ILLICIT OPIOIDS

While Greater 

Attention Given to 

Combating Synthetic 

Opioids, Agencies 

Need to Better Assess 

their Efforts

Report to Congressional Requesters

March 2018

GAO-18-205

United States Government Accountability Office
United States Government Accountability Office

 

Highlights of GAO-18-205, a report to 

congressional requesters

March 2018

ILLICIT OPIOIDS

While Greater Attention Given to Combating 

Synthetic Opioids, Agencies Need to Better Assess 

their Efforts 

What GAO Found

Federal agencies collaborate with foreign governments, such as China, Mexico, 

and Canada, as well as with international organizations, to limit the production of 

illicit synthetic opioids. They do this by enhancing investigations, sharing 

information on emerging trends, helping to expand the regulation of illicit 

substances, and building capacity to thwart the distribution of illicit drugs. 

Federal agencies have ongoing efforts to limit the domestic availability of and 

enhance their response to illicit synthetic opioids. For example, federal efforts 

include treating overdose death scenes as crime scenes where officers collect 

evidence to investigate and identify the drug source. 

Overdose Deaths Involving Synthetic Opioids and Size of a Lethal Dose of Fentanyl

Federal agencies have also documented specific strategies to combat illicit 

opioids. However, only one of the five strategies we reviewed included outcome, 

or results-oriented measures—largely due to agency perceptions that designing 

such measures posed challenges. The Government Performance and Results 

Act Modernization Act of 2010 directs agencies to develop goals, as well as 

performance indicators. Without specific outcome-oriented performance 

measures, federal agencies will not be able to truly assess whether their 

respective investments and efforts are helping them to limit the availability of and 

better respond to the synthetic opioid threat. We also found that while federal law 

enforcement agencies are increasingly coordinating with the public health sector

to share overdose information, both sectors reported ongoing data sharing 

obstacles and related challenges with the timeliness, accuracy, and accessibility 

of overdose data. Standards for Internal Control in the Federal Government 

states that information for decision-making should be appropriate, current, 

complete, accurate, accessible, and provided on a timely basis. Embarking on a 

concerted effort, led by the Office of National Drug Control Policy (ONDCP), to 

examine and address data related concerns will enhance agencies’ efforts

continue to understand and respond to the opioid epidemic. 

Federal agencies have adapted to the opioid epidemic by, among other things,

expanding prevention programs and treatment options. For example, agencies 

have increased engagement with medical professionals about the implications of 

prescribing practices to help reduce opioid abuse, and provided additional 

resources to states and localities to expand the distribution and use of overdose 

reversal and treatment options. 

View GAO-18-205. For more information, 

contact Diana Maurer at (202) 512-8777 or 

maurerd@gao.gov. 

Why GAO Did This Study

Increased illicit use of synthetic (manmade) opioids has contributed to drugrelated overdose deaths. Synthetic 

opioids like fentanyl—a substance 100 

times stronger than morphine—

accounted for more than 19,000 of the

nearly 64,000 overdose deaths in 

2016, the most recent year for which 

federal data are available. GAO was 

asked to review U.S. agency efforts to 

combat illicit synthetic opioids. 

This report examines how U.S. 

agencies (1) work with international 

partners to limit production of illicit 

synthetic opioids; (2) work domestically 

to limit the availability of and enhance 

their response to these drugs and how 

agencies can improve their 

effectiveness; (3) measure 

performance in their documented 

opioid response strategies; and (4) 

have adapted their approaches to 

prevention and treatment. 

GAO reviewed documents that 

described agencies’ international 

coordination efforts, domestic opioid 

reduction strategies and prevention 

and treatment approaches, and 

interviewed international and federal

agency officials engaged in drug 

control policy. GAO also interviewed 

state and local law enforcement and 

public health officials in seven states, 

selected in part for their high rates of 

overdose deaths. 

What GAO Recommends

GAO is making six recommendations, 

including that agencies develop 

performance metrics. DHS agreed, 

ONDCP did not state whether they 

agreed or disagreed, and DOJ did not 

agree with GAO’s recommendations. 

GAO continues to believe that these 

recommendations remain valid.
Page i GAO-18-205 Combating Synthetic Opioids

Letter 1

Background 5

U.S. Agencies Collaborate with Foreign Governments and 

International Organizations to Limit Production of Illicit Synthetic 

Opioids 17

U.S. Agencies Have Modified Practices and Enhanced 

Coordination Domestically to Limit Illicit Synthetic Opioids, but 

Could Better Allocate Resources and Enhance Data Usage 29

Many U.S. Agencies’ Documented Opioid Response Strategies 

Lack Outcome-Oriented Performance Measures 46

U.S. Agencies Adapted to the Opioid Epidemic by Expanding 

Education Campaigns, Treatment Options, and Partnerships 53

Conclusions 63

Recommendations for Executive Action 64

Agency Comments, Third Party Views, and Our Evaluation 65

Appendix I Objectives, Scope, and Methodology 70

Appendix II The Evolution of Federal Guidance for the Safe Handling of 

Synthetic Opioids for First Responders and Continuing Efforts to 

Enhance the Evidence Basis for Safe Handling Measures 74

Appendix III Comments from the Department of Homeland Security 78

Appendix IV Comments from the Office of National Drug Control Policy 81

Appendix V Comments from the Department of Justice 84

Appendix VI GAO Contact and Staff Acknowledgments 88

Contents
Page ii GAO-18-205 Combating Synthetic Opioids

Table

Table 1: Examples of Federal Agencies Involved in Combating 

Drug Trafficking and Drug Use 13

Figures

Figure 1: Drugs Involved in U.S. Overdose Deaths (1999-2016)a 5

Figure 2: Comparison of a Potentially Lethal Dose of Fentanyl to a 

U.S. Penny 6

Figure 3: How Opioids Affect the Brain 7

Figure 4: Flow of Illicit Synthetic Opioids from China to the United 

States 10

Figure 5: Scope of Federal Law Enforcement Agencies’ Targets 

for Drug Investigations and Prosecutions 30

Figure 6: Examples of Investigative Approaches that Select Law 

Enforcement Agencies Encourage Agents to Use at 

Overdose Death Scenes 32

Figure 7: Inbound International Mail at the New York International 

Mail Facility 36

Figure 8: Customs and Border Protection’s (CBP) Process for 

Identifying Illicit Synthetic Opioids 38

Figure 9: Examples of Personal Protective Equipment Used to 

Respond to Most Fentanyl Encounters 75

Figure 10: Example of a Specialized Full-Body Suit Used to 

Respond to Scenes of Gross Fentanyl Contamination 76

Abbreviations

AACT American Academy of Clinical Toxicology

ACMT American College of Medical Toxicology

CBP U.S. Customs and Border Protection

CDC Centers for Disease Control and Prevention

DARE Drug Abuse Resistance Education

DEA Drug Enforcement Administration

DHS Department of Homeland Security

DOD Department of Defense

DOJ Department of Justice
Page iii GAO-18-205 Combating Synthetic Opioids

EAD Electronic Advance Data

EOUSA Executive Office for United States Attorneys

FBI Federal Bureau of Investigation

FDA Food and Drug Administration

HARP Heroin Availability Reduction Plan

HHS Department of Health and Human Services

HIDTA High-Intensity Drug Trafficking Areas

HIPAA Health Insurance Portability and Accountability Act of 1996

HRS Heroin Response Strategy

ICE-HSI U.S. Immigration and Customs Enforcement – Homeland 

 Security Investigations

INCB International Narcotics Control Board

LSSD Laboratories and Scientific Services Directorate

MAT Medication-Assisted Treatment

NIDA National Institute on Drug Abuse

NIOSH National Institute for Occupational Safety and Health

NIST National Institute of Standards and Technology

NTC National Targeting Center

OCDETF Organized Crime Drug Enforcement Task Forces 

ONDCP Office of National Drug Control Policy

SAMHSA Substance Abuse and Mental Health Services 

 Administration

UNODC United Nations Office on Drugs and Crime

USAO United States Attorney’s Office

USPIS United States Postal Inspection Service

USPS United States Postal Service

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Page 1 GAO-18-205 Combating Synthetic Opioids

441 G St. N.W.

Washington, DC 20548

March 29, 2018

Congressional Requesters

Though drug misuse and abuse in our nation is not a new phenomenon, 

the scale and impact of illicit drug use in this country has reached new 

heights. Policymakers, criminal justice officials, healthcare providers, and 

the public at large are turning with renewed attention to the drug epidemic 

and its impact on our nation. Deaths from drug overdoses have risen 

steadily over the past two decades and are the leading cause of death 

due to injuries in the United States. In fact, according to the Centers for 

Disease Control and Prevention (CDC), drug overdose deaths surpass 

the annual number of traffic fatalities, as well as deaths due to firearms, 

suicide, and homicide, respectively. According to figures from the CDC’s 

National Center for Health Statistics, in 2016, the most recent year for 

which national data are available, there were nearly 64,000 deaths from 

drug overdoses, or approximately 175 people every day.

Recently, there has been a rise in opioid use in the United States 

involving both the nonmedical use of prescription drugs and more 

traditional illicit opioids, such as heroin. Coinciding with this increase, 

there also has been a significant increase in the use of man-made 

(synthetic) opioids, such as fentanyl and fentanyl analogues, which is a 

main contributor to the spikes in overdose deaths.1 For example, 

according to CDC, of the nearly 64,000 drug overdose deaths in 2016, 

more than 15,000 involved heroin and more than 19,000 involved 

synthetic opioids such as fentanyl and fentanyl analogues. Public health 

and law enforcement experts expect this number to continue to increase.

You asked us to review the federal efforts to combat synthetic opioids. In 

this report, we examine the following: (1) how U.S. agencies work with 

international partners to limit the production of illicit synthetic opioids; (2) 

how U.S. agencies work domestically to limit the availability of and 

enhance their response to illicit synthetic opioids and how agencies can 

improve the effectiveness of these efforts; (3) how U.S. agencies’ 

documented opioid-response strategies measure performance; and (4) 

 

1

An analogue is a drug molecule that shares structural similarities with the original 

compound. It may also share pharmacological similarities.

Letter
Page 2 GAO-18-205 Combating Synthetic Opioids

how U.S. agencies have adapted prevention and treatment approaches in 

light of the illicit synthetic opioid epidemic.

To understand how U.S. agencies work with international partners to limit 

the production of illicit synthetic opioids, we collected information and 

interviewed officials from federal agencies that engage with international 

organizations and foreign governments on efforts related to international 

drug control scheduling, information sharing, and capacity building.2

These agencies included the Department of Homeland Security (DHS); 

Department of Defense (DOD); Department of Justice (DOJ); Department 

of Health and Human Services (HHS); Department of State (State); and 

Office of National Drug Control Policy (ONDCP). These agencies 

collaborate with the United Nations Office on Drugs and Crime (UNODC) 

and the International Narcotics Control Board (INCB) on issues related to 

illicit synthetic opioids. We interviewed officials from UNODC and INCB to 

learn about their roles in limiting the international production of these illicit 

substances.

Further, we interviewed federal law enforcement officials from the U.S. 

Drug Enforcement Administration (DEA), U.S. Customs and Border 

Protection (CBP), U.S. Immigration and Customs Enforcement-Homeland 

Security Investigations (ICE-HSI), and Federal Bureau of Investigation 

(FBI) stationed in China (including Hong Kong), Mexico, and Canada to 

understand their roles in those countries. This included their efforts to 

share information, coordinate investigations, encourage capacity building, 

and engage in drug scheduling efforts with foreign counterparts, including

any challenges they may face operating in a foreign environment. We 

focused our review on these three countries based on documentary and 

testimonial evidence provided by DHS, DOJ, and State that indicated the 

majority of illicit synthetic opioids in the U.S. market are produced in 

China and either shipped directly into the United States or shipped into 

Mexico or Canada first, before being trafficked across the border.

To examine how U.S. agencies work domestically to limit the availability 

of and enhance their response to illicit synthetic opioids and to determine 

how agencies can improve the effectiveness of their efforts, we reviewed 

various documents that, among other things, outlined federal agencies’ 

 

2

The process of drug scheduling involves categorizing a drug based on the substance’s 

medical use, potential for abuse, and risk of dependence. This is intended to ensure the 

continued access and availability of controlled substances for medical purposes while 

preventing their diversion into illicit channels. 
Page 3 GAO-18-205 Combating Synthetic Opioids

approaches to limit opioid distribution across the country. These 

documents included federal guidance for first responders on the safe 

handling of fentanyl and DEA documents that discuss the nature of the 

drug threats in the United States. Further, we interviewed cognizant law 

enforcement officials from DEA, CBP, ICE-HSI, and FBI—as well as 

officials from the United States Postal Service (USPS) and ONDCP, 

among others, about their efforts to reduce the domestic availability of 

synthetic opioids and how they coordinate with state and local law 

enforcement agencies and public health entities, such as medical 

examiners and coroners. We also interviewed federal officials working to 

test technologies to identify synthetic opioids, such as researchers from 

the Department of Commerce’s National Institute of Standards and 

Technology (NIST), and talked to experts from the American College of 

Medical Toxicology about the safe handling of synthetic opioids for first 

responders.

Additionally, we selected states to visit that (1) participate in federal drug 

control efforts, such as ONDCP’s High Intensity Drug Trafficking Areas’ 

(HIDTA) program, which coordinates efforts within specifically designated 

drug trafficking areas, and (2) experienced high rates of overdose deaths 

attributable to synthetic opioids, based on data from the CDC. These 

states included New York, New Jersey, Massachusetts, New Hampshire, 

Ohio, Kentucky, and Tennessee. We interviewed federal, state, and local 

law enforcement and public health officials to understand any challenges 

they may be facing in helping to limit illicit synthetic opioids, the unique 

efforts in which they were engaged, and the extent of their engagement 

with federal counterparts. Further, to better understand the issues with 

synthetic opioid trafficking at the southwest border, we visited Los 

Angeles and San Diego, including the San Ysidro Port of Entry, where 

CBP had conducted a pilot program using technology to detect illicit 

synthetic opioids. While there, we interviewed federal law enforcement 

officials about their actions to reduce the flow of synthetic opioids across 

the border and how they coordinate their efforts.

To examine how U.S. agencies’ documented opioid-response strategies 

measure performance, we first queried the federal agencies that are 

working to limit the domestic availability of synthetic opioids to identify any 

strategies that they had developed. We then reviewed the five 

documented strategies that the agencies provided to determine whether 

the agencies had built-in measures to assess the effectiveness of their 

efforts. Next, we assessed the nature and scope of the available 

measures against the Government Performance and Results Act 

Modernization Act of 2010. This act directs agencies to develop goals, as 
Page 4 GAO-18-205 Combating Synthetic Opioids

well as performance measures, to provide federal agencies with 

information on how resources and efforts should be allocated to ensure 

effectiveness and keep program partners focused on the key goals of a 

program.3

To determine how U.S. agencies have adapted their approaches to 

prevention and treatment in response to the illicit synthetic opioid 

epidemic, we reviewed federal agency documents on the types of 

prevention and treatment now available for opioid abuse. In addition, we 

interviewed federal officials from agencies such as HHS’s Substance 

Abuse and Mental Health Services Administration (SAMHSA) and the 

National Institute on Drug Abuse (NIDA), about their roles in preventing 

and treating opioid abuse, and any related initiatives they have that 

involve synthetic opioids. Further, we interviewed regional HIDTA officials 

and participants, United States Attorney’s Office (USAO) district officials, 

and other key groups, such as state and local public safety and public 

health agencies in the states we visited, to better understand how federal, 

state, and local entities have coordinated across disciplines. We also 

attended the public sessions of the President’s Commission on 

Combating Drug Addiction and the Opioid Crisis (President’s 

Commission) and reviewed its reports and related recommendations. For 

additional details on our scope and methodology, see appendix I.

We conducted this performance audit from January 2017 through March 

2018 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

 

3

The Government Performance and Results Act of 1993, Pub. L. No. 103-62, 107 Stat. 

285 (1993), sets out the performance planning and reporting framework. The Government 

Performance and Results Act Modernization Act of 2010, Pub. L. No. 111-352, 124 Stat. 

3866 (2011), enhanced the Government Performance and Results Act by providing 

important tools that can help decision makers address challenges facing the federal 

government, help resolve longstanding performance and management problems, and 

provide greater accountability for results. 
Page 5 GAO-18-205 Combating Synthetic Opioids

Synthetic opioids are chemically produced in a laboratory, as opposed to 

opiates derived from the poppy plant, such as heroin and morphine. Their 

chemical structure can be either identical to or different from naturally 

occurring opioids and their effects are designed to mimic or even 

enhance those of natural drugs. According to the CDC, among the nearly 

64,000 drug overdose deaths in 2016, the sharpest increase occurred 

among deaths related to synthetic opioids, such as fentanyl and fentanyl 

analogues (see fig. 1). These data show that overdose deaths involving 

synthetic opioids increased from 9,580 in 2015 (18 percent of all 

overdose deaths) to 19,413 in 2016 (31 percent of all overdose deaths)—

an increase of more than 100 percent. A majority of these deaths are 

likely attributable to illicit fentanyl.

Figure 1: Drugs Involved in U.S. Overdose Deaths (1999-2016)a 

a

Measurement of specific drug death rates can be affected by a number of factors, including that the 

substances tested for and the circumstances under which the toxicology tests are performed vary by 

jurisdiction. 

Background

Synthetic Opioid 

Production, Potency, 

Overdose Trends, and 

Effects on the Brain
Page 6 GAO-18-205 Combating Synthetic Opioids

The high potency of fentanyl and related synthetic opioids can increase 

the risk of overdose.4

 According to DEA, two milligrams of fentanyl can 

cause a lethal overdose (see fig. 2).

Figure 2: Comparison of a Potentially Lethal Dose of Fentanyl to a U.S. Penny

Fentanyl’s potency—100 times stronger than morphine and 50 times 

stronger than heroin—is attributable to its chemical structure. This allows 

fentanyl to pass the blood-brain barrier much more efficiently than other 

types of opioids.5 Like heroin, morphine, and other opioid drugs, fentanyl 

works by binding to the body’s opioid receptors, which are found in areas 

of the brain that control pain and emotions. When opioid drugs bind to 

 

4

For the purposes of our report we are defining potency as a measure of drug activity 

expressed in terms of the amount required to produce an effect of given intensity. A highly 

potent drug evokes a given response at low concentrations, while a drug of lower potency 

evokes the same response only at higher concentrations.

5

The blood-brain barrier is comprised of a network of blood vessels that create a boundary 

between the brain and the bloodstream that helps to block harmful substances from 

entering the brain. 
Page 7 GAO-18-205 Combating Synthetic Opioids

these receptors, they can drive up dopamine levels in the brain, 

producing a state of euphoria (see fig. 3). 

Figure 3: How Opioids Affect the Brain

Fentanyl is a drug that can be legally prescribed by a physician to treat 

pain, such as from advanced cancer. According to the CDC, the rates for 

fentanyl prescriptions have remained stable—demonstrating that the 

recent increase in fentanyl misuse is largely attributable to illicitly 

produced, non-pharmaceutical fentanyl. When produced clandestinely, 

synthetic opioids are not typically controlled pharmaceutical substances 

intended for legitimate medical use. Rather, they have slightly modified 

molecular structures intended to circumvent the controlled substances 

specifically listed in drug scheduling laws.

In the United States, the Controlled Substances Act regulates drug 

scheduling.6 Enacted in 1970, this act assigns controlled substances—

including narcotics, stimulants, depressants, hallucinogens, and anabolic 

steroids—to one of five schedules based on the substance’s medical use, 

potential for abuse, and risk of dependence. Schedule I contains drugs or 

other substances that have been found to have a high potential for abuse, 

have no currently accepted medical use in treatment in the United States, 

and have a lack of accepted safety for use of the drug or other substance 

 

6

Pub. L. No. 91-513, tit. II, 84 Stat. 1236, 1242-84 (codified as amended at 21 U.S.C. § 

801 et seq.).

Current Drug Scheduling 

Laws
Page 8 GAO-18-205 Combating Synthetic Opioids

under medical supervision.7 As a result, these drugs may not be 

prescribed, administered, or dispensed for medical use. In contrast, drugs 

in Schedules II, III, IV, and V include substances that have recognized 

medical uses and may be manufactured, distributed, and dispensed in

accordance with the Controlled Substances Act. Fentanyl is a Schedule II 

drug under the Controlled Substances Act. A substance is placed on 

Schedule II if the drug or other substance have been found to (1) have a 

high potential for abuse, (2) have a currently accepted medical use in 

treatment in the United States or a currently accepted medical use with 

severe restrictions, and (3) abuse of the drug or substance may lead to 

severe psychological or physical dependence.8 In contrast, cough syrup 

with the opioid codeine added, is a Schedule V drug.9

Under the Controlled Substance Analogue Enforcement Act of 1986, as 

amended, a “controlled substance analogue”—generally a chemical 

substantially similar to a controlled substance which has a stimulant, 

depressant, or hallucinogenic effect on the central nervous system in a 

manner equivalent to or greater than the controlled substance— is, to the 

extent intended for human consumption, to be treated under any federal 

law as if it were a controlled substance in schedule I.10 In part, this act 

regulates emerging variations of synthetic opioids that are not yet 

scheduled. In November 2017, DEA also announced efforts to initiate 

emergency scheduling for all fentanyl-related analogues, which would 

subject anyone who possesses, imports, distributes, or manufactures any 

illicit fentanyl analogue to the same criminal prosecution as for fentanyl 

and other controlled substances.11

Internationally, three United Nations conventions establish applicable 

control measures intended to ensure that narcotic drugs and psychotropic 

 

7

21 U.S.C. § 812(b)(1). 

8

21 U.S.C. § 812(b)(2). 

9

Generally, the preparation of the drug must have less than 200 milligrams of codeine or 

per 100 milliliters of nonnarcotic cough syrup to be considered a Schedule V drug. 

