Who Needs Federal Drug Regulations? Scott Burris, JD Sarah - - PowerPoint PPT Presentation

Mapping Medical Marijuana: Who Needs Federal Drug Regulations?

Scott Burris, JD Sarah Krieger, MPH Leslie Allen, JD Rosalie Liccardo Pacula, PhD Jennifer K. Ibrahim, PhD, MPH

Marijuana’s Legal Status in the U.S.

Medicine in a Legal Vacuum

States - “Laboratories of Democracy”

• Beyond regulating legal drugs
• Our study (1) provides a detailed mapping of current MM laws; and,

(2) compares state vs. federal drug regulatory strategies

Data and Methods

Mapping Medical Marijuana (MM)

As of July 2016, 24 states and the District of Columbia authorize the use of medical marijuana AK, AZ, CA, CO, CT, DC, DE, HI, IL, MA, MD, ME, MI, MN, MT, NH, NJ, NM, NV, NY, OR, PA, RI, VT, WA

Indications – er, Qualifying Diseases*

5 10 15 20 25 30 # of states PTSD Hepatitis C Amyotrophic Lateral Sclerosis Alzheimer's and/or Parkinson's Disease Crohn's disease Cachexia, cancer, glaucoma, HIV/AIDS, epilepsy, and/or multiple sclerosis

*CA, DC, MA and NH authorize physicians to prescribe MM for any illness/symptom for which marijuana may provide relief

MM Product Safety Laws

Label Requirements (21) Mandatory Product Testing (14) Package Requirements (18)

MM Dispensary Laws

Product Supply Source (20) Waste Disposal (15) Dispensary Licensure (21)

Patient Protection

Patient Discrimination (12) Patient Registration & Patient Privacy (24)

Regulating Medicine: Federal vs. State

Regulation Federal State Drug indication Permits off-label use Qualifying condition required Drug safety/efficacy FDA - clinical trials & safety reporting N/A Patient privacy HIPAA Explicit privacy provisions Patient discrimination ADA prohibits discrimination Explicit discrimination provisions Restrict use locations N/A Prohibits MM use in specific places Treatment denial N/A State may revoke patient registration Dispensaries CSA - storage, purchase, sales reporting Regulates #, location, stock amount Product supply CSA - secure supply chain Regulates supply source Package/label FDA - label and package requirements Explicit MM package/label laws Medical waste CSA - disposal of unused medication Explicit waste protocols

Policy Experiment, Research Opportunity

• Patient access and MM use
• MM supply chain
• Patient safety
• Harm reduction

***How successful (or not) are states at regulating a new pharmaceutical product?***

Conclusion

• “Medicine” without robust efficacy or safety testing
• Unique regulatory challenge for states
• Evolving legal landscape
• Identify and promote effective policies

Questions?

Temple’s Center for Public Health Law Research Team Scott Burris, JD Heidi Grunwald, PhD Lindsay Cloud, JD Jennifer Ibrahim, PhD Bethany Saxon, MS Prescription Drug Abuse Policy System (http://www.pdaps.org/)