Editor's note: Last week, US Sen. Cory Booker issued a Tweet and, along with four other US senators, signed a letter to US President Joseph Biden citing a paper co-authored by Concordia's Christopher W. Cunningham, PhD. Below, Cunningham offers an explanation of the issue at hand and an overview of the paper at the heart of the discussion.

Over 36,000 Americans died in 2019 from overdoses involving synthetic opioids. That is approximately the number of people living in Mequon, Thiensville, and Cedarburg. That’s a lot of people.

Synthetic opioids like fentanyl make up the “third wave” in the ongoing opioid public health crisis that was declared by President Trump in 2017. Like other abused opioids, such as heroin and oxycodone, fentanyl can cause dependence, addiction, and respiratory depression/arrest. A particular challenge with fentanyl is that, as a fully synthetic substance, clandestine chemists can alter the structure of the drug to evade detection by law enforcement agencies and possibly avoid prosecution in federal courts.

In response to this challenge, the US Drug Enforcement Administration (DEA) issued a temporary scheduling order in 2018 that defined all “fentanyl-related substances” as Schedule I substances under the Controlled Substances Act (CSA) based on their chemical structure alone. The CSA defines Schedule I substances as those agents that have a high potential for abuse and no currently accepted medical use. By classifying substances based on chemical structure alone, this order removes the requirement that a substance has demonstrated abuse liability before being labeled a dangerous substance.

While this certainly seems logical, this sort of action has unintended consequences, as colleagues and I recently discussed in a manuscript published last month. One particular consequence revolves around the ability of scientists to conduct research using fentanyl-related substances. This scheduling order makes it more difficult for chemists like me to collaborate with pharmacologists to develop medications that will save lives. This additional barrier makes it harder for us to develop fentanyl-specific antidotes and vaccines, and discourages private industry from entering this desperately-needed market.

Cunningham scholarly article

Legislators are taking notice. Just last week, a group of US senators led by Cory Booker (D-NJ) sent a letter to President Joseph Biden citing our paper that urged his administration to reconsider the class-wide scheduling order. While recognizing the need for law enforcement to be proactive in getting dangerous drugs off the streets, this letter detailed the opportunities for legislators to remove barriers that impede researchers’ and scientists’ ability to develop evidence-based solutions to the fentanyl crisis. Legislators will be discussing the temporary scheduling order next month, meaning our work will influence policy in the very near future.

A letter to US President Joseph Biden

I am so glad to be a professor at Concordia University Wisconsin. The university has supported me on numerous trips to Washington, DC, to advocate on behalf of substance abuse research. Department funds were instrumental in allowing me to meet with Wisconsin Representatives Grothman (WI-6) and Pocan (WI-2), and Senator Baldwin.

Christopher W. Cunningham, PhD, is an associate professor of pharmaceutical and administrative sciences within Concordia University Wisconsin’s School of Pharmacy. He earned his BS in Chemistry and Germanic Studies from the University of Maryland, College Park, and his PhD in Pharmaceutical Sciences from the University of Maryland School of Pharmacy in Baltimore. He completed postdoctoral studies at the University of Kansas, and has been at Concordia since 2011.

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