Fighting Fentanyl: The Biden Administration’s Failure of Leadership

The number of Americans dying from accidental drug overdoses has grown sharply in recent years, exceeding 100,000 annually and reaching 77,000 for deaths associated with opioids for the year ending November 2021, according to the most recent provisional data from the Centers for Disease Control and Prevention.[1] This opioid death toll is 55% greater than for the year ending in November 2019, when a period of rapid growth in overdose deaths began. Unfortunately, the Biden administration in its newly issued National Drug Control Strategy (NDCS),[2] does little to show the necessary leadership in the fight against one of our nation’s biggest public health challenges.

Synthetic opioids, including fentanyl, underlie the recent growth in overdose deaths, having been involved in 66% of the overdose deaths over a recent 12-month period.[3] The administration acknowledges this, but while the NDCS claims to use a data-driven, evidence-based strategy to combat fatal overdoses, it does not contain evidence of a pivot in resources or enforcement methods to address the growth in deaths from these synthetic opioids.

The administration’s April 2021 commitment to reducing the supply of illicit drugs, including fentanyl, has been ineffectual and the new NDCS does not provide much hope for improvement. [4] It does not report any measure of the reduction in the fentanyl supply over the last year. It also does not commit the administration to a specific and measurable future reduction in supply of fentanyl or of illicit opioids by a given date. Instead, the strategy presents a collection of performance “objectives” that amount to improvements in the process of law enforcement.[5]

The NDCS’s seventh goal, for example, is to reduce the supply of illicit drugs into the United States.[6] The goal’s underlying objectives are to increase the number of drug trafficking targets identified in asset freezes and seizures, increase the number of defendants convicted in active investigations using financial crimes network data, and to increase the percent of organized crime drug enforcement task force investigations linked to specific Mexican drug cartels. Goal seven’s objectives also include reductions in the “potential” production of heroin, primarily in Mexico (but not, say, Afghanistan),[7] and the number of “incident reports” of precursor chemicals sources from China or India. Thus, whether the NDCS will indeed reduce supply and by how much is an open question. Given that the official objectives are process oriented and not directly related to the goal of reducing supply, there is ample room for skepticism that the supply of illicit opioids in the U.S. will actually fall.

Importantly, the new NDCS neglects to provide information about key measures of reductions in supply—such as the quantity of opioids seized, after adjustments are made for purity or strength. It is also silent about trends in the black-market prices of opioids, adjusted for purity or strength. Data on such prices are important because they are proxies for the effectiveness of efforts to reduce supply and higher prices are known to reduce use and abuse. Although estimates of this relationship are uncertain, in an April 2019 report,[8] the President’s Council of Economic Advisers used estimates of the relationship between price and demand for opioids developed by California State University at Sacramento economist Craig A. Gallet,[9] who found that a 10% increase in price reduces heroin use by approximately 5%.

The NDCS neglects data on opioid seizures and illicit opioid prices that may currently exist within federal agencies and does not make any commitment to greater development or disclosure of such data. This neglect occurs even though the 2019 Council of Economic Advisers report provides estimates of purity-adjusted seizures and purity-adjusted black-market prices, illustrating how those estimates are useful in understanding the effects of federal policies.

The lack of interest in managing efforts to reduce supply of illicit drugs is not new. In April of last year, the White House listed seven drug policy priorities, which included treatment, racial equity, harm-reduction efforts, prevention, employment and addiction in the workplace, and recovery support services—but only one priority focused on the need to reduce the supply of illicit opioids.[10] Undoubtedly, there is a need for treatment and support services (though critics express doubts about the effectiveness of harm-reduction programs), but reducing the supply of illicit opioids is key to limiting the number of Americans dying.[11] Yet the White House presented this supposed “policy priority” without including any measure or standard to judge the administration’s effectiveness in achieving it.

