Introduction: Welcome to the director's corner, an audio podcast series featuring the director of FDA Center for Drug Evaluation and Research.

Hi. I’m Colleen Labbe from the CDER Office of Communications. Today, I’m joined by CDER Director, Dr. Janet Woodcock. For this session, Dr. Woodcock and I will be discussing how the FDA has been addressing the opioid epidemic that is affecting many communities in the United States.

Colleen Labbe: Hi, Dr. Woodcock. Thanks for joining me today.

Dr. Woodcock: Happy to be here.

Colleen Labbe: So, let’s begin by talking about the agency’s recent actions to address the opioid epidemic. It certainly has been a busy year. What has CDER done with regard to the various opioid safety labeling changes announced this year?

Dr. Woodcock: Well, you know, there are many ways that you can affect opioid prescribing of the number of opioids that are out there, and many federal agencies and states and everyone have been working together. And part of our effort has been to change the labels – the actual instructions for use and warnings and so forth on opioid labels—to get more information to practitioners. So, we’ve actually changed product labels for hundreds of opioid products with numerous updates. One thing we did was add a boxed warning with safety information on all the immediate release opioid products. Those are the ones that work right away and don’t work over a long [period of] time. That warning has to do with their inherent risks—we strengthened the warnings about their risks. We also added a warning about using benzodiazepines – or as people call them “benzos” – along with opioids. Both of these [drugs] have respiratory depression characteristics, and [in the event of] an overdose—if people take too many of both of them—they could increase their risk of very serious problems, including death. And then for women who are pregnant, it’s very important that they be on treatment for their opioids and not abusing opioids during that time. There are medication- assisted treatments, such as methadone and buprenorphine, that FDA has approved, that are fairly widely used for treatment of opioid addiction. But there can be risks to the newborn from the mother being chronically on these, and that can be managed in the hospital properly and can be dealt with. But people need to recognize this could happen, so more information was added to the label. This is called the “NOW Syndrome.” [neonatal opioid withdrawal syndrome]. It’s when the mother has been taking a treatment for opioid addiction during pregnancy and the newborn will need to be tapered off, because [the newborn] has been habituated to the presence of opioids.

Colleen Labbe: Several studies have found that the number of prescriptions written for opioids has been declining over the last three years. What do you think has contributed to this drop?

Dr. Woodcock: Well, that’s a really good question. We have thought for a long time that there are too many opioid prescriptions. We don’t need 200 million separate opioid prescriptions to manage pain in the United States. So, there have been many voices. I think this is a sustained collaborative effort among the federal agencies – including FDA – plus state governments, local agencies, professional societies, and hospitals, to address the epidemic by putting out guidelines, such as CDC did. States and other localities have limited the amount of medicines that can be prescribed at once. FDA upscheduled certain drugs and put them in a schedule where you can’t as easily get prescriptions, like just phone in and get a whole lot of extra refills, and so forth. So, each one of these in and of itself didn’t make a huge difference, but collectively it’s starting to turn down the rate of prescribing in the United States.

Colleen Labbe: So, how is FDA ensuring that prescribers are aware of and understand the safety issues associated with these drugs?

Dr. Woodcock: Well, FDA has worked for a long time on prescriber education. A number of years ago, we put in place a REMS program, which is Risk Evaluation Mitigation Strategy program, where we required that manufacturers of extended release or long-acting opioids provide funding for independent, continuing medical education groups to develop CME (continuing medical education) on these topics.  The CME had to meet criteria that FDA developed. We called it a blueprint of areas that should be covered. This is very extensive education on the actual pharmacologic properties of these very potent opioids, and a very large number of people have taken this training. So, the FDA held a meeting this year and asked about the training and what should occur with training. We had long advocated as part of the administration’s initiative that prescribers should be required to get training as part of their DEA registration. You have to get a number from the DEA before you can prescribe opioids or other controlled substances. However, that has not gone through and therefore, we asked what else should be done for making sure that people who prescribe these drugs are properly trained. And we are exploring ways that can be done without making a huge burden on the health care system. So, we are in the process of continuing to explore that. In the meantime, I see that medical schools and nursing schools, and other places are making sure there is training for new trainees about opioids. Many states have made pain management training or opioid training mandatory for state licensure. So, again, there are multiple efforts coming together that hopefully will result in the fact that prescribers of all kinds are adequately trained on both the uses of these drugs and their liabilities, including the possibility of abuse and addiction.

Colleen Labbe: So, let’s look ahead. What’s next for CDER in our efforts to address the opioid epidemic?

Dr. Woodcock: Well, we will be considering another recommendation, which is that the immediate release opioids be added to the REMS program that we already have for the extended-release/long acting [opioids]. So that’s something we’re considering and working on. We are definitely going to expand our blueprint that I referred to earlier—this set of things that [a practitioner] should be trained on—to include pain management, because for an immediate release opioid, the question is, should you write [a prescription for] an opioid or give [the patient] some other kind of treatment or pain management intervention that would perhaps have fewer liabilities? So, we are definitely thinking about how we can make sure that practitioners are trained on pain management and aren’t just automatically reaching for the prescription pad every time people come in with a complaint of pain. And then we are going to be continuing to work with the stakeholders about the issue of mandatory training, and how can we make sure that all practitioners—be they physicians, nurse practitioners, dentists, etc.,—that all prescribers who prescribe opioids really are armed with the correct tools to understand the uses and liabilities of these drugs and the alternatives to them. This is not an easy intervention to make, and we have heard that many of the professional societies do not feel that a federal mandate is the best option. So we need to think through various ways this could be brought about, and we are working on that.

Colleen Labbe: Dr. Woodcock, thank you for sitting down with me today to talk about this very important issue.

Dr. Woodcock: You are most welcome.

Exit: Thanks for listening. For more information about what you heard today, please visit our web site at FDA Drugs.

For more information about opioid medications, visit Opioid Medications.

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