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Statement by FDA Commissioner on Agency's Work to Address Opioid Crisis

Statement by FDA Commissioner on Agency's Work to Address Opioid Crisis

by americanpharmaceuticalreview

August 30, 2018

Over the past 17 months, we've set out to address the opioid crisis forcefully, using all the agency's tools and authorities. These steps have been part of a comprehensive approach that the Secretary of Health and Human Services has outlined. Our efforts at the U.S. Food and Drug Administration are part of these broader efforts and cut across three broad areas.

Statement by FDA Commissioner on Agency's Work to Address Opioid Crisis

First, we set out to cut the rate of new addiction. We did this in part by taking new steps to rationalize the prescribing of opioids, and amounts dispensed, as a way to reduce exposure to the drugs in the medical setting.

Second, we've stepped up enforcement of the marketing and sale of illicit opioids. One way that we're doing this is by targeting online sites that enable the illegal sale of these drugs and their shipment through the mail.

Finally, we've undertaken new efforts to support novel product innovation. This includes innovation in treatments for opioid addiction, and efforts to promote their more widespread use. And it also includes steps to advance the development of non-addictive treatments for pain. We have great concern for the millions of Americans who live with chronic pain and for whom traditional treatment options have been exhausted.

I want to take this opportunity to provide an update on some of the work we are doing across each of these three areas and some of the new efforts we're going to pursue.

To pursue these goals, and many other commitments, in the last 17 months, we've taken a range of new steps.

We set out to extend our risk evaluation and mitigation strategy program to cover the immediate release formulations of opioid drugs, and we've updated our educational content for providers to include information on non-opioid alternatives. We also, for the first time, extended this training to non-physician prescribers.

And we've advanced a broad effort to develop evidence-based guidelines for opioid prescribing. We want to make sure that when opioids are used, the amount dispensed comports with the clinical reasons why these drugs are being used in the first place. No more 30-day prescriptions for a tooth extraction or an appendectomy.

We've also taken steps to protect children from unnecessary exposure to certain opioids in some common prescription cough and cold medicines.

We committed to look closely at the risks associated with the illicit use of these drugs as a factor in how we evaluate their pre- and post-market safety. We requested the market withdrawal of one drug – Opana ER – based on a consideration of risks that were manifest only when this drug was being misused and abused. We'll soon release new guidance outlining how we make these considerations of risks associated with illicit use a clear factor in our pre- and post-market regulatory decisions.

We also took enforcement actions, including work in collaboration with the Federal Trade Commission targeting the proliferation of products on websites that marketed unapproved treatments for pain and addiction. With additional actions that we took yesterday, we've brought to 70 the number of web sites that we've targeted this summer for marketing unapproved opioid drugs. More enforcement actions are on the way. We also formed a broad collaboration with legitimate internet sites – including leading social media platforms – to target the sale of opioids in ways that are visible to the public, and in some ways that are not apparent.

We sharply expanded our oversight of drugs being shipped illegally through international mail facilities, growing by nearly a factor of 10 the number of packages that the FDA is able to open and inspect. We have also increased our special agents doing criminal work at the ports of entry as well as cybercrime, strategic intelligence and strategic analysis units – all of whom are critical to effective enforcement. And we launched major operations with other federal partners to target these shipments and get an accurate estimate of how many opioids are coming in illegally through ...

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