Partnership for Safe Medicines’ Statement on Congressional Action to Permanently Schedule Fentanyl-Related Analogues and Substances

Washington, D.C. (July 21, 2021) – Shabbir Safdar, Executive Director of the Partnership for Safe Medicines, released the following statement today in response to Congressional actions to permanently scheduling illicitly manufactured and deadly fentanyl:

Over the past few months, several bipartisan legislative measures to permanently schedule fentanyl-related analogues and substances have been introduced by members of Congress. PSM applauds these efforts, which take science-based and balanced approaches to fentanyl scheduling. These bipartisan measures highlight the devastating impacts counterfeit medicines laced with fentanyl have on the lives of everyday Americans, their families, and their communities.

The United States continues to see a rise in overdose deaths across the country due to fentanyl-related substances. Preliminary data from the CDC shows overdose deaths in the U.S. surging to 93,331 in 2020, the most recorded in any year – a 30% rise in overdose deaths from 2019, primarily driven by the prevalence of opioids, fentanyl, and fentanyl-related substances. The Drug Enforcement Administration (DEA), in its 2020 National Drug Threat Assessment, found that “illicit fentanyl — produced in foreign clandestine laboratories and trafficked into the United States in powder and pill form — is primarily responsible for fueling the ongoing opioid crisis.” According to the DEA, “fentanyl-laced counterfeit pills continue to be trafficked across the country and remain significant contributors to the rates of overdose deaths observed across the country”.

Additionally, the Director of National Intelligence called the threat of foreign illicit drugs, particularly illicitly-manufactured fentanyl that is smuggled in by organized crime networks and responsible for killing thousands annually, a critical threat to Americans in its 2021 Annual Threat Assessment report. The prevalence of fentanyl-related substances within our communities is a worsening health crisis, and the COVID-19 pandemic continues to make matters worse.

Permanently scheduling fentanyl and fentanyl-related analogues and substances offers a way in which the U.S. can respond to this troubling trend and gives law enforcement the ability to pursue illicit bad actors who are contributing to the opioid epidemic. In January 2020, Congress unanimously approved the reauthorization of DEA’s February 2018 temporary scheduling of synthetic fentanyl analogues as Schedule I controlled substances. In May 2020, right before the temporary order’s expiration, Congress again extended the deadline. However, that temporary scheduling is once again set to expire on October 22, 2021.

“PSM understands more work needs to be done to effectively address this ongoing epidemic and applauds Congress’ efforts to work with public health experts, criminal justice experts, law enforcement, the scientific community and the Biden Administration on a balanced, science-based and equitable solution, yet there is only a short time before the temporary scheduling is once again set to expire. Congress must act to pass legislation addressing the continual looming expiration of the temporary emergency scheduling order for fentanyl analogues through a balanced, evidence-based approach that ensures science and research drive progress forward, while addressing the inequities and disparities often found within minimum sentencing requirements can be finalized,” said Safdar.

Almost everyone across the United States has experienced the impacts of the opioid epidemic, including the impact of counterfeit fentanyl-laced medicines. In recent years, fentanyl has been combined with a wide variety of fake prescription medicines, such as opioids and Xanax, and has led to numerous overdoses and deaths nationwide. Our priority must be to strengthen our communities against the opioid epidemic by keeping fentanyl out of our communities. Current legislative proposals do just that and PSM strongly urges Congress to pass these measures during the 117th Congress so we can protect our communities against the growing opioid crisis in America.

Addressing fentanyl-analogue scheduling is not only a law enforcement priority, but also an important criminal justice tool for the victims of fentanyl poisoning. The voices of families who lost a loved one to counterfeit fentanyl-laced prescription drugs is what keeps us awake at night and highlights the urgency of this issue.

“My only son, Joe, was killed by a counterfeit oxycodone pill that was laced with fentanyl and given to him by someone he considered a friend. Joe’s life was taken just weeks before his son was to be born and never got the chance to meet him. A couple of grains of fentanyl killed my child, left my grandson an orphan, and changed all of our lives in a tragic way. Do not think that it cannot happen to you because it can and it will,” said Lisa Hicks, a Georgia mother who lost her son in February 2015.

Lisa is not alone. Families across the country are feeling the effects of counterfeit medicines, with every state reporting at least one death related to illicit fentanyl-related substances.

“My daughter Ashley died from taking a pill that looked like her daily medication. The pill was a counterfeit that was poisoned with fentanyl and given to her from a trusted person. Counterfeits kill. There is no second chance for Ashley,” said Andrea Thomas, an advocate with Voices For Awareness in Colorado and who lost her daughter in June 2018.

Bipartisan leadership is critical to combatting the prevalence of illicit counterfeit drugs and protecting families and communities across the country. Our communities are hurting.

We must not give up the fight against these illicit substances and work hard to protect our communities against the opioid epidemic by keeping deadly fentanyl and fentanyl-related analogues out of our communities through a science-driven, balanced approach. PSM stands ready to work with Congress and the Biden Administration in finding permanent solutions to these ongoing challenges.

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About the Partnership for Safe Medicines

The Partnership for Safe Medicines (PSM) is a public health group comprised of over 40 non-profit organizations that are committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard or otherwise unsafe medicines. To learn more, visit


Shabbir Safdar
Executive Director