This deficiency is notable because the White House’s policy priority document acknowledged the importance of controlling supply, noting “The availability of drugs with historically high purity and low price, along with the increased lethality of synthetic opioids, helps drive the overdose and addiction epidemic.”[12] President Biden remarked in his 2022 State of the Union address that the administration intends to “stop the flow of illicit drugs by working with state and local law enforcement to go after traffickers,” but an executive order to fight the global illicit drug trade stopped well short of a specific commitment to restrict the supply of illicit opioids.[13]

Synthetic opioids, principally fentanyl and closely related substances called fentanyl analogues, account for 70,000 predicted opioid overdose deaths for the year ending November 2021, an increase of more than 90% in just two years.[14] The Food and Drug Administration (FDA) approved prescription fentanyl analgesics (drugs commonly known as “painkillers”) to treat severe pain, such as in late-stage cancer cases.[15] The fentanyl-associated deaths reported by CDC, however, overwhelmingly stem from illicitly manufactured fentanyl and fentanyl analogues, [16] which are imported mostly from China and Mexico.[17]

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It is essential for policymakers to focus on limiting the volume of illicitly manufactured opioids like fentanyl to better protect public health. The volume of prescription opioids dispensed has been in steep decline for years, so diverted prescription opioids (legally obtained pharmaceuticals that are resold or distributed on the street) seem quite unlikely to be the source of the recent growth in opioid-associated deaths.

In December 2020, the research firm IQVIA concluded, “Total national prescription opioid use has declined to 60% of the peak volume in 2011 after another year of double digit decline expected in 2020.”[18] It also found the greatest reductions in prescription opioid use were in the higher-risk patient groups taking more than 90 morphine milligram equivalents (MMEs) daily, a dosage amount the CDC warns providers to “avoid or carefully justify” before prescribing.[19] While these reductions in clinical use of opioids as pain relievers cut opportunities for misuse and abuse, they also complicated patient access to necessary pain relief. To reduce such unintended effects, the CDC recently issued new draft clinical practice guidelines for prescribing opioids, emphasizing they “are not intended to be applied as inflexible standards” and touting “individualized, patient-centered” care.[20]

Limiting the supply of illicitly manufactured drugs may be very challenging, however. Consider that the total volume of prescription opioids dispensed in 2020 was 100 billion MMEs, according to IQVIA.[21] In other words, about 100 metric tons of pure morphine.

Health-care researchers convert doses of different types of opioids to MMEs using conversion factors that depend on dosage form—for example, whether the drugs are injected or ingested. While such conversion factors are the subject of ongoing research and discussion, in 2019, a U.S. Dept. of Health and Human Services (HHS) task force on pain reported that fentanyl is “50 times more potent than morphine.”[22] Using this conversion factor suggests that a bit more than two metric tons of (nearly) pure fentanyl could have roughly the same physiological effect as the entire volume of prescription opioids dispensed in the U.S. during 2020—that’s two tons of fentanyl vs. 100 metric tons of morphine. Put differently, in a single trip, one heavy-duty pickup truck can carry enough fentanyl—roughly two metric tons of more than 95% purity—to damage public health as much as if every single FDA-approved prescription opioid dispensed in 2020 was diverted onto the black market.

Even this comparison understates the dangers of illicitly manufactured fentanyl and fentanyl analogues. Parcels of such drugs are not labeled with the standards of prescription drugs, so any given amount is more likely to cause harm than the same dose of a prescription opioid drug diverted to misuse or abuse.

Unfortunately, there is a major impediment to thoroughly evaluating the limited effects of federal policies to fight illicit synthetic opioids. The U.S. apparently lacks timely pertinent data about several aspects of federal drug control policies. This lack of data is inconsistent with federal law and highlights the absence of forceful executive leadership in controlling opioid abuse and deaths.

The 2018 SUPPORT Act requires reporting of the “total amount” of illicit drugs “seized and disrupted in the calendar year and each of the previous 3 calendar years.”[23] To implement the SUPPORT Act, the White House Office of National Drug Control Policy (ONDCP) manages a Drug Control Data Dashboard that compiles, synthesizes, and presents data from various federal agencies.[24] The dashboard, unfortunately, provides less data about the biggest source of growth in recent overdose deaths—illicitly manufactured fentanyl and fentanyl analogues— than for other drugs. Thus, these ONDCP dashboard data on fentanyl and fentanyl analogues are silent about progress toward the White House’s stated policy priorities.

