Remarks at the Public Workshop on Strategies for Promoting the Safe Use and Appropriate Prescribing of Prescription Opioids February 15, 2018

Speech | In Person

• Speech by: Scott Gottlieb, M.D.

Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Public Workshop on Strategies for Promoting the Safe Use and Appropriate Prescribing of Prescription Opioids
National Press Club, Washington, DC

I want to start out today by reflecting on one of the great triumphs of the modern era -- the battles we won in the war against pathogens. These victories were achieved through the introduction of antibiotics and vaccines. Our triumphs were so swift that it seemed in 1969, the Surgeon General said it was time to “close the book on infectious disease.”

But the cunning of the pathogens, and the power of natural selection, was underestimated. The bugs adapted to our innovations. And the nature of many diseases continued to evolve and evade our initial successes.

We’re in the midst of a new epidemic of opioid addiction. Like epidemics caused by pathogens, this one is also evolving – finding ways to evade our policy interventions. Staying one step ahead of our efforts.

And so what began as an epidemic caused by short- acting prescription opioids evolved;, as new, more powerful, and longer-acting formulations of those drugs came onto the market. People went from swallowing pills to crushing them, and snorting and injecting their ingredients.

The epidemic evolved still further as addicts moved onto low-cost alternatives, which were increasingly street drugs. So even as prescribing of opioid drugs have begun to fall, in part as doctors take heed of the risks of over-prescribing, opioid related deaths are on the rise. The addiction crisis has evolved to street drugs that are often laced with lethal doses of super potent formulations of counterfeit fentanyl.

Like a deadly pathogen, just when we’ve advanced policy to address one aspect of this crisis – it mutates into a new and more deadly form.

The latest data shows that drug overdose deaths in the U.S. climbed by about 21% between 2015 and 2016 — from a record high of more than 52,000 deaths to nearly 64,000. About two-thirds of those overdoses were linked to opioids. A crisis that began with prescription drugs has evolved into a much more insidious threat involving illicit fentanyl.

In the early days of this crisis, before we had a clear picture of how bad it’d be; many people often characterized opioid addiction as a problem of non-medical abuse. But the evidence always suggested that addiction occurring in both medical and non-medical users, rather than abuse alone, was a key driver of the epidemic. We were slow to see it.

As a nation, we did eventually engage more vigorously. But we were late to treat opioid addiction like an epidemic. We were late to reach for more aggressive interventions. And now the addiction crisis is burgeoning out of control. We find ourselves at a point where our interventions are being outmatched by its constant evolution.

Addressing this crisis will involve the concerted efforts of many stakeholders – public and private, local and federal. FDA’s potential to impact this crisis has been, regrettably, diminished over time. Not because our tools are less relevant. Rather, because the scope of the epidemic has grown so much larger than the range of our purview.

But at FDA, we still have a very important role to play. This is especially true when it comes to helping make sure that fewer new people become addicted through the medical use of these drugs.

We have an important role to play in supporting the development of improved medication-assisted treatments for opioid dependence, which will expand treatment options for those currently addicted to opioids. We also have a role in helping support the development of new, safe and effective treatments for pain that don’t carry all the same risks of addiction as opioid medicines. And we have a role to play in interdicting illicit drugs that are pouring into our country, often through the mail.

I want to focus my remarks today on the first challenge: The steps we’re already taking to reduce the incidence of new addiction that’s derived from the medical use of prescription opioids.

We know that a lot of the new addiction is still the result of the medical use of opioid medicines. Some proportions of those who are addicted are patients who were first exposed to opioids through a lawful prescription. So, a key to reducing the rate of new addiction is to rationalize prescribing. To make sure that people are prescribed opioids only when it’s medically indicated. And when a prescription is written, it’s for a dose and duration of use that comports closely with the clinical purpose.

There’s a lot we’re already doing to address this challenge. We recently expanded our risk management plans to incorporate all opioid drugs that are intended for use in the outpatient setting -- including the immediate-release formulations -- for the first time.

We’ve re-drafted our Blueprint for how providers should be educated about prescribing. And we’re requiring this training be extended to all providers who are likely to come into contact with patients who are prescribed these medicines, including nurses and pharmacists.

FDA also is taking immediate action where needed, as we did with FDA’s first-of-its-kind request to remove a marketed opioid pain drug from sale due to the public health consequences associated with the product’s abuse and misuse.

