Rx Summit marijuana 150407.pptx

Marijuana: Emerging Medical and Legal Issues Michael C. Barnes April 7, 2015 Conflict of Interest Disclosure The Center for Lawful Access and Abuse Deterrence (CLAAD) receives funding from businesses in the health care industry that share CLAAD’s mission to reduce prescripMon drug fraud, diversion, misuse, and abuse while advancing consumer access to high-­‐quality health care. CLAAD’s funders include pharmaceuMcal companies, treatment centers, and laboratories, and are disclosed on its website, www.claad.org. CLAAD is managed by DCBA Law & Policy. DCBA also provides legal and policy counsel to professionals and businesses whose acMviMes align with CLAAD’s mission. To avoid conflicts of interest, DCBA adheres to the District of Columbia Rules of Professional Conduct §§ 1.7-­‐1.9. Preview • 
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Legal Status of Marijuana Federal Supremacy Concerns Related to the Current System Federal Drug Authority State AcMons & ImplicaMons PoliMcal RealiMes & Where To Go From Here Issues on the Horizon Legal Status of Marijuana •  WA, CO, OR, AK, and DC have legalized marijuana. •  Ballot iniMaMves in 2016: AZ, CA, MA, ME, NV. •  23 States and DC have legalized marijuana for medicinal purposes. •  Trend toward legalizaMon. –  83% not bothered if marijuana is used in people’s homes (Pew Research) –  64% of Democrats; 39% of Republicans (Gallup) –  63% of Republican Millennials (Pew Research) Legal Status of Marijuana •  Under Federal law, marijuana is illegal. –  CSA: Schedule I; “no accepted medical use.” –  FDA analysis (at DEA request) of whether to down-­‐
schedule •  Consult with NIDA •  Route through HHS –  FDA supports medical research on marijuana •  Congress has prohibited DoJ from spending any money in 2015 to prevent states "from implemenMng their own State laws that authorize … medical marijuana." Federal Supremacy •  Gonzales v. Raich (2004) –  Congress may regulate purely intrastate acMviMes that have a substanMal effect on interstate commerce. –  Local marijuana culMvaMon and use affects naMonal market. •  10th Amendment reserves for the States Plenary Police Powers to protect health, safety and welfare. •  When in conflict, fed. law prevails (Art. VI, cl. 2). –  Complex pre-­‐empMon tests (see NAMSDL, CRS documents) •  Express •  Implied •  Conflict: –  Does state law make it impossible to comply w/ federal law? –  Does state law create an obstacle to compliance w/ federal law? –  States are not required to enforce federal law. Concerns Regarding the Current System •  Who has the final say? –  Federal and state laws conflict; ciMzens can use marijuana in accordance with state law but be arrested and prosecuted under federal law. •  DOJ: Marijuana is illegal, but federal enforcement is limited. –  Sales to minors or that benefit criminal enterprise. –  Diversion from states where it is legal to other states •  Outside of those “enforcement prioriMes,” DoJ leaves it to the states. Federal Drug Authority •  Maine foreign drug importaMon law. –  2013 Maine law permired ciMzens to purchase drugs from certain foreign countries (not FDA regulated). –  Federal court decision (Oulere v. Mills, Feb. 2015). •  Federal government regulates foreign commerce. •  Maine law compromised the “Mghtly regulated structure” set up by federal law. •  FDCA encompasses enMre field of drug approvals and markeMng; state law is pre-­‐empted. •  Congress did not occupy enMre field of controlled substance regulaMon in adopMng the CSA. State AcMons & ImplicaMons •  ER Hydrocodone: FDA approved, states pushed back. –  Mass. enacted an emergency medicaMon ban –  U.S. Dist. Ct.: FDCA encompasses enMre field of drug approvals and markeMng; state law is pre-­‐empted. •  Inconsistencies between state and federal law create confusion and possibility of conflict –  Lack of clarity as to systems and processes. –  Marijuana is not the only issue: 2nd Amendment PreservaMon Act (AK, ID, KS, MO) prohibits state law enforcement officials from enforcing federal gun control laws. PoliMcal RealiMes •  Growing funding and influence for legalizaMon advocates. •  Governments see opportunity for tax revenue. –  CO revenue so high it violated taxpayers’ bill of rights. –  Federal Marijuana Tax Revenue Act of 2015 (12 Dem co-­‐sponsors). •  Current policies are piecemeal; do not fit into exisMng systems. –  FDA: Greatest benefits would arise if legal smoking age were 25. –  Minors may access (and smoke) medical marijuana in CA. •  Need for reasonable policy that recognizes poliMcal realiMes –  Marijuana legalizaMon trend. –  Medical heroin campaign underway. –  LiberalizaMon models in Vancouver, Portugal, Uruguay, Switzerland. Where To Go From Here •  As supply increases, demand can be expected to rise. •  Demand reducMon is essenMal. –  Personal health. –  Personal and professional compeMMveness. •  Treatment providers must be prepared … or not? –  How treat marijuana use: Like alcohol? Like tobacco/nicoMne? –  Will HCPs even strive to treat marijuana use? •  Local public nuisance ordinances to ban dispensaries? (City of Riverside v. Inland Empire PaMents Health) •  How to regulate marijuana? Like alcohol? Like tobacco/
nicoMne? (H.R. 1013: Regulate Marijuana Like Alcohol Act) Issues on the Horizon •  Coats v. Dish Network –  CO Ct. of Appeals upheld e’r right to fire e’ee who tested + for marijuana (used for medicinal purposes) –  CO S. Ct. heard oral arguments, to decide this year •  Lawsuits against Colorado based on varying arguments –  OK and NE (federal supremacy) –  AnM-­‐crime group Safe Streets Alliance –  Sheriffs and prosecutors: does oath of office impose a duty to enforce federal law? AZ Ct. App. said no. (Reed-­‐Kaliher v. Hoggar) •  FDA analysis and recommendaMon to DEA (routed through HHS) Conclusion •  Thanks to Cindy Lackey, Nancy Hale, Karen Kelly, and Dr. Shanna Babalonis •  QuesMons and discussion at end of session •  Contact –  LinkedIn.com/in/michaelcbarnes –  @mcbtweets –  www.claad.org –  @claad_coaliMon •  Thank you