Alice P. Mead†
Modern medicine increasingly seeks to provide treatment approaches that are “evidence based.” Specifically, the Food, Drug, and Cosmetic Act (FDCA) has been developed over the last 100 years to implement cutting-edge scientific knowledge, with the goal of ensuring that new medications are carefully tested for quality, safety, and efficacy. The Food and Drug Administration (FDA), the agency charged with enforcing the FDCA, closely scrutinizes all aspects of medication development.
This system of medication development also enhances and supports the effectiveness of the physician-patient relationship. Medications that successfully pass through this process are accompanied upon marketing by extensive preclinical and clinical testing which provide a robust body of risk/benefit and pharmacological data. Physicians rely upon these data to inform their prescribing decisions and to facilitate informed consent discussions with their patients.
Furthermore, the FDA process has additional aspects that further protect patient welfare. Medications are approved for marketing only for use in a particular medical condition and by a specified patient population. The FDA requires that manufacturers’ promotional claims be limited to those supported by clinical trial data. Manufacturing facilities are registered with, and inspected by, the FDA to ensure that the manufacturing process is conducted in accordance with validated quality control tools. Medications must be prescribed and dispensed under the supervision of physicians and pharmacists, labeled with instructions for use, and accompanied by information about side effects. While not without its flaws, the FDA process assures the purity, identity, and potency/standardization of products and it is resoundingly supported by all major medical organizations.
How does “medical marijuana” comport with this FDA paradigm?