British drug manufacturer GW Pharma and its American subsidiary, Greenwich BioSciences, have responded to Leafly’s report last week about the company’s attempts to move proprietary cannabidiol (CBD) bills through at least two state legislatures.
That report noted that the company’s lobbyists were moving in anticipation of the FDA’s expected approval of Epidiolex, a CBD-based drug that’s currently in Phase III trials. GW/Greenwich is pushing bills through legislatures in South Dakota and Nebraska, where all forms of cannabis medicine remain illegal. The bills would specifically make only FDA-approved forms of CBD legal under state law.
As Leafly reported, the effect of such a law would be to give GW/Greenwich a virtual monopoly on legal CBD sales—at least temporarily. The original story also noted that the company has recently hired local political lobbyists in at least nine states.
Steven Schultz, director of investor relations for GW/Greenwich, issued a response to the story to Alan Brochstein at New Cannabis Ventures. Schultz said he believed the story contained “significant factual errors,” although he did not offer evidence of error.
Here is the company’s statement to Brochstein in full:
GW expects to submit a NDA for Epidiolex in mid-2017 and wishes to ensure that, subject to FDA approval, Epidiolex can be made available to patients in as timely a manner as possible. One of the necessary steps to achieve this goal includes being proactive at the state level so that, once Epidiolex is approved by FDA and rescheduled by DEA, patients will be able to have access to the product in their states. This two-step process, both the DEA and local state rescheduling, is required to achieve full rescheduling and make our medicine available to appropriate patients with a doctor’s prescription.
It is important to stress that none of GW’s work involves opposing “medical marijuana” or “CBD access.” GW’s sole focus is on creating a pathway for our medicine, once approved by FDA. State and federal rescheduling of an FDA-approved product comprised of CBD will have no impact on existing (or future) state laws that allow the medical use of marijuana or of non-FDA approved CBD products.
Greenwich Biosciences/GW is not creating a monopoly. Rather, we are blazing a trail for any other CBD prescription medications that may follow since these regulations would not be specific to GW. In fact, it is likely new companies may be encouraged to enter the field of cannabinoid research, leading to a greater number of cannabinoid treatment options for patients, not fewer.
Unfortunately, the Leafly article does not mention the fact that GW is currently providing Epidiolex without cost to over 1,200 patients through compassionate use programs. GW’s goal is to provide an additional CBD option that meets the definition of, and has the hallmarks of, a modern medicine.
In a separate response to Leafly this afternoon, Schultz wrote that “it is not generally understood that rescheduling involves state rescheduling along with DEA rescheduling to enable FDA approved medicines that are Schedule 1 to be made available to patients.” Schultz added that GW/Greenwich remains “focused on this task, and understand what it takes at the state level–hence the local representatives.”
It may not be GW/Greenwich’s intention to create a monopoly on CBD products. Our original story noted that the proposed legislation “would effectively give GW/Greenwich a temporary monopoly on legal CBD products in South Dakota and Nebraska.” We stand by that statement. The company’s proprietary drug, Epidiolex, is the only CBD-based pharmaceutical nearing FDA approval. Hundreds of CBD oil manufacturers exist in medical marijuana states around the country, but the proposed legislation would make Epidiolex the one and only CBD drug legally available to epilepsy patients in states affected by the proposed bills, at least until another CBD-based drug receives FDA approval.
Whether intended or not, that is effectively a temporary monopoly.
The company has recently hired local political lobbyists in at least 22 states.
It’s true that GW/Greenwich has not publicly opposed the spread of medical cannabis legalization laws. Neither has it worked with local medical marijuana advocates, who have struggled for years to gain legal access to medical cannabis. Some of those advocates now worry that the GW/Greenwich legislation may undermine their own legalization efforts while limiting patients to a single CBD source.
National cannabis advocacy groups are somewhat divided on the issue. Beth Collins, director of government relations for Americans for Safe Access, told Leafly that her group is “not opposed to these bills as long as they don’t derail other efforts for full-plant legislation.” Collins noted that “there have been many instances where those with intractable epilepsy and other conditions have not responded well to Epidiolex, but have done very well on natural, less purified CBD extracts, such as Haleigh’s Hope or Charlotte’s Web.”
Those same concerns have led local leaders of Students for Sensible Drug Policy to oppose the bill in Nebraska. NORML Deputy Director Paul Armentano told Leafly on Wednesday that his group is discouraging support of the South Dakota bill. The clause that legalizes only FDA-approved forms of CBD, Armentano said, “essentially guts the bill.”
GW’s donation of Epidiolex to more than 1,200 patients is a truly commendable gesture. At the same time, it has no bearing on the company’s political push in American statehouses.
In our report last week, Leafly reported that GW/Greenwich had retained the services of political lobbyists in nine states. That portion of the story was, in fact, incorrect. Upon review of more recently filed state lobbying disclosure documents, we found that the company actually has contracted with lobbyists in at least 22 states for the 2017 legislative season.