- Speech by
Robert M. Califf, M.D., MACC
Commissioner of Food and Drugs - Food and Drug Administration
(Remarks as prepared for delivery)
Good morning. I’m glad that I can be with you once again for this important meeting.
I want to thank Nancy Hale and Operation UNITE for inviting me, and for continuing your work to make this event a must-attend for those involved in addressing the opioid crisis.
Congressman Rogers, you may not have known the magnitude of the impact of this event when you conceived of it 11 years ago, but you have made a big difference in this difficult and complex problem that has affected so many of us.
When I appeared at this gathering in 2016, during my first stint as FDA Commissioner, I was struck by the enormous breadth of topics addressed during this meeting, as well as by the engagement of such a broad range of stakeholders. I’ve had a chance to review this year’s agenda and speak with many who are presenting at this meeting, all looking to collaborate and solve problems. While I can’t attend the entire meeting, you can rest assured that I will get updates on what has been discussed and suggested for the future.
But I’m delighted to join this esteemed group again. This annual gathering is an important opportunity to hear your ideas, benefit from your expertise, and explore ways to collaborate.
When I was asked to return to the role of Commissioner, I knew our nation had many weighty public health challenges, including the ongoing COVID-19 pandemic. I also knew that the opioid crisis that has devastated so many individuals, families, and communities remained and would require my attention. I’ve seen first-hand the impact of opioids in my professional life as a physician through my government and academic roles, in my personal experience as a husband, parent, and grandparent, and in my role providing community based clinical care.
Upon leaving the FDA five years ago, for instance, I helped form a non-profit addiction treatment and recovery center in Dayton, Ohio. As the Chair of that organization’s board, I learned a great deal about on-the-ground efforts to prevent misuse and addiction, reduce fatal overdoses, and provide evidence-based treatment and recovery support. I was humbled and gained tremendous respect for the array of people working together across a community battle this problem.
As you well know, and as is evidenced by the participation in this meeting, dealing with this crisis requires a team in which every team member does his or her part. And I intend for FDA to do its part, as well as function as an effective team member.
Now that I’m back as commissioner of the FDA, one of my roles in this job is to share with you some of the important work that we’ve been doing to help respond to this crisis.
I wish I were also in a position to tell you that we have all the answers and that there are one or two things left to do to address this crisis. Unfortunately, I can’t tell you that. It’s not that we’re not working hard, or haven’t made headway.
Make no mistake. The FDA is committed to responding to all aspects of this ongoing crisis. And we’ve made some significant progress. As you’ll hear in a moment, we are taking a fresh look at the things we have done, and we’re ready to change our approach if the evidence calls for it.
For instance, we’ve already made important safety labeling changes for opioids, benzodiazepines, and other medicines in the controlled substances category. But we’re also currently reconsidering our approach to labeling of opioids to make sure it supports the best prescribing practices, given the important expansion of research that informs us in this stage in the crisis.
We’ve also prioritized ways to work better with clinicians and provider organizations. We recognize that many people in need have lacked access to proper medications for opioid use disorder, so as a part of this work we’ve collaborated with our federal partners to increase availability of these important medications. Here again, we’re taking a new look at what we need to address in this important area for prescribers.
We’ve continued to support development of novel non-addictive treatments for pain, including non-opioid analgesics and medical devices. As someone who has decades of experience in developing new medicines, I am not satisfied that enough progress is being made. We’ll be looking at ways to accelerate progress in this arena through better science and facilitation of clinical development.
These developments are an important part of our overall response to this crisis. But they are nowhere near enough. We do a disservice to those who have already suffered and those who may become victims if we don’t speak frankly about where we’ve fallen short, what challenges we currently face, and what is required for us to address the challenges that may still lie ahead.
I know that you have heard from the experts tracking this crisis that we are not where we need to be. In an era in which good news is emphasized, this is not a popular message.
Because our work is grounded in science and transparency, I firmly believe that if we don’t speak honestly and openly, we’ll repeat mistakes of the past and not find the answers we need to gain real traction – and possibly even lose ground.
