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Gottlieb: Immediate Release Opioids to be Subject to REMS

Posted 28 September 2017 | By Michael Mezher 

Gottlieb: Immediate Release Opioids to be Subject to REMS

FDA Commissioner Scott Gottlieb on Thursday said that immediate-release (IR) opioids will be subject to the same risk evaluation and mitigation strategy (REMS) as extended-release and long-acting (ER/LA) opioids.

The agency first required a REMS for ER/LA opioids in 2012.

"This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements," Gottlieb writes.

But Gottlieb cautioned that the process to extend the REMS to IR opioids "could take about a year to finalize."

The move comes a year and a half after the agency announced a class-wide labeling change for IR opioids that added a boxed warning describing the serious risk of misuse, abuse, addiction, overdose and death posed by the drugs, as well as a warning that chronic opioid use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS).

Under the REMS, manufacturers of IR opioids will be required to make training available to healthcare providers based on information in FDA's "blueprint" on opioid education. According to Gottlieb, the blueprint is also being updated to include information on non-opioid alternatives for pain management and "basic information about addiction medicine and opioid use disorders."

Notably, the training is not mandatory for healthcare professionals, though Gottlieb said FDA is still considering its options for mandatory training.

In a separate notice published in the Federal Register Thursday, FDA asked for input on additional steps it can take to ensure the appropriate use of opioids, including whether the agency should institute some form of mandatory prescriber education or if it should add recommended treatment durations for specific uses to opioid labeling.

Once in place, REMS will apply to some 277 IR opioids, in addition to the 64 ER/LA formulations that are already subject to the REMS.

Gottlieb also said the training programs will now be made available other healthcare professionals involved with pain management, such as nurses and pharmacists. In the past, the training was provided only to opioid prescribers.

"FDA believes that all health care professionals involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving an opioid analgesic, they can help ensure that the product is properly indicated for the patient and used under appropriate clinical care," Gottlieb writes.

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