Appeal for Legislative Action to Address Rems Concerns

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision under the Food and Drug Administration Amendments Act (FDAAA), which was enacted in 2007, that provides the FDA with authority to restrict distribution of drugs that have safety concerns. Bruce Leicher, President of the Biosimilars Council and the VP and General Counsel of Momenta explained that abuse of REMS by innovator companies can prevent distribution of reference products to biosimilar companies, potentially raising a significant hurdle to the development of biosimilar products. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) confirmed that there have been more than 150 complaints from generic companies regarding difficulties faced in obtaining samples of non-biologic compounds for equivalence testing. Dr. Woodcock stated that the FDA does not have the authority to compel drug companies to disseminate samples of their drugs for studies by generic and biosimilar companies.

In a later hearing held by the House Subcommittee on Health Care, Benefits, and Administration, Bruce Leicher and Dr. Gerard Anderson, Director for Johns Hopkins Center for Hospital Finance and Management testified regarding REMS issues. While Mr. Leicher asserted that it was time for legislation to address the REMS “concerns”, Dr. Anderson advocated passing of the Fair Access for Safe and Timely Generics Act (FAST) bill. The FAST bill, which was introduced in the House in June 2015, would require innovator companies to provide requested samples of their products to generic and biosimilar manufacturers within 30 days of their request.

We will continue to update our readers on this subject.