Medical Marijuana Case Study

19096 Words77 Pages
ASAM Medical Marijuana Task Force White Paper Research into the therapeutic potential of cannabis and cannabinoids has lagged behind that of other modern medications. The recent discovery and elucidation of the endocannabinoid receptor system, coupled with improvements in technology and new research tools, has facilitated analytical, pharmacological, and other preclinical research. Clinical research is also increasing, although only a small number of controlled studies meeting modern scientific standards have been published. Executive Summary All cannabis-based and cannabinoid products should be subjected to the rigorous scrutiny of the FDA regulatory process. This process provides important protections for patients, making products available…show more content…
The registration and inspection procedures ensure that the manufacturing process is conducted in accordance with validated quality control tools and measures. Manufacturers’ promotional activities are limited to those claims supported by the product’s label. Products are prescribed and dispensed under the close supervision of licensed health care providers, primarily physicians and pharmacists. In addition, the FDA has recently indicated that products, both with and without abuse potential, 54 must develop special plans to identify, evaluate, and mitigate the product’s risks. Such plans must include, where relevant, the risks of abuse and diversion. 55 56 By contrast, herbal products and other dietary supplements are subject to a far lesser degree of supervision. Composition and quality are uncertain; clinical data on safety and efficacy are limited; and physicians generally do not feel qualified to opine about specific products’ risks and benefits for particular medical conditions. 57 Various scholars have suggested that the FDA should more stringently regulate many dietary supplements. 58 Generally, dietary supplements are ingested orally and lack abuse potential. 59 Despite the reduced level of regulatory scrutiny and quality assurance, public interest in botanically derived treatments continues to rise. Acknowledging such interest, and the fact that technology has improved significantly in recent decades, the FDA issued a 2004 guidance document that sets forth the principles to which pharmaceutical manufacturers must adhere when developing prescription medications derived from complex botanical material. 60 The Guidance permits some leniency in the biochemical characterization of a prospective botanical agent the early stages of research; however, at
Open Document