Tag Archives: US

Epidiolex-GW

Epidiolex Gives GW Pharmaceuticals Boost In Global Markets

By Marguerite Arnold
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Epidiolex-GW

GW Pharmaceuticals scored a significant victory in the United States with its cannabis-based epilepsy drug Epidiolex in mid-April. The company received approval from a U.S. Food and Drug Administration (FDA) panel for its use in treating two forms of drug-resistant epilepsy.

The drug was granted “orphan drug” status in the EU a year ago.Will this be enough to move the conversation forward about cannabis as medicine in the United States? 

So what does the future hold for this drug and a company, which has visited this space before? Remember Sativex?. The Company now faces real competition from a raft of companies moving into this space from just about everywhere – both from Canada and of course Europe itself.

The FDA Might be on the Verge of Approving its First Cannabis-Based Drug

It is not like this is either the FDA’s or GW Pharma’s first discussion about the medical efficacy of cannabinoids. Sativex, a mouth spray containing THC, was never granted approval in the United States for the treatment of MS – although it received such approvals in Europe.

Epidiolex-GWIf the FDA approves Epidiolex (made from CBD), it will be the first cannabinoid-based drug approved in the United States by the federal agency.

Will this be enough to move the conversation forward about cannabis as medicine in the United States? What will happen in the EU?

A Divergent and Highly Different Drug Market

Will the FDA finally approve at least one form of a CBD-based drug? The chances are that Epidiolex might finally move the agency to approve. However,this is not, despite the hype that the company has made in the press about this, the first cannabinoid-based drug to be approved in the United States. It might be, however, the first drug based on actual natural cannabinoids rather than synthetic ones that it approves for some purpose. Both Cesamet and Dronabinol (or Marinol) are synthetic cannabinoid drugs approved for several conditions from chronic pain caused by chemo to Parkinson’s.

GW logo-2But those who are hoping that this drug approval might open the floodgates at the FDA for startersshould take a pew. While Sativex was not approved in the United States, it was made available after 2011 for MS patients, particularly in Germany, which has the highest rate of MS of any European country. The problem? It was just too expensive for most people to afford – since their insurance would not cover it. And doctors were even more resistant to prescribing than they are now. So even getting a prescription was almost impossible.

That conversation was different in Europe post-2013, and there were people who managed to get a doctor to write a prescription not to mention afford the eye-watering prices sans insurance coverage.

That said, given the choice between whole plant meds, most people still prefer bud cannabis to the spray variety. And in Europe right now, that is what is on the table.

What Will This Mean in the US vs Europe?

In the US, the first thing that FDA approval will mean is drug sales for only one branded drug. That is the cynicism at play here. Furthermore, it also neatly dodges the THC issue.

In Europe? Particularly Germany? This development is not likely to make much of a dent. GW is competing with every single Canadian producer with flower-based oil – and on both the medical and non-medical CBD front. That also now includes local producers. Further, this is a market which prizes genericized drugs over name brands. In France, the distribution of Sativex was held up, primarily because of the row over cost. And who would pay.

It is also unlikely that the FDA approval in the United States will change the discussion either in the US on a federal level – or in Europe.

The most important place this news already made a dent? GW Pharma’s stock price – at least temporarily. It is also a spot of good news the company really needs. In February, the company’s GWP42006 drug designed for focal seizures (drug resistant epilepsy) failed to outperform placebo results and wiped 5% off the company’s stock.

Ex-Im Europe: The Face of the Current Cannabis Market

By Marguerite Arnold
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In the United States, the idea of transporting cannabidiol (CBD), let alone medical cannabis across state lines is still verboten. As a result, a patchwork of very different state industries has sprung up across the map, with different regulatory mandates everywhere. While it is very clear that California will set the tone for the rest of the United States in the future, that is not a simple conversation. Even in-state and in the present.

In the meantime, of course, federal reform has yet to come. And everywhere else, there is a very different environment developing.

In Canada, “territorial” reform does mean there will be different quality or other regulatory guidelines depending on where you are. The main difference between the territories appears to be at point of retail – at least for now. Notably, recreational dispensaries in the East will be controlled by the government in an ABC package store model. That will not be the case across all provinces however. Look for legal challenges as the rec market gets underway.

EU flagIn Europe, the conversation is already different – and based on the realities of geopolitics. Europe is a conglomeration of federally governed nation-states rather than more locally administered territories, supposedly under federal leadership and control (as in the US). That said, there is common EU law that also governs forward reform everywhere now, just as it hindered national drug reform until a few years ago on the cannabis front.

