2nd FDA Online Opioid Summit April 2, 2019

Speech | Virtual

• Speech by: Scott Gottlieb, M.D.

Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
2nd FDA Online Opioid Summit
April 2, 2019
White Oak, MD

(Remarks as prepared for delivery)

Good afternoon.

Today’s gathering includes key internet stakeholders, government organizations, academic research institutions, and advocacy groups who’ve come together with the same purpose:

Finding ways to work together to combat the opioid crisis, and specifically illegal sales of opioids online.

I’d like to thank my FDA colleagues, and many public and private sector partners, who’ve joined us today to make our discussions so productive.

The opioid epidemic is the deadliest, and most complex public health crisis facing America. It requires unprecedented collaboration and coordination to stem the lethal tide of addiction that’s ravaging our families and communities.

Last June, our first Online Opioid Summit initiated an unprecedented and productive dialogue on the expanding threat posed by illicit opioid analgesics sold online. It committed internet stakeholders to adopting concrete strategies and tools to reduce the availability of illicit products purchased through online channels.

For example, Google now deindexes websites based on FDA warning letters that cite the unlawful sale of opioids to U.S. consumers. And social media platforms such as Facebook and Instagram are redirecting users who are looking to purchase opioids online to the Substance Abuse and Mental Health Service Administration National Helpline.

In February, Google, in collaboration with Walgreens and CVS, launched a pilot program to use Google’s search function to highlight safe opioid disposal sites in response to the query “drug drop off near me.” It automatically links to a map of more than 3,500 sites in seven states where patients can safely dispose of excess quantities of analgesic opioids. These excess drugs put families and communities at risk of addiction and overdose from pills diverted from medicine cabinets.

In 2018 the FDA continued to work with our federal and state partners on numerous other changes to achieve more appropriate prescribing.

Rationalizing prescribing practices by providers remains a cornerstone of FDA’s multipronged efforts to reduce the rate of new addiction.

Working with providers is also a key part of our efforts to reduce the stigma associated with seeking Medication Assisted Treatment (MAT) and ensuring that MAT is widely accessible to help those addicted to opioids return to productive and sober lives in their communities.

Our efforts, in coordination with many federal, state, and professional partners, are having an impact. But much more must be done.

Since 2015, the estimated number of opioid analgesic prescriptions dispensed from U.S. outpatient retail pharmacies (which may be the most vulnerable to abuse or diversion) have fallen by 24 percent.

Notably, prescriptions of higher strength opioids (90+ morphine milligram equivalents/unit) have fallen even more steeply since 2015, accounting for less than 1 percent of all opioid analgesic units (e.g., tablets) dispensed in 2018.

However, the rate of overdose deaths continues to increase. This is due in part to the increasing abuse of potent adulterated or illicitly manufactured fentanyl products purchased through online channels and sold as street drugs.

Illicit opioids account for a sharply rising fraction of the total exposure and number of deaths attributable to these drugs.

As a result, we’re increasingly focused on illicit online purchases. The flow of drugs on the surface and dark web has become a more significant part of the epidemic relative to prescribed opioids.

These products are not only cheap and easily accessible.

They’re also incredibly deadly.

The Customs and Border Patrol reports “the preponderance of illicit opioids consumed in the United States are smuggled into the country via the Southwest Border (SWB) and through international mail and express consignment hubs.”

For instance, in late January, the Customs and Border Patrol seized more than 250 pounds of illicitly manufactured fentanyl – roughly a tenth of a metric ton - is enough to kill 115 million Americans.

To put that seizure into perspective, total prescription opioid analgesics dispensed in 2018 were approximately 150 metric tons of pure oral morphine equivalent in 2018, down from a peak of over 200 metric tons around 2011, and falling steadily.

So, one question is how does the quantity of opioids being legally prescribed compare to the flows of fentanyl illegally entering the U.S. In other words, even as we reduce prescribing, how much is that reduction being dwarfed by the illicit flows of super-potent fentanyl?

Converting fentanyl to oral morphine equivalent is tricky, because it varies with how the illicit fentanyl is consumed, such as orally or through an injection, disclaimer iconand may vary with dose and prior opioid use.

Using disclaimer icona simple factor of 100, however, would suggest that 1.5 tons of pure fentanyl – or less than two metric tons of fentanyl that’s 90 percent pure--would be roughly comparable to all of the opioid analgesics being lawfully prescribed by doctors.

This quantity of fentanyl would fit in a truck, a shipping container, or a speedboat. But it’s vastly more dangerous than comparable prescription opioid analgesics, because people with opioid use disorders who consume street fentanyl could not possibly know the dose.

