Report to Congressional Requesters

United States General Accounting Office 

GAO

December 2003 PRESCRIPTION 

DRUGS 

OxyContin Abuse and 

Diversion and Efforts 

to Address the 

Problem 

GAO-04-110 
www.gao.gov/cgi-bin/getrpt?GAO-04-110.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Marcia Crosse 

at (202) 512-7119. 

Highlights of GAO-04-110, a report to 

congressional requesters 

December 2003

PRESCRIPTION DRUGS 

OxyContin Abuse and Diversion and 

Efforts to Address the Problem 

Purdue conducted an extensive campaign to market and promote OxyContin 

using an expanded sales force to encourage physicians, including primary 

care specialists, to prescribe OxyContin not only for cancer pain but also as 

an initial opioid treatment for moderate-to-severe noncancer pain. 

OxyContin prescriptions, particularly those for noncancer pain, grew 

rapidly, and by 2003 nearly half of all OxyContin prescribers were primary 

care physicians. The Drug Enforcement Administration (DEA) has 

expressed concern that Purdue’s aggressive marketing of OxyContin focused 

on promoting the drug to treat a wide range of conditions to physicians who 

may not have been adequately trained in pain management. FDA has taken 

two actions against Purdue for OxyContin advertising violations. Further, 

Purdue did not submit an OxyContin promotional video for FDA review 

upon its initial use in 1998, as required by FDA regulations. 

Several factors may have contributed to the abuse and diversion of 

OxyContin. The active ingredient in OxyContin is twice as potent as 

morphine, which may have made it an attractive target for misuse. Further, 

the original label’s safety warning advising patients not to crush the tablets 

because of the possible rapid release of a potentially toxic amount of 

oxycodone may have inadvertently alerted abusers to methods for abuse. 

Moreover, the significant increase in OxyContin’s availability in the 

marketplace may have increased opportunities to obtain the drug illicitly in 

some states. Finally, the history of abuse and diversion of prescription 

drugs, including opioids, in some states may have predisposed certain areas 

to problems with OxyContin. However, GAO could not assess the 

relationship between the increased availability of OxyContin and locations 

of abuse and diversion because the data on abuse and diversion are not 

reliable, comprehensive, or timely. 

Federal and state agencies and Purdue have taken actions to address the 

abuse and diversion of OxyContin. FDA approved a stronger safety warning 

on OxyContin’s label. In addition, FDA and Purdue collaborated on a risk 

management plan to help detect and prevent OxyContin abuse and diversion,

an approach that was not used at the time OxyContin was approved. FDA 

plans to provide guidance to the pharmaceutical industry by September 2004 

on risk management plans, which are an optional feature of new drug 

applications. DEA has established a national action plan to prevent abuse 

and diversion of OxyContin. State agencies have investigated reports of 

abuse and diversion. In addition to developing a risk management plan, 

Purdue has initiated several OxyContin-related educational programs, taken 

disciplinary action against sales representatives who improperly promoted 

OxyContin, and referred physicians suspected of improper prescribing 

practices to the authorities. 

Amid heightened awareness that 

many patients with cancer and 

other chronic diseases suffer from 

undertreated pain, the Food and 

Drug Administration (FDA) 

approved Purdue Pharma’s 

controlled-release pain reliever 

OxyContin in 1995. Sales grew 

rapidly, and by 2001 OxyContin had 

become the most prescribed brandname narcotic medication for 

treating moderate-to-severe pain. 

In early 2000, reports began to 

surface about abuse and diversion 

for illicit use of OxyContin, which 

contains the opioid oxycodone. 

GAO was asked to examine 

concerns about these issues. 

Specifically, GAO reviewed (1) how 

OxyContin was marketed and 

promoted, (2) what factors 

contributed to the abuse and 

diversion of OxyContin, and 

(3) what actions have been taken to

address OxyContin abuse and 

diversion. 

To improve efforts to prevent or 

identify abuse and diversion of 

controlled substances such as 

OxyContin, FDA’s risk 

management plan guidance should 

encourage pharmaceutical 

manufacturers with new drug 

applications to submit plans that 

contain a strategy for identifying 

potential problems with abuse and 

diversion. FDA concurred with 

GAO’s recommendation. DEA 

agreed that such risk management 

plans are important, and Purdue 

stated that the report appeared to 

be fair and balanced. 
Page i GAO-04-110 OxyContin Abuse and Diversion 

Letter 1

Results in Brief 4

Background 7

Purdue Conducted an Extensive Campaign to Market and Promote 

OxyContin 16

Several Factors May Have Contributed to OxyContin Abuse and 

Diversion, but Relationship to Availability Cannot Be Assessed 29

Federal and State Agencies and Purdue Have Taken Actions to 

Prevent Abuse and Diversion of OxyContin 34

Conclusions 41

Recommendation for Executive Action 42

Agency and Purdue Comments and Our Evaluation 43

Appendix I Scope and Methodology 46 

Appendix II Summary of FDA Changes to the Original Approved 

OxyContin Label 48 

Appendix III Databases Used to Monitor Abuse and Diversion of 

OxyContin and Its Active Ingredient Oxycodone 51 

DAWN Data 51

NFLIS Data 51

STRIDE Data 52

National Survey on Drug Use and Health Data 52

Monitoring the Future Survey Data 52

Appendix IV Comments from the Food and Drug Administration 53 

Appendix V Comments from the Drug Enforcement 

Administration 56 

Contents 
Page ii GAO-04-110 OxyContin Abuse and Diversion 

Tables 

Table 1: Sales Representative Positions Available for OxyContin 

Promotion, 1996 through 2002 19

Table 2: Total OxyContin Sales and Prescriptions for 1996 through 

2002 with Percentage Increases from Year to Year 31

Table 3: Selected Language Approved by FDA in Warning Sections 

of OxyContin Labels, 1995 and 2001 35

Table 4: Selected Language Approved by FDA in the Indication 

Sections of OxyContin Labels, 1995 and 2001 35

Table 5: FDA Changes to the Original OxyContin Label Made from 

June 1996 through July 2001 48

Figure 

Figure 1: Promotional Spending for Three Opioid Analgesics in 

First 6 Years of Sales 22
Page iii GAO-04-110 OxyContin Abuse and Diversion 

Abbreviations 

DAWN Drug Abuse Warning Network 

DEA Drug Enforcement Administration 

FDA Food and Drug Administration 

FD&C Act Federal Food, Drug and Cosmetic Act 

HHS Department of Health and Human Services 

HIDTA High Intensity Drug Trafficking Area 

JCAHO Joint Commission on Accreditation of Healthcare 

 Organizations 

NFLIS National Forensic Laboratory Information System 

ONDCP Office of National Drug Control Policy 

PDUFA Prescription Drug User Fee Act of 1992 

PhRMA Pharmaceutical Research and Manufacturers of America 

RADARS Researched Abuse, Diversion, and Addiction-Related 

 Surveillance 

SAMHSA Substance Abuse and Mental Health Services 

 Administration 

STRIDE System to Retrieve Information from Drug Evidence 

WHO World Health Organization 

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. It may be reproduced and distributed in its entirety without further 

permission from GAO. However, because this work may contain copyrighted images or 

other material, permission from the copyright holder may be necessary if you wish to 

reproduce this material separately. 
Page 1 GAO-04-110 OxyContin Abuse and Diversion 

December 23, 2003 

The Honorable Frank R. Wolf 

Chairman 

Subcommittee on Commerce, Justice, State, and the Judiciary, 

 and Related Agencies 

Committee on Appropriations 

House of Representatives 

The Honorable James C. Greenwood 

Chairman 

Subcommittee on Oversight and Investigations 

Committee on Energy and Commerce 

House of Representatives 

The Honorable Harold Rogers 

House of Representatives 

Patients with cancer may suffer from fairly constant pain for months or 

years. Patients with other diseases or conditions, such as rheumatoid 

arthritis, osteoarthritis, chronic back pain, or sickle cell anemia, may also 

suffer from pain that lasts for extended periods of time. Since 1986, the 

World Health Organization (WHO) and others have reported that the 

inadequate treatment of cancer and noncancer pain is a serious public 

health concern. To address this concern, efforts have been made to better 

educate health care professionals on the need to improve the treatment of 

both cancer and noncancer pain, including the appropriate role of 

prescription drugs. 

Amid the heightened awareness that many people were suffering from 

undertreated pain, in 1995 the Food and Drug Administration (FDA) 

approved the new drug OxyContin, a controlled-release semisynthetic 

opioid analgesic manufactured by Purdue Pharma L.P.,1

 for the treatment 

of moderate-to-severe pain lasting more than a few days.2

 According to 

 1

OxyContin is an opioid analgesic—a narcotic substance that relieves a person’s pain 

without causing the loss of consciousness. Hereafter, we refer to the company as Purdue. 

2

As discussed later in this report, FDA approved the revised OxyContin label in July 2001 to 

describe the time frame as “when a continuous around-the-clock analgesic is needed for an 

extended period of time.” 

United States General Accounting Office 

Washington, DC 20548 
Page 2 GAO-04-110 OxyContin Abuse and Diversion 

Purdue, OxyContin provides patients with continuous relief from pain 

over a 12-hour period, reduces pain fluctuations, requires fewer daily 

doses to help patients adhere to their prescribed regimen more easily, 

allows them to sleep through the night, and allows a physician to increase 

the OxyContin dose for a patient as needed to relieve pain.3

 Sales of the 

drug increased rapidly following its introduction to the marketplace in 

1996. By 2001, sales had exceeded $1 billion annually, and OxyContin had 

become the most frequently prescribed brand-name narcotic medication 

for treating moderate-to-severe pain in the United States. 

In early 2000, media reports began to surface in several states that 

OxyContin was being abused—that is, used for nontherapeutic purposes 

or for purposes other than those for which it was prescribed—and illegally 

diverted.4

 According to FDA and the Drug Enforcement Administration 

(DEA), the abuse of OxyContin is associated with serious consequences, 

including addiction, overdose, and death.5

 When OxyContin was approved, 

the federal government classified it as a schedule II controlled substance 

under the Controlled Substances Act because it has a high potential for 

abuse and may lead to severe psychological or physical dependence.6

 DEA 

has characterized the pharmacological effects of OxyContin, and its active 

ingredient oxycodone, as similar to those of heroin. Media reports 

indicated that abusers were crushing OxyContin tablets and snorting the 

powder or dissolving it in water and injecting it to defeat the intended 

controlled-release effect of the drug and attain a “rush” or “high” through 

 3

According to FDA, there is no known limit to the amount of oxycodone, the active 

ingredient in OxyContin, that can be used to treat pain. 

4

Prescription drug diversion can involve such activities as “doctor shopping” by individuals 

who visit numerous physicians to obtain multiple prescriptions, prescription forgery, and 

pharmacy theft. Diversion can also involve illegal sales of prescription drugs by physicians, 

patients, or pharmacists, as well as obtaining controlled substances from Internet 

pharmacies without a valid prescription. 

5

According to the National Institute on Drug Abuse, addiction is a chronic, relapsing 

disease, characterized by compulsive drug seeking and use and by neurochemical and 

molecular changes in the brain, whereas physical dependence is an adaptive physiological 

state that can occur with regular drug use and results in withdrawal symptoms when drug 

use is discontinued. 

6

Under the Controlled Substances Act, which was enacted in 1970, drugs are classified as 

controlled substances and placed into one of five schedules based on their medicinal value, 

potential for abuse, and safety or dependence liability. Schedule I drugs have no medicinal 

value; have not been approved by FDA; and along with schedule II drugs, have the highest 

potential for abuse. Schedule II drugs have the highest potential for abuse of any approved 

drugs. 
Page 3 GAO-04-110 OxyContin Abuse and Diversion 

the body’s rapid absorption of oxycodone. During a December 2001 

congressional hearing, witnesses from DEA and other law enforcement 

officials from Kentucky, Virginia, and West Virginia described the growing 

problem of abuse and diversion of OxyContin.7

 Questions were raised 

about what factors may have caused the abuse and diversion, including 

whether Purdue’s efforts to market the drug may have contributed to the 

problem. In February 2002, another congressional hearing was conducted 

on federal, state, and local efforts to decrease the abuse and diversion of 

OxyContin.8

Because of your concerns about these issues, you asked us to examine the 

marketing and promotion of OxyContin and its abuse and diversion. 

Specifically, we addressed the following questions: 

1. How has Purdue marketed and promoted OxyContin? 

2. What factors contributed to the abuse and diversion of OxyContin? 

3. What actions have been taken to address OxyContin abuse and 

diversion? 

To identify how Purdue marketed and promoted OxyContin, we 

interviewed Purdue officials and analyzed company documents and data. 

We also interviewed selected Purdue sales representatives who were high 

and midrange sales performers during 2001 and physicians who were 

among the highest prescribers of OxyContin. To determine how Purdue’s 

marketing and promotion of OxyContin compared to that of other drugs, 

we examined the promotional materials and information related to FDA 

actions and interviewed officials from companies that manufacture and 

market three other opioid drugs, Avinza, Kadian, and Oramorph SR, that 

like OxyContin are classified as schedule II controlled substances.9

Because of their concern about the proprietary nature of the information, 

 7

OxyContin, Hearings of the Subcommittee on the Departments of Commerce, Justice, and 

State, the Judiciary, and Related Agencies, House Committee on Appropriations, 107th 

Cong. Part 10 (Dec. 11, 2001). 

8

OxyContin: Balancing Risks and Benefits, Hearing of the Senate Committee on Health, 

Education, Labor, and Pensions, 107th Cong. 287 (Feb. 12, 2002). 

9

Avinza was approved by FDA in 2002 and is marketed by Ligand Pharmaceuticals; Kadian 

was approved in 1996 and is marketed by Alpharma-US Human Pharmaceuticals; and 

Oramorph SR was approved in 1991 and is now owned by Élan Corporation, which told us 

it is not currently marketing the drug. 
Page 4 GAO-04-110 OxyContin Abuse and Diversion 

the three companies that market these drugs did not provide us with the 

same level of detail about the marketing and promotion of their drugs as 

did Purdue. We also examined data from DEA on promotional 

expenditures for OxyContin and two other schedule II controlled 

substances. To examine what factors may have contributed to the abuse 

and diversion of OxyContin, we interviewed officials from DEA, FDA, and 

Purdue and physicians who prescribe OxyContin. We also analyzed IMS 

Health data on sales of OxyContin nationwide and Purdue’s distribution of 

sales representatives, as part of an effort to compare the areas with large 

sales growth and more sales representatives per capita with the areas 

where abuse and diversion problems were identified. However, limitations 

on the abuse and diversion data prevented an assessment of the 

relationship between the availability of OxyContin and areas where the 

drug was abused or diverted. To determine what actions have been taken 

to address OxyContin abuse and diversion, we interviewed FDA officials 

and examined FDA information regarding the drug’s approval and 

marketing and promotion. We also interviewed DEA officials and 

examined how DEA determined the prevalence of OxyContin abuse and 

diversion nationally. In addition, we examined state efforts to identify 

those involved in the abuse and diversion of OxyContin. We also reviewed 

actions taken by Purdue to address this problem. (See app. I for a detailed 

discussion of our methodology.) 

We performed our work from August 2002 through October 2003, in 

accordance with generally accepted government auditing standards. 

Purdue conducted an extensive campaign to market and promote 

OxyContin using an expanded sales force and multiple promotional 

approaches to encourage physicians, including primary care specialists, to 

prescribe OxyContin as an initial opioid treatment for noncancer pain. 