ONDCP provides data on “How much drugs were seized?” but not for fentanyl and fentanyl analogues. The dashboard provides no seizure data for some drugs at all. For cocaine, ecstasy, heroin, marijuana, and methamphetamine, the dashboard provides data in kilograms, and sometimes in milliliters and dosage units. ONDCP’s dashboard also presents no information on the co-occurrence of drugs in seized drug products. Such mixed products may be especially dangerous to users, who may be unaware that what they think is “only” marijuana is mixed with fentanyl.

The U.S. Drug Enforcement Administration (DEA) claimed in a December 2021 press release that it seized “enough fentanyl in 2021 to provide a lethal dose to every American.”[25] This DEA notice emphasized fentanyl-laced fake prescription pills and total seizures of “more than 1500 pounds and over eight million fake prescription pills.” It provided, however, no information about the percent of seized drug products containing fentanyl that were actually tested for purity or strength or the average purity or strength of fentanyl in those products.

Data on the ONDCP dashboard about the annual total of “forensic lab submissions” for “fentanyl”— which exploded from 4,642 in 2014, to 34,204 in 2016, to 83,765 in 2018[26]— have no practical utility. They are based on voluntary reporting by a set of undisclosed local, state, and federal agencies, and thus are very difficult to link to evaluations of the performance of any agency or any specific federal policy. Without knowing more about how data is submitted and how submission criteria may change, it is unclear what inferences can be supported by data on voluntary submissions to labs.

In addition, without information on the volume of seized products, (e.g., kilograms), it is entirely unclear what the mere number of submissions might mean for public health or the effectiveness of law enforcement efforts. Further, there is no information about the purity (or strength) of seized drugs—which is essential to determine the implications for public health. Seized illicit fentanyl may be more than 90% pure, as can be the case for shipments from China, or only 5% pure, as with shipments from Mexico, a difference with implications for opioid abuse and harm that may differ by roughly a factor of 20.[27] Finally, the most recent data—from 2018— are simply too stale to help policymakers trying to understand and fight the latest twist of the opioid epidemic.[28]

The ONDCP’s Data Dashboard also provides data on trends in prices and purity, since these can be useful measures of access or the effectiveness of efforts to limit supply, but only for cocaine, methamphetamine and heroin, not fentanyl and its analogues, and only through 2016.[29] These data are completely inadequate to help understand the causes of the worsening of synthetic opioid overdose deaths since 2019.[30] Missing in both ONDCP’s and DEA’s reports is discussion and analysis of data on prices of fentanyl and prices of street drugs combining, say, heroin and fentanyl. Such data may be available internally to these agencies, but in that case, there is no reason to think that they are used in policy development or formulation, and they do not support budget requests to Congress or congressional oversight.

Some information about black market drug prices is available through anonymous crowdsourced websites, such as RADARS.org,[31] but it is unclear whether crowd-sourcing can serve as a reliable source of information about potency-adjusted prices for powdered fentanyl sold without standardized labeling. In a 2019 special report on chemical signatures of fentanyl, the DEA reported a wide range of strengths of fentanyl powders and fake prescription pills seized within given states, making clear such data were not representative.[32] Law enforcement agencies should collect, compile, and report representative data on the volume, purity, and value of illicit drug shipments seized by law enforcement agencies.

The lack of data necessary for meaningful evaluation extends beyond fentanyl per se to fentanyl analogues. The Forensic Technology Center of Excellence, a grantee of the U.S. Dept. of Justice’s National Institute of Justice, sponsored a 2020 podcast indicating that new fentanyl analogues appeared in street drugs at an alarming rate and that researchers are working to create alternative screening methods to detect the ever-evolving fentanyl compounds in today’s seized drugs.[33]

The ONDCP and the CDC provide no data on trends in deaths associated specifically with fentanyl analogues. The new National Drug Control Strategy does not identify deaths specifically associated with fentanyl analogues or have a plan to improve reporting of such deaths.