10Controlled Substance Analogue Enforcement Act of 1986, Pub. L. No. 99-570, 100 Stat. 

3207-13 (1986). See 21 U.S.C. § 813. 

11See 21 U.S.C. § 811(h) and 28 C.F.R. § 0.100. 
Page 9 GAO-18-205 Combating Synthetic Opioids

substances are available for medical and scientific purposes,12 while 

preventing them from being diverted into illegal channels.13 These three 

conventions are the 1961 Single Convention on Narcotic Drugs (as 

amended by the 1972 Protocol), the 1971 Convention on Psychotropic 

Substances, and the 1988 Convention against Illicit Traffic in Narcotic 

Drugs and Psychotropic Substances. The 1961 and 1971 Conventions 

classify controlled substances in four Schedules, according to their 

perceived therapeutic value and potential risk of abuse. The 1988 

Convention also lists precursor chemicals and other substances 

frequently used in the illicit manufacture of narcotic drugs and 

psychotropic substances. It also provides for measures to prevent the 

diversion of chemicals into illicit channels, including the monitoring of their 

international trade.

According to U.S. law enforcement agencies, the majority of synthetic 

opioids in the illegal drug market are illicitly produced by foreign sources, 

primarily in China, and trafficked either directly into the United States or 

indirectly through Mexico and Canada. Illicit manufacturing and trafficking 

via these three primary routes is demonstrated in figure 4 and explained 

below: 

 

12In the context of international drug control, “narcotic drug” means any of the substances, 

natural or synthetic, in Schedules I and II of the 1961 Single Convention on Narcotic 

Drugs. In medicine, the term usually refers to opiates or opioids. “Psychoactive 

substances” refer to any chemical agent that affects the mind or mental processes. In the 

context of international drug control, “psychotropic substances” mean any substance, 

natural or synthetic, or any natural material in Schedule I, II, III, or IV of the 1971 

Convention on Psychotropic Substances. 

13A convention is a formal agreement between United Nations member states; generally, 

the generic term ‘convention’ is synonymous with the generic term ‘treaty.’ Conventions 

are normally open for participation by the international community as a whole, or by a 

large number of member states. Generally, a convention begins as an international 

meeting of representatives from many nations that results in general agreement about 

procedures or actions they will take on specific topics.

Synthetic Opioids in the 

United States
Page 10 GAO-18-205 Combating Synthetic Opioids

Figure 4: Flow of Illicit Synthetic Opioids from China to the United States

1. Direct from China: China is a global source of fentanyl and other illicit 

substances. According to the U.S.-China Economic and Security 

Review Commission, thousands of pharmaceutical and chemical

companies operate, both legally and illegally, in the country.14 Further, 

these companies produce massive quantities of pharmaceutical and 

chemical products daily. DEA and others report that certain Chinese 

chemical exporters utilize various covert methods to ship drugs to the 

 

14The U.S.-China Economic and Security Review Commission was established on

October 30, 2000 pursuant to the Floyd D. Spence National Defense Authorization Act for 

Fiscal Year 2001, Pub. L. No. 106-398, § 1238, 114 Stat. 1654, 1654A-334 to 1654A-338 

(codified as amended at 22 U.S.C. § 7002). The purpose of this Commission is to monitor, 

investigate, and submit to Congress an annual report on the national security implications 

of the bilateral trade and economic relationship between the United States and the 

People’s Republic of China, and to provide recommendations, where appropriate, to 

Congress for legislative and administrative action. 
Page 11 GAO-18-205 Combating Synthetic Opioids

United States, including sending illicit materials through a chain of 

forwarding systems, mislabeling narcotic shipments, and modifying 

chemicals so they are not controlled in the United States. U.S.-based 

consumers can also purchase fentanyl illicitly through both the Dark 

and Surface Web in very small, high-purity quantities.15 These 

packages are shipped through both express consignment carriers, 

such as FedEx and the United Parcel Service (UPS), and traditional 

international mail.

2. From Mexico across the southwest border: Mexico is rarely the final 

destination for illicit drug shipments; most fentanyl products sent to 

Mexico are repackaged and smuggled into the United States, 

according to the U.S.-China Economic and Security Review 

Commission. Mexican drug trafficking organizations act as the 

country’s primary conduit for Chinese fentanyl destined for the United 

States, purchasing bulk shipments and trafficking it—either alone or 

mixed with other drugs like heroin—across the U.S. border along 

established drug routes. The increasing adulteration of heroin with 

highly potent fentanyl and other synthetic opioids has exacerbated 

overdose deaths in the United States, according to DEA. While 

Mexico is the primary source of heroin for the U.S. market, it is 

unclear how much market share fentanyl has gained from heroin 

because the two markets are so intertwined. The illicit nature of these 

smuggling operations makes it difficult to quantify the volume of 

fentanyl flowing from Mexico to the United States. U.S. law 

enforcement agencies suggest that fentanyl may also be produced in 

Mexico with precursor chemicals sourced from China.

3. From Canada across the northern border: Along with shipments 

directly to the United States, Chinese producers are also shipping 

fentanyl to Canada before the drug is trafficked across the U.S. 

northern border. Collaboration and information sharing between DEA 

and Canada’s Royal Canadian Mounted Police confirms this cross-

 

15According to the Congressional Research Service, the layers of the Internet go far 

beyond the surface content that many can easily access in their daily searches. The 

Surface Web is a portion of the World Wide Web that is readily available to the general 

public and searchable with standard web search engines. The Dark Web contains content 

that has been intentionally concealed and requires specialized software for access. The 

Dark Web may be used for legitimate purposes; for example, some news organizations 

have sites on the Dark Web that enable users to transmit information anonymously. 

However, some users may access the Dark Web to conceal criminal or otherwise 

malicious activities. Congressional Research Service, Dark Web, R44101 (Washington, 

DC.: Mar. 10, 2017).
Page 12 GAO-18-205 Combating Synthetic Opioids

border fentanyl trafficking.16 However, according to the U.S.-China 

Economic and Security Review Commission, this occurs less 

frequently than the trafficking across the U.S. southern border.

DEA reported in its 2017 National Drug Threat Assessment that illicit 

fentanyl entering into the United States is traditionally mixed into or sold 

as heroin. Additionally, in recent years, law enforcement agencies have 

increasingly encountered counterfeit prescription opioid pills and other 

drugs containing fentanyl, often mixed in without the user’s knowledge.

The profitability of synthetic opioids incentivizes drug traffickers since so 

little of the substance is needed to produce the high users seek. For 

example, DEA reported that traffickers could purchase a kilogram of illicit 

fentanyl for a few thousand dollars from a Chinese supplier, create 

counterfeit prescription pills using illicit pill presses, and collect up to $20 

million in revenue.

Drug interdiction efforts show an increase in smuggling of synthetic 

opioids. DEA’s 2017 National Drug Threat Assessment indicates that U.S. 

law enforcement agencies seized a record-high 287 kilograms of fentanyl 

in 2016—a 72 percent increase from the 167 kilograms seized in 2015. 

For example, according to CBP’s National Targeting Center, CBP 

seizures of synthetic opioids alone increased from approximately 1 

kilogram in fiscal year 2013 to nearly 90 kilograms in fiscal year 2015 and 

nearly 200 kilograms in fiscal year 2016.

Combating the opioid crisis requires the coordinated efforts of many 

federal agencies across many levels of government. Overall, the federal 

government response is not specifically focused on synthetic opioids, but 

rather the larger opioid issue, which includes heroin and prescription 

opioids. This is because synthetic opioids are often mixed in or sold as 

other opioids, the same drug trafficking organizations and trafficking 

routes are being utilized, and federal agencies want to avoid responses to 

one type of opioid that may inadvertently have a negative impact on 

 

16The Royal Canadian Mounted Police is responsible for national law enforcement, 

including border security, in Canada. The Canada Border Services Agency is Canada’s 

federal customs agency. We have previously reported on the challenges of security along 

the U.S.-Canadian border. See GAO, Border Security: Enhanced DHS Oversight and 

Assessment of Interagency Coordination Is Needed for the Northern Border, GAO-11-97 

(Washington, D.C.: Dec. 17, 2010). 

Federal Agencies Involved 

in Combating Drug 

Trafficking and Misuse
Page 13 GAO-18-205 Combating Synthetic Opioids

another. Table 1 summarizes some of the federal agencies that are 

involved in combating drug trafficking and drug use.

Table 1: Examples of Federal Agencies Involved in Combating Drug Trafficking and Drug Use 

Agency Tasks

Department of Defense (DOD)

Joint Interagency Task Force West & Joint 

Interagency Task Force South

• Detects and monitors illicit drug trafficking, and facilitates 

international and interagency interdiction

National Guard • Supports the detection, interdiction, disruption, and curtailment of 

drug trafficking activities and use at all levels of government, through 

use of military skills and resources

Department of Health & Human Services (HHS)

Centers for Disease Control and Prevention (CDC) • Detects and responds to new and emerging health threats causing 

death and disability for Americans

• Uses science and technology to prevent disease

• Promotes healthy and safe behaviors, communities, and 

environment

Food and Drug Administration (FDA) • Protects public health by ensuring the safety, efficacy, and security 

of human and veterinary drugs, biological products, and medical 

devices

• Coordinates with DEA on scheduling drugs under the Controlled 

Substances Acta

• Collaborates with CBP to prevent the importation of unapproved 

drugs and investigates their distribution

• Inspects registered facilities that manufacture drugs approved for 

marketing in the United States

National Institutes of Health • Supports research to protect and improve public health, prevent 

disease, and expand medical knowledge

• Includes the National Institute on Drug Abuse (NIDA), which 

supports research on the causes and consequences of drug misuse

Substance Abuse and Mental Health Services 

Administration (SAMHSA)

• Develops best practices and expertise in preventing and treating 

mental and substance use disorders

• Evaluates and disseminates evidence-based behavioral health 

practices

• Supports behavioral health programs and services with grant 

funding

• Supports behavioral health with data from national surveys and 

surveillance
Page 14 GAO-18-205 Combating Synthetic Opioids

Agency Tasks

Department of Homeland Security (DHS)

Customs and Border Protection (CBP) • Manages and controls the border, including the enforcement of

customs, immigration, border security, and agricultural laws. This 

includes screening inbound cargo at ports of entry, including 

international mail and express consignment carrier items

• Collaborates with FDA to prevent the importation of unapproved 

drugs and investigates their distribution

U.S. Coast Guard • Conducts maritime drug interdiction

• Contributes vessels and aircraft deployed to disrupt illicit drug 

smuggling

U.S. Immigration and Customs Enforcement (ICE) • Enforces federal laws governing border control, customs, trade, and 

immigration

• ICE’s Homeland Security Investigations (HSI) investigates the illegal 

movement of goods within and out of the U.S., including narcotics

Department of Justice (DOJ)

Criminal Division • Develops, enforces, and supervises application of federal criminal 

laws except those assigned to other divisions

• Advises the Attorney General, Congress, the Office of Management 

and Budget, and the White House on matters of criminal law and 

assists federal prosecutors

Drug Enforcement Administration (DEA) • Enforces laws and regulations related to the growing, manufacture, 

or distribution of controlled substances

• Conducts investigations in coordination with international, state, 

local and tribal law enforcement agencies

• Coordinates with FDA on scheduling drugs under the Controlled 

Substances Acta

Federal Bureau of Investigation (FBI) • National security organization with intelligence and law enforcement 

responsibilities, including terrorism, cyber-attacks, and other major 

criminal threats

Office of Justice Programs • Disseminates information on strategies for crime control and 

prevention to federal, state, local, and tribal justice systems

• Administers grant programs to develop and implement these 

strategies

Organized Crime Drug Enforcement Task Forces 

(OCDETF)

• Identifies, targets, disrupts, and dismantles major drug trafficking 

organizations, money laundering organizations, and related criminal 

enterprises

• Coordinates prosecutor-led, intelligence-driven multi-agency and 

multijurisdictional task forces, including DOJ, DHS, and USPS 

component agencies 

U.S. Attorney’s Office (USAO) • Enforces federal laws throughout the country, including drug 

trafficking and production offenses

Department of State

Bureau of International Narcotics and Law 

Enforcement Affairs

• Helps foreign governments implement programs to reduce the 

demand for and supply of illicit drugs
Page 15 GAO-18-205 Combating Synthetic Opioids

Agency Tasks

Office of National Drug Control Policy (ONDCP) • Advises the President on drug-control issues

• Coordinates drug-control activities and funding across the federal 

government

• Develops the annual National Drug Control Strategy

• Administers the High Intensity Drug Trafficking Areas (HIDTA) 

Program and the Drug-Free Communities grant programb

• Leads the interagency National Heroin Coordination Group, which 

developed the Heroin Availability Reduction Plan 

United States Postal Service (USPS)

U.S. Postal Inspection Service (USPIS) • Protects against and prevents criminal attacks to postal employees, 

customers, infrastructure, and the U.S. Mail

• Enforces laws that defend the nation’s mail system from illegal or 

dangerous use

• As the federal law enforcement arm of the USPS, investigates cases 

and prepares them for court along with U.S. Attorneys, other law 

enforcement, and local prosecutors

Source: GAO Analysis of Agency Documents | GAO-18-205

a

Enacted in 1970, the Controlled Substances Act and its implementing regulations establish a 

framework for the federal government to regulate the use of these substances for legitimate medical, 

scientific, research, and industrial purposes, while preventing them from being diverted for illegal 

purposes. This act assigns controlled substances—including narcotics, stimulants, depressants, 

hallucinogens, and anabolic steroids—to one of five schedules based on the substance’s medical 

use, potential for abuse, and risk of dependence. FDA compiles and transmits to DEA a medical and 

scientific evaluation regarding a drug or other substance, recommending whether the drug should be 

controlled, and in what schedule it should be placed.

b

The Drug-Free Communities Support program provides grants to community coalitions to create and 

sustain reduction in local youth substance use. For more information, see GAO, Drug-Free 

Communities Support Program: Agencies Have Strengthened Collaboration but Could Enhance 

Grantee Compliance and Performance Monitoring, GAO-17-120 (Washington, D.C.: Feb. 7, 2017)

Comprehensive Addiction and Recovery Act: Enacted in 2016, this act 

encompasses six different areas for a coordinated federal response to the 

opioid epidemic: prevention, treatment, recovery, law enforcement, 

criminal justice reform, and overdose reversal. Generally, the act 

authorizes nearly $181 million each year from fiscal year 2017 through 

fiscal year 2021, to be funded through the annual appropriations 

process.17 The funding, if appropriated, would support programs such as 

those expanding first responders’ access to naloxone—an opioid 

antagonist that is used to reverse the effects of an overdose. It would also 

fund programs to treat opioid addiction, such as Medication-Assisted 

 

17Pub. L. No. 114-198, 130 Stat. 695 (2016).

Recently Enacted Funding 

Streams and the Newly 

Chartered Presidential 

Commission
Page 16 GAO-18-205 Combating Synthetic Opioids

Treatment (MAT)—an evidence-based approach that complements 

medication with behavioral therapy.18

21st Century Cures Act: Also enacted in 2016, this act authorizes $1 

billion in new funding to combat the opioid crisis.19 Early efforts funded 

expansion of community-based efforts for drug use prevention and 

access to treatment.20

The President’s Commission on Combating Drug Addiction and the 

Opioid Crisis: Executive Order 13784 established the President’s 

Commission in March 2017 to study the scope and effectiveness of the 

federal response to drug addiction and the opioid crisis and to make 

recommendations to the President for improving the federal response.21

The President’s Commission issued an interim report in July 2017 and its 

final report in November 2017.22 ONDCP provides administrative support 

to the President’s Commission.

 

18We have done prior work on Medication-Assisted Treatment programs. See GAO, 

Opioid Addiction: Laws, Regulations, and Other Factors Can Affect Medication-Assisted 

Treatment Access, GAO-16-833, (Washington, D.C., September 27, 2016) and GAO, 

Opioid Use Disorders: HHS Needs Measures to Assess the Effectiveness of Efforts to 

Expand Medication-Assisted Treatment, GAO-18-44, (Washington, D.C., October 31, 

2017).

19Pub. L. No. 114-255, 130 Stat. 1033 (2016).

20Further Continuing and Security Assistance Appropriations Act, 2017, Pub. L. No. 114-

254, 130 Stat. 1005, 1021 (2016). See 21st Century Cures Act, Pub. L. No. 114-255, 

§1003, 130 Stat. 1033, 1044-46 (2016). 

21Exec. Order No. 13,784, 82 Fed. Reg. 16,283 (Mar. 29, 2017).

22The President’s Commission on Combating Drug Addiction and the Opioid Crisis, Final 

Report, November 1, 2017.
Page 17 GAO-18-205 Combating Synthetic Opioids

Several U.S. federal agencies, such as DOJ and DHS, collaborate with 

each other and with foreign governments to (1) enhance drug 

investigations by building law enforcement capacity and coordinating 

resources, and (2) share information related to illicit synthetic opioids. 

According to agency officials working in foreign countries, U.S. officials 

must pursue investigations alongside their foreign counterparts because 

they do not have authority to carry out investigations on their own. For 

example, DEA, ICE-HSI, CBP, and FBI officials stationed at the U.S. 

embassies in Beijing, Mexico City, and Ottawa, as well as the U.S. 

Consulate Generals in Hong Kong and Macau, collaborate with their 

foreign counterparts on issues related to illicit synthetic opioids.23 Further, 

these officials are often co-located and work with other federal agencies, 

such as State, on these issues. U.S. officials that we spoke with 

acknowledged some difficulties in working with foreign counterparts, such 

as competing priorities and the inability to share certain information. 

Despite these difficulties, several federal agencies told us they continue 

to collaborate with foreign governments to limit the production of illicit 

synthetic opioids.

 

23DEA, ICE-HSI, CBP, and FBI also have officials stationed at other locations around 

Mexico, Canada, and China, often at one of the U.S. Consulates. In many cases, these 

four agencies are co-located with each other as well as with other federal law enforcement 

agencies. Based on prior work, co-locating agencies can lead to information sharing 

across organizational boundaries. GAO, Managing for Results: Key Considerations for 

Implementing Interagency Collaborative Mechanisms, GAO-12-1022 (Washington, D.C.: 

Sept. 27, 2012) 

U.S. Agencies 

Collaborate with 

Foreign Governments 

and International 

Organizations to Limit 

Production of Illicit 

Synthetic Opioids

Federal Agencies 

Collaborate with Foreign 

Governments to Enhance 

Investigations and Share 

Information
Page 18 GAO-18-205 Combating Synthetic Opioids

Cooperation on synthetic opioids between the United States and China 

has increased over recent years. According to DOJ, this is primarily due 

to relationships developed by DEA’s Beijing Country Office, as well as 

DHS, at the operational level. However, DEA, ICE-HSI, and CBP officials 

acknowledged that they face difficulties in targeting and seizing illicit 

synthetic opioids bound for the United States from China due to the 

innovative practices of labs and shippers. For example, China can 

schedule certain drugs or substances in an effort to limit illicit activities 

and use. Yet, according to DEA, ICE-HSI, and CBP officials, clandestine 

labs in China can change the molecular structure of a substance so that it 

is no longer controlled.24 Further, these same officials told us that 

clandestine labs do this much more quickly than the average length of 

time it takes to schedule a new or altered substance in China. ICE-HSI 

officials in China told us that this seriously hinders their ability, as well as 

DEA, CBP, and FBI’s ability, to stem the flow of illicit synthetic opioids into 

the United States from China. DEA officials stated that this also affects 

Chinese law enforcement and customs officials because they cannot 

seize substances, such as those bound for the United States, that are not 

domestically controlled. Further, DEA’s 2017 National Drug Threat 

Assessment states that drug traffickers can send illicit synthetic opioids 

from China through freight forwarders, thereby masking the origins of the 

package.25 ICE-HSI and CBP officials in China also noted that, in their 

experience, Chinese officials require a substantial amount of law 

enforcement information on suspected illicit production before they will act 

on leads from U.S. agencies, which can potentially slow investigations. 

However, U.S. agencies told us they continue to collaborate with China to 

schedule synthetic opioids and conduct investigations despite inherent 

difficulties. Agencies reported the following collaboration:

 

24For example, furanyl fentanyl is a synthetic opioid and analogue of fentanyl. The 

molecular structure of furanyl fentanyl and fentanyl differ by one group of atoms in a 

specific position. Labs can synthesize furanyl fentanyl using similar precursors and 

methods as those developed for fentanyl by changing one of the precursor chemicals. 

Furanyl fentanyl was not controlled in China until March 2017.

25Several DEA investigations have revealed that the original supplier will provide an illicit 

package to a freight forwarding company or individual, who then transfers it to another 

freight forwarder, who then takes custody and presents the package to customs for export. 