However, now, because European countries are also moving towards reform but doing so in very different ways in an environment with open borders, the market here is developing into one of the most potentially fertile (and experienced) ex-im markets for the cannabis plant anywhere. On both the consumer and medical fronts, even though these labels mean different things here than they do elsewhere.

The Drivers

Medical reform in Europe basically opens the conversation to a regulated transfer of both non and fully loaded narcotic product across sovereign national borders. This is already happening even between nation-states where medical (read THC infused) cannabis is not federally legal yet, but it is has been accepted (even as a highly restricted drug). This means that Europe has already begun to see transfer of both consumer and medical product between states. In the former case, this is also regulated under food and cosmetic safety laws.

Cannabis in this environment is “just another drug.”While a lot of this so far has been via the strategic rollout of the big Canadian LPs as they attempt to carve up European cannabis territory dominance and distribution like a game of Risk, it is not limited to the same.

Pharmaceutical distributors across Europe are hip to the fact, now, that the continent’s largest drug market (Germany) has changed the law to cover cannabis under insurance and track its issuance by legal prescription. So is everyone in the non-medical CBD game.

As a result, even mainstream distributors are flocking to the game in a big way. Cannabis in this environment is “just another drug.” If not, even more significantly, a consumer product.

Game Time

The race for Europe is on. And further, in a way that is not being seen anywhere else in the world right now. And not just in pharmacies. When Ritter Sport begins to add cannabis to its famous chocolate (even if for now “just” CBD) for this year’s 4/20 auf Deutschland, you know there is something fundamental and mainstream going on. Lidl – a German discount grocery chain that stretches across Europe, has just introduced CBD-based cannabis edibles – in Switzerland.

As a result of this swift maturation, it is also creating from the beginning a highly professional industry that is essentially just adding cannabis to a list of pharmaceutical products already on a list. Or even just other grocery (or cosmetic) items.

spektrum logo
Spektrum, Alcaliber and Canopy are part of some of the larger deals in Europe

In general, and even including CBD, these are also products that are produced somewhere in Europe. As of this year, however, that will include more THC from Portugal, Spain and most certainly Eastern Europe. It will also mean hemp producers from across the continent suddenly have a new market. In many different countries.

This means that the industry itself is far more sophisticated and indeed used to the language and procedures of not only big Euro pharma, but also mainstreamed distribution (straight to pharmacy and even supermarket chains).

It also means, however, understanding the shifting regulations. In general, the focus on ex-im across Europe is also beginning to standardize an industry that has been left out of the global game, on purpose, for the last 100 years. Medical cannabis, grown in Spain under the aegis of Alcaliber (a major existing opioid producer) can enter Germany thanks to the existing partnership with Spektrum and Canopy, who have a medical import license and source cannabis from several parts of Europe at this point. It also means that regular hemp producers, if they can establish the right brand and entry points, have a new opportunity that exists far outside of Switzerland, to create cross-European presence.

And all of this industry regulation is also setting a timeline, if not deadline, on other kinds of reform not seen elsewhere, anywhere, yet.

Jeff Sessions and Eric Holder

Jeff Sessions Rescinds Cole Memo

By Aaron G. Biros
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Jeff Sessions and Eric Holder

According to The Associated Press, U.S. Attorney General Jeff Sessions rescinded the Cole Memo today, an Obama-era policy barring Department of Justice officials from going after state-legal cannabis businesses. This move comes just after California, the nation’s most populous state, legalized adult use sales of cannabis. Previously, the Cole Memo has served as a kind of stopgap for states to conduct legal cannabis markets, giving them peace of mind that the federal government wouldn’t interfere.

Sen. Jeff Sessions (R-AL)
Photo: Gage Skidmore, Flickr

Ushering in 2018 with a bang, California’s cannabis businesses finally celebrated their new market launch on New Year’s Day. Even CNN rang in the New Year with copious amounts of cannabis, sending journalist Randi Kaye to Denver where she was passed joints and even donned a gas mask bong.

One fifth of the entire United States population now live in states where adult use cannabis sales are legal. A majority of states in the country have some form of cannabis legalization law on the books.

According to The Associated Press, AG Sessions’ new policy will leave it up to federal prosecutors to determine how they wish to enforce federal law and the controlled substances act. Sessions has been historically conflicted with federal policy surrounding legal cannabis and has repeatedly expressed his disdain for the drug.

But his back and forth on policy directives has been largely symbolic until now. In January last year, Sessions said he would uphold federal law but expressed openness to ending the conflict between state and federal laws. In February of last year, he tied legal cannabis to violence in a press conference where he alluded to greater enforcement. But flip-flopping again in March of last year, he said the Cole Memo is valid and appropriate after a speech.

