When Things Go Wrong Ep 5: Biden's Scheduling Directive... What Could Go Right?

Our CEO David Vaillencourt, is joined by Alena Rodriguez - cannabis policy and laboratory consultant and Andrew Kline - firmwide co-chair of the Cannabis Industry Group at Perkins Coie law firm where we discuss:
- What governmental processes are involved in the re-scheduling vs de-scheduling of cannabis
- Predictions around quality assurance, quality control, and related lab testing impacts in a federally legal marketplace
- What approach the industry should advocate for and why
04:02 Start of show
06:02 Poll question discussion
07:15 About Andrew Kline
09:32 About Alena Rodriguez
11:55 Summary of Biden's directive
16:23 Governmental processes involved in rescheduling vs descheduling
21:38 Importance of Biden's initiative to our industry
26:34 Major impacts to industry when re or descheduling occurs
29:40 Impact to industry - testing and quality control (and brief mention of Dormant Commerce Clause)
36:20 Impact to industry - Does this mean a prescription drug model?
41:20 Federal vs states? - and
44:39 FDA perspectives and the National Cannabis Lab Coalition (NCLC)
48:03 Technical aspects of NCLC recommendations
51:44 What approach should the industry be advocating for and why?
54:49 The advice for business operators wanting to prepare for federal de or rescheduling
Links:
Andrew Kline bio: www.perkinscoi...
NCLC white paper: www.perkinscoi...
Americans for Safe Access: www.safeaccess...
ASA's 8-factor report (2016): www.safeaccess...
FDA paper "Quality Standards in State Programs Permitting Cannabis for Medical Uses" (2021): pubmed.ncbi.nl...
Botanical Drug Development: Guidance for Industry
AOAC CASP Program: www.aoac.org/s...
ASTM Committee D37 on Standards: www.astmcannab...
OECD Case Study on ASTM International: www.oecd.org/g...
US Pharmacopeia on Cannabis: www.usp.org/di...

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