The combination of a chain of freight forwarders and multiple custody transfers makes it 

difficult for Chinese and U.S. law enforcement to track these packages. In May 2015, 

Chinese customs officials seized 46 kilograms of fentanyl and 26 kilograms of acetyl 

fentanyl hidden in a cargo container destined for Mexico. According to DEA, the 

substances had been transferred through five different freight forwarders before arriving at 

Chinese customs. 

Combating Synthetic Opioids with China

China is a major source of supply for illicit 

synthetic opioids bound for the United States, 

Canada, and Mexico. According to the 

Department of State’s 2017 International 

Narcotics Control Strategy Report, China’s 

insufficient regulatory oversight of the 

precursor chemical industry, corruption 

among government and business officials, 

lower production costs, myriad transportation 

options, and illegal factories make it an ideal 

source for precursor chemicals intended for 

illicit drug production. The Drug Enforcement 

Administration’s reporting indicates that many 

Chinese laboratories illicitly manufacturing 

synthetic drugs also manufacture legitimate 

chemicals for purchase by U.S. companies. 

This means that laboratories responsible for 

supplying illicit synthetic opioids can also run 

legitimate businesses. State’s 2017 Report 

emphasizes the need for China and the 

United States to work together to reduce the 

supply of illicit synthetic opioids to the United 

States.

Source: U.S. Department of State and Drug Enforcement 

Administration; Map Resources (map). | GAO-18-205

Enhancing Investigations in 

China, including Hong Kong
Page 19 GAO-18-205 Combating Synthetic Opioids

• DEA officials in China reported that they work with their Chinese 

counterparts by providing assistance and information to support 

regulation of certain synthetic opioids, precursor chemicals, and 

emerging analogues. This can significantly reduce the illicit movement 

of that substance to the United States, according to DEA officials. For 

example, China controlled eight new psychoactive substances,

26 such 

as carfentanil and U-47700 in 2017 and two fentanyl precursors in 

February 2018.27 According to DEA, these actions were a culmination 

of ongoing cooperation with Chinese counterparts. Additionally, DEA 

shares detailed information with the Ministry of Public Security about 

substances encountered in the United States that they suspect 

originated in China. DEA coordinates these efforts with ICE-HSI and 

CBP. According to DEA officials in China, such cooperation is vital 

given the ability of clandestine labs in China to evade drug-scheduling 

regulations.

• DEA exchanges law enforcement information with agency officials in 

China on seizures of synthetic opioids, which can support 

investigations in Beijing or the United States into illicit drug shipments 

from China. Officials explained that based on this information, their 

counterparts can open an investigation and ask DEA to collaborate on 

collecting further law enforcement information. Occasionally, this 

involves officials from DEA’s Special Testing and Research 

Laboratory working with Chinese chemists on seizure and forensic 

analyses from drug evidence.

• FBI officials in Beijing told us they support DEA efforts by providing 

information related to ongoing FBI domestic drug trafficking 

investigations with a nexus to China. For example, FBI sponsored a 

working group in September 2017 to discuss issues related to 

counterterrorism, transnational crimes, and narcotics; Chinese 

 

26New psychoactive substances are substances of abuse, in either a pure form or a 

preparation, that are not controlled under the 1961 or 1971 Convention, but that may pose 

a public health threat. In this context, the term “new” does not necessarily refer to new 

inventions but to substances that have recently become available. 

27Carfentanil is a fentanyl-related compound that is 10,000 times more potent than 

morphine (100 times stronger than fentanyl) and is the most potent commercially used 

opioid. Carfentanil is controlled in the United States as a Schedule II substance and is not 

approved for use in humans. It is used as a tranquilizing agent by veterinarians in zoos 

and other large wildlife environments for elephants and other large mammals. U-47700 is 

a synthetic opioid that is 7.5 times the potency of morphine and is controlled as a 

Schedule I substance with no accepted medical use. 
Page 20 GAO-18-205 Combating Synthetic Opioids

• officials from the Ministry of Public Security attended.28

In Mexico, U.S. agencies reported efforts to strengthen Mexico’s capacity 

to identify, investigate, interdict, and dismantle clandestine drug 

laboratories as well as disrupt trafficking networks. According to agency 

officials, these efforts aim to help Mexican law enforcement in light of 

unique challenges, such as the large number of active drug trafficking 

organizations in Mexico, which makes it difficult for U.S. and Mexican 

federal law enforcement to focus efforts solely on illicit synthetic opioids. 

Another challenge, according to ICE-HSI officials, is that officers stationed 

in Mexico must focus on a number of competing priorities in addition to 

illicit synthetic opioids, such as human trafficking, immigration 

enforcement, and money laundering. Further, according to ICE-HSI 

officials, coordination on controlled deliveries can be difficult because 

Mexican officials, historically, have employed a different approach to 

these operations.29 Agency efforts have helped address some of these 

inherent difficulties, such as: 

• DEA and State’s Clandestine Laboratory Initiative aims to strengthen 

Mexican law enforcement’s capabilities through training and 

specialized equipment. This initiative aims to target drug trafficking 

organizations that manufacture and distribute synthetic drugs, such as 

fentanyl, disrupt and dismantle clandestine labs, develop successful

 

28FBI convened this working group in advance of the October 2017 meeting of the U.S.-

China Law Enforcement and Cybersecurity Dialogue. At this meeting, DOJ and DHS 

officials met with China’s Ministry of Public Security to discuss enhanced cooperation that 

could include combating the illicit production and trafficking of fentanyl and fentanylrelated substances and precursor chemicals. Discussions addressed, in part, scheduling 

actions, the use of express mail and consignment services, and the sharing of package 

tracking information to help identify individuals and criminal networks responsible for 

narcotics trafficking. 

29Law enforcement agencies use the technique of controlled delivery after they detect a 

package of illicit drugs. A law enforcement agency allows the package to go forward to its 

destination under the control and surveillance of law enforcement officers in order to 

secure evidence against the organizers of such illicit drug traffic. ICE-HSI officials we 

spoke with stated that Mexican law enforcement has traditionally seized and destroyed

illicit drugs rather than identifying distribution networks and final destinations.

Combating Synthetic Opioids with Mexico

Mexico is a major transit country for illicit 

synthetic opioids destined for the United 

States. According to the Department of 

State’s 2017 International Narcotics Control 

Strategy Report, increased seizures along the 

U.S.-Mexico border suggest a rise in fentanyl 

production and trafficking. Synthetic drugs, 

such as fentanyl, are increasingly transported 

in loads with other drugs and sometimes

pressed into pills to be sold as legitimate 

prescription medications. For example, in 

early 2016, U.S. authorities seized over 1,000 

counterfeit oxycodone tablets containing 

fentanyl as they were being smuggled from 

Mexico into California. State’s 2017 Report 

emphasizes that the most effective and costefficient way to reduce supplies of these drugs 

in the U.S. market is to collaborate with transit 

countries, such as Mexico.

Source: U.S. Department of State; Map Resources (map). | 

GAO-18-205

Enhancing Investigations in 

Mexico
Page 21 GAO-18-205 Combating Synthetic Opioids

criminal prosecutions, reduce the overall supply of narcotics, and 

strengthen law enforcement collection methods.30

ICE-HSI and State officials reported that they provide training and 

coordinate with law enforcement officers in Mexico to identify targets, 

collect and share evidence, and facilitate the prosecution of 

transnational criminal organizations, both in Mexico and through the 

U.S. judicial system. Specifically, ICE-HSI and State fund training for 

the Mexican Transnational Criminal Investigative Unit—a unit that was 

established in 2017, is led by ICE-HSI, and comprises ICE-HSI 

special agents and U.S.-vetted Mexican law enforcement officers.

To synchronize U.S. and Mexican investigative efforts to combat heroin 

and fentanyl production and trafficking, DEA established the U.S. 

Embassy Interagency Heroin-Fentanyl Working Group in Mexico City in 

2015.31 ONDCP co-chairs the working group, which includes participation 

from all U.S. federal law enforcement agencies represented in Mexico 

City (e.g., ICE-HSI, CBP, and FBI) as well as State. In addition, the DEAled Bilateral Heroin and Fentanyl Investigation Group meets every 2 

weeks to discuss ongoing bilateral investigations, according to DEA 

officials. Mexico’s federal police and the Mexican Attorney General’s 

Office co-chair this group.

DEA officials also told us they work directly with the Mexican Attorney 

General’s Office and the Mexican federal police to conduct bilateral 

investigations with the goal of extraditing individuals suspected of 

involvement in narcotics trafficking to the United States for prosecution, 

when appropriate. For example, DEA’s Mexico City Heroin Enforcement 

Group works on fentanyl-related investigations alongside the Mexican 

Attorney General’s Office. In addition, DEA’s Mexico City Diversion 

Investigative Group pursues bilateral investigations with Mexico’s federal 

police targeting Mexico-based organizations involved in fentanyl 

trafficking, according to DEA officials. In addition, FBI officials in Mexico 

 

30We previously reported on equipment and training provided to Mexico by the United 

States under the Merida Initiative, a bilateral effort aimed at supporting counternarcotic 

and related law enforcement activities. The Clandestine Laboratory Initiative is funded 

through the Merida Initiative. GAO, Merida Initiative: The United States Has Provided 

Counternarcotics and Anticrime Support but Needs Better Performance Measures, 

GAO-10-837 (Washington, D.C.: July 21, 2010). 

31Further, DEA established Mexico Sensitive Investigations Units to cooperatively train, 

equip, mentor, and support specialized units within host nation police forces and to 

develop and share information in order to thwart major international drug trafficking 

organizations and transnational criminal organizations impacting the United States.
Page 22 GAO-18-205 Combating Synthetic Opioids

reported that they share information regarding clandestine laboratories 

with DEA and Mexican officials and assist in joint investigations and 

seizures related to the illicit shipment of narcotics.

U.S. agencies cooperate extensively with Canada on bilateral law 

enforcement and counterdrug efforts, including conducting joint 

operations. According to officials, they engage in collaborative efforts 

despite inherent challenges, such as Canadian privacy laws, which 

impede the ability of the Royal Canadian Mounted Police to share certain 

information with U.S. law enforcement agencies. In addition, ICE-HSI 

officials noted that, historically, it has been difficult to target and interdict 

small quantities of illicit synthetic opioids shipped from Canada into the 

United States because the Canada Border Services Agency was 

previously prohibited from opening packages that weighed less than 30 

grams unless they obtained permission from either the addressee or the 

sender. Further, ICE-HSI officials told us that Canadian law requires the 

public disclosure of the identities of undercover agents used in 

investigations. According to ICE-HSI officials in Canada, this can 

compromise other ongoing investigations and deter U.S. agencies’ use of 

undercover officers in future investigations involving Canada, ultimately 

limiting investigative capabilities. However, U.S. efforts have helped 

address some of these unique challenges, such as:

• DEA and the Royal Canadian Mounted Police have a long-standing 

memorandum of understanding by which their representatives can 

work directly with each other on drug-related matters. While officials 

told us that the Royal Canadian Mounted Police is often willing to 

exchange law enforcement information, U.S. agencies generally run 

parallel narcotics investigations. For example, DEA officials in 

Vancouver reported that they work with the Royal Canadian Mounted 

Police to further investigations related to fentanyl trafficking between 

Canada and the United States.

• ICE-HSI officials in Canada reported that they engage with their 

foreign counterparts to target potential shipments of illicit synthetic 

opioids and perform controlled deliveries. For example, ICE-HSI and 

DEA officials in Hong Kong worked with local customs and law 

enforcement authorities in 2017 to seize roughly 50 packages 

containing fentanyl that were bound for the United States and 

Canada. ICE-HSI and Canadian officials in Ottawa then collaborated 

on an international controlled delivery with information provided by 

USPIS and DEA. State officials also told us that an amendment to 

Canada’s Customs Act in May 2017 gave Canadian border officials 

the authority to open international mail of any weight if they have 

Enhancing Investigations in 

Canada

Combating Synthetic Opioids with Canada

Illicit synthetic opioids, such as fentanyl, 

transit through Canada before entering the 

United States. According to the Department of 

State’s 2017 International Narcotics Control 

Strategy Report, the use of fentanyl among 

drug users has caused thousands of fatal 

overdoses in the United States, Canada, and 

some European countries. Canadian officials 

report increasing imports of fentanyl from 

China, largely via mail and courier. According 

to the Drug Enforcement Administration, 

Canadian officials have seized fully functional 

fentanyl synthesis and pill-producing 

clandestine laboratories. State’s 2017 Report 

emphasizes the need to work with Canada to 

stem the flow of illegal drugs across the 

shared border, and enhance regulatory 

frameworks to prevent access to precursor 

chemicals and lab equipment for criminal use.

Source: U.S. Department of State and Drug Enforcement 

Administration: Map Resources (map). | GAO-18-205
Page 23 GAO-18-205 Combating Synthetic Opioids

reasonable grounds to suspect the item may contain prohibited, 

controlled, or regulated goods. Such an amendment could help the 

Canada Border Services Agency target and interdict shipments of 

illicit synthetic opioids, thereby increasing information sharing with 

U.S. law enforcement agencies.

• According to ICE-HSI, the Canada Border Services Agency and 

Canada Post flag shipments of pill presses bound for the United 

States and notify ICE-HSI officials in Canada so that ICE-HSI can 

check for connections to open investigations.32 Further, ICE-HSI 

officials in Canada reported that they work with the Royal Canadian 

Mounted Police to investigate companies that produce pill presses 

and find ways to prosecute individuals in the United States that are 

suspected of involvement in the smuggling of these machines. 

According to State officials, Canada’s federal government passed 

legislation in May 2017 to regulate the importation of pill presses and 

harmonize their rules with those of the United States. Previously, the 

lack of regulation had posed problems, but such regulation could now 

help U.S. agencies address the unregistered import of machines into 

the United States for illicit use.

• FBI and ICE-HSI officials reported that they have met with Canadian 

officials to share trends and targeting strategies in fentanyl-related 

investigations. For example, FBI officials told us they facilitated a 

Virtual Currency Practitioner’s Workshop in Ottawa in December 2017 

to share investigative best practices and identify opportunities for joint 

investigations with the Royal Canadian Mounted Police regarding the 

use of cryptocurrencies and money laundering in conjunction with 

online illicit opioid investigations.33

Agencies at the U.S. Embassy in Ottawa also collaborate on 

counternarcotic efforts through the Law Enforcement Working Group, 

 

32According to DEA, traffickers purchase industrial pill presses from China to create 

counterfeit prescription opioid pills containing fentanyl to supply illicit U.S. drug markets. 

Under U.S. law, DEA must be notified of the importation of a pill press into the United 

States. However, foreign pill press vendors often mislabel the equipment or send it 

disassembled to avoid law enforcement detection, according to DEA. See 21 U.S.C. § 

830. See also 21 C.F.R. §§ 1310.05, 1310.06. 

33Cryptocurrencies, such as Bitcoin, provide people around the world with new and 

innovative ways of engaging in legitimate commerce by virtually exchanging currency. 

However, individuals can subvert these technologies to conduct and obscure criminal 

activity. According to DOJ, although cryptocurrencies have known legitimate uses, the 

virtual currency can be used—just like cash—to facilitate illicit transactions and to launder 

criminal proceeds. 
Page 24 GAO-18-205 Combating Synthetic Opioids

which generally meets twice a month. Participants in the working group 

told us they have discussed issues related to illicit synthetic opioids since 

2016. For example, FBI is actively involved in this working group and 

exchanges law enforcement information with interagency partners, 

according to agency officials. In addition, CBP officials in Canada told us 

they regularly support DEA, ICE-HSI, and FBI enforcement and 

investigative efforts related to synthetic opioids trafficking by sharing 

information such as seizure data and trends, and key contacts.

Federal agencies, such as DEA, ICE-HSI, CBP, State, and FBI, stated 

that they share information with their foreign counterparts to develop 

bilateral and multilateral approaches to limit the production of illicit 

synthetic opioids: 

• Mexico and State organized the first National Forensic Chemist 

Fentanyl Conference in May 2017 for U.S. and Mexican law 

enforcement and regulatory agencies to share best practices for the 

detection, identification, analysis, and handling of fentanyl. According 

to State, Mexico committed to improving the exchange of intelligence 

on illicit opioids between Mexico, the United States, and Canada at 

this conference. Additionally, officials from Mexico’s Attorney 

General’s Office and DEA shared updated fentanyl detection 

protocols as well as new methods to identify synthetic opioids in 

laboratory settings.

• The United States joined Mexico and Canada in October 2016 for the 

first North American Drug Dialogue to exchange information on drug 

trends in the Northern Hemisphere, illicit opioid use, and shared 

approaches to addressing the heroin and fentanyl crisis. Members of 

this tri-lateral group met again in December 2017 in Mexico City to 

review progress made and discuss the increase in synthetic drugs, 

the diversion of chemicals from licit to illicit use, and current activities 

to reduce the demand for drugs. According to State, Canada agreed 

to host the third North American Drug Dialogue in 2018.

• According to officials, the U.S.-China Joint Liaison Group on Law 

Enforcement Cooperation (Joint Liaison Group) and its CounterNarcotics Working Group meets annually to exchange views and 

information, discuss pertinent laws, regulations, policies, and 

procedures, seek progress and address challenges, and find 

mechanisms to cooperate on investigations related to drug use and 

Sharing Information with China 

(including Hong Kong), Mexico, 

and Canada
Page 25 GAO-18-205 Combating Synthetic Opioids

trafficking of illicit synthetic opioids.34 The last Joint Liaison Group and 

Counter-Narcotics Working Group annual meetings occurred between 

September and November 2016 but State officials told us these 

groups plan to meet again.

According to officials, prior discussions at Joint Liaison Group and 

Counter-Narcotics Working Group meetings helped lead China to enact 

wide-reaching legislation in October 2015 that allowed the Chinese 

government to schedule new and emerging drugs deemed to have no 

identified medical use, including substances not used within China.35

According to DOJ officials, this legislation also established immediate 

controls over 116 new psychoactive substances, such as fentanyl and 

several fentanyl analogues. DEA reported a marked reduction in seizures 

and availability of many of the new psychoactive substances newly 

controlled by China within the United States, according to State’s 2017 

International Narcotics Control Strategy Report and DEA’s 2017 National 

Drug Threat Assessment. DEA officials told us they expect additional 

scheduling to yield similar results. Further, according to State, China’s 

enactment of this legislation provides a mechanism for enhanced 

cooperation with the United States and other international partners to 

control the spread of new psychoactive substances. Nevertheless, 

fentanyl and related analogues continue to be a challenge for law 

enforcement in the United States, according to ONDCP.

U.S. officials acknowledged that some difficulties in working with foreign 

governments are inherent to operating in an environment that is largely 

outside their control and are not unique to the issue of limiting the illicit 

production of synthetic opioids. However, State asserts that partnerships 

 

34State, DOJ, and DHS co-chair the Joint Liaison Group along with China’s Ministry of 

Public Security, Ministry of Foreign Affairs, and Ministry of Supervision. The CounterNarcotics Working Group is chaired by DOJ and China’s Ministry of Public Security. The 

Ministry of Public Security’s Narcotics Control Bureau is the primary national drug 

enforcement entity in China and works in conjunction with provincial public security bureau 

offices. The Anti-Smuggling Bureau within the General Administration of Customs is also 

responsible for the enforcement of China’s drug control laws at seaports, airports, and 

land border checkpoints. DEA officials told us they work with these agencies on 

investigations, information sharing, and drug control scheduling. DEA also exchanges law 

enforcement information with the Ministry of Public Security through the Bilateral Drug 

Intelligence Working Group. 

35Further, according to agency officials, DEA and Chinese officials have met regularly 

over the past year to discuss mutual interests and shared responsibilities in countering the 

threat from fentanyl-class substances. These discussions included exchanging information 

on emerging substances’ scientific data and trafficking trends, so that they may be 

considered for control in China. 
Page 26 GAO-18-205 Combating Synthetic Opioids

between the United States and foreign governments are an effective and 

cost efficient means to reduce the production of illegal drugs at their 

source and disrupt the movement of drugs in transit.

Several U.S. federal agencies reported collaboration with UNODC, INCB 

and the Commission on Narcotic Drugs (Commission) to place synthetic 

opioids and precursor chemicals and analogues under international 

control via international conventions.36 Further, these agencies reported 

that they collaborate with INCB to monitor United Nations member states’ 

compliance with international drug control conventions and prevent the 

diversion of legitimate chemicals into illicit traffic.

37 Agencies reported the 

following collaboration:

• State leads the U.S. delegation at annual sessions of the Commission 

during which participants consider and adopt resolutions to reduce the 

manufacture, distribution, and availability of illicit synthetic drugs and 

precursor chemicals. Officials told us that in response to the domestic 

opioid crisis, the U.S. delegation requested in 2016 that the United 

Nations Secretary-General initiate the process to consider two 

fentanyl precursor chemicals for international control. As a result, 

United Nations member states voted in favor of these controls at the 

Commission’s 2017 meeting as well as additional controls for a 

 

36UNODC supports member states, such as the United States, China, Canada, and 

Mexico, in their efforts against illicit drugs, crime, and terrorism by conducting research 

and engaging in capacity-building projects, among other things. The United States assists 

the Commission in fulfilling its mandates to monitor the world drug situation, develop 

strategies on international drug control, and recommend measures to address the world 

drug problem.

37The INCB is an independent, quasi-judicial expert body that, among other things, assists 

member states in monitoring the international trade of precursor chemicals and assesses 

chemicals used to make illicit drugs, to determine if they should be placed under 

international control. 

