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As part of its Unapproved Drugs Initiative designed to remove unapproved drugs from the market by means of a “risk-based enforcement program” that concentrates on products that “pose the highest threat to public health and without imposing undue burdens on consumers, or unnecessarily disrupting the market,” the FDA in September 2010 ordered a halt to the manufacture, distribution, and marketing of unapproved single-ingredient oral colchicine. These medications were and are widely used for the daily prevention of gout and to treat acute gout flare-ups and Familial Mediterranean Fever. Although the FDA acknowledged that “many single-ingredient oral colchicine products have been used by the medical community for decades,” because these medications had not received “mandatory modern-day FDA-approval” they rarely provided physicians and patients with the important safety data and information about drug interactions and dosing that are essential when making informed treatment decisions. Thus, the FDA action to ban their sale and distribution. At the time of the announcement, Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research (CDER), said “The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets. Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients.” Noting that the unapproved colchicines medications had never been evaluated by the FDA and thus should not be viewed as generic drugs, which must be “approved by the FDA to assure that the approved generic drug products meet the same standards as the innovator drug,” Deborah M. 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