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Speech | In Person

Event Title
Remarks by FDA Commissioner Robert Califf to the 2023 Rx and Illicit Drug Summit
April 10, 2023

Speech by
Robert M. Califf, M.D., MACC

(Remarks as prepared for delivery)


Good morning. I want to thank Nancy Hale, Operation Unite, and Congressman Hal Rogers for inviting me to be with you at this important gathering.  I can think of no more important place to be than with all of you in Atlanta to discuss what is one of the most significant and challenging public health crises our nation continues to face—one that causes enormous harm to individuals, families, and society.  We at FDA are dedicated to working with you and others in our communities to bring this crisis to an end as soon as we possibly can.

I want to recognize Congressman Rogers’s important work in this area, including his leadership in creating this meeting.  Since the first of these annual gatherings in 2012, thousands of affected individuals and their families and other stakeholders from communities across the nation have come together to share information, build partnerships, and empower each other to help bring about the change necessary to save future generations from the continuing tragedy of this evolving crisis. 

I have had the opportunity to work on this issue for many years.  As an intensive care cardiologist for over three decades, I’ve seen first-hand the risks that patients face from substance use, including stimulants such as cocaine and methamphetamine that cause heart attacks and strokes. And throughout my career until assuming this job, I’ve worked with individuals struggling with substance use disorders and overdoses in a busy outpatient clinic.  And between my FDA stints, I helped form and served on the board of a not for profit in Dayton, Ohio with a mission of healing people experiencing substance use disorders through learning, science and partnership.

These experiences have strengthened my belief in the importance of community-based efforts to respond to overdoses, prevent misuse and addiction, and provide evidence-based treatment and support.  

As FDA Commissioner, I’ve worked on policies to help respond to this crisis. While I am a strong advocate for the team approach to dealing with these complex issues. I also believe that one must clean up one’s own home base to be a strong member of the team.  Accordingly, this issue has been an agency priority throughout both my current and former tenure.  Although I’m pleased that we’ve seen some important advances and policy changes addressing critical areas of need, we have many important actions left to take, especially given the changing nature of the crisis. 

The FDA’s Overdose Prevention Framework, which aligns with the Department of Health and Human Services Overdose Prevention Strategy and National Drug Control Strategy, identifies four priority areas: primary prevention, harm reduction, development of treatments for substance use disorder, and protecting the public from unapproved, diverted, or counterfeit drugs that present overdose risks.  Developing a plan is hard work, but nothing compared to the complexity of implementing it in the field. 
This afternoon I’d like to update you on some recent developments and discuss how we continue to adapt our approach as we are informed by the scientific data and other evidence. We’ve instituted several important actions recently, from our decision last month to approve the first nonprescription naloxone product, to our efforts to expand opioid disposal options to reduce opportunities for nonmedical use, accidental exposure, and overdose, to our work to limit the availability and prevent the distribution of illicit controlled substances, including, most recently, fentanyl laced with xylazine.

I also want to offer some thoughts about next steps – ways we can effectively embrace cutting edge science and technology to support even more powerful advances to help bring an end to this crisis.

Unfortunately, we must begin with the distressing fact that while we have made progress in many areas, the crisis has grown into an even more dangerous public health challenge.  Last year, we had more than 107,000 overdose deaths, which means each day nearly 300 people died from a drug overdose. As you know, these deaths are primarily driven by fentanyl and its analogs. Additionally, other controlled substances, such as stimulants and benzodiazepines, are being used in combination with opioids. And new challenges continue to arise. 

For example, we’ve seen an increasing number of overdoses connected to products laced with xylazine.  Xylazine is the active ingredient in veterinary medicine approved as a sedative and analgesic.  Xylazine is an effective medication for animals, often in the most trying circumstances of emergency injuries, but it can cause serious and life-threatening toxicity in humans when combined with opioids. And, distressingly, xylazine is being used in combination with opioids such as illicit fentanyl because of its reported effect of prolonging and heightening the drug effect. 

We recently issued an alert to health care professionals warning of possible xylazine inclusion in fentanyl, heroin, and other illicit drug overdoses.  Importantly, naloxone does not reverse its effects, and while there is a reversal agent approved for animal use, we do not have human data at this point.  And we’ve issued an import alert to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the country.  This will help reduce the availability of this product for improper use.

We also continue to focus on expanding access to overdose reversal products, including naloxone. FDA has long prioritized the availability and accessibility of naloxone products.  We’ve accelerated our efforts in the last few years to make this life-saving product more readily available to those who need it.  

My own familiarity with naloxone as a life-saving drug pre-dates the current overdose crisis, as  I’ve had many occasions to use naloxone when cardiac patients were overtreated and suffered from respiratory depression or stopped breathing.  Like a defibrillator used to treat someone who has a cardiac arrest, as was the case with Damar Hamlin of the Buffalo Bills, naloxone can be a game-changer.  And in both cases, I’ve seen that medical miracle where someone is brought back to life.  