Federal Agencies 

Collaborate with 

International 

Organizations on Drug 

Control Scheduling and 

Information Sharing

International Drug Control 

Scheduling
Page 27 GAO-18-205 Combating Synthetic Opioids

synthetic opioid analogue.38 Multiple federal agencies told us they 

hope to schedule additional synthetic opioids at the Commission’s 

March 2018 meeting; for instance, State asserted that it would push 

for additional international controls on carfentanil at the 2018 meeting.

Federal agencies, such as FDA, DEA, and NIDA, also told us they 

provide information to the World Health Organization, upon request, 

regarding synthetic opioids.39 The World Health Organization uses 

this information to assess these drugs and make recommendations 

for international drug scheduling.

UNODC and INCB officials told us their collaboration with U.S. federal 

agencies on illicit synthetic opioids and their precursors has informed law 

enforcement work around the world and strengthened international 

information sharing, which has helped to build capacity to thwart the 

distribution of illicit drugs. Agencies reported the following collaboration:

• State provides funding to support the international detection and 

tracking of chemicals diverted from their lawful purpose to illicit drug 

traffic, according to INCB officials. INCB maintains multiple online 

platforms that facilitate communication on shipments and seizures of 

the chemicals, including those required for the manufacture of illicit 

synthetic opioids, such as fentanyl. INCB also facilitates contact 

between member states to further investigations involving these 

substances; for example, INCB officials told us they assisted DEA in a

2017 fentanyl seizure by connecting officials with their Hong Kong 

counterparts. According to INCB officials, State also provided funding 

in February 2017 to organize an international conference where 

participating countries, including the United States and China, 

discussed measures governments could take to prevent the diversion 

of precursor chemicals and address new psychoactive substances, 

such as fentanyl analogues.

 

38Generally, adopted changes are to be incorporated by member states—such as the

United States, China, Mexico, and Canada—within 180 days. However, according to 

INCB, countries often need more than 180 days to implement the changes. For example, 

China announced that scheduling controls on these two fentanyl precursor chemicals 

would take effect on February 1, 2018, after the Commission’s March 2017 meeting. In 

such instances, international drug conventions allow member states to apply a minimum 

set of control measures in the interim, to satisfy their treaty obligations.

39FDA coordinates data collection, including obtaining public comments, and submits this 

information to the World Health Organization. 

Information Sharing and 

Capacity Building
Page 28 GAO-18-205 Combating Synthetic Opioids

• State, DEA, and UNODC officials told us they provide technical 

assistance, training, and capacity building to help countries strengthen 

their law enforcement and judicial capacity to investigate and 

prosecute offenders before illicit drugs can reach the United States. 

For example, UNODC partners with U.S. federal agencies to train 

foreign law enforcement on identifying new psychoactive substances.

• Federal agencies, such as DEA, provide data to UNODC’s Global 

SMART (Synthetics Monitoring: Analyses, Reporting, and Trends) 

Program, which captures information on forensics, seizures, chemical 

names, consumption trends, and trafficking patterns. According to 

UNODC, this information informs the analysis of synthetic drugs, 

including opioids, in relevant publications such as its annual World 

Drug Report. Further, officials reported that DEA’s Special Testing 

and Research Laboratory and Office of Diversion Control have served 

as advisors for this program and participated in INCB task forces 

related to new psychoactive substances and precursor chemicals. 

DEA has also cooperated in related INCB-facilitated investigations; 

according to INCB, shared information and cooperation helps 

disseminate practices globally for preventing new psychoactive 

substances and precursor chemicals from reaching consumer 

markets.

• UNODC officials told us that NIDA provides funding support for 

international research on treatment standards. In addition, UNODC 

officials reported that they use SAMHSA tools to implement evidencebased practices in prevention and treatment. According to UNODC, 

these efforts inform proposed resolutions and recommendations at the 

Commission’s annual meetings.
Page 29 GAO-18-205 Combating Synthetic Opioids

Federal agencies have ongoing efforts to limit the domestic availability of 

synthetic opioids and to enhance their response to synthetic opioid 

threats. These efforts include: (1) modifying their approaches to 

investigating and prosecuting cases, (2) enhancing the targeting, 

interdiction, and seizure of illicit synthetic opioids, and (3) extending 

collaboration among law enforcement and public health officials to share 

information and data. However, federal agencies face continuing 

challenges and have opportunities to enhance the effectiveness of some 

of these efforts by better allocating resources and enhancing their use of 

data.

The current threat of synthetic opioids and the increase in overdose 

deaths has resulted in federal agencies modifying their approach to 

investigations and prosecutions of these cases, such as by reevaluating 

who they target, adjusting their investigation techniques, and 

consolidating resources. Federal agencies reported the following actions:

• According to officials, OCDETF has broadened its scope of targets to 

encompass the entire supply chain involved in opioid trafficking, due 

in part to an increased recognition that lower-level suppliers are 

integral to the causal chain of overdose deaths. To do this, they have 

deployed personnel and resources to support investigations and 

prosecutions of doctors, pharmacists, and other medical professionals 

who illegally divert prescription opioids. They have also targeted 

street-level and mid-level distributors, rather than focusing more 

heavily on traditional targets, such as cartels. Other federal law 

enforcement agencies have taken a similar approach (see fig. 5).

U.S. Agencies Have 

Modified Practices 

and Enhanced 

Coordination 

Domestically to Limit 

Illicit Synthetic 

Opioids, but Could 

Better Allocate 

Resources and 

Enhance Data Usage

U.S. Agencies Have 

Modified Investigative and 

Prosecutorial Practices 

Related to Illicit Opioids
Page 30 GAO-18-205 Combating Synthetic Opioids

Figure 5: Scope of Federal Law Enforcement Agencies’ Targets for Drug Investigations and Prosecutions

• FBI officials told us that because some drug trafficking has become 

internet-based, they have had to adjust their investigative approaches 

in such cases. Officials noted that numerous online vendors are taking 

advantage of technology to advertise fentanyl and other illicit 

substances while obfuscating identities and locations. FBI officials 

noted that online undercover operations and confidential informants 

must be used to make contact with these sellers and attempt to 

uncover their true identities and locations.

• In November 2017, the Attorney General and the Acting DEA 

Administrator announced the formation of a new DEA Field Division, 

based in Louisville, Kentucky, which will include Kentucky, 

Tennessee, and West Virginia.40 According to the Acting DEA 

Administrator, DEA anticipates that this consolidation of resources will 

 

40Prior to the addition of this field office, DEA had 21 field divisions. The addition of this 

field division is the first time a new field division has been added in 20 years. According to 

DEA officials, making this office a field division will better align DEA with the U.S. 

Attorney’s Office districts in those areas, similar to the current configuration of other 

agencies like FBI as well as the local HIDTA program. 
Page 31 GAO-18-205 Combating Synthetic Opioids

produce more effective investigations on heroin, fentanyl, and 

prescription opioid trafficking, as the move will unify drug trafficking 

investigations under a single Special Agent in Charge.

• Federal agencies have also coordinated to develop guidance to first 

responders for the safe handling of synthetic opioids during their 

investigations. In particular, the White House’s National Security 

Council convened a federal working group with the goal of identifying 

the most up-to-date scientific data regarding fentanyl, while taking into 

account the uncontrollable environment in which first responders 

operate. The group was comprised of law enforcement agencies, 

such as DEA, FBI, DHS, and USPIS, federal health agencies, such as 

CDC, the National Institute for Occupational Safety and Health

(NIOSH) and HHS, and others, such as ONDCP. It also sought the 

support of expert groups such as the American College of Medical 

Toxicology and those representing state and local law enforcement 

agencies, first responder groups, and health officials. Because of the 

working group’s efforts, the National Security Council issued new 

government-wide guidance in November 2017 to provide an 

authoritative source for safety recommendations for the first 

responder community. See appendix II for more information on this 

effort.

• Federal law enforcement is also changing the way that it approaches 

overdose deaths. According to some law enforcement officials we 

spoke with, prior to this change in approach, a law enforcement officer 

would respond to the scene of an overdose death by calling in the 

medical examiner or coroner’s office to remove the body, disposing of 

any drug paraphernalia, and completing an incident report. Now 

however, federal law enforcement agencies are increasingly treating 

such scenes like crime scene investigations where officers collect 

evidence to investigate and identify the source of the drugs involved. 

These agencies are also encouraging state and local law enforcement 

agencies to adopt the approach. According to the FBI, in Cleveland, 

Ohio, the USAO, along with state and local law enforcement 

agencies, the local medical examiner’s office, and the FBI combined 

to devise a coordinated law enforcement response to the heroin 

epidemic. These partners created the Heroin Involved Death 

Investigation Team, which responds to every heroin overdose in 

Cuyahoga County. The team members process the location as a 

crime scene, attempting to preserve all available evidence and 

interview as many witnesses as possible to help identify the source of 

the heroin. In addition, the DEA office in Manchester, New Hampshire 

and the New Hampshire Department of Justice have created business 

cards that law enforcement officers can carry in their pockets with 
Page 32 GAO-18-205 Combating Synthetic Opioids

detailed information and techniques on how to collect specific 

evidence at overdose death scenes (see fig. 6).

Figure 6: Examples of Investigative Approaches that Select Law Enforcement 

Agencies Encourage Agents to Use at Overdose Death Scenes

• Further, through OCDETF’s National Heroin/Opioid Initiative, federal 

prosecutors are encouraged to work not only with their component 

federal agencies, but also with state and local investigators, 

prosecutors, and teams in other jurisdictions to coordinate opioid 

investigations and bring prosecutions to the most appropriate judicial 

venues. For example, the USAO in North Dakota worked with local 

and state police, DEA, ICE-HSI, their OCDETF counterparts in 

Oregon, and law enforcement officials in Canada and China to 

respond to an overdose death of a teenager in Grand Forks, North 

Dakota. In doing so, they were able to follow the supply chain of the 

source drugs to Oregon, on to Canada, and ultimately to a Chinese 

opioid manufacturer.

Additionally, given the rise in deaths attributable to drug overdoses, 

officials from 8 of the 9 USAOs we spoke with are increasingly pursuing 

sentencing enhancements when charging drug suppliers in cases where 

drug distribution results in an overdose causing death or serious bodily 

injury to the user.41 Such enhancements carry a higher mandatory 

minimum sentence than charges for drug possession or distribution that 

does not cause death or serious injury. USAO representatives told us 

 

41A “sentencing enhancement” augments/increases a sentence or term of imprisonment 

that would be imposed for an underlying criminal act by adding time to the sentence or 

term of imprisonment under certain defined circumstances. For example, under 21 U.S.C. 

§§ 841(b)(1)(A)(vi), 841(b)(1)(B)(vi), individuals who distribute particular threshold 

amounts of fentanyl or certain fentanyl analogues are subject to mandatory-minimum 

penalties of 5 or 10 years in prison. If the distribution results in death or serious bodily 

injury, individuals are subject to enhanced mandatory-minimum penalties of at least 20 

years in prison. 
Page 33 GAO-18-205 Combating Synthetic Opioids

they are actively pursuing such enhancements for synthetic opioids cases 

if they can establish a link between an overdose death and the source of 

the drugs that caused the overdose.42 Some USAO officials told us that in 

the past, these types of charges were typically not pursued for 

prosecution because it can be difficult in drug cases to link the cause of 

death to a specific drug beyond a reasonable doubt. One of the reasons 

given by the USAOs with whom we spoke for why it is difficult to establish 

such a link is that the “cause of death” that prosecutors receive from 

medical examiners and coroners often cites more than one drug as the 

cause if multiple drugs were found in the system. This can make it difficult 

for prosecutors to make a case that a synthetic opioid like fentanyl was 

responsible for the death and not the other drugs identified through 

toxicology testing.

According to a medical examiner we spoke with, medical examiners and 

coroners may not always order toxicology tests for substances like 

fentanyl, and it is not always part of the typical battery of drugs included in 

the standard toxicology test. Some of the reasons for not testing for 

fentanyl identified by medical examiners and coroners with whom we 

spoke included the lack of resources to conduct such a test or that there 

was no indication at the time of an autopsy that a fentanyl test was 

needed. However, as overdose deaths continue to rise, medical 

examiners and coroners are starting to test for fentanyl and its analogues 

more frequently. For example, one medical examiner in New York City 

told us that, starting in July 2016, fentanyl has been routinely included in 

the toxicology tests that they perform. Additionally, some USAO officials 

told us that they are able to use expert witnesses, such as a medical 

examiner, coroner, or toxicologist during the trial to establish that the 

synthetic opioid was responsible for the death.

In addition to pursuing such charges, several of the representatives from 

the USAOs with whom we spoke indicated that the emergence of

synthetic opioids like fentanyl has caused them to reevaluate the typical 

criteria for which they would accept cases for prosecution based on the 

type of drug and the quantity seized. Specifically, some attorneys in the 

USAOs we spoke with are now using their discretion to prosecute 

fentanyl cases, even though such cases involve small quantities of the 

drug relative to other drugs like heroin or cocaine. In addition, given the 

 

42Representatives from the one USAO of the 9 we met with who were not pursuing 

homicide charges against suppliers of drugs who cause an overdose are from districts 

near the southwest border and told us that drug trafficking is their primary concern. 
Page 34 GAO-18-205 Combating Synthetic Opioids

ever-changing nature of synthetic drugs, attorneys in several of the 

USAOs we spoke with are increasingly relying on the Controlled 

Substances Analogue Enforcement Act of 1986, as amended, to 

prosecute cases involving analogues of controlled substances like 

fentanyl that are not currently scheduled.43 Further, in November 2017, 

the Attorney General directed each of the 93 U.S. Attorneys to designate 

an opioid coordinator to work with prosecutors and with federal, state, 

local, and tribal law enforcement to coordinate federal opioid prosecutions 

in every district.44

Federal agencies are working together to coordinate their efforts at the 

CBP’s National Targeting Center (NTC), express consignment carrier 

facilities, international mail facilities, and land ports of entry to enhance 

the targeting, interdiction (interception), and seizure of packages. 

Nevertheless, we found that CBP is not taking a risk-based approach to 

address the accumulating backlog of suspicious packages waiting for 

testing at some of its labs.

CBP’s NTC coordinates examination of cargo that may be connected to 

terrorism or other crimes, such as narcotics smuggling, human trafficking, 

merchandise counterfeiting, and money laundering. To do this, NTC 

identifies high-risk cargo destined for the United States prior to its arrival. 

For example, NTC uses a risk-based approach and various information 

sources to identify shipments that may contain illicit synthetic opioids. The 

NTC includes participants from across the federal government, such as 

ICE-HSI, FDA’s Office of Criminal Investigation, the USPIS, and FBI, and 

provides advance targeting and research for CBP field units. The NTC 

also works with the intelligence community, foreign counterparts, and 

investigative and law enforcement agencies. In addition, NTC is 

 

43See 21 U.S.C. § 813.

44The Attorney General’s directive required every U.S. Attorney to designate an Opioid 

Coordinator by the close of business on Dec. 15, 2017. Each USAO Opioid Coordinator is

responsible for facilitating intake of cases involving prescription opioids, heroin, and 

fentanyl; convening a task force of federal, state, local, and tribal law enforcement to 

identify opioid cases for federal prosecution, facilitate interdiction efforts, and tailoring his 

or her district’s response to the needs of the community it serves; providing legal advice 

and training to Assistant United States Attorneys regarding the prosecution of opioid 

offenses; maintaining statistics on the opioid prosecutions in the district; and developing 

and continually evaluating the effectiveness of the Office’s strategy to combat the opioid 

epidemic.

U.S. Agencies Have 

Enhanced Coordination to 

Limit Illicit Synthetic 

Opioids, but CBP’s 

Approach to Allocating 

Resources Has 

Weaknesses

Increasing Coordination at the 

National Targeting Center
Page 35 GAO-18-205 Combating Synthetic Opioids

increasing its coordination with other federal agencies, like USPS, as well 

as international partners such as customs officials from Canada. For 

example, according to USPIS officials, in September 2017, the agency 

placed an analyst with the narcotics section of the NTC and in January 

2018 placed an additional postal inspector at NTC to work with CBP on 

combating the synthetic opioid problem. Further, ICE-HSI officials told us 

in June 2017 that a Canadian customs official is posted at the NTC.

As we reported in August 2017, CBP works with express consignment 

operators, such as FedEx and UPS as well as the USPS, to inspect 

express cargo and inbound international mail.45 Express consignment 

operators are required to provide CBP with “electronic advance data” 

(EAD) —such as the sender’s and recipient’s name and address—for all 

inbound express cargo. According to officials from State and USPS, 

international postal arrangements and federal law currently do not require 

EAD for most mail, although specific bilateral agreements provide for it for 

a portion of the mail stream from some countries, including China.46

According to State, in October 2017, the Universal Postal Union adopted 

a global messaging standard for EAD for mail items between its 192 

participating countries.47 This step, combined with the earlier adoption of 

Universal Postal Union regulations governing the exchange of EAD, will 

enable the United States and other countries to begin to require EAD for 

mail from countries with the ability to provide it beginning in January 

2018. Nevertheless, according to officials from State, it will take several 

years for many countries to develop the capacity to provide this data. 

Because of the lack of EAD, CBP officials explained that the processing 

of inbound international mail is primarily manual and resource intensive, 

requiring CBP officers to sort through large bags or bins of parcels. For 

example, the international mail facility at John F. Kennedy International

Airport in New York receives hundreds of thousands of pieces of mail per 

day.

 

45GAO, International Mail Security: Costs and Benefits of Using Electronic Data to Screen 

Mail Need to Be Assessed, GAO-17-606, (Washington, D.C., August 2, 2017). 

46See Trade Act of 2002, Pub. L. No. 107-210, § 343, 116 Stat. 933, 981-83 (2002).

47The international movement of mail amongst member countries is governed under the 

Universal Postal Convention by the Universal Postal Union, a United Nations specialized 

agency with over 190 member countries. 

Implementing Pilots at 

International Mail Facilities
Page 36 GAO-18-205 Combating Synthetic Opioids

Figure 7: Inbound International Mail at the New York International Mail Facility

CBP and USPS jointly initiated two ongoing pilot programs at the 

international mail facilities at John F. Kennedy International Airport in New 

York (in November 2015) and at Los Angeles International Airport in 

California (in June 2017) to target mail for inspection using EAD received 

on inbound mail packages from two countries, including China. We 

previously examined these pilot programs and found that the agencies 

could improve implementation. Accordingly, we recommended in August 

2017 that CBP and USPS (1) establish measureable performance goals 

to assess the pilots and (2) evaluate the costs and benefits of using EAD 

to target mail for inspection compared with other targeting methods. Both 

CBP and USPS agreed with these recommendations and have begun 

taking steps to implement them. According to USPS officials, as of the 

end of 2017, the pilot program had been expanded to all five international 

mail facilities. Fully implementing our prior recommendations will position 

these agencies to assess the value of these pilots to their operations and 

make well-informed decisions in the management of these pilots in the 

future.

Federal agencies are assessing and deploying new drug detection 

technologies at land ports. For example, after completing a pilot study in 

2016 at the San Ysidro Port of Entry, CBP deployed two new detection 

devices, TruNarc and Gemini, at ports throughout the country. In addition, 

researchers at NIST published a study in June 2017 that assessed the 

Deploying and Advancing New 

Drug Detection Technologies 

at Land Ports
Page 37 GAO-18-205 Combating Synthetic Opioids

capabilities and sensitivities of existing technologies to detect trace 

amounts of fentanyl and 16 other analogues, including carfentanil, even 

when those substances were mixed with other drugs or adulterants, like 

caffeine. NIST researchers found that the existing technology was 

capable of presumptively identifying these substances in trace amounts, 

meaning that officers could detect the substance on the suspect’s hands 

or on the drug’s packaging without opening it—enhancing officer safety 

while providing them with information to begin an investigation without 

having to wait for results from laboratory analysis.

However, agency officials are aware that there are certain limitations in 

the available detection technologies, such as the inability to see through 

certain types of packaging and the challenges involved with maintaining 

up-to-date technology on the emerging drugs of concern. For example, 

the technology is limited by how extensive the “library” is, which includes 

all of the drug signatures that the technology can detect. Agencies like 

NIST, DEA’s Special Testing and Research Laboratory, and CBP’s 

Laboratories and Scientific Services Directorate (LSSD) are working to 

develop new data for the libraries of the various devices. These libraries 

contain drug-specific characteristics that can be used for drug 

identification and to deploy the information to manufacturers and forensic 

labs. Doing this will help keep their technology and testing methods up to 

date with emergent drug trends. In its final report, the President’s 

Commission acknowledged the importance of such technology and 

recommended that CBP and the USPIS use additional technologies and 

drug detection canines to expand efforts to intercept fentanyl and other 

synthetic opioids in envelopes and packages at international mail 

processing distribution centers. As of January 2018, CBP and USPIS 

were in the process of evaluating additional methods to detect fentanyl 

and other synthetic opioids and as of March 2018, CBP was deploying 

additional devices to aid in the detection of illicit items. In addition, 

according to CBP, by the end of March 2018, all of the agency’s canine 

teams will be trained to detect fentanyl.

