Remarks by Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Workshop on Packaging, Storage, and Disposal Options to Enhance Opioid Safety -- Exploring the Path Forward
Silver Spring, MD
Dec. 11, 2017
(Remarks as prepared for delivery)
I want to thank you for joining us today, for this discussion on how packaging options could play a role in driving more appropriate prescribing of opioids. It’s widely accepted that the epidemic of opioid addiction has reached tragic proportions. The scope of the crisis makes this problem very hard to fully remedy. I think it’s clear to all of us involved, that there’s no single solution. There’s no magic bullet.
And no one agency can, acting on its own, unilaterally stem this crisis.
It’s going to take concerted and coordinated action by everyone involved. And it’s going to take layers of different solutions, to start reducing the rate of new addiction, and helping those who are currently addicted make the transition to living lives of sobriety.
We need to be creative and take advantage of every tool and opportunity we have to advance these goals.
Taking on this crisis remains my highest priority since I landed in my role as FDA Commissioner; and it’s one of the highest priorities of the administration as well. I believe that how we package opioids can be a big part of a framework that drives more appropriate prescribing.
That’s why I think today’s discussion is so important.
In conjunction with today’s meeting, our Opioid Policy Steering Committee is also publishing a federal register (FR) notice that asks certain questions related to steps we might take to better address this crisis.
The two actions – the meeting today, and the questions we’re seeking comment on in the new FR notice – share some common threads about the steps we might take going forward. Let me tell you how.
There are a lot of challenges when it comes to the way that opioids are being prescribed. If there weren’t tragic mistakes being made, we wouldn’t have the crisis that we now face. And because the epidemic has grown so vast, so pervasive, and so deadly; the kinds of actions we must consider -- to stem the tragedy -- are in my view, going to be far more intrusive than the steps we might have taken a decade ago that could have slowed the rate of new addiction and the scope of this crisis.
The days of thinking incrementally are over. We need to embrace actions that transform us away from the current crisis. I divide the clinical challenges we face into three broad categories of behaviors. These are by no means comprehensive. But I want you to know how I’m thinking about the problem as we pursue solutions that FDA can implement. And how the topics we discuss at today’s meeting could fit into better product regulation to address how opioids are dispensed.
This meeting is about the use of packaging solutions more broadly, beyond the use in limiting quantities of opioids available for misuse. This includes the use of packaging innovations to improve storage and disposal and measure adherence. All this work has as a goal preventing misuse. For example, improving disposal of unneeded opioids is another highly effective way to reduce the supply on the market. But packaging can also be a tool to address certain aspects of the prescribing challenges that we face related to opioids. And with respect to those clinical challenges, I see three broad areas of prescribing activity that we need to take new steps to try and address.
First, there’s over-prescribing for routine medical problems that can probably be suitably addressed with non-opioid alternatives. This is, for example, a 30-day supply of Vicodin for a tooth extraction or for a routine musculoskeletal injury. Why couldn’t a three-day course of treatment be sufficient for a first dispense, or a trial of ibuprofen?
We know that some of this over-exposure to opioid drugs ends up fueling new addiction. And multiple studies have shown that excessive quantities of opioid medications are routinely prescribed for all types of surgical procedures, as well as after emergency department visits for painful conditions, and most patients save leftover pills. So large amounts of opioids are unnecessarily made available for diversion.
Second, there’s simply too much long-term prescribing of opioids. This is where the guidelines put forward by the Centers for Disease Control and Prevention (CDC) can become an important benchmark for more rational and appropriate prescribing, especially for non-cancer indications; and why it’s critical for insurers to pay for non-pharmacological approaches to pain management. These CDC guidelines can help to help inform our own regulatory decision making as we at FDA consider measures to help curb over-prescribing and to see opioids used only in those circumstances where they can make a meaningful difference for patients and are appropriately monitored to assure they are working. We can pursue these goals, for example, through labeling changes, or measures to more directly influence prescriber behavior.
Third are the pill mills – the egregious prescribing that often crosses into criminal activity. Our colleagues at the Drug Enforcement Agency have taken vigorous and brave efforts to shut these outlets down. Our own Office of Criminal Investigations at FDA assists in some of these efforts. Unfortunately, many pill mills still exist. It’s going to take significant resources and efforts to fully eliminate these practices.
Today I want to focus on the first issue; the routine over-prescribing of opioids for more common medical problems – including conditions that might be appropriately handled with non-opioid alternatives.
In my view, the question is this: How can we put some speed bumps in front of this behavior, to tell everyone to slow down a little. That’s where changes in packaging could be part of a more comprehensive approach to reducing routine over-prescribing.
Consider this one, hypothetical scenario:
Imagine if FDA worked with medical professional societies to create expert guidelines about what appropriate prescribing and dispensing should be for different medical needs. Under this hypothetical, the dental society might promulgate guidelines that stipulate that no dental procedure should require more than a four-day course of treatment on the initial fill. If these guidelines were in place and had sufficient scientific support, then under our current regulations we’d be able to incorporate this information into product labeling.
