by Tara Sklar
At the Food and Drug Law Institute (FDLI) 2018 Annual Conference, the Commissioner of Food and Drugs, Scott Gottlieb, gave the Keynote Address to kick-off the largest turnout yet for this event of over 900 attendees. Commissioner Gottlieb’s remarks started off with how previous FDA Commissioners used this opportunity to recap the past year, but he would be different, he would lay out the strategic priorities for next year.
The room went nearly silent, as Commissioner Gottlieb steadily went through the many sectors the agency oversees, and where he believes the FDA will play a larger leadership role, including in the epidemics of addition (opioid crisis), drug costs, and greater access to generic competition. He laid out a vision that most people in the room would probably subscribe to, including “You’re public health minded, and work hard to deliver innovations that’ll advance human health. The problem is that a few bad apples, that game the system, can tarnish the entire brand of an otherwise principled industry.”[1] Close to the end of his thirty-minute speech, Commissioner Gottlieb firmly addressed the companies that produce e-cigarettes, and said, “If you target kids, then we’re going to target you.”[2]
Indeed, Commissioner Gottlieb mentioned so many FDA strategic priorities, and in such unequivocal detail for how they plan to regulate, that when the President & CEO of the FDLI, Amy Comstock Rick, thanked him and introduced the follow-up panel to discuss the issues Commissioner Gottlieb raised, she said, “We reserved one-hour in the conference to discuss Commissioner Gottlieb’s Keynote Address, but we may need five.” However, there was an area that was not brought up in Commissioner Gottlieb’s wide-ranging speech, despite its very active place in the media and scientific journals calling for the FDA to have a greater role, and more consistent guidance, and this prominent area is the future regulation of cannabis.
It is a notable absence, given that irrespective of Commissioner Gottlieb not once mentioning cannabis, Rick still used one of her few valuable discussion questions to ask the follow-up panel about it. To which, a member of the panel said there are 29 states that have passed medical marijuana, and nine states, including all of the west coast, have passed recreational marijuana. There are over 50 million Americans that now have regular access to cannabis, and yet the FDA remains silent on how to regulate this burgeoning new field.
Members of the panel offered practical suggestions for the FDA to consider greater involvement, such as recommending removal of marijuana as a Schedule I Drug, when they are consulted for a rescheduling condition. Arguably, there may be enough evidence now to show some medical benefit for certain populations with specific ailments, namely those with cancer undergoing chemotherapy treatment and those with AIDS wasting syndrome. Also, a member of the panel suggested the FDA could conduct risk-assessments of edibles with cannabinoids, and will probably find there is reasonable benefit with low risk. This approach could produce evidence that would further support the rescheduling of marijuana as a Schedule I Drug.
There is a clear disconnect between the gap in Commissioner Gottlieb’s remarks and what is a priority for industry players in the food and drug world. For example, FDLI is hosting with Georgetown Law and the O’Neill Institute an entire symposium, “Federal Regulation of Cannabis” next fall.[3] Rick stated she has received an unprecedented response in the number of abstracts received, as many people are attempting to grapple with the complex ethical and legal questions in this growing field.
The continued hands-off approach to regulate cannabis by the FDA also seems in stark contrast to the direct action Commissioner Gottlieb proposed to taking on tobacco and e-cigarettes, particularly as it pertains to products and advertisements that target youth. An increasing number of studies are examining marijuana and adolescents from health and access perspectives,[4] and those who conduct clinical trials in the field would benefit from receiving guidance from the FDA.
The remarks by members of the panel following Commissioner Gottlieb’s Keynote Address at the 2018 FDLI Annual Conference, and many stakeholders in the field, encourage the FDA to recommend rescheduling marijuana from its current Schedule I Drug status. A recommendation by the FDA to reschedule marijuana could be a critical step to pulling the lever to increase the evidence base. Over 50 million Americans and counting are partaking in medical and recreational marijuana – how much longer before we know whether this “drug” can truly help us or might be hurting us?
[1] Keynote Address by Commissioner Gottlieb to the 2018 FDLI Annual Conference, Washington DC, May 3, 2018. Accessed at: https://www.fda.gov/NewsEvents/Speeches/ucm606541.htm
[2] Ibid.
[3] Food and Drug Law Journal 2018 Symposium. What is the Path Forward for Federal Regulation of Cannabis. Available at: www.fdli.org/symposium18
[4] Cancilliere, M. K., et al. (2018) “Effects of co-occurring marijuana use and anxiety on brain structure and functioning: A systematic review of adolescent studies,” Journal of Adolescence 65: 177-188; Hanson, K., et al. (2018) “Washington state retail marijuana legalization: Parent and adolescent preferences for marijuana messages in a sample of low-income families,” Journal of Studies on Alcohol and Drugs 79(2): 309-317; Rusby, J. C., et al. (2018) “Legalization of recreational marijuana and community sales policy in Oregon: Impact on adolescent willingness and intent to use, parent use, and adolescent use,” Psychology of Addictive Behaviors 32(1): 84-92.
