Where There is Smoke, There is Fire!

The FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER), gave a presentation on April 12, 2016 entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.”  A key take-away from the presentation was that the Agency supports the development of drugs derived from marijuana (MJ).  This included mention of a guidance on the use of botanicals and the availability of Agency tools for expedited development (i.e., orphan disease, fast track).  In 2016, there were four states which had legalized MJ.  As of 2018, there are nine states where MJ is legal and can be used for medical purposes.

From a more global perspective, there are efforts underway in Canada to legalize recreational marijuana by July 2018.  In addition, countries in Latin America and Europe are adopting medical cannabis programs, with Germany discussing legalizing recreational marijuana.  The economic impact globally is currently estimated to be eight billion dollars and is projected to quadruple by 2021.

Medical marijuana or tetrahydrocannabinol (THC) has not been approved by the FDA for any use.  No drugs containing plant-derived THC or cannabidiol (CBD) have been approved.  CBD, a derivative of THC, in synthetic form has been approved for use in two drug products and is under clinical investigation for additional new drugs.  One synthetic compound that mimics the effects of CBD and is not related to compounds derived from the plant form has also been approved.

In the pharmaceutical manufacturing space, CURE Pharmaceutical, an innovative drug delivery and development company, has announced the acquisition of two patents that ensure CURE has a competitive advantage in the extraction and purification of cannabis plant material, as well as subsequent processing of cannabis extracts for drug formulation.  (April 4, 2018, GLOBE NEWSWIRE).

To take advantage of the incredible potential for new, safe, and effective treatments derived from the MJ platform, the pharmaceutical arena must traverse a new and developing regulatory framework.  Regulations have and will create challenges to ensure product safety, manage liability, and deliver efficacy for every part of the MJ supply chain.  As an example, testing labs have disclosed data indicating a high percentage of California-produced cannabis contains and still tests positive for pesticides.  The state is now requiring mandatory testing.

Another major problem in the MJ industry underscores the issue of potency and labelling.  Consumers do not know what they are purchasing in the dispensary.  For an MJ product used as medicine, the difference in the amount of active ingredients found in the many different strains of MJ is an important efficacy and safety concern.

The MJ industry is poised, ready, and making ever-increasing in-roads towards the development of safe and effective treatments for important disorders that are currently baffling traditional/classical drug development efforts.  It is in the pharmaceutical community’s interest to stay abreast of the latest developments, hurdles, and opportunities to support these efforts in the pursuit of novel, medically significant treatments.

*This is an update to a blog presented on the Lachman site on April 29, 2016 entitled, “Up in Smoke.