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Prescription Opioid Abuse and Misuse Issues: FDA Briefing for Stakeholders

Remarks by Margaret A. Hamburg, M.D., Commissioner of Food and Drugs
Washington, D.C.
February 27, 2014

Related remarks:

Thank you Secretary Sebelius. Good afternoon everyone and thanks for joining this important briefing. I want to start by thanking Director Botticelli and Secretary Sebelius for their leadership on what is a critical public health problem impacting our nation. 

You’ve just heard the very grim statistics. An alarming number of Americans are dying from overdose of prescription and illicit opioid pain medicines.

And there are many more individuals and their families whose lives have been shattered by prescription opioid abuse, misuse and addiction. I personally have met with some of these devastated families who have shared their stories with me. 

For more than a decade, FDA has been actively working within our laws and regulations to address the urgent public health concerns around the misuse, abuse, addiction, overdose from prescription opioid medications.

At the same time, we are working to meet the medical needs of the millions of Americans who live every day fighting intense, serious pain and who rely on pain medicine for relief and some hope of a quality life. 

As an agency, we firmly believe that any actions we take to advance our concerns about the risks of these medications should not be done at the expense of ensuring access to effective and appropriate pain drugs for patients who need them.

I want to emphasize that tackling the opioid epidemic is a high priority for FDA. We have pursued a comprehensive, science-based approach that addresses misuse, abuse and addiction, targeting key drivers of the problem and at critical points along the lifecycle of an opioid product.

This approach draws on FDA’s critical role in developing, reviewing and approving drugs, reviewing scientific data to assure accurate drug prescribing information and monitoring the safety, efficacy and quality of a drug even after approval.

At the premarket stage of product development, we are working with other federal agencies and scientists to advance our understanding of the mechanisms for pain and how to treat it, including the search for new non-opioid medications for pain. We have also actively encouraged the still-evolving technology around abuse-deterrent formulations. At the post-market stage, we’ve revised the labeling of opioid medications to foster their safe and appropriate use, and we’ve required companies to conduct additional post-market research studies to explore unanswered questions.

We know that the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications, and the illegal activity of a small number of health care providers. This highlights the important role that education of prescribers and patients can play in addressing this epidemic.

The FDA has taken steps to address this by requiring that manufacturers of long-acting and extended-release opioids ensure that prescriber training programs — offered by accredited continuing education provider — are made available for all U.S. licensed prescribers, using a syllabus developed by FDA with input from many stakeholders.

And importantly, the FDA has been working hard to encourage the development of products that treat opioid abuse, such as buprenorphine for use in medication-assisted treatment, as well as those products that reverse overdose.

So today I am happy to announce the FDA’s approval of a product aimed at saving the lives of people who have overdosed on an opioid. 

Currently, a medication known as naloxone is the standard treatment for rapidly reversing a drug overdose whether it is from a prescription opioid or an illicit drug. But existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.

The prescription product we are approving today, Evzio, manufactured by the Richmond, Virginia-based company Kaleo, delivers a single dose of naloxone via a hand-held auto-injector in a matter of seconds.

The product is available via a doctor’s prescription, can be purchased by opioid users or their families, and can be readily stored in a medicine chest or kept in a pocket. Once the device is turned on, it provides verbal instruction to the user, guiding them through the steps needed to deliver the medication, similar to the verbal instructions that accompany automated defibrillators commonly found in public facilities.  The last instruction the device gives is to call 911 because this product is not a substitute for emergency treatment.

For years the lack of a lay friendly delivery system has made it difficult to make naloxone broadly available to the public.

FDA recognized that issue and in April 2012 held a workshop to discuss what steps were needed to develop alternative delivery technologies and actively encouraged manufacturers all over the world to participate in that dialogue. We continue to encourage the innovation of different delivery technologies for this medication.

Reflecting FDA’s commitment to encouraging important new therapies, the FDA worked very hard on the review of Evzio, which was granted priority status and was reviewed by the agency in just 15 weeks.

While the larger goal is to reduce the need for products like Evzio by preventing opioid addiction and abuse, the opportunity to have an easy to use  auto-injector available in an emergency is an are extremely important innovation that will help to save lives.

We organized this call today because we wanted to share this important information with you all and provide some context around FDA’s overall approach to this critical public health issue. We certainly welcome your thoughts about how Evzio and other products can be integrated into your own approaches to the opioid epidemic. It’s something we’ll continue to think about and work on.  Indeed, next week, we intend to be active participants at a meeting on naloxone access in states and communities sponsored by the Clinton Foundation.

