FDA takes further steps to strengthen REMS program to confront opioid crisis

Statement From: Commissioner of Food and Drugs - Food and Drug Administration, Stephen M. Hahn M.D.

While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis. We remain committed to using all facets of our regulatory authority to lessen the impact of opioid addiction, misuse, and abuse while also striking a careful balance between patient access and safety to ensure that patients suffering from significant pain have access to appropriate medication.

To that end, the FDA has been and continues to address this public health crisis on a number of fronts, including efforts to:

  • Decrease unnecessary exposure to prescription opioids and prevent new addiction;
  • Support the treatment of those with opioid use disorder;
  • Foster the development of new and effective pain therapies; and
  • Take action against those who contribute to the illegal importation and sale of opioid products.

Part of our regulatory authority efforts include requiring Risk Evaluation and Mitigation Strategies (REMS) for various opioid analgesics to help mitigate the serious risks associated with their use.

Today, we took further steps to strengthen the REMS program for transmucosal immediate-release fentanyl (TIRF) products to help ensure that the benefits of these drugs continue to outweigh the risks.

TIRF medicines contain fentanyl, a powerful opioid, and are used to manage breakthrough pain in adults with cancer who are routinely taking other opioid pain medicines around-the-clock for pain. To use the TIRF medicines safely, these patients must be opioid tolerant based on concurrent regular use of another opioid medication.

Despite the decline in the use of TIRF medicines in recent years, data have suggested that prescribing of TIRF medicines still occurs in patients who are not opioid tolerant. With this in mind, the FDA finalized modifications to the REMS program to address the persistence of these concerning prescribing practices. These changes will also improve our ability to monitor for adverse events and ensure safe use of these medicines.

In particular, this program has been strengthened to:  

  • Require that prescribers document a patient's opioid tolerance with each prescription of a TIRF medicine for outpatient use;
  • Require outpatient pharmacies dispensing TIRF medicines to document and verify a patient's opioid tolerance before dispensing;
  • Require inpatient pharmacies to develop internal policies and procedures to verify opioid tolerance in patients who require TIRF medicines while hospitalized; and
  • Require a new patient registry for use, along with other data sources, to monitor for accidental exposure, misuse, abuse, addiction, and overdose.

In addition to the modifications to fortify the TIRF REMS program, the FDA also continues efforts to evaluate the opioid analgesic (OA) REMS. Earlier this month, we hosted a workshop inviting scientific discussions about methods to evaluate the impact of the OA REMS on prescriber behavior and patient outcomes. The goal of the OA REMS is to educate prescribers and other health care providers (including pharmacists) on the treatment and monitoring of patients with pain. The public workshop served as a forum for public scientific discussion of innovative, multidisciplinary methods to consider when evaluating the OA REMS education program. The FDA will use these discussions to ensure that the methods ultimately used to evaluate the OA REMS are scientifically sound.

Effectively addressing the opioid crisis requires continued focus and collaboration across many different stakeholders. The FDA's REMS are an important tool, and it's critical we ensure they are continuing to fulfill their purpose.  

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