We’ve worked closely with harm reduction groups to gather feedback about the biggest challenges they face to increasing access to naloxone. Using this information and other data, we’ve taken a number of actions to eliminate or reduce the impact of these obstacles. Most recently, the FDA approved the first nonprescription naloxone nasal spray.  This groundbreaking approval paves the way for this life-saving medication to be sold directly to consumers in drug stores, convenience stores, grocery stores and gas stations, as well as online.  

We’ve also made some important progress on our primary prevention priority, including our comprehensive approach to expand opioid disposal options.  This supports patients’ ability to safely and securely dispose of their unused opioid analgesics, as well as remove unwanted and excess prescription opioid analgesics from the home. It is an essential way to reduce opportunities for nonmedical use, accidental exposure, and overdose.

Last week, we announced two actions as part of this effort. First, we are requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers.  This action was developed in conjunction with the US Postal Service, and it underscores the importance of collaborating with our federal partners.  Second, recognizing our new authorities provided by Congress, we issued a Federal Register notice requesting information and comments about in-home disposal. That notice also announced a public workshop on this topic in June hosted by the National Academies of Sciences, Engineering, and Medicine, in which FDA will be an active participant.   

Earlier, I noted the priority of the FDA’s overdose prevention framework involving protecting the public from unapproved, diverted, or counterfeit drugs that increase overdose risks. Our work in this area is currently focused on preventing the growing problem of distribution of synthetic opioids, which are entering the United States illegally.  These drugs, often super-potent and laced with dangerous combinations, are increasingly available online with a profound impact on this crisis. 

These activities include examining suspicious mail packages that come through our international mail facilities. We are increasing resources and identifying innovative ways to expand our impact in this area, but we continue to lack adequate funding and staff to respond to the enormous demands.   Through partnership with Customs and Border Protection (CBP) and the DEA we are extending our enforcement reach as far as possible.

For instance, building on a Memorandum of Understanding the FDA signed with CBP and the U.S. Immigration and Customs Enforcement, Homeland Security Investigations, we launched a National Operational Strategy targeting opioids and other unapproved drugs at multiple international mail facilities and several courier hubs from March through September 2022. In partnership with CBP, the operation successfully intercepted more than 390,000 tablets and capsules of unapproved drugs (including opioids) from entering U.S. commerce. This operation has expanded this year to include ports along the Mexican and Canadian borders. 

We’ve also begun to establish satellite laboratories at the international mail facilities in partnership with CBP, which allow us to conduct rapid field testing and provide immediate analysis of products using specialized analytical equipment. Our first such permanent space opened in  2021 at the Chicago O’Hare facility, and we are adding additional laboratory screening stations at other locations, including Miami and New York.  Our Forensic Chemistry Center in Cincinnati continues to lead the way in deploying technologies and methods to help our investigators and analysts in the field to quickly identify new illicit drugs. And new opioid and satellite technology laboratories will be fully operational later this year. 

Our Office of Criminal Investigations continues to protect consumers and patients by prosecuting and preventing the serious crime of health care professionals tampering with opioids intended for patient use, and preventing illegal online sales of opioids and counterfeit medicines. We also continue to monitor the marketplace for incidents of health fraud, including products fraudulently claiming to prevent, treat, mitigate, or cure opioid addiction and withdrawal. 

As I hope you see, we’re responding to this crisis in many different ways, and I believe that our interventions are making an important difference.  But we have a long way to go, and we need to continue to think strategically and creatively about what’s next. So let me offer a few thoughts on where we might go from here. 

One issue of far reaching impact that we need to continue to focus on and that also has long been a passion for me – is the need for good data.  Our policies and actions in response to the overdose crisis are informed and guided by the quality and quantity of the data and the evidence generated. That’s why the FDA has invested significant resources to develop a data-driven, national-level systems dynamic model of the opioid crisis, named Simulation of Opioid Use, Response, Consequences, and Effects, or SOURCE.  SOURCE is designed to help us get a better handle on predicting (and thus responding to) important features of the opioid crisis, including opioid misuse rates, opioid use disorder prevalence, and overdose deaths.  

As we continue to enhance SOURCE through acquisition and incorporation of new data, exploration of more targeted modeling approaches, and supplemental research projects, we also have begun a more targeted systems modeling effort designed to better understand barriers and facilitators to uptake of medications for opioid use disorder and help patients achieve stable recovery.  No surprise to you, all of our modeling indicates that right now optimizing the distribution of naloxone is the most important action to reduce overdose death.  Regarding the newer modeling work on medications for opioid use disorder, we plan to use that data to inform our individual and interagency efforts to increase access to medication for opioid use disorder.

