Incentives for Drug Development — The Curious Case of Colchicine

Abstract

In their Perspective article, Kesselheim and Solomon (June 3 issue)¹ note that the approval of oral colchicine (Colcrys) by the Food and Drug Administration (FDA) resulted in a substantial increase in the drug's price. Because URL Pharma was the first to submit clinical trial data and be granted approval for oral colchicine, federal law required that the company be given marketing exclusivity for the indication of acute gout for 3 years and for the indication of familial Mediterranean fever for 7 years. Congress wrote these laws to encourage innovation, although such regulations sometimes have a broader sweep. The FDA is required to implement the laws as written and has no authority to regulate drug prices. Manufacturers could seek approval for colchicine for chronic gout; no marketing exclusivity exists for this indication.