FDA Unveils New Steps to Address the Opioid Crisis

FDA logo on large outdoor sign

As the opioid crisis continues in the United States, the U.S. Food and Drug Administration (FDA) has drafted new plans that will allow it to address past mistakes and “get ahead” of the situation that claims the lives of over 100 Americans per day.

FDA Commissioner Scott Gottlieb said the agency has learned from past mistakes it, as well as other agencies made in order to stem the opioid crisis. In a statement issued Tuesday, Gottlieb said the FDA intends to “make sure that we’re acting forcefully enough to address new threats that could extend this crisis.” Gottlieb said the agency has changed its approach to the opioid crisis and will take a more aggressive approach on regulatory actions.

“At the FDA, we’ve committed to taking more rapid action in the face of new threats, like the growing prevalence of illicit fentanyl that’s contributing to overdose deaths, or the continued prevalence of prescriptions being written for durations of use that are too long for the clinical circumstances for which they’re intended. We’ve changed the way we’re tackling these issues and stepped up our intervention when it comes to opioids, Gottlieb said.

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He noted that the agency made a mistake to wait for “the accumulation of definitive evidence of harm” kept the FDA behind a crisis that was quickly, and sometimes unnoticeably evolving in communities across the country.

Over the course of 2018, the FDA began to implement policies and controls that would help slow the potential for abuse of prescribed opioids. More action will be taken throughout this year, Gottlieb said. The FDA, he said, is taking new steps to reduce exposure to opioid analgesics by helping to ensure that these drugs are appropriately prescribed, with dose, quantity and treatment durations that match the indication.

Passage of the SUPPORT Act has provided the FDA with important new authorities to assist in our effort to reduce the risk of addiction and misuse associated with opioid analgesics, Gottlieb said, As an example, the law allows the FDA to require certain packaging be made available for opioids and other drugs that pose a serious risk of abuse or overdose if the FDA determines that such packaging may mitigate such risks. In the first half of this year, Gottlieb said the FDA plans to implement initial steps to require a unit of dose packaging in the first half of 2019. The kinds of packaging that Gottlieb is describing could help reduce over-prescribing by giving providers a convenient option that contains only enough drug doses for up to a few days of opioid treatment at standard dosing. Citing FDA data, Gottlieb said it suggests that for many acute pain indications where opioids are used, a day or two of the dispensed drug is the appropriate quantity.

Also this year, Gottlieb said the FDA will consider a framework that will allow the FDA to “formally evaluate each candidate opioid in the context of how a novel opioid might fit into the overall therapeutic armamentarium that’s available to patients and providers.” With this framework, Gottlieb said it will allow the FDA to address questions it is frequently asked about whether or not new opioid-based drugs would provide greater benefit and safety to patients than existing opioid treatments.

For those caught up in the addiction of opioids, Gottlieb said the FDA will prioritize new efforts to advance therapies for treatment. This includes new guidance aimed at supporting the development of novel medicines as well as novel medical devices such as digital health tools, advancing new policies to promote the adoption of safe and effective medication-assisted treatment, he said.

The agency will also focus on approving new non-addictive treatments of pain, as well as advance new steps to promote the development of abuse-deterrent formulations of opioids. The FDA will also work with law enforcement to target those who unlawfully market or distribute illicit opioids and other unapproved drugs, Gottlieb said.

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