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  1. Speeches by FDA Officials


Event Title
Remarks at the FDA Online Opioid Summit
June 27, 2018

Speech by
Scott Gottlieb, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( May 2017 - April 2019 )

Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
FDA Online Opioid Summit --
Reducing Availability of Illicit Opioids Online

White Oak, MD

(Remarks as prepared for delivery)

Good afternoon. It’s a pleasure to be with you today.

Opioid addiction and abuse is an immense public health crisis.

And addressing it is one of my and FDA’s highest priorities.

On average, 115 Americans die every day from an opioid overdose.  In 2016, opioids killed more than 42,000 people, surpassing even the number of deaths resulting from traffic accidents in the United States. 

This crisis has taken many dangerous turns, and has always remained one step beyond our grasp as it swelled out of control. Now we’re seeing a skyrocketing increase in accidental drug overdoses due to dangerous opioids like fentanyl.  Increasingly people are going on-line to illegally buy opioids like Vicodin or Percocet or Oxycontin, but what we believe they’re really getting is pressed fentanyl. At doses that can be lethal.

The metrics are staggering. And they demand that all Americans work together to reduce the harsh impact opioid addiction and abuse has on the lives of so many of our neighbors, family members, and friends. 

To do so, we need to address the different facets of the opioid crisis, and its evolution from an epidemic mostly involving prescription drugs to one that’s increasingly fueled by illicit substances being purchased online or off the street. This will take a concerted and multi-pronged approach.

And it’ll require us to learn from the lessons of the past. 

One of the primary lessons we learned is how quickly actions taken to curtail opioid abuse and misuse in one part of the market can be thwarted as demand shifts to other, even more dangerous channels.

This history challenges us to deal briskly when new aspects of the addiction crisis emerge. We need to give the criminal purveyors of these products no quarter. That’s what we’re aiming to do.

I don’t want to be caught one step behind a dangerous new turn of this crisis. That’s why we’re going to hit back hard against the illegal sales of illicit drugs like fentanyl -- drugs that are being bought and sold online in many cases, and are flowing through international mail facilities.

Our overall approach to this epidemic has focused on three areas of action. First, the steps we’re taking steps to decrease exposure to prescription opioids to reduce the rate of new addiction. This speaks only to those who become medically addicted to opioids -- people whose first exposure is through a lawful prescription. That represents a declining percentage of the overall rate of new addiction, as more people have their first exposure to opioids from an illicit drug.

The second area of focus is on new technology that can improve the treatment of pain and addiction, with pain medicines that are less likely to lead to addiction, and drugs treatments that are better able to help treat the consequences of abuse and misuse. And so, we’re taking new steps to develop guidance that we believe will make it more clear and efficient for those who aim to develop more innovative treatments for addiction. At the same time, we’re developing better guidance for those who develop treatments for pain that might have all the benefits of opioids in terms of analgesia, without the same risks of addiction.

The third area of focus is what I want to expand on today – and that’s our efforts to increase our enforcement activities to crack down on illegal sales of opioids. We share jurisdiction for this work with many other agencies. For FDA, the area of our most concerted focus is when it comes to illicit drugs sold on-line and typically shipped through the mail. This is where we have a significant role to play. And this is where we’re stepping up our work.

Last year, FDA Office of Criminal Investigations opened 339 port of entry (POE) investigations and we have opened 167 so far this year.  In 2017, 19 of these POE investigations (a subset of overall opioid investigations) involved opioid products, while this year 25 port of entry investigations have related to opioids, including fentanyl, demonstrating the growing scope of this problem and the attention the agency is directing towards the problem.

The investigations have proven to be successful in holding criminals accountable.  In 2017, overall port of entry investigations resulted in 115 arrests or prosecutions, more than 60 guilty pleas and more than 80 convictions.  So far this year, more than 90 arrests or prosecutions, more than 65 guilty pleas and 80 convictions have resulted from POE investigations. 