On the issue of illegal narcotics like fentanyl that are coming into the U.S. through mail facilities: We tripled the number of inspectors we have in the International Mail Facilities (IMF), allowing us to quadruple the number of suspicious packages that we’re able to open and inspect. We sharply increased the number of agents we have working the dark web, looking for sources of fentanyl. And we’re looking for ways to build out our footprint in the IMF still further, so that we can stop, inspect, and test more packages that contain suspicious drugs, and trace illegal narcotics back to their source; to bring action against their purveyors.

Under the leadership of Opioid Policy Steering Committee, which I formed when I arrived at FDA last May, we’re also re-evaluating how already marketed drugs are used, both for legitimate purposes and misuse and abuse. In particular, we’re looking closely at certain opioids that may have a higher abuse potential, like oxymorphone.

And we find ourselves in some unlikely places as this crisis takes on a new dimension. Who would have predicted, just a short time ago, that we would have to take regulatory action to prevent the abuse of Loperamide. And who would have thought that Kratom would become a new gateway to addiction -- abused for its opioid properties.

The opioid crisis is taking many new, and unpredictable turns. And our experience demonstrates that we need to be vigilant and aggressive at the outset, as these new threats emerge. Our experience has shown that if new problems fester, they can quickly spiral out of our control.
And there are some new concerns we have.

One relates to the possible risk of misuse and abuse of gabapentinoids.

Gabapentinoids are FDA-approved drugs that are not opioids and have been approved to treat a variety of conditions including postherpetic neuralgia, fibromyalgia, partial onset seizures, and neuropathic pain associated with diabetes or spinal cord injuries.

Some literature suggests that clinicians may be prescribing these drugs off-label to patients with various types of pain, as alternatives to opioids, outside the approved indications for gabapentinoids.

Our preliminary findings show that abuse of gabapentinoids doesn’t yet appear widespread. But use continues to increase, especially for gabapentin. FDA is investigating whether their abuse or misuse is also increasing and, if so, what should be done to address the problem.

Although limited, the data suggest that gabapentinoid misuse and abuse may be growing, both when taken alone and when taken with opioids, benzodiazepines, or other central nervous system depressants.

We’re concerned that the misuse and abuse of these drugs may result in serious adverse events such as respiratory depression and death. We want to understand changes in how patients are using these medicines.

Among other steps that we’re taking: we’ve looked at social media sites where opioid users share comments that describe methods and motivations for misusing or abusing gabapentinoids. And we’ve tasked our surveillance and epidemiology group inside FDA – who are focused on spotting early patterns of abuse of controlled substances – with investigating the use patterns of the gabapentinoids.

We’ll have more to say about our work on this challenge soon. Our swift attention to this matter is, in part, a consequence of the lessons of history. We need to investigate and respond to signs of abuse as soon as any signal emerges. We need to get ahead of these problems.

And getting ahead of new threats, or addressing those crises that are already fully manifest, will sometimes require forceful actions. The scope of this epidemic demands that we consider more potent steps.

One action that we’re examining is the blister packaging of the immediate release formulations of opioid drugs. I believe that this merits consideration through a careful, science-based process.

We need to ask: Would requiring IR opioids to be packaged in unit dose blister packs, where the number of pills contained in a pack comported with appropriate durations of use – say a 3, 5, or 7 day supply – help ensure providers dispense only the amount of drug needed for the common, short-term uses for which these medicines are often intended?

In December, the FDA hosted a public workshop on the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioids.

New types of packaging -- rather than a typical bottle with a 30-day supply – could remind prescribers to restrict the number of opioids dispensed to patients, in turn reducing the total amount of opioids. It could also reduce inappropriate access to opioids by kids. This would also address the problem of excess supply in the U.S.

Packaged in this fashion, the belief is more doctors may opt for these shorter durations of use. This would reduce overall exposure, and the rate of new addiction. Moreover, provided FDA concluded that there was sufficient scientific support for these shorter durations of use, this could provide the basis for further regulatory action to drive more appropriate prescribing. And so, we’re actively exploring our authorities in this area and also looking at how we can work voluntarily with the supply chain and manufacturers to get IR opioids in blister packs.

We’ve used packaging to address safety concerns in the past. Most recently, we requested that manufacturers of Loperamide make packaging changes, such as using blister packs, to address the abuse and misuse of that OTC product.

I’m certain there will be more to come on this topic. We’re taking an all of the above approach in our efforts to combat this immense public health emergency. All reasonable steps are on the table.

With millions of Americans misusing prescription opioids and more than 40 people dying every day from overdoses involving opioid medications, it’s become abundantly clear that we need to do everything we can, along with our partners, to get ahead of this crisis.

We appreciate your input today. We’ll continue to seek feedback from a broad group of stakeholders and explore a range of approaches to tackle this epidemic, and help ensure proper treatment for pain.