FDA Increases REMS Requirements for Opioids

On Sept. 28, 2017, in a FDAVoice blog post, FDA Commissioner Scott Gottlieb, MD, announced that immediate-release (IR) opioids will be subject to “more stringent” requirements under a Risk Evaluation and Mitigation Strategy (REMS). The new requirements, which include training for healthcare providers, are part of the agency’s battle against opioid addiction in the United States. The agency sent out letters this week to manufacturers informing them of the new requirements.

The new REMS requirements will put IR opioids under the same level of regulation as extended release/long-acting (ER/LA) formulations. Makers of ER/LA opioid analgesics provide unrestricted grants to continuing education providers to teach healthcare professionals about these products based on FDA-provided content. FDA will add information on pain management to this content, including information on chronic pain management, non-opioid alternatives, non-pharmacologic pain treatment, and prescription drugs. This training will also be made available to nurses and pharmacists who help patients manage chronic pain.

“While some of the ER/LA manufacturers also make IR opioids, today’s action will greatly expand the number of products covered by the REMS. The existing REMS currently includes 64 ER/LA opioid analgesic products. Once the action is finalized, an additional 277 IR opioid analgesics will be subject to these REMS requirements,” Gottlieb said in the blog post.

Source: FDA