FDA’s Office of Criminal Investigations is actively pursuing illegal and dangerous internet drug sales.  OCI’s current investigations include the counterfeiting and illicit manufacturing of opioid products and other illicit pharmaceuticals being distributed on the surface web and dark web, as well as other investigations surrounding the facilitation and sale of these illicit drugs online. 

Further demonstrating the major shift of our investigative resources toward cracking down on illegally operated, on-line sites that sell opioids, we just recently sent warning letters to Internet networks operating more than 50 web sites that we believe were engaging in unlawful activity.

This is just the beginning.

We already have doubled the number of special agents we have at the ports of entry and intend to nearly double this number again as a result of the additional funding. Congress recently granted us to ramp up enforcement activities in the international mail facilities. 

We’ll use these resources to interdict more illegal products flowing across our borders including products ordered online, as well as shifting more of our criminal investigative resources to target on-line opioid sales. This is a conscious policy decision by the FDA as we believe that these on-line sales represent one of the highest areas of risk facing Americans.

In addition to the numbers I ran through, we have many additional enforcement efforts already underway. We’ll have more takedowns to announce soon, especially as we shift more resources into investigating these violative activities. We know that controlled substances are being trafficked online via different strategies and vendors. We will go after the source and the intermediaries who make this trafficking possible.

Our work also includes closer collaboration with partners at Customs and Border Protection and the Drug Enforcement Administration to take additional action against illicit trafficking in opioids. We believe some of these illegal pills are actually counterfeit products containing pressed fentanyl instead of the perhaps lower doses of opioids patients believe they are obtaining. Either way, they are dangerous. People are taking a huge risk buying illegal products online, in part because when they get pressed fentanyl instead of opioids they may be more accustomed to, that risk can be deadly.  I’ll have more to say on these efforts soon.

Our efforts also include working collaboratively with responsible Internet firms who share our concerns and our commitment to public health. And who are committed to working together to address issues of abuse and misuse and the flow of illegal opioids being sold on-line. That is the focus of today’s discussion, and goal we all share.

We know that our efforts alone, and the work we do in collaboration with DEA and CBP, can’t address all online risks if we’re not working collaboratively with responsible partners. We can’t just play whack-a-mole with illegal sites, shutting down URLs only to watch new ones pop up under different names. We need to choke off this activity at its source, and frustrate it at every turn.

Because even as lawful prescribing of opioids is declining, the number of overdose deaths is on the rise. This is one measure of an addiction crisis that has taken a dangerous new turn, as more of the abuse and misuse shifts to street drugs. We thought that if we could bring down exposure in the medical setting, we’d reduce the rates of new addiction. We may accomplish that. But we now know it’s not enough. Unscripted endings are rarely that simple. More of the currently addicted, and the newly addicted, are using dangerous street drugs. And so, we need to turn our focus to this new threat.

And I want to thank all of you for joining us today, and for your continued commitment to these efforts and your willingness to partner with us in addressing these public health challenges.

Based on some of our recent experiences working with Internet stakeholders, I know that you want to act and can do so quickly.

For instance, I recently wrote to online distributors of OTC loperamide asking them to take voluntary steps to help reduce the risks of loperamide abuse and misuse.  First, I asked them not to sell bundled amounts of loperamide that contain more than one package of the drug. And second, I asked them to ensure that consumers can easily access and read the product labeling and warnings for drugs sold on shelves or on websites before purchase.

We appreciate the responsiveness from large online retailers to these requests. It shows not only their commitment to addressing this crisis, but also, to acting quickly when such new threats are identified.

The easy availability of opioids online is a major public health concern. Cutting off this flow of illicit Internet traffic in opioids is critical. And we need your help, collaboration, ideas, and commitment to addressing this critical facet of the opioid epidemic. Only by working together can we address the severity of the public health emergency we are facing.

As all of us here know well, illegal online pharmacies, drug dealers, and others are increasingly using the Internet to further their illicit distribution of opioids, where their risk of detection and the likelihood of repercussions are seen as significantly reduced.

