REMS Hurdles To Generic Entry: From Brand Access To Patent Claims

Can generic manufacturers use patented elements of a drug distribution plan? Will FDA accept an alternative REMS program? Will brand companies have to provide access to their products? As the number of brand products subject to REMS grows, so do the unanswered questions for generic firms.

Generic manufacturers have long worried that brand companies could use Risk Evaluation and Mitigation Strategies to thwart generic competition, with controversy focusing on the ability of ANDA sponsors to access an innovator product for bioequivalence testing when a REMS restricts its distribution. But as FDA settles into the REMS era and the number of products subject to the programs continues to grow, there are a host of other factors that may impede generic entry.

Former Apotex Inc. attorney Shashank Upadhye rattled off numerous legal questions surrounding REMS at the American Conference Institute’s annual...