Jack Henningfield, Reginald Fant and Daniel Wang
The confusing and conflicting legal status of cannabis and its active constituents can inhibit product development as companies encounter significant and unique barriers to approval and appropriate scheduling. In a complementary webinar, Jack Henningfield, Ph.D., and Daniel Wang described how the development and regulatory submission of other CNS-active drugs, including the development of the FDA-required abuse potential assessment, provide important precedents and models for cannabinoids.
“Product form and composition are important determinants of scheduling and potential claims. An early assessment can help avoid late stage surprises that add time and cost to development.” – Jack Henningfield
In the case of cannabinoids, an abuse potential assessment, conducted in accordance with the 2017 FDA Guidance on Assessment of Abuse Potential of Drugs, would consider the source of the active ingredients, the content and strength of active ingredients, the route of administration, any subjective effects, and whether the formulation can be manipulated or tampered. These factors can be indicative of the likelihood of diversion and dependence. From a health policy perspective, second hand exposure to the constituents of cannabinoid products would also be important.
The webinar will be available until March 2019 at https://xtalks.com/webinars/cannabinoid-abuse-potential-assessment-the-8-factor-analysis/.
Christine Sweeney and George Quesnelle
FDA approval of an Rx-to-OTC switch depend on anticipation of issues likely to be raised by FDA division and nonprescription staff, as well as other policy stakeholders. Commercial success following approval similarly requires addressing issues even before submission and looking beyond FDA approval.
“Rx-to-OTC switch is not a regulatory check-box exercise, it’s a policy change, supported by argument and data.” – Christine Sweeney
In a two-part webinar (recording available at the links below until February 2019), we discussed the importance of:
- Thoughtful selection of switch candidates through regulatory and commercial feasibility assessments
- Early development of FDA strategy, taking into consideration development of a sound Drug Facts Label and other consumer information materials, as well as well-designed consumer studies. These studies include label comprehension, self-selection and, if needed, behavioral (actual use) data to demonstrate the drug can be used safely and effectively in the nonprescription setting
- Identifying and addressing concerns of FDA and other key stakeholders with science-based, data-driven responses
- Building a compelling benefit/risk case for the switch
- Strong leadership and project management linking regulatory, clinical, medical and commercial strategies and workstreams
- Sound preliminary forecasts requiring consumer behavior insights
“A successful Rx-to-OTC switch process looks beyond FDA approval to encompass the pathway for commercial success.” – George Quesnelle
To access our two-part webinar series on Rx-to-OTC Switch, click here:
Part 1 of 2: Planning for Regulatory Success
Part 2 of 2: Rx-to-OTC Switch: Planning for Commercial Success