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FDA Commissioner Asks Staff for ‘More Forceful Steps’ to Stem the Opioid Crisis | FDA Voice

FDA Commissioner Asks Staff for ‘More Forceful Steps’ to Stem the Opioid Crisis | FDA Voice | Pharma Industry Regulation |

As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases of addiction.


I sent an email to all of my colleagues at FDA, sharing with them the first steps I plan to take to better achieve this public health goal. With this, my first post to the FDA Voice blog, I also wanted to share my plans with you.


As a first step, I am establishing an Opioid Policy Steering Committee that will bring together some of the agency’s most senior career leaders to explore and develop additional tools or strategies FDA can use to confront this crisis.


The initial questions I have 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?


Further Reading:

  • “FDA OKs Pfizer's Abuse Deterrent Opioid Troxyca ER Despite Public Citizen Testimony”;
  • “Former FDA Commish Kessler Slams Docs, #FDA for Opioid Epidemic”;
  • “Opioid Epidemic Getting Worse Due to FDA, Which Now Says It Will Change Its Ways”;
  • “Dr. Gottlieb's Comments on Opioid Epidemic at His Senate Confirmation Hearing”;
  • “FDA Requires New Safety Warnings to be Added to Prescription Opioid Drug Labels”;
Pharma Guy's insight:

Too little, too late?

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