Gottlieb Announces Possible FDA Strategies to Combat Opioid Crisis

FDA Commissioner Scott Gottlieb, MD, announced the agency's newest plans to address the ongoing opioid epidemic.

Scott Gottlieb, MD

Scott Gottlieb, MD, the commissioner of the US Food and Drug Administration (FDA), released a statement on Tuesday reaffirming the agency’s efforts to address the opioid epidemic.

The statement specifically addressed new strategies that the agency can utilize to reduce the impact opioids are having on the American public. These strategies included new measures in the packaging of prescriptions, and the use of technologies to monitor patient use of opioids and that encourage proper disposal of unused prescriptions.

“We believe that innovation in packaging, storage, and disposal could have a meaningful impact on preventing or deterring misuse, abuse, or inappropriate access to prescription opioids — especially when coupled with additional efforts that the FDA and others are undertaking to reduce the scope of the opioid epidemic,” Gottlieb said in the statement.

One of the options detailed by Gottlieb included prescribing opioids in a short-term supply, packaged in a way that limits the number of pills dispensed at one time in order to discourage overuse. The example used by Gottlieb was a blister pack with a “defined duration of use” that could be set for a limited dose amount.

Additionally, the commissioner highlighted a need for packaging innovations that could allow for easier tracking of doses taken by patients to improve the monitoring of opioid use. The use of technologies to monitor use was also mentioned as an option the FDA could explore.

“To achieve these goals, one area we’ve committed to exploring further is how opioid drug products are packaged, stored and ultimately — when no longer needed – discarded,” Gottlieb said. “The FDA is committed to exploring our existing authorities to find new and impactful ways of regulating these product features to improve patient safety.”

In the same statement, the agency also announced a workshop to address the public knowledge of the crisis and to address pain management in a more effective and safe manner. According to Gottlieb, the workshop will involve 3 topics: the specific issues that packaging innovations could address, the definition of guiding principles in the design of product features to apply these innovations, and how data will be collected to evaluate their implementation.

“We look forward to the two-day meeting and the opportunity to discuss the potential for new, innovative tools and strategies the FDA can take to address the public health crisis of opioid addiction,” Gottlieb said.

The 2-day public workshop, “Packaging, Storage, and Disposal Options to Enhance Opioid Safety - Exploring the Path Forward,” will take place in Silver Spring, Maryland on December 11 and 12. More information can be found here.