Customs and Border Patrol (CBP) also reports that “a majority of the illicit fentanyl in the United States is manufactured in clandestine labs in China”. And CBP’s Office of Field Operations seizures of illicit opioids have nearly quadrupled from 2016-18, “driven by the dramatic rise in fentanyl seizures in the express consignment and mail environments.”

Fentanyl entering the U.S. from the southwest border, typically in vehicles, is approximately 7 percent pure fentanyl. Fentanyl arriving from China via express consignment and international mail facilities is nearly 90 percent pure, and is correspondingly more lethal.

Further, this fentanyl is often made into pills that look like other prescription opioids. This is because it takes very little to produce a high with fentanyl, making it a cheaper option.

This is especially risky when people taking drugs don’t realize they might contain fentanyl as a cheap but dangerous additive. They might be taking stronger opioids than they’re used to and can be more likely to overdose.

With users having no way to assess the potency of these products, addicts purchasing illicit painkillers online are taking deadly risks with just a single purchase. 

Even though it’s illegal to sell unapproved opioids online to U.S. consumers, we continue to see websites that make it easy for U.S. consumers to purchase these products.

Since 2017, we’ve issued 25 warning letters identifying more than 450 websites for illegally offering for sale potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol and oxycodone.  Two of these warning letters were posted on our website this morning. The warning letters request that these website operators immediately stop illegally offering opioids for sale to U.S. consumers.

Cutting off this illicit internet traffic is critical. And we’ll continue to pursue all available means of enforcement to stop these online drug dealers.

Tomorrow, we’ll be announcing a partnership between FDA and U.S. Customs and Border Protection (CBP) that’ll expand our ongoing collaboration. We’re working to maximize each agency’s inspection and detection capabilities to protect Americans from illegal and harmful products entering the U.S. through the nation’s International Mail Facilities (IMF) and Ports of Entry.

Strengthening information sharing between our agencies, along with additional shared scientific lab space at high risk and high volume IMF locations, will enable us to identify and interdict more of these illicit shipments before they reach our communities.

The agency will also continue to take aggressive action as appropriate to warn website operators who violate federal law by offering unapproved opioids for sale to U.S. consumers.

To help achieve our shared goals, the focus of today’s Summit has been expanded to registries and registrars since these entities play a critical role when it comes to patients’ ability to buy illegal opioids online.

We’re grateful that registries and registrars are working to be part of the solution to this public health crisis. Today’s discussion focused on how to maximize the impact of our efforts to reduce the availability of opioids online. For example, registries can remove domain names for websites that illegally offer opioids for sale online.

I urge these stakeholders to take action to protect consumers and continue the efforts underway to address this public health crisis.

I also continue to applaud other internet stakeholders such as social media companies, search engines, and online marketplaces that have joined the discussion today and further demonstrated their commitment to protecting consumers.

But I’d also like to acknowledge the special role that the National Telecommunication and Information Administration (NTIA) played in highlighting the productive role that Registries and Registrars could play, helping us to identify new opportunities for productive partnerships to address the sale of opioids online, and showing extraordinary leadership in their engagement with the agency.

I’m also pleased to announce that the FDA and the NTIA are partnering in an effort to combat the opioid crisis. This is a novel approach to working with key domain name industry stakeholders. This partnership will enhance the FDA’s efforts to protect U.S. consumers from opioids that are illegally being offered for sale online.

The event today is an important step in bringing parties together to talk through meaningful solutions and pave the way for future collaboration.

In coordination with NTIA, disclaimer iconNeustar announced yesterday that it has taken action in response to the epidemic. For example, Neustar deactivated three domain names cited in FDA warning letters for the unlawful sale of opioids online. Neustar has implemented systems and processes to continue to monitor and address this type of illegal activity.

Following today’s event, FDA and NTIA will develop a framework for collaboration with key domain industry stakeholders that have a role in the registration of domain names, including Neustar, Verisign and Public Interest Registry. This collaboration will be focused on reducing the availability of opioids illegally offered for sale online.

I’m proud of the actions the FDA has taken over the last two years to help address the opioid crisis, while maintaining access to opioid analgesics for patients with intractable pain, like that associated with metastatic cancer. But this addiction crisis is far from resolved.

The impact of the opioid epidemic has been magnified because it festered invisibly and for too long in neglected communities where jobs and hope have become increasingly scarce.  Because of these trends, U.S. life expectancy has declined for two out of the last three years, largely due to increases in drug overdoses and suicide.

This is an issue that will challenge us for years to come. Our collaboration is another important step in confronting this continuing crisis.

Thank you.