Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online

Opioid addiction and abuse remains an immense public health crisis. We’re committed to continuing to take new steps to address these protracted dangers from every possible angle.

A crisis of this magnitude requires broad, collaborative and creative approaches. We’re especially aware that as we take more actions to curb the lawful prescribing of prescription opioids, our actions will inevitably push more and more people to obtaining opioids from illicit sources. And we know that digital drug dealers and other criminals are increasingly selling their illicit opioids through the internet, including social media and illegal online pharmacies. This activity is contributing to the public health emergency of opioid-related overdose deaths that have ripped apart families and communities. We aim to confront these new threats.

We know that the internet – both the surface and the dark web – aren’t the only marketplaces for the illegal sale of prescription drugs. But they’re perhaps the most far-reaching conduit for illicit drugs, and these new avenues present unique challenges for tech companies, law enforcement, as well as for the FDA.

As we discussed yesterday, there’s no gray area here: no controlled substances, including opioids, can be lawfully sold or even offered to be sold online. In the past, we’ve been one step behind the opioid epidemic. We cannot continue to be. We must stay one step ahead of this burgeoning crisis by frustrating and eventually stopping these digital drug dealers. We cannot ignore this space simply because other illicit sources of opioids, such as diversion, theft and smuggling, are still the more predominant routes by which people currently obtain illegal drugs. We’re going to take new steps, and direct new investigative and criminal oversight resources, to stop the illegal sale of opioids online. But we cannot do it alone.

Yesterday, the FDA hosted leaders from a variety of internet stakeholders. This meeting included leaders from other government agencies, tech companies, academic researchers and advocacy groups.

We had an open and collaborative discussion about the illegal sale of opioids online at our Online Opioid Summit. During this meeting, we heard presentations on research that’s being done to better understand how and where these sales are occurring, ways to utilize big data solutions and artificial intelligence, as well as the importance of consumer education to recognize illegal channels. We also discussed ways to connect individuals and families with trusted resources for dealing with substance abuse or addiction.

We appreciate the candid dialogue we had with summit participants, and their willingness to share information about the unique nature of their platforms, as well as existing surveillance and security protocols. While we agreed to safeguard some of the sensitive discussion points, especially to make sure that we don’t tip off the bad actors who are closely watching our tactics and trying to stay ahead of our efforts, in the interest of transparency, I want to provide an overview of some of the main themes and takeaways from the presentations and roundtable discussion that took place throughout the day.

We heard from all the attendees about the important efforts they’re taking to tackle this problem, and it’s important that we acknowledge that positive steps are underway. We also discussed the various challenges that stakeholders viewed as potential barriers to take the next steps in some cases, from a lack of data that would help inform their approaches, to the potential policy and regulatory concerns.

Some of the approaches we heard during the summit were promoting legitimate or educational content in top search results or social media posts, and making it harder for individuals to find illegal sellers online. We also discussed ways to make use of big data and machine learning/artificial intelligence to identify illegal activity. And we heard about efforts to make public health resources more accessible – such as educational information about the risks of purchasing opioids online, and connecting individuals and family members to validated treatment programs to support those who are seeking a path toward recovery.

At the summit, I also shared the steps we have taken at the FDA to enhance our vigilance against illicit activity on the internet. This includes highlighting some of our recent criminal enforcement work, and reaffirming that we are shifting even more resources toward these efforts. Last year, the FDA’s 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 toward the problem.

We’ll focus additional resources behind our criminal enforcement work. And we’ll have much more to say about these activities in the coming months. 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.

Despite our best efforts, we recognize that for every website or illegal online pharmacy we succeed in shutting down, there are others that replace them. The federal government’s enforcement activities alone cannot stifle the flow of drugs sold online. I want to be clear that we see this summit as a first step in a long-term collaboration on these efforts and the beginning of an ongoing dialogue. We need to work together on shared solutions to address the problem of opioids being illegally sold online. And we need internet companies to be our partners in this effort as we all take on the social responsibility for implementing those solutions.

We also know internet stakeholders didn’t create this problem and they shouldn’t be the only ones charged with tackling it. But as experts in their fields, they know the technological solutions that are possible and therefore play a valuable role in joining us to develop modern approaches to this growing problem.

The companies and organizations that joined our meeting told us that they are eager to access more data and guidance from the experts. That group of experts around the table includes those who are in recovery and have been touched by this epidemic. We’re proud to have had representatives attend from the Partnership for Drug-Free Kids and Young People in Recovery to share their insights. Yesterday’s event builds on the work we are doing in this area. We recently hosted a meeting with the patient community. This gathering included people with opioid use disorder and the groups who represent them, allowing their unique perspectives to inform our thinking. We’re committed to keeping a seat at the table for that community.

The magnitude of this public health crisis requires the adoption of a forward-looking, socially responsible, collective approach to eliminating illegal opioid distribution via the internet. Our work together is just beginning. We’ll continue to share additional steps, including setting up follow-up meetings and establishing work groups to share best practices among government and internet stakeholders. I believe we achieved our goal for yesterday’s summit — to bring together the internet ecosystem and other stakeholders, including government, to begin the dialogue of how we can make a meaningful impact in decreasing the availability of opioids online. It’s clear that everyone in room has a shared desire to prevent bad actors from selling illicit drugs online, and a commitment to doing their part to combat the opioid epidemic.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Source: U.S. Food and Drug Administration (FDA.gov)