Democrat lawmakers call on FDA to take steps to prevent misuse of Orange Book

Sen. Eliz­a­beth War­ren (D-MA) and Rep. Prami­la Jaya­pal (D-WA) are call­ing on the FDA to make re­forms to the Or­ange Book of gener­ic drug patents in an ef­fort to crack down on an­ti­com­pet­i­tive busi­ness prac­tices by name brand drug com­pa­nies.

In a let­ter sent to FDA Com­mis­sion­er Robert Califf on Tues­day, the law­mak­ers asked the FDA to make sev­er­al changes to its sys­tem for main­tain­ing the Or­ange Book, the agency’s com­pre­hen­sive list of patent and ex­clu­siv­i­ty in­for­ma­tion on FDA-ap­proved drug prod­ucts.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.