“I Didn’t Inhale” – But FDA’s Position on Medical Marijuana is Still Cloudy

June 25, 2014

By James C. Shehan & Karla L. Palmer

In a curious posting on Friday, June 20, 2014, FDA with little fanfare set forth its latest position on medical marijuana.   Amounting to little more than a statement of general support of scientific research on medical marijuana use, coming 18 years after California passed the nation’s first medical marijuana law, and with 22 states and the District of Columbia now allowing medical use, FDA’s statement is not exactly clear, not exactly bold, and is about as timely as Jeff Spicoli was for history class.

FDA’s latest position is also somewhat at odds with DEA’s refusal to grant a petition to reschedule marijuana due to a lack of adequate and well-controlled studies demonstrating safety and efficacy, which decision was upheld by the D.C. Circuit a little more than a year ago (and posted about here).  DEA staked that position notwithstanding over two hundred comments on the petition, many of which in fact addressed adequate and well-controlled studies.  DEA relied as it is required to do on HHS’s medical and scientific evaluation of medical marijuana use in denying the rescheduling petition (almost a dozen years after it was filed).  DEA stated that the limited existing clinical evidence was not adequate to warrant rescheduling.  Relying on HHS, DEA found there were no “adequate and well-controlled studies proving efficacy” of the use of marijuana in medical treatment.

FDA’s latest statement — cast as “advice to caregivers and patients“– begins with a cautionary heading likely borrowed from Reefer Madness: “Untested Drugs Can Have Unknown Consequences.”  The Agency then observes that there is a demand for “treatment options for unmet medical needs,” which has “[i]n some instances,” led patients and their caregivers to turn to marijuana for conditions such as glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders.  FDA acknowledges the significant scientific interest that exists for the use of marijuana for treatment of various medical conditions.  FDA also notes that it has approved one drug containing a synthetic version of an active substance present in marijuana and one drug containing a synthetic substance similar to marijuana compounds but not present in marijuana.

With this background, FDA summarizes the IND and NDA processes for studying and gaining approval for new drugs.  Interestingly, it also describes the expanded access process and declares its willingness to work with the patient and medical communities, as well as our “federal partners” to allow access to experimental treatments.  To our knowledge, expanded access has never been used for marijuana.

Turning to the likely point of the posting, — “FDA Supports Sound Scientific Research” – FDA asserts that it “has an important role to play in supporting scientific research into the medical uses of marijuana.” and expresses its support for “those in the medical research community who intend to study marijuana.” FDA also notes that it supports research into the medical use of marijuana through cooperation with the DEA and The National Institute on Drug Abuse (NIDA) within NIH.  It also refers to discussions with state officials in Florida, Georgia, Louisiana, New York and Pennsylvania about how their plans for medical research of marijuana and its derivatives can meet federal requirements and scientific standards.  The posting concludes with links to two other FDA documents: FDA and Marijuana: Questions and Answers, and Marijuana Research with Human Subjects.

Although FDA fails to mention that marijuana use – both medical and recreational – is legal in at least two states and being considered by others, there can be no doubt that state actions on medical and recreational marijuana and the conflict between state and federal laws and regulations have left the federal government in a difficult position.  And FDA’s public position in support of careful scientific research is certainly consistent with its mandate and history.  But again, coming 18 years after the states have moved forward on this topic and with hundreds of thousands of Americans already using medical  marijuana (not to mention the millions of recreational users), one questions whether this guidance comes too little and too late to matter.

For those of who are puzzled by the Jeff Spicoli reference in the first paragraph, we close with a relevant quote on timeliness from the 1982 classic film, “Fast Times at Ridgemont High.”  Mr. Hand, US history teacher: “What’s the reason for your truancy?”  Jeff Spicoli, student and habitual marijuana user: “Just couldn’t make it on time.”