OxyContin sales and prescriptions grew rapidly following its market 

introduction in 1996, with the growth in prescriptions for noncancer pain 

outpacing the growth in prescriptions for cancer pain from 1997 through 

2002. By 2003, nearly half of all OxyContin prescribers were primary care 

physicians. DEA has expressed concern that Purdue’s aggressive 

marketing of OxyContin focused on promoting the drug to treat a wide 

range of conditions to physicians who may not have been adequately 

trained in pain management. Purdue has been cited twice by FDA for using 

potentially false or misleading medical journal advertisements for 

OxyContin that violated the Federal Food, Drug and Cosmetic Act (FD&C 

Act), including one advertisement that failed to include warnings about the 

potentially fatal risks associated with OxyContin use. Further, Purdue did 

Results in Brief 
Page 5 GAO-04-110 OxyContin Abuse and Diversion 

not submit an OxyContin promotional video for FDA review at the time of 

its initial distribution in 1998, as required by FDA regulations. Therefore, 

FDA did not have the opportunity to review the video at the time of its 

distribution to ensure that the information it contained was truthful, 

balanced, and accurately communicated. FDA reviewed a similar video in 

2002 and told us that the video appeared to have made unsubstantiated 

claims about OxyContin and minimized its risks. 

Several factors may have contributed to OxyContin’s abuse and diversion. 

OxyContin’s controlled-release formulation, which made the drug 

beneficial for the relief of moderate-to-severe pain over an extended 

period of time, enabled the drug to contain more of the active ingredient 

oxycodone than other, non-controlled-release oxycodone-containing 

drugs. This feature may have made OxyContin an attractive target for 

abuse and diversion, according to DEA. OxyContin’s controlled-release 

formulation, which delayed the drug’s absorption, also led FDA to include 

language in the original label stating that OxyContin had a lower potential 

for abuse than other oxycodone products. FDA officials thought that the 

controlled-release feature would make the drug less attractive to abusers. 

However, FDA did not recognize that the drug could be dissolved in water 

and injected, which disrupted the controlled-release characteristics and 

created an immediate rush or high, thereby increasing the potential for 

abuse. In addition, the safety warning on the label that advised patients 

not to crush the tablets because a rapid release of a potentially toxic 

amount of the drug could result—a customary precaution for controlledrelease medications—may have inadvertently alerted abusers to a possible 

method for misusing the drug. The rapid growth in OxyContin sales, which 

increased the drug’s availability in the marketplace, may have made it 

easier for abusers to obtain the drug for illicit purposes. Further, some 

geographic areas have been shown to have a history of prescription drug 

abuse and diversion that may have predisposed some states to the abuse 

and diversion of OxyContin. However, we could not assess the 

relationship between the increased availability of OxyContin and locations 

where it is being abused and diverted because the data on abuse and 

diversion are not reliable, comprehensive, or timely. 

Since 2000, federal and state agencies and Purdue have taken several 

actions to try to address abuse and diversion of OxyContin. In July 2001, 

FDA approved a revised OxyContin label adding the highest level of safety 

warning that FDA can place on an approved drug product. The agency also 

collaborated with Purdue to develop and implement a risk management 

plan to help detect and prevent abuse and diversion of OxyContin. Risk 

management plans were not used at the time OxyContin was approved. 
Page 6 GAO-04-110 OxyContin Abuse and Diversion 

The plans are an optional feature of new drug applications that are 

intended to decrease product risks by using one or more interventions or 

tools beyond the approved product labeling. FDA plans to provide 

guidance on risk management plans to the pharmaceutical industry by 

September 2004. Also at the federal level, DEA initiated 257 OxyContinrelated abuse and diversion cases in fiscal years 2001 and 2002, which 

resulted in 302 arrests and about $1 million in fines. At the state level, 

Medicaid fraud control units have investigated OxyContin abuse and 

diversion; however, they do not maintain precise data on the number of 

investigations and enforcement actions completed. Similarly, state medical 

licensure boards have investigated complaints about physicians who were 

suspected of abuse and diversion of controlled substances, but they could 

not provide data on the number of investigations involving OxyContin. 

Purdue has initiated education programs and other activities for 

physicians, pharmacists, and the public to address OxyContin abuse and 

diversion. Purdue has also taken disciplinary action against its sales 

representatives who improperly promoted OxyContin and has referred 

physicians who were suspected of misprescribing OxyContin to the 

appropriate authorities. Although Purdue has used very specific 

information on physician prescribing practices to market and promote 

OxyContin since its approval, it was not until October 2002 that Purdue 

began to use this information and other indicators to identify patterns of 

prescribing that could point to possible improper sales representative 

promotion or physician abuse and diversion of OxyContin. 

To improve efforts to prevent or identify the abuse and diversion of 

schedule II controlled substances such as oxycodone, we recommend that 

FDA’s risk management plan guidance encourage the pharmaceutical 

manufacturers that submit new drug applications for these substances to 

include plans that contain a strategy for monitoring the use of these drugs 

and identifying potential abuse and diversion problems. 

We received comments on a draft of this report from FDA, DEA, and 

Purdue. FDA agreed with our recommendation that risk management 

plans for schedule II controlled substances contain a strategy for 

monitoring and identifying potential abuse and diversion problems. DEA 

reiterated its statement that Purdue’s aggressive marketing of OxyContin 

exacerbated the abuse and diversion problems and noted that it is 

essential that risk management plans be put in place prior to the 

introduction of controlled substances into the marketplace. Purdue said 

the report appeared to be fair and balanced, but that we should add the 

media as one of the factors contributing to abuse and diversion problems 
Page 7 GAO-04-110 OxyContin Abuse and Diversion 

with OxyContin. We incorporated their technical comments where 

appropriate. 

Ensuring that pharmaceuticals are available for those with legitimate 

medical need while combating the abuse and diversion of prescription 

drugs involves the efforts of both federal and state government agencies. 

Under the FD&C Act, FDA is responsible for ensuring that drugs are safe 

and effective before they are available in the marketplace. The Controlled 

Substances Act,10 which is administered by DEA, provides the legal 

framework for the federal government’s oversight of the manufacture and 

wholesale distribution of controlled substances, that is, drugs and other 

chemicals that have a potential for abuse. The states address certain issues 

involving controlled substances through their own controlled substances 

acts and their regulation of the practice of medicine and pharmacy. In 

response to concerns about the influence of pharmaceutical marketing 

and promotional activities on physician prescribing practices, both the 

pharmaceutical industry and the Department of Health and Human 

Services’s (HHS) Office of Inspector General have issued voluntary 

guidelines on appropriate marketing and promotion of prescription drugs. 

As the incidence and prevalence of painful diseases have grown along with 

the aging of the population, there has been a growing acknowledgment of 

the importance of providing effective pain relief. Pain can be characterized 

in terms of intensity—mild to severe—and duration—acute (sudden onset) 

or chronic (long term). The appropriate medical treatment varies 

according to these two dimensions. 

In 1986, WHO determined that cancer pain could be relieved in most if not 

all patients, and it encouraged physicians to prescribe opioid analgesics. 

WHO developed a three-step analgesic ladder as a practice guideline to 

provide a sequential use of different drugs for cancer pain management. 

For the first pain step, treatment with nonopioid analgesics, such as 

aspirin or ibuprofen, is recommended. If pain is not relieved, then an 

opioid such as codeine should be used for mild-to-moderate pain as the 

second step. For the third step—moderate-to-severe pain—opioids such as 

morphine should be used. 

 10Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (Pub. L. No. 

91-513, §§100 et seq., 84 Stat. 1236, 1242 et seq.). 

Background 

Medical Treatment of Pain 
Page 8 GAO-04-110 OxyContin Abuse and Diversion 

Beginning in the mid-1990s, various national pain-related organizations 

issued pain treatment and management guidelines, which included the use 

of opioid analgesics in treating both cancer and noncancer pain. In 1995, 

the American Pain Society recommended that pain should be treated as 

the fifth vital sign11 to ensure that it would become common practice for 

health care providers to ask about pain when conducting patient 

evaluations. The practice guidelines issued by the Agency for Health Care 

Policy and Research provided physicians and other health care 

professionals with information on the management of acute pain in 1992 

and cancer pain in 1994, respectively.12 Health care providers and hospitals 

were further required to ensure that their patients received appropriate 

pain treatment when the Joint Commission on Accreditation of Healthcare 

Organizations (JCAHO), a national health care facility standards-setting 

and accrediting body, implemented its pain standards for hospital 

accreditation in 2001. 

OxyContin, a schedule II drug manufactured by Purdue Pharma L.P., was 

approved by FDA in 1995 for the treatment of moderate-to-severe pain 

lasting more than a few days, as indicated in the original label.13 OxyContin 

followed Purdue’s older product, MS Contin, a morphine-based product 

that was approved in 1984 for a similar intensity and duration of pain and 

during its early years of marketing was promoted for the treatment of 

cancer pain. The active ingredient in OxyContin tablets is oxycodone, a 

compound that is similar to morphine and is also found in oxycodonecombination pain relief drugs such as Percocet, Percodan, and Tylox. 

Because of its controlled-release property, OxyContin contains more 

active ingredient and needs to be taken less often (twice a day) than these 

 11The other four vital signs physicians use to assess patients are pulse, blood pressure, core 

temperature, and respiration. 

12In 1999, the name of the Agency for Health Care Policy and Research was changed to the 

Agency for Healthcare Research and Quality. The agency, which is part of HHS, is 

responsible for supporting research designed to improve the quality of health care, reduce 

its costs, and broaden access to essential services. 

13When we refer to OxyContin’s label we are also referring to the drug’s package insert that 

contains the same information about the product. 

OxyContin 
Page 9 GAO-04-110 OxyContin Abuse and Diversion 

other oxycodone-containing drugs.14 The OxyContin label originally 

approved by FDA indicated that the controlled-release characteristics of 

OxyContin were believed to reduce its potential for abuse. The label also 

contained a warning that OxyContin tablets were to be swallowed whole, 

and were not to be broken, chewed, or crushed because this could lead to 

the rapid release and absorption of a potentially toxic dose of oxycodone. 

Such a safety warning is customary for schedule II controlled-release 

medications. FDA first approved the marketing and use of OxyContin in 

10-, 20-, and 40-milligram controlled-release tablets. FDA later approved 

80- and 160-milligram controlled-release tablets for use by patients who 

were already taking opioids.15 In July 2001, FDA approved the revised label 

to state that the drug is approved for the treatment of moderate-to-severe 

pain in patients who require “a continuous around-the-clock analgesic for 

an extended period of time.” (See app. II for a summary of the changes 

that were made by FDA to the original OxyContin label.) 

OxyContin sales and prescriptions grew rapidly following its market 

introduction in 1996. Fortuitous timing may have contributed to this 

growth, as the launching of the drug occurred during the national focus on 

the inadequacy of patient pain treatment and management. In 1997, 

OxyContin’s sales and prescriptions began increasing significantly, and 

they continued to increase through 2002. In both 2001 and 2002, 

OxyContin’s sales exceeded $1 billion, and prescriptions were over 7 

million. The drug became Purdue’s main product, accounting for 90 

percent of the company’s total prescription sales by 2001. 

Media reports of OxyContin abuse and diversion began to surface in 2000. 

These reports first appeared in rural areas of some states, generally in the 

Appalachian region, and continued to spread to other rural areas and 

larger cities in several states. Rural communities in Maine, Kentucky, Ohio, 

Pennsylvania, Virginia, and West Virginia were reportedly being devastated 

by the abuse and diversion of OxyContin. For example, media reports told 

of persons and communities that had been adversely affected by the rise of 

addiction and deaths related to OxyContin. One report noted that drug 

 14For example, according to Purdue’s comparable dose guide a patient taking one Percodan 

4.5-milligram tablet or one Tylox 5-milligram tablet every 6 hours can be converted to 

either a 10- or a 20-milligram OxyContin tablet to be taken every 12 hours. For a 12-hour 

dosing period, one OxyContin tablet replaces two Percodan or Tylox tablets, and one 

OxyContin tablet contains twice as much oxycodone as one of the other tablets. 

15In April 2001, Purdue discontinued distribution of the 160-milligram tablets because of 

OxyContin abuse and diversion concerns. 
Page 10 GAO-04-110 OxyContin Abuse and Diversion 

treatment centers and emergency rooms in a particular area were 

receiving new patients who were addicted to OxyContin as early as 1999. 

Pain patients, teens, and recreational drug users who had abused 

OxyContin reportedly entered drug treatment centers sweating and 

vomiting from withdrawal. In West Virginia, as many as one-half of the 

approximately 300 patients admitted to a drug treatment clinic in 2000 

were treated for OxyContin addiction. The media also reported on deaths 

due to OxyContin. For example, a newspaper’s investigation of autopsy 

reports involving oxycodone-related deaths found that OxyContin had 

been involved in over 200 overdose deaths in Florida since 2000.16 In 

another case, a forensic toxicologist commented that he had reviewed a 

number of fatal overdose cases in which individuals took a large dose of 

OxyContin, in combination with alcohol or other drugs. 

After learning about the initial reports of abuse and diversion of 

OxyContin in Maine in 2000, Purdue formed a response team made up of 

its top executives and physicians to initiate meetings with federal and 

state officials in Maine to gain an understanding of the scope of the 

problem and to devise strategies for preventing abuse and diversion. After 

these meetings, Purdue distributed brochures to health care professionals 

that described several steps that could be taken to prevent prescription 

drug abuse and diversion. In response to the abuse and diversion reports, 

DEA analyzed data collected from medical examiner autopsy reports and 

crime scene investigation reports. The most recent data available from 

DEA show that as of February 2002, the agency had verified 146 deaths 

nationally involving OxyContin in 2000 and 2001. 

According to Purdue, as of early October 2003, over 300 lawsuits 

concerning OxyContin were pending against Purdue, and 50 additional 

lawsuits had been dismissed. The cases involve many allegations, 

including, for example, that Purdue used improper sales tactics and 

overpromoted OxyContin causing the drug to be inappropriately 

prescribed by physicians, and that Purdue took inadequate actions to 

prevent addiction, abuse, and diversion of the drug. The lawsuits have 

been brought in 25 states and the District of Columbia in both federal and 

state courts. 

 16Doris Bloodsworth, “Pain Pill Leaves Death Trail: A Nine-Month Investigation Raises 

Many Questions about Purdue Pharma’s Powerful Drug OxyContin,” Orlando Sentinel, 

Oct. 19, 2003. 
Page 11 GAO-04-110 OxyContin Abuse and Diversion 

The Controlled Substances Act established a classification structure for 

drugs and chemicals used in the manufacture of drugs that are designated 

as controlled substances.17 Controlled substances are classified by DEA 

into five schedules on the basis of their medicinal value, potential for 

abuse, and safety or dependence liability. Schedule I drugs—including 

heroin, marijuana, and LSD—have a high potential for abuse and no 

currently accepted medical use. Schedule II drugs—which include opioids 

such as morphine and oxycodone, the primary ingredient in OxyContin—

have a high potential for abuse among drugs with an accepted medical use 

and may lead to severe psychological or physical dependence. Drugs on 

schedules III through V have medical uses and successively lower 

potentials for abuse and dependence. Schedule III drugs include anabolic 

steroids, codeine, hydrocodone in combination with aspirin or 

acetaminophen, and some barbiturates. Schedule IV contains such drugs 

as the antianxiety drugs diazepam (Valium) and alprazolam (Xanax). 

Schedule V includes preparations such as cough syrups with codeine. All 

scheduled drugs except those in schedule I are legally available to the 

public with a prescription.18

Under the FD&C Act and implementing regulations, FDA is responsible for 

ensuring that all new drugs are safe and effective. FDA reviews scientific 

and clinical data to decide whether to approve drugs based on their 

intended use, effectiveness, and the risks and benefits for the intended 

population, and also monitors drugs for continued safety after they are in 

use. 

FDA also regulates the advertising and promotion of prescription drugs 

under the FD&C Act. FDA carries out this responsibility by ensuring that 

prescription drug advertising and promotion is truthful, balanced, and 

accurately communicated.19 The FD&C Act makes no distinction between 

 17Section 201, classified to 21 U.S.C. § 811. 

