Earlier this week, we highlighted a story published on Leafly regarding lobbying efforts by GW Pharma (NASDAQ: GWPH). Leafly’s Bruce Barcott discovered that GW Pharma and its U.S. subsidiary, Greenwich BioSciences, had engaged lobbyists in several states and were also supporting legislation that would require any potential medical cannabis suppliers in Nebraska and South Dakota to have their products approved by the FDA. Many are concerned that the state-legal cannabis programs are at risk of FDA regulatory oversight, which would risk patient access to products at an affordable price.
We reached out to the company to get a better understanding of its intentions, and Steven Schultz, Director of Investor Relations provided us with a statement in response to the Leafly story, which it believes contained “significant factual errors”:
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.
The company’s position, then, is that its lobbying efforts are necessary in some states because they require rescheduling that goes beyond the DEA. We also spoke with Mr. Schultz, who said that the company supports the legislation in any state that would allow patients to have access to Epidiolex which would not be the case at present.
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