The United States Food and Drug Administration (FDA) offers a podcast series, known as the Director’s Corner, that features the director of the FDA Center for Drug Evaluation and Research (CDER). One of the most recent episodes featured an interview with Dr. Janet Woodcock, by Colleen Labbe from the CDER Office of Communications, who discussed the way the FDA has been addressing the opioid epidemic affecting many communities around the United States.
CDER’s Response to FDA Labeling Changes
One of the first questions asked of Dr. Woodcock was what, exactly, CDER did with regard to the various opioid safety labeling changes that were announced in 2016. Dr. Woodcock noted that “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.” CDER has actually changed the product labels for hundreds of opioid products with numerous updates, including adding a boxed warning with safety information on all the immediate release opioid products. Dr. Woodcock said that the reason for the boxed warning on immediate release opioid products has to do “with their inherent risks – we strengthened the warnings about their risks.”
CDER also added a warning about using benzodiazepines – also known as “benzos.” Benzos, as well as opioids, have respiratory depression characteristics, and in the event of an overdose, patients can increase their risk of very serious problems, including death.
Additionally, Dr. Woodcock noted, pregnant women should be on treatment for their opioids and not abusing opioids throughout their pregnancy. She continued, “there are medication-assisted treatments, such as methadone and buprenorphine, that the 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.” However, Dr. Woodcock and CDER wanted to draw more attention to these potential problems, so more information was added to the labels, referring to this as the “NOW Syndrome,” which stands for neonatal opioid withdrawal syndrome.
Decline in Opioid Prescriptions
Labbe asked Dr. Woodcock about the decline in the number of prescriptions written for opioids over the last three years, and what she believes has contributed to the drop. Dr. Woodcock responded, “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.”
Dr. Woodcock stated that the FDA has worked for a long time on prescriber education and referred to the Risk Evaluation Mitigation Strategy (REMS) program, where the FDA required that manufacturers of extended release or long-acting opioids provide funding for independent, continuing medical education groups to develop continuing medical education (CME) on these topics, which had to meet FDA-developed criteria.
The FDA has “long advocated as part of the administration’s initiative that prescribers should be required to get training as part of their DEA registration,” and held a meeting in 2016 focused on the training of prescribers. The FDA continues to review ways to ensure prescribers are properly trained and educated without “making a huge burden on the health care system,” but in the meantime, “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.”
What Does the Future Hold?
As far as future CDER efforts to address the opioid epidemic, it 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. CDER also plans to expand the “blueprint” for the requirements that a practitioner should be trained on to include pain management. CDER wants to ensure 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.”
CDER also plans to work with stakeholders about mandatory training and how it can be ensured that all practitioners (physicians, nurse practitioners, dentists, etc.) who prescribe opioids are “armed with the correct tools to understand the uses and liabilities of these drugs and the alternatives to them.”