18Some schedule V drugs that contain limited quantities of certain narcotic and stimulant 

drugs are available over the counter, without a prescription. 

19FDA regulations require that promotional labeling and advertisements be submitted to 

FDA at the time of initial dissemination (for labeling) and initial publication (for 

advertisements). The FD&C Act defines labeling to include all labels and other written, 

printed, or graphic matter accompanying an article. For example, promotional materials 

commonly shown or given to physicians, such as sales aids and branded promotional items, 

are regulated as promotional labeling. FDA may also regulate promotion by sales 

representatives on computer programs, through fax machines, or on electronic bulletin 

boards. 

Controlled Substances Act 

FDA’s Regulation of 

Prescription Drugs 
Page 12 GAO-04-110 OxyContin Abuse and Diversion 

controlled substances and other prescription drugs in the oversight of 

promotional activities. FDA told us that the agency takes a risk-based 

approach to enforcement, whereby drugs with more serious risks, such as 

opioids, are given closer scrutiny in monitoring promotional messages and 

activities, but the agency has no specific guidance or policy on this 

approach. The FD&C Act and its implementing regulations require that all 

promotional materials for prescription drugs be submitted to FDA at the 

time the materials are first disseminated or used, but it generally is not 

required that these materials be approved by FDA before their use. As a 

result, FDA’s actions to address violations occur after the materials have 

already appeared in public. In fiscal year 2002, FDA had 39 staff positions 

dedicated to oversight of drug advertising and promotion of all 

pharmaceuticals distributed in the United States. According to FDA, most 

of the staff focuses on the oversight of promotional communications to 

physicians. FDA officials told us that in 2001 it received approximately 

34,000 pieces of promotional material, including consumer advertisements 

and promotions to physicians, and received and reviewed 230 complaints 

about allegedly misleading advertisements, including materials directed at 

health professionals.20

FDA issues two types of letters to address violations of the FD&C Act: 

untitled letters and warning letters. Untitled letters are issued for 

violations such as overstating the effectiveness of the drug, suggesting a 

broader range of indicated uses than the drug has been approved for, and 

making misleading claims because of inadequate context or lack of 

balanced information. Warning letters are issued for more serious 

violations, such as those involving safety or health risks, or for continued 

violations of the act. Warning letters generally advise a pharmaceutical 

manufacturer that FDA may take further enforcement actions, such as 

seeking judicial remediation, without notifying the company and may ask 

the manufacturer to conduct a new advertising campaign to correct 

inaccurate impressions left by the advertisements. 

Under the Controlled Substances Act, FDA notifies DEA if FDA is 

reviewing a new drug application for a drug that has a stimulant, 

depressant, or hallucinogenic effect on the central nervous system and has 

abuse potential. FDA performs a medical and scientific assessment as 

 20For details on FDA’s oversight of drug advertising see U.S. General Accounting Office, 

Prescription Drugs: FDA Oversight of Direct-to-Consumer Advertising Has Limitations, 

GAO-03-177 (Washington, D.C.: Oct. 28, 2002). 
Page 13 GAO-04-110 OxyContin Abuse and Diversion 

required by the Controlled Substances Act, and recommends to DEA an 

initial schedule level to be assigned to a new controlled substance. 

FDA plans to provide guidance to the pharmaceutical industry on the 

development, implementation, and evaluation of risk management plans as 

a result of the reauthorization of the Prescription Drug User Fee Act of 

1992 (PDUFA).21 FDA expects to issue this guidance by September 30, 

2004. FDA defines a risk management program as a strategic safety 

program that is designed to decrease product risks by using one or more 

interventions or tools beyond the approved product labeling. Interventions 

used in risk management plans may include postmarketing surveillance, 

education and outreach programs to health professionals or consumers, 

informed consent agreements for patients, limitations on the supply or 

refills of products, and restrictions on individuals who may prescribe and 

dispense drug products. All drug manufacturers have the option to develop 

and submit risk management plans to FDA as part of their new drug 

applications. 

DEA is the primary federal agency responsible for enforcing the 

Controlled Substances Act. DEA has the authority to regulate transactions 

involving the sale and distribution of controlled substances at the 

manufacturer and wholesale distributor levels. DEA registers legitimate 

handlers of controlled substances—including manufacturers, distributors, 

hospitals, pharmacies, practitioners, and researchers—who must comply 

with regulations relating to drug security and accountability through the 

maintenance of inventories and records. All registrants, including 

pharmacies, are required to maintain records of controlled substances that 

have been manufactured, purchased, and sold. Manufacturers and 

distributors are also required to report their annual inventories of 

controlled substances to DEA. The data provided to DEA are available for 

use in monitoring the distribution of controlled substances throughout the 

United States and identifying retail-level registrants that received unusual 

quantities of controlled substances. DEA regulations for schedule II 

prescription drugs, unlike those for other prescription drugs, require that 

each prescription must be written and signed by the physician and may 

not be telephoned in to the pharmacy except in an emergency. Also, a 

 21The Prescription Drug User Fee Act of 1992, Pub. L. No. 102-571, title I, 106 Stat. 4491, was 

reauthorized by the Food and Drug Modernization Act of 1997, Pub. L. No. 105-115, 111 

Stat. 2296, and, most recently, by the Prescription Drug User Fee Amendments of 2002, 

Pub. L. No. 107-188, title V, subtitle A, 116 Stat. 594, 687. 

DEA’s Regulation of 

Controlled Substances 
Page 14 GAO-04-110 OxyContin Abuse and Diversion 

prescription for a schedule II drug may not be refilled. A physician is 

required to provide a new prescription each time a patient obtains more of 

the drug. DEA also sets limits on the quantity of schedule II controlled 

substances that may be produced in the United States in any given year. 

Specifically, DEA sets aggregate production quotas that limit the 

production of bulk raw materials used in the manufacture of controlled 

substances. DEA determines these quotas based on a variety of data 

including sales, production, inventories, and exports. Individual 

companies must apply to DEA for manufacturing or procurement quotas 

for specific pharmaceutical products. For example, Purdue has a 

procurement quota for oxycodone, the principle ingredient in OxyContin, 

that allows the company to purchase specified quantities of oxycodone 

from bulk manufacturers. 

State laws govern the prescribing and dispensing of prescription drugs by 

licensed health care professionals. Each state requires that physicians 

practicing in the state be licensed, and state medical practice laws 

generally outline standards for the practice of medicine and delegate the 

responsibility of regulating physicians to state medical boards. States also 

require pharmacists and pharmacies to be licensed. The regulation of the 

practice of pharmacy is based on state pharmacy practice acts and 

regulations enforced by the state boards of pharmacy. According to the 

National Association of Boards of Pharmacy, all state pharmacy laws 

require that records of prescription drugs dispensed to patients be 

maintained and that state pharmacy boards have access to the prescription 

records. State regulatory boards face new challenges with the advent of 

Internet pharmacies, because they enable pharmacies and physicians to 

anonymously reach across state borders to prescribe, sell, and dispense 

prescription drugs without complying with state requirements.22 In some 

cases, consumers can purchase prescription drugs, including controlled 

substances, such as OxyContin, from Internet pharmacies without a valid 

prescription. 

 22For more details on Internet pharmacies, see U.S. General Accounting Office, Internet 

Pharmacies: Adding Disclosure Requirements Would Aid State and Federal Oversight, 

GAO-01-69 (Washington, D.C.: Oct. 19, 2000). 

States’ Regulation of the 

Practice of Medicine and 

Pharmacy and Role in 

Monitoring Illegal Use and 

Diversion of Prescription 

Drugs 
Page 15 GAO-04-110 OxyContin Abuse and Diversion 

In addition to these regulatory boards, 15 states operate prescription drug 

monitoring programs as a means to control the illegal diversion of 

prescription drugs that are controlled substances. Prescription drug 

monitoring programs are designed to facilitate the collection, analysis, and 

reporting of information on the prescribing, dispensing, and use of 

controlled substances within a state. They provide data and analysis to 

state law enforcement and regulatory agencies to assist in identifying and 

investigating activities potentially related to the illegal prescribing, 

dispensing, and procuring of controlled substances. For example, 

physicians in Kentucky can use the program to check a patient’s 

prescription drug history to determine if the individual may be “doctor 

shopping” to seek multiple controlled substance prescriptions. An 

overriding goal of prescription drug monitoring programs is to support 

both the state laws ensuring access to appropriate pharmaceutical care by 

citizens and the state laws deterring diversion. As we have reported, state 

prescription drug monitoring programs offer state regulators an efficient 

means of detecting and deterring illegal diversion. However, few states 

proactively analyze prescription data to identify individuals, physicians, or 

pharmacies that have unusual use, prescribing, or dispensing patterns that 

may suggest potential drug diversion or abuse. Although three states can 

respond to requests for information within 3 to 4 hours, providing 

information on suspected illegal prescribing, dispensing, or doctor 

shopping at the time a prescription is written or sold would require states 

to improve computer capabilities. In addition, state prescription drug 

monitoring programs may require additional legal authority to analyze data 

proactively.23

At the time that OxyContin was first marketed, there were no industry or 

federal guidelines for the promotion of prescription drugs. Voluntary 

guidelines regarding how drug companies should market and promote 

their drugs to health care professionals were issued in July 2002 by the 

Pharmaceutical Research and Manufacturers of America (PhRMA). In 

April 2003, HHS’s Office of Inspector General issued voluntary guidelines 

for how drug companies should market and promote their products to 

federal health care programs. Neither set of guidelines distinguishes 

between controlled and noncontrolled substances. 

 23For more details on these programs, see U.S. General Accounting Office, Prescription 

Drugs: State Monitoring Programs Provide Useful Tool to Reduce Diversion, GAO-02-634

(Washington, D.C.: May 17, 2002). 

Guidelines for Marketing 

Drugs to Health Care 

Professionals 
Page 16 GAO-04-110 OxyContin Abuse and Diversion 

PhRMA’s voluntary code of conduct for sales representatives states that 

interactions with health care professionals should be to inform these 

professionals about products, to provide scientific and educational 

information, and to support medical research and education.24 The 

question-and-answer section of the code addresses companies’ use of 

branded promotional items, stating, for example, that golf balls and sports 

bags should not be distributed because they are not primarily for the 

benefit of patients, but that speaker training programs held at golf resorts 

may be acceptable if participants are receiving extensive training. Purdue 

adopted the code. 

In April 2003, HHS’s Office of Inspector General issued final voluntary 

guidance for drug companies’ interactions with health care professionals 

in connection with federal health care programs, including Medicare and 

Medicaid. Among the guidelines were cautions for companies against 

offering inappropriate travel, meals, and gifts to influence the prescribing 

of drugs; making excessive payments to physicians for consulting and 

research services; and paying physicians to switch their patients from 

competitors’ drugs. 

Purdue conducted an extensive campaign to market and promote 

OxyContin that focused on encouraging physicians, including those in 

primary care specialties, to prescribe the drug for noncancer as well as 

cancer pain. To implement its OxyContin campaign, Purdue significantly 

increased its sales force and used multiple promotional approaches. 

OxyContin sales and prescriptions grew rapidly following its market 

introduction, with the growth in prescriptions for noncancer pain 

outpacing the growth in prescriptions for cancer pain. DEA has expressed 

concern that Purdue marketed OxyContin for a wide variety of conditions 

to physicians who may not have been adequately trained in pain 

management. Purdue has been cited twice by FDA for OxyContin 

advertisements in medical journals that violated the FD&C Act. FDA has 

also taken similar actions against manufacturers of two of the three 

comparable schedule II controlled substances we examined, to ensure that 

 24In addition, the American Medical Association, a professional association for physicians, 

issued guidelines in 1990 regarding gifts given to physicians by drug industry 

representatives. For example, physicians may accept individual gifts of nominal value that 

are related to their work, such as notepads and pens, and may attend conferences 

sponsored by drug companies that are educational and for which appropriate disclosure of 

financial support or conflicts of interest is made. 

Purdue Conducted an 

Extensive Campaign 

to Market and 

Promote OxyContin 
Page 17 GAO-04-110 OxyContin Abuse and Diversion 

their marketing and promotion were truthful, balanced, and accurately 

communicated. In addition, Purdue provided two promotional videos to 

physicians that, according to FDA appear to have made unsubstantiated 

claims and minimized the risks of OxyContin. The first video was available 

for about 3 years without being submitted to FDA for review. 

From the outset of the OxyContin marketing campaign, Purdue promoted 

the drug to physicians for noncancer pain conditions that can be caused 

by arthritis, injuries, and chronic diseases, in addition to cancer pain. 

Purdue directed its sales representatives to focus on the physicians in 

their sales territories who were high opioid prescribers. This group 

included cancer and pain specialists, primary care physicians, and 

physicians who were high prescribers of Purdue’s older product, MS 

Contin. One of Purdue’s goals was to identify primary care physicians who 

would expand the company’s OxyContin prescribing base. Sales 

representatives were also directed to call on oncology nurses, consultant 

pharmacists, hospices, hospitals, and nursing homes. 

From OxyContin’s launch until its July 2001 label change, Purdue used two 

key promotional messages for primary care physicians and other high 

prescribers. The first was that physicians should prescribe OxyContin for 

their pain patients both as the drug “to start with and to stay with.” The 

second contrasted dosing with other opioid pain relievers with OxyContin 

dosing as “the hard way versus the easy way” to dose because OxyContin’s 

twice-a-day dosing was more convenient for patients.25 Purdue’s sales 

representatives promoted OxyContin to physicians as an initial opioid 

treatment for moderate-to-severe pain lasting more than a few days, to be 

prescribed instead of other single-entity opioid analgesics or short-acting 

combination opioid pain relievers. Purdue has stated that by 2003 primary 

care physicians had grown to constitute nearly half of all OxyContin 

prescribers, based on data from IMS Health, an information service 

providing pharmaceutical market research. DEA’s analysis of physicians 

prescribing OxyContin found that the scope of medical specialties was 

wider for OxyContin than five other controlled-release, schedule II 

narcotic analgesics. DEA expressed concern that this resulted in 

 25Following OxyContin’s July 2001 label change, Purdue modified its promotional messages 

but continued to focus on encouraging physicians to prescribe OxyContin for patients 

taking pain relievers every 4 to 6 hours. In 2003, Purdue began using the promotional claim 

“there can be life with relief” in OxyContin promotion. 

Purdue Focused on 

Promoting OxyContin for 

Treatment of Noncancer 

Pain 
Page 18 GAO-04-110 OxyContin Abuse and Diversion 

OxyContin’s being promoted to physicians who were not adequately 

trained in pain management. 

Purdue’s promotion of OxyContin for the treatment of noncancer pain 

contributed to a greater increase in prescriptions for noncancer pain than 

for cancer pain from 1997 through 2002.26 According to IMS Health data, 

the annual number of OxyContin prescriptions for noncancer pain 

increased nearly tenfold, from about 670,000 in 1997 to about 6.2 million in 

2002.27 In contrast, during the same 6 years, the annual number of 

OxyContin prescriptions for cancer pain increased about fourfold, from 

about 250,000 in 1997 to just over 1 million in 2002. The noncancer 

prescriptions therefore increased from about 73 percent of total 

OxyContin prescriptions to about 85 percent during that period, while the 

cancer prescriptions decreased from about 27 percent of the total to about 

15 percent. IMS Health data indicated that prescriptions for other schedule 

II opioid drugs, such as Duragesic28 and morphine products, for noncancer 

pain also increased during this period. Duragesic prescriptions for 

noncancer pain were about 46 percent of its total prescriptions in 1997, 

and increased to about 72 percent of its total in 2002. Morphine products, 

including, for example, Purdue’s MS Contin, also experienced an increase 

in their noncancer prescriptions during the same period. Their noncancer 

prescriptions were about 42 percent of total prescriptions in 1997, and 

increased to about 65 percent in 2002. DEA has cited Purdue’s focus on 

promoting OxyContin for treating a wide range of conditions as one of the 

reasons the agency considered Purdue’s marketing of OxyContin to be 

overly aggressive. 

