The House Committee on Energy and Commerce

Prepared Statement of The Honorable Ed Whitfield

Safety of Imported Pharmaceuticals: Strengthening Efforts to Combat the Sales of Controlled Substances Over the Internet

Subcommittee on Oversight and Investigations
December 13, 2005

Today's hearing focuses on strengthening the efforts to combat the sales of controlled substances over the Internet. What are these controlled substances of concern? Prescription drugs with wide appeal among drug abusers such as Percoset, Vicodin, and Darvon, anabolic steroids, and Valium.

We at this Committee have long been interested in and committed to protecting the safety of America's pharmaceutical supply. The Committee has played a key role in the enactment of the Prescription Drug Marketing Act in 1987, and the Bioterrorism Preparedness Act in 2002. To that end, this Subcommittee has held a number of hearings related to the safety of imported drugs over the last seven years. However, today's hearing focuses on a subset of imported drug concerns: the particular problem of controlled substances sold over the Internet by rogue pharmacies. Unfortunately, with the advent of the Internet in the last few years, obtaining controlled substances illicitly online has become too convenient. Most illicit Internet pharmacies offer controlled substances without valid prescriptions. Many of these sites substitute a simple online questionnaire for a face-to-face examination of the patient by a physician.

While the Government Accountability Office (GAO) recently found that there is no systematic collection of data on the volume of controlled substances encountered at mail and carrier facilities to establish an exact measurement, the federal authorities do not dispute that this volume is substantial and have undertaken actions to curb this problem. Available information documents a growing and serious public health priority justifying the actions already undertaken as well as other possible future actions. For example, according to the FDA/Customs blitz conducted in the summer of 2003 at the Miami, New York (JFK Airport), San Francisco, and Carson, CA international mail facilities, of the imported pharmaceutical product found, 28 percent of the drugs tested were controlled substances, representing over 25 different control substances. Based on the JFK estimate by senior Customs officials that 40,000 parcels containing drugs are imported through that airport on a daily basis, as many as 11,200 drug parcels containing controlled substances are imported daily through JFK.

A February 2004 study by the National Center on Addiction and Substance Abuse in partnership with a private investigative firm documented the availability of controlled prescription drugs on the Internet. It is important to note that it is difficult to ascertain the exact number of these Internet pharmacies. Of the 495 websites offering Schedule II-V controlled prescription drugs identified in the study, only about a third (157) were "anchor" sites, where consumers actually purchase the drugs. 90% of these sites did not require a prescription. 47% of these sites disclosed that the drugs would be coming from outside the United States and 25% gave no indication where the drugs would be coming from. The remaining sixty-eight percent of the 495 total websites were portal sites. Portal sites do not sell drugs but act as a conduit to other websites, including anchor sites, which sell the drugs. The report also found that 73% of drugs offered on these websites were Schedule II and III controlled substances. Only 6% of the websites in the study required a prescription in order to purchase drugs. About half of the sites offered only an online "consultation," a practice that the American Medical Association has found not to meet appropriate standards of medical care.

Likewise, we will hear testimony from the GAO about its recent report that also documented the wide availability of highly addictive controlled substances over the Internet. And as the GAO notes in its report, both the Drug Enforcement Administration (DEA) and the Office of National Drug Control Policy (ONDCP) have found that the easy availability of controlled substances directly to consumers over the Internet has significant implications for public health, given the opportunities for misuse and abuse of these addictive drugs.

According to an article in the February 21, 2005 U.S. News and World Report, although prescription-drug abuse is rising among all age groups, law enforcement officials are especially concerned about abuse among teenagers: One in 10 high school seniors has tried the painkiller Vicodin without a prescription, and 1 in 20 has taken the potent pill OxyContin. For young people in particular, online pharmacies seem especially seductive. For this generation, the Internet is a familiar medium and it feels safe. Controlled substances are easily sold over the Internet by not attracting attention and looking legitimate. Postings skillfully blend these drugs with other apparently legal or "lifestyle" drugs. The seduction and convenience of the Internet coupled with the wide availability of controlled substances raises a disturbing prospect of many young people hooked on drugs with the ease of logging on to a computer.

The convenience and seductiveness of the Internet and the wide availability of controlled substances over the Internet has already had tragic consequences. On February 21, 2001, Ryan Haight died at the age of 18 of an overdose after mixing morphine and two prescription antidepressants with Hydrocodone, a potent and highly addictive painkiller that he bought from an Internet pharmacy in Oklahoma. Ryan was 17 and complaining of back and joint pain when he started ordering prescription painkillers from Internet pharmacies. On June 7, 2001, the parents of Todd Rode (pronounced RO-DEE) told this Subcommittee their heart-wrenching story of finding their son dead in his apartment. According to the medical examiner, Todd's death was caused by a massive overdose of controlled substances that Todd ordered from a foreign Internet pharmacy. Last year, DEA testified that its investigations have discovered 14 deaths or overdoses and 15 people who have entered treatment or sustained injuries from drugs obtained over the Internet.