According to CBP officials, as seizures have increased, so has the need 

for additional laboratory testing at LSSD to confirm the identity of the 

suspicious substances. When CBP interdicts a suspicious package at the 

port of entry, officers inspect its contents. They then can use detection 

technology to conduct a presumptive test to help them determine whether 

the package might contain illicit materials and therefore should be seized

or detained for further analysis. However, in order for law enforcement to 

be position to prosecute the case, CBP must also send the contents of 

the seized package to the laboratory for confirmatory testing (see fig. 10). 

CBP is Not Taking a RiskBased Approach to Allocating 

Laboratory Resources
Page 38 GAO-18-205 Combating Synthetic Opioids

Across the country, CBP has eight main laboratory facilities—each 

managed by a Director—and mobile units that can travel and deploy to 

provide “surge support,” bringing all the necessary personnel and 

equipment to the desired port of entry. Some of these mobile units have 

chemists that work at the port of entry full time and others have part-time 

chemists.

Figure 8: Customs and Border Protection’s (CBP) Process for Identifying Illicit Synthetic Opioids

a

In each instance, LSSD communicates testing results back to CBP officers at the ports of entry.

According to CBP LSSD officials, the recent surge in narcotics smuggling 

and interdictions of narcotics, including synthetic opioids is overwhelming 

the LSSD current capacity load, resulting in significant backlogs at all 

LSSD facilities. For example, according to CBP, CBP seizures of 

synthetic opioids alone increased from approximately 1 kilogram in fiscal 

year 2013 to nearly 90 kilograms in fiscal year 2015 and nearly 200 

kilograms in fiscal year 2016.
Page 39 GAO-18-205 Combating Synthetic Opioids

CBP officials at the ports told us that, depending on the level of support 

that they receive from LSSD, sometimes they can get testing results in 24 

hours and other times it can take months. For example, CBP officials 

have LSSD staff on-site full time at one international mail facility, which 

officials said allows them to receive test results back within 24 hours. 

Alternatively, CBP officials at another international mail facility told us that 

LSSD’s turnaround time for processing and testing samples is much 

longer. This facility receives hundreds of thousands of pieces of mail per 

day and about two-thirds of all international mail entering the United 

States. According to CBP officials there, it can take anywhere from weeks 

to months to receive testing results, as they only have laboratory staff onsite 2 days a month. While they wait on testing and for LSSD to report 

back on the parcel’s contents, CBP officials at that facility told us they 

cannot work with ICE-HSI in pursuing their investigations. They also 

stressed that the testing of these samples are holding up the delivery of 

packages that recipients are waiting to receive. This can affect USPS or 

express consignment carrier customer service and may affect the 

likelihood that a controlled delivery will result in an arrest. They explained 

that a delay in an investigation may prevent law enforcement officers from 

taking enforcement action, such as making an arrest. 

CBP LSSD officials told us they have taken steps to try and manage their 

backlog, such as limiting the number of samples that ports of entry can 

submit for testing per day, reassigning chemists working in other areas to 

work on narcotics cases or sending samples to labs with a lesser backlog 

to process.48 However, we found that CBP LSSD does not have a 

documented risk-based process in place to assess how best to allocate 

its limited staff in consideration of its volume. In particular, CBP LSSD 

officials acknowledge that they are not allocating their LSSD staff 

according to the volume at each port and the associated risk of the 

packages. Instead, CBP LSSD officials told us they prioritize lab work for 

those seizures that the officers believe are highly suspicious and whose 

testing (1) will lead to a controlled delivery, (2) confirms whether a person 

who is detained on account of the seizure can be released, or (3) will 

provide key information to assist an active investigation.49 Further, despite 

 

48According to LSSD officials, the limitations on the number of samples that ports of entry 

can submit for testing per day was removed in January 2018. 

49Law enforcement agencies use the technique of controlled delivery after they detect a 

package of illicit drugs. A law enforcement agency allows the package to go forward to its 

destination under the control and surveillance of law enforcement officers in order to 

secure evidence against the organizers of such illicit drug traffic.
Page 40 GAO-18-205 Combating Synthetic Opioids

communicating to us that this was how they prioritized lab work, officials 

could not provide documentation, such as an operational plan, that this 

was how they were making their day-to-day decisions. Moreover, despite 

the steps that LSSD has taken to attempt to better manage their 

backlogs, significant backlogs for laboratory testing continue to persist, 

which prevents law enforcement from taking the very actions that LSSD 

officials have stated influence how they prioritize their lab work.

CBP LSSD officials noted they face challenges retaining and recruiting 

chemists, such as the time it takes to conduct the necessary security 

clearances to bring a qualified candidate on board. They also said they 

have a limited budget to hire new chemists and noted that even if they 

were fully staffed at their authorized staffing levels, the backlogs and 

volume of incoming samples to test would still present ongoing 

challenges.50 Nevertheless, the officials could not provide evidence that 

they were making decisions to allocate positions and personnel across 

the labs in a way that accounted for factors such as the volume of the 

incoming packages and risk associated with these packages at each port.

The Office of Management and Budget’s guiding principles for risk 

analysis state that agencies should seek to compare risks to inform 

priority setting. Further, these principles state that agencies should set 

priorities for managing risks so that those actions resulting in the greatest 

net improvement are taken first, accounting for relevant management and 

social considerations. Given that officials told us that one of LSSD’s key 

priorities is to focus on cases that will result in controlled deliveries, it is 

critical for CBP to consider volume and risk when determining which ports 

have the highest need for laboratory staff allocations so that they can 

reduce the backlogs that are preventing such deliveries from occurring. 

Moreover, Standards for Internal Control in the Federal Government 

stress the importance of documenting internal controls to meet 

operational needs to ensure that controls are communicated to those 

responsible for executing those controls, and capable of being monitored 

 

50In February 2018, the President signed the International Narcotics Trafficking 

Emergency Response by Detecting Incoming Contraband with Technology (INTERDICT)

Act, Pub. L. No. 115-112, 131 Stat. 2274, which authorized $9,000,000 to be appropriated 

in additional funding to ensure CBP has resources, including chemical screening devices, 

personnel and scientists, available during all operational hours to prevent, detect, and 

interdict the unlawful importation of fentanyl, other synthetic opioids, and other narcotics 

and psychoactive substances. According to CBP officials, once funding is allocated and 

implementation takes place, these resources should help LSSD significantly reduce its 

backlog for drug analysis.
Page 41 GAO-18-205 Combating Synthetic Opioids

and evaluated. Such controls, in this case, could include documenting the 

key decisions and approaches in developing a risk-based approach to

prioritizing laboratory staff allocations. Comparing risks and volume 

across ports of entry, allocating laboratory resources accordingly, and 

documenting this process will help CBP ensure that LSSD’s priorities can 

be accomplished as effectively and efficiently as possible, particularly in 

light of historic backlogs, increasing demand for testing, and limited 

budgetary resources.

In response to the current threat of synthetic opioids, federal law 

enforcement agencies have recognized the importance of expanding their 

collaboration both within law enforcement, and to those in the public 

health sector. However, both law enforcement and public health officials 

we spoke with reported challenges with the timeliness, accuracy, and 

accessibility of overdose data.

Within law enforcement, federal law enforcement agencies have 

expanded collaboration by forming working groups and task forces 

dedicated to combating heroin and illicit fentanyl. For example, in 2014, 

DEA established the Heroin/Fentanyl Working Group, which includes 

federal agencies such as DOD, CBP, FBI, USPIS, and ICE-HSI. The 

group emphasizes the coordination of drug cases involving synthetic 

opioids, especially those involving major drug trafficking organizations 

that operate across jurisdictional boundaries on a regional, national, and 

international level. They also use various techniques to target these 

organizations to better understand how they operate and develop 

information that can be passed on to the field. In addition, in October 

2017, DEA established six enforcement teams—comprised of DEA 

agents and state and local task force officers—focused on combating the 

flow of heroin and illicit fentanyl that are based in communities facing 

significant challenges with heroin and fentanyl. Law enforcement 

agencies are also expanding their collaboration under HIDTA’s Heroin 

Response Strategy (HRS), which we discuss in more detail later in this 

report. For example, each HRS-participating HIDTA has a drug 

intelligence officer located in each state where the HIDTA operates to 

help share information across jurisdictions. The drug intelligence officers 

receive information about felony drug arrests from multiple sources and 

connect the arresting agency with appropriate in- and out-of-state law 

enforcement agencies.

Federal law enforcement agencies have also engaged more directly with 

public health agencies. For example, each HIDTA that participates in 

U.S. Law Enforcement 

and Public Health Officials 

Have Coordinated to 

Share Information, but 

Data Timeliness, Accuracy, 

and Accessibility Pose 

Challenges
Page 42 GAO-18-205 Combating Synthetic Opioids

HRS has public health analysts who are managed by the CDC and, 

according to ONDCP, tasked with enhancing the timeliness and accuracy 

of state drug use indicator data, such as data on overdose deaths and 

naloxone distribution. Many of these health analysts have been able to 

help agencies gain access to fatal and non-fatal overdose data and made 

use of data in innovative ways. For example, the Washington-Baltimore 

HIDTA has developed a new technology called ODMAP that provides 

real-time overdose surveillance data across jurisdictions to support public 

safety and health efforts to mobilize an immediate response to an 

overdose spike. It links first responders on the scene to a mapping tool to 

report overdoses that can then be tracked to stimulate a real-time 

response and strategic analysis across jurisdictions.

Despite such initiatives, each of the six HIDTAs we spoke with indicated 

that accessing and analyzing these data continue to pose challenges, a 

view also shared by nearly all of the law enforcement and public health 

officials with whom we spoke. In particular, officials cited timeliness, 

accuracy, and the accessibility of overdose-related data as their primary 

concerns.

Law enforcement and public health officials indicated that they have a 

need for fatal overdose death data to help them identify trends, but the 

lag in receiving it poses a challenge. Overdose data traditionally comes 

from the official cause of death listed on the death certificate that is 

prepared by medical examiners or coroners. However, toxicology test 

results can take months to obtain. For example, officials from the Ohio 

HIDTA told us that in cases where people die of overdoses at hospitals, 

the toxicology results can take 2 months or more to be completed. 

Therefore, it is very difficult for law enforcement and public health officials 

to have timely data on overdose deaths so they can anticipate and 

respond to emerging trends. 

Law enforcement and public health officials we spoke with also 

highlighted concerns with the accuracy of the overdose death data they 

receive. For example, some of the data may be incomplete because 

medical examiners and coroners may not always test for synthetic opioids 

like fentanyl in their toxicology tests. For example, an official from the 

Appalachia HIDTA told us that the underreporting of opioid-related 

overdoses is an ongoing challenge in the region because, in part, such 

tests are more often performed by local coroners, rather than by medical

examiners who have more training. An undercount of the number of 

overdose deaths attributable to synthetic opioids like fentanyl may affect 

the scope of law enforcement and public health officials’ response.

Timeliness

Accuracy
Page 43 GAO-18-205 Combating Synthetic Opioids

In addition to issues with the timeliness and accuracy of data, much of the 

relevant data for law enforcement and public health officials has legal 

restrictions for how it can be shared and analyzed to protect patient 

privacy. For example, by law, the New Hampshire Prescription Drug 

Monitoring Program may only provide information in the program to 

authorized law enforcement officials on a case-by-case basis for the 

purpose of investigation and prosecution of a criminal offense when 

presented with a court order based on probable cause.51 In addition, no 

law enforcement agency or official may have direct access to the 

program. DEA officials told us that obtaining such information is difficult 

and that as a result, law enforcement agencies have to resort to other 

means, such as conversations with pharmacists and treatment providers 

to get information needed to further their investigations.

Further, Massachusetts public health officials told us that, until recently, 

they had a limited understanding of the extent of the opioid problem in the 

state because relevant data sets like the state’s Prescription Drug 

Monitoring Program database and cause of death data were legally 

restricted from being shared. However, officials explained that the 

Massachusetts Legislature passed Chapter 55 of the Acts of 2015, which 

required the development of a statewide report on opioid trends, lifted 

many of the legal restrictions on data, and allowed different law 

enforcement and public health datasets to be analyzed together for the 

first time.52 As a result, a Massachusetts public health official told us that 

they were able to identify that cocaine users were overdosing on cocaine 

laced with fentanyl and planned to target these users with prevention and 

safe use messaging.

In addition, law enforcement and public health officials we spoke to 

indicated a need for data on non-fatal overdoses to help them identify and 

investigate the sources of these drugs in their communities and to be able 

to direct people to available drug treatment programs. They particularly 

noted that data of this kind would provide an early warning system for law 

enforcement and public health officials to anticipate and respond to 

emerging drug overdose trends. For example, a public health analyst 

 

51N.H. Rev. Stat. Ann. § 318-B:35. Prescription Drug Monitoring Programs are state-run 

databases that collect data about controlled substance prescriptions dispensed by 

pharmacies and doctors. These programs permit authorized users, including prescribers 

and dispensers, to monitor dispensing activity. In certain states, law enforcement officers 

may also seek and obtain authorization to access program data. 

522015 Mass. Adv. Legis. Serv. 55.

Accessibility
Page 44 GAO-18-205 Combating Synthetic Opioids

from the New England HIDTA told us that in Connecticut, officials are 

unable to estimate the number of non-fatal overdoses because of privacy 

restrictions on accessing the data. According to law enforcement officials,

when medical professionals typically treat a non-fatal overdose, the 

individual does not directly interact with law enforcement. As a result, 

those treatment encounters are never officially relayed to law 

enforcement because of patient protections embedded into laws like the 

federal Health Insurance Portability and Accountability Act (HIPAA).53

According to some law enforcement officials with whom we spoke, while 

HIPAA does have a law enforcement exemption if certain requirements 

are met, such as obtaining a court order, the requirements that must be 

met are an access challenge that hinders their investigations.

Agencies have taken some steps to improve the quality and timeliness of 

forensic science and medical examiner and coroner services, such as: 

• DOJ’s National Institute of Justice has a National Forensic Science 

Improvement Award grant program that can support data 

improvements. However, this funding program is not strictly dedicated 

to medical examiners and coroner services as the grant also provides 

funding to improve the quality and timeliness for all forensic science 

services.54 In fiscal year 2017, the agency awarded approximately 

$10.6 million to 62 grantees under this program.

• As of September 2017, CDC funded 32 states and the District of 

Columbia under the Enhanced State Opioid Overdose Surveillance 

program, which aims to improve the timeliness of reporting of both 

fatal and nonfatal overdoses. Also, through an expansion in funding 

for this program, all awarded states including the District of Columbia

will use the funding to directly support medical examiners and 

coroners, including for comprehensive toxicology testing.

 

53See 45 C.F.R. § 164.512(f). HIPAA established national standards for electronic health 

care transactions and national identifiers for providers, health insurance plans, and 

employers, and provided for the establishment of privacy and security standards for 

handling health information. Generally, HIPAA prohibits the release of information without 

the authorization of the patient except in specific situations identified in the regulations. 

54In 2017, the National Institute of Justice also initiated the Strengthening the Medical 

Examiner-Coroner System Program, a competitive grant program designed to support the 

enhancement of medicolegal death investigation services and increase the supply of 

forensic pathologists nationwide by supporting forensic pathology fellowships and 

providing resources necessary for medical examiner and coroner offices to achieve 

accreditation.
Page 45 GAO-18-205 Combating Synthetic Opioids

• In August 2017, CDC and the Association of State and Territorial 

Health Officials hosted a meeting regarding citing specific information 

about drugs on death certificates. According to CDC officials, this 

meeting brought together local, state, and federal stakeholders to 

create actionable priorities to improve drug specificity in the death 

certificate reporting.

• As reported in September 2016, CDC’s National Center for Health 

Statistics, the National Institutes of Health, and other federal agencies 

served on a committee under the auspices of the President’s National 

Science and Technology Council to address issues related to 

accessing and working with data that medical examiners and coroners 

provide during death investigations.55 The committee’s work was 

focused on death investigations overall, and not just on those 

attributable to overdoses, but the 12 recommendations it made in 

2016 have the potential to enhance the capacity and quality of the 

larger death investigation system that medical examiner and coroner 

offices, in part, support.

Standards for Internal Control in the Federal Government states that 

agencies should use quality information to make informed decisions and 

that quality information is appropriate, current, complete, accurate, 

accessible, and provided on a timely basis.56 While some efforts are 

newly underway, many federal, state, and local officials acknowledged to 

us the ongoing need for better data usage—for both fatal and non-fatal 

overdose cases. In particular, ONDCP officials told us that understanding 

and improving data collection activities related to the opioid epidemic 

remains important. Further, the President’s Commission identified a 

number of challenges in its 2017 report related to agencies having quality 

information and made a number of recommendations for ways to address 

 

55According to the Council’s report, “the nation’s approximately 2,400 medical-examiner 

and coroner (ME/C) jurisdictions investigate nearly 500,000 deaths each year and perform 

post-mortem examinations and/or autopsies to determine the cause and manner of death. 

While the function and organization of these offices vary by state, medical examiners and 

coroners typically investigate deaths that are sudden and unexpected, deaths that have 

no attending physician, and all suspicious or violent deaths. Strengthening the ME/C 

system is critical for improving the accuracy and reliability of these death investigations 

and will benefit public health and safety programs, law-enforcement investigations, and 

the development of interventions to prevent deaths nationwide.” See Executive Office of 

the President National Science and Technology Council, Strengthening The MedicolegalDeath-Investigation System: Improving Data Systems. (Washington, D.C., September 

2016).

56GAO, Standards for Internal Control in the Federal Government, GAO-14-704G, 

(Washington, D.C., September 2014). 
Page 46 GAO-18-205 Combating Synthetic Opioids

them. For example, the President’s Commission recommended, broadly, 

a federal effort to strengthen data collection activities. In its report, the

President’s Commission noted this would “enable real-time surveillance of 

the opioid crisis at the national, state, local, and tribal levels.” As of 

December 2017, the administration was still considering the these 

recommendations and how to address them.

As demonstrated through its management of programs like HIDTA’s HRS, 

an agency like ONDCP is uniquely positioned to collaborate with its law 

enforcement and public health counterparts to lead a specific review on 

ways to improve the timeliness, accuracy, and accessibility of fatal and 

non-fatal overdose data that provide critical information to understand and 

respond to the opioid epidemic. Such a review should expand on and 

leverage the findings from previous federal studies. It should also assess 

the benefits and scalability of ongoing efforts to leverage data systems, 

such as the Washington-Baltimore HIDTA’s ODMAP program, and 

examine ways in which laws that restrict access to public health data to 

protect patient privacy have exemptions for law enforcement entities that 

could be more widely leveraged while appropriately protecting patient 

privacy.

A number of federal agencies have documented specific strategies to 

combat illicit opioids.57 However, only three of the five strategies we 

assessed—ONDCP’s Heroin Availability Reduction Plan (HARP); 

HIDTA’s HRS; and DEA’s 360 Strategy—included performance measures 

to gauge the effectiveness of the efforts described in each strategy, and 

only HARP included outcome-oriented performance measures.

We have long reported on the importance of measuring program 

performance.58 Our prior reports and guidance have stated that 

performance measurement should evaluate both processes (outputs) and 

 

57None of the five strategies we reviewed are specifically focused on synthetic opioids but 

rather on the larger opioid issue, which includes heroin and often prescription opioids. 

According to ONDCP, this is because (1) synthetic opioids are often mixed in or sold as 

other opioids, (2) the same drug-trafficking organizations and trafficking routes are being 

utilized, and (3) federal agencies want to avoid responses to one type of opioid that 

inadvertently has a negative impact on another. For example, law enforcement would not 

want to focus all their enforcement efforts on reducing the availability of prescription 

opioids because it may cause people to seek out illicit drugs like heroin. 

58GAO-14-207; GAO-12-208G; GAO-11-646SP; and GAO/GGD-96-118. 

Many U.S. Agencies’ 

Documented Opioid 

Response Strategies 

Lack OutcomeOriented 

Performance 

Measures
Page 47 GAO-18-205 Combating Synthetic Opioids

outcomes related to program activities. Specifically, we have noted that 

output measures address the type or level of program activities 

conducted and the direct products or services delivered by a program, 

such as the number of presentations given, while outcome measures 

address the results of products and services, such as reductions in 

overdose deaths. Outcome measures can help in assessing the status of 

program operations, identifying areas that need improvement, and 

ensuring accountability for end results. Further, the Government 

Performance and Results Act Modernization Act of 2010 directs agencies 

to develop goals, as well as performance measures.59 Such measures 

provide federal agencies with information on how resources and efforts 

should be allocated to ensure effectiveness and keep program partners 

focused on the key goals of a program. Without specific goals and 

outcome-oriented performance measures, federal agencies will not be 

able to truly assess whether their respective investments and efforts are 

helping them achieve the goals set out in their strategies. Moreover, as 

stated in the final report of the President’s Commission, “if we are to 

invest in combating [the opioid] epidemic, we must invest in only those 

programs that achieve quantifiable goals and metrics.”60

ONDCP’s HARP, implemented in 2016, aims to provide a roadmap to 

guide and synchronize interagency activities, performed through 

ONDCP’s National Heroin Coordination Group, to reduce the supply of 

heroin, fentanyl, and fentanyl analogues in the U.S. market. The HARP is 

a 5-year plan, partitioned into 6 month time periods, focused on the 

following strategic end state goals:

1. A significant reduction in the number of heroin-involved deaths in the 

United States due to a disruption in the heroin and fentanyl supply 

chains;

2. A detectable decrease in the availability of those drugs in the U.S. 

market; and

3. [Agencies experiencing] the complementary effects of international 

engagement, law enforcement, and public health efforts.