Even so, many have worked hard to develop creative and effective responses to this crisis. Yet, in spite of all of this important work, in some ways we are worse off than we were a decade ago.
According to our colleagues at the CDC, an estimated 106,854 Americans died of a drug overdose between December 2020 and November 2021 – another record high. While the number of prescription opioids dispensed has been steadily declining since 2012, illicit fentanyl and its analogues have become major drivers of overdose deaths.
The diversity of the agenda at this meeting brings home the point that there’s no single reason for this crisis, and many of them are not within the FDA’s wheelhouse. Certainly, one obvious factor is the isolation and psychological stressors imposed by the COVID-19 pandemic on individuals with substance use disorder. These include disruptions in treatment access, social connections, and other critical supports individuals rely on for recovery. We know that we will only succeed if we do our part in a manner that takes these changes in the environment into account.
We are also alarmed about the growth in use of other controlled substances, including benzodiazepines and stimulants, particularly methamphetamine, being used in combination with opioids.
I want to specifically acknowledge the increasing resurgence of methamphetamine, driven by the same chemistry capabilities that are causing so much availability of super-potent fentanyl.
In recognition of these complex challenges and the evolving nature of the broadened overdose crisis, we fully support HHS’ Overdose Prevention Strategy—a comprehensive framework that we were excited to help develop and now will use to work with others to implement.
HHS has identified four priority areas: primary prevention, harm reduction, evidence-based treatment, and recovery support. We’re taking a close look at our own priorities to align with HHS to ensure we’re putting forth interventions that will have the most meaningful and greatest impact.
For instance, we’re focusing on what we can do to address the frightening increase in illicit synthetic opioids, which are entering the United States illegally and are increasingly available online.
The FDA’s Cybercrime Investigation Unit has been working for a number of years to disrupt and dismantle the growing number of dark web marketplaces, vendors, and networks that are manufacturing and selling counterfeit, misbranded, and unapproved drugs.
In one investigation in Massachusetts, for example, a man who called himself “KillWill” distributed counterfeit oxycodone pills that bore markings similar to the Mallinckrodt Pharmaceutical company’s oxycodone tablets. Instead of containing oxycodone hydrochloride, the tablets were made up of heroin and fentanyl.
We’re also continuing to collaborate with the DEA to crack down on activities that contribute to potential abuse, misuse, and overdoses. Just last week, FDA and DEA issued joint warning letters to operators of two websites illegally selling amphetamine drug products marketed as Adderall. Administrator Milgram and I are focused on this, and will do everything we can to bring to justice those involved in this kind of illegal and dangerous activity.
All of these efforts go hand in hand with our enforcement and interdiction work at international mail facilities. In fiscal year 2021, FDA reviewed over 96,000 products at international mail facilities that includes nearly 70,000 drug products, including opioids, with 97% destruction rate for those products refused.
One important area of focus involves responding to and preempting the enormous amounts of misinformation out there, particularly on social media. Many of these cases involve active disinformation efforts. Everyone in this audience knows that the promotion of long-acting opioids as non-addictive was one of the most damaging misinformation campaigns of our history.
Now we have mail order pills sold as less potent opioids but that are laced with super-potent and much more dangerous fentanyl and methamphetamine. This growing problem with unreliable information readily available on digital sources is much broader than this crisis, and we frankly need to devise a better strategy to go on the offense rather than a reactive strategy.
The distortions and half-truths that flow from these digital communications undermine public trust in essential scientific work. But they also pose an enormous risk to public health itself, through their negative influence on individual behaviors. They can lead people to make poor or misinformed decisions that actually cause physical harm. And misinformation about science and health care is in fact killing people. It’s why we need to develop a comprehensive and effective response to it.
Part of this response requires providing reliable information that is accurate and up to date. For instance, we’re focused on using evidence to inform prescribing practices and safe disposal and we support the guidelines under revision by the CDC.
I want to call out my colleagues in the health professions, especially leaders of academic medical centers, professional societies and health systems. We need them to become much more active in training and educating our professionals both about this crisis and their role in countering misinformation.
