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

Brand name companies’ use of restricted distribution programs to block the development of generic drugs has been an unintended consequence of the FDA Amendments Act of 2007. The generics industry has long complained that the use of FDA-required risk management plans prevents access to affordable medicines. While that battle has ranged in the courts, FDA has remained quiet on the subject. Until now.