Written Statement of
Joseph T. Rannazzisi
United States Department of Justice
United States House of Representatives Energy & Commerce Committee
Chairman Whitfield, Ranking Member Stupak, and distinguished Members of the Subcommittee, on behalf of Administrator Karen P. Tandy, and the men and women of the Drug Enforcement Administration, thank you for the opportunity to discuss our efforts to combat the illegal distribution of controlled substance pharmaceuticals via the Internet.
The illegal sale of pharmaceuticals over the Internet, the most dangerous of which are also controlled substances, continues to be a significant challenge facing the DEA. Internet-based drug traffickers, most commonly selling pharmaceutical substances or those marketed as pharmaceutical substances, often mask their activities as those of legitimate online pharmacies. Their illicit products have no guarantee of safety or effectiveness and offer no assurance of meeting appropriate handling, storage, or shipping standards. Perhaps most disturbing is that many of these Internet pharmaceutical sites—calling them “pharmacies” gives them more credit than they deserve-- are hiding behind a façade of legitimacy by pretending to ask customers health questions. After customers fill out a superficial questionnaire, which is given an even more cursory review (if any) by a doctor employed by the internet pharmacy, these sites provide pharmaceutical products with no face-to-face medical examination, no tests, no drug interaction screening, and no follow-up care.
Trends in Abuse
Problem of Internet Drug Trafficking
Internet drug traffickers offer drugs for sale without a prescription, without benefit of a legitimate doctor-patient relationship, and at highly inflated prices. Recent DEA investigations involving pharmaceutical drug traffickers using the façade of legitimate online pharmacies reveal pharmaceutical controlled substances being sold at four to ten times the price offered by legitimate “brick and mortar” pharmacies. In all cases, the online scheme is perpetrated by collaborators seeking to profit by trafficking either diverted or counterfeit drugs.
Purchasing pharmaceuticals over the Internet exposes consumers to risks such as purchasing a product that is counterfeit, is improperly handled or stored, is contaminated, or is lacking any warnings or instructions for use. With few exceptions, the consumer has no idea of the content of the substances they are receiving.
Internet traffickers who illegally offer pharmaceutical controlled substances through their websites frequently share characteristics, such as:
Pharmaceuticals can be purchased legitimately over the Internet, but only if the proper protocols are followed. Currently, there are only 12 DEA-registered pharmacies that have been included on a list of Verified Internet Pharmacy Practice Sites (VIPPS) compiled by the National Association of Boards of Pharmacy (NABP), an independent, non-profit organization of licensing boards. The NABP list identifies to the public those online pharmacy practice sites that are appropriately licensed, are legitimately operating via the Internet, and that have successfully completed a rigorous criteria review and inspection. Most other Internet pharmaceutical sales in the United States are legally suspect and potentially very dangerous.
DEA Enforcement Activity
The DEA focuses a significant amount of its resources on attacking Priority Target Organizations (PTOs), which are major drug supply and money laundering organizations operating at the international, national, regional, and local levels that have a significant impact on drug availability. DEA’s core competency, the disruption and dismantlement of drug trafficking organizations impacting the United States, is an integral component to both the Department of Justice’s Strategic Plan for Fiscal Years 2003 – 2008 and The President’s National Drug Control Strategy, February 2005. A concerted organizational attack is the focus of our effort to counter drug traffickers utilizing the Internet to facilitate their illicit trade.
As of October 2005, DEA has initiated 236 investigations of online sales of controlled substances without a prescription. In FY 2004, as a result of online pharmacy investigations, DEA seized over $14.5 million in cash, bank accounts, property and computers—a 480 percent increase over 2003 ($2.5 million). Two operations in particular warrant specific mention:
Operation Cyber Chase
I highlighted the cooperation between the DEA and our international, federal, state, and local law enforcement partners because, particularly when we are discussing Internet investigations, no significant investigation could take place without a well coordinated effort. Traditional geographic lines of jurisdiction do not exist on the Internet, yet law enforcement must abide by such limits. This means that collaboration is a key component to successfully investigating and arresting those who are nothing more than drug dealers utilizing the anonymity of the Internet to ply their trade.
To better facilitate this interagency cooperation, a federal interagency task force was established in early 2004 with the purpose addressing Internet diversion of drugs and conducting public outreach on pharmaceutical issues in general. Among other groups, DEA, ONDCP, ICE, CBP, and FDA have been represented at task force meetings past and present. A major focus of this evolving task force has been to reach out to business leaders in key industry sectors that provide services used by Internet pharmaceutical trafficking groups. The purpose of this outreach has been twofold: to raise awareness of the problem; and to elicit voluntary efforts to restrict their services from being used by illicit Internet pharmaceutical traffickers. The task force has also provided support to DEA through ICE and CBP special authorities. ICE and CBP have primary jurisdiction in the enforcement of trans-border smuggling laws and periodically conduct interdiction operations at international mail facilities to identify packages containing illicit pharmaceuticals. The task force meets quarterly and is currently evaluating options for establishing a single reporting point for businesses to report suspicious Internet pharmaceutical sites.
