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Greenwich Biosciences has engaged the well connected California-based lobbyist Kurt Sternbridge, to handle the states of Arizona and Idaho, with implications that he may be the lobbyist in California as well. In Wisconsin, the company hired the lobbying firm, Martin Schreiber & Associates. In Florida, Douglas Russell, a former top official with the state’s health care industry was engaged and in Washington State, Stephen J. Buckner was hired. In Minnesota, the company retained Randy Morris.
Neither GW Pharma nor Greenwich Biosciences has made any announcement, nor is there any mention at the companies’ websites about the Nebraska and South Dakota bills, nor the hiring of the lobbyists.
It’s clear that GW’s lobbyists were instructed to act now, before the approval by the Food and Drug Administration (FDA) of the company’s drug, Epidiolex for Dravet Syndrome, a rare form of childhood epilepsy. Epidiolex is a plant-derived, CBD-based formulation that is currently completing Phase 3 trials under FDA protocols. FDA approval for Epidiolex could happen as early as this summer. Epidiolex is also undergoing FDA trials for Lennox-Gastaut syndrome.
The obvious question is why GW chose to take this approach when it has two other pathways available to monopolize the U.S. market for CBD formulations.
Upon the FDA approval of Epidiolex, with its active compound, CBD, it precludes the use of that compound for other “non-FDA approved” health or medical purposes. Then the FDA could issue cease and desist orders to anyone selling products containing CBD for health, wellness, or medical purposes. This FDA action could include companies selling products containing CBD in state-licensed marijuana businesses as well as companies selling the products in stores or online.
GW also has another arrow in its quiver and that arrow is that it holds a significant number of patents as well as a number of applied for patents. Once Epidiolex is approved by the FDA, and when there is a commercial reason to do so, GW could start threatening legal action against any company infringing on its patents or selling any product containing CBD.
GW’s strategy may be seen by its board and management as a brilliant move. It takes the pressure off of GW and lays the blame at the feet of the states that pass the legislation. It avoids the probable uproar and protests from current patients, families, and caregivers. Most importantly it gives GW a monopoly on the product.
It is probably that GW assumes that the hemp and CBD industries are so fragmented and disorganized that they will pose almost no threat to this legislation. The patient and caregiver population are of little concern because they are unlikely to be able to organize a grassroots campaign to take on a multi-billion dollar company.
The bottom line, if America’s hemp and CBD industries want to continue to exist, they must take GW’s shot across the bow seriously.