Remarks by Janet Woodcock, M.D.: Third FDA Online Opioid Summit

Speech by
Janet Woodcock, M.D.
Acting Commissioner of Food and Drugs - Food and Drug Administration (January 2021 - September 2021)

Remarks by Janet Woodcock, M.D.
Acting Commissioner of Food and Drugs
Third FDA Online Opioid Summit - Reducing the Availability of Opioids Online
September 9, 2021
Virtual

(Remarks as prepared for delivery)

Good morning. I am pleased to welcome you to FDA’s third Online Opioid Summit.

I want to offer my gratitude to the attendees and organizers for joining today’s virtual event and for your work in putting together such an important agenda. It is encouraging to see so many participants, some who have attended previously and some who are joining for the first time.

This summit offers the opportunity for key stakeholders to come together to collaborate, leverage expertise, and explore innovative solutions to help reduce the availability of opioids online.

The opioid crisis continues to be a national public health emergency, with devastating and far-reaching consequences extending into nearly every community. Responding to this crisis remains a top priority for the FDA.

Over the past year and a half, the impact of the opioid crisis has been heightened as a result of the unparalleled challenges associated with the Covid-19 global pandemic.

Even as the pandemic progressed and the FDA DOUBLED DOWN in our response to this public health emergency, we became particularly troubled with its impact on those with substance use disorder who found themselves isolated and unable to access or maintain the support they rely on for recovery.

We are also concerned more broadly about the effect that the pandemic’s burden of illness, death, economic challenge, anxiety, distress, and uncertainty is having on the ongoing opioid epidemic.

Provisional data from the CDC show that our concerns are warranted. The number of overdose deaths during the 12-month period ending in December 2020, rose to over 93,331, which is the highest ever recorded for overdose deaths in a 12-month period. Opioids were involved in approximately 75% of these deaths

At the same time, this alarming increase is being driven by the increased availability of synthetic opioids, including illicit fentanyl, which are entering the United States illegally.

An important part of FDA’s multipronged response to the opioid crisis is reducing the volume of opioids entering this country outside of the legitimate supply chain, including through illegal online sales.

Your work here is an important part of this piece of the FDA’s response. Given the complexity of the issue, it is imperative that we include stakeholders from a variety of sectors in the conversation – government organizations, advocacy groups, academic institutions, and the Internet itself.

I’ll talk more about this shortly, but I also want to note that the FDA remains focused on examining and responding to all facets of opioid abuse, misuse, addiction, overdose, and death in the U.S.

To this end, we’ve identified are focused on four priority action areas, which are:

1. supporting the treatment of those with opioid use disorder
2. decreasing exposure and preventing new addiction;
3. fostering the development of novel non-opioid pain treatment therapies; and
4. improving enforcement and assessing benefit and risk.

On the treatment front, we are focused on fostering policies supporting the development of new treatment options, including, overdose reversal agents, and treatments for opioid use disorder.

The FDA is also committed to expanding access to naloxone, a life-saving treatment for opioid overdoses.

To that end, FDA spearheaded efforts to support the approval of over-the-counter naloxone.

We also approved a supplemental new drug application extending the shelf life of naloxone nasal spray from 24 months to 36 months.

And recently we approved a higher dose naloxone hydrochloride nasal spray product that delivers eight milligrams of naloxone into the nasal cavity.

The FDA is also working diligently to implement the SUPPORT Act, also known as the Substance Use- Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, which provided the Agency new authorities and directives to confront the opioid crisis.

Through our execution of this law, we are encouraging the development of novel pain therapies, exploring both drug treatments and device solutions. To this end, the agency has sought out public input and is working to clarify our regulatory pathway to foster innovative, non-addictive treatments.

The FDA is also advancing the development of evidence-based guidelines, including supporting relevant professional organizations in their efforts to develop, disseminate, implement, and guidelines that promotes more appropriate prescribing practices

The SUPPORT Act also provided FDA with new Risk Evaluation and Mitigation Strategies (REMS) authority to mandate safety-enhancing packaging, disposal packaging, or disposal systems in certain circumstances. We are continuing to consider how, and under what circumstances, we might use this authority regarding opioid packaging and disposal.

We have also taken action to strengthen information about the risks associated with opioids in drug labeling.

For example, last year FDA announced the requirement that labeling for opioid pain medicine and medicine to treat opioid use disorder be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment.

FDA has also required updates to the boxed warning for benzodiazepines to warn of serious risks associated with these products. Abuse and misuse of benzodiazepines can result in overdose or death, especially when combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs.

As I noted earlier, an important part of our work is focused on our continuing efforts to prevent illegal drugs, including opioids, from entering the U.S. market. As part of this effort, we are taking action against bad actors engaged in the unlawful sale and distribution of these products to U.S. consumers.

This includes ramping up enforcement and interdiction work at international mail facilities.

In fiscal year 2020, FDA reviewed over 50,000 products at international mail facilities and identified 215 opioids, with 98.6% being either destroyed, refused, or referred to FDA’s Office of Criminal Investigations and the U.S. Customs and Border Protection.

Additionally, in partnership with CBP, we established a satellite laboratory at the Chicago international mail facility which increased package screenings for the presence of opioids.

Last fall, FDA, CBP, and the U.S. Immigration and Customs Enforcement, Homeland Security Investigations signed a memorandum of understanding to stop harmful products that pose a threat to public health from entering the U.S. through international mail facilities.

As part of this collaborative effort, we will continue to partner with CBP and ICE in joint operations at the international mail facilities to target illicit opioids, including unapproved fentanyl and other unapproved or unlawful drugs, medical devices and dietary supplements regulated under the Federal Food, Drug, and Cosmetic Act.

This meeting is focused on another aspect of this crackdown, the targeting of illegal online sales of unapproved and misbranded drug products, including opioids, through surveillance and enforcement activities.

Our Office of Criminal Investigations has conducted several investigations impacting how prescription opioids are marketed and highlighting the availability of counterfeit opioids for sale on the internet.

These investigations have involved medical professionals, transnational drug counterfeiting groups and multi-national pharmaceutical companies that recklessly contribute to the opioid crisis.

FDA continues to send warning letters to online networks that operate websites marketing potentially dangerous, unapproved and misbranded opioids.

We have also taken action against websites selling opioids with other controlled substances such as benzodiazepines.

Just last week, we issued two warning letters that cite unapproved and misbranded opioids and benzodiazepines that were being sold on the same sites.

In June of last year, FDA partnered with the National Telecommunications and Information Administration and participating domain name registries to launch a 120-day pilot to help reduce the availability of unapproved opioids illegally offered for sale online.

As a result of actions taken by the registries as part of this pilot, nearly 30 websites illegally offering opioids for sale became inaccessible to the public.

I want to commend many of the internet stakeholders for the steps they have taken to address this critical issue.

But we have much more to do.

And so, we must continue to collaborate, build on our successes, and look for novel tools and approaches to target and prevent unsafe online pharmacies and other bad actors from selling dangerous and deadly illicit opioids on internet platforms to U.S. consumers.

Today’s Online Opioid Summit is an important part of this continuing effort to find and implement innovative solutions to prevent the illegal sale of opioids through internet platforms and services.

We look forward to hearing from you today on how we can continue the work we’ve started toward this goal, and ultimately, toward changing the trajectory of the overdose crisis.

Thank you.