Jim Seely: Time to regulate medical marijuana

Dear Editor,
It’s time we stopped the charade on “Medicinal Marijuana”.   It is either a drug with known potency, efficacy, safety, impurities and side-effects, or it’s simply a recreational drug.   If the former, then for the sake of those who count on this drug to treat a variety of ailments, it should have the same level of quality assurance you get from any other prescribed, FDA approved, medicines.
The Federal Food, Drug, and Cosmetic (FD&C) Act requires that new drugs be shown to be safe and effective for their intended use before being marketed in the U.S. FDA’s drug marketing approval process requires well-controlled (i.e. placebo controlled) clinical trials that provide the necessary scientific data upon which FDA makes its approval and labeling decisions.  The labeling must be specific for the particular indication(s) where it has proven efficacy…meaning it would be illegal to sell it for any arbitrary ailment.  In addition to efficacy, any side effects or safety concerns must also be reported (i.e. Caution:  use of this product main cause severe loss of cognitive function in some patients..).  For more information see the International Conference on Harmonization; Guidance on General Considerations for Clinical Trials [Docket No: 97D-00188] http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073132.pdf  .
Marketing approval also requires that there are appropriate controls in place for production and manufacturing, as well as laboratory testing of the drug.   The FDA document Q7A, “Good Manufacturing Practices for Active Pharmaceutical Ingredients”  (http://www.fda.gov/cder/guidance/index.htm ) describes guidance for personnel, design and construction of facilities, process equipment, documentation and record keeping, materials management, production, packaging and labeling, storage and distribution, laboratory controls, certificate of analysis, etc., etc.   Facilities can be inspected at any time by the FDA to ensure that these practices are in place.  If you think these regulations only apply to “drugs” such as Lipitor or other “chemically synthesized” medications, consider that it also applies to: “Active Pharmaceutical Ingredients (in this case THC, and possibly other ingredients) consisting of comminuted or powdered herbs.” (Q7A).   In this case there needs to be practices in place for collection of plants and/or cultivation and harvesting, cutting and comminuting (shredding or pulverizing), physical processing and packaging–as well as laboratory testing for potency, impurities and other quality attributes.
While marijuana has legitimate medicinal benefits for some, there certainly are many others who use some “ailment” as a ruse to get pot for recreational purposes (well, DUH!!).   Given that pot dispensaries now outnumber Starbucks in L.A., it would seem that it would be in the public’s best interest for medical marijuana to go through the FDA approval process so it can be legalized–and regulated–like any other drug.   That way, patients that really need it can get it by prescription…and everyone else can go back to “sneaking” it like before.  (BTW, tax revenues from sales of legalized pot would be a very nice “side-effect”.)

Jim Seely
Louisville