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  4. FDA: Using Science and Teamwork to End the Opioid Crisis - 04/19/2017
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Speech | In Person

Event Title
FDA: Using Science and Teamwork to End the Opioid Crisis
April 19, 2017

Speech by

Remarks by Stephen M. Ostroff, M.D.
Commissioner of Food and Drugs
National Prescription Drug Abuse Summit
Atlanta, Georgia

Thank you, President Capilouto, for the kind introduction.  Let me also thank Congressman Rogers and Nancy Hale for providing the opportunity to be here today. This is my third time attending this meeting and I'm very pleased to be here.

But most of all let me thank you in the audience for the difficult but vital work that you do each and every day to fight the opioid epidemic.  It's YOU who insisted that this epidemic must be a front burner issue. It's YOU who reached out to those who struggle with addiction to help them find a pathway that hopefully leads to recovery.  And it's YOU who continue to advocate and make a difference for so many people, giving us hope that we can turn the tide on this terrible problem. 

To see evidence of your efforts, look at how this meeting has grown in size and prominence in just the 2 years since I last spoke to you.  Meetings like this provide us an opportunity to learn from each other about what seems to be working, what isn’t, and how best to focus our efforts to bring this epidemic under control and save lives.  

As you know well, in 2015 overdose deaths surpassed the 50,000 mark in this country, and almost two thirds of those losses were associated with opioids.  Each of us in one way or another have been touched personally by the misuse and abuse of drugs - whether in our own families, our neighborhoods, our workplaces, or with someone in our care.  There’s a name and a face and a story behind every one of those deaths.  And it is this personal connection that drives our deep commitment to combat this crisis.

FDA has a special role and obligation to help address the opioid crisis.

What We Do 

As you know, prescription opioid pain medications require FDA approval before they can come to market. But so do the lifesaving drugs that treat addiction and reverse overdoses. We have made it a priority to bring these lifesaving products to market as quickly as possible.

As discussed by Francis Collins, we also fully support the development of non-addictive, alternative medications for pain, as well as medical devices to treat pain.   We work to ensure that drug prescribing information on the label clearly and accurately conveys benefits and risks.

The central challenge we as a nation face is that when opioids are prescribed and used appropriately, they are effective at treating pain. But when they are used inappropriately they lead to bad and dangerous outcomes.  Let's be clear -- there are far more opioids dispensed than are needed to treat pain.  That ’s a fact that has to change. And while it is changing, as recent data show there have been declines in overall opioid prescriptions, much more needs to be done to reverse this. 


Those of you who were here last year heard Rob Califf talk about our 8-step agenda to respond to the crisis.

I’m pleased to report that in the past year we’ve made progress on all eight steps.  Time doesn’t permit me to mention all we have done. So I’ll touch on a few highlights:

Critical to addressing opioid over-prescribing is prescriber training. Since 2013, FDA has required that manufacturers of extended release or long-acting opioids provide voluntary prescriber education that addresses both the appropriate use of those medication and how to recognize opioid misuse, abuse, and addiction by patients.  Tens of thousands of prescribers have taken this training, which is based on an FDA blueprint and free of commercial bias.

We continue to work hard to improve this program and think about additional methods to be able to provide this educational material.  This past Monday we announced a public meeting for May 9-10 to obtain input on issues and challenges with Federal and state efforts to support training for health-care providers on pain management and the safe use of opioids. We hope that some of you in the audience will take part in this discussion.

Last year we required stronger warnings on immediate release opioid products often prescribed after minor surgeries, provided a clearer explanation about approved indications and limitations on use for these products and required a patient-friendly Medication Guide, which explains the risks and benefits of drugs.  Previously, this information had only been required for extended release and long acting forms.

And, because in some instances patients are prescribed opioids over an extended period, whether appropriate or inappropriate, we’ve updated our requirements for studies that sponsors must perform after their drug is approved.  This will make manufacturers collect better data on what happens to patients who use these drugs, especially if they are used over the long term.

We remain firmly committed to bring abuse-deterrent formulations of opioids to market – make no doubt about that; nine such products have now been approved. We’ve also issued draft guidance on the development of generic versions of abuse-deterrent formulations, an important  step since generics are a large share of the market. This will assure that generic versions are no less abuse-deterrent than the nine innovator drugs they reference.

For people in recovery from opioid addiction, we’ve now approved an implant that delivers six months of continuous treatment.  This is an especially helpful option for patients who can’t reliably or safely handle a pill or film that may end-up lost, forgotten or stolen.  There has been a tremendous outpouring of interest in this product by both patients and prescribers and many of you in this audience, highlighting the critical need for more options for treating opioid dependence.  We hear you and we want to help.

We’ve also made additional progress on naloxone, as mentioned by Dr. Collins.  We have also sponsored a competition to develop a mobile app that will use crowd-sourcing technology to match people who have naloxone in their possession with those nearby who are overdosing and need this particular drug.  We believe this will save lives. And we’re conducting research on naloxone labeling that will hopefully lead to its over-the-counter availability.  

FDA routinely seek expert advice from our advisory committees and other groups to help us better evaluate opioid products.  And we will continue to do so.

It’s gratifying to see evidence that the actions that we and other agencies have taken are making an impact. Last year we published a study showing that  the Drug Enforcement Agency’s 2014 decision to up-schedule hydrocodone from schedule III to schedule II based on our recommendation resulted in a 13 percent decline in the number of pills dispensed.

Looking Ahead

Let me say that there is still much for FDA to do. But I want to assure you that we will continue to make the opioid epidemic an agency priority, regardless of who is in the front office.  We’re partnering with CDC on their prescribing guidelines and helping them build better sources of data on abuse, overdose, and death from substance abuse.  And we’re engaging with the National Institute on Drug Abuse in research on non-addictive treatments for pain.

We also need to better understand the role and use of abuse deterrent technologies. In one study, nearly half of doctors surveyed believed that abuse-deterrent formulations were less addictive than their counterparts.  Of course, they’re designed to make it more difficult for people to manipulate the drug to make it easier to snort, crush, or inject the drug but they can still be addictive when taken orally.  They are abuse-deterrent but not abuse-proof. We need to be able to better communicate what these drugs can and cannot do. And we are exploring other avenues to deter abuse including innovative packaging solutions.

Last year we published a consumer-focused article on what to ask your doctor before taking prescription opioids. It sounds pretty simple, but arming patients with such a check list can lead to powerful results. I encourage as many of you as possible to download this resource – and get creative about how you might distribute it. 

In closing, let me promise you that FDA is firmly committed to work with you to turn the tide and produce a better future.  We can’t cannot bring back those who have been tragically lost, but we can help those who need help now and in the future. 

Reversing the opioid epidemic won’t be easy. It’s one of the great public health challenges of our time, without question, I believe.  But working together we can meet the challenge.

Thank you for listening, and for continuing to share your ideas with us.

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