Sen. Cory Gardner (R-CO)
Image: Gage Skidmore, Flickr

The Trump Administration’s confusing and often-unclear stance on cannabis has only fueled more speculation, worries and fear that cannabis businesses are no longer safe from federal prosecution.

The cannabis industry and politicians around the country were quick to respond to the AG’s new policy shift. Sen. Cory Gardner (R-CO) said he would be holding up DoJ nominees, “until the Attorney General lives up to the commitment he made to me prior to his confirmation.” The Cannabis Control Commission of Massachusetts, the regulatory body tasked with overseeing the state’s legal cannabis industry, says “nothing has changed” and that it will continue their work to legalize and regulate the cannabis industry.

Steve Schain, Esq. practicing at the Hoban law Group

Steve Schain, Esq., an attorney with Hoban Law Group, a prominent cannabis law firm, says this only fuels the confusion. “With Jeff Sessions threatening to singlehandedly crush $7.2 billion legalized marijuana industry spanning 30 states, generating millions in taxes and providing tens of thousands of jobs, much confusion abounds,” says Schain. “While unclear if merely a ‘knee jerk reaction’ to California program’s launch breadth of coverage, unless and until the United States Department of Justice provides an official statement, publication, or other specific information, neither legalized marijuana’s current status – nor the Federal Government lack of Congressional mandate or funds to derail state programs – has changed.”

Omar Figueroa, a well-known California cannabis attorney, urges clients and friends to start getting informed. “Which district is your ‘commercial cannabis activity’ operation(s) located? Who is the US Attorney for that district? What is that US Attorney’s cannabis policy? The answers to these questions just became extremely important. Please contact us for legal advice and representation.”

Advocates and activists were also very quick to condemn Sessions’ move, including Matthew Schweich, interim executive director for the Marijuana Policy Project (MPP). “This extremely misguided action will enable a federal crackdown on states’ rights with regard to marijuana policy,” says Schweich. “Attorney General Sessions has decided to use the power of the federal government to attack the ability of states to decide their own laws. A majority of Americans support legalization, and Sessions has simply decided to ignore their views. In the states where marijuana is legal, voters approved those legalization policies at the ballot box. This is a direct attack on the will of the people.”

National Cannabis Industry Association (NCIA) Executive Director Aaron Smith gave the following statement in a press release:

“This news from the Department of Justice is disturbing, especially in light of the fact that 73% of voters oppose federal interference with state cannabis laws. But, the rescinding of this memo does not necessarily mean that any major change in enforcement policy is on the horizon. This has been, and still will be, a matter of prosecutorial discretion. We therefore hope that Department of Justice officials, including U.S. Attorneys, will continue to uphold President Trump’s campaign promise to not interfere with state cannabis programs, which have been overwhelmingly successful in undercutting the criminal market.

In addition to safely regulating the production and sale of cannabis, state-based cannabis programs have created tens of thousands of jobs and generated more than a billion dollars in state and local tax revenue to date. Any significant change in federal enforcement policy will result in higher unemployment and will take funds away from education and other beneficial programs. Those revenues will instead go back to drug cartels and other criminal actors.”

Could this move be a genuine policy shift that will cause a crackdown on the legal cannabis industry? One action that could prevent the DoJ’s ability to target cannabis businesses relies on a Senate vote passing the Leahy Amendment as part of the Omnibus Appropriations Bill. That amendment would prevent the DoJ from using resources to go after state-legal medical cannabis laws, but does not exactly protect companies operating under adult use and recreational laws.

Is it possible that this is just the Trump Administration moving public eyes away from the bombshell revelations in Michael Wolff’s book and Trump’s feud with Steve Bannon? The current administration has a history of creating headlines amidst unrelated controversy, deflecting a public relations crisis from the public eye.

Marguerite Arnold

The Great Cannabis Branding Conundrum in Europe

By Marguerite Arnold
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Marguerite Arnold

Cannabranding is buzzy. In the United States and in Canada, it is a vertical that is developing fast along with the multi-billion dollar legitimizing cannabis market. In both the United States and Canada, digital marketing to promote brands is a hot topic.

Social media has firmly rolled over traditional advertising barriers even as it still remains a landmine. And if there were ever a “fun” brand to be associated with, cannabis carries a lot of plusses. Starting with the rapidly fading stigma. According to Adweek, there were 170 advertising and marketing agencies picking up national cannabis business in the United States, with additional firms serving smaller firms or markets at the beginning of the year.

