FDA Online Controlled Substances Summit, Washington, D.C. - 09/11/2025

Speech | Mixed

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Good afternoon. On behalf of the FDA, I am pleased to welcome you to the sixth Online Controlled Substances Summit. Thank you for the introduction, Susan, and thanks to the Reagan-Udall Foundation and the FDA team for your efforts in convening this Summit. And to our speakers, panelists, and attendees, thank you for taking the time to participate in what should be an important and interesting conversation.

Throughout my time on Capitol Hill, I got to see how devastating the overdose and poisoning crisis is-not just for individuals, but for entire families and communities. The stories from parents who thought it was just another day to get their child up for school, and instead finds them not alive in their own bed. And when investigated, often the pill that led to this tragic outcome was ordered online, through an app, and delivered nearby or to the door. While the federal government has taken action, drug overdoses and poisonings remain the leading cause of death among Americans aged 18-44. Addressing this crisis is one of the many critical priorities this Administration is taking to Make America Healthy Again.

Evolution and Changing Landscape of the Overdose Crisis

When I first started on the Hill in 2011, pill mills of prescription medication were a top concern. Since then, the crisis has expanded beyond prescription opioids. Now, fatal overdoses often involve illicit, synthetic opioids such as fentanyl or its analogues. And we've seen opioids used in combination with other controlled substances, including benzodiazepines, stimulants, and xylazine. Polysubstance use is increasing, and there are reports of emerging threats such as nitazenes, earlier this week.

FDA has taken bold action to try to warn the public about concentrated, synethic 7-OH (seven hydroxy), a concentrated byproduct of the kratom plant, which can be easily purchased in high concentrations from gas stations, convenience stores, vape shops, and yes, online as well. It's particularly concerning since some of these products may appeal to kids, such as eye-catching gummies, candies, and ice cream cones.

FDA is committed to working with state, local, and federal government partners, physicians, families, to address known and emerging threats.

FDA Role

Part of that role is doing our part to help to ensure a safe supply chain for prescription medication and making sure the public is aware of the safest channels from which to get their medication. Patients and families may not realize that some online pharmacies are unlicensed, or that a cheaper prescription medication dispensed through this illegitimate online pharmacy may be unsafe and ineffective.

FDA also can help facilitate innovation to reduce reliance on controlled substances and help those who may have a substance use disorder achieve recovery. Prescribed controlled substances are important treatment options for patients who need them, but that does not mean we shouldn't have more options. Just yesterday, FDA released draft guidance to help innovators who want to bring novel, non-opioid treatments for chronic pain. And there is more that can be done to help those with substance use disorder have more options to help on their path to recovery.

Summit Overview

So, while FDA is working more broadly than just looking at controlled substances available online, I am glad that today's Summit on online availability of controlled substances will explore innovative strategies to curb the illegal online sale of these products. The spread of prescription drugs illegally sold directly to consumers, including kids, through unsafe websites and social media platforms presents unique challenges for regulators, law enforcement, policymakers, families, clinicians, and others who are working to prevent these dangerous products from harming the American public.

Conclusion

During today's Summit, three of my colleagues, Marta Sokolowska and Sangeeta Chatterjee from the Center for Drug Evaluation and Research, and Jake Ellis from the Office of Criminal Investigations in the Office of Inspections and Investigations, will highlight this evolving threat. They will also highlight the FDA's efforts to protect the American public through compliance and enforcement actions as well as outreach.

As we open our sixth Summit, we'll also hear from stakeholders from the public and private sector, including those from the online ecosystem, academia, regulatory, and global organizations, on how to help navigate these challenges and develop strategic and effective solutions.

I'm looking forward to the conversations and collective actions continuing beyond the Summit. Through innovation and collaboration, we can further alter the trajectory of this crisis, preventing overdoses and poisonings.

Thank you.

• Content current as of:

  09/15/2025

• Regulated Product(s)

  • Drugs