I want to extend my warmest greetings to all of you who are participating in this year’s
virtual Rx Drug Abuse and Heroin Summit.
I was looking forward to being with you in Nashville this year, but, unfortunately, as
you are well aware, the ongoing COVID-19 Pandemic has altered those plans – and, of course, impacted
everyone’s lives in unprecedented ways.
The FDA is helping lead the government response to the pandemic, working closely with
health care professionals and institutions on the front lines to support an all hands
approach across government and the private sector.
We’re focused on several different areas, including developing and supporting medical
countermeasures to diagnose, treat and prevent the disease.
We’re also engaged with partners across the U.S. government, academia, and regulated industry
to explore, expedite, and facilitate the development and ensure the availability of promising and
critical medical products to prevent and treat this novel virus.
We want to make sure in this sea of new potential therapeutics, that we focus on the most promising
treatments and continue efforts to appropriately protect the public health.
In this work and all of our work, we will continue to embrace the priniciple at the core of our
agency's mission... that our focus is science-based and that all of our decisions must be based on
good data and sound science.
We want to bring hope, but not false hope.
We’re also working to make sure the public gets the products they’re promised.
We’re keeping an eye on, and warning consumers to be cautious of, websites and stores selling
products that claim to prevent, treat, diagnose or cure COVID-19 or unauthorized fraudulent
test kits.
Fraudulent products that haven’t been evaluated by the FDA for safety and effectiveness could
be dangerous to patients.
Food availability and food safety are also vital to Americans’ well-being, and the
FDA is working hard to help ensure the foods you, your family, and your pets eat are safe
and available.
So as you can tell, we’re facing some big – indeed unprecedented -- health and logistical
challenges.
In light of these challenges, I want to specially commend the organizers of the conference for
their efforts to ensure that this important meeting is taking place.
This conference is a vitally important gathering – helping to forge critical connections
and provide essential information, education and support to efforts to combat the opioid
and stimulant crisis, which continues to affect our communities, schools, friends, families,
and children.
I am pleased that this work was not deterred.
At the FDA, we’re following a similar dual path.
Even as our staff works tirelessly to find answers and respond to the corona virus outbreak,
we remain focused on our other important day-to-day, mission critical work.
And among FDA’s many important responsibilities, none are more important than our continued
efforts to battle and overcome the opioid crisis that has devastated the lives of so
many in this country.
In my work as a cancer doctor, I’ve seen the pain that can come from chronic illness,
as well as the destruction and turmoil that can upend families and communities as a result
of addiction to prescription pain killers.
That’s why our work on this crisis remains an urgent priority for me and a top public
health issue for the FDA.
It’s why we’re continuing full speed ahead to implement the SUPPORT Act, which stands
for Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for
Patients and Communities, a law that provided our agency new authorities to build upon our
efforts to confront the changing nature of the opioid crisis.
We continue to advocate and approve new and innovative ways to support treatment for addiction
and overdoses.
Some of these approaches have particular relevance during this time of “social distancing,”
when individuals are more isolated.
This situation can pose a special challenge to those who rely on the support and assistance
of others for treatments they receive, in visits to clinics, or through actions from
first responders who may otherwise be overwhelmed with coronavirus emergencies.
I want to urge all of you to maintain social distancing so that we can bring this pandemic
under control.
But it’s also critical, especially if you are suffering from opioid use disorder, that
you take necessary medicines and seek appropriate help, using all available tools, including
newer options such as telemedicine.
For the FDA, coronavirus is a critical public health emergency and we are doing everything
in our power to help people who need it.
We are not forgetting the work that needs to continue to address the opioids crisis.
I do not have time today to discuss all of our many activities, therefore I will focus
on one area I am particularly interested in; our work to provide treatments for opioid
overdoses.
The FDA’s efforts to increase access to the life-saving drug Naloxone, which can reverse
the powerful effects of an opioid overdose, whether from a prescribed medicine or an illicit
drug, can play an important role in some of these situations.
Overdoses can happen at any time, and Naloxone can be administered by anyone.
To make it as easy as possible for people to use, FDA has approved three different forms
of naloxone – injectable, auto-injector and nasal spray.
Extending this work, just last month we approved a generic single-dose pre-filled syringe version
of naloxone, which provides another new and easier treatment option to stop or reverse
the effects of an opioid overdose.
We are also working hard to support manufacturers who are interested in developing over the
counter naloxone products.
Overall, these efforts are aimed at making naloxone broadly available in ways that help
assure it is used to save lives.
It is our public health duty.
In short, we continue to be focused on finding and providing solutions.
The FDA remains committed to addressing this national crisis on all fronts, from decreasing
exposure to opioids and preventing new addiction, to supporting the treatment of those with
opioid use disorder, to fostering the development of new and effective pain treatment therapies,
and taking action against those who contribute to the illegal importation and sale of opioid
products.
We are also collecting input from key stakeholders, including patients, harm reduction groups,
clinicians, researchers and industry about methods to support the development of methamphetamine
and cocaine use disorder treatment.
It’s worth noting that our response to the Corona virus mirrors our efforts to overcome
the opioid epidemic in at least one important way – the understanding that it requires
all of us working together.
Indeed, it’s due in large part to your work and voices – patients, family members, caregivers,
doctors, first responders, or others involved in addressing this crisis – that we have
been so successful in focusing attention on this critical and complex public health problem.
As we move forward, I assure you that this continues to be an issue of the highest priority
for the FDA, and we look forward to continuing to work closely with you to bring an end to
this epidemic, and to joining together in person for your next meeting.
Thank you again for your concern, your advocacy, your passion, and your leadership.