 26IMS Health reported noncancer prescriptions written for the following types of pain 

conditions: surgical aftercare; musculoskeletal disorders including back and neck 

disorders, arthritis conditions, and injuries and trauma including bone fractures; central 

nervous system disorders including headache conditions such as migraines; genitourinary 

disorders including kidney stones; and other types of general pain. 

27The IMS Health data included information from the National Disease and Therapeutics 

Index and the National Prescription Audit. The National Disease and Therapeutics Index 

does not capture data from anesthesiologists and dental specialties. The National 

Prescription Audit data include retail pharmacy, long-term-care, and mail-order 

prescriptions. 

28Duragesic is a skin patch used to deliver the opioid pain reliever fentanyl over a 72-hour 

period. 
Page 19 GAO-04-110 OxyContin Abuse and Diversion 

Purdue significantly increased its sales force to market and promote 

OxyContin to physicians and other health care practitioners. In 1996, 

Purdue began promoting OxyContin with a sales force of approximately 

300 representatives in its Prescription Sales Division.29 Through a 1996 

copromotion agreement, Abbott Laboratories provided at least another 

300 representatives, doubling the total OxyContin sales force.30 By 2000, 

Purdue had more than doubled its own internal sales force to 671. The 

expanded sales force included sales representatives from the Hospital 

Specialty Division, which was created in 2000 to increase promotional 

visits on physicians located in hospitals. (See table 1.) 

Table 1: Sales Representative Positions Available for OxyContin Promotion, 1996 

through 2002 

Positions availablea

 1996 1997 1998 1999 2000 2001 2002

Purdue Prescription Sales Division 318 319 377 471 562 641 641

Purdue Hospital Specialty Division 0 0 0 0 109 125 126

Subtotal—All Purdue sales 

representatives 318 319 377 471 671 766 767

Abbott Laboratories sales 

representativesb

 300 300 300 300 300 300 300

Total 618 619 677 771 971 1,066 1,067

Source: GAO analysis of Purdue data. 

a

All positions were not necessarily filled in a given year. 

b

Under the OxyContin copromotion agreement, Abbott Laboratories provided at least 300 sales 

representatives each year. 

The manufacturers of two of the three comparable schedule II drugs have 

smaller sales forces than Purdue. Currently, the manufacturer of Kadian 

has about 100 sales representatives and is considering entering into a 

copromotion agreement. Elan, the current owner of Oramorph SR, has 

approximately 300 representatives, but told us that it is not currently 

marketing Oramorph SR. The manufacturer of Avinza had approximately 

50 representatives at its product launch. In early 2003, Avinza’s 

manufacturer announced that more than 700 additional sales 

 29These sales representatives were also responsible for promoting other Purdue products. 

30Abbott Laboratories sales representatives’ promotion of OxyContin is limited to hospitalbased anesthesiologists and surgeons and major hospitals, medical centers, and 

freestanding pain clinics. 

Purdue Significantly 

Increased Its Sales Force 

to Market and Promote 

OxyContin 
Page 20 GAO-04-110 OxyContin Abuse and Diversion 

representatives would be promoting the drug under its copromotion 

agreement with the pharmaceutical manufacturer Organon—for a total of 

more than 800 representatives. 

By more than doubling its total sales representatives, Purdue significantly 

increased the number of physicians to whom it was promoting OxyContin. 

Each Purdue sales representative has a specific sales territory and is 

responsible for developing a list of about 105 to 140 physicians to call on 

who already prescribe opioids or who are candidates for prescribing 

opioids. In 1996, the 300-plus Purdue sales representatives had a total 

physician call list of approximately 33,400 to 44,500. By 2000, the nearly 

700 representatives had a total call list of approximately 70,500 to 94,000 

physicians. Each Purdue sales representative is expected to make about 35 

physician calls per week and typically calls on each physician every 3 to 4 

weeks. Each hospital sales representative is expected to make about 50 

calls per week and typically calls on each facility every 4 weeks. 

Purdue stated it offered a “better than industry average” salary and sales 

bonuses to attract top sales representatives and provide incentives to 

boost OxyContin sales as it had done for MS Contin. Although the sales 

representatives were primarily focused on OxyContin promotion, the 

amount of the bonus depended on whether a representative met the sales 

quotas in his or her sales territory for all company products. As 

OxyContin’s sales increased, Purdue’s growth-based portion of the bonus 

formula increased the OxyContin sales quotas necessary to earn the same 

base sales bonus amounts. The amount of total bonuses that Purdue 

estimated were tied to OxyContin sales increased significantly from about 

$1 million in 1996, when OxyContin was first marketed, to about $40 

million in 2001. Beginning in 2000, when the newly created hospital 

specialty representatives began promoting OxyContin, their estimated 

total bonuses were approximately $6 million annually. In 2001, the average 

annual salary for a Purdue sales representative was $55,000, and the 

average annual bonus was $71,500. During the same year, the highest 

annual sales bonus was nearly $240,000, and the lowest was nearly 

$15,000. In 2001, Purdue decided to limit the sales bonus a representative 

could earn based on the growth in prescribing of a single physician after a 

meeting with the U.S. Attorney for the Western District of Virginia at 

which the company was informed of the possibility that a bonus could be 

based on the prescribing of one physician. 
Page 21 GAO-04-110 OxyContin Abuse and Diversion 

In addition to expanding its sales force, Purdue used multiple approaches 

to market and promote OxyContin. These approaches included expanding 

its physician speaker bureau and conducting speaker training conferences, 

sponsoring pain-related educational programs, issuing OxyContin starter 

coupons for patients’ initial prescriptions, sponsoring pain-related Web 

sites, advertising OxyContin in medical journals, and distributing 

OxyContin marketing items to health care professionals. 

In our report on direct-to-consumer advertising, we found that most 

promotional spending is targeted to physicians.31 For example, in 2001, 29 

percent of spending on pharmaceutical promotional activities was related 

to activities of pharmaceutical sales representatives directed to 

physicians, and 2 percent was for journal advertising—both activities 

Purdue uses for its OxyContin promotion. The remaining 69 percent of 

pharmaceutical promotional spending involved sampling (55 percent), 

which is the practice of providing drug samples during sales visits to 

physician offices, and direct-to-consumer advertising (14 percent)—both 

activities that Purdue has stated it does not use for OxyContin. 

According to DEA’s analysis of IMS Health data, Purdue spent 

approximately 6 to 12 times more on promotional efforts during 

OxyContin’s first 6 years on the market than it had spent on its older 

product, MS Contin, during its first 6 years, or than had been spent by 

Janssen Pharmaceutical Products, L.P., for one of OxyContin’s drug 

competitors, Duragesic. (See fig. 1.) 

 31U.S. General Accounting Office, Prescription Drugs: FDA Oversight of Direct-toConsumer Advertising Has Limitations, GAO-03-177 (Washington, D.C.: Oct. 28, 2002). 

Purdue Employed Multiple 

Approaches to Market and 

Promote OxyContin 
Page 22 GAO-04-110 OxyContin Abuse and Diversion 

Figure 1: Promotional Spending for Three Opioid Analgesics in First 6 Years of 

Sales 

Note: Dollars are 2002 adjusted. 

During the first 5 years that OxyContin was marketed, Purdue conducted 

over 40 national pain management and speaker training conferences, 

usually in resort locations such as Boca Raton, Florida, and Scottsdale, 

Arizona, to recruit and train health care practitioners for its national 

speaker bureau. The trained speakers were then made available to speak 

about the appropriate use of opioids, including oxycodone, the active 

ingredient in OxyContin, to their colleagues in various settings, such as 

local medical conferences and grand round presentations in hospitals 

involving physicians, residents, and interns. Over the 5 years, these 

conferences were attended by more than 5,000 physicians, pharmacists, 

and nurses, whose travel, lodging, and meal costs were paid by the 

company. Purdue told us that less than 1 percent annually of the 

physicians called on by Purdue sales representatives attended these 

conferences. Purdue told us it discontinued conducting these conferences 

in fall 2000. Purdue’s speaker bureau list from 1996 through mid-2002 

included nearly 2,500 physicians, of whom over 1,000 were active 

participants. Purdue has paid participants a fee for speaking based on the 

physician’s qualifications; the type of program and time commitment 

30

25

20

15

10

5

0

MS Contin: 1984-1989

OxyContin: 1996-2001

Duragesic: 1991-1996

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6

Source: DEA and IMS Health, Integrated Promotional Service Audit.

Absolute dollars in millions
Page 23 GAO-04-110 OxyContin Abuse and Diversion 

involved; and expenses such as airfare, hotel, and food. The company 

currently marketing the comparable drug Avinza has a physician speaker 

bureau, but does not sponsor speaker training and conferences at resort 

locations. Kadian’s current company does not have a physician speaker 

bureau and has not held any conferences. 

From 1996, when OxyContin was introduced to the market, to July 2002, 

Purdue has funded over 20,000 pain-related educational programs through 

direct sponsorship or financial grants. These grants included support for 

programs to provide physicians with opportunities to earn required 

continuing medical education credits, such as grand round presentations 

at hospitals and medical education seminars at state and local medical 

conferences. During 2001 and 2002, Purdue funded a series of nine 

programs throughout the country to educate hospital physicians and staff 

on how to comply with JCAHO’s pain standards for hospitals and to 

discuss postoperative pain treatment. Purdue was one of only two drug 

companies that provided funding for JCAHO’s pain management 

educational programs.32 Under an agreement with JCAHO, Purdue was the 

only drug company allowed to distribute certain educational videos and a 

book about pain management; these materials were also available for 

purchase from JCAHO’s Web site. Purdue’s participation in these activities 

with JCAHO may have facilitated its access to hospitals to promote 

OxyContin. 

For the first time in marketing any of its products, Purdue used a patient 

starter coupon program for OxyContin to provide patients with a free 

limited-time prescription. Unlike patient assistance programs, which 

provide free prescriptions to patients in financial need, a coupon program 

is intended to enable a patient to try a new drug through a one-time free 

prescription. A sales representative distributes coupons to a physician, 

who decides whether to offer one to a patient, and then the patient 

redeems it for a free prescription through a participating pharmacy. The 

program began in 1998 and ran intermittently for 4 years. In 1998 and 1999, 

each sales representative had 25 coupons that were redeemable for a free 

30-day supply. In 2000 each representative had 90 coupons for a 7-day 

supply, and in 2001 each had 10 coupons for a 7-day supply. 

Approximately 34,000 coupons had been redeemed nationally when the 

 32During 2000 through 2002, JCAHO sponsored a series of educational programs on pain 

management standards with various cosponsors, including pain-related groups such as the 

American Pain Society and the American Academy of Pain Medicine. 
Page 24 GAO-04-110 OxyContin Abuse and Diversion 

program was terminated following the July 2001 OxyContin label change. 

The manufacturers of two of the comparable drugs we examined—Avinza 

and Kadian—used coupon programs to introduce patients to their 

products. Avinza’s coupon program requires patients to make a copayment 

to cover part of the drug’s cost. 

Purdue has also used Web sites to provide pain-related information to 

consumers and others. In addition to its corporate Web site, which 

provides product information, Purdue established the “Partners Against 

Pain” Web site in 1997 to provide consumers with information about pain 

management and pain treatment options. According to FDA, the Web site 

also contained information about OxyContin. Separate sections provide 

information for patients and caregivers, medical professionals, and 

institutions. The Web site includes a “Find a Doctor” feature to enable 

consumers to find physicians who treat pain in their geographic area.33 As 

of July 2002, over 33,000 physicians were included. Ligand, which markets 

Avinza, one of the comparable drugs, has also used a corporate Web site to 

provide product information. Purdue has also funded Web sites, such as 

FamilyPractice.com, that provide physicians with free continuing medical 

educational programs on pain management.34 Purdue has also provided 

funding for Web site development and support for health care groups such 

as the American Chronic Pain Association and the American Academy of 

Pain Medicine. In addition, Purdue is one of 28 corporate donors—which 

include all three comparable drug companies—listed on the Web site of 

the American Pain Society, the mission of which is to improve pain-related 

education, treatment, and professional practice. Purdue also sponsors 

painfullyobvious.com, which it describes as a youth-focused “message 

campaign designed to provide information—and stimulate open 

discussions—on the dangers of abusing prescription drugs.” 

Purdue also provided its sales representatives with 14,000 copies of a 

promotional video in 1999 to distribute to physicians. Entitled From One 

Pain Patient to Another: Advice from Patients Who Have Found Relief, 

the video was to encourage patients to report their pain and to alleviate 

patients’ concerns about taking opioids. Purdue stated that the video was 

to be used “in physician waiting rooms, as a ‘check out’ item for an office’s 

 33The “Find a Doctor” feature is a physician listing service provided by the National 

Physicians DataSource, LLC. 

34Purdue has also helped to fund the Dannemiller Memorial Education Foundation and the 

American Academy of Physician Assistants Web sites. 
Page 25 GAO-04-110 OxyContin Abuse and Diversion 

patient education library, or as an educational tool for office or hospital 

staff to utilize with patients and their families.” Copies of the video were 

also available for ordering on the “Partners Against Pain” Web site from 

June 2000 through July 2001. The video did not need to be submitted to 

FDA for its review because it did not contain any information about 

OxyContin. However, the video included a statement that opioid 

analgesics have been shown to cause addiction in less than 1 percent of 

patients. According to FDA, this statement has not been substantiated. 

As part of its marketing campaign, Purdue distributed several types of 

branded promotional items to health care practitioners. Among these 

items were OxyContin fishing hats, stuffed plush toys, coffee mugs with 

heat-activated messages, music compact discs, luggage tags, and pens 

containing a pullout conversion chart showing physicians how to calculate 

the dosage to convert a patient to OxyContin from other opioid pain 

relievers.35 In May 2002, in anticipation of PhRMA’s voluntary guidance for 

sales representatives’ interactions with health care professionals, Purdue 

instructed its sales force to destroy any remaining inventory of non-healthrelated promotional items, such as stuffed toys or golf balls. In early 2003, 

Purdue began distributing an OxyContin branded goniometer—a range 

and motion measurement guide. According to DEA, Purdue’s use of 

branded promotional items to market OxyContin was unprecedented 

among schedule II opioids, and was an indicator of Purdue’s aggressive 

and inappropriate marketing of OxyContin. 

Another approach Purdue used to promote OxyContin was to place 

advertisements in medical journals. Purdue’s annual spending for 

OxyContin advertisements increased from about $700,000 in 1996 to about 

$4.6 million in 2001. All three companies that marketed the comparable 

drugs have also used medical journal advertisements to promote their 

products. 

Purdue has been cited twice by FDA for using advertisements in 

professional medical journals that violated the FD&C Act. In May 2000, 

FDA issued an untitled letter to Purdue regarding a professional medical 

 35It is common drug industry practice for companies to provide conversion tables for sales 

representatives to distribute to health care practitioners. Purdue used a similar pen for its 

older product, MS Contin. 

