How to shut down the fentanyl-related substance machine
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Annualized deaths caused by fentanyl and fentanyl-related substances now surpass heroin and are lowering the average American life expectancy for the first time since the development of immunizations and antibiotics. Congress needs to act or the death toll will continue to escalate. As well, the administration needs to keep the heat on China, whose labs continue to produce deadly amounts for export.

As an emergency physician, one of the saddest parts of my job is telling someone their loved one overdosed and is never coming home. It’s why I helped craft Wisconsin’s prescription opioid reform strategy. If federal policymakers would simply adopt what’s working in Wisconsin, we might have a better chance at stopping this scourge sweeping through communities across America.

Prior to statutory change in Wisconsin, only when a death occurred could the Wisconsin Controlled Substance Board (CSB) use emergency scheduling authority to control each new discrete fentanyl variant. In 2017, Wisconsin Act 60 passed unanimously, giving the Wisconsin CSB fentanyl-class scheduling authority. Shortly thereafter, the U.S. Drug Enforcement Administration (DEA) followed Wisconsin’s lead and started to use emergency powers to temporarily schedule fentanyl as a class for the entire U.S. By removing the incentive for foreign chemical and drug manufacturers to modify the fentanyl molecule just enough to stay ahead of U.S. scheduling and skirt law enforcement, the creation of new fentanyl-related substances has ground to a halt internationally. According to the National Forensic Laboratory Information System (NFLIS), from 2016 to early 2018, at least 20 new deadly fentanyl-related substances were found; since April 2018, there have been only three.


Like a Stop sign erected to make roads safer, the Stopping Overdoses of Fentanyl Analogues (SOFA) Act – a federal bill modeled on the Wisconsin law -- will advance a permanent fix to stop the creation and flow of deadly fentanyl poisons at their origins, namely drug labs overseas. By design, it’s preventative, not punitive. Yet the bill has detractors. What are their concerns and have they been sufficiently addressed?

One concern is that research into new drug therapies will be stopped. It’s simply not the case. During bill drafting in Wisconsin, great care was given to insure the detailed scheduling language was narrowly crafted. Only molecules almost identical to the fentanyl molecule, with specified minor structural differences, are controlled. Additionally, the DEA proactively simplified research requirements on fentanyls while still maintaining oversight. In the past year, six research requests were submitted for the fentanyl class substances and the DEA approved all in an average of 53 days. In total in the U.S., there are only 19 research registrations for the fentanyl class, many of which are through the Department of Defense to conduct chemical weapons research.

Others take issue with the proposed structure which would allow the DEA to schedule fentanyl-related substances according to only those narrow circumstances specified in the Act as opposed to the current review structure whereby the DEA and Food and Drug Administration (FDA) individually review chemical compounds and assign a controlled substance classification. Given the extreme lethality of fentanyl-related substances, which no one contests, a process that is streamlined, narrowly crafted and enables swift action by regulators is the appropriate course.

Finally, others have alleged societal costs of increased incarceration of people with substance use disorder. In fact, it’s the opposite. There will be fewer incarcerations because individuals will have less access to these poisons for themselves and others.

The facts are indisputable: temporary fentanyl-class scheduling plus less deadly fentanyls on the street equals more Americans alive today than otherwise would be.


In a recent drug bust at the Nogales, Ariz., border crossing, 115 KG of fentanyl was seized – an amount small enough to fit in a footlocker and potent enough to kill 57 million people. When a mere teaspoon can kill 2,000 people, why is Congress stalling to enact a small fix that has been tested and proven effective and which could have a huge and positive impact?

The targeted control of fentanyls as a class and not as discrete chemicals is not a minor change to the U.S. Controlled Substance Act; it has been carefully and thoughtfully crafted. In fact, in September 2018, in an almost unheard of bipartisan act of support all 50 State Attorneys General signed a letter urging Congress to enact the SOFA Act.

Unless Congress acts by Feb. 1, 2020 to make the temporary language permanent, international drug labs will resort to their old ways and develop new fentanyls to skirt the law. With SOFA as its blueprint, Congress should act now to shut down the fentanyl-related substance machine once and for all.

Dr. Tim Westlake is an emergency physician in Wisconsin, a primary architect of the state’s prescription opioid reform strategy, vice chairman of the Wisconsin Medical Examining Board, and member of the state’s Controlled Substances Board.