The National Drug Control Strategy takes no steps to make use of new data collection methods that might provide real-time tracking of opioid use to help law enforcement agencies and improve public health. It simply states that the U.S. could learn from the European experience.[34] A 2019 academic study showed that wastewater-based testing for opioids including fentanyl could forecast overdoses and deaths.[35] The National Institutes of Health reported a year ago that human opioid exposure can be measured through wastewater.[36] Canada used new techniques to analyze occurrence of fentanyl in sewage and found that fentanyl levels were much higher in early 2020 than in early 2019 for several major Canadian cities.[37] By contrast, the CDC currently sees sewage epidemiology as a tool to track fentanyl usage as something not for “immediate use” but rather to consider “down the road.”[38] The federal disinterest in using new data-collection methods like sewage epidemiology to fight the opioid epidemic reveals the absence of White House leadership in this campaign.

Perhaps the most recent relevant data for opioid use in U.S. is from the National Survey of Drug Use and Health for 2020 showing the prevalence of self-reported misuse of opioids. From 2019 to 2020, the number of U.S. residents reporting opioid misuse in the prior month fell slightly, from about 3.1 million to 2.9 million.[39] These figures are very imperfect measures of prevalence, however, because of stigma-driven underreporting and differences in stigma associated with pill misuse and other forms of drug misuse and abuse. In addition, many drug users may be unaware of the contents of the drugs they use, as may be the case if marijuana is infused with fentanyl. Most surprisingly, the survey does not ask respondents whether they use fentanyl that is not in the form of prescription drugs, that is, fentanyl illicitly manufactured in clandestine laboratories.[40] Thus, the survey results cannot speak at all to the driver of opioid overdose deaths in the U.S.—misuse of synthetic opioids.

The fight to limit the supply of opioids need not conflict with nationwide efforts to improve the equity of law enforcement actions regarding drug crimes. Federal sentencing guidelines currently provide for longer sentences if perpetrators are found to be trafficking larger amounts of drug products containing controlled substances. Guidelines also specify that criminals will face higher sentences if they deceive buyers about the contents of the drug products they traffic, for example, by not mentioning that fentanyl is mixed with the heroin or the marijuana. But federal sentencing guidelines are silent on strength or purity.[41] Thus, a guy peddling a kilo of fentanyl that is more than 95% pure now faces the same recommended sentences as someone else convicted of trafficking a kilo that is less than 5% pure, even if the abuse potential differs by a factor of 20. The basic principle of justice that more harmful crimes merit stronger penalties suggests that sentencing guidelines should point to longer sentences for sellers of illicit opioids of greater strength or purity.

In 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) recommended that federal agencies adopt a systems-analysis approach to support the fight against the opioid epidemic, including quantitative modeling that incorporates interrelationships among policies to provide access to prescription opioids while limiting abuse and policies to fight illicitly manufactured opioids.[42] It recommended, among other things, that federal agencies consider how policies and programs for prescription opioids may impact the market for illicit opioids.[43] Yet five years after the report, there is no published rigorous quantitative modeling of black markets for opioids, either prescription or illicitly manufactured.[44]

What should the federal government do to fight the large increase in accidental overdose deaths from opioids? Congress and the administration need to commit to a genuinely data-driven campaign against dangerous addictive opioids like illicitly manufactured fentanyl and fentanyl analogues. This means regular, timely reporting on the quantities of seized drug products, what drugs they contain, and their purity or strength. It means systematic tracking of the prices of different illicit drug products containing opioids and adjusting those prices to account for purity. It means committing to reporting overdose deaths associated with various drugs with a one-week delay by a specific date, for example, 2025. And it means energetic leadership collecting and synthesizing better and more timely actionable data on opioid use and abuse through methods like sewage epidemiology. Such data are essential for congressional oversight, meaningful evaluations of the effectiveness of federal programs for an empirically driven fight against opioid misuse and abuse, and—most importantly—to save lives.

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