OxyContin Advertisements 

Violated the FD&C Act 
Page 26 GAO-04-110 OxyContin Abuse and Diversion 

journal advertisement for OxyContin.36 FDA noted that among other 

problems, the advertisement implied that OxyContin had been studied for 

all types of arthritis pain when it had been studied only in patients with 

moderate-to-severe osteoarthritis pain, the advertisement suggested 

OxyContin could be used as an initial therapy for the treatment of 

osteoarthritis pain without substantial evidence to support this claim, and 

the advertisement promoted OxyContin in a selected class of patients—

the elderly—without presenting risk information applicable to that class of 

patients.37 Purdue agreed to stop dissemination of the advertisement. The 

second action taken by FDA was more serious. In January 2003, FDA 

issued a warning letter to Purdue regarding two professional medical 

journal advertisements for OxyContin that minimized its risks and 

overstated its efficacy, by failing to prominently present information from 

the boxed warning on the potentially fatal risks associated with OxyContin 

and its abuse liability, along with omitting important information about the 

limitations on the indicated use of OxyContin.38 The FDA requested that 

Purdue cease disseminating these advertisements and any similar violative 

materials and provide a plan of corrective action. In response, Purdue 

issued a corrected advertisement, which called attention to the warning 

letter and the cited violations and directed the reader to the prominently 

featured boxed warning and indication information for OxyContin.39 The 

FDA letter was one of only four warning letters issued to drug 

manufacturers during the first 8 months of 2003.40

In addition, in follow-up discussions with Purdue officials on the January 

2003 warning letter, FDA expressed concerns about some of the 

information on Purdue’s “Partners Against Pain” Web site. The Web site 

appeared to suggest unapproved uses of OxyContin for postoperative pain 

that may have been inconsistent with OxyContin’s labeling and lacked risk 

 36FDA indicated that in 2000, it issued 75 untitled letters to 46 drug manufacturers, as well 

as 4 warning letters to 4 drug manufacturers, for using promotional activities that violated 

the FD&C Act. 

37The advertisement appeared in the New England Journal of Medicine in May 2000. 

38The advertisements appeared in the Journal of the American Medical Association in 

October and November 2002. 

39According to FDA, the corrective advertisement ran for 3 months and appeared in 

approximately 30 medical journals. 

40FDA indicated that from January through August 2003, it issued 4 warning letters to four 

manufacturers and 12 untitled letters to seven drug manufacturers for using promotional 

activities that violated the FD&C Act. 
Page 27 GAO-04-110 OxyContin Abuse and Diversion 

information about the drug. For example, one section of the Web site did 

not disclose that OxyContin is not indicated for pain in the immediate 

postoperative period—the first 12 to 24 hours following surgery—for 

patients not previously taking the drug, because its safety in this setting 

has not been established. The Web site also did not disclose that 

OxyContin is indicated for postoperative pain in patients already taking 

the drug or for use after the first 24 hours following surgery only if the 

pain is moderate to severe and expected to persist for an extended period 

of time. Purdue voluntarily removed all sections of the Web site that were 

of concern to FDA. 

FDA has also sent enforcement letters to other manufacturers of 

controlled substances for marketing and promotion violations of the 

FD&C Act. For example, in 1996, FDA issued an untitled letter to Zeneca 

Pharmaceuticals, at the time the promoter of Kadian,41 for providing 

information about the drug to a health professional prior to its approval in 

the United States. Roxane Laboratories, the manufacturer of Oramorph 

SR, was issued four untitled letters between 1993 and 1995 for making 

misleading and possibly false statements. Roxane used children in an 

advertisement even though Oramorph SR had not been evaluated in 

children, and a Roxane sales representative issued a promotional letter to 

a pharmacist that claimed, among other things, that Oramorph SR was 

superior to MS Contin in providing pain relief. FDA has sent no 

enforcement letters to Ligand Pharmaceuticals concerning Avinza. 

Beginning in 1998, Purdue, as part of its marketing and promotion of 

OxyContin, distributed 15,000 copies of an OxyContin video to physicians 

without submitting it to FDA for review. This video, entitled I Got My Life 

Back: Patients in Pain Tell Their Story, presented the pain relief 

experiences of various patients and the pain medications, including 

OxyContin, they had been prescribed. FDA regulations require 

pharmaceutical manufacturers to submit all promotional materials for 

approved prescription drug products to the agency at the time of their 

initial use. Because Purdue did not comply with this regulation, FDA did 

not have an opportunity to review the video to ensure that the information 

it contained was truthful, balanced, and accurately communicated. Purdue 

has acknowledged the oversight of not submitting the video to FDA for 

 41Zeneca Pharmaceuticals promoted Kadian for Faulding Laboratories, the drug’s 

manufacturer at that time. 

Purdue Distributed an 

OxyContin Video without 

FDA’s Review That 

Appears to Have Made 

Unsubstantiated Claims 

and Minimized Risks 
Page 28 GAO-04-110 OxyContin Abuse and Diversion 

review. In February 2001, Purdue submitted a second version of the video 

to FDA, which included information about the 160-milligram OxyContin 

tablet. FDA did not review this second version until October 2002, after we 

inquired about its content. FDA told us it found that the second version of 

the video appeared to make unsubstantiated claims regarding OxyContin’s 

effect on patients’ quality of life and ability to perform daily activities and 

minimized the risks associated with the drug. 

The 1998 video used a physician spokesperson to describe patients with 

different pain syndromes and the limitations that each patient faced in his 

or her daily activities. Each patient’s pain treatment was discussed, along 

with the dose amounts and brand names of the prescription drugs, 

including OxyContin, that either had been prescribed in the past or were 

being prescribed at that time. The physician in the videos also stated that 

opioid analgesics have been shown to cause addiction in less than 1 

percent of patients—a fact that FDA has stated has not been substantiated. 

At the end of the video, the OxyContin label was scrolled for the viewer. 

In 2000, Purdue submitted another promotional video to FDA entitled I 

Got My Life Back: A Two Year Follow up of Patients in Pain, and it 

submitted a second version of this video in 2001, which also included 

information on the 160-milligram OxyContin tablet. Purdue distributed 

12,000 copies of these videos to physicians. Both versions scrolled the 

OxyContin label at the end of the videos. FDA stated that it did not review 

either of these videos for enforcement purposes because of limited 

resources. Distribution of all four Purdue videos was discontinued by July 

2001, in response to OxyContin’s labeling changes, which required the 

company to modify all of its promotional materials, but copies of the 

videos that had already been distributed were not retrieved and destroyed. 

FDA said that it receives numerous marketing and promotional materials 

for promoted prescription drugs and that while every effort is made to 

review the materials, it cannot guarantee that all materials are reviewed 

because of limited resources and competing priorities. FDA officials also 

stated that pharmaceutical companies do not always submit promotional 

materials as required by regulations and that in such instances FDA would 

not have a record of the promotional pieces. 
Page 29 GAO-04-110 OxyContin Abuse and Diversion 

There are several factors that may have contributed to the abuse and 

diversion of OxyContin. OxyContin’s formulation as a controlled-release 

opioid that is twice as potent as morphine may have made it an attractive 

target for abuse and diversion. In addition, the original label’s safety 

warning advising patients not to crush the tablets because of the possible 

rapid release of a potentially toxic amount of oxycodone may have 

inadvertently alerted abusers to possible methods for misuse. Further, the 

rapid growth in OxyContin sales increased the drug’s availability in the 

marketplace and may have contributed to opportunities to obtain the drug 

illicitly. The history of abuse and diversion of prescription drugs in some 

geographic areas, such as those within the Appalachian region, may have 

predisposed some states to problems with OxyContin. However, we could 

not assess the relationship between the growth in OxyContin prescriptions 

or increased availability with the drug’s abuse and diversion because the 

data on abuse and diversion are not reliable, comprehensive, or timely. 

While OxyContin’s potency and controlled-release feature may have made 

the drug beneficial for the relief of moderate-to-severe pain over an 

extended period of time, DEA has stated that those attributes of its 

formulation have also made it an attractive target for abuse and diversion. 

According to recent studies, oxycodone, the active ingredient in 

OxyContin, is twice as potent as morphine.42 In addition, OxyContin’s 

controlled-release feature allows a tablet to contain more active ingredient 

than other, non-controlled-release oxycodone-containing drugs. 

One factor that may have contributed to the abuse and diversion of 

OxyContin was FDA’s original decision to label the drug as having less 

abuse potential than other oxycodone products because of its controlledrelease formulation. FDA officials said when OxyContin was approved the 

agency believed that the controlled-release formulation would result in 

less abuse potential because, when taken properly, the drug would be 

absorbed slowly, without an immediate rush or high. FDA officials 

acknowledged that the initial wording of OxyContin’s label was 

“unfortunate” but was based on what was known about the product at that 

time. 

 42See, for example, G.B. Curtis, et al. “Relative Potency of Controlled-Release Oxycodone 

and Morphine in a Postoperative Pain Model,” European Journal of Clinical 

Pharmacology, vol. 55, no. 6 (1999): 55:425-429. 

Several Factors May 

Have Contributed to 

OxyContin Abuse and 

Diversion, but 

Relationship to 

Availability Cannot Be 

Assessed 

OxyContin’s Formulation 

May Have Made It an 

Inviting Drug for Abuse 

and Diversion 
Page 30 GAO-04-110 OxyContin Abuse and Diversion 

FDA officials told us that abusers typically seek a drug that is intense and 

fast-acting. When OxyContin was approved, FDA did not recognize that if 

the drug is dissolved in water and injected its controlled-release 

characteristics could be disrupted, creating an immediate rush or high and 

thereby increasing the potential for misuse and abuse. DEA officials told 

us that OxyContin became a target for abusers and diverters because the 

tablet contained larger amounts of active ingredient and the controlledrelease formulation was easy for abusers to compromise. 

The safety warning on the OxyContin label may also have contributed to 

the drug’s potential for abuse and diversion, by inadvertently providing 

abusers with information on how the drug could be misused. The label 

included the warning that the tablets should not be broken, chewed, or 

crushed because such action could result in the rapid release and 

absorption of a potentially toxic dose of oxycodone. FDA places similar 

safety warnings on other drugs to ensure that they are used properly. FDA 

officials stated that neither they nor other experts anticipated that 

crushing the controlled-release tablet and intravenously injecting or 

snorting the drug would become widespread and lead to a high level of 

abuse. 

The large amount of OxyContin available in the marketplace may have 

increased opportunities for abuse and diversion. Both DEA and Purdue 

have stated that an increase in a drug’s availability in the marketplace may 

be a factor that attracts interest by those who abuse and divert drugs. 

Following its market introduction in 1996, OxyContin sales and 

prescriptions grew rapidly through 2002. In 2001 and 2002 combined, sales 

of OxyContin approached $3 billion, and over 14 million prescriptions for 

the drug were dispensed. (See table 2.) OxyContin also became the topselling brand-name narcotic pain reliever in 2001 and was ranked 15th on a 

list of the nation’s top 50 prescription drugs by retail sales.43

 43This information is from the National Institute for Health Care Management’s Prescription 

Drug Expenditures reports for 2000 and 2001, prepared using American Institutes for 

Research analysis of Scott-Levin Prescription Audit Data. OxyContin was ranked 18th in 

2000. 

OxyContin’s Wide 

Availability May Have 

Increased Opportunities 

for Illicit Use 
Page 31 GAO-04-110 OxyContin Abuse and Diversion 

Table 2: Total OxyContin Sales and Prescriptions for 1996 through 2002 with 

Percentage Increases from Year to Year 

Year Sales

Percentage 

increase

Number of 

prescriptions

Percentage 

increase

1996 $44,790,000 N/A 316,786 N/A

1997 125,464,000 180 924,375 192

1998 286,486,000 128 1,910,944 107

1999 555,239,000 94 3,504,827 83

2000 981,643,000 77 5,932,981 69

2001 1,354,717,000 38 7,183,327 21

2002 1,536,816,000 13 7,234,204 7

Sources: Purdue and IMS Health. 

Legend: N/A = not applicable. 

Note: GAO analysis of OxyContin sales and prescription data from Purdue and IMS Health, which 

includes data from all 50 states and the District of Columbia. Sales include combined retail and 

nonretail sales in drugstores, hospitals, and long-term-care facilities from the IMS Health U.S. 

National Sales database. Prescriptions include retail pharmacy, long-term-care, and mail-order 

prescriptions from IMS Health’s National Prescriptions Audit. 

According to DEA, the abuse and diversion of OxyContin in some states 

may have reflected the geographic area’s history of prescription drug 

abuse. The White House Office of National Drug Control Policy (ONDCP) 

designates geographic areas with illegal drug trade activities for allocation 

of federal resources to link local, state, and federal drug investigation and 

enforcement efforts. These areas, known as High-Intensity Drug 

Trafficking Areas (HIDTA), are designated by ONDCP in consultation with 

the Attorney General, the Secretary of the Treasury, heads of drug control 

agencies, and governors in the states involved.44

According to a 2001 HIDTA report,45 the Appalachian region, which 

encompasses parts of Kentucky, Tennessee, Virginia, and West Virginia, 

 44In making a designation, ONDCP considers whether the geographic area is a center of 

drug production, manufacturing, importation, or distribution; whether state and local law 

enforcement agencies have committed resources to respond aggressively to the drug 

trafficking problem; whether drug activities in the area are having a harmful impact on 

other areas of the country; and whether a significant increase in federal resources is 

necessary to respond to the area’s drug-related activities. 

45Appalachia High Intensity Drug Trafficking Area Task Force, The OxyContin Threat in 

Appalachia (London, Ky.: August 2001). 

History of Prescription 

Drug Abuse in Some States 

May Have Predisposed 

Them to Problems with 

OxyContin 
Page 32 GAO-04-110 OxyContin Abuse and Diversion 

has been severely affected by prescription drug abuse, particularly pain 

relievers, including oxycodone, for many years. Three of the four states—

Kentucky, Virginia, and West Virginia—were among the initial states to 

report OxyContin abuse and diversion. Historically, oxycodone, 

manufactured under brand names such as Percocet, Percodan, and Tylox, 

was among the most diverted prescription drugs in Appalachia. According 

to the report, OxyContin has become the drug of choice of abusers in 

several areas within the region. The report indicates that many areas of the 

Appalachian region are rural and poverty-stricken, and the profit potential 

resulting from the illicit sale of OxyContin may have contributed to its 

diversion and abuse. In some parts of Kentucky, a 20-milligram OxyContin 

tablet, which can be purchased by legitimate patients for about $2, can be 

sold illicitly for as much as $25. The potential to supplement their incomes 

can lure legitimate patients into selling some of their OxyContin to street 

dealers, according to the HIDTA report. 

The databases DEA uses to track the abuse and diversion of controlled 

substances all have limitations that prevent an assessment of the 

relationship between the availability of OxyContin and areas where the 

drug is being abused or diverted. Specifically, these databases, which 

generally do not provide information on specific brand-name drugs such 

as OxyContin, are based on data gathered from limited sources in specific 

geographic areas and have a significant time lag. As a result, they do not 

provide reliable, complete, or timely information that could be used to 

identify abuse and diversion of a specific drug. 

DEA officials told us that it is difficult to obtain reliable data on what 

controlled substances are being abused by individuals and diverted from 

pharmacies because available drug abuse and diversion tracking systems 

do not capture data on a specific brand-name product or indicate where a 

drug product is being abused and diverted on a state and local level. 

Because of the time lags in reporting information, the data reflect a 

delayed response to any emerging drug abuse and diversion problem. For 

example, the Drug Abuse Warning Network (DAWN) estimates national 

drug-related emergency department visits or deaths involving abused 

drugs using data collected by the Substance Abuse and Mental Health 

Services Administration (SAMHSA). The data are collected from hospital 

emergency departments in 21 metropolitan areas that have agreed to 

voluntarily report drug-abuse-related information from a sample of patient 

Limitations on Abuse and 

Diversion Data Prevent 

Assessment of the 

Relationship with 

OxyContin’s Availability 
Page 33 GAO-04-110 OxyContin Abuse and Diversion 

medical records, and from medical examiners in 42 metropolitan areas.46

However, DAWN cannot make estimates for rural areas, where initial 

OxyContin abuse and diversion problems were reported to be most 

prevalent, nor does it usually provide drug-product-specific information, 

and its data have a lag time of about 1 year. DEA stated that development 

of enhanced data collection systems is needed to provide “credible, legally 

defensible evidence concerning drug abuse trends in America.”47

DEA relies primarily on reports from its field offices to determine where 

abuse and diversion are occurring. DEA officials stated that the initial 

areas that experienced OxyContin abuse and diversion problems included 

rural areas within 8 states—Alaska, Kentucky, Maine, Maryland, Ohio, 

Pennsylvania, Virginia, and West Virginia. In July 2002, DEA told us that it 

learned that OxyContin abuse and diversion problems had spread into 

larger areas of the initial 8 states, as well as parts of 15 other states, to 

involve almost half of the 50 states.48 According to DEA officials, while 

DEA field offices continue to report OxyContin as a drug of choice among 

abusers, OxyContin has not been and is not now considered the most 

highly abused and diverted prescription drug nationally.49 OxyContin is the 

most abused single-entity prescription product according to those DEA 

state and divisional offices that report OxyContin abuse. 

