Changes in Prescription Drug and Healthcare Use After a Large Price Increase for Colchicine

Prior to 2010, colchicine was available as an inexpensive generic but was not formally approved by the U.S. FDA; colchicine had been used for decades before the FDA began requiring new drugs to show formal proof of efficacy in the 1960s. In 2010, after a manufacturer-sponsored clinical trial of colchicine's efficacy, the FDA approved brand-name Colcrys and awarded the manufacturer 3 years of market exclusivity; all generic colchicine was removed from the market (NEJM JW Gen Med Jul 1 2010). After this change, the price of colchicine increased drastically, and its use decreased. In this retrospective cohort study, researchers use 2.7 million patient-years of observations for patients with gout (mean age, 57) during 2007 to 2019 to evaluate a…