FDA Proposes a Plan for Opioid Drug Use, Overdose ReductionBy
The US Food and Drug and Administration (FDA) has introduced a plan, the Overdose Prevention Framework, to provide its four main priorities to prevent opioid drug overdoses, which includes ways to manage prescription drug use, encourage innovation in substance-deterrent drugs, and to stem the flow of counterfeit drugs.
The four priorities within the FDA Overdose Prevention Framework are:
- Supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing.
- Encouraging harm reduction through innovation and education.
- Advancing development of evidence-based treatments for substance use disorders.
- Protecting the public from unapproved, diverted, or counterfeit drugs presenting overdose risks.
Below are some activities under each of those priorities that the FDA is exploring.
Supporting primary prevention
Looking forward, the FDA is exploring several strategies to support primary prevention, including re-examining the role of opioid analgesic prescriber education, including the need for a mandatory unified, national-level education program to adequately inform opioid analgesic prescribers on managing pain. To support our considerations, the agency has held two Duke-Margolis workshops on Reconsidering Mandatory Opioid Prescriber Education and Identifying Key Competencies for Opioid Prescriber Education.
Additionally, it is also exploring the need for potential new authorities for opioid approval standards, including whether drug developers seeking approval for the marketing of new opioid analgesics should be required to demonstrate that their products offer material safety advantages over existing approved opioid analgesics.
The agency is also considering additional disposal options, including a potential change that would require opioid analgesics dispensed in outpatient settings to be dispensed with prepaid mail-back envelopes and patient education on safe disposal of opioids. The agency says it also intends to publish a draft guidance for development of non-addictive treatments for chronic pain, following the February 2022 publication of a draft guidance, Development of Non-Opioid Analgesics for Acute Pain. The FDA says that these draft guidances should help stimulate academia and industry to improve the current inadequate pipeline of new interventions.
Encouraging harm reduction
The agency says it will also follow up on its analysis of 11 types of high-level hypothetical strategies, ranging from opioid use disorder prevention to harm reduction, and the effects projected by models developed that those strategies could have on the opioid crisis. The FDA says it is actively pursuing multiple strategies identified by models with a focus on reducing the risk of opioid overdose involving fentanyl use. These include increasing the distribution of naloxone and recent support of two roundtables on community and clinical perspectives on fentanyl drug checking. The FDA says it plans to build on its actions to help expand the availability and access to overdose reversal products, including naloxone. It noted that despite state naloxone access laws, including standing orders, the prescription status for naloxone continues to pose a barrier to wider access. As such, an over-the-counter (OTC) naloxone switch remains a high priority.
Advancing evidence-based treatments for substance use disorders
Through collaboration with other federal agencies, the FDA noted its to efforts to broaden access to medications for opioid use disorder. The FDA says it will continue to support development of new interventions and work with implementation partners, to evaluate treatments to reduce substance use disorder, including evaluating the potential for digital interventions and other devices to help with reduce substance use disorder.
The FDA stated that cracking down on the market for diverted prescription and illegal drugs and securing the supply chain for approved medications, including opioids and other controlled substances, remains a top priority. The agency says it will further develop its surveillance, enforcement, and interdiction work targeting illegal, unapproved, counterfeit, and potentially dangerous products at international mail facilities, express courier hubs, and ports of entry across the US. It will build on its surveillance, compliance, and enforcement actions, including to address health fraud. This includes joint interdiction operations with other federal agencies such as Customs and Border Protection.