for US Attorneys in Terms of Marijuana Prosecution

Seth Goldberg
Seth A. Goldberg

In speaking at the Georgetown Law Center on March 10, 2018, AG Sessions said the following:  “We’re not going to be able, even if we desire, to take over state enforcement of routine cases that might occur.  Federal agents are highly paid, highly trained.  They work on cases involving cartels, international organizations, major distribution networks, large amounts of cash. They deal with criminal organizations, RICO type cases, and we’re not out there prosecuting those types of cases everyday.”

Although, in making the above comments, Sessions was clear that marijuana was still illegal in the U.S., he appears to have drawn a box around those types of marijuana-related criminal activities on which federal prosecutors are focused.  The above comments are not inconsistent with the Sessions memo of January 4, 2018, and may help clarify what prosecutorial discretion looks like under that memo.  Based on the above comments, it would seem that activities conducted pursuant to state marijuana programs are not the types of activities on which federal prosecutors are focused.

Cannabis Trading on Major U.S. Stock Exchange

Seth Goldberg
Seth A. Goldberg

Another breakthrough for the cannabis space occurred on Tuesday, February 27, 2018, when Toronto-based Cronos Group Inc. began trading on the Nasdaq Stock Market. (MJN:CN). This marks the first listing of a company focused purely on cannabis on a major U.S. stock exchange.  The listing of Cronos comes within two months of the memorandum issued by Attorney General Sessions that rescinded the federal government’s previous guidance regarding enforcement of state-lawful cannabis activities under the Cole Memorandum.  That earlier guidance is credited with providing the cannabis space with a window of opportunity for the warp-speed growth the space has seen in recent years.  The Sessions memo was intended to slow the growth of the cannabis space, especially with respect to the capital markets.  The Nasdaq listing of Cronos suggests that 2018 could be another strong year for cannabis-related investments; 2017 was believed to have resulted in approximately $2 billion in cannabis-related investments in the U.S.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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