FDA Announces New Policy Steps to Address Opioid Crisis

The US Food and Drug Administration (FDA) is looking into proactive and “more forceful steps” to deal with the ongoing opioid addiction crisis, according to a statement released today by FDA commissioner Scott Gottlieb, MD.

This includes forming a new steering committee, asking the public to share their ideas and experiences in online forums and at an upcoming 2-day meeting scheduled for July 10 and 11, and delving into medications’ abuse-deterrent properties in order to see whether more can be done.

“The FDA is committed to looking at all facets of this complex issue and collaborating on various approaches, as there are no simple answers to reverse this epidemic,” said Dr Gottlieb in the release.

The steering committee will “examine additional regulatory and policy actions that we can take to combat the crisis,” he reported, adding that assessing ways to reduce new cases of addiction will be a priority for the new group.

Discussion at the public meeting will center on whether abuse-deterrent properties are actually helping and, if not, whether they can be improved.

Some of the products include formulations that make snorting, crushing, and/or injecting the drug difficult. Others have added an ingredient, such as naloxone, to block the high of the opioid.

“This has been an important area of innovation that the FDA continues to support,” Dr Gottlieb said. “However, we recognize that there is a gap in our understanding of whether these products result in a real-world, meaningful decrease in the frequency and patterns of opioid misuse and abuse.”

“May Hold Promise”

Although the FDA is requiring marketing companies to conduct postapproval research into these issues, the agency notes that more answers are needed to form the basis of strong regulatory decisions.

Plans for the public workshop include discussions on how to better use existing data for real-world evaluations of the abuse-deterrent products and how to create new data sources and study designs.

Dr Gottlieb noted that that none of the deterrent properties are absolutely abuse-proof, but they still “may hold promise” as part of a broader plan.

“One thing is clear: we need better scientific information to understand how to optimize our assessment of abuse deterrent formulations, and I look forward to a productive discussion on how to best tackle this challenge,” he said.

On June 8, the FDA announced it had asked Endo Pharmaceuticals to remove its abuse-deterrent extended-release formulation of oxymorphone (Opana ER) from the market, after a review of postmarketing data showed a significant shift in the route of abuse of the product from nasal to injection after its reformulation. Injection abuse of reformulated product has been associated with an outbreak of HIV infection and hepatitis C, as well as cases of thrombotic microangiopathy, the statement noted.

The move marked the first time the FDA has taken steps to remove a currently marketed opioid pain medication from sale because of the public health consequences of abuse. “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks,” the FDA said in a statement.

The FDA has released an issues paper explaining existing public health and regulatory challenges, as well as registration information and the process for submitting comments for the meeting. The meeting will be held from 8:30 am to 5:30 pm on July 10 and 11 in Silver Spring, Maryland. The public workshop will also be streamed live online.

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