Yet battles that should be dated with the year 2017 in the mirror, are still raging and underway even in these jurisdictions. No matter what or where, advertising remains complicated. Beyond the American hemisphere, the issue of branding is a still-slumbering giant that may yet awake in the second part of the next decade. For the most part, that will have to await the advent of recreational use, at least within Europe.Are there successful brands already established in the world of cannabis? Of course.

How brands enter the market in the EU in fact, based on their social media and internet influence elsewhere, is very much a part of that discussion. So far in Europe, there has been no federal recreational reform. Medical use is still in front of legislatures. As a result, that means that more traditional social media efforts in particular, are verboten when launched in country.

With foreign firms now entering the EU market, the big question is, can such firms establish a brand presence here (or for any of their products?) Or will that too, be launched from abroad?

And how exactly will that fare in Europe, particularly in places like Germany, where the overwhelming pressure is on to treat cannabis just like another narcotic? And in particular, a generic drug.

A Brief History of Advertising in Cannabis

Hard as it is to believe, just four years ago, there was no legal, functioning recreational market anywhere. Weedmaps and Leafly were the only game in town when it came to advertising, along with growing free press coverage, in particular for small companies who were starting to establish market presence in the legalizing cannabis business. In fact Weedmaps and Leafly can be effectively credited, certainly in the United States, with putting cannabis advertising, along with dispensaries and prescribing doctors, on the map.

The impact of a California media industry on this issue, especially with state recreational legalization imminent, cannot be underestimated. However, these days, it is not the only game in town.

Fast forward to 2017, and the world of cannabranding has exploded, no surprise, in the world of social media. “Bud porn” proliferates on Instagram. In fact, an Instagram account, along with YouTube videos, Facebook posts and Twitter pictures are derigeur for pot companies these days as much as they are for anyone else. Free media is still a force.

However even here, the rules and enforcement of the same, at least in the United States, are still shadowed with uncertainty. Federal Schedule I status means that technically, even the big social media giants are in the same boat as traditional advertising mediums (like print or even internet-based media). Section 843 of the Controlled Substances Act specifically prohibits “communications facilities” from advertising Schedule I drugs. However the internet has never really been brought under FCC guidelines – and on many fronts. See “bud porn”, as the first example. Cannabis “advertising” such as it has clearly developed, is absolutely another one.

And into this gap have poured cannabis-branding initiatives galore. One of the most corporately ambitious so far? Netflix, with not only pot-branded entertainment, but its own brands of cannabis. It is far from the only one. Google Adwords also changed its policies with regard to medical advertising this year. The advent of a recreational market in California will absolutely drive this issue globally. But beyond California state borders, how will more local laws be enforced? And by whom? Is anyone at the FCC or Jeff Sessions’ Justice Department considering the national impact of any cannabis branding launched in California, for example? And where would they start? Would corporate advertising that is present at national conferences be targeted too? Along with the growing cannabisHow will such firms establish branding in a world so totally off-limits to “brand” advertising? conference economy itself which is already multi-state? The situation is already slippery. Abroad, could or would BfArM, the German federal agency overseeing the regulation of narcotic drugs (including cannabis), bring suit against Facebook for distributing California-sourced advertising for an Australian firm now doing business in Europe?

Clearly, there are landmines everywhere one looks. And not just for the big guys. The path is still littered with issues and problems for smaller, U.S.-based initiatives. Accounts can be blocked arbitrarily on social media and have been, such as on Facebook. In sum, however, it is also very clear that the preponderance of a tide is shifting. The industry as well as internet-based branding, is winning.

Especially as recreational reform blooms in Canada and California.

Advertising, in a digital world, has no borders. And cannabis branding is about to test exactly how accurate that mantra is. Or at least how much the location of one’s server counts. And it may be that because of this issue, the entire enchilada is about to jump the shark, if not a few international borders.

The Awakening Canadian Giant

North of the American border, the great Canadian recreational cannabis experiment is more than just in the offing. The train is puffing with steam at the station. The impact of a federally legal, recreational market that Canada will become as of next summer, cannot be underestimated from the advertising and branding front.

First, it means that Canadian companies will be able to advertise and promote their brands to at least a domestic audience. Granted, they will undoubtedly face the same issues as liquor companies in some ways. But promoting specific brands and labels has already hit the Canadian social media universe. See the efforts of all the major pot-producing companies with domestic server and corporate presence.

In turn, this has further opened another question. If digital and social media has no boundaries, what does that mean for the rest of the world? Particularly those countries now also watching the larger Canadian corporates establish both growing and distribution presence within their borders, and with strict advertising bans on cannabis domestically. That includes bans on advertising marijuana as medicine.