According to a 2015 study by Carnegie Mellon University, revenues from online illicit drug sales grew from between $15 to 17 million in 2012 to a total of $150 to 180 million in 2015. 

A January 2018 report by the Senate Permanent Subcommittee on Investigations provided compelling evidence that average Americans can now purchase illicit opioids online – with credit cards, Bitcoin, or PayPal. They can then have it sent to virtually anywhere in the U.S.

They were focused on fentanyl sales.

The senate investigators found hundreds of transactions in more than 40 states, adding up to more than $750 million worth of fentanyl by its street value, from just six online sellers, resulting in several deaths.

Research by the National Association of Boards of Pharmacy found that when searching online for prescription opioids across the three major search engines, nearly 91% of the first search results led users to an illegal online drug seller offering prescription opioids. 

That’s why we’re here today. The adoption of a far more proactive approach to addressing this public health emergency by FDA and internet stakeholders is not only critical, but it’s long overdue. 

I recognize, and appreciate, that some of you are already taking important measures to address the opioid epidemic, and I want to commend these efforts. We know some of you have also worked collaboratively with FDA in the past and we are grateful for this. Moreover, I understand that some of these efforts are best done quietly, so that we don’t tip off the bad actors about our tactics.

FDA will safeguard the regulatory and investigative efforts that must remain discrete to have their full public health purpose.

To highlight some of the public activities: Google now de-indexes web pages — in other words, it hides them from U.S.-based searchers – based on administrative agency findings, such as those communicated through a warning letter by the FDA, that sites illegally distribute material that risks physical harm to consumers. 

To take another example, since 2015, Microsoft’s Bing attaches a pop-up warning to websites identified in FDA-issued Internet pharmacy warning letters. It warns consumers that the website may be dangerous because FDA issued a warning letter related to its activities.

The pop-up also provides a link to the FDA warning letter and to The Center for Safe Internet Pharmacy. This is a website that serves as an educational tool for consumers for buying prescription drugs online.

And Facebook recently announced that users attempting to purchase opioids on-line using its site or seeking out addiction treatment will be instead redirected to information about a federal crisis help line.

These are important steps.

We want to build on them. Working together, we need do even more to protect the American public within the Internet ecosystem. 

Our team at FDA has ideas for further proactive steps that we believe can be taken. And we want to discuss these with you today, as well as gather additional ideas from you about what actions would be most impactful. You have the greatest sphere of influence and expertise to transform this space. And we know you want to help us curb the opioid epidemic, which has been devastating many Americans.

Our aim today is to identify some specific, proactive measures that Internet stakeholders, in collaboration with FDA, can take to reduce the availability of opioids online.  By sharing best practices, together we can help reduce the number of Americans who are at risk.

These commitments may differ based on your company’s role in the Internet ecosystem. For example, de-indexing webpages to hide sites facilitating opioid sales; modifying algorithms to direct potential opioid purchasers to educational and treatment resources; or proactively detecting and removing social media posts and advertisements facilitating access to opioids. These are all steps that can help address this crisis. We want your insights and suggestions on how we can best approach this crisis.  We hope to have your commitment in setting out specific actions that can be taken to address these dangerous trends.

In the next session – which we’ve structured as a private roundtable discussion given some of the security sensitivities – we aim to have a robust dialogue about these potential steps. This includes identifying other measures that could be taken. We also want to discuss challenges associated with implementing these measures, and steps we can take to share best practices. Coming out of this session, we hope to have several concrete solutions to reduce the availability of opioids online.

We recognize that today is just the first step in a broader collaboration on these efforts -- and the beginning of an ongoing dialogue.

We hope to reconvene to build on the progress we make today.

Deaths due to opioids purchased online are preventable.  We know you share our commitment to tackling this epidemic. And I’m confident that we have the right people in the room today to make an immediate and meaningful difference in this crisis. We have structured our afternoon session as a closed session to encourage open discussion of the issues and protect the sensitive information and tactics that may be shared as we work on solutions to combat the illicit trade of opioids online. We appreciate your commitment to these efforts, and are grateful for your joining us today.

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