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Speech by FDA Commissioner Robert M. Califf to the 2016 Rx Opioid and Drug Abuse Summit

Speech by Robert M. Califf, M.D.
Commissioner of Food and Drugs
Rx Opioid and Drug Abuse Summit
Atlanta, Georgia
March 29, 2016

Thank you. I am delighted to be here with all of you representing the FDA.

Chairman Rogers, I want to thank you for your leadership in the fight against prescription drug abuse in Washington, in your home state of Kentucky and here at the Summit. Just a quick look around this gathering makes clear what your organization, Operation Unite, has accomplished in building the Rx Summit, now in its fifth year. And I also want to thank you for your kind comments at the beginning of this meeting. I hope my performance as FDA commissioner will live up to your expectations.

I also want to acknowledge my distinguished colleagues from HHS and the White House, who have spoken so eloquently already about the challenges we face and their efforts to combat this crisis. If you want to talk about the definition of fun for someone like me, it’s getting to wake up in the morning and give Francis Collins a call, ask him what’s going on at the NIH that’s new in terms of cures and treatments, call Andy Slavitt over at CMS and ask him what can we do to fix the reimbursement system so that doctors and patients get what they deserve. And of course I should note that we report to Sylvia Burwell, who is absolutely driven to do everything we possibly can on the issue we’re discussing at this meeting. And I don’t want to leave out Tom Frieden, who so ably heads up the CDC. We all have a lot in common and try to work together to help where we can.

After all, opioid addiction is a complex issue and it does require all of us working together to defeat this vast and insidious epidemic that has touched every corner of our nation and has devastated the lives of so many.

This morning, I want to update you on the unprecedented actions FDA is taking in response to the crisis. But before I do I also want to say a word about the allusions that people have made to the “culture” at FDA. I just want to let everyone know that as the leader at FDA, I’ve found FDA to be amazingly full of extraordinarily hard-working, dedicated, people who have to make very difficult decisions that in almost every instance will disappoint some and please others. I’m not asking for your sympathy when I say that. It’s part of the job. What I am asking is that you work with us as we adjust the decisions we make in a situation that’s so fluid as an evolving epidemic that you’re here to solve. Please work with us. Give us the feedback. We can take it. And we will make adjustments as we go along.

As you may know, I was only recently confirmed as FDA commissioner. But I came to the agency as a practicing physician, a researcher, and a health system administrator with a history of involvement in pain management, including the use of opioids. I have first-hand experience with the benefits as well as the catastrophic harms that can come from these powerful drugs.

As a clinical researcher, I worked with and helped oversee the data coordinating center of NIH’s NIDA clinical trial network, which was involved in some of the early medication-assisted treatment studies on opioids, and I learned a lot about it. And as part of my work with the CMS and NIH, I was the leader of a study in North Carolina, Mississippi, and West Virginia, developing approaches to the treatment of chronic disease in rural communities. I know there are a lot of you here that are from rural communities, and it was a real eye-opening experience to think about how to administer health care in much more difficult circumstances than in an academic medical center.

West Virginia, in particular, is a state where the unrelenting burden of work in the coal mines often leads to serious and chronic back pain. An important source of relief for these hard working men and women comes from the prescription of opioid medications.

But, over the course of my practice, and this research, I’ve also witnessed the devastating consequences for patients who get trapped in the destructive spiral of opioid addiction. We really have to keep this in mind. In fact, our work in these rural communities was focused on diabetes, but we found opioid addiction to be such a problem that NIDA gave us a special grant to work on screening patients for opioid addiction as part of our diabetes work.

I bring this experience and perspective to my new role at FDA, and I have a deep commitment to contributing to the solution to this crisis.

And make no mistake, FDA has an integral role to play in addressing the opioid epidemic. Opioids challenge our usual model for prescription drugs. Typically, when we consider whether a drug is safe, the primary consideration is for safety for its intended use with a specific patient population. When we develop drugs for a heart attack we think about the person having the attack, and not so much about everyone else who might be affected.

But I certainly don’t have to tell this audience that opioids raise more complicated issues. The decisions we make about opioids involve an extraordinarily complex balance between the need to treat pain, while also preventing addiction and abuse of such a highly addictive medication. And I’m pausing on the word abuse because as we go through this, the language is going to need to change, as several other speakers have said. But this process involves not only the patients but anyone else who has access to the drug.