The Most Compelling Cannabis Brand Remains Legalization

Are there successful brands already established in the world of cannabis? Of course. Think only of the many celebrity-backed brands (even for medical) that you have probably heard of in the last few years. There are likely to be more.

However the reality is that in many jurisdictions, starting with Germany, such branding theoretically at least, stops at the border. The many firms who are establishing presence here on the distribution and potentially cultivation side, do nothing more than promote their company names at industry events.

How will such firms establish branding in a world so totally off-limits to “brand” advertising?

For now, one of those answers is to establish a presence as a serious pharmaceutical company. Another of course, is to become more vocal over the need for further reform and patient access. So far, that issue has remained one mostly vocalized by reform groups on the ground. That could change, particularly with further delays in implementing medical programs in Europe. Celebrity-backed appearances in media on this issue go far.

And for the meantime? Branding specialists will have to hope that advertising campaigns developed off-shore begin to meet targeted European patient groups.

Even if the first message is the concept of cannabis as legitimate medicine.

FDAlogo

FDA Issues Warning To CBD Companies

By Aaron G. Biros
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FDAlogo

On November 1st, the U.S. Food and Drug Administration (FDA) published a press release addressing warning letters issued to four companies. The warning letters, sent to companies marketing cannabidiol (CBD) products with therapeutic claims, cites unsubstantiated claims about their products’ ability to treat or cure cancer and other diseases.

A snippet of the warning letter issued to Greenroads

According to the press release, the four companies that received warning letters are Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC. The press release called their marketing campaigns “deceptive” for “unproven treatments.” Here is the letter they sent to Greenroads Health.

“As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes,” reads the FDA statement. “Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective.”

According to the press release, the FDA has issued ninety warning letters in the past ten years, with around twelve this year, to companies making fraudulent claims about cancer therapies. Here are some examples of claims made by companies that the FDA took issue with:

  • “Combats tumor and cancer cells;”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells;”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” says FDA Commissioner Scott Gottlieb, M.D. “We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products. There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

 

Jeff Sessions and Eric Holder

AG Sessions: Cole Memo is Valid, But Skeptical of Medical Cannabis

By Aaron G. Biros
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Jeff Sessions and Eric Holder

Answering questions following a speech in Richmond, Virginia, Attorney General Jeff Sessions told reporters he thinks the Cole Memo is a valid way to deal with state cannabis laws and said medical cannabis is “hyped, maybe too much.” According to a MassRoots blog post by Tom Angell, Sessions spoke yesterday regarding cannabis, addressing it as he tip-toed around his previous statements, like calling cannabis use unhealthy or the infamous “Good people don’t smoke marijuana” line.

This time around, Sessions’ words on legal cannabis were more carefully chosen. “The Cole Memorandum set up some policies under President Obama’s Department of Justice about how cases should be selected in those states and what would be appropriate for federal prosecution, much of which I think is valid,” Sessions told reporters. The Cole Memo essentially set up a framework for states with legal cannabis laws to avoid federal enforcement of the Controlled Substances Act.

AG Jeff Sessions (left), next to Eric Holder (right), who was the US Attorney General from 2009 to 2015 under Obama and when the Cole Memo was issued. Image: Ryan J. Reilly, Flickr

These comments do fall in line with some of his previous statements, like suggesting he wants to uphold federal law. During the speech in Richmond, Sessions denied any possibility that cannabis could be a solution to the opioid crisis. “I reject the idea that America will be a better place if marijuana is sold in every corner store,” says Sessions. “And I am astonished to hear people suggest that we can solve our heroin crisis by legalizing marijuana – so people can trade one life-wrecking dependency for another that’s only slightly less awful.” These statements echo much of what White House press secretary Sean Spicer said weeks ago, citing the opioid crisis as possibly linked to recreational cannabis consumption.

Sessions admitted to reporters that he acknowledges the benefits of medical cannabis, but says he is still skeptical of the idea, saying it has been overhyped. “It’s possible that some dosages can be constructed in a way that might be beneficial,” says Sessions. “But if you ever just smoke marijuana, for example, where you have no idea how much THC you’re getting it’s probably not a good way to administer a medicinal amount- so, forgive me if I’m a bit dubious about that.” Sessions pontificating the medical efficacy of delivery methods for cannabinoids could suggest he is trying to familiarize himself more with the science behind medical cannabis.

According to a Politico article, Sessions privately told senators that he would respect states’ rights on the issue and uphold Obama-era policies, perhaps referring to the Cole Memo. While Sessions’ most recent remarks could signal a less aggressive approach toward legal cannabis, he still makes his position clear as a Drug War stalwart. “Our nation needs to say clearly once again that using drugs will destroy your life,” Says Sessions.