Once these were part of our labeling, it opens up certain possibilities about how we drive more appropriate prescribing.
Could we, for example, require that the Immediate Release (IR) drugs be packaged in units that comport with the majority of these consensus durations? Let’s say that recommendations from most of the medical societies clustered around proposals for two, four, and six-day courses of therapy. Could we require certain drugs to be packaged in these units, like we see prednisone packs currently sold on the market? Could then electronic prescribing systems bring these options up as a default for clinicians?
Then, once we had more recommendations for shorter-term use – and packaging that contained these shorter duration, dispensed units – we could then consider linking quality metrics to these thresholds.
Educational requirements could also play a role. If doctors wanted to prescribe the packs of four or six day courses of treatment, they could continue to write for these drugs in the manner they prescribe today. But if they wanted to prescribe a 30—day course of therapy, they’d have to go through some additional certification steps, like mandatory educational requirements. You can start to see how packaging can become part of a more comprehensive approach.
This is just one idea. I’m sure you all have many more. That’s why we want to hear from you, and why we’re so grateful for your joining us.
Our goal for this scientific workshop is to develop information that can lead to more innovative solutions that involve changes in packaging.
First, we need to fully define the specific problems that these types of packaging, storage, and disposal options can help address.
Second, we want to more clearly define the guiding principles that the scientific community should consider in designing packaging, storage, and disposal options aimed at enhancing opioid safety.
Finally, we want to better define the types of data needed to evaluate these packaging, storage, and disposal options in both the premarket and post-market settings. We need to make sure steps we take work.
In addition to the idea for a blister pack that has a defined duration of use that might be for only a limited number of doses, there are other considerations where packaging can play an important role.
Other packaging innovations could make it easier to track the number of doses that have been taken. Still other options could work to improve storage and encourage prompt disposal to reduce the available supply and reduce the risk for third-party access, such as a child accidentally ingesting pills they found in a medicine cabinet.
There are also technologies that could allow providers, pharmacists or family members to monitor patient use of prescription opioids.
FDA is committed to exploring our existing authorities to find new and impactful ways of regulating packaging, storage, and disposal options to improve safety. All the while, keeping in mind, the balance we need to strike between those who need these medicines to function in their daily lives; which may unfortunately be filled with pain from a chronic disease or cancer. We need to balance our steps to address the opioid epidemic with the legitimate needs of patients with painful conditions.
As this meeting today gets underway, we’re also announcing in the federal register today a public hearing we plan to hold, and a series of questions we intend to ask in a new, public docket. These two steps are part of one comprehensive policy effort that’s underway at FDA.
Among the questions we posed today in the FR: We’re asking the public for information on how we could take steps to see limits placed on dispensing based on the medical condition for which opioids are being prescribed. We’re also asking for input on whether and how we might improve education and training for providers, including mandatory education. As the example I outlined earlier illustrates, the answers to these and similar questions, and the role of packaging, are intertwined.
It’s an example of how we need to consider all the various steps we might take as part of one framework for encouraging more appropriate use of opioid drugs if we’re going to tackle this crisis.
The notice we released today, and the questions we ask, also foreshadow other ideas we are contemplating. Picture this as one example: a doctor believes it’s necessary to prescribe an opioid analgesic to one of their patients. When entering the electronic prescription into their computer, they’re prompted that the number of pills they’re seeking to prescribe is higher than recommended for a particular clinical need. In order to proceed, the doctor would provide justification as to why the quantity they seek to prescribe is medically necessary or consider alternative treatment options for their patient.
Importantly, this wouldn’t take the place of a prescriber’s best clinical judgment or limit access for patients for whom chronic use of opioids is the most appropriate therapy. But it would give providers the chance to carefully consider whether the amount prescribed is proper for their patient or if there are non-opioid drugs that could be used instead.
This is where our efforts to talk to those involved in managing the delivery of care, like insurers, health systems, and pharmacy benefit managers, has also been helpful to us as we consider new approaches. They have the capacity to implement programs that are leveraged off of the tools we can help create, and information we make available.
Another approach the Opioid Policy Steering Committee is considering would require drug sponsors to create a nationwide prescription drug monitoring database – an approach that we believe could be more effective in helping health care providers identify patients who could be misusing or abusing prescription opioids and provide real-time alerts about potentially harmful drug-drug combinations.
The public hearing we’re announcing today in the federal register will be an important opportunity to bring stakeholders together to discuss these and other new approaches – what they might look like, how they’d be implemented, their challenges, and how we’d measure the impact on the opioid crisis. While we recognize that some of the ideas we’re exploring are unprecedented, the tragic truth is that this crisis is so immense that we need to consider a range of more impactful options that we may not have considered before. Ultimately we believe it’s our obligation to identify and explore every option available to us. We’re determined to make sure that, when combined with other efforts we and others are taking; new steps yield meaningful results.
I look forward to hearing a summary of what will no doubt be a very important discussion today. Thank you for taking time out of your busy schedules to join us in this struggle to improve public health.