 46The reliability of the data collected depends on whether the emergency room patient visit 

was reported as drug related, whether the patient reported taking a particular drug, and 

whether the emergency room physician indicated a drug’s brand name in the patient’s 

medical record. 

47See app. III for more details on the abuse and diversion databases DEA uses. 

48The 15 states are Alabama, Arizona, Colorado, Connecticut, Florida, Louisiana, 

Massachusetts, Mississippi, Missouri, New Jersey, North Carolina, South Carolina, Texas, 

Washington, and Wisconsin. 

49Hydrocodone products, such as Anexsia, Hycodan, Lorcet, Lortab, and Vicodin, remain 

among the most abused and diverted scheduled prescription drugs nationally. 
Page 34 GAO-04-110 OxyContin Abuse and Diversion 

Since becoming aware of reports of abuse and diversion of OxyContin, 

federal and state agencies and Purdue have taken actions intended to 

address these problems. To protect the public health, FDA has 

strengthened OxyContin label warnings and requested that Purdue 

develop and implement an OxyContin risk management plan. In addition, 

DEA has stepped up law enforcement actions to prevent abuse and 

diversion of OxyContin. State Medicaid fraud control units have also 

attempted to identify those involved in the abuse and diversion of 

OxyContin. Purdue has initiated drug abuse and diversion education 

programs, taken disciplinary actions against sales representatives who 

improperly promote OxyContin, and referred physicians who were 

suspected of improperly prescribing OxyContin to the appropriate 

authorities. However, until fall 2002 Purdue did not analyze its 

comprehensive physician prescribing reports, which it routinely uses in 

marketing and promoting OxyContin, and other indicators to identify 

possible physician abuse and diversion. 

Reports of abuse and diversion of OxyContin that were associated with an 

increasing incidence of addiction, overdose, and death prompted FDA to 

revise the drug’s label and take other actions to protect the public health. 

In July 2001, FDA reevaluated OxyContin’s label and made several changes 

in an effort to strengthen the “Warnings” section of the label. FDA added a 

subsection—“Misuse, Abuse, and Diversion of Opioids”—to stress that 

physicians and pharmacists should be alert to the risk of misuse, abuse, 

and diversion when prescribing or dispensing OxyContin. FDA also added 

a black box warning—the highest level of warning FDA can place on an 

approved drug product. FDA highlighted the language from the original 

1995 label—stating that OxyContin is a schedule II controlled substance 

with an abuse liability similar to morphine—by moving it into the black 

box. Also, while the original label suggested that taking broken, chewed, 

or crushed OxyContin tablets “could lead to the rapid release and 

absorption of a potentially toxic dose of oxycodone,” a more strongly 

worded warning in the black box stated that taking the drug in this manner 

“leads to rapid release and absorption of a potentially fatal dose of 

oxycodone” (emphasis added). (See table 3.) In addition to the black box 

warning, FDA also changed the language in the original label that 

described the incidence of addiction inadvertently induced by physician 

prescribing as rare if opioids are legitimately used in the management of 

pain. The revised label stated that data are not available to “establish the 

true incidence of addiction in chronic patients.” 

Federal and State 

Agencies and Purdue 

Have Taken Actions 

to Prevent Abuse and 

Diversion of 

OxyContin 

Reports of Abuse and 

Diversion Led to Label 

Changes and Other Actions 

by FDA 
Page 35 GAO-04-110 OxyContin Abuse and Diversion 

Table 3: Selected Language Approved by FDA in Warning Sections of OxyContin 

Labels, 1995 and 2001 

Warning label in 1995 Black box warning in 2001 

“Warning: 

OxyContin Tablets are to be swallowed 

whole, and are not to be broken, chewed, or 

crushed. Taking broken, chewed, or crushed 

OxyContin Tablets could lead to the rapid 

release and absorption of a potentially toxic 

dose of oxycodone.” 

“Warning: OxyContin is an opioid agonist 

and a Schedule II controlled substance 

with an abuse liability similar to 

morphine.” 

“OxyContin Tablets are to be swallowed 

whole and are not to be broken, chewed, 

or crushed. Taking broken, chewed, or 

crushed OxyContin Tablets leads to rapid 

release and absorption of a potentially 

fatal dose of oxycodone.” (emphasis 

added) 

Source: FDA-approved label for Purdue’s OxyContin. 

As mentioned earlier, the indication described in the original label was 

also revised to clarify the appropriate time period for which OxyContin 

should be prescribed for patients experiencing moderate-to-severe pain. 

The language in the 1995 label was changed from “where use of an opioid 

analgesic is appropriate for more than a few days” to “when a continuous, 

around-the-clock analgesic is needed for an extended period of time.” (See 

table 4.) A summary of changes made by FDA to the original OxyContin 

label is given in appendix II. 

Table 4: Selected Language Approved by FDA in the Indication Sections of 

OxyContin Labels, 1995 and 2001 

Indication in 1995 Black box indication change in 2001 

“OxyContin Tablets are a controlled-release 

oral formulation of oxycodone hydrochloride 

indicated for the management of moderateto-severe pain where use of an opioid 

analgesic is appropriate for more than a few 

days.” 

“OxyContin Tablets are a controlled-release 

oral formulation of oxycodone hydrochloride 

indicated for the management of moderateto-severe pain when a continuous, 

around-the-clock analgesic is needed 

for an extended period of time.” 

(emphasis added) 

Source: FDA-approved label for Purdue’s OxyContin. 

Beginning in early 2001, FDA collaborated with Purdue to develop and 

implement a risk management plan to help identify and prevent abuse and 

diversion of OxyContin. As a part of the risk management plan in 

connection with the labeling changes, Purdue was asked by FDA to revise 

all of its promotional materials for OxyContin to reflect the labeling 
Page 36 GAO-04-110 OxyContin Abuse and Diversion 

changes. In August 2001, FDA sent a letter to Purdue stating that all future 

promotional materials for OxyContin should prominently disclose the 

information contained in the boxed warning; the new warnings that 

address misuse, abuse, diversion, and addiction; and the new precautions 

and revised indication for OxyContin. Purdue agreed to comply with this 

request. 

FDA officials told us that it is standard procedure to contact a drug 

manufacturer when the agency becomes aware of reports of abuse and 

diversion of a drug product so that FDA and the drug manufacturer can 

tailor a specific response to the problem. While FDA’s experience with 

risk management plans is relatively new, agency officials told us that 

OxyContin provided the opportunity to explore the use of the plans to help 

identify abuse and diversion problems. FDA is currently making decisions 

about whether risk management plans will be requested for selected 

opioid products. Also, in September 2003, FDA’s Anesthetic and Life 

Support Drugs Advisory Committee held a public hearing to discuss its 

current review of proposed risk management plans for opioid analgesic 

drug products to develop strategies for providing patients with access to 

pain treatment while limiting the abuse and diversion of these products. 

FDA has also taken other actions to address the abuse and diversion of 

OxyContin. It put information on its Web site for patients regarding the 

appropriate use of OxyContin.50 FDA worked with Purdue to develop 

“Dear Health Care Professional” letters, which the company distributed 

widely to health care professionals to alert them that the package insert 

had been revised to clarify the indication and strengthen the warnings 

related to misuse, abuse, and diversion. FDA also has worked with DEA, 

SAMHSA, the National Institute on Drug Abuse, ONDCP, and the Centers 

for Disease Control and Prevention to share information and insights on 

the problem of abuse and diversion of OxyContin. 

In April 2001, DEA developed a national action plan to deter abuse and 

diversion of OxyContin. According to DEA officials, this marked the first 

time the agency had targeted a specific brand-name product for 

monitoring because of the level and frequency of abuse and diversion 

associated with the drug. Key components of the action plan include 

coordinating enforcement and intelligence operations with other law 

 50See www.fda.gov/cder/drug/infopage/oxycontin/default.htm. 

DEA Developed an Action 

Plan to Deter OxyContin 

Abuse and Diversion 
Page 37 GAO-04-110 OxyContin Abuse and Diversion 

enforcement agencies to target people and organizations involved in abuse 

and diversion of OxyContin, pursuing regulatory and administrative action 

to limit abusers’ access to OxyContin, and building national outreach 

efforts to educate the public on the dangers related to the abuse and 

diversion of OxyContin. DEA has also set Purdue’s procurement quota for 

oxycodone at levels lower than the levels requested by Purdue. 

DEA has increased enforcement efforts to prevent abuse and diversion of 

OxyContin. From fiscal year 1996 through fiscal year 2002, DEA initiated 

313 investigations involving OxyContin, resulting in 401 arrests. Most of 

the investigations and arrests occurred after the initiation of the action 

plan. Since the plan was enacted, DEA initiated 257 investigations and 

made 302 arrests in fiscal years 2001 and 2002. Among those arrested were 

several physicians and pharmacists. Fifteen health care professionals 

either voluntarily surrendered their controlled substance registrations or 

were immediately suspended from registration by DEA. In addition, DEA 

reported that $1,077,500 in fines was assessed and $742,678 in cash was 

seized by law enforcement agencies in OxyContin-related cases in 2001 

and 2002. 

Among several regulatory and administrative actions taken to limit 

abusers’ access to OxyContin and controlled substances, DEA’s Office of 

Diversion Control, in collaboration with the Department of Justice’s Office 

of Justice Programs, Bureau of Justice Assistance, provides grants to 

states for the establishment of prescription drug monitoring programs. The 

conference committee report for the fiscal year 2002 appropriation to the 

Department of Justice directed the Office of Justice Programs to make a 

$2 million grant in support of the Harold Rogers Prescription Drug 

Monitoring Program, which enhances the capacity of regulatory and law 

enforcement agencies to collect and analyze controlled substance 

prescription data. The program provided grants to establish new 

monitoring programs in Ohio, Pennsylvania, Virginia, and West Virginia. 

California, Kentucky, Massachusetts, Nevada, and Utah also received 

grants to enhance existing monitoring programs. 

DEA has also attempted to raise national awareness of the dangers 

associated with abuse and diversion of OxyContin. In October 2001 DEA 

joined 21 national pain and health organizations in issuing a consensus 

statement calling for a balanced policy on prescription medication use. 

According to the statement, such a policy would acknowledge that health 

care professionals and DEA share responsibility for ensuring that 

prescription medications, such as OxyContin, are available to patients who 

need them and for preventing these drugs from becoming a source of 
Page 38 GAO-04-110 OxyContin Abuse and Diversion 

abuse and diversion. DEA and the health organizations also called for a 

renewed focus on educating health professionals, law enforcement, and 

the public about the appropriate use of opioid pain medications in order to 

promote responsible prescribing and limit instances of abuse and 

diversion. DEA is also working with FDA to encourage state medical 

boards to require, as a condition of their state licensing, that physicians 

obtain continuing medical education on pain management. 

When OxyContin was first introduced to the market in 1996, DEA granted 

Purdue’s initial procurement quota request for oxycodone. According to 

DEA, increases in the quota were granted for the first several years. 

Subsequently, concern over the dramatic increases in sales caused DEA to 

request additional information to support Purdue’s requests to increase 

the quota. In the last several years, DEA has taken the additional step of 

lowering the procurement quota requested by Purdue for the manufacture 

of OxyContin as a means for addressing abuse and diversion. However, 

DEA has cited the difficulty of determining an appropriate level while 

ensuring that adequate quantities were available for legitimate medical 

use, as there are no direct measures available to establish legitimate 

medical need. 

State Medicaid fraud control units and medical licensure boards have 

taken action in response to reports of abuse and diversion of OxyContin. 

State Medicaid fraud control units have conducted investigations of abuse 

and diversion of OxyContin, but generally do not maintain precise data on 

the number of investigations and enforcement actions completed. 

Although complete information was not available from directors of state 

Medicaid fraud control units in Kentucky, Maryland, Pennsylvania, 

Virginia, and West Virginia with whom we spoke, each of those directors 

told us that abuse and diversion of OxyContin is a problem in his or her 

state. The directors told us that they had investigated cases that involved 

physicians or individuals who had either been indicted or prosecuted for 

writing medically unnecessary OxyContin prescriptions in exchange for 

cash or sexual relationships. 

State medical licensure boards have also responded to complaints about 

physicians who were suspected of abuse and diversion of controlled 

substances, but like the Medicaid fraud control units, the boards generally 

do not maintain data on the number of investigations that involved 

OxyContin. Representatives of state boards of medicine in Kentucky, 

Pennsylvania, Virginia, and West Virginia told us that they have received 

complaints from various sources, such as government agencies, health 

State Agencies Have 

Responded to Reports of 

OxyContin Abuse and 

Diversion 
Page 39 GAO-04-110 OxyContin Abuse and Diversion 

care professionals, and anonymous tipsters, about physicians suspected of 

abuse and diversion of controlled substances. However, each of the four 

representatives stated that his or her board does not track the complaints 

by specific drug type and consequently cannot determine whether the 

complaints received allege physicians’ misuse of OxyContin. Each of the 

four representatives also told us that his or her medical licensure board 

has adopted or strengthened guidelines or regulations for physicians on 

prescribing, administering, and dispensing controlled substances in the 

treatment of chronic pain. For example, in March 2001, the Kentucky 

Board of Medical Licensure adopted guidelines to clarify the board’s 

position on the use of controlled substances for nonterminal/nonmalignant 

chronic pain.51 The boards of medicine in Pennsylvania, Virginia, and West 

Virginia each have guidelines for the appropriate use of controlled 

substances that are similar to those adopted by Kentucky. 

In response to concerns about abuse and diversion of OxyContin, in April 

2001 FDA and Purdue began to discuss the development of a risk 

management plan to help detect and prevent abuse and diversion of 

OxyContin. Purdue submitted its risk management plan to FDA for review 

in August 2001.52 The plan includes some actions that Purdue proposed to 

take, as well as others that it has already taken. Purdue’s risk management 

plan includes actions such as strengthening the safety warnings on 

OxyContin’s label for professionals and patients, training Purdue’s sales 

force on the revised label, conducting comprehensive education programs 

for health care professionals, and developing a database for identifying 

and monitoring abuse and diversion of OxyContin. 

Under the risk management plan, OxyContin’s label was strengthened, 

effective in July 2001, by revising the physician prescribing information 

and adding a black box warning to call attention to OxyContin’s potential 

 51The Kentucky guidelines for the use of controlled substances in pain treatment provide 

that (1) a complete medical history and examination be conducted and documented in 

patient medical records, (2) a written treatment plan state objectives for determining 

treatment success, (3) the risks and benefits of the use of controlled substances be 

discussed by physician and patient, (4) periodic review of the course of treatment be 

conducted, (5) consultation or referral to an expert in pain management be considered for 

patients who are at risk for substance abuse, (6) patient’s medical record be kept accurate 

and complete, and (7) physicians be in compliance with applicable federal and state 

controlled substance laws and regulations. 

52Amended versions of Purdue’s risk management plan for OxyContin were submitted to 

FDA for review in April 2002 and in March 2003. 

