In news that could have profound implications for the legality and availability of cannabidiol (CBD) products, Leafly News has learned that the British pharmaceutical company GW Pharma and its American subsidiary Greenwich BioSciences are quietly moving proprietary CBD bills through at least two U.S. state legislatures, and could have plans for similar bills in other states.
The proposed measures, both taken from the same template, would effectively give GW/Greenwich a temporary monopoly on legal CBD products in South Dakota and Nebraska.
The pharmaceutical company’s lobbyists are moving in anticipation of the FDA’s expected approval of Epidiolex, a CBD-based drug that’s currently in Phase III clinical trials. Epidiolex has been developed by GW/Greenwich for the treatment of several rare childhood-onset epilepsy disorders. The company has been developing the drug for years, and FDA approval could come as early as this summer.
In a possibly related development, Greenwich BioSciences has recently retained the services of registered political lobbyists in at least nine state capitals. It’s unclear why the company chose South Dakota and Nebraska as pilot sites for these bills. Neither state allows any kind of medical cannabis, but both operate in fairly obscure regions where legislative bills typically don’t attract a lot of attention.
The move has alarmed some patient advocates in South Dakota and Nebraska, who have been fighting for years to pass medical cannabis laws. They fear that GW’s move could preempt their own efforts, undercut support for full medical legalization, and limit patient options to the GW/Greenwich patented product.
“SB 95 will block all current and readily-available CBD options for South Dakota’s children,” Melissa Mentele told Leafly. Mentele is the chairperson of New Approach South Dakota, the state’s main cannabis reform group. “It will make Epidiolex the only option. As we know, one medicine does not work for all patients. We can’t take away options for these catastrophically ill children and their families.”
“The ‘FDA approved’ language is being pushed heavily by GW and Greenwich BioSciences for a reason,” Mentele added. “They want to be the only option in South Dakota. What happens when the only option doesn’t work?”
Leafly has reached out to Greenwich BioSciences for comment. The company has yet to respond
The South Dakota bill, SB 95, had its first committee hearing earlier this week. The bill exempts cannabidiol from the definition of marijuana and moves CBD from a state-designated Schedule I drug to a Schedule IV substance. The piece of the bill that’s critical to GW/Greenwich: These moves affect only cannabidiol products that have received federal FDA approval. Epidiolex is currently the only widely known CBD product nearing full FDA approval.
If the bill passes, GW Pharma and Greenwich Biosciences will effectively own a legal monopoly on CBD products in South Dakota and Nebraska—at least until another CBD-based product achieves FDA approval.
A national lobbyist hiring spree
GW Pharma and Greenwich BioSciences have never been active in American politics on the state level, in part because they really didn’t have a product to sell. With Epidiolex approaching market readiness, however, the companies have acquired political muscle all over the country. And they’re not exactly advertising it.
No mention of the South Dakota or Nebraska bills—or any bills potentially in the works in other states—can be found anywhere on the company’s websites.
At the same time, Greenwich BioSciences has recently retained the services of registered political lobbyists in a number of different states.
- In South Dakota, the company is repped by Dennis Duncan, a Sioux Falls lawyer who’s known around Pierre as a longtime lobbyist. In Madison, Wisconsin state legislators are considering two separate cannabidiol legalization bills. Neither of those bills currently mention Epidiolex or FDA approval, but Greenwich BioSciences recently hired the local lobbying shop Martin Schreiber & Associates to look after its interests in the state capital.
- In Nebraska, Greenwich BioSciences has retained the Lincoln lobbying shop Mueller Robak.
- In Florida, the company has retained Douglas Russell, a former top official at the state’s heath care agency, to look after its interests in Tallahassee.
- In Minnesota, no CBD bill has been introduced in the state legislature, but Greenwich BioSciences recently retained the St. Paul lobbyist Randy Morris as the company’s registered agent.
- In Washington state, last month Greenwich BioSciences began paying political lobbyist Stephen J. Buckner $3,500 per month to look after its affairs. There is, as of yet, no CBD bill in Olympia.
- In Idaho and Arizona, the company has retained the services of California-based lobbyist Kurt Stembridge. Stembridge may also be representing the company in Sacramento.
In South Dakota, lobbyist Dennis Duncan testified before a state senate committee earlier this week in favor of SB 95. He called attention to the bill’s pre-emptive requirement: “Before this drug can be rescheduled, it can be done only after FDA approval,” he said. “So it can’t be prescribed or dispensed prior to FDA approval.”
South Dakota Sen. Blake Curd, the state senate majority leader, sponsored the current bill. He gave a stirring endorsement of the safety of cannabidiol to his colleagues. “The one distinct difference with CBD oil is that it has no known lethal dose, no known toxic effect, and no known euphoria,” he said.
“You are more likely to drown in a vat of CBD oil than you are from taking it in any form,” Sen. Curd said.
Medical marijuana advocates introduced an MMJ bill last year, but Curd amended it to allow only possession and use of CBD for patients with severe seizure conditions. The bill ultimately failed.
Votes swing once GW backs it
Until now, the GW/Greenwich political move has flown mostly under the radar. Yesterday Cory Allen Heidelberger, a South Dakota political watchdog who puts out the Dakota Free Press, published the first skeptical take on SB 95. Heidelberger noted that South Dakota Attorney General Marty Jackley, one of the most powerful figures in state politics, “sat quietly behind the lobbyists for Greenwich BioSciences.” Jackley opposed last year’s bill on CBD, but has written in support of GW Pharma-developed products. Many of last year’s cannabidiol legalization opponents in South Dakota have similarly faded away in the face of this year’s GW/Greenwich bill.
Most national cannabis groups and patient advocates are unaware of company’s political move on cannabidiol. NORML has been tracking the South Dakota bill on its Action Alert List, but most groups haven’t given the CBD bills high priority.*
Mentele, chairperson of New Approach South Dakota, found out about them just a few days ago.
In Nebraska, only local patient advocates were available to testify against the bill, introduced there as LB 167. Jane Stanley, a patient with interstitial cystitis, told a legislative committee that CBD was the only medicine that helps her. But legalizing only in GW/Greenwich’s FDA-approved form would not allow her to benefit from the full healing benefits of cannabis.
“When you start isolating the cannabinoids from cannabis, it’s like taking out the codeine from hydrocodone and expecting it to do the same thing,” Stanley said.
Dexter Schrodt also testified against the Nebraska bill. He’s head of the local chapter of Students for Sensible Drug Policy (SSDP). Edward Williams, leader of Nebraska Veterans for Medical Marijuana, also spoke in opposition.
Speaking in favor of the bill in Lincoln were Michelle Welborn, founder of the national Intractable Childhood Epilepsy Alliance; and Kim Robak, co-founder of the Lincoln lobby shop Mueller Robak.
The testimony of Welborn and Robak was curious, though. Welborn is a national patient advocate; she’s also the founder of Bravo Pharmaceuticals, a biotech startup that seeks to license products for rare diseases, including intractable childhood epilepsy.
On the agenda for the Jan. 25 Nebraska state senate committee meeting, which considered the Greenwich BioSciences-focused CBD bill, Kim Robak was listed as a representative of the Nebraska Medical Association. That is true—her lobbying shop is their registered agent. But Robak’s firm is also a registered and paid lobbyist for Greenwich BioSciences.
Leafly will continue to follow developments surrounding these and other CBD-related bills. For more information on cannabis-related legislation currently in play in statehouses around the country, see our updated bill tracking page.
* Update 2/22/2017: In its original form, this article failed to note NORML’s updates on South Dakota’s SB 95. Leafly regrets the error. Check out NORML’s Action Center for more info on other bills in play this year.