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Regulatory Focus™ > News Articles > 2019 > 2 > FDA Plots New Ways to Address Opioid Epidemic in 2019

FDA Plots New Ways to Address Opioid Epidemic in 2019

Posted 26 February 2019 | By Zachary Brennan 

FDA Plots New Ways to Address Opioid Epidemic in 2019

While acknowledging “past mistakes” related to the opioid epidemic, the US Food and Drug Administration (FDA) on Tuesday drew up new actions it will take to stem the crisis in 2019.

The comments and commitments from FDA follow a report from "60 Minutes" last Sunday questioning if FDA enabled an expansion of the opioid epidemic.

But moving forward, FDA says it has new tools to help combat the crisis. For instance, passage of the Support Act last October has provided the agency with new authorities to allow FDA to require certain packaging to be made available for opioids and other drugs that pose a serious risk of abuse or overdose.

“We plan to implement the initial steps to require unit of dose packaging in the first half of 2019. Specifically, the FDA is considering use of this new authority to mandate that certain solid, oral dosage forms of immediate-release formulations of opioid analgesics indicated for treatment of acute pain be made available in short-duration packaging for outpatient dispensing,” FDA Commissioner Scott Gottlieb said.

He noted that such packaging could reduce over-prescribing by giving providers an option that contains only enough drug doses for up to a few days of opioid treatment.

The law also allows FDA to require manufacturers to develop “disposal technologies (such as a mail-back pouches) to get unused medications out of medicine cabinets,” which is another new authority FDA plans to implement in the first half of 2019.

Caution in approving new opioids and re-evaluating current Risk Evaluation and Mitigation Strategy (REMS) programs for opioids are two other areas the agency plans to pursue. A recent article published in JAMA details how a class-wide REMS did not prevent the inappropriate prescribing of transmucosal immediate-release fentanyl medicines.

Gottlieb said FDA will “address the question we’re frequently asked as to whether new opioid drugs should offer some comparative benefit over existing drugs. This process could include seeking revisions to statutory authorities to allow us to change the weight we give to meaningful therapeutic differentiation for proposed new opioids, including relative safety or effectiveness advantages over existing treatments.”

As part of efforts to promote the development of drugs to treat pain that are not addictive, FDA later this year also will issue updated guidance outlining the appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain.

“We’ll also advance new steps to promote the development of abuse-deterrent formulations of opioids by exploring new methods for analyzing and evaluating abuse-deterrent features; further evaluating the nomenclature used to describe these abuse-deterrent features; and facilitating development of science for generic versions of these products,” Gottlieb added.

And on the enforcement end of opioids, FDA is working in partnership with US Customs and Border Protection (CBP) to expand information sharing and maximize each agency’s inspection and detection capabilities at the border to protect the public from illegal and potentially harmful products entering the US.

As part of the 2019 budget, the agency also received $20 million to create a large-scale data warehouse to improve its analytic capabilities to better evaluate social and clinical trends that are affecting the trajectory of the opioid crisis.

Gottlieb Statement


© 2021 Regulatory Affairs Professionals Society.

Tags: epidemic, FDA, opioids

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