Today, this balancing act is all the more difficult because it occurs against a backdrop of this escalating misuse, addiction, overdose, and death that you’re going to spend the rest of this meeting talking about and covering so diligently.

That’s why, earlier this year FDA decided to reassess our strategy towards opioids along the entire lifecycle of these drugs, including whether we should reconsider the risk-benefit paradigm we currently use.

The Opioids Action Plan that we announced in February is designed to use every possible tool at our disposal to reverse the epidemic, taking aggressive actions in those instances when doing so will make a positive difference, while still providing patients in pain access to effective relief. 

These include reviewing and strengthening labeling and post-market surveillance, prioritizing the development of abuse deterrent formulations and overdose treatments, encouraging the development of new non-opioid alternatives for pain management, increasing education and training for prescribers, and developing a better evidence base to inform the study and development of these products.

At the core of this action plan is dedication to a major reduction in the number of opioids used in this country. Far more prescriptions are written than are needed to responsibly treat the conditions for which they were prescribed. That excess only serves to flood our society with diverted opioid medications.  We must break this excess prescribing pattern. And prescribers should be focused on matching the clinical need and the prescription as exactly as possible. While I do have a script, I’m not averse to preaching. My grandfather was a Baptist minister so I’m very clear about this.

There is no one cause for this complex public health crisis, however. And so our response is broad, comprehensive, and integrally linked to Federal and societal partners to address multiple sources.

It is designed to get industry to strengthen its role in curbing this epidemic by strengthening product labeling and shouldering corporate responsibility.

It is designed to help patients and their families better understand and ask about alternatives for pain management.
And it is designed to encourage doctors to focus on their choice of opioids in the context of comprehensive pain management.

Certain questions should become as routine as asking patients about their medical history.  Is there a non-opioid option? If an opioid is necessary – what is the appropriate dose and duration? How many pills does my patient really need? I’ve heard even from some members of this audience that they recently got 30-90 days of medication for a relatively minor pain situation. Does my patient understand the risk of addiction – and also the real world risk of making pills accessible to family members and others?  And how do we jointly develop a detailed and realistic plan for patient follow-up?  

I’ll note here that most medical practices in the United States now are owned or in long-term contracts with integrated health systems. So now we extend the responsibility beyond the pharmaceutical companies and the doctors to those who lead integrated health systems who are able to monitor, through electronic prescribing, every prescription that is written. What’s being done there to curb the overprescribing that we’re currently seeing?

I’m pleased that prescribers are also hearing this message from other Federal agencies, such as through the new CDC prescription guidelines, which, make no mistake about it, we’re fully supporting, and the Surgeon General’s important campaign to mobilize providers to take a leadership role in changing practice and policy.

One change we just announced will help in this regard. Last week we required a tough new safety labeling requirement for all immediate-release (or IR) opioid pain medications that are frequently prescribed by doctors and dentists for acute pain.  Chairman Rogers noted this and we appreciate his support. This important change builds on a similar labeling change requirement that we instituted for Extended-Release/Long-Acting (or ER/LA) opioid analgesics in the past.

In addition to providing specific information about risks, it clarifies that because of these risks, many IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options are inadequate or not tolerated. 

Because education of prescribers is such a critical piece of our overall action plan, we also have called for a joint Advisory Committee meeting in early May to discuss and evaluate a training program that has been in place for ER/LA drugs since 2013. Companies that make these drugs are required to fund low or no cost courses for prescribers on the appropriate use of these products. The courses must follow an online FDA curriculum. And I hope that a good many of you will be at this hearing and the public testimony portion and look with us at the study of this program.

In total, over 100,000 practitioners have completed the training in these voluntary continuing education programs, including more than 38,000 prescribers. The topics for the two-day May meeting include possible expansion of the scope and content of prescriber education, ways to increase the number of prescribers who receive training on pain management, and whether to expand the program to include IR opioids. 

Our action plan also recognizes the importance of seeking new ways to formulate opioids to discourage tampering with the drugs in order to receive a faster high, a problem that I know you’re grappling with and will talk about during this meeting. Last week we issued a draft guidance for industry that will help them develop abuse-deterrent formulations and ensure that generic versions of approved opioids with ADFs are no less abuse-deterrent than the brand name drug.

