Medicinal Cannabis: Lessons for Scheduling and FDA’s Expectations for Respiratory Drug Delivery

Categories: Abuse Potential Assessment, Cannabis, Eight Factor Analysis, FDA

Development of cannabinoid-based medicines is a rapidly growing area of interest for patients with unmet needs as well as the pharmaceutical industry. The path forward, however, is fraught with technical and regulatory issues that require a thoughtful approach early and throughout the development process.

At two recent medicinal cannabinoid conferences, CannMed 2017 and the 2017 International Cannabinoid Research Society (ICRS) Symposium, Michael Hufford and Daniel Wang presented their insights into federal regulations relevant to medicinal cannabinoids and how companies might begin to navigate these complex issues.

At the CannMed 2017 Conference, focused on the intersection of clinical application, medical research, cannabis-based therapeutics, cannabis safety and production, Michael Hufford and Daniel Wang separately presented on federal regulations relevant to medicinal cannabinoids.

Dr. Hufford described parallel regulatory changes between FDA expectations of respiratory drug delivery devices and regulatory and engineering challenges for the vaping and medicinal cannabis industry. Seen through the lens of pharmaceutical regulations, many existing respiratory delivery systems for medicinal cannabis and nicotine have multiple limitations, including variations in particle size leading to variable deposition and absorption and variable doses of compounds emitted both between devices, as well as within devices, over time. Engineering principles drawn from the field of respiratory drug delivery may help to address some of these concerns, including control of particle size and deposition, inhalation rates and resistance, timing of aerosol delivery, and paths to achieving consistency in emitted dose.

At CannMed and ICRS 2017, Mr. Wang described the influence of the Controlled Substances Act (CSA), in particular the role of the eight-factor assessment described in the CSA, as a starting point for the types of testing and outcomes that would likely be required to support placement of cannabinoid-based drugs in schedules less restrictive than Schedule I.

Both CannMed abstracts can be found here: http://www.cannmedevents.com/poster-presenters/