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June 15, 2017

Gottlieb Establishes Committee to Address Opioid Crisis

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FDA Commissioner Scott Gottlieb – sworn in on May 11, 2017 – has established a steering committee to address the opioid crisis and advise regulators on such steps as prescription limits. Gottlieb, who said overuse of painkillers was his top priority during his confirmation hearing, wrote in a blog post that he “believes it is within the scope of FDA’s regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients.”

Before announcing the steering committee, Gottlieb made sure to acknowledge the work that has been done by FDA to date, and how many people are working hard on this problem.

Gottlieb noted the committee will address whether the FDA should mandate training for health professionals and work with providers to ensure the number of doses prescribed is closely related to the condition for which a patient is being treated. Gottlieb mentioned how there are few situations when a patient needs a 30-day supply of opioids. The committee will also consider whether the agency's drug review process for opioids adequately considers risk and the potential for abuse.

Specifically, there are three initial questions Gottlieb has asked the Steering Committee to answer. They are:

  1. 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?
  2. 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.
  3. 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?

The actions are the first Gottlieb has taken on opioid misuse since taking the helm of the FDA. The steering committee will be made up of senior agency leaders and will solicit public comment.

Gottlieb closes his blog by noting,

Working together, we need to do all we can to get ahead of this crisis. That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider. I look forward to working closely with my FDA colleagues as we quickly move forward, capitalizing on good work that has already been done, and expanding those efforts in novel directions. I will keep you updated on our work as we continue to confront this epidemic.

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