Although there are limits to abuse-deterrent formulations that we well recognize, and we need more data on their effects in practice, as one piece of a broader strategy they offer a promising path for the development of products that are more effective in deterring abuse than non-ADF opioids, by both patients and non-patients.

Ensuring appropriate access to generic forms of abuse-deterrent opioids is an important element in that broader strategy.  We’ve noticed in prescribing patterns that abuse-deterrent formulations have not taken a large share of the market, perhaps in part due to the much higher cost without generic formulations on the market.  So the availability of less costly generic products has the potential to increase the use of abuse-deterrent formulations.

Some have said that one way that FDA could reduce the use of opioids is to limit the number of opioids it approves. But there are limits to what we can do under the current law. Under the current law, FDA is obligated to approve an application for a generic drug unless the product fails to demonstrate bioequivalence to the innovator or it does not meet other standards. This is a difficult problem that we’ll be talking about more in the near future.

An essential piece of developing new abuse deterrent products is having the necessary data on the impact of existing ADF products.  That’s why FDA has made the decision that all sponsors of brand name products with approved abuse-deterrent labeling must conduct long-term studies to assess their effectiveness in reducing abuse in practice. To generate further discussion and ideas on this topic that could lead to more effective ADFs, we have scheduled three advisory committee meetings on ADF opioids in May and June. You can see there will be plenty of opportunity for discussions, and we do seek your input and guidance on these issues.

The search for adequate scientific evidence is key to much of the work being done in opioids, not just ADFs. There currently is a dearth of data across the field of chronic pain treatment. For an agency like ours, which relies on high-quality scientific evidence, we need a much more robust national research effort to inform doctors and patients about the long-term benefits or risks associated with the use of opioids for treating chronic pain. I’ll note here that just last week a team from FDA met with a team from NIH to talk about what we can do together to stimulate this research effort that’s very much needed.

As you’ve heard, the Department of Health and Human Service recently announced a National Pain Strategy, which is focused on producing more research and increased collaboration to strengthen understanding about appropriate management of chronic pain while encouraging more informed prescribing of opioid medications. I’m pleased that FDA is playing a role in this important effort. We’re also taking a number of additional actions.

One step is to issue revised post-marketing study requirements for ER/LA analgesics. This requires drug sponsors to conduct a series of eleven studies on questions that are critical for ensuring safe prescribing, and that will generate better data regarding the long-term impact of the use of these products.

Our search for supporting evidence and reliable data also involves collaboration with public and private partners to strengthen our evidence base.  I’ll note here that PCORI, the Patient Centered Outcomes Research Institute is just initiating a 40 million dollar program to study ways to spare opioids in the treatment of pain. I also very much want to reinforce the PMI initiative that Francis introduced at the end of his talk. And I hope all of you will push the NIH to open it up as soon as possible, and then all of your families will volunteer to participate. It’s been touted as over a million Americans. But what we’d really like to see is 10 or 100 million Americans volunteering. Because then we’d have the kind of information we need to make the best decisions on behalf of the public.

As more evidence comes in we are committed to adapting our strategy to optimize our effectiveness. And I can’t stress this enough. We really urge you get out there after this meeting and push as hard as you can to get as much valid scientific evidence so that we can make better decisions.

Earlier this month we convened a special meeting of the FDA Science Board focused on the issue of opioid abuse.  I want to stress this is just the beginning. I’ve already outlined a number of other public meetings that will be held. And I’m also very pleased to announce that we just signed a contract with the prestigious National Academy of Medicine (NAM) to assist us in developing an updated risk-benefit regulatory framework for opioid review, approval, and monitoring that balances individual need for pain control with considerations of the broader public health consequences of abuse and misuse. We’ve heard many people call for such an evaluation and we’re taking it very seriously and it’s being done independently of the FDA so that we can get the best advice.

Our action plan also involves expanding the availability of medications to treat opioid addiction and overdose. Among the most important developments in this area is naloxone, a life-saving drug that has the ability to reverse an opioid overdose. As a practicing intensivist cardiologist for many years I’ve had the chance to personally reverse opioid overdoses in the course of treating severe chest pains, so I have a healthy appreciation for the amazing life-saving effect that can occur here in the way that other speakers have discussed.

