PW01-007 – Colchicine brand switching in FMF patients

Introduction In July of 2009 the U.S. Food and Drug Administration enacted new regulation of colchicine under the “Unapproved Drugs Program.” Like other old drugs that were on the market before the existence of the FDA, colchicine had never been subjected to FDA-required safety and efficacy trials. One company elected to put colchicine through the FDA’s approval protocol and when approval was granted in 2009 the FDA announced a ban on five unapproved brands of colchicine on the market and gave proprietary rights to one approved brand. The sudden brand changes that followed this regulation led to a therapeutic crisis for FMF patients in the U.S. and coincidentally revealed heretofore unrecognized patterns in patient response to different brands of colchicine.