Moreover, in the course of its oversight work, the Committee has become acquainted with ICG, Inc. of Princeton, New Jersey and its investigative work on Internet pharmacies. Last July, ICG provided a briefing I convened for the Subcommittee members. As a result of that briefing, I requested as a test of its investigative capabilities that ICG gather intelligence on a series of websites selling controlled substances identified by the Majority and Minority Committee staff. The results of that work as well as other investigations of websites marketing controlled substances will be presented publicly for the first time at this hearing. This White Paper will provide more details for consideration in how to strengthen efforts to combat sales of controlled substances over the Internet. In addition, at the invitation of the Majority and Minority Committee staff, ICG last week briefed representatives from credit card companies, consignment carriers, and the Internet community. That meeting has already led to beneficial exchanges of information and may lead to constructive and proactive working relationships in the private sector.

While we note the growing problem of controlled substances over the Internet and consider additional new approaches to curb the sales of these products, we will also examine what the federal agencies have accomplished, especially during the last year.

For example, last September, the DEA announced a new "Virtual Enforcement Initiative," part of which included Operation CYBERx. That investigation led to the arrests of 17 people who operated rogue Internet pharmacies that took orders for controlled substances over the Internet and then shipped these products to U.S. citizens without a valid prescription. Those arrested included the ringleaders of more than 4,600 rogue Internet pharmacy websites. On July 15, 2005, the Attorney General of the State of Florida announced the state's largest prosecution of an organization filling Internet order for controlled substances. These arrests in this operation resulted from an investigation involving a collaborative task force involving the DEA. Last April, the DEA led Operation Cyber Chase, which resulted in more than 20 arrests in eight U.S. cities and four foreign countries, shutting down an organization that ran over 200 web sites illegally selling what were identified as controlled substances such as Ritalin, Xanax, and Valium.

In September 2004, the Bureau of Customs and Border Protection ('Customs") implemented a national policy for processing controlled substances, schedule III through V, imported through the mail and carrier facilities. Under this new policy, packages containing controlled substances in schedules III through V are no longer transferred to FDA for disposition , released to the addressee, or returned to the sender. Instead, Customs can now hold these packages as unclaimed or abandoned property as an alternative to seizure. According to the GAO, Customs reported that the recent policy improved their ability to quickly process the volume of this category of packages. Customs recently reported to this Committee that a full year of this new policy resulted in over 72,000 interdictions, with almost all of these parcels abandoned and disposed, and only 120 individuals electing to pursue a formal seizure proceeding. As the GAO noted, with Customs implementing this new policy, a more reliable and systematic approach to data gathering could result by using information collected by Customs and FDA at various field locations, including the number of packages deemed abandoned by CBP. Finally, the GAO notes that working groups of a federal interagency task force are working cooperatively with the carriers, credit card companies, and Internet businesses to develop more policy solutions relevant to the imported controlled substances problem.

I personally have been very interested in the safety of imported drugs, and in particular, the problem of controlled substances. The people in my homestate of Kentucky have been significantly harmed by prescription drug abuse, including the misuse of controlled drugs containing hydrocodone. In light of this concern, I am pleased to say that the State of Kentucky recently enacted a new law this year, and effective this past June, that law makes it illegal to ship a prescription drug to a pharmacy or a pharmacist not registered with the Kentucky State Board of Pharmacy. As a result of this law, under the auspices of the Kentucky Bureau of Investigation, UPS and FedEx have worked successfully to intercept illegal shipments. I realize the issue under examination today is a national problem concerning a global threat of controlled substances sold over the Internet. I am not suggesting that the Kentucky law is instructive as a particular policy solution to controlled substances over the Internet. But the positive developments in Kentucky remind me of what America can accomplish in solving a problem when we are all united, focused, and supportive of efforts to combat a prescription drug abuse problem.

I believe this is a crucial time for the U.S. Congress to send a unified, bipartisan, unmistakable message about stopping the illicit sales of controlled substances over the Internet. That clear, unified message will have a tremendous impact in providing further support to the Executive Branch and the private sector to intensify the focus of the laser beam against illicit sales of controlled substances over the Internet.

Already, in preparing for this hearing, I can identify several ideas worthy of legislative consideration in addressing this issue. First, the July 2005 National Center on Addiction and Substance Abuse report specifically recommended that Congress should clarify federal law to prohibit sale or purchase of controlled prescription drugs on the Internet without an original copy of a prescription issued by a licensed, DEA-certified physician, licensed in the state of purchase, based on a physical examination and evaluation, and to impose higher penalties for illegal sale to minors. That is a recommendation that I will explore at this hearing. Second, Congress should consider increasing penalties for Schedule III drugs. Why is it that there do not appear to be websites explicitly marketing heroin or cocaine? There may be several reasons, but one factor may be the harsher penalties. The penalties for crimes involving Schedule III drugs are substantially less than for those in Schedules I and II. We should consider increasing penalties for Schedule III drugs illicitly marketed over the Internet. Third, we should consider extending the coverage of forfeiture authority for Customs from not just Schedule I and II drugs but also to Schedule III drugs. Information and testimony gained today may help determine whether Congress pursues these proposals, and other measures. I invite Congressman Stupak, the Ranking Member, to join with me as a bipartisan team to spearhead Congressional action on this front.

I am hopeful that today we will learn much more about the nature of the problem, the actions taken to combat it, and what actions could be taken to help aid the effort, including legislation. I thank all of the witnesses for testifying today and look forward to their testimony. I now recognize my friend, Congressman Bart Stupak, the Ranking Member, for his opening statement.