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The Biden administration Monday to combat the problem of fentanyl being laced with xylazine, a veterinary tranquilizer implicated in increasing numbers of overdose deaths.

"In the 12 months ending in January, we lost -- tragically -- more than 109,000 Americans to drug overdoses," White House Domestic Policy Advisor Neera Tanden, JD, said Monday on a phone call with reporters. "Almost seven in 10 overdose deaths can be attributed to synthetic opioids like fentanyl, and fentanyl adulterated with xylazine presents another rising threat."

"A recent CDC report found that xylazine was detected in nearly 11% of fentanyl-involved deaths," she said. "The proportion of xylazine-involved deaths in this country is continuously growing and is of great concern to this administration. Every one of these numbers is tragic. They represent individuals, families, friends, and communities torn apart by opioids. Addressing this crisis is a top priority for this administration."

Rahul Gupta, MD, director of the White House's Office of National Drug Control Policy (ONDCP) noted on the call that on April 12, he designated fentanyl adulterated with xylazine as an emerging threat to the nation. "Today, I'm announcing that the White House is releasing our national response plan to coordinate a whole-of-government response to this threat," he said.

Gupta described his recent visit to a clinic located in Philadelphia's Kensington neighborhood, an area hit hard by xylazine-laced fentanyl. Noting that xylazine produces deep flesh wounds in users that require extensive medical intervention, he added, "Not only did I see courageous people doing active wound management of individuals, but I also heard from each patient their own unique situation and challenges ... If we thought fentanyl was dangerous, fentanyl combined with xylazine is even deadlier."

Gupta outlined the six "pillars" of the administration's response:

Testing. "Testing for xylazine is currently ongoing in community and law enforcement settings, but not enough," Gupta said. "We need more testing to get a national picture of the threat. So the federal government will work towards standardizing forensic testing practices, towards developing new tests for clinical settings, towards deployment testing in community settings, as well as targeting testing to those who need it."

Expanding data collection. "We need even better data to see the full picture of the spread and to inform our comprehensive response," he said. "This is also going to help us evaluate our efforts and adjust course as needed."

Implementing and expanding evidence-based prevention, harm reduction, and treatment. "Right now, the medical community knows how xylazine adulterated with fentanyl affects individuals, but there is not a single, agreed-upon framework for treating them," said Gupta. "So we're developing that treatment framework, as well as overdose prevention and other harm reduction strategies, for those in communities, in carceral settings, as well as healthcare settings. We're going to educate and equip healthcare providers, harm reduction staff, health sector payers, as well as first responders on the best practices to treat these flesh wounds."

Determining where the xylazine is coming from and disrupting the supply. "We know that xylazine is coming from online vendors overseas, including those in China, and it's mixed into drugs in the United States," he said. "Diverted veterinary xylazine also comes from Puerto Rico by mail and other means. To a lesser extent, some drug traffickers are also mixing xylazine into fentanyl in Mexico. So we're going to go further and identify the illicit supply chain and develop strategies for interdicting illicit xylazine."

Exploring scheduling and other regulatory options under the Controlled Substances Act. "This would enable both civil and criminal actions both in interdicting and reducing the illicit supply of xylazine," said Gupta. "At the same same time, we will maintain the legitimate supply of xylazine for use in veterinary medicine."

Increasing research. "We need to know more about fentanyl combined with xylazine," he added. "We're going to support research aimed at developing effective treatments, investigating how xylazine impacts human physiology and behavior, as well as identifying social outcomes of xylazine abuse."

During a question-and-answer session, administration officials discussed their concerns regarding xylazine scheduling. "We want to look at what makes sense to ensure [scheduling] without disrupting the veterinary industry, because it is one of those situations where it's an important tool in the toolbox for ... veterinary medicine," a senior administration official said. "At the same time [we want to] allow our law enforcement colleagues to take decisive action when they come across those illicit xylazine products that are shipped oftentimes either from China or Mexico."

As the Biden administration tackles xylazine and fentanyl, "we also have things where we think Congress can play a key role," another official said. "Scheduling xylazine is one of them; permanently scheduling fentanyl and related substances before that [law] expires the end of next year is another ... So it's worth reminding all of us that a component to what we hope to get done as we continue to up our game on this whole problem set, is to engage our colleagues on Capitol Hill to make progress legislatively, where that exceeds what we're able to do as an executive branch."

Andrew Kolodny, MD, an expert in opioid policy and addiction medicine at Brandeis University in Waltham, Massachusetts, criticized the plan for failing to take a harder line on scheduling xylazine. "There's a lot of gravy here and no meat," he said in a phone call.

Noting that the said that officials want to "ensure we are using every lever we have to protect public health and public safety," Kolodny added, "They're talking about using every lever, but not using the most obvious lever -- to schedule xylazine in the U.S. and seek international scheduling so it doesn't flood into the country ... Why they're soft-pedaling there, I don't really understand." Kolodny said that if the administration pushed harder to pass a introduced in the House in April, "it should happen pretty quickly."

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