In addition, while opioid prescriptions continue to drop, multiple studies have confirmed that patients receive more opioid analgesic tablets than needed following surgical procedures. And there are further concerns about these drugs being prescribed to vulnerable populations, such as children and adolescents.
Let me offer an example from personal experience. A close relative, a former nurse, recently had a procedure to treat her severe carpal tunnel syndrome. After her surgery, she was prescribed a month’s worth of opioids to help with the anticipated pain. She ended up using exactly one pill and was left with a month’s supply of extras. We all know that situations like this have started too many treacherous journeys for family members who now are tempted by the opioids in the medicine cabinet.
Situations like this are why the FDA developed our Remove the Risk campaign, which aims to raise awareness about proper disposal of prescription opioids and decrease unnecessary exposure to opioids. But we recognize that an awareness campaign is not enough.
To this end, I’m pleased to announce that the FDA today issued a potential change to require opioid analgesics used in outpatient settings to be dispensed with prepaid mail-back envelopes and that pharmacists provide patient education on safe disposal of opioids. Mailback envelopes would provide another convenient, safe disposal option for patients. While the FDA has been active in supporting the disposal of unused opioid pills, we believe this new approach could help remove more drugs from the medicine cabinets.
We also want to find a path for adoption of at-home disposal solutions. And we are re-examining the potential utility of blister packaging to stem the problem of accidental ingestion by children and to address the ongoing problem of clinicians prescribing excessive numbers of tablets in some situations.
As I mentioned earlier, we are also re-examining the role of prescriber education, including the need for a unified, national level education program to adequately inform prescribers on managing pain. This would include, but not be limited to the proper use of opioid analgesics, as well as recognition and treatment of substance use disorders.
Here again, we need health systems, academic medical centers and professional organizations to join with us to integrate appropriate prescribing as an active part of clinical quality rather than relying on didactic education. The dental profession has stepped up over the past year and developed improved educational program—hopefully others will join in.
Education and communication are also a key part of our work to support increased availability and awareness of naloxone products. For instance, we’ve required drug manufacturers for all opioid pain relievers and medicines to treat opioid use disorder to add recommendations about naloxone to the prescribing information.
We’re also continuing our efforts to encourage manufacturers to pursue approval of over-the-counter naloxone products and to bring other similar new products to market. I’m pleased to see that a bipartisan group of House and Senate members recently urged manufacturers of naloxone to apply for OTC status for their products. It will require collaboration to ensure that an important policy like this moves forward, since many of the approaches that have been effective for optimizing the use of other medicines don’t work for opioids, and market forces don’t necessarily reward changes that would help with this crisis.
For many years, the FDA has based decisions on whether to approve drugs, including opioids, on a framework for the assessment of the benefits and risks of a drug. That approach is the authority Congress mandated for us. When it comes to opioids, we take into account public health factors such as the impact on family and others when reaching the regulatory decision of whether to approve a drug.
Through experience, however, we have learned that even this improvement in our framework isn’t suited to address the risks posed by opioids. To be clear, the FDA lacks the statutory authority to require that drug developers seeking approval for the marketing of new opioid products demonstrate that their products offer material safety advantages (such as a reduction in abuse liability or a reduction in respiratory depression) over existing approved opioids.
I am committed to working to address this discontinuity, but, again, it will likely require Congressional action to give us the necessary authority.
We are also giving considerable thought to how evidence on long term effectiveness of opioids can be generated through studies that give us the answers we need while being feasible and ethical.
In closing, let me circle back to a reality I mentioned at the beginning of my remarks – the importance of collaboration among stakeholders.
Strategic and collaborative tactics are clearly evident in this meeting, through the diversity of participant affiliations, the breadth of the meeting agenda, and the zeal with which you approach this work.
There is no single answer, and there is a lot we don’t yet know. Working together, driven by a constantly increasing knowledge base about the science of drugs and our response to them and about societal factors that lead to the problems we’re addressing at this meeting, we will make a difference.
So, I look forward to sharing in your energy, your commitment, and your teamwork. Together, we can bring new opportunities and hope to the millions of Americans affected by this crisis.