Since the 1960s there has only ever been one federally licensed farm that grows cannabis for researchers, and it’s at the University of Mississippi. In 2016, the US Drug Enforcement Administration announced that it would license additional growers, and more than thirty entities rushed in from all over the world to apply. As Cannabis Wire first reported, this included major companies like Battelle, which is perhaps better known for its work with the US government on Homeland Security and National Security issues. Then, in August 2019, the DEA said, essentially, that it was starting over. Since then, for those dozens of applicants, it’s been a waiting game while the DEA’s proposed rules for applicants are under White House review.
One of those applicants, Cannabis Wire learned, met in November 2019 with the White House Office of Management and Budget (OMB) about the DEA’s proposed rules for applicants, which have been awaiting approval from the OMB since last August. So we caught up with the founder of that company, Biopharmaceutical Research Company, to learn more about this meeting, and this years-long process of preparing for an historic opportunity. We spoke with George Hodkin, the former Navy SEAL who launched the company in 2017.
(This conversation has been edited for length and clarity.)
Cannabis Wire: Tell me about your company. What are you working on, and what’s in the pipeline?
George Hodgin: I started Biopharmaceutical Research Company in 2017 after seeing several of my veteran teammates struggling with visible and invisible wounds. Many of them were turning to cannabis. And after watching their experience, I realized that the key to truly treating cannabis as a medicine—and potentially helping my own friends, veteran teammates, and other patient populations—is expanding research for cultivation. So I started the business, BRC, exclusively to do that, to produce cannabis for federally-approved research and drug development. We do not participate in the medical or recreational market. We don’t violate federal law. Everything we do is within the DEA and FDA framework.
Cannabis Wire: Is there a particular application for cannabis that you find the most intriguing? Or is it the possibilities that you’re interested in?
George Hodgin: We hold a DEA registration, and with that registration we conduct lots of compliant cannabis activity. Typically it’s with products that we source legally, obviously, through the National Institute on Drug Abuse, or products that we are importing into the United States.
As a veteran and somebody who fought for the country, it is really saddening that we can’t produce the products that we’d like to study, and that researchers and veterans are asking for, in the US. We have to import them. Particularly with the Trump administration’s focus on America First, it doesn’t feel right that we’re having to import. We want to be the one-stop shop for a federally approved researcher to access cannabis for whatever indication they choose. We are interested in studying both the adverse and therapeutic effects of cannabis. So we aren’t focused on a particular indication.
That said, with the amount of people suffering from pain and with no alternatives to opioids— particularly for veterans suffering from wartime wounds—those are the things that are most exciting to me, both as the leader of the company and selfishly because I see so many of my veteran friends who have no other option but to be treated with opioids, and we all know how that turns out. I think it’s incredibly irresponsible of the federal government to say, look, we won’t allow marijuana to be produced for research purposes because we’re concerned about the optics and long term health effects. But we’d love to prescribe you lots of opioids to treat your pain. That, to me, is very irresponsible.
Cannabis Wire: Are you able to share which countries or which entities you were able to import cannabis from?
George Hodgin: We have imported from the Netherlands. We believe that was the first federally legal import of marijuana. And when I say marijuana, I mean THC cannabis, not hemp cannabis. Assuming that the federal government continues to delay the production of cannabis for research in the United States, we’ll continue to import products legally from around the world. I’d prefer that the tax revenue and the intellectual property and the job creation stay here in America. But if the federal government just refuses, like they’ve done for over three years, to let people produce for research, then I suppose we’ll have to spend our dollars elsewhere.
Cannabis Wire: So why did you decide to meet with the White House Office of Management and Budget? What were you hoping to get out of that meeting?
George Hodgin: We were encouraged by the fact that the interagency community was receptive to taking a meeting with us and ensuring that our voice and concerns were heard. We made it abundantly clear that there are several ways to work within the Controlled Substances Act and within the framework of the international narcotics treaties. It is very possible to work within those frameworks and produce the types of cannabis that people need to research. And we also pointed out to them that there are dozens of countries that are signatories to the same treaty that the United States is a signatory to, and all of those countries seem to have found ways to have robust cannabis-research production programs without the roadblocks that the United States is currently self-imposing.
Cannabis Wire: How much communication has there been? How much insight do you have into what is actually coming down from regulators?
George Hodgin: None. All we have been told for over three years is effectively: Don’t call us, we’ll call you, we’re working on it. If we filed to be a Schedule One manufacturer of another drug besides cannabis, there is a very direct pathway for how to do that. And we could do it. Our team has done that professionally for years, decades. They’re all from Schedule One manufacturers, all of our team. None of them have ever waited more than a year for registration, communication, and even our compliance experts are bewildered about why the government intends to treat cannabis differently than any other Schedule One. Why is it taking DEA over three years to redefine the mechanisms for producing a Schedule One drug?
Cannabis Wire: So are you in conversations with any of the other applicants about your experiences? Or are people mostly keeping to themselves?
George Hodgin: The latter. I know I can speak for all of the applicants saying the uncertainty around the registration process is a real source of frustration that prevents smart business planning. We have no direction, so we don’t even know if it’s a competitive process. They haven’t said anything. Any other drug or chemical or molecule of any other schedule, there would be certainty and clarity around the production and registration process. The fact that the federal government is treating cannabis differently is bewildering and disappointing. The entire industry, we’re all sort of just looking at each other and, like, really?
Cannabis Wire: Once you’re licensed, what does it allow you to do? Where does your funding come from at that point? Is it through grants, research grants? What sort of doors does it open to get a license outside of just being able to supply researchers with cannabis?
George Hodgin: We’re focused on the first step. Right now, in the country, two hundred million consumers live in a place where they can legally access a variety of cannabis genetics and cannabis products—unless they’re a scientist or a doctor. That to me is a fundamental national health problem. Securing this license allows us to start supplying cannabis for researchers to answer the fundamental medical and health policy questions around cannabis. How do you create a breathalyzer for cannabis, or an impairment test? What’s a fair THC level for cannabis impairment? All of these questions.
Is cannabis good for PTSD? Some people say yes. Some people say no. Until you run robust clinical trials, all of these questions will remain unanswered. And consumers, doctors, law enforcement, policymakers will all be making critical decisions that are not based on sound data. So our immediate goal is to get the license and start producing the cannabis products that researchers need so that they can answer these questions. What if a researcher finds out a formulation that indeed does treat chronic pain? Can you imagine the health care savings that we would have in this country if people aren’t having to be treated for opioid dependency after they’ve been treated with opioids? I think the downstream effects are just incredible.
In my mind, nothing happens on a federal level in any way for meaningful cannabis reform until these research licenses are granted. We’re at a complete stalemate because of this catch-22 until the research happens, irrespective of where the research takes you. Like three years ago, a politician could afford to just not have an opinion on cannabis. That’s no longer the case. So now the fallback is “I’m interested in learning more. But I’ve got to hear the research.” Well, until these research permits are granted, there will be no meaningful research. And until that happens, we’re going to be stuck.