Of the five federal opioid response strategies that we assessed, only 

ONDCP’s HARP contained goals with outcome-oriented performance 

 

59Pub. L. No. 111-352, 124 Stat. 3866 (2011).

60The President’s Commission on Combating Drug Addiction and the Opioid Crisis, Final 

Report, November 1, 2017.

ONDCP’s Heroin Availability 

Reduction Plan (HARP)
Page 48 GAO-18-205 Combating Synthetic Opioids

measures that aim to assess the effectiveness of these efforts. For 

example, for its first goal, the HARP includes an outcome-oriented 

measure related to the rate of heroin-involved overdose deaths that it 

tracks through the CDC’s cause of death data. In addition, officials 

acknowledged the difficulties in the timeliness of this data, which is 

released annually, and the strategy establishes incremental metrics that 

are based off state-level data that are released on a quarterly basis.

The HIDTA program’s HRS, started in August 2015, seeks to establish a 

cross-disciplinary initiative that brings public health and public safety 

partners together at the federal, state, and local level to reduce drug 

overdose fatalities and disrupt trafficking in illicit opioids.61 HRS sets out 

four overall goals that the participating HIDTAs should be working to:

1. Create and coordinate shared data regimes that allow public health, 

law enforcement, and others to respond quickly and effectively to the 

opioid overdose epidemic;

2. Develop and support strategic, evidence-based responses to 

generate immediate reductions in the number of overdose-related 

fatalities;

3. Promote and support efforts to prevent or reduce opioid misuse; and

4. Promote the active engagement of local communities in the 

discussion, planning, and implementation of HRS goals and activities.

HRS does include some output-oriented performance measures, such as 

the number of individuals referred to public health agencies for follow-up; 

however, HRS does not include any outcome-oriented performance 

measures. In the case of HRS, an example of an outcome-oriented 

performance measure that links closely to its current goals might be the 

number of overdose deaths.

According to ONDCP and HIDTA officials, it was not possible to set 

outcome-oriented performance measures for HRS because the program 

is funded through discretionary funds year-to-year and the funding stream 

is not guaranteed. However, given that the program competes for limited 

 

61Apart from HRS, the HIDTA program as a whole has output-oriented performance 

measures used to track the effectiveness of their efforts. For example, one of the HIDTA 

goals is to disrupt the market for illegal drugs by dismantling or disrupting drug trafficking 

and/or money laundering organizations. One measure that is used to assess effectiveness 

is to report on the return on investment based on the value of drugs, cash, and assets 

seized from these organizations. 

HIDTA’s Heroin Response 

Strategy (HRS)
Page 49 GAO-18-205 Combating Synthetic Opioids

discretionary funding, it is essential that HRS establish outcome-oriented 

performance measures so that HIDTA participants can demonstrate 

whether their goals are being achieved over time and that the program is 

a worthwhile investment. HIDTA officials also stated that outcomeoriented performance measures, such as reducing overdose deaths, 

require the collaboration and support of a variety of partners and HIDTA 

cannot direct their activities. Thus, HIDTA officials believe the measures 

that HRS has put into place are those that relate to activities for which 

HIDTA is directly responsible. While we acknowledge that it may be 

difficult to single out HIDTA’s contribution to these activities, the stated 

goals of HRS revolve around the collaboration between HIDTA and its 

partners. Therefore establishing outcome-oriented performance 

measures, such as the number of overdose deaths, would enhance 

HIDTAs’ ability to assess whether these collaborative efforts are 

producing intended results.

OCDETF’s National Heroin Initiative started in December 2014 with the 

goal of supporting local and regional initiatives to disrupt the flow of 

heroin into communities in every OCDETF region across the country. The 

initiative aims to bring together otherwise disparate agencies,

investigations, and information to develop a coordinated law enforcement 

action plan involving federal, state, tribal, and local authorities. The 

strategy outlines the mechanisms by which OCDETF will provide its field 

components with discrete amounts of operational funding.62 This funding 

supports the development of creative strategies and initiatives to identify 

and exploit the vulnerabilities of criminal organizations responsible for 

illegal trafficking of opioid drugs in the United States. The supporting

objectives to the goal include identifying, disrupting, and dismantling the 

most significant criminal organizations responsible for the manufacture 

and distribution of heroin intended for consumption in the United States, 

collecting intelligence, and facilitating law enforcement coordination, 

among others. The strategy does not include performance measures, 

outcome-oriented or otherwise, to assess progress specific to the 

National Heroin Initiative. However, the initiative does require each field 

component to submit quarterly reports detailing all of the relevant data 

that is pertinent to the area where they work. These reports include 

measures that OCDETF then uses to assess its overall performance, 

 

62OCDETF field components include members of federal, state, and local law 

enforcement agencies that are investigating and prosecuting OCDETF cases on the local 

level. 

OCDETF’s National Heroin 

Initiative
Page 50 GAO-18-205 Combating Synthetic Opioids

such as OCDETF conviction rates. Field components also participate in a 

conference call with other funded entities to share information.

According to the OCDETF Heroin Initiative Coordinator, each OCDETF 

field component operates in a district with unique needs and challenges 

and therefore there are not overarching performance measures, outcomeoriented or otherwise. However, without establishing outcome-oriented 

performance measures for the National Heroin Initiative, OCDETF is 

unable to fully determine whether the resource investment made into the 

initiative and participating field components achieves the initiative’s 

overall goals. In addition, establishing such outcome-oriented 

performance measures would allow OCDETF to compare the 

performance of participating field components to better understand which 

efforts are working well and what efforts may need additional attention.

In September 2016, the Attorney General announced the Department’s 

strategy to combat the opioid epidemic, which rested on three pillars: 

prevention, enforcement, and treatment. According to officials from the 

Office of the Deputy Attorney General, although this strategy started 

under the prior administration, it is still in effect and DOJ has expanded its 

opioid efforts in the new administration. In particular, in late December 

2017, the Attorney General announced the creation of a new senior-level 

position—the Director of Opioid Enforcement and Prevention Efforts 

within the Deputy Attorney General’s office. Once selected, the Director 

will be responsible for assisting the Attorney General, Deputy Attorney 

General, and department components in formulating and implementing 

DOJ initiatives, policies, grants, and programs related to opioids, and 

coordinating these efforts with law enforcement.

Nevertheless, we found that DOJ’s department-wide strategy does not 

outline goals or include outcome-oriented performance measures to 

assess the impact of their efforts. Accompanying the Attorney General’s 

announcement of the strategy was a memorandum from the Deputy 

Attorney General to all United States Attorneys directing them to draft a 

district-specific strategy to address the opioid epidemic that focuses on 

the same three pillars. Other than indicating that the district-specific 

strategies should focus on the three pillars, the Deputy Attorney General’s 

memorandum does not set out overall goals and performance measures 

that the districts should use to assess the effectiveness of their efforts, 

nor does it direct the Executive Office for the United States Attorneys 

DOJ and U.S. Attorneys 

Offices’ Strategies to Address 

the Opioid Epidemic
Page 51 GAO-18-205 Combating Synthetic Opioids

(EOUSA)—the office within DOJ that supports the USAOs nationwide—to 

do so.63

According to DOJ officials, developing goals and outcome-oriented 

performance measures, such as those related to drug trafficking or 

overdose rates, for their department-wide opioid strategy is difficult 

because the federal government still does not have a complete 

understanding of the opioid problem. From their perspective, the 

emergence of new opioid threats in recent years, such as new potent 

fentanyl analogues, pose unique challenges for the USAOs in identifying 

and prosecuting domestic and international supply sources, deterring 

trafficking, and preventing public harm. Further, they noted that the nature 

of the opioid problem varies among the 93 USAOs. However, without 

establishing goals and outcome-oriented performance measures as a 

means to assess the effectiveness of its strategy, it is difficult for DOJ to 

set a course for its efforts and understand whether the efforts the 

department is undertaking as a part of the strategy are having the 

intended impact. Further, establishing outcome-oriented performance 

measures for its efforts will provide DOJ a mechanism to better 

understand the opioid problem as it continues to progress and adjust its 

course, if needed, along the way.

DEA’s 360 Strategy was implemented in November 2015 with the intent 

to bring together three key DEA activities— enforcement operations, 

diversion control initiatives, and demand reduction efforts— under one 

strategy targeted toward opioids. The strategy is currently being rolled out 

in ten pilot areas throughout the United States, such as Milwaukee, 

Wisconsin and Manchester, New Hampshire on a 1 year, time-limited 

basis.

DEA’s 360 Strategy has three main goals:

1. Stopping the deadly cycle of heroin and opioid pill abuse by 

eliminating drug trafficking organizations and gangs fueling violence 

on the streets and cycles of addiction in our communities;

 

63In March 2017, EOUSA finalized a compilation report of all the individual strategies that 

each of the 93 USAOs had submitted. It distributed the report to every USAO, as well as 

to ONDCP, as a means to share promising practices on the unique efforts being taken at 

the local levels. 

DEA’s 360 Strategy

U.S. Drug Enforcement Administration 

360 Pilot Cities

1. Louisville, Kentucky

2. Milwaukee, Wisconsin

3. St. Louis, Missouri

4. Pittsburgh, Pennsylvania

5. Dayton, Ohio

6. Albuquerque, New Mexico

7. Charleston, West Virginia

8. Manchester, New Hampshire

9. South Jersey, New Jersey

10. Salt Lake City, Utah

Source: U.S. Drug Enforcement Administration. | 

GAO-18-205
Page 52 GAO-18-205 Combating Synthetic Opioids

2. Partnering with the medical community and others to raise awareness 

of the dangers of prescription opioid misuse and the link to heroin; 

and

3. Strengthening community organizations best positioned to provide 

long-term help and support for building drug-free communities.

DEA’s 360 Strategy includes output-oriented performance measures for 

these demand reduction efforts, which include measures such as the 

number of participants in its activities and the number of presentations 

given. However, the 360 Strategy does not include goals or outputoriented measures for the other two activities embodied in the strategy—

enforcement operations and diversion control initiatives—and does not 

include outcome-oriented measures for any of the three activities.

DEA has issued a solicitation for a Performance Analysis Pilot to assess 

the reach and impact of outreach activities in Milwaukee using the 

established performance measures and, according to DEA officials, the 

agency intends to deploy such assessments in other pilot locations 

contingent upon the availability of funding. However, given the lack of 

goals for two parts of the strategy as well as the lack of outcome-oriented 

performance measures in all three parts of the 360 Strategy, it is unclear 

the extent to which this pilot can accurately and fully gauge these efforts 

and their overall effectiveness. According to DEA officials, DEA did not 

establish outcome-oriented performance measures for the 360 Strategy, 

since it is a time-limited, 1-year project in each city, and outcomes, such 

as changes in drug use behavior, are difficult to measure and achieve 

over such a short period. Further, they believe that the output-oriented 

measures that are in place for the demand reduction activities position 

them to understand the reach and impact of their efforts, even though 

such measures do not speak to the results the strategy aims to achieve. 

Although DEA has set these pilot programs to be time-limited and 

measuring outcomes over a short period can be challenging, the 

programs these pilots develop are intended to be sustained in the 

communities once the official pilots are complete. Therefore, establishing 

goals and outcome-oriented performance measures for each of the three 

parts of the strategy at the pilot’s onset will better enable DEA officials to 

understand what they are trying to achieve and whether or not the 

activities they have included in their strategy are yielding desired results.

Further, having such measures at the pilot’s inception will position the 

local communities to be able to measure progress after the official pilots 

have ended.
Page 53 GAO-18-205 Combating Synthetic Opioids

As part of their response to the opioid epidemic, agency officials from 

DHS, DOJ, and ONDCP reported that they have generally continued their 

prevention efforts, and provided examples of expanded education 

campaigns in response to the synthetic opioid threat. Further, federal 

agencies reported providing additional funding for overdose reversal and 

treatment options, including distribution and use as well as efforts to 

improve their availability and effectiveness. Lastly, officials reported an 

increase in partnerships across federal, state, and local agencies and 

across education, public health, and law enforcement sectors to 

coordinate their responses to the growth in synthetic opioid use.

As the threat of synthetic opioids has grown more severe, officials have 

stressed the importance of researching what works in prevention efforts 

and applying the findings, expanding federal law enforcement agency 

community outreach, and engaging medical professionals on the subject

of addiction.

Officials with whom we spoke as well as previously issued federal agency 

reports stressed the importance of researching existing prevention 

programs to identify what works and replicating the effective programs 

across the country—particularly in light of the changing nature of drug 

use. For example, participants at a Comptroller General forum on 

preventing illicit drug use in June of 2016 stated that widely used 

programs like Drug Abuse Resistance Education (DARE) have not been 

proven effective.64 Instead, they noted that the research shows that 

programs in schools and community settings that focus more broadly on 

combating risky behaviors and strengthening family and community ties 

have greater benefits than those that are more narrowly targeted to 

warnings about specific drugs.65 Officials stated that since the main risk 

factors for substance use include impulsivity and high risk-taking, 

developing skills in youth to control their impulses and understand the 

 

64DARE is a school-based substance abuse prevention program taught to students in 

elementary school, middle school, and high school. A previous GAO report in 2003 

reviewed evaluations of DARE’s long-term effectiveness and found that there were no 

statistically significant differences in illicit drug use between students who received DARE 

lessons in the fifth or sixth grade and those who did not. See GAO, Youth Illicit Drug Use 

Prevention: DARE Long-Term Evaluations and Federal Efforts to Identify Effective 

Programs, GAO-03-172R (Washington, D.C.: Jan. 15, 2003)

65GAO, Highlights of a Forum: Preventing Illicit Drug Use, GAO-17-146SP (Washington, 

D.C.: Nov. 14, 2016) 

U.S. Agencies 

Adapted to the Opioid 

Epidemic by 

Expanding Education 

Campaigns, 

Treatment Options, 

and Partnerships

Prevention Efforts 

Researching What Works in 

Prevention Efforts
Page 54 GAO-18-205 Combating Synthetic Opioids

consequences of risk means that they can apply these skills in 

adolescence when opportunities to engage in substance abuse are more 

likely to present themselves.

The U.S. Surgeon General’s November 2016 report on addiction in 

America further emphasized that effective prevention programs can 

reduce substance misuse and related threats to public health by focusing 

on a skills-development approach.66 In addition, NIDA officials we spoke 

with affirmed this view, and described the funding NIDA provides to 

research and implement several evidence-based prevention programs 

that aim to enhance parenting skills and youth behavior management. 

These include the Nurse-Family Partnership, the Good Behavior Game, 

and the Strengthening Families Program.67

DOJ and HIDTA officials we spoke with acknowledged the importance of 

education campaigns, and described some of their locally based, 

expanded community outreach efforts. USAO District of New Hampshire 

officials stated that they have partnered with DEA as part of DEA’s 360 

Strategy to conduct outreach to schools in the 360 pilot communities. As 

part of these efforts, DEA’s Manchester field office hosted a youth summit 

with more than 8,500 youth in attendance and broadcast to over 35,000 

youth around the state. The summit included presentations by the 

Attorney General and families affected by opioid use about the impact of 

opioids and the need for prevention efforts.

Additionally, USAO Central District of California officials stated that they 

have focused on sending speakers to conduct trainings for college 

students about synthetic opioids and why they are a problem, how they 

differ from prescription drugs, and what to do in the event of an overdose. 

 

66U.S. Department of Health and Human Services (HHS), Office of the Surgeon General, 

Facing Addiction in America: The Surgeon General’s Report on Alcohol, Drugs, and 

Health. Washington, DC: HHS, November 2016.

67The Nurse-Family Partnership involves nurses providing home visitation interventions 

for at-risk, first-time mothers during pregnancy to provide ongoing education and support. 

It has shown significant reduction in the use of alcohol in teenagers compared to those 

who did not receive the intervention. The Good Behavior Game is a classroom behavior 

management program that rewards children for acting appropriately during instructional 

times. It significantly lowered rates of alcohol, other substance misuse, and substance use 

disorders in the children when they reached ages 19 to 21. The Strengthening Families 

Program consists of a seven-session, family-focused program to teach parenting skills 

and adolescent substance refusal skills. It was associated with reductions in tobacco, 

alcohol, and drug use up to 9 years after the intervention as well as reductions in 

prescription drug misuse up to 13 years afterwards.

Expanding Federal Law 

Enforcement Agency 

Community Outreach
Page 55 GAO-18-205 Combating Synthetic Opioids

District officials stated they have also previously sent speakers to the 

University of Southern California’s forensic social work school to discuss 

how to recognize signs of addiction and help drug users. Similarly, DEA 

makes a variety of resources about drug use publicly available. For 

example, their Get Smart About Drugs website includes information for 

parents, educators, and caregivers on how to identify illicit drugs and 

paraphernalia, emerging drug trends, and the health effects of drug use.

Several HIDTA officials also stated that they provide funding to local 

programs aimed at at-risk populations. For example, New York and New 

Jersey HIDTA officials reported that they provide funding to several 

prevention programs. These included Saturday Night Lights, a program 

that the Manhattan District Attorney initiated where local YMCAs provide 

coaches, sports programs, and a safe space for children on Saturday 

nights, and Harlem Children’s Zone, which provides a range of family 

services, social services, and health programs.68 Los Angeles HIDTA 

officials reported being part of the Safe Med LA coalition, which focuses

on reducing prescription drug misuse and overdose deaths. The coalition 

works on efforts ranging from community education, promoting 

medication-assisted treatment, safe drug disposal, and safe prescription 

practices for doctors.

Agency officials also emphasized the emerging need to better train and 

engage medical professionals in prevention efforts and explained their 

increasing role in this area. For example, in March 2016 the CDC 

developed and issued voluntary guidelines for primary care physicians 

prescribing opioids to patients with chronic pain.69 The CDC stated that, 

among other goals, it intends for the guidelines to help reduce the number 

of persons who develop opioid use disorder, overdose, or other adverse 

events related to opioids. CDC officials also reported that after releasing 

the guidelines, the agency has developed training materials on the topic, 

including several webinars. Approximately 60 medical schools have 

signed a pledge to incorporate the guidelines into their educational 

curriculums. According to CDC officials, they are also in the process of 

 

68The Harlem Children’s Zone is a non-profit organization that funds and operates a 

neighborhood-based system of education and social services for the children of lowincome families in Harlem, New York. 

69Deborah Dowell et al., CDC Guideline for Prescribing Opioids for Chronic Pain—United 

States, 2016, Morbidity and Mortality Weekly Report Recommendations and Reports 

(United States: Centers for Disease Control and Prevention, Mar. 18, 2016).

Engaging Medical 

Professionals in Prevention 

Efforts
Page 56 GAO-18-205 Combating Synthetic Opioids

developing more comprehensive training modules that will qualify as 

continuing education credits for physicians and nurses.

Additionally, New England HIDTA officials reported that they worked with 

public health officials in the region on the Safe and Competent Opioid 

Prescribing Education of Pain training program for physicians. This 

training includes material on how to assess patients’ risk of opioid misuse, 

how to distinguish drug-seeking behavior from pain, and how to educate 

patients on the risks of opioids. 

In response to the ongoing opioid epidemic, federal agencies reported 

providing funding for the distribution and use of naloxone and MAT 

services, as well as efforts to improve their availability and effectiveness. 

Officials also reported exploring vaccines to counteract opioid effects in 

the body.

Naloxone is an opioid antagonist that reverses overdoses by displacing 

opioids from receptors in the brain and blocking effects on breathing and 

heart rates.70 The FDA originally approved the drug in 1971 and it 

continues to be used for a variety of opioid overdoses, including illicit 

synthetic opioids. In 2015, DOJ’s Bureau of Justice Assistance developed 

a Law Enforcement Naloxone Toolkit, which was made available online 

for state, local, and tribal law enforcement agencies. The toolkit provides 

answers to frequently asked questions about naloxone and training 

materials about its use. Over the next 2 years, naloxone use was found to 

be widespread and support had built for its use among the public. In fact, 

the Network for Public Health Law (Network) reported in 2017 that all 50 

states and the District of Columbia had passed legislation to improve 

access to naloxone for laypeople.71 In addition, the Network reported that 

40 states and the District of Columbia had passed Good Samaritan laws 

that provide protection from arrest or prosecution for individuals who 

report overdoses in good faith. Further, officials with all six HIDTAs we 

interviewed reported efforts in their regions to improve the availability of 

naloxone to first responders or the public.

 

70The FDA has approved a nasal spray formulation of naloxone hydrochloride known as 

Narcan. For the purposes of this report, we will refer to the drug as naloxone in general.

71The Network for Public Health Law, Legal Interventions to Reduce Overdose Mortality: 

Naloxone Access and Overdose Good Samaritan Laws (Edina, MN: Robert Wood 

Johnson Foundation, 2017). 

Overdose Reversal and 

Treatment Options

Naloxone
Page 57 GAO-18-205 Combating Synthetic Opioids

HHS officials reported taking a number of actions that may improve the 

availability and effectiveness of naloxone and similar opioid antagonists. 

