Dr. Williams: Welcome to another episode of our podcast series, “Q&A with FDA”, from the FDA’s Division of Drug Information, where we answer some of the most frequently asked questions that we’ve received. In fact, since 2016, opioid related questions have frequently been in the weekly top five inquiry topics.
My name is Dr. Celia Williams. Today we are joined by Dr. Marta Sokolowska, the Deputy Center Director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research (or CDER), to discuss FDA’s new Overdose Prevention Framework. Marta serves as the Center’s executive-level leader responsible for advancing FDA’s public health response to the non-medical use of substances with abuse potential. She is a recognized expert in drug abuse liability and scheduling strategies and advises senior FDA officials on shaping scientific and policy interventions and executing strategies pertaining to the use of controlled substances and behavioral health programs.
Hi Marta, thanks for joining us today!!
Dr. Sokolowska: My pleasure.
Dr. Williams: FDA recently published its Overdose Prevention Framework in response to the evolving overdose crisis. Will you describe the Framework for our listeners?
Dr. Sokolowska: Absolutely. We recognized that the drug overdose crisis is multifaceted and has evolved beyond prescription opioids, and so we needed to broaden our approach beyond opioid use and overdoses. Our vision is to undertake impactful, creative actions to prevent drug overdoses and reduce deaths. The Framework consists of four overarching priorities: The first, supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; second, encouraging harm reduction through innovation and education; third, advancing development of evidence-based treatments for substance use disorders; and fourth, protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks. The Framework is guided by four cross-cutting principles: equity; data and evidence; coordination, collaboration, and integration; and stigma reduction.
Dr. Williams: Let’s start with the first priority – Can you provide more details about the strategy that will support primary prevention?
Dr. Sokolowska: We are exploring a number of strategies to support primary prevention, such as additional disposal options for opioid analgesics and the need for potential new authorities for opioid approval standards. We are also re-examining the role of opioid analgesic prescriber education and exploring the need for a mandatory unified, national-level education program to adequately inform opioid analgesic prescribers on managing pain. In addition, we are supporting the development of three sets of evidence-based clinical guidelines: one for the treatment of acute dental pain, another for the management of postoperative pain in obstetric patients, and a third one for the safe tapering of benzodiazepines.
Dr. Williams: This mix of strategies to reduce unnecessary exposures and prevent substance use disorders is likely reassuring to many of our listeners. Can you explain more about the second priority?
Dr. Sokolowska: That would be encouraging harm reduction through innovation and education. We are actively pursuing strategies to reduce the risk of opioid overdose, with focus on increasing access to naloxone. As part of our approach in September the FDA issued the immediately-in-effect guidance “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (or DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency.” This guidance clarifies the scope of the public health emergency exclusion and exemptions under the DSCSA as they apply to the distribution of naloxone to harm reduction programs during the opioid PHE. This guidance acknowledges and builds upon FDA’s awareness of the importance of naloxone access and availability for undeserved communities through entities such as harm reduction programs. We issued this guidance to help address some of the obstacles to naloxone access identified during community engagements. Although this guidance does not address the current prescription-only status of FDA-approved naloxone products, we consider an over-the-counter naloxone switch as especially high priority. We continue to encourage and advise industry in the development of over-the-counter naloxone, as well as working with industry to bring novel and generic naloxone products to market.
Dr. Williams: Advancing evidence-based treatments, what can listeners expect from this third priority?
Dr. Sokolowska: Yes. We have been working with our federal partners to broaden access to medications for opioid use disorder, a proven intervention to improve outcomes for people suffering from this disorder. We also continue to support development of new interventions. For example, we held a public workshop on research agenda for treatment development for stimulant use disorder last year. We are now looking to build on that workshop and resulting white paper by exploring a draft guidance on development of stimulant use disorder treatments.
Dr. Williams: And the fourth priority -- protecting the public from unapproved, diverted, or counterfeit drugs. This is an activity in which FDA has been engaged for some time.
Dr. Sokolowska: That’s right. Cracking down on the market for diverted prescription and illegal drugs and securing the supply chain for legitimate medications, including opioids, is a top priority. For instance, FDA has been aggressively working to address controlled substances illegally sold online, including through high-impact partnerships with major registries and the National Telecommunications and Information Administration. We also partnered with the Drug Enforcement Administration to issue first-of-a-kind joint warning letters to operators of two websites illegally selling Schedule II stimulants, including amphetamine drug products marketed as Adderall.
Dr. Williams: This truly is a collaboration across the government! Thank you Marta for your time and insight today! Do you have any final remarks you would like to share?
Dr. Sokolowska: Yes. Keep in mind that these activities are flexible and can be adjusted should we need to recalibrate our approach as the crisis evolves. Overdose prevention is a complex problem, and no one action or one agency will solve this crisis. However, our actions in partnership with other stakeholders can move us in the right direction, and we welcome working with all partners.
Dr. Williams: For additional information, visit the Food and Drug Administration Overdose Prevention Framework webpage. Thanks for tuning in to “Q&A with FDA” podcast series. The full podcast and transcript of this recording is available at fda.gov/QAwithFDA. And if you have drug-related questions, reach out to us at email@example.com.