FDA Highlights New Strategies to Combat the Opioid Epidemic

The opioid epidemic has been making headlines due to a boom in overdoses and related deaths over the past few years. Many consumer and advocacy groups have blamed manufacturers for facilitating the epidemic, while other members of the pharmaceutical supply chain have also been implicated.

In a recent interview with 60 Minutes and The Washington Post, Joe Rannazzisi, former deputy assistant administrator at the DEA Office of Diversion Control, detailed how the opioid epidemic exploded due to efforts from stakeholders that allowed hundreds of millions of pills to flow through “rogue pharmacies” and pain clinics.

Last week, President Donald Trump declared the opioid epidemic a public health emergency in an effort to bolster efforts against the crisis, which has been claiming lives across the country, according to The New York Times.

In a newly released statement, FDA Commissioner Scott Gottlieb, MD, outlined the agency’s dedication to fighting the epidemic through new innovations.

“One of my highest priorities as the Commissioner of the US Food and Drug Administration is to take whatever steps we can to reduce the scope and human tragedy created by the epidemic of addiction to opioids,” Dr Gottlieb wrote.

Currently, the FDA is focused on helping patients receive proper treatment for substance use disorders, while also reducing unnecessary exposure to opioids.

In addition to current efforts, Dr Gottlieb said the FDA is looking for new ways to develop creative solutions to lower exposure to opioids and ensure the drugs are not prescribed off-label, according to the statement.

The FDA is investigating how opioids are packaged, stored, and disposed of when no longer needed. The agency plans to partner with authorities to determine better ways to regulate the drugs and improve patient safety.

Dr Gottlieb said that the FDA is considering a blister pack solution that has a limited number of doses for a short-term supply of the drugs. New packaging efforts could track how many doses have been taken, while others could improve storage and lower the risk for other individuals to gain access to the drugs, according to the release. Additional solutions exist that allow pharmacists and other healthcare providers to monitor drug use.

In May, the FDA launched the Opioid Policy Steering Committee to determine how the agency can regulate packaging to ensure appropriate opioid prescribing practices, among other policies.

An internal FDA task force is currently conducting research to inform policies and is consulting experts on the opioid epidemic, according to the release.

The FDA is launching a public 2-day workshop to address the challenges of pain management and combat the opioid epidemic. The goals of the workshop are to define how packaging and disposal solutions can help, clearly define which product design features should be included in new solutions, and which types of data are needed to evaluate new packaging, according to the FDA.

“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,” Dr Gottlieb concluded. “We look forward to the 2-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.”