REMS “Abuses” Concern FDA, But Can Scolding Help Speed Generic Entry?

Innovator drug companies have become increasingly crafty at using Risk Evaluation & Mitigation Strategies to block the development of generic competitors – to the point where they are abusing the system, FDA Office of New Drugs Director John Jenkins, MD, declared during the FDA/CMS Summit for Biopharmaceutical Executives in Washington, D.C. in December.

Without naming names, Jenkins said that “some innovators have very cleverly taken it as an opportunity to evergreen their products” and “have become really aggressive in using that strategy and...