Purdue Is Implementing a 

Risk Management Plan for 

OxyContin 
Page 40 GAO-04-110 OxyContin Abuse and Diversion 

for misuse, abuse, and diversion. (See app. II.) Purdue trained its sales 

force on the specifics of the revised label and provided sales 

representatives with updated information on the appropriate use of opioid 

analgesics, legal guidelines associated with promotion of its products, and 

their responsibility and role in reporting adverse events. Purdue also 

reiterated to its sales representatives that failure to promote products 

according to the approved label, promotional materials, and applicable 

FDA standards would result in disciplinary action by the company. 

According to Purdue, from April 2001 through May 2003 at least 10 Purdue 

employees were disciplined for using unapproved materials in promoting 

OxyContin. Disciplinary actions included warning letters, suspension 

without pay, and termination. 

Purdue also has provided education programs for health care 

professionals and the public under its risk management plan. For example, 

in 2001 Purdue supported seminars that examined ways health care 

professionals can help prevent abuse and diversion of opioids. Purdue 

worked with DEA and other law enforcement agencies to develop and 

implement antidiversion educational programs. In 2002, Purdue also 

launched the Web site painfullyobvious.com to educate teenagers, parents, 

law enforcement officers, and discussion leaders about the dangers of 

prescription drug abuse. 

Because reliable data on the abuse and diversion of controlled substance 

drugs are not available, Purdue developed the Researched Abuse, 

Diversion, and Addiction-Related Surveillance (RADARS) System, as part 

of its risk management plan, to study the nature and extent of abuse of 

OxyContin and other schedule II and III prescription medications and to 

implement interventions to reduce abuse and diversion.53 According to 

Purdue, RADARS collects and computes abuse, diversion, and addiction 

rates for certain drugs based on population and determines national and 

local trends. 

Since the launch of OxyContin, Purdue has provided its sales force with 

considerable information to help target physicians and prioritize sales 

contacts within a sales territory. Sales representatives routinely receive 

daily, weekly, monthly, and quarterly physician prescribing reports based 

 53RADARS will collect information on brand-name and generic versions of buprenorphine, 

fentanyl, hydrocodone, hydromorphone, oxycodone, morphine, and methadone. 

Benzodiazepine is scheduled to be added to RADARS in late 2003. 
Page 41 GAO-04-110 OxyContin Abuse and Diversion 

on IMS Health data that specify the physicians who have written 

prescriptions for OxyContin and other opioid analgesics, and the number 

of prescriptions written. Although this information has always been 

available for use by Purdue and its sales representatives, it was not until 

fall 2002 that Purdue directed its sales representatives to begin using 11 

indicators to identify possible abuse and diversion and to report the 

incidents to Purdue’s General Counsel’s Office for investigation. Among 

the possible indicators are a sudden unexplained change in a physician’s 

prescribing patterns that is not accounted for by changes in patient 

numbers, information from credible sources such as a pharmacist that a 

physician or his or her patients are diverting medications, or a physician 

who writes a large number of prescriptions for patients who pay with 

cash. As of September 2003, Purdue—through its own investigations—had 

identified 39 physicians and other health care professionals who were 

referred to legal, medical, or regulatory authorities for further action. Most 

of the 39 referrals stemmed from reports by Purdue’s sales force. 

Other actions included in the plan that were taken by Purdue prior to 

submission of its risk management plan include discontinuance of the 160-

milligram tablet of OxyContin to reduce the risk of overdose from this 

dosage strength, the development of unique markings for OxyContin 

tablets intended for distribution in Mexico and Canada to assist law 

enforcement in identifying OxyContin illegally smuggled into the United 

States, and the distribution of free tamper-resistant prescription pads 

designed to prevent altering or copying of the prescription. Purdue also 

implemented a program in 2001 to attempt to predict “hot spots” where 

OxyContin abuse and diversion were likely to occur, but discontinued the 

program in 2002 when Purdue concluded that nearly two-thirds of the 

counties identified had no abuse and diversion. 

At present, both federal agencies and the states have responsibilities 

involving prescription drugs and their abuse and diversion. FDA is 

responsible for approving new drugs and ensuring that the materials drug 

companies use to market and promote these drugs are truthful, balanced, 

and accurate. However, FDA examines these promotional materials only 

after they have been used in the marketplace because the FD&C Act 

generally does not give FDA authority to review these materials before the 

drug companies use them. Moreover, the FD&C Act provisions governing 

drug approval and promotional materials make no distinction between 

controlled substances, such as OxyContin, and other prescription drugs. 

DEA is responsible for registering handlers of controlled substances, 

approving production quotas and monitoring distribution of controlled 

Conclusions 
Page 42 GAO-04-110 OxyContin Abuse and Diversion 

substances to the retail level. It is the states, however, that are responsible 

for overseeing the practice of medicine and pharmacy where drugs are 

prescribed and dispensed. Some states have established prescription drug 

monitoring programs to help them detect and deter abuse and diversion. 

However, these programs exist in only 15 states and most do not 

proactively analyze prescription data to identify individuals, physicians, or 

pharmacies that have unusual use, prescribing, or dispensing patterns that 

may suggest potential drug diversion or abuse. 

The significant growth in the use of OxyContin to treat patients suffering 

from chronic pain has been accompanied by widespread reports of abuse 

and diversion that have in some cases led to deaths. The problem of abuse 

and diversion has highlighted shortcomings at the time of approval in the 

labeling of schedule II controlled substances, such as OxyContin, and in 

the plans in place to detect misuse, as well as in the infrastructure for 

detecting and preventing the abuse and diversion of schedule II controlled 

substances already on the market. 

Addressing abuse and diversion problems requires the collaborative 

efforts of pharmaceutical manufacturers; the federal and state agencies 

that oversee the approval and use of prescription drugs, particularly 

controlled substances; the health care providers who prescribe and 

dispense them; and law enforcement. After the problems with OxyContin 

began to surface, FDA and Purdue collaborated on a risk management 

plan to help detect and prevent abuse and diversion. Although risk 

management plans were not in use when OxyContin was approved, they 

are now an optional feature of new drug applications. FDA plans to 

complete its guidance to the pharmaceutical industry on risk management 

plans by September 30, 2004. The development of this guidance, coupled 

with FDA’s current review of proposed risk management plans for 

modified-release opioid analgesics, provides an opportunity to help ensure 

that manufacturers include a strategy to monitor the use of these drugs 

and to identify potential problems with abuse and diversion. 

To improve efforts to prevent or identify the abuse and diversion of 

schedule II controlled substances, we recommend that the Commissioner 

of Food and Drugs ensure that FDA’s risk management plan guidance 

encourages pharmaceutical manufacturers that submit new drug 

applications for these substances to include plans that contain a strategy 

for monitoring the use of these drugs and identifying potential abuse and 

diversion problems. 

Recommendation for 

Executive Action 
Page 43 GAO-04-110 OxyContin Abuse and Diversion 

We provided a draft of this report to FDA, DEA, and Purdue, the 

manufacturer of OxyContin, for their review. FDA and DEA provided 

written comments. (See apps. IV and V.) Purdue’s representatives provided 

oral comments. 

FDA said that it agreed with our recommendation that its risk 

management plan guidance should encourage all pharmaceutical 

manufacturers submitting new drug applications for schedule II controlled 

substances to include strategies to address abuse and diversion concerns. 

FDA stated that the agency is working on the risk management plan 

guidance. FDA also noted that the FD&C Act makes no distinction 

between controlled substances and other prescription drugs in its 

provisions regulating promotion, but that as a matter of general policy, the 

agency more closely scrutinizes promotion of drugs with more serious risk 

profiles. However, FDA does not have written guidance that specifies that 

promotional materials for controlled substances receive priority or special 

attention over similar materials for other prescription drugs. Furthermore, 

our finding that FDA did not review any of the OxyContin promotional 

videos provided by Purdue until we brought them to the agency’s attention 

raises questions about whether FDA provides extra attention to 

promotional materials for controlled substances that by definition have a 

high potential for abuse and may lead to severe psychological or physical 

dependence. FDA recommended that we clarify our description of the 

content of the warning letter issued to Purdue and provide additional 

information describing the extent of the corrective action taken by 

Purdue. FDA also recommended noting in the report that part of the risk 

management plan in connection with the 2001 labeling changes was a 

requirement that all OxyContin promotional materials be revised to reflect 

the labeling changes and all future materials prominently disclose this 

information. Finally, FDA noted that the promotional videos discussed in 

the report were submitted by Purdue prior to the labeling change and 

discontinued as a result of the labeling change. As we note in the report, 

Purdue acknowledged that all the promotional videos were not submitted 

to FDA at the time they were distributed. Moreover, although Purdue told 

us that these videos were no longer distributed after the label change, 

those videos that had been distributed were not collected and destroyed. 

We revised the report to reflect FDA’s general comments. FDA also 

provided technical comments that we incorporated where appropriate. 

In its written comments, DEA agreed that the data on abuse and diversion 

are not reliable, comprehensive, or timely, as we reported. DEA reiterated 

its previous statement that Purdue’s aggressive marketing of OxyContin 

fueled demand for the drug and exacerbated the drug’s abuse and 

Agency and Purdue 

Comments and Our 

Evaluation 
Page 44 GAO-04-110 OxyContin Abuse and Diversion 

diversion. DEA also stated that Purdue minimized the abuse risk 

associated with OxyContin. We agree with DEA that Purdue conducted an 

extensive campaign to market and promote OxyContin using an expanded 

sales force and multiple promotional approaches to encourage physicians, 

including primary care specialists, to prescribe OxyContin as an initial 

opioid treatment for noncancer pain, and that these efforts may have 

contributed to the problems with abuse and diversion by increasing the 

availability of the drug in the marketplace. However, we also noted that 

other factors may have contributed to these problems. We also agree that 

Purdue marketed OxyContin as having a low abuse liability, but we noted 

that this was based on information in the original label approved by FDA. 

DEA also acknowledged that the lack of a real measure of legitimate 

medical need for a specific product (OxyContin), substance (oxycodone), 

or even a class of substances (controlled release opioid analgesics) makes 

it difficult to limit manufacturing as a means of deterring abuse and 

diversion. DEA also noted that it is essential that risk management plans 

be put in place prior to the introduction of controlled substances into the 

marketplace, consistent with our recommendation. We revised the report 

to provide some additional detail on problems associated with OxyContin 

and Purdue’s marketing efforts. DEA provided some technical comments 

on the draft report that we incorporated where appropriate. 

Purdue representatives provided oral comments on a draft of this report. 

In general, they thought the report was fair and balanced; however, they 

offered both general and technical comments. Specifically, Purdue stated 

that the report should add the media as a factor contributing to the abuse 

and diversion of OxyContin because media stories provided the public 

with information on how to “get high” from using OxyContin incorrectly. 

Our report notes that the safety warning on the original label may have 

inadvertently alerted abusers to a possible method for misusing the drug. 

However, we note that the original label was publicly available from FDA 

once OxyContin was approved for marketing. Purdue also suggested that 

we include Duragesic, also a schedule II opioid analgesic, as a fourth 

comparable drug to OxyContin. The three comparable drugs we used in 

the report were chosen in consultation with FDA as comparable opioid 

analgesics to OxyContin, because they were time-released, morphinebased schedule II drugs formulated as tablets like OxyContin. In contrast, 

Duragesic, which contains the opioid analgesic fentanyl and provides pain 

relief over a 72-hour period, is formulated as a skin patch to be worn 

rather than as a tablet. Purdue representatives also provided technical 

comments that were incorporated where appropriate. 
Page 45 GAO-04-110 OxyContin Abuse and Diversion 

We also provided sections of this draft report to the manufacturers of 

three comparative drugs we examined. Two of the three companies with a 

drug product used as a comparable drug to OxyContin reviewed the 

portions of the draft report concerning their own product, and provided 

technical comments, which were incorporated where appropriate. The 

third company did not respond to our request for comments. 

As agreed with your offices, unless you publicly announce this report’s 

contents earlier, we plan no further distribution until 30 days after its issue 

date. At that time, we will send copies of this report to the Commissioner 

of Food and Drugs, the Administrator of the Drug Enforcement 

Administration, Purdue, and the other pharmaceutical companies whose 

drugs we examined. We will also make copies available to others upon 

request. In addition, the report will be available at no charge on the GAO 

Web site at http://www.gao.gov. 

If you or your staffs have any questions about this report, please call me at 

(202) 512-7119 or John Hansen at (202) 512-7105. Major contributors to 

this report were George Bogart, Darryl Joyce, Roseanne Price, and Opal 

Winebrenner. 

Marcia Crosse 

Director, Health Care—Public Health 

 and Military Health Care Issues 
Appendix I: Scope and Methodology 

Page 46 GAO-04-110 OxyContin Abuse and Diversion 

To identify the strategies and approaches used by Purdue Pharma L.P. 

(Purdue) to market and promote OxyContin, we interviewed Purdue 

officials and analyzed company documents and data. Specifically, we 

interviewed Purdue officials concerning its marketing and promotional 

strategies for OxyContin, including its targeting of physicians with specific 

specialties and its sales compensation plan to provide sales 

representatives with incentives for the drug’s sales. We also interviewed 

selected Purdue sales representatives who had high and midrange sales 

during 2001 from Kentucky, Pennsylvania, Virginia, and West Virginia—

four states that were initially identified by the Drug Enforcement Agency 

(DEA) as having a high incidence of OxyContin drug abuse and 

diversion—and from California, Massachusetts, and New Jersey—three 

states that DEA did not initially identify as having problems with 

OxyContin. We asked the sales representatives about their training, 

promotional strategies and activities, and targeting of physicians. We also 

interviewed physicians who were among the highest prescribers of 

OxyContin regarding their experiences with Purdue sales representatives, 

including the strategies used to promote OxyContin, as well as their 

experiences with sales representatives of manufacturers of other opioid 

analgesics. We reviewed Purdue’s quarterly action plans for marketing and 

promoting OxyContin for 1996 through 2003, Purdue’s sales representative 

training materials, and materials from ongoing OxyContin-related 

litigation. To obtain information on how Purdue’s marketing and 

promotion of OxyContin compared to that of other companies, we 

identified, in consultation with the Food and Drug Administration (FDA), 

three opioid analgesics that were similar to OxyContin. The three drugs—

Avinza, Kadian, and Oramorph SR—are all time-released, morphine-based 

analgesics that are classified as schedule II controlled substances. We 

examined the promotional materials each drug’s manufacturer submitted 

to FDA and any actions FDA had taken against the manufacturers related 

to how the drugs were marketed or promoted. We also interviewed 

company officials about how they marketed and promoted their respective 

drugs. Because of their concerns about proprietary information, the three 

companies did not provide us with the same level of detail about their 

drugs’ marketing and promotion as did Purdue. 

To examine factors that contributed to the abuse and diversion of 

OxyContin, we reviewed DEA abuse and diversion data as part of an effort 

to compare them with DEA’s OxyContin state distribution data and with 

IMS Health data on the rates of OxyContin sales and prescription 

dispensing to determine if they occurred in similar geographic areas. We 

also analyzed the distribution of Purdue sales representatives by state and 

compared them with the availability of OxyContin and abuse and diversion 

Appendix I: Scope and Methodology 
Appendix I: Scope and Methodology 

Page 47 GAO-04-110 OxyContin Abuse and Diversion 

data to determine whether states with high rates of OxyContin sales and 

prescription dispensing and abuse and diversion problems had more sales 

representatives per capita than other states. However, limitations in the 

abuse and diversion data prevent an assessment of the relationship 

between the availability of OxyContin and areas where the drug was 

abused and diverted. We also reviewed the High Intensity Drug Trafficking 

Area (HIDTA) reports on states with histories of illegal drug activities. We 

interviewed DEA and FDA officials, physicians who prescribed 

OxyContin, officials from physician licensing boards in selected states, 

officials from national health practitioner groups, and company officials 

and sales representatives about why OxyContin abuse and diversion have 

occurred. 