FDA will continue to work to reduce the risks of misuse, abuse and overdose of prescription opioids.  But we cannot solve this complex problem alone. It really does require a comprehensive and coordinated approach with our federal partners, including the White House Office of National Drug Control Policy, the Drug Enforcement Administration and many of our sister agencies within the Department of Health and Human Services. It also includes many of you on the phone – those from state and local government officials, public health experts, health care professionals, addiction experts, researchers, industry, and patient advocacy organizations.

So, just as FDA repeatedly considers what more we can do to combat the misuse, abuse, addiction overdose and death from opioids, I ask all of you to do the same within your own spheres.

I am confident that by working together we can continue to make strides against the opioid epidemic.

Remarks from Acting Director Botticelli

Thank you Steven and good afternoon.

I want to thank Secretary Sebelius and Commissioner Hamburg for their leadership on this issue.

Today, the opioid drug abuse epidemic is affecting people all over this country.

More people die from drug overdose, driven by prescription painkillers, than by homicides or traffic crashes in America. 

In 2010, approximately 100 Americans died from overdoses every day. Prescription painkillers were involved in over 16,600 deaths that year and heroin in about 3,000.

Recently, my former boss, the Governor of Massachusetts, declared a public health emergency due to the devastating effect opioid abuse is having on the Commonwealth.

We visited Taunton, Massachusetts, with Senator Markey in February. By then, that town had already seen 60 overdoses in 2014 alone.

As of mid-March, that number surpassed 100.

During our visit, city and state leaders, first responders, and parents all packed into a room on the ground floor of the fire station – it was standing room only. We heard from the mayor of a neighboring town where eight people had died from overdose in only six days.

We heard from several community leaders about the urgent need for more treatment beds.

We heard from a mom who found her son unconscious and overdosing, and used naloxone to revive him.

In the middle of the meeting, we were interrupted by the 911 dispatcher over the intercom – and first responders were summoned to the site of a possible overdose, as we spoke.

Earlier this year, news of Phillip Seymour Hoffman’s tragic death dramatically increased public interest in halting the spread of this epidemic. But since his passing, more than 6,000 others have died of a drug overdose.

They are the face of this emergency — them, and the family members and friends they have left behind.

Overdose deaths are a matter of great concern for this Administration.

Heroin use remains relatively low in the United States as compared to other drugs, but there has been a troubling increase in the number of people using heroin in recent years – from 373,000 past-year users in 2007 to 669,000 in 2012.

It is impossible to understand the heroin problem in the U.S. without also understanding the nature of the prescription drug abuse epidemic -- the two are linked.

The abuse of prescription painkillers still represents the majority of opioid abuse in this country.

A recent report from the Substance Abuse and Mental Health Services Administration (SAMHSA) found that four out of five recent heroin initiates (79.5 percent) had previously used prescription pain relievers non-medically.

Here is what we know for sure: we cannot arrest our way out of this problem. Science has shown us that drug addiction is a disease of the brain – a disease that can be prevented, treated, and from which one can recover. 

Substance use disorders, including those driven by opioid use, are progressive diseases. This demands that we treat the challenge as a public health issue, as well as a public safety issue, by emphasizing prevention, treatment, and smart-on-crime approaches that seek to break the cycle of drug use, crime, and addiction.

As hard as we try to prevent addiction from ever developing, today’s announcement is proof that we don’t always succeed, and an emergency, life-saving intervention is necessary.

Because police officers, firefighters, and EMTs are often the first on the scene of an overdose, the Obama Administration strongly encourages local law enforcement agencies to train and equip their personnel with this lifesaving drug.  

We know that the men and women in law enforcement understand saving a life is more important than making an arrest. 

And we’ve seen great success resulting from programs that equip police with naloxone. Back in 2009, the Massachusetts town of Quincy entered into a partnership between local mental health and addiction organizations, the police department, and the Department of Public Health.

Together, these groups began a program to train officers to resuscitate overdose victims with a nasal naloxone spray. Since the program began in 2010, officers in Quincy have reversed more than 200 overdoses. 

My office is determined to help state and local first responders replicate the Quincy model across the country. 

In fact, the New York/New Jersey High Intensity Drug Trafficking Area program, a grant program funded by ONDCP, provided funding for a pilot program in a New York City Police Department precinct on Staten Island to train and equip police officers with naloxone. 

Today’s announcement will help make naloxone even more accessible.

But it is not enough to save lives from overdose. A smart public health approach requires us to catch the signs and symptoms of substance use earlier – before it develops into a chronic disorder – and connect people to treatment when they need it, not just when it becomes available.

