The Food and Drug Administration Amendments Act (FDAAA) of 2007 (P.L. 110-85) gave FDA the authority to require manufacturers to create Risk Evaluation and Mitigation Strategies (REMS) to ensure that the benefits of a drug outweigh its risks. The purpose of REMS is to provide additional safety measures for a drug that would otherwise not be allowed on the market due to safety concerns.
For the most part, since 2007, REMS have been developed and implemented on an individual product level, requiring different processes, procedures and systems to implement. Even when several drugs of a similar composition or indication for use are grouped together into a “class-wide” REMS, operational differences still exist from REMS to REMS. Depending on the type of REMS, healthcare distributors provide administrative support to manufacturers’ programs. For example, some REMS include certification requirements that limit who may order the drug and, by extension, to whom the distributor may distribute the drug. While there have been improvements to the REMS implementation processes, healthcare distributors, prescribers and dispensers still must adjust to differing REMS requirements as each manufacturer may design their REMS with differing components.
HDMA supports patient safety initiatives such as REMS to ensure patient access to needed medications. We also strongly support efforts by FDA and other stakeholders to standardize REMS to ensure that program components are consistent across drugs and to reduce the associated costs and burden throughout the supply chain.