Another area we’re looking to generate additional evidence on to inform our work involves the uncertainty about the effectiveness of long-term opioid use. Our colleagues at the Centers for Disease Control and Prevention affirmed the lack of evidence in this area in their recently updated Clinical Practice Guideline for Prescribing Opioids for Pain.  I’m pleased that next week we’ll be holding an FDA advisory committee meeting to discuss a post-marketing requirement that the FDA issued to application holders of extended-release and long-acting opioid analgesics, and to evaluate long-term efficacy of opioid analgesics and the risk of opioid-induced hyperalgesia, a phenomenon in which opiates actually seem to cause an increase in pain. This is a step in the right direction, and we need well-designed studies to penetrate our long-standing failure, including the failure of government, the industry and academia, to develop reliable evidence about this issue. 

Understanding the nature and impact of these drugs is only part of the solution.  Behavioral health is another key factor in responding to many public health issues, including the opioid crisis.  We’ve seen the impact this can have in our work on the use of tobacco products, which shares a number of the challenges involved in opioid use.
Within the U.S., we see enormous disparities as a function of demographics -- race, ethnicity, wealth and education.  People of color have shorter life spans, on average, and live in poorer health, as do people with limited education and lower wealth levels.  And one of the largest areas of difference is a function of geography — where we live. People in rural settings in general are seeing a dramatic decline in health and life expectancy.  Many of these disparities are reflected in the overdose crisis. We have a robust understanding of the trends and the factors that underly them, but we now need to develop effective interventions for these social factors. 

We also need to look at new ways to embrace scientific and technological advances.  Perhaps the most important rapidly developing area is digital health technology, which offer enormous possibilities across the public health spectrum, potentially including ways to respond to opioid use disorder, such as providing useful diagnostic or monitoring capabilities, as well as for general wellness. This could include anything from an app that encourages healthy habits to a machine learning algorithm for risk prediction, to a wearable or fitness tracker with capability to detect signs of respiratory depression or possible overdose.   

One of my favorite terms is ecological momentary assessment.  The ability to use cell phone technology coupled with sensors to assess what is happening in the moment gives us a chance to understand much better what is driving certain situations, such as relapse, for example.  And perhaps more importantly, the same technology offers an opportunity to intervene to make a difference in real time.  The regulation of this type of technology, particularly now with large language models, such as Chat GPT, will require intelligent integration of the technology with the social, behavioral and clinical environments.

The FDA has granted marketing authorization or clearance to several categories of medical devices intended to help patients suffering from opioid use disorder. And multiple innovative products are in development. For example, we authorized the marketing of an app and a virtual reality system for chronic pain reduction, as well as apps that provide cognitive behavioral therapy to treat SUD and to increase OUD patient retention in outpatient treatment, and a device used to monitor vital signs  
This is a developing area, but early efforts show promise, and research and development is active and productive. While there is a lot of work to do, there is good reason to think that we will see innovative solutions that can result in improved outcomes. 
One of the guiding principles for our work is collaboration. Indeed, there are few areas where collaboration is more important than among the industries that support health care and public health.  

One aspect of this involves providing a combination of factors to encourage the pharmaceutical and device industries to focus on some of these challenges.  Investing in the development of non-addictive treatments for pain has been an expensive edeavor with very high failure rates, leading to less investment.  Digital behavioral interventions are growing rapidly, but developing persuasive evidence that they work has been challenging and reimbursement has been difficult.

We must also continue to push our health and medical care institutions, which are among the greatest concentrations of wealth and capital in our society, and by a large margin the top or second largest employers, to engage fully on this issue.  Leaders in the pharmaceutical and health care industries are faced with difficult tradeoffs about where they invest, and we must work together to put this issue in the top tier of their concern so that they develop clinics and distributed high quality care in the places where they will make a difference and support front-line clinicians to do the work.

Many of these important potential interventions are not directly in FDA’s control, but we do have a seat at the table and we will be relentless in our own domain and working with the many partners needed to succeed in this complex environment.  

I firmly believe that working together we can find answers to many of the big questions that continue to plague us: whether it is new treatments to address chronic pain; ensuring that the products currently available effectively meet public health needs; removing obstacles that make development, approval, and real-world use of these products so challenging; incorporating the experiences of people who use drugs, patients, families, friends, harm reduction organizations, first responders, clinicians, researchers, and federal partners to ensure we have the most complete understanding of this issue; addressing the social determinants that have such an impact on the health of our nation; or continuing to encourage innovation in how to address overdose in community and clinical settings.  

There is much to consider as we confront this difficult problem together.  This gathering is a perfect setting for this conversation.  And I look forward to continuing that conversation and working with all of you as we move forward.

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