Remarks by Dr. Janet Woodcock
Acting Commissioner of Food and Drugs
April 8, 2021
(Remarks as prepared for delivery)
Thank you. It is an honor to be with you today.
I want to thank the organizers of this Summit for once again putting together such a rich and comprehensive program.
This conference has long played a key role in the effort to shine a spotlight on the opioid crisis that has devastated families and communities across the nation.
It is a unique resource for collaboration, information-gathering, and a forum for policies and new ideas in our work to overcome this enduring crisis.
Impact of COVID
As you know, this past year has presented some extraordinary challenges for our nation, due to the impact of the SARS-CoV-2 virus. The resulting public health emergency has disrupted almost every aspect of our lives.
Individuals, families, and communities have faced turmoil, economic hardships, and profound personal pain and tragedy.
Since the earliest days of the pandemic, the FDA has been immersed in combatting this emergency.
I am pleased that we are finally seeing signs of success, with a return to normalcy on the horizon. But make no mistake, this battle is still ongoing.
Of course, as we confronted this crisis, the many other public health challenges we face as a nation did not vanish.
Indeed, the opioid crisis is still with us and has continued to expand and impose its own devastation on families and communities across the nation.
To those individuals and families affected by the opioid crisis, the impact and experiences of COVID-19 may sound all too familiar.
The opioid crisis has remained an urgent public health priority for the FDA. One particular area of concern for us early on in the pandemic was the impact of increased isolation on those battling the burden of substance use disorder, and what we could do to counter this and to support efforts to maintain treatment and personal contact for members of these vulnerable groups.
As we heard from one individual in long term recovery, "The opposite of addiction is connection, not isolation."
Indeed, the increased isolation of the past year may be a contributing factor in the rise in the number of overdose deaths over this period, a complication of the documented psychological distress caused by the imposed isolation during the COVID-19 pandemic.
The Changing Shape of the Crisis
According to the Centers for Disease Control and Prevention’s provisional data, there were a reported 85,516 drug overdose deaths in the 12-month period ending in August 2020 – the highest number of overdose deaths ever recorded in a 12-month period.
Part of this continues to be the result of misuse and abuse of prescription opioid analgesics. But we’ve seen the opioid crisis morph from one that focused on prescription drugs to an emergency that increasingly involves other illicit drugs, including some extraordinarily potent and dangerous versions of these substances.
While the number of prescription opioids dispensed has steadily declined since 2012, opioid overdose deaths continue to rise. In recent years illicit opioids, largely driven by fentanyl, have become key contributors to the opioid crisis.
We are now seeing widespread use of stimulants, particularly methamphetamine, in combination with opioids. The complexity of addressing polysubstance use makes our efforts all the more important.
To this end, we also recognize that there is an urgent need for safe and effective stimulant overdose reversal agents and pharmacological treatment for stimulant use disorder, and we’re working hard to accelerate development in this field.
The Promise of Telehealth
During the pandemic, we’ve worked to provide support for those seeking treatment for opioid use disorder by expanding our longstanding commitment to support digital health, through our recently established Digital Center of Health Excellence.
We know that increasing the availability of digital health devices like mobile medical apps offers the potential to play a unique and important role in treatment efforts. This is particularly important in helping individuals keep engaged in their medication-assisted treatment programs and providing clinicians with new ways to intervene and support treatment.
We’ve seen significant recent progress in advancing the use of telehealth and health information technology as well as the regulatory expansion of telehealth and e-prescribing to include treatment for opioid use disorder, and we applaud the important work to drive these efforts by our federal colleagues, including DEA, SAMHSA, and CMS.
Your input provides us with the best information about the effectiveness of digital health devices and mobile apps, and gives us additional means to support and expand safe and effective patient-focused technology. So, we want to hear from you.
Improving Clinical Options for OUD Treatment and Prescription Information
We also continue to be focused on fostering policies that support the treatment of those with Opioid Use Disorder (OUD), combined with the development of new and effective pain treatment therapies.
On the treatment front, we published a final guidance for industry, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment.” This guidance is intended to help sponsors develop drugs for treatment of OUD, by identifying clinical endpoints acceptable for demonstrating drug effectiveness.
This goes hand in hand with the FDA’s continuing efforts to develop a better framework for medical prescribing and reducing the excessive number of prescription drugs that still flood the market.
We need to ensure that prescribers and patients are fully informed about risks and benefits of these drugs, and there is alignment between the clinical need and the prescription – that is, that prescriptions are written for the correct and necessary treatment and accurately match the patient’s actual need.
One way the FDA is working to expand safe and appropriate prescribing and broaden the knowledge of patients and prescribers is through development of evidence-based guidelines. That will identify and address gaps in understanding and support more appropriate prescribing practices.
Strengthening Drug Labeling
Another way is by strengthening our messaging in the drug label itself.
