The U.S. Food and Drug Administration (FDA) launched this week REMS@FDA, a Risk Evaluation and Mitigation Strategy (REMS) database website. The new, user-friendly website contains a table of all currently approved individual and shared REMS, as well as a link to historical REMS. The table provides an at-a-glance overview of elements included in each REMS and links to detailed pages for the REMS. All REMS materials are downloadable in PDF format.
The Food and Drug Administration Amendments Act of 2007 granted the FDA the authority to require REMS from drug and biologics manufacturers for products to ensure that any serious risks are outweighed by its benefits. REMS requirements can impose special duties on manufacturers, wholesalers, pharmacists, physicians, and/or patients. Failure to comply with a REMS potentially has significant legal consequences and patient safety implications.
This blog post was co-authored by Amy Westergren, a 2015 summer associate in Cooley’s New York office.