ASA Commends FDA Decision: Agency Announces REMS is Necessary for Prescribing Immediate Release Opioids
ASA commends FDA for its recent announcement regarding the expansion of the Risk Evaluation and Mitigation Strategy (REMS) program for opioids. At a meeting
of the Food and Drug Administration (FDA) convened for a discussion on opioid formulations with properties designed to deter abuse, Commissioner Scott Gottlieb, M.D. announced the need for REMS to apply to all classes of opioids – a position long supported by ASA.
In a statement
about steps the FDA is taking to address the nation’s opioid crisis, the Commissioner said:
“As one step, we’ve determined that a Risk Evaluation and Mitigation Strategy plan or REMS is necessary for the prescribing of immediate release opioid products. This regulatory tool is needed to ensure that the benefits of how these drugs are prescribed continue to outweigh the risks of misuse, abuse, addiction, overdose, and death. It’s time to take direct action to address the close to 200 million opioid analgesic prescriptions each year that are for the immediate release products.”
In 2007, legislation was enacted that gave FDA the authority to require a Risk Evaluation and Mitigation Strategy-(REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. The Extended-Release and Long-Acting (ER/LA) Opioid Analgesic REMS was approved in 2012 and is one strategy among multiple national and state efforts to reduce the opioid misuse and abuse. As part of the REMS, all ER/LA opioid analgesic companies must provide certain education for prescribers of these medications. During that time, FDA developed the Blueprint for Prescriber Education
, which describes the content that should be included in the education and the core messages that should be communicated to prescribers. Over the years, FDA has modified the Blueprint and most recently, released revisions
expanding the Blueprint to incorporate pain management and extend training to other health care professionals involved in the management of patients with pain (e.g. nurses and pharmacists).
The Commissioner’s announcement was made in conjunction with the close of the public comment period on revisions
to the FDA Blueprint. ASA is pleased the FDA has considered feedback from ASA and other stakeholders. In the Society's formal comments this month
, ASA recommended that REMS apply to all opioid products— immediate release, in addition to extended release and long acting opioid analgesics. This is not the first time that ASA has made this recommendation. ASA advocated for this important concept when providing feedback on the initial draft Blueprint in 2011
, as well as in 2016 when FDA was reevaluating the REMS program, explaining that ER/ LA formulations
only account for a small portion of total prescriptions. More recently, in May, ASA conveyed
that application of REMS to all opioid products is a crucial component of prescriber education at an FDA public workshop on health care provider training and education.
ASA is pleased FDA is taking this important step as one of the many actions the agency plans to take to address the nation’s opioid crisis.
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