Gottlieb Establishes FDA Committee to Confront Opioid Crisis

Posted 23 May 2017 By Zachary Brennan

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Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction."

As a first step, Gottlieb announced the establishment of an Opioid Policy Steering Committee to bring together some of the agency’s senior career leaders to explore and develop tools or strategies to confront the crisis.

The initial questions Gottlieb has tasked the steering committee to answer are:

  • "Are there circumstances under which FDA should require some form of mandatory education for health care professionals, to make certain that prescribing doctors are properly informed about appropriate prescribing recommendations, understand how to identify the risk of abuse in individual patients, and know how to get addicted patients into treatment?
  • Should FDA take additional steps, under our risk management authorities, to make sure that the number of opioid doses that an individual patient can be prescribed is more closely tailored to the medical indication? For example, only a few situations require a 30-day supply. In those cases, we want to make sure patients have what they need. But there are plenty of situations where the best prescription is a two- or three-day course of treatment. So, are there things FDA can do to make sure that the dispensing of opioids more consistently reflects the clinical circumstances? This might require FDA to work more closely with provider groups to develop standards for prescribing opioids in different clinical settings.
  • Is FDA using the proper policy framework to adequately consider the risk of abuse and misuse as part of the drug review process for the approval of these medicines? Are we doing enough when we evaluate new opioid drugs for market authorization, and do we need additional policies in this area?"

Gottlieb noted that the committee will have a broad mandate to consider whatever additional questions FDA should be seeking to answer, and it will solicit input and engage the public.

Earlier this month, the agency began weighing its options for improving healthcare provider training and education on prescribing opioids. It also proposed some changes to its blueprint for opioid prescriber education.

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Categories: Drugs, Crisis management, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: opioids, Scott Gottlieb, Opioid Policy Steering Committee

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