To this end, we acted last year to address the serious risks of abuse, addiction, physical dependence, and withdrawal reactions associated with benzodiazepine medications.
Benzodiazepines are widely used to treat many conditions, including anxiety, insomnia, and seizures. Abuse and misuse can result in overdose or death, especially when benzodiazepines are combined with other medicines, such as opioid pain relievers, alcohol, or illicit drugs.
Last September, we issued a Drug Safety Communication announcing the requirement that the Boxed Warning be updated for all benzodiazepine medicines.
And in February of this year, we instituted class-wide safety labeling changes. Benzodiazepine labeling now contains warnings about the serious risks and harms associated with these medicines.
Another significant action was our issuance of a Safety Labeling Change and Drug Safety Communication announcing the requirement that the drug manufacturers for all opioid pain relievers and medicines to treat OUD must add new recommendations about naloxone.
An important goal of this change was to encourage health care professionals and their patients to discuss the need for naloxone and assess each patient’s need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are being prescribed or renewed.
The FDA has approved three different forms of naloxone – syringe injectable, auto-injector and nasal spray, all of which are appropriate for community use, and we continue to support expanding access to this potentially life-saving treatment.
As part of this commitment, the FDA proactively led efforts to facilitate the switch from prescription to nonprescription (OTC) naloxone. Our experts spearheaded unprecedented work to design, test, and validate the key labeling requirements necessary to approve an OTC naloxone, and used their findings to create model Drug Facts Labels for industry to ease the burden of product development. We continue to work closely with applicants to advise, support, and encourage the development of OTC naloxone and bring new products to market.
And last August, the FDA approved a prior approval supplemental new drug application that provides for a shelf life extension for Narcan nasal spray and updates to the product labeling.
Risk Evaluation and Mitigation Strategies
An important piece of our continuing work involves requiring Risk Evaluation and Mitigation Strategies (or REMS) for various opioid analgesics to help mitigate the serious risks associated with their use.
Despite the challenges of COVID-19, we are continuing our efforts to evaluate and explore use of REMS to combat the opioid crisis. In December, for instance, we hosted a workshop inviting scientific discussions about methods to evaluate the impact of the Opioid Analgesic REMS on prescriber behavior and patient outcomes.
While we know the important role that REMS can play in providing patients and prescribers with additional knowledge and safety information, we also understand that for now, the education program for this is still optional training for prescribers.
So, we need to continue to encourage participation in these education programs and, where possible, link it with other types of training on treating pain and OUD. The FDA will also continue to explore ways to broaden access to training and work with our federal partners to promote and improve training participation.
Prioritizing education and training can also help address issues of stigma among providers, increase availability of treatment, and bring OUD treatment closer in line with how other chronic diseases are treated.
The FDA is aware that stigma permeates social and cultural attitudes, but it also can be found within institutional practices and regulations. A multitude of opioid-related policies – whether at the local level, such as in a doctor’s office, or at the state or federal government level – may discourage treatment and contribute to lack of treatment parity between OUD and other chronic diseases, for example, diabetes and cardiovascular disease, which in turn perpetuates stigma.
Our agency firmly believes that improving education and training is directly tied to improving both patient access and patient outcomes to treatment, and over time, we look to make a positive impact in these challenging areas.
Preventing Sales of Illegal Drugs
As we work to find new treatments, strengthen safety measures, and ultimately lower the number of opioid and stimulant overdose deaths, we also continue our rigorous efforts to crack down on the illicit market for diverted opioids and illegal drugs and secure the supply chain for legitimate medications, including opioids.
We have sent numerous warning letters to online networks that operate websites marketing potentially dangerous, unapproved and misbranded versions of opioid medications.
This is important because not only are unapproved versions of opioids like oxycodone and tramadol illegally sold on these sites, but patients may unknowingly receive adulterated drugs other than those they ordered. As we are learning from our research, patients are experiencing dangerous side effects from opioids purchased online, including overdose.
To protect consumers, we are committed to monitoring and working to combat illegal online sales of other controlled substances as well.
We’ve also increased our enforcement and interdiction work targeting illegal, unapproved, counterfeit and potentially dangerous products being shipped illegally through international mail facilities (IMFs). This represents an important source of illicit drugs brought into the U.S., including products laced with lethal doses of fentanyl. An important way to help end the opioid crisis is to prevent the sale of stolen or diverted drugs.
Ultimately, much of our work in these areas requires collaboration. Working with patients and their families is one of the most effective ways to learn what works, find answers, and develop new approaches to the treatment of opioid use disorder.
Our goal is to provide more Americans who suffer from opioid use disorder with more options and greater support. I know that we can defeat this public health crisis, just as we are responding to, and overcoming the COVID-19 emergency, and I look forward to continuing to work with you to achieve this goal.
Thank you for your attention.