FDA has taken a number of steps in the last few years to spur the development and greater availability of this product.

Just yesterday, I had an invigorating meeting with the University of Kentucky researchers who are passionate about this area and have ideas on how a coordinated federal effort can help expand availability of naloxone products, directly saving lives.

One exciting possibility that FDA has been working on involves our active support for the development of potential over-the-counter (OTC) versions of naloxone. Some states have taken steps to expand access to naloxone in pharmacies. I will note that Naloxone still needs to be dispensed pursuant to a prescription under federal law. That’s why we intend to work closely with industry to further pursue OTC naloxone development and help meet the urgent need for wider access to this life-saving medication. But also to work with the whole chain of pharmacists, nurse practitioners, and others that need to be involved in community-based care to make these products available and to educate as many as possible in how to use them.

As I hope this brief summary indicates, at FDA we are dedicated to finding solutions to this crisis and to working together with others to turn this situation around.

I want to return to a statistic that underscores the challenge we face, but also offers us a very real pathway to overcoming this crisis.  And this is the number of annual opioid prescriptions written in the United States, which is roughly equal to the number of adults in the population. I think you’ll agree with me that this correlation is simply unacceptable. And, ultimately, it is up to each of the parties in the drug production and prescription chain to take action to lower that number. As you’ve heard, this is already underway, but we need to accelerate it.

We need the medical professions to “step up to the plate” with us to curb this excessive prescribing. Furthermore, those prescriptions that are written must be for the correct and necessary treatment -- matching the prescription to the true patient need. And again, integrated health systems have an important role to play here.

As a practicing doctor until recently, I understand the stress involved in multiple requirements for increased education and the extreme pressure to move patients in and out of clinics.  And I’ve heard stories at this meeting of practitioners unable to generate an adequate income in their practice if they take the time necessary to practice integrated pain management. But we can no longer tolerate the usual excuses or the old ways of doing business.

Voluntary training under FDA’s current program offered by manufacturers of extended-release opioids is not enough. I have lots of experience with continuing education. In fact, it’s likely that the prescribers who take the training are the ones who need it the least! In other words, we need to reach the practitioners who don’t sign up for voluntary training.

That’s why we support mandatory training and education, not only about opioid prescribing, but about pain management. And I think you’ll hear more about this this afternoon from the President.

And beyond the doctors we need the entire teams for pain management to undergo this training because many others in the clinic are really responsible for the delivery of much of the care that patients need. After all, the goal should be effective treatment at the lowest possible risk, so when opioids are not used, practitioners should be skilled in integrative pain management methods. Such training should also include assessing and addressing signs of misuse and dependence. I’ll add here that the payment system must be reformed. I was really heartened to hear many of the comments made by Chairman Rogers and Mr. Botticelli about efforts underway to change the payment system to provide the integrated care system that’s needed.

Industry has other important roles to play as well. We have required that companies conduct a number of important post-market studies. We’re also encouraging them to innovate, and to develop better abuse-deterrent formulations, new medication-assisted treatments, and over the counter versions of naloxone. Ultimately, we want them to put more attention on the development and promotion of non-opioid alternative drugs for pain relief. We need to work together as patients and as a community to develop incentives to get industry to pay more attention to this. I am not happy with the pipeline that is coming through despite all the work that is being done at NIH.

I believe this is a matter of corporate responsibility, not just a government requirement.  Corporate boards and executives have been noticeably silent on this issue. They have a duty to examine what their companies can do to stem this epidemic that goes beyond the minimum requirements, including careful examination of promotional practices.

We cannot wait any longer. Too many lives have already been lost.

In short, there is no magic bullet for solving this crisis. It requires hard work, creative ideas, and collaboration -- across government, with industry, the medical profession, health care providers, and, most importantly, patients and their families.

I want to pause here to say that at the FDA a major focus is hearing from patients and families very directly. And we encourage you to keep talking to us, even if you give us tough messages. We can take it. We need to be interacting with you to understand how to make the best decisions.

FDA is committed to doing what it takes to achieve success, ensure the judicious and responsible use of opioids, and bring an end to this epidemic. We look forward to working with all of you on reaching this critical goal.

Thanks for your attention.

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