We know that getting, and keeping, people into treatment is also an effective way to prevent overdose – and this Administration is dramatically expanding access to drug treatment. 

Under the Affordable Care Act, insurance companies are now required to provide treatment for substance use disorders and cover it just as they would cover any other chronic disease, such as diabetes or cancer.  This represents the largest expansion of treatment access in a generation and will help guide millions into successful recovery.

The most effective way to treat substance use disorders driven by heroin or prescription drugs involves the use of medication-assisted treatment, an approach to treating opioid addiction using FDA-approved medication, including methadone, buprenorphine, and naltrexone.  Medication-assisted treatment already has helped thousands of people in long-term recovery.

Opioid abuse in America is a public health emergency, but you can do something about it.

First, take advantage of DEA’s upcoming National Take-Back Day.  On April 26th, DEA will have thousands of locations across the Nation set up for communities to turn in unused, unneeded, or expired medications – no questions asked.  For more information on how to participate, visit DEA.gov.

Second, encourage friends or family members who may know someone with a substance use disorder to seek help immediately. To find a treatment facility in your area, visit findtreatment.SAMHSA.gov or call 1-800-662-HELP. 

Finally, we encourage everyone to download SAMHSA’s Opioid Overdose Prevention Toolkit.  The guide describes the signs and symptoms of an overdose, explains who is at risk, and outlines strategies for preventing the loss of life. To learn more, visit SAMHSA.gov.

Once again, thank you for inviting me here today, and I look forward to taking your questions.

And with that, I will turn it over to Secretary Sebelius.

Remarks from Secretary Sebelius

Thank you, Acting Director Botticelli. 

We at HHS are very engaged on the public health concerns regarding misuse and abuse of prescription opioids. 

As you may know, opioid sales increased fourfold between 1999 and 2010, and were paralleled by related opioid overdose deaths. 

In fact, opioid-related deaths now outnumber those involving all illicit drugs, such as heroin and cocaine, combined.

And yet, for people suffering from severe chronic pain, opioids are a coping lifeline that allows them to manage their conditions.  

When addressing the opioid problem, it is imperative that we consider those who rely upon and appropriately use their medications, as well as those who would misuse them.

In that light, the Department of Health and Human Services is pursuing a comprehensive strategy that protects the legitimate use of these drugs while targeting the small percentage of prescribers and patients who drive the abuse epidemic.

We are focused on three main objectives:

  1. Providing prescribers with knowledge to make better decisions and identify opioid-related problems in their patients; 
  2. Reducing inappropriate access to opioids; and 
  3. Increasing access to effective overdose and addiction treatment.   

From "doctor shopping" to poor care coordination, there are many factors that play into the over-prescription of opioids. That’s why CDC, NIH and other agencies across HHS are committed to the better educating doctors and prescribers.

For example, CMS is developing educational literature concerning prescription drug abuse, which states will be able to share with providers.

SAMHSA and NIDA have developed continuing education courses for current primary care physicians to help them build safe prescribing skills and manage pain for patients who abuse opioids.

FDA recently announced class-wide safety labeling changes and new requirements for opioid analgesics intended to treat pain.

And the NIDA even hosts an addiction performance project, featuring the addiction themed play “A Long Days’ Journey into Night.”

Our efforts to reduce access to inappropriate opioids centers around smarter regulation and innovative alternatives. This means better tracking of pill mill laws through the CDC, and CMS guidance on utilization controls and initiatives that identify high-risk patients. Additionally, NIH and the FDA are supporting research and development of non-addictive medication alternatives and abuse deterrents.

Finally, we are working to help those who have already fallen into addiction. NIDA supports the development of medications that can rapidly reverse opioid overdoses, as well as the development of improved treatment strategies for opioid dependence.

HRSA is funding screening, intervention, and referral services at its Federally Qualified Health Centers. SAMHSA has funded the development of treatment initiatives through medical schools, provides related block grants, and maintains a national helpline to connect individuals with abuse treatment services.

And today, FDA is unveiling a new approach to reverse overdoses caused by opioid drugs: the approval of a more user-friendly version of the drug naloxone.

Naloxone is already a staple of treatment for opioid overdose in emergency departments and in ambulances. With this change, first responders, family members or caregivers will have access to this life-saving drug with a prescription.

These just a few examples of the initiatives we are implementing across our agency. With that said, the federal government cannot tackle this problem alone. States are key players, and my department supports their efforts to combat opioid abuse. And in the coming months, we hope to increase our engagement with states.

Now I’d like to introduce FDA Commissioner Peggy Hamburg to expand on the FDA’s exciting announcement today.