FDA Outlines New Requirements for Immediate-Release OpioidsBy
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb outlined the agency’s plan for combating opioid abuse, which involved new requirements for manufacturers of immediate-release (IR) opioids and for products using abuse-deterrent formulations.
In a September 28, 2017 blog post on FDA Voice, the FDA’s blog, Gottlieb reported the agency has 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 under a Risk Evaluation and Mitigation Strategy (REMS). The REMS requires that training be made available to healthcare providers who prescribe IR opioids, including training on safe prescribing practices and consideration of non-opioid alternatives.
“With respect to the new REMS measures to address the safer use of the IR opioid pain medications, these short-acting drugs will now be subject to the same regulatory requirements as the extended release/long-acting (ER/LA) opioid analgesic formulations,” Gottlieb said. “Since 2012, manufacturers of ER/LA opioid analgesics have been subject to a REMS, which requires, as its primary component, that training be made available to prescribers of those products. To meet this requirement, the sponsors of the ER/LA opioid analgesics have been providing unrestricted grants to accredited continuing education providers for the development of education courses for healthcare professionals based on content outlined by [the] FDA, which the agency calls the ‘Blueprint.’ [The] FDA is now extending these REMS requirements to the IR manufacturers.”
In addition to expanding the REMS to include IR products, the FDA is modifying the content of the educational “Blueprint” required under the REMS. The agency is adding content on pain management, including non-opioid alternatives. This includes: principles related to acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (both non-opioid analgesic and opioid analgesic). The revised Blueprint will also cover information about the safe use of opioids, and basic information about addiction medicine and opioid use disorders.
The FDA’s new Opioid Policy Steering Committee, created in May 2017 to develop ways the agency can decrease the severity of the country’s opioid crisis, is also considering whether there are circumstances when the FDA should require some form of mandatory education for healthcare professionals, and how the agency would pursue such a goal.
Sending out the manufacturer notification letters is the first step in extending the REMS to IR drugs. The agency said that process could take about a year to finalize. While some of the ER/LA manufacturers also make IR opioids, FDA expects to 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, according to the FDA.
Gottlieb said that the FDA also will soon issue a final guidance document that will assist potential applicants seeking approval of a generic version of abuse-deterrent formulations of opioid drugs. He said that most of the currently approved opioids with labeling describing abuse-deterrent properties are ER/LA formulations of opioids and that these drugs are generally formulated to be more resistant to the sort of manipulation that would otherwise make them amenable to snorting and/or injecting. “Addicted patients who start by using the IR drugs will sometimes migrate onto the ER/LA formulations, and then try to manipulate those higher-dose formulations in ways that can provide a more immediate ‘high’” through injection or snorting.” He added that there are currently only brand name abuse-deterrent formulations.