As an Emergency Physician on the front lines of the opioid epidemic, it is unthinkable to me that policymakers might leave open a deadly loophole in controlled substance scheduling, making it harder for law enforcement to keep fentanyl variants out of the United States. Let me explain.

In the U.S. alone, fentanyl and its related substances are now responsible for over 29,000 overdose deaths per year, which make them the deadliest drugs in existence. “Bad guys” in foreign chemical companies have taken advantage of existing scheduling laws to create new legal fentanyl variants. These untested chemicals are then produced abroad, mostly in China, and trafficked legally into the U.S. to enter the opioid supply.


A bill introduced last Congress, the Stopping Overdoses of Fentanyl Analogues Act or SOFA Act would control fentanyls structurally as a class. In Hill testimony last year, I urged policymakers to pass it. Yet, obstacles persist, including – and surprisingly -- from the U.S. Department of Health and Human Services (HHS). HHS is opposed to the class control of fentanyls for fear such action will negatively impact research. This position is not evidenced in the data. The effectiveness of SOFA, however, is.

The SOFA Act is modeled after a Wisconsin law developed in partnership with the Drug Enforcement Administration (DEA). It is novel, catch-all legislative language that targets only the likely bioactive modifications of the fentanyl molecule itself; no other opioids or drugs are included. It ensures that law enforcement can schedule proactively and not wait until loved ones die in order to control the modified fentanyl-related substance that killed them.

Essentially, the SOFA Act would unplug the entire fentanyl machine and shut down illicit development and production of deadly fentanyls.

One year ago, the DEA published language identical to Wisconsin law in an emergency temporary scheduling order. It has already proven extremely effective. In just the past 12 months, the appearance of fentanyl-related substances in the United States has ground to a screeching halt. So effective, in fact, that last summer, a bipartisan letter signed by Attorneys General representing all 50 states, Washington D.C. and Puerto Rico, was sent to Congress recommending swift passage of the SOFA Act.

Last fall, three other important things happened. First, a senior official for the State Department Bureau of International Narcotics Law Enforcement (INL) testified that a top priority was to obtain fentanyl-class scheduling in China. Second, a congressional delegation guided by Terry Branstad, U.S. Ambassador to China, and led by Sen. Lamar AlexanderAndrew (Lamar) Lamar AlexanderThe Hill's Morning Report - Presented by JUUL Labs - Trump attack on progressive Dems draws sharp rebuke Republicans make U-turn on health care Trump announces, endorses ambassador to Japan's Tennessee Senate bid MORE (R-Tenn.), visited China with the express goal of encouraging the Chinese to put in place fentanyl-class language. Third, the issue was discussed in trade negotiations between Presidents Trump and Xi Jinping at the G20. When China then announced it would enact fentanyl-class scheduling law, it was touted as a major success. Yet, China almost always follows our lead, and will likely enact permanent controls only after we do.  

The fact is, U.S. fentanyl-class control is not law yet. Unless Congress acts to make it permanent, the emergency temporary control order issued last year will expire in February 2020.

In response to research concerns raised by HHS, the DEA simplified research requirements on fentanyls. The agency streamlined the research registration process, requiring a single registration for all chemicals in the entire fentanyl class instead of separate registrations for each individual substance like it does for all other substances. Currently, there are 14 research registrations for fentanyl-related substances, of which only two new ones were added in the last year.

Fentanyls are so deadly they have been weaponized and are classifiable as chemical weapons. The lethal dose of fentanyl is just 2mg, which makes them as lethal as the deadliest nerve agents. One teaspoon can kill 2,000 people. A shockingly small amount.

In my job in the emergency department, in my role on the Wisconsin Controlled Substance Board and as a medical regulator, I have witnessed more tragedy than I care to recall. The case for making permanent fentanyl-class controls is not just the right policy, it’s personal. I have told more than enough families their loved one is never coming home.  

As such, and on behalf of Americans who are suffering in communities across this great nation, I call on Congress to acknowledge the DEA’s response to the Department of HHS’ concerns and the bipartisan consensus of state AGs in supporting fentanyl-class control language, and delay no more in moving forward with the SOFA Act.

Dr. Tim Westlake is a full-time Emergency Physician; Parent of teenage daughters; Vice Chairman of the Wisconsin State Medical Examining Board, where he serves as Chairman of the Licensing and Controlled Substance Committees; and, member of the Wisconsin State Controlled Substances Board.