FDA officials stated that they have developed model labeling for a 

potential over-the-counter naloxone that can be sold without a 

prescription. They also noted that a formal research study is ongoing to 

determine whether consumers can comprehend that label and 

understand how to use naloxone in an emergency situation, without any 

help from a healthcare professional. They have also incentivized the 

development of new opioid overdose reversal treatments using the FDA’s 

expedited review program. For example, they approved both the first 

auto-injector of naloxone and a nasal spray formulation of naloxone under 

the program. Both FDA and NIDA officials reported that there may be a 

need for new drugs designed to treat overdoses resulting from highpotency opioids such as carfentanil. Naloxone can reverse carfentanil 

overdoses, but multiple doses may be required. FDA officials stated that 

they have contracted for a high-priority study of the relationship between 

the chemical structure of synthetic opioids and their effects in the body to 

better understand the requirements for reversing this type of overdose.

MAT services, though not specific to synthetic opioids, consist of a 

combination of medications and behavioral therapies that are used to 

treat substance use disorders. They have been shown to be more 

effective than abstinence-based treatments at reducing illicit drug use and 

overdose deaths, improving retention in treatment, and reducing HIV and 

hepatitis C transmission.72 Medications that the FDA currently approves 

for use in MAT include methadone, buprenorphine, and naltrexone.73

Examples of behavioral therapies include cognitive behavioral therapy 

and contingency management.74

 

72U.S. Department of Health and Human Services (HHS), Office of the Surgeon General, 

Facing Addiction in America: The Surgeon General’s Report on Alcohol, Drugs, and 

Health. Washington, DC: HHS, November 2016. 

73Methadone is an opioid agonist that helps prevent withdrawal symptoms during 

detoxification therapy and reduce cravings for opioids during maintenance therapy. 

Buprenorphine is also an opioid agonist that reduces or eliminates withdrawal symptoms 

and cravings for opioids. Naltrexone is an opioid antagonist that prevents opioids from 

binding to and activating opioid receptors. This blocks the effects on the user and is used 

to prevent relapses after detoxification therapy.

74Cognitive behavioral therapy involves modifying behaviors and improving coping skills 

by identifying and modifying dysfunctional thinking. Contingency management involves 

giving rewards to support positive behavioral changes. 

Medication-Assisted Treatment 

(MAT)
Page 58 GAO-18-205 Combating Synthetic Opioids

Prior GAO reports have highlighted that only a portion of individuals who 

need MAT are receiving it and federal agencies are seeking to expand its 

availability in response to the opioid epidemic.75 According to ONDCP 

officials, they have formed a MAT working group to raise awareness, 

increase support for MAT services for opioid users, and coordinate with 

SAMHSA and Bureau of Justice Assistance to introduce it as an option in 

drug court cases.76 SAMHSA officials stated that they provide funding 

through several programs that can be used to provide MAT services. One 

new source of funding is through the State Targeted Response to the 

Opioid Crisis grant program, which was authorized in the 21st Century 

Cures Act.77 Another funding source is the Medication Assisted Treatment 

– Prescription Drug and Opioid Addiction grant program. SAMHSA issues 

this funding to states to provide MAT and recovery support services to 

individuals with opioid use disorders. According to SAMHSA officials, 

there are currently 22 states receiving these funds. Officials reported that 

existing SAMSHA block grants to states might also be used for MAT 

services. 

NIDA officials also stated that they are providing funding for research 

projects related to MAT. These included projects supporting the 

development of specific new medications as well as basic medical 

research that contributes to the future development of new medications. 

NIDA officials stated that short-term projects include developing improved 

formulations of existing medications or different delivery methods. For 

example, they cited a formulation of buprenorphine that lasts for 6 months 

and is delivered through biodegradable implants. Of the three drugs 

approved for use in MAT, naltrexone has been available for the shortest 

amount of time. According to NIDA officials, the oral formulation of 

naltrexone has not been shown to be particularly effective at treating 

substance use disorders, but the 30-day injected formulation (XR-NTX) 

has evidence that it is effective at reducing opioid use. NIDA recently 

completed a comparison study of the effectiveness of a

 

75GAO, Opioid Use Disorders: HHS Needs Measures to Assess the Effectiveness of 

Efforts to Expand Access to Medication-Assisted Treatment, GAO-18-44 (Washington, 

D.C., Oct. 31, 2017). 

76Drug courts are designed to offer alternatives to adjudication or incarceration for criminal 

defendants with substance use disorders, generally requiring participating in substance 

use treatment programs and other social services. See GAO, Adult Drug Courts: Studies 

Show Courts Reduce Recidivism, but DOJ Could Enhance Future Performance Measure 

Revision Efforts, GAO-12-53 (Washington, D.C.: Dec. 9, 2011). 

77Pub. L. No. 114-255, § 1003, 130 Stat. 1033, 1044-1046 (2016).
Page 59 GAO-18-205 Combating Synthetic Opioids

buprenorphine/naloxone combination and extended release naltrexone 

that was published in November 2017 and demonstrated that, once 

initiated, the buprenorphine/naloxone combination and XR-NTX are 

equally safe and effective.78 The National Institutes of Health is also

establishing public–private partnerships with pharmaceutical companies 

to accelerate the development of medications to treat opioid addiction. 

Further, after two clinical studies, the FDA announced its approval on 

November 30, 2017 of Sublocade, the first once-monthly injectable 

buprenorphine that can reduce the burden of daily medication for some 

eligible patients as part of MAT.

In addition to funding for MAT-specific research, NIDA has also funded 

research into several opioid vaccines that attempt to counteract the 

effects of opioids in the body. NIDA officials stated that they have 

provided funding to develop a fentanyl vaccine, which is expected to enter 

primate testing in the fall of 2017 and, if successful, be ready for market in 

7 to 10 years. There are also heroin/HIV and oxycodone vaccines being 

developed, although they are both in the pre-clinical stages.79 FDA 

officials stated that they could not provide details on specific vaccines 

under development, but that these types of vaccines would be eligible for 

an expedited development process. 

Federal, state, and local agencies have reported enhancing older or more 

loosely coordinated public safety and public health partnerships. Two 

examples—the HIDTA program and the use of emergency declarations—

illustrate how these stronger partnerships have worked to better target 

prevention and treatment efforts in light of the emergence of synthetic 

opioids.

In the New York/New Jersey region, HIDTA officials stated that they 

participate in the RX Stat Initiative, which consists of regular monthly 

meetings between 44 federal, state, and local government agencies. 

HIDTA officials stated that the reason for RX Stat’s formation was to 

 

78Joshua D. Lee et al., “Comparative Effectiveness of Extended-Release Naltrexone 

Versus Buprenorphine-Naloxone for Opioid Relapse Prevention (X:BOT): A Multicentre,

Open-Label, Randomised Controlled Trial”, The Lancet, vol. 391, no. 10118 (January 

2018): 309-318, 27.

79C.R. Alving et al,, “Heroin-HIV-1 (H2) Vaccine: Induction of Dual Immunologic Effects 

with a Heroin Hapten-Conjugate and an HIV-1 Envelope V2 Peptide with Liposomal Lipid 

A as an Adjuvant” NPJ Vaccines (2017).

Opioid Vaccines

Partnerships

HIDTA Program
Page 60 GAO-18-205 Combating Synthetic Opioids

bridge the gap between public health agencies’ population-level view of 

the opioid problem and public safety agencies’ case-level view. 

Participants include DEA, the New York Office of the Chief Medical 

Examiner, the New York Police Department, and the New York Housing 

Department. HIDTA officials in the region reported that the initiative has 

been beneficial because it helped them understand the scope of the 

opioid abuse problem and target approaches in order to address it more 

effectively. The RX Stat Operations group has also helped by analyzing 

data on overdose victims, including information on their medical, criminal, 

and personal histories. This has allowed RX Stat participants to discuss 

strategies for preventing future overdoses. According to officials, the New 

York/New Jersey HIDTA is currently attempting to acquire more data on 

overdose deaths from the New York Fire Department as well as private 

ambulance companies for use in RX Stat analysis and discussion.

New England HIDTA officials stated that they began a partnership with 

the Massachusetts Department of Public Health under the HRS. Prior to 

the partnership, HIDTA officials reported that they had a more limited 

understanding of the public health consequences of the opioid epidemic 

in the region and what data was available. A Massachusetts public health 

official stated that the New England HIDTA has facilitated communication 

and information sharing in the region, and a public health analyst added 

that the New England HIDTA has facilitated aggregation of information on 

drug overdoses at the state level. As previously mentioned, the 

Massachusetts Department of Public Health is working on a data linkage 

project, called Chapter 55, which will link systems, including data on 

medical examiner toxicology reports, the state’s Prescription Drug 

Monitoring Program, and ambulance and paramedic reports. State and 

local law enforcement data are currently being added to the project. 

According to a Massachusetts public health official, the enhanced data 

allows the agency to identify populations at risk for opioid overdoses. For 

example, the agency previously received information on instances of 

cocaine laced with fentanyl, indicating that both heroin and cocaine users 

needed to receive information about the dangers posed by synthetic 

opioids.

Appalachia HIDTA officials stated that prior to their partnership efforts 

there was a lack of communication and information sharing between law 

enforcement agencies and medical organizations in the region, such as 

first responders and hospitals. They reported addressing this through 

collaboration with public health analysts who are co-located with DEA, 

FBI, National Guard, and the Kentucky State Police. Among other things, 

this partnership has enabled them to access hospital data more quickly 
Page 61 GAO-18-205 Combating Synthetic Opioids

than they had been able to previously. In another example, San DiegoImperial County HIDTA officials reported assigning public health analysts 

to law enforcement agencies in order to help direct individuals to 

treatment options. This partnership helped avoid potential repeat arrests 

of the same individuals, who had previously been cycling in and out of the 

criminal justice system for their drug use and addiction.

Officials in the New England HIDTA and San Diego-Imperial County 

HIDTA also cited the Police Assisted Addiction and Recovery Initiative 

program as an example of coordination between public health and public 

safety agencies in their regions. Under this program, drug users who ask 

for help at a police department are placed in a treatment program rather 

than in jail. This program also works to provide naloxone to police 

departments and overdose victims.

Another approach that demonstrates the gains from partnerships is the 

use of emergency declarations, which allow for centralized coordination of 

federal, state, and local agencies’ efforts in response to the impact of 

synthetic opioids and other drugs in certain states. According to the 

Association of State and Territorial Health Officials, as of January 2018, 

eight states have issued emergency declarations related to the opioid 

epidemic: Massachusetts, Virginia, Alaska, Maryland, Florida, Arizona, 

South Carolina, and Pennsylvania.80 The Alaska emergency declaration 

authorized the Commissioner and State Medical Officer of the Alaska 

Department of Health and Social Services to coordinate a statewide 

Overdose Response Program. The declaration also issued a standing 

order that allows local and regional overdose response programs, 

healthcare officials, first responders, and the public to dispense and 

administer naloxone. A follow-up administrative order directed the State 

Medical Officer to establish, coordinate, and manage an incident 

command structure to address the opioid epidemic. The Arizona 

emergency declaration required the Director of Arizona’s Department of 

Health Services to develop guidelines for healthcare providers on 

responsible prescribing practices, as well as to develop and provide 

training to local law enforcement agencies on protocols for carrying, 

handling, and administering naloxone for overdoses.

 

80The emergency declaration in Virginia was issued by the State Health Commissioner, 

who later clarified that it was not a Governor’s emergency declaration and does not have 

the force of law. However, it also included a standing order to state pharmacists allowing 

individuals to purchase naloxone without having to get a prescription.

Emergency Declarations
Page 62 GAO-18-205 Combating Synthetic Opioids

Officials with the Maryland Opioid Operational Command Center stated 

that the Governor of Maryland first engaged emergency managers about 

organizing coordinated efforts to address the opioid epidemic using 

FEMA’s National Incident Management System framework.81 The 

Governor subsequently declared a state of emergency in March 2017. 

According to Maryland officials, they are using a modified version of this 

framework because it is scalable and allows them to integrate state and 

local efforts. Maryland officials are also currently using the HIDTA 

program to help facilitate coordination because it already offers 

information sharing between public safety and public health agencies.

Maryland officials told us in the summer of 2017 that a federal emergency 

declaration would allow the federal government to centralize state efforts 

and address the opioid epidemic as a crisis. For example, it could allow 

the HHS Secretary to negotiate reduced pricing on naloxone for all 

government agencies. On July 31, 2017, the President’s Commission 

released an interim report that included a recommendation for the 

President to declare a national emergency under either the Public Health 

Service Act82 or the Stafford Act.83 On October 26, 2017, the President 

directed the Acting HHS Secretary to declare the drug demand and opioid 

crisis to be a public health emergency. The President also issued a 

memorandum to the heads of executive departments and agencies 

 

81According to FEMA, the National Incident Management System is intended to provide a 

consistent national framework and approach for governments, the private sector, and 

nongovernmental organizations to work together to respond to incidents regardless of the 

cause, size, location, or complexity. This allows them to integrate their efforts and 

establish a unified command.

82The Public Health Service Act, as amended, includes the ability for the HHS Secretary 

to declare a public health emergency presented by a disease or disorder, or by significant 

outbreaks of infectious disease or bioterrorist attacks. Among other things, the declaration 

allows the Secretary to respond to the emergency by making grants and entering 

contracts, accessing appropriated funds in the Public Health Emergency Fund, and 

waiving or modifying some requirements. Public health emergencies terminate when the 

HHS Secretary declares that the emergency no longer exists, or 90 days after the initial 

determination. The HHS Secretary may renew determinations. See 42 U.S.C § 247d.

83The Robert T. Stafford Disaster Relief and Emergency Assistance Act, Pub. L. No. 100-

707, 102 Stat. 4689 (1988), allows the President to declare an “emergency” or “major 

disaster.” “Emergencies” consist of “any occasion or instance for which, in the 

determination of the President, Federal assistance is needed to supplement State and 

local efforts and capabilities to save lives and to protect property and public health and 

safety, or to lessen or avert the threat of a catastrophe in any part of the United States.” In 

declared emergencies, the President may direct federal agencies to support state and 

local assistance efforts, coordinate disaster relief assistance, remove debris, and assist in 

distribution of supplies. See 42 U.S.C. §§ 5121-5206.
Page 63 GAO-18-205 Combating Synthetic Opioids

directing them to exercise all appropriate emergency authorities to reduce 

the number of deaths and minimize the devastation inflicted on American 

communities. That same day, the Acting HHS Secretary declared the 

public health emergency under the Public Health Service Act.84

While it is too soon to tell what specific actions will be taken in response 

to the public health emergency declaration, the President’s remarks 

mentioned several new measures that the administration plans to 

undertake, including:

• Removing a restriction on providing care at treatment facilities with 

more than 16 beds;85

• Implementing recommendations based on a review and evaluation of 

the President’s Commission final report;

• Developing and conducting an advertising campaign aimed at 

preventing people from initially using drugs.

In 2016, 19,413 Americans died from an overdose involving synthetic 

opioids. This was more than double the number in 2015 and a dramatic 

increase of over 525 percent from the 3,105 overdose deaths involving 

synthetic opioids in 2013. Combating this alarming trend is a governmentwide responsibility that requires contributions from departments and 

agencies working in a coordinated effort. While federal agencies have in 

many ways enhanced their approaches to limit the production, availability, 

and demand for potent synthetic opioids, further efforts are needed to 

assess the effectiveness of these approaches and to ensure that the 

invested resources are yielding intended results. In particular, better 

prioritizing investments in resources and staff that exist at many of CBP’s 

laboratories will help address backlogs and thus help law enforcement 

agencies better investigate and consider prosecution in drug-related 

cases. Moreover, embarking on a concerted effort to examine and 

address data related concerns, such as timeliness and accuracy, will 

allow law enforcement and public health agencies to better share 

information as they continue to understand and respond to the opioid 

 

84The Acting HHS Secretary renewed the October 26, 2017 determination on January 19, 

2018 for another 90-day period. 

85This would allow for state waivers of the “Institutes for Mental Diseases” exclusion, 

which prohibits federal Medicaid funds from being used to reimburse inpatient facilities 

with more than 16 beds that treat “mental diseases.” 

Conclusions
Page 64 GAO-18-205 Combating Synthetic Opioids

epidemic. Furthermore, establishing goals and outcome-oriented 

performance measures for some of the existing strategies will help 

agencies assess whether the resources they have invested in their efforts 

are yielding their intended results.

We are making a total of six recommendations, including one to CBP, two 

to ONDCP, one to OCDETF, one to DOJ, and one to DEA. Specifically:

We are making one recommendation to CBP:

The Commissioner of CBP should, in consultation with the Executive 

Director of CBP’s LSSD and the Laboratory Directors, assess volume 

and risk at each port of entry to determine those with the greatest 

need for resources, use this information as a basis for staff 

allocations, and document its risk-based, staff allocation process to 

ensure that CBP and LSSD priorities can be accomplished as 

effectively and efficiently as possible. (Recommendation 1)

We are making two recommendations to ONDCP:

The Director of ONDCP, in collaboration with law enforcement and 

public health counterparts, should lead a review on ways to improve 

the timeliness, accuracy, and accessibility of fatal and non-fatal 

overdose data from law enforcement and public health sources that 

provide critical information to understand and respond to the opioid 

epidemic. Such a review should expand on and leverage the findings 

from previous federal studies. It should also assess the benefits and 

scalability of ongoing efforts to leverage data systems, such as the 

Washington-Baltimore HIDTA’s OD MAP program, and examine ways 

in which laws that restrict access to public health data to protect 

patient privacy have exemptions for law enforcement entities that 

could be more widely leveraged while protecting patient privacy. 

(Recommendation 2)

The Director of ONDCP should work with the HIDTAs participating in 

the Heroin Response Strategy to establish outcome-oriented 

performance measures for the four main goals set out in the strategy. 

(Recommendation 3)

Recommendations for 

Executive Action
Page 65 GAO-18-205 Combating Synthetic Opioids

We are making one recommendation to OCDETF:

The Executive Director of OCDETF should work with the National 

Heroin Initiative Coordinator to establish outcome-oriented 

performance measures for the goals set out for National Heroin 

Initiative. (Recommendation 4)

We are making one recommendation to DOJ:

The Attorney General should, in consultation with its relevant 

components such as DEA and EOUSA, establish goals and outcomeoriented performance measures for its Strategy to Combat the Opioid 

Epidemic. (Recommendation 5)

We are making one recommendation to DEA:

The DEA Administrator should establish goals and outcome-oriented 

performance measures for the enforcement and diversion control 

activities within the 360 Strategy and establish outcome-oriented 

performance measures for the community engagement activities 

within the 360 Strategy. (Recommendation 6)

We provided a draft of this product to DHS, ONDCP, DOJ, Commerce, 

DOD, HHS, State, and USPS for comment. Each agency provided 

technical comments, which we incorporated as appropriate. DHS, 

ONDCP, and DOJ provided written comments which are reproduced in 

appendices III, IV, and V, respectively. In addition, we also obtained thirdparty comments from UNODC, INCB, and the ACMT, which we 

incorporated as appropriate. 

In its written comments, DHS concurred with our recommendation that 

CBP assess the volume and risk at each port of entry to determine those 

ports with the greatest need for laboratory resources, use this information 

as a basis for staff allocations, and document the process. Specifically, 

the Department stated that CBP plans to establish a working group to 

assess LSSD risk and resource allocations, analyze and assess its 

current program to support analysis and triage of suspected chemical 

parcels and determine whether the program can be expanded for 24/7 

operations. CBP plans to then finalize and implement any necessary 

changes to policies and procedures by the end of fiscal year 2018. 

Agency Comments, 

Third Party Views,

and Our Evaluation
Page 66 GAO-18-205 Combating Synthetic Opioids

In its written comments, ONDCP did not explicitly state whether it 

concurred with the two recommendations directed to the agency. 

However, ONDCP raised concerns but said it will take the 

recommendations under consideration. We first recommended that 

ONDCP lead a review on ways to improve the timeliness, accuracy and 

accessibility of overdose data from law enforcement and public health 

sources. In response, ONDCP stated that the agency already conducts 

activities where it brings together public health and public safety experts 

through its National Heroin Coordination Group to, among other things, 

share useful practices and relevant data. We agree that the National 

Heroin Coordination Group provides a mechanism to discuss these 

issues across the public health and public safety disciplines, which is 

consistent with its broad mission to lead interagency efforts to reduce the 

supply of heroin and fentanyl in the United States. However, the National 

Heroin Coordination Group and ONDCP have not taken action to 

specifically address our recommendation, which is focused on reviewing 

ways to improve overdose data in a more concerted manner. Further, 

ONDCP’s response did not address how the office is working to find ways 

to improve the timeliness, accuracy, and accessibility of data that provide 

critical information to understanding and responding to the opioid 

epidemic. During our review, the lack of timely, accurate, and accessible 

information was one of the most pervasive concerns we heard from the 

public health and law enforcement officials with whom we spoke. As we 

note in our report, ONDCP is uniquely positioned to bring together law 

enforcement and public health officials in a concerted effort to better 

understand the specific obstacles involved and how the federal 

government can work to improve national-level data and support the data 

improvement efforts occurring at the state and local levels. 

