Author Affiliation: Department of Clinical Pharmacy, University of California, San Francisco.
In 1763, Baron von Storck demonstrated that colchicum extract was useful in the treatment of gout. Some 50 years later, an alkaloid was identified from the autumn crocus (Colchicum autumnale), which ultimately resulted in the discovery of colchicine. While used in the United States for decades, colchicine, similar to other older drugs, had never been approved with respect to efficacy and safety. The Food, Drug, and Cosmetics Act of 19381 and its 1962 amendments (Kefauver Harris Amendments) charged the US Food and Drug Administration (FDA) with approving medications based on safety and efficacy. Drugs that entered the market before the passage of the 1938 act or the 1962 amendments to the act, including colchicine, are often referred to as grandfathered drugs. Under the 1962 grandfather clause, a drug was exempted from the effectiveness requirements if its composition and labeling had not changed since 1962 and if it was sold commercially in the United States. While many older drugs without FDA approval claim to be grandfathered, very few marketed drugs are truly entitled to grandfather status because most differ from the previous versions in some respect, such as formulation, dosage or strength, or dosage form. The 1938 act and the 1962 amendments require the FDA to review and approve medications already being marketed; colchicine is one such unapproved product, which has been awaiting FDA approval since 1938.
Guglielmo BJ. The Colchicine Debacle. JAMA Intern Med. 2013;173(3):184-185. doi:10.1001/jamainternmed.2013.1405