FDA Addresses Stimulant Surge, Prescription Warning Labels, Stigma

Although the number of prescription opioids dispensed in the U.S. has declined since 2012, opioid overdose deaths continue to rise. The presence of fentanyl and a widespread increase in the use of stimulants, particularly methamphetamine, in combination with opioids, are two major factors on the radar of the Food & Drug Administration.

Janet Woodcock, MD, the administration’s acting director, shared with Rx Drug Abuse & Heroin Summit attendees some steps FDA is taking to address those challenges and others in a session presented Thursday.

“The complexity of addressing poly-substance use makes our efforts all the more important,” Woodcock said. “To this end, we recognize there’s an urgent need for stimulant overdose reversal agents and pharmacological treatments for stimulant use disorder. We’re working hard to accelerate development in this field.”

Woodcock discussed several other FDA priorities related to the opioid crisis:

Telehealth expansion. The increased availability of digital health devices and mobile medical apps is playing an important role in treatment efforts, particularly with regards to keeping patients engaged in their medication-assisted treatment programs and providing clinicians with new ways to intervene and support treatment, Woodcock said. She added that telehealth solutions also provide agency to individuals with use disorders so that they are not entirely dependent on providers for support.

Woodcock encouraged attendees to provide feedback to FDA about the effectiveness of digital health devices and mobile apps, which gives the administration the means to support and expand safe and effective technologies. “We want to hear from you,” she said.

Prescribing safety. FDA is working to develop a better framework for medical prescribing and reducing the number of prescription drugs that flood the market, Woodcock said. The administration wants patients and prescribers to be fully informed about the risks associated with medications and ensure prescriptions for opioid medications match patients’ needs.

Labeling. Last year, FDA addressed the risk of abuse, addiction, physical dependence and withdrawal reactions associated with benzodiazepine medications, which are widely used to treat conditions that include anxiety, insomnia and seizures. Benzodiazepines have the potential for abuse, misuse or overdose when combined with opioid pain relievers, alcohol or illicit drugs, Woodcock said.

FDA in recent months has updated warning label requirements for benzodiazepine medications and implemented other classwide safety label changes. FDA also issued a safety label change in drug safety communication announcing the requirement that drug manufacturers for all opioid pain relievers and medicines to treat OUD must add new recommendations about naloxone. The goal of this change, Woodcock said, was to encourage patients and providers to discuss the need for a naloxone prescription when opioid pain relievers or medicines to treat OUD are prescribed or renewed.

Professional education. FDA has also prioritized education and training to reduce stigma among providers to bring OUD treatment into alignment with how other chronic diseases are treated.

“Our agency firmly believes that improving education and training is directly tied to improving patient access and outcomes for treatment, and over time, we will look to make a positive impact in these challenging areas.”