The Food and Drug Administration Amendments Act (FDAAA) of 2007, signed on September 27, 2007, by President George W. Bush, created section 505-1 of the Food, Drug, and Cosmetic Act (FD&C Act) which authorizes FDA to require a Risk Evaluation and Mitigation Strategies (REMS) for certain drugs if FDA determines that a REMS is necessary to ensure the benefits of a drug or biological product outweigh its risks.
REMS stands for Risk Evaluation and Mitigation Strategy. It’s a drug safety program required by the U.S. Food and Drug Administration (FDA) for certain medications with serious safety concerns to ensure that the benefits of the drug outweigh its risks. REMS programs aim to prevent, monitor, and manage specific serious risks associated with a drug by educating and reinforcing safe use behaviors, according to the FDA
Why REMS in SPL?FDA has chosen to transition REMS to SPL format for several reasons. In the current PDF submission model, REMS exhibit little standardization in description, format or terminology and vary widely in their ease of use. Submission of REMS in SPL will help to clarify and standardize REMS content across the industry, making FDA review procedures more efficient. In addition, REMS in SPL will increase access and ease of use for all REMS content stakeholders, including sponsors, FDA, providers, prescribers and patients, with the ultimate goal of improving patient safety.
Structured REMS data in a format like SPL can help integrate REMS into the healthcare system and ensure stakeholder awareness of and compliance with REMS.
FDA has chosen to transition REMS to SPL format for several reasons. In the current PDF submission model, REMS exhibit little standardization in description, format or terminology and vary widely in their ease of use. Submission of REMS in SPL will help to clarify and standardize REMS content across the industry, making FDA review procedures more efficient. In addition, REMS in SPL will increase access and ease of use for all REMS content stakeholders, including sponsors, FDA, providers, prescribers and patients, with the ultimate goal of improving patient safety.
Elements to Assure Safe Use (ETASU)All REMS should include one or more overall goals, and if the REMS has Elements to Assure Safe Use (ETASUs), the REMS must include one or more goals to mitigate a specific serious risk listed in the labeling of the drug and for which the ETASU are required.
Section 505-1(f) of the FD&C Act lists certain Elements to Assure Safe Use that may be required if the drug has been shown to be effective, but is associated with a specific serious risk and can be approved only if, or would be withdrawn unless, such elements are required as part of a strategy to mitigate the specific serious risk(s) listed in the labeling of the product.
Want to Learn More?If you have questions about how REMS impacts your organization or how we can help you navigate compliance requirements, please contact us or speak with one of our compliance specialists.