We also recommended that ONDCP coordinate with the HIDTAs 

participating in the Heroin Response Strategy (HRS) to establish 

outcome-oriented performance measures to assess progress towards the 

four main goals set out in the strategy. In its response, ONDCP stated 

that HRS’s output-oriented performance metrics comprise activities for 

which HIDTAs are directly responsible and HIDTAs cannot set 

performance metrics aimed at goals for which they are not solely 

responsible. We disagree. Because the stated goals of HRS revolve 

around the collaboration between HIDTA and its partners, establishing 

outcome-oriented performance measures, such as the number of 

overdose deaths, would enhance HIDTAs’ ability to assess whether these 

collaborative efforts are producing intended results. This is especially true 

because, as ONDCP notes in its response, the mission of the HRS is to 

reduce overdose deaths, so the agency should establish a way to track its 
Page 67 GAO-18-205 Combating Synthetic Opioids

progress in achieving this mission. Further, in its response, ONDCP 

states that “[s]olutions for ending this crisis can be enhanced by such 

information gathering, but cannot wait in the development and perfection 

of techniques before taking action.” Our draft report did not state that 

actions should cease while addressing our recommendations. We believe 

that ONDCP should continue to take action to address the synthetic 

opioid crisis while also developing performance measures to help ensure 

that the activities we highlight in our report are making progress toward 

the intended results. 

In its written comments, DOJ disagreed with our three recommendations 

related to the establishment of goals and/or outcome-oriented 

performance metrics for (1) OCDETF’s National Heroin Initiative, (2) the 

DOJ-wide opioid strategy, and (3) DEA’s 360 Strategy. In general, the 

Department stated that it is difficult to develop outcome-oriented 

performance measures because: 

• the opioid threat continues to emerge;

• the nature of the opioid threat varies amongst districts and cities;

and districts and cities have their own unique sets of risk and 

protective factors that contribute to and help mitigate local drug 

use;

• local sub-initiatives do not lend themselves to having long-term 

performance measures; and

• it is difficult to measure the success of any one strategy in 

isolation. 

While we acknowledge in our report that developing meaningful outcomeoriented performance measures can be challenging given the nature of 

the opioid threat, we also note that other agencies have been able to 

create such measures with success. For example, ONDCP’s Heroin 

Availability Reduction Plan includes an outcome-oriented measure related 

to the rate of heroin-involved overdose deaths. Furthermore, while we 

acknowledge in our report that it may be difficult to single out an individual 

agency’s contribution to these activities, we continue to believe that 

finding meaningful ways to measure any federal strategy designed to 

combat it is important, particularly because the threat is imminent and 

evolving. With a growing number of overdose deaths in recent years, 

establishing outcome-oriented performance measures for its efforts under 

the three strategies will help DOJ establish a baseline, chart its progress, 

and adjust its course as needed. Without goals and measures in place,

DOJ and its cognizant agencies will not have the information needed to 
Page 68 GAO-18-205 Combating Synthetic Opioids

assess whether the resources they have invested—and continue to 

invest—in these local efforts are yielding their intended results.

As agreed with your offices, unless you publicly announce the contents 

of this report earlier, we plan no further distribution until 14 days from the 

report date. At that time, we will send copies to the appropriate 

congressional committees and members, the Secretary of the 

Department of Homeland Security, the Director of the Office of National

Drug Control Policy, the Assistant Attorney General for Administration,

the Secretary of the Department of Commerce, the Secretary of the

Department of Defense, Secretary of the Department of Health and

Human Services, Secretary of the Department of State, and the

Postmaster General of the United States Postal Service, and other

interested parties. In addition, the report is available at no charge on the

GAO website at http://www.gao.gov. 

If you or your staff have any questions about this report, please contact 

me at (202) 512-8777 or maurerd@gao.gov. Contact points for our 

Offices of Congressional Relations and Public Affairs may be found on 

the last page of this report. GAO staff who made key contributions to this 

report are listed in appendix VI.

Diana Maurer, Director

Homeland Security and Justice Issues
Page 69 GAO-18-205 Combating Synthetic Opioids

List of Requesters

The Honorable Lamar Alexander

Chairman

The Honorable Patty Murray

Ranking Member

Committee on Health, Education, Labor, and Pensions

United States Senate

The Honorable Ron Johnson

Chairman

The Honorable Claire McCaskill

Ranking Member

Committee on Homeland Security and Governmental Affairs

United States Senate

The Honorable Rob Portman

Chairman

The Honorable Thomas Carper

Ranking Member

Permanent Subcommittee on Investigations

Committee on Homeland Security and Governmental Affairs

United States Senate

The Honorable Greg Walden

Chairman

The Honorable Frank Pallone, Jr.

Ranking Member

Committee on Energy and Commerce

House of Representatives

The Honorable Christopher Coons

United States Senate

The Honorable Bill Cassidy

United States Senate
Appendix I: Objectives, Scope, and 

Methodology

Page 70 GAO-18-205 Combating Synthetic Opioids

In this report, we examine how U.S. agencies:

1. work with international partners to limit the production of illicit 

synthetic opioids; 

2. work domestically to limit the availability of and enhance their 

response to illicit synthetic opioids and how they can improve the

effectiveness of their efforts;

3. measure performance in their documented opioid-response 

strategies; and

4. adapted their prevention and treatment approaches in light of the illicit 

synthetic opioid epidemic.

To understand how U.S. agencies work with international partners to limit 

the production of illicit synthetic opioids, we collected information from 

federal agencies that are engaged in foreign or domestic drug control 

activities, including the Department of Defense (DOD); Department of 

Justice (DOJ); the Department of State (State); and the Office of National 

Drug Control Policy (ONDCP). For example, we reviewed State’s 2017 

International Narcotics Control Strategy Report, the Drug Enforcement 

Administration’s (DEA) 2017 National Drug Threat Assessment; and 

ONDCP’s 2016 National Drug Control Strategy which helped explain 

bilateral and multilateral engagement on issues related to illicit synthetic 

opioids. To learn about federal efforts to engage with international 

organizations and foreign governments on efforts related to international 

drug control scheduling, information sharing, and capacity building, we 

interviewed officials from Department of Health and Human Services 

(HHS); the Department of Homeland Security (DHS); DOJ; State; and 

ONDCP. In addition, we interviewed officials from the United Nations 

Office on Drugs and Crime and the International Narcotics Control Board 

to learn about their functions and the role of these organizations in limiting 

the international production of these illicit substances. 

Further, we interviewed federal law enforcement officials from DEA, U.S. 

Customs and Border Protection (CBP), the Federal Bureau of 

Investigation (FBI), and U.S. Immigration and Customs EnforcementHomeland Security Investigations (ICE-HSI) stationed in Mexico, Canada, 

and China as well as DEA officials stationed in Hong Kong to understand 

their roles in those specific countries. This included their efforts to share 

information, coordinate investigations, encourage capacity building, and 

engage in drug scheduling with foreign counterparts as well as any 

challenges they may face operating in a foreign environment. We also 

interviewed officials from DEA, CBP, ICE-HSI, State, and the FBI located 

Appendix I: Objectives, Scope, and 

Methodology
Appendix I: Objectives, Scope, and 

Methodology

Page 71 GAO-18-205 Combating Synthetic Opioids

in the United States to learn more about their efforts with Mexico, 

Canada, and China. We focused our review on these three countries 

based on documentary and testimonial evidence provided by DHS, DOJ, 

and State, which showed that the majority of illicit synthetic opioids in the 

U.S. market are produced in China and either shipped directly into the 

United States or shipped into Mexico or Canada before being trafficked 

across the border. Finally, we coordinated with the inspector general (IG) 

offices at the relevant agencies and with the Supreme Audit Institutions of 

Mexico, Canada, and China to identify any past or ongoing related work 

related to the international production of illicit synthetic opioids.

To examine how U.S. agencies work domestically to limit the availability 

of and enhance their response to illicit synthetic opioids and how they can 

improve the effectiveness of their efforts, we reviewed a number of 

pertinent documents. These included federal agency guidance for first 

responders on the safe handling of fentanyl; DEA documents which aim 

to further understanding on the drug threat in the United States; and

ONDCP’s High Intensity Drug Trafficking Areas’ (HIDTA) Annual 

Performance Reports, which describe the actions each HIDTA—the 

organization tasked with coordinating efforts within the designated drug 

trafficking area—has undertaken.

Further, we interviewed cognizant federal law enforcement officials from 

DEA, CBP, ICE-HSI, and FBI—as well as officials from the DOD’s 

National Guard Counterdrug Program; the United States Postal Service

and the United States Postal Inspection Service; and ONDCP to 

understand their actions to reduce the availability of synthetic opioids 

domestically and how they coordinate with state and local law 

enforcement agencies and public health entities, such as medical 

examiners and coroners. We also interviewed federal officials working to 

test technologies to identify synthetic opioids, such as researchers from 

the Department of Commerce’s National Institute of Standards and 

Technology, and talked to experts from the American College of Medical 

Toxicology about the safe handling of synthetic opioids for first 

responders.

Additionally, we selected states to visit that (1) participate in federal drug 

control efforts, such as ONDCP’s HIDTA program, and (2) experience 

high rates of overdose deaths, based on data from the Centers for 

Disease Control and Prevention (CDC). These states included New York, 

New Jersey, Massachusetts, New Hampshire, Ohio, Kentucky, and 

Tennessee. While on-site, we interviewed state and local law 

enforcement and public health officials to understand the challenges they 
Appendix I: Objectives, Scope, and 

Methodology

Page 72 GAO-18-205 Combating Synthetic Opioids

were facing, the unique efforts in which they were engaged, and the 

nature and extent of their engagement with federal counterparts.

In addition, we interviewed representatives from the United States 

Attorney’s Offices (USAO) and HIDTAs with jurisdictions in the states to 

learn more about their engagement therein. Similarly, we visited 

California to learn about federal drug control efforts in relation to synthetic 

opioids and interviewed law enforcement officials from DEA, USAOs, 

CBP, and ICE-HSI—as well as HIDTA officials—to understand their 

actions to reduce the flow of illicit synthetic opioids coming across the 

southwest border and how they coordinate these efforts. While HIDTA 

officials stated that California does not experience high rates of overdose 

deaths attributable to synthetic opioids, other officials stated that drug 

trafficking organizations move illicit synthetic opioids from Mexico into 

California; we visited and interviewed officials at the San Ysidro Port of 

Entry to better understand these issues. Further, CBP conducted a pilot 

of drug detection technologies at the San Ysidro Port of Entry. Finally, we 

coordinated with the IG offices at the relevant federal and state audit 

offices to identify any past or ongoing related work related to the efforts to 

limit the domestic availability of illicit synthetic opioids.

To examine how U.S. agencies’ documented opioid-response strategies 

measure performance, we queried the federal agencies that are working 

to limit the domestic availability of synthetic opioids to identify any 

strategies that they had developed. We then reviewed the five federal 

opioid strategies that were identified to determine whether agencies had 

built-in measures to assess the effectiveness of their efforts. The 

Government Performance and Results Act Modernization Act of 2010 

requires that agencies establish goals and performance indicators to 

measure their progress in achieving agency objectives.

To determine how U.S. agencies have adapted their approaches to 

prevention and treatment in light of the illicit synthetic opioid epidemic, we 

reviewed documents on the types of prevention and treatment for opioid 

use, as well as related efforts by federal agencies. These included CDC’s

Guidelines for Prescribing Opioids for Chronic Pain; the Substance Abuse 

and Mental Health Services Administration’s (SAMHSA) Opioid Overdose 

Prevention Toolkit; ONDCP’s Heroin Response Strategy; the Surgeon 

General’s Report on Alcohol, Drugs, and Health; and prior work we 

issued related to illicit drug treatment and prevention. In addition, we 

interviewed officials at the CDC; the Food and Drug Administration; the 

National Institutes of Health’s National Institute on Drug Abuse; and 

SAMHSA about their agencies’ roles in preventing and treating opioid use 
Appendix I: Objectives, Scope, and 

Methodology

Page 73 GAO-18-205 Combating Synthetic Opioids

as well as what initiatives, if any, they have that are specifically related to 

synthetic opioids. In addition, we talked with academics we identified 

through their published research on opioid issues and with organizations 

that have provided technical assistance to federal agencies on drug 

prevention and treatment. In the states we selected for our visits, we 

interviewed state and local officials at public safety and public health 

agencies to collect information on their prevention and treatment efforts to 

address the opioid epidemic. Further, we interviewed regional HIDTA 

officials and participants, USAO district officials, and other key groups to 

better understand how federal, state, and local efforts have been 

coordinated across disciplines. We also attended the public sessions of 

the President’s Commission on Combating Drug Addiction and the Opioid 

Crisis and reviewed their reports and related documents. Finally, we 

coordinated with the IG offices at the relevant agencies to identify any 

past or ongoing related work related to opioid-related drug prevention and 

treatment programs.

We conducted this performance audit from January 2017 through March 

2018 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.
Appendix II: The Evolution of Federal 

Guidance for the Safe Handling of Synthetic 

Opioids for First Responders and Continuing 

Efforts to Enhance the Evidence Basis for Safe 

Handling Measures

Page 74 GAO-18-205 Combating Synthetic Opioids

Given the exceptional potency of synthetic opioids, law enforcement and public 

health officials have become increasingly concerned about the risks from potential 

exposures, such as breathing in minute quantities of synthetic opioids while 

responding to medical calls, crime scenes, or during drug raids. Federal agencies 

(e.g. the Drug Enforcement Administration (DEA) and the National Institute for 

Occupational Safety and Health (NIOSH) at the Centers for Disease Control and 

Prevention (CDC)); organizations (e.g. the Interagency Board1

); and expert groups 

(e.g. the American College of Medical Toxicology (ACMT) and American Academy of 

Clinical Toxicology (AACT)2

) have each developed written guidance and standard 

operating procedures that modified work practices for handling substances known or 

suspected to be fentanyl.3 However, the intended audience for the guidance, the 

approaches that these federal agencies used to develop the guidance, and the 

recommendations included in the guidance differed. According to the Office of 

National Drug Control Policy (ONDCP), these differences in various agencies’ 

guidance have resulted in confusion among the first responder community.

In part to address this confusion, during our review, the White House’s National 

Security Council (NSC) convened a federal working group with the goal of identifying 

the most up-to-date scientific data regarding fentanyl, while taking into account the 

uncontrollable environment in which first responders operate. The group was 

comprised of federal law enforcement agencies, such as DEA, the Federal Bureau of 

Investigation, the Department of Homeland Security, and the United States Postal 

Inspection Service, federal health agencies, such as CDC, NIOSH, and the 

Department of Health and Human Services (HHS), and others, such as ONDCP. It 

also sought the support of expert groups such as ACMT and those representing 

state and local law enforcement agencies, first responder groups, and health 

officials.

 

1

The Interagency Board is a voluntary collaborative panel of more than 150 emergency preparedness 

and response practitioners that represent federal, state, and local first responders from fire service, law 

enforcement, medical/health, and military sectors. 

2

The ACMT is a professional, nonprofit association of physicians with recognized expertise in medical 

toxicology—a medical subspecialty focusing on the diagnosis, management and prevention of 

poisoning and other adverse health effects due to medications, occupational and environmental toxins, 

and biological agents. The AACT is a non-profit multi-disciplinary organization that aims to unite

scientists and clinicians in the advancement of research, education, prevention and treatment of 

diseases caused by chemicals, drugs and toxins.

3

Other agencies, such as CBP and the U.S. Coast Guard, have also developed guidance for the safe 

handling of fentanyl; however, their guidance is largely based on those produced by DEA, with special 

processes that are agency-specific. 

Appendix II: The Evolution of Federal Guidance for 

the Safe Handling of Synthetic Opioids for First 

Responders and Continuing Efforts to Enhance 

the Evidence Basis for Safe Handling Measures
Appendix II: The Evolution of Federal 

Guidance for the Safe Handling of Synthetic 

Opioids for First Responders and Continuing 

Efforts to Enhance the Evidence Basis for Safe 

Handling Measures

Page 75 GAO-18-205 Combating Synthetic Opioids

Because of the working group’s efforts, the NSC issued new government-wide 

guidance in November 2017 to provide an authoritative source for safety 

recommendations for the first responder community. In particular, the guidance 

addresses: 

• the common ways that first responders may encounter fentanyl in the field;

• the basic personal protective equipment that can protect first responders from 

most encounters with fentanyl, such as nitrile gloves, NIOSH-approved respirator 

masks, and eye protection (see fig. 9);

• the symptoms of opioid exposure, such as slow breathing and drowsiness; and

• ways to respond to such exposure, such as by administering the opioid reversal 

medication naloxone.

Figure 9: Examples of Personal Protective Equipment Used to Respond to Most Fentanyl 

Encounters

Further, in cases where the level of exposure may be higher than the first responder 

may routinely encounter, such as at a location where fentanyl is being mixed with 

other drugs, it directs the reader to follow his or her agency guidelines. For example, 

DEA’s guidance notes that if someone encounters a situation of where the scene is 

highly contaminated from fentanyl, then he or she needs to wear a specialized fullbody suit with a self-contained breathing apparatus, such as a Level A suit (see fig.

10).
Appendix II: The Evolution of Federal 

Guidance for the Safe Handling of Synthetic 

Opioids for First Responders and Continuing 

Efforts to Enhance the Evidence Basis for Safe 

Handling Measures

Page 76 GAO-18-205 Combating Synthetic Opioids

Figure 10: Example of a Specialized Full-Body Suit Used to Respond to Scenes of Gross 

Fentanyl Contamination

According to ONDCP, the 2017 National Security Council guidance is now the 

standard, evidence-based federal government baseline for safe handling of fentanyl. 

ONDCP officials said they anticipate that this guidance could supersede federal 

agencies’ previously developed guidance and that agencies can add to the Council’s 

guidance as they see fit. The final report for the President’s Commission on 

Combating Drug Addiction and the Opioid Crisis, which was issued in November 

2017, recommended that the White House develop a national outreach plan for the 

Council’s guidance and that federal agencies should partner with states to develop 

and standardize data collection, analytics, and information-sharing related to first 

responder opioid-intoxication incidents. As of December 2017, the Administration 

has published the guidance on its website, and according to ONDCP officials, the 

participating agencies and stakeholder groups have shared the guidance. Further, 

according to ONDCP, a short instructional video on fentanyl handling is in 

development to maximize awareness across the first responder community.
Appendix II: The Evolution of Federal 

Guidance for the Safe Handling of Synthetic 

Opioids for First Responders and Continuing 

Efforts to Enhance the Evidence Basis for Safe 

Handling Measures

Page 77 GAO-18-205 Combating Synthetic Opioids

Although the NSC effort has resulted in the issuance of government-wide evidencebased guidance, the officials we spoke with whose agencies were involved in the 

effort acknowledged that the evidence base in this arena is still developing as the 

data regarding actual incidents of accidental exposure is somewhat limited. To 

address the data gaps, agencies like NIOSH are taking several steps. For example, 

NIOSH officials told us that they have spoken to dozens of law enforcement officers 

and emergency medical service providers at the state and local level to gather “real 

world” information needed to provide recommended protective measures. In addition, 

they stated that NIOSH partnered with HHS to gather news reports of potential 

exposure to law enforcement and emergency medical service providers and followed 

up on these reports to gather additional information.

According to the ACMT expert we spoke with, developing an evidence base to craft 

reasonable guidance for personal protective equipment could be done by collecting 

blood and urine samples from first responders who are believed to have had 

accidental exposure. The clinicians would then compare the results to the sample of 

the drug taken for testing by law enforcement. If the two matched, then it would be 

clear that the drug had permeated the first responder’s skin and bloodstream. These 

occupational exposure evaluations would also note the symptoms the first responder 

experienced and the circumstances of the exposure and analyze that information to 

look for common scenarios in which exposure caused harm. ACMT is encouraging 

this type of data collection and analysis among those working in emergency 

medicine and poison control centers.
Appendix III: Comments from the Department 

of Homeland Security

Page 78 GAO-18-205 Combating Synthetic Opioids

Appendix III: Comments from the 

Department of Homeland Security
Appendix III: Comments from the Department 

of Homeland Security

Page 79 GAO-18-205 Combating Synthetic Opioids
Appendix III: Comments from the Department 

of Homeland Security

Page 80 GAO-18-205 Combating Synthetic Opioids
Appendix IV: Comments from the Office of 

National Drug Control Policy

Page 81 GAO-18-205 Combating Synthetic Opioids

Appendix IV: Comments from the Office of 

National Drug Control Policy
Appendix IV: Comments from the Office of 

National Drug Control Policy

Page 82 GAO-18-205 Combating Synthetic Opioids
Appendix IV: Comments from the Office of 

National Drug Control Policy

Page 83 GAO-18-205 Combating Synthetic Opioids
Appendix V: Comments from the Department 

of Justice

Page 84 GAO-18-205 Combating Synthetic Opioids

Appendix V: Comments from the Department 

of Justice
Appendix V: Comments from the Department 

of Justice

Page 85 GAO-18-205 Combating Synthetic Opioids
Appendix V: Comments from the Department 

of Justice

Page 86 GAO-18-205 Combating Synthetic Opioids
Appendix V: Comments from the Department 

of Justice

Page 87 GAO-18-205 Combating Synthetic Opioids
Appendix VI: GAO Contact and Staff 

Acknowledgments 

Page 88 GAO-18-205 Combating Synthetic Opioids 

Diana Maurer, (202) 512-8777 or maurerd@gao.gov

In addition to the contact named above, Joy Booth (Assistant Director), 

Julia Vieweg (Analyst-in-Charge), Jane Eyre, Steve Komadina, Sylvia 

Bascope, and Mara McMillen made key contributions to this report. Willie 

Commons III, Dominick Dale, Eric Hauswirth, Amanda Miller, and 

Rebecca Parkhurst, also contributed to the work. 

Appendix VI: GAO Contact and Staff 

Acknowledgments 

GAO Contact 

Staff 

Acknowledgments 

(101357)
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