On September 24, 2024, the Association of Cannabinoid Specialists (www.cannaspecialists.com) hosted a paneled event surrounding the topic of policy and rescheduling, and what it means for patients and clinicians.
To watch the recording of the event, click here.
Panelists
The format was a paneled discussion featuring three lawyers, a cannabinoid physician, and a moderator in front of a live audience reading questions submitted to ACS prior to the event.
The panel consisted of:
Jordan Tishler, MD
Dr. Tishler is a Cannabinoid Specialist. He is the Founder and President of the Association of Cannabinoid Specialists, and is faculty at both the Mass General Brigham and Harvard Medical School.
Dr. Tishler is a national/international Keynote speaker and author on a variety of topics related to the medical applications of cannabinoids. He maintains a steady roster of Ph.D. candidates and resident-trainees in his clinic, InhaleMD.
He is recipient of Clinician of the Year awards from Americans for Safe Access and the Marfan’s Society. He is an advisor to Massachusetts Cannabis Control Commission, Massachusetts, Georgia, and Alabama Medical Societies, and board member of Council for Federal Cannabis Regulation, and advisor to Massachusetts Patient Advocacy Alliance, and was awarded lifetime membership on the Hadassah Physician’s Council for his work in cannabinoid medicine.
Kristine Blackwood
Kristine Blackwood is a health policy consultant in Washington, D.C., representing health policy clients on Capitol Hill. Kristine draws from more than twenty years in leadership positions at the US Department of Health and Human Services and the US Department of Justice, and as senior staff on House and Senate Committees with health care jurisdiction.
Prior to opening her own consulting firm in January 2024, she served as Counsel for the Public Policy Practice at Arnold & Porter for nine years, representing a wide range of health care sector clients on Capitol Hill and with the Executive Branch, including medical societies and health professional association, research organizations, children’s hospitals, health IT providers; and medical product manufacturers, and advising cannabis industry stakeholders on legislative drafting and strategy.
Bryant Godfrey
Bryant Godfrey is a partner in the Washington, D.C. office of Foley Hoag and is Co-Chair of the firm’s FDA Practice Group. He provides strategic regulatory advice to large pharmaceutical, medical device and biotech companies, startups, and trade associations, helping them to navigate challenges relating to the development, manufacturing, approval and promotion of drugs, biologics, medical devices, and combination products. Having spent nearly a decade at the US Food and Drug Administration (FDA) in senior regulatory and policy roles, Bryant advises FDA-regulated companies on a broad range of FDA regulatory, policy, compliance, enforcement and strategic matters.
Bryant's experience encompasses a wide range of issues relating to product jurisdiction, medical product development and approval/clearance, labeling, advertising and promotion, scientific exchange, investigations of off-label marketing, post-marketing commitments and requirements. His work also includes Current Good Manufacturing Practices (CGMPs), Clinical Laboratory Improvement Amendments (CLIA) compliance, drug supply chain, FDA inspections, recalls, cannabis-derived products, and foods/dietary supplements.
Mark Bolton
Mark Bolton serves as Head of Global Public Policy for Jazz Pharmaceuticals. In that capacity, Mark oversees all international, federal, and state public policy for Jazz.
Before joining Jazz, Mark was a partner at the law firm Brownstein Hyatt Farber Schreck in Denver. Mark also previously served as Sr. Deputy Legal Counsel and Director of Marijuana Coordination for Governor John Hickenlooper of Colorado. During his time in Governor Hickenlooper’s office, Mark administered cannabis policy issues for the state and oversaw the cannabis-related work of 12 state agencies and hundreds of agency employees, and advised numerous other jurisdictions (national, state and local) regarding legalization and regulation of cannabis.
Hot Topics
Hot topic questions included:
"What does federal rescheduling of cannabis mean?"
"What is the difference between de-scheduling and rescheduling cannabis, and what are the roles of FDA and DEA if cannabis is de-scheduled vs. rescheduled?"
"What is the pathway under FDA for cannabis to become an approved medication?"
"Do you foresee a time when this will be "prescribed" like regular medicines? Will it become a requirement if rescheduled into III?"
"Will rescheduling encourage insurance companies to cover medical consultations and the cannabis products themselves?"
"Will rescheduling actually improve 280E tax status for businesses?"
Themes
The recurring themes throughout the questions were FDA regulation and what the future holds for cannabis patients, clinicians, and businesses if rescheduling happens. Right now, with so many unknown factors, our panel could only give us educated guesses based as to how this may play out and how rescheduling may affect cannabinoid medicine in both the short and long term.
To join the Association of Cannabinoid Specialists, click here.
For information on free student memberships or discounted memberships for recent graduates, email [email protected]
To watch the recording of the event, click here.