In January and July 2005, DEA in conjunction with the Department of Justice Narcotics and Dangerous Drugs Section hosted a training seminar for Assistant United States Attorneys and DEA personnel to share information on prosecution and investigative strategies for targeting pharmaceutical diversion of controlled substances.
DEA/Private Industry Initiatives
To successfully ply their trade, Internet drug traffickers must rely extensively on the commercial services of three principal business sectors: (1) providers of various internet services – including web hosting, domain name registration, and search; (2) express package delivery companies; and (3) financial services companies, including major credit card companies and third party payment service providers. The DEA has reached out to each of these sectors and is working to educate and facilitate their assistance in shutting down Internet drug trafficking operations.
Several interagency meetings have been held with senior managers and legal counsel from leading Internet, express parcel carriers, and financial services companies. These meetings provided an opportunity for government and the private sector to reach a better understanding of relevant federal laws and explore areas of potential cooperation and voluntary industry actions to curb the expanding illicit sale of pharmaceuticals over the Internet.
DEA Field Offices have also taken action to help with this threat. Diversion Investigators conduct on-site licensing inspections to ensure that the pharmacy is aware of its responsibilities under the law. New pharmacy applicants or those seeking a renewal through on-line procedures are now linked to the April 2001 Federal Registrant Guidance Document regarding “Dispensing and Purchasing Controlled Substances over the Internet.” Titled “Retail Pharmacy Advisory,” this pop up link takes the applicant to the aforementioned Federal Register notice outlining important information for prescribers, pharmacists, and law enforcement alike.
We believe that because of this initiative, many illegal Internet pharmaceutical sites are now unable to purchase large quantities of controlled substances for illegal sale domestically. While this is an effective approach to go after some of the domestic sources of illegal pharmaceuticals supplying the Internet, this will not affect foreign sources of pharmaceuticals. The global nature of the Internet adds to this challenge, as many substances which are controlled in the United States are not controlled elsewhere, and therefore offering to sell these substances on line is not illegal per se.
As a consequence of these and other initiatives, DEA is able to effectively monitor both the supply and dispensing sides of the domestic Internet trafficking problem. The communication between the DEA and the distributors continues to increase. An example of increased cooperation is the fact that distributors are notifying DEA of potential targets, unusual purchasing patterns, and queries from the potential illegitimate Internet pharmacies who have been effectively cut off from supplies by this initiative.
Although no special DEA registration is currently required to market controlled substances online, the tangible aspects of manufacturing, distributing, prescribing, and dispensing pharmaceutical controlled substances remain squarely under the jurisdiction of the Controlled Substances Act. Any legitimate transaction over the Internet must be in compliance with these existing laws. Additional clarification of the roles and responsibilities for professionals seeking to use the Internet to meet the needs of clients would not only allow us to more readily identify legitimate online pharmacies and persons operating and promoting them, but it would also assist in gathering information pointing to patterns of abuse. Such clarification would also help us investigate the illegal traffickers hiding behind the façade of an otherwise legitimate practice.
In addition, there exists no statutory definition specifically outlining what constitutes a valid “doctor/patient” relationship. Further, the penalties associated with the illegal sale of Schedule III-V substances are not as significant as may be warranted.
This does not mean however that Internet drug traffickers can operate freely, as demonstrated by Operations CYBERx and Cyber Chase. The DEA will continue to promote public/private sector and international collaborative actions and use our existing authority to investigate and arrest the individuals illegally selling controlled substances. The increasing support that we receive from key sectors of the Internet-related business community is essential to turning the tide in this critical area of drug trafficking and abuse. The DEA is committed to developing this relationship even further.
The Internet is a universe that by its very nature is impossible to fully monitor, regulate, and control. While drug traffickers who exploit the Internet to target America’s most vulnerable continue to pose a significant threat to citizens’ lives and health across the country, the DEA has learned from experience and refined its methods by which we identify, pursue, and ultimately dismantle these groups.
I appreciate the opportunity to testify here today and look forward to answering any questions the subcommittee may have.
I Non-medicinal use of prescription-type pain relievers, tranquilizers, stimulants, or sedatives; does not include over-the-counter drugs