To determine the efforts federal and state agencies and Purdue have made 

to identify and prevent abuse and diversion of controlled substances such 

as OxyContin, we interviewed FDA officials and analyzed information 

from FDA regarding the marketing and promotion of controlled 

substances, specifically OxyContin; FDA’s decision to approve the original 

label for OxyContin; and FDA’s subsequent decision to revise OxyContin’s 

labeling, as well as FDA’s role in monitoring OxyContin’s marketing and 

advertising activities. We also interviewed DEA officials about the 

agency’s efforts to identify and prevent abuse and diversion, including its 

national action plan for OxyContin, and how it determines the prevalence 

of OxyContin abuse and diversion nationally. We also interviewed officials 

from national practitioner associations, Medicaid fraud control units, and 

physician licensing boards in states with initial reports of abuse and 

diversion—Kentucky, Maryland, Pennsylvania, Virginia, and West 

Virginia—regarding concerns they had about the abuse and diversion of 

OxyContin. We reviewed Purdue’s OxyContin risk management plan 

submissions to FDA from 2001 through 2003 to identify actions taken by 

Purdue to address abuse and diversion of OxyContin. 
Appendix II: Summary of FDA Changes to the 

Original Approved OxyContin Label 

Page 48 GAO-04-110 OxyContin Abuse and Diversion 

Table 5 provides a description of the changes made by FDA to sections of 

the original OxyContin approved label from June 1996 through July 2001. 

These changes included a black box warning, the strongest warning an 

FDA-approved drug can carry, and specifically addressed areas of concern 

related to the opioid characteristics of oxycodone and its risk of abuse and 

diversion. 

Table 5: FDA Changes to the Original OxyContin Label Made from June 1996 through July 2001 

Summary of FDA changes to original 

OxyContin label in 2001 Language in OxyContin label approved in 2001 

Black box warning was added to stress the opioid 

nature of oxycodone and risks for abuse and 

diversion of the drug. 

“WARNING: 

OxyContin is an opioid agonist and a Schedule II controlled substance 

with an abuse liability similar to morphine. 

Oxycodone can be abused in a manner similar to other opioid agonists, legal or 

illicit. This should be considered when prescribing or dispensing OxyContin in 

situations where the physician or pharmacist is concerned about an increased 

risk of misuse, abuse, or diversion. 

OxyContin Tablets are a controlled-release oral formulation of oxycodone 

hydrochloride indicated for the management of moderate to severe pain 

when a continuous, around-the-clock analgesic is needed for an extended 

period of time. 

OxyContin Tablets are NOT intended for use as a prn analgesic. OxyContin 80 

mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS 

ONLY. These tablet strengths may cause fatal respiratory depression 

when administered to patients not previously exposed to opioids. 

OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT 

TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, 

OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND 

ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.” 

Clinical pharmacology 

—Provides a pharmacological description of 

oxycodone as a pure opioid agonist whose principal 

action is analgesia. 

—Identifies other members of the opioid agonist 

class, such as morphine, hydromorphone, fentanyl, 

and hydrocodone. 

—Describes the pharmacological properties of 

opioids in general (anxiolysis, euphoria, feelings of 

relaxation, respiratory depression, constipation, 

miosis, cough suppression, and analgesia). 

—Describes respiratory depression as one of the 

most serious side effects of opioids that could lead 

to overdose or death. 

“CLINICAL PHARMACOLOGY 

Oxycodone is a pure agonist opioid whose principal therapeutic action is 

analgesia. Other members of the class known as opioid agonists include 

substances such as morphine, hydromorphone, fentanyl, codeine, and 

hydrocodone. Pharmacological effects of opioid agonists include anxiolysis, 

euphoria, feelings of relaxation, respiratory depression, constipation, miosis, 

and cough suppression, as well as analgesia. Like all pure opioid agonist 

analgesics, with increasing doses there is increasing analgesia, unlike with 

mixed agonist/antagonists or non-opioid analgesics, where there is a limit to the 

analgesic effect with increasing doses. With pure opioid agonist analgesics, 

there is no defined maximum dose; the ceiling to analgesic effectiveness is 

imposed only by side effects, the more serious of which may include 

somnolence and respiratory depression.” 

Appendix II: Summary of FDA Changes to the 

Original Approved OxyContin Label 
Appendix II: Summary of FDA Changes to the 

Original Approved OxyContin Label 

Page 49 GAO-04-110 OxyContin Abuse and Diversion 

Summary of FDA changes to original 

OxyContin label in 2001 Language in OxyContin label approved in 2001 

Misuse, abuse, and diversion of opioids 

A subsection on misuse, abuse and diversion was 

added to the WARNINGS section of the label. 

—Characterizes oxycodone as an opioid agonist of 

the morphine-type and stresses that opioid agonists 

are sought by drug abusers and people with 

addiction disorders and are subject to diversion. 

—Makes clear that oxycodone can be abused in a 

manner similar to other opioid agonists, legal or 

illicit, and that physicians and pharmacists should 

be aware of and alert to risk of misuse, abuse, and 

diversion when prescribing or dispensing 

oxycodone. 

—Modifies original label statement that iatrogenic 

addiction (addiction induced inadvertently by a 

physician or a physician’s treatment) is rare if 

opioids were legitimately used in the management 

of pain to state that data are not available to 

establish the true incidence of addiction in chronic 

patients. 

“Misuse, Abuse and Diversion of Opioids 

Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by 

drug abusers and people with addiction disorders and are subject to criminal 

diversion. 

Oxycodone can be abused in a manner similar to other opioid agonists, legal or 

illicit. This should be considered when prescribing or dispensing OxyContin in 

situations where the physician or pharmacist is concerned about an increased 

risk of misuse, abuse, or diversion. 

OxyContin has been reported as being abused by crushing, chewing, snorting, 

or injecting the dissolved product. These practices will result in the uncontrolled 

delivery of the opioid and pose a significant risk to the abuser that could result 

in overdose and death (see WARNINGS and DRUG ABUSE AND 

ADDICTION). 

Concerns about abuse, addiction, and diversion should not prevent the proper 

management of pain. The development of addiction to opioid analgesics in 

properly managed patients with pain has been reported to be rare. However, 

data are not available to establish the true incidence of addiction in chronic pain 

patients. 

Healthcare professionals should contact their State Professional Licensing 

Board, or State Controlled Substances Authority for information on how to 

prevent and detect abuse of this product.” 
Appendix II: Summary of FDA Changes to the 

Original Approved OxyContin Label 

Page 50 GAO-04-110 OxyContin Abuse and Diversion 

Summary of FDA changes to original 

OxyContin label in 2001 Language in OxyContin label approved in 2001 

Drug abuse and addiction 

—Emphasizes that the abuse potential of 

oxycodone is equivalent to that of morphine. 

—Describes the controlled status of OxyContin and 

emphasizes that, like morphine and other opioids 

used in analgesia, oxycodone can be abused and 

is subject to criminal diversion. 

—Stresses proper prescribing practices, 

dispensing, and storage. 

—Deletes statement that delayed absorption of 

OxyContin was believed to reduce the abuse 

liability of the drug. 

—Stresses the risks associated with parenteral 

injection of OxyContin and reiterates the original 

label’s description of drug addiction and “drugseeking” behaviors commonly in addicts and 

abusers. 

“DRUG ABUSE AND ADDICTION 

OxyContin is a mu-agonist with an abuse liability similar to morphine and 

is a Schedule II controlled substance. Oxycodone, like morphine and 

other opioids used in analgesia, can be abused and is subject to criminal 

diversion. 

Drug addiction is characterized by compulsive use, use for non-medical 

purposes, and continued use despite harm or risk of harm. Drug addiction is a 

treatable disease, utilizing a multi-disciplinary approach, but relapse is common.

“Drug-seeking” behavior is very common in addicts and drug abusers. Drugseeking tactics include emergency calls or visits near the end of office hours, 

refusal to undergo appropriate examination, testing or referral, repeated “loss” 

of prescriptions, tampering with prescriptions, and reluctance to provide prior 

medical records or contact information for other treating physician(s). “Doctor 

shopping” to obtain additional prescriptions is common among drug abusers 

and people suffering from untreated addiction. 

Abuse and addiction are separate and distinct from physical dependence and 

tolerance. Physicians should be aware that addiction may not be accompanied 

by concurrent tolerance and symptoms of physical dependence in all addicts. In 

addition, abuse of opioids can occur in the absence of true addiction and is 

characterized by misuse for non-medical purposes, often in combination with 

other psychoactive substances. OxyContin, like other opioids, has been 

diverted for non-medical use. Careful record keeping of prescribing information, 

including quantity, frequency, and renewal requests is strongly advised. 

Proper assessment of the patient, proper prescribing practices, periodic 

reevaluation of therapy, and proper dispensing and storage are appropriate 

measures that help to limit abuse of opioid drugs. 

OxyContin consists of a dual-polymer matrix, intended for oral use only. 

Abuse of the crushed tablet poses a hazard of overdose and death. This 

risk is increased with concurrent abuse of alcohol and other substances. 

With parenteral abuse, the tablet excipients, especially talc, can be 

expected to result in local tissue necrosis, infection, pulmonary 

granulomas, and increased risk of enocarditis and valvular heart injury. 

Parenteral drug abuse is commonly associated with transmission of 

infectious disease such as hepatitis and HIV.” 

Safety and handling 

—Emphasizes the controlled status of OxyContin. 

—Alerts health care professionals that OxyContin 

could be a target for theft and diversion and 

instructs that they should contact their State 

Professional Licensing Board or State Controlled 

Substances Authority for information on how to 

prevent and detect abuse or diversion of the 

product. 

“SAFETY AND HANDLING 

OxyContin Tablets are solid dosage forms that contain oxycodone which is a 

controlled substance. Like morphine, oxycodone is controlled under Schedule II 

of the Controlled Substances Act. 

OxyContin has been targeted for theft and diversion by criminals. Healthcare 

professionals should contact their State Professional Licensing Board or State 

Controlled Substances Authority for information on how to prevent and detect 

abuse or diversion of this product.” 

Source: FDA-approved label for Purdue’s OxyContin. 
Appendix III: Databases Used to Monitor 

Abuse and Diversion of OxyContin and Its 

Active Ingredient Oxycodone 

Page 51 GAO-04-110 OxyContin Abuse and Diversion 

DEA uses several databases to monitor abuse and diversion of controlled 

substances, including OxyContin and its active ingredient oxycodone. 

Specifically, the agency monitors three major databases—the Drug Abuse 

Warning Network (DAWN), the National Forensic Laboratory Information 

System (NFLIS), and the System to Retrieve Information from Drug 

Evidence (STRIDE).1 DEA also monitors other data sources to identify 

trends in OxyContin abuse and diversion, such as the Substance Abuse 

and Mental Health Services Administration’s (SAMHSA) National Survey 

on Drug Use and Health, formerly the National Household Survey on Drug 

Abuse, and the Monitoring the Future Study funded by the National 

Institute on Drug Abuse.2

SAMHSA operates the DAWN system, which estimates national drugrelated emergency department visits and provides death counts involving 

abused drugs. DAWN collects data semiannually on drug abuse from 

hospital emergency department admission and medical examiner data 

from 21 metropolitan areas and a limited number of metropolitan medical 

examiners who agree to voluntarily report medical record samples. The 

emergency department and medical examiner data generally do not 

differentiate oxycodone from OxyContin, unless the individual provides 

the information to the hospital or identifiable tablets are found with the 

person. Although samples from hospitals outside the 21 metropolitan areas 

are also available, DAWN is not able to make drug-related emergency 

department visit or death estimates for rural or suburban areas. 

NFLIS, a DEA-sponsored project initiated in 1997, collects the results of 

state and local forensic laboratories’ analyses of drugs seized as evidence 

by law enforcement agencies. NFLIS is used to track drug abuse and 

trafficking involving both controlled and noncontrolled substances and 

reports results by a drug’s substance, such as oxycodone, and not by its 

brand name. DEA stated that because new laboratories are being added, 

 1

Other databases used by DEA to assess changes in drug abuse and diversion include the 

Drug Early Warning System, the Drug and Alcohol Services Information System, the 

Treatment Episode Data Set, the National Survey of Substance Abuse Treatment Services, 

the Uniform Facility Data Set, the Poison Control Center Data or Toxic Exposure 

Surveillance System, the Automation of Reports and Consolidated Ordering System, the 

DEA Theft System, and the DEA Field Reports and Investigative Teletypes. 

2

The National Institute on Drug Abuse is part of the National Institutes of Health within the 

Department of Health and Human Services. 

Appendix III: Databases Used to Monitor 

Abuse and Diversion of OxyContin and Its 

Active Ingredient Oxycodone 

DAWN Data 

NFLIS Data 
Appendix III: Databases Used to Monitor 

Abuse and Diversion of OxyContin and Its 

Active Ingredient Oxycodone 

Page 52 GAO-04-110 OxyContin Abuse and Diversion 

its data should not yet be used for trending purposes. As of March 2003, 

35 state laboratories and 52 local or municipal laboratories participated in 

the project. 

STRIDE, another DEA database, reports the results of chemical evidence 

analysis done by DEA laboratories in drug diversion and trafficking cases. 

Oxycodone data are reported by combining single and combination 

oxycodone drugs and do not provide specific enough information to 

distinguish OxyContin cases and exhibits. The database’s lag time, which 

varies by laboratory, depends on how quickly the findings are entered 

after the seizure of the drug substance and its analysis. 

The National Survey on Drug Use and Health, another SAMHSA database, 

is used to develop national and state estimates of trends in drug 

consumption.3

 Prior to 2001, the self-reported survey asked participants if 

they had illicitly used any drug containing oxycodone. In 2001, the survey 

included a separate section for pain relievers, and asked participants if 

they had used OxyContin, identifying it by its brand name, that had not 

been prescribed for them. State samples from the survey are combined to 

make national- and state-level estimates of drug use, and because the 

estimated numbers derived for OxyContin are so small, it is not possible to 

project illicit OxyContin use on a regional, state, or county basis. 

The Monitoring the Future Survey, funded by the National Institute on 

Drug Abuse and conducted by the University of Michigan, annually 

monitors the illicit use of drugs by adolescent students in the 8th, 10th, 

and 12th grades. The 2002 survey included new questions using the brand 

names of four drugs, including OxyContin, in its survey on the annual and 

30-day prevalence of drug use. 

 3

Self-reporting individuals are interviewed regarding their illicit drug use over three 

periods—within the last 30 days, during the past year, and during their lifetime. The survey 

data are limited, as it is not possible to determine specifically which year respondents may 

have used a drug illicitly, because they are asked both whether they have ever used the 

drug illicitly in their lifetime and whether they have used it during the past year. 

STRIDE Data 

National Survey on 

Drug Use and Health 

Data 

Monitoring the Future 

Survey Data 
Appendix IV: Comments from the Food and 

Drug Administration 

Page 53 GAO-04-110 OxyContin Abuse and Diversion 

Appendix IV: Comments from the Food and 

Drug Administration 
Appendix IV: Comments from the Food and 

Drug Administration 

Page 54 GAO-04-110 OxyContin Abuse and Diversion 
Appendix IV: Comments from the Food and 

Drug Administration 

Page 55 GAO-04-110 OxyContin Abuse and Diversion 
Appendix V: Comments from the Drug 

Enforcement Administration 

Page 56 GAO-04-110 OxyContin Abuse and Diversion 

Appendix V: Comments from the Drug 

Enforcement Administration 
Appendix V: Comments from the Drug 

Enforcement Administration 

Page 57 GAO-04-110 OxyContin Abuse and Diversion (290206) 
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