As you may know, FDA recently began accepting Risk Evaluation and Mitigation Strategy (REMS) submissions in Structured Product Labeling (SPL) format. Although the FDA’s targeted date for acceptance was delayed slightly from September 2, the agency told us that it is ready to accept REMS SPL submissions as of September 30.
Some industry members may question whether REMS in SPL is worth the effort, since SPL is not yet mandated for REMS.
Here are four great reasons to get start submitting REMS in SPL now:
FDA has indicated that a mandate is coming. REMS SPL is a priority for FDA and for industry stakeholders, including the National Counsel for Prescription Drug Programs. The FDA views it as a key step in its mission to ensure and improve drug safety. Sponsors can delay getting on board with this initiative but eventually they will have no choice.
SPL will standardize REMS content and improve accessibility of critical information needed to ensure safe use, providing links throughout the healthcare technology chain. REMS SPL can be connected to SPL drug labeling documents and to a patient’s Electronic Health Record (EHR).
Drug sponsors are already investing in SPL. SPL is the format designated by the FDA for electronic Drug Listing, Drug Establishment Registration, NDC Labeler Code Requests, GDUFA Self-Identification submissions and more. To meet these requirements, drug sponsors should already have a partnership with an SPL software/services vendor, such as Reed Tech, or be using other SPL tools and internal expertise. REMS in SPL is the natural next step.
FDA is offering help to early adopters. Free assistance is currently available for sponsors who need help creating the REMS Summary section. This is an opportunity for sponsors with REMS products to learn directly from the FDA about how to meet coming requirements.
If you would like to discuss implementing REMS SPL within your organization with an SPL subject matter expert, you can also contact us anytime.