Did the DEA Just Kick Open the Door for the Pharmaceuticalization of Pot?
While much ink has been spilled over the last few days regarding DEA’s refusal to recognize marijuana as a medicine and its unwillingness to reclassify it under federal law, far less attention has been paid to a separate decision by the agency to create, for the first time, a “clear legal pathway” for pharmaceutical companies to engage in cannabis-specific “drug product development.”
The DEA’s intent is articulated in the August 11 edition of the US Federal Register, available online here, in a notice entitled ‘Applications to Become Registered Under the Controlled Substances Act to Manufacture Marijuana to Supply Researchers in the United States.’ A summary of the document provided by the agency states, “To facilitate research involving marijuana and its chemical constituents, DEA is adopting a new policy that is designed to increase the number of entities registered under the Controlled Substances Act to grow (manufacture) marijuana to supply legitimate researchers in the United States.”
At first glance, this change would appear to be a welcome one. After all, since 1968 federal bureaucrats have permitted only a single agency – the University of Mississippi via an exclusive contract with the US National Institute of Drug Abuse – to legally produce cannabis for FDA-approved research trials, an arbitrary prohibition that does not exist for other controlled substances and that has led to limited drug supplies and accusations that federally-backed research is skewed largely toward identifying pot’s potential harms rather than it benefits.
But upon closer inspection, the DEA makes it clear that its new policy is motivated by more than simply a willingness to increase the nation’s federal supply of legal pot. Rather, the agency’s ultimate goal looks to be the domestic production of pharmaceutically produced medical cannabis products.
States the agency: “The historical system, under which NIDA relied on one grower to supply marijuana on a contract basis, was designed primarily to supply marijuana for use in federally funded research – not for commercial product development. Thus, under the historical system, there was no clear legal pathway for commercial enterprises to produce marijuana for product development. In contrast, under the new approach explained in this policy statement, persons may become registered with DEA to grow marijuana not only to supply federally funded or other academic researchers, but also for strictly commercial endeavors funded by the private sector and aimed at drug product development (emphasis mine). … In other words, in lieu of requiring the growers to operate under a contract with NIDA, a registered grower will be permitted to operate independently, provided the grower agrees (through a written memorandum of agreement with DEA) that it will only distribute marijuana with prior, written approval from DEA. … [U]nder the new approach, should the state of scientific knowledge advance in the future such that a marijuana-derived drug is shown to be safe and effective for medical use, pharmaceutical firms will have a legal means of producing such drugs in the United States – independent of the NIDA contract process (emphasis mine).”
In short, the DEA is providing a roadmap for Big Pharma to enter the marijuana drug development market.
Of course, pharmaceutical companies have long been aware of marijuana’s market potential and have sought to capitalize from it. A 2006 NIH report, entitled ‘The endocannabinoid system as an emerging target of pharmacotherapy” states, “The growing interest in the underlying science (surrounding the therapeutic effects of cannabis) has been matched by a growth in the number of cannabinoid drugs in pharmaceutical development from two in 1995 to 27 in 2004.”
Yet, historically, this interest in commercial drug development has largely been limited to the creation of synthetic agonists that mimic natural components of the plant – such as the FDA-approved drugs Marinol, Cesamet, and Syndros. (A synthetic version of the anti-convulsant cannabinoid cannabidiol (CBD) is also in development.) But with the DEA’s newly adopted policy, US pharmaceutical firms can for the first time contemplate becoming involved with developing and/or patenting medicines derived from the actual plant itself – either in the form of standardized cannabis strains or extracts. (A British biotech licensed by the UK government to grow pot has already utilized this strategy to develop two specific cannabis plant-based extract drugs, Sativex and Epidiolex.)
Thursday’s notice from the DEA isn’t the first time that the anti-drug agency has courted Big Pharma. As reported in Alternet in 2011, the DEA previously acknowledged its intent to expand the federal government's schedule III listing to include pharmaceutical products containing plant-derived THC while simultaneously maintaining existing criminal prohibitions on the plant itself.
In the five years since then, it appears that attitudes at the nation’s largest anti-drug agency haven’t changed. Clinical investigations of the cannabis plant, a substance the DEA still sees as illegitimate, are largely to be discouraged, while the development of new marijuana-derived pharmaceuticals are to be encouraged. Consequently, it is apparent that the DEA’s longstanding refusal to recognize herbal cannabis as a legitimate therapeutic treatment is here to stay. Therefore it is incumbent that members of Congress act swiftly to amend cannabis’ criminal status so that federal law finally comports with public opinion, scientific consensus, and the plant’s rapidly changing legal status under state laws.