As prescription drug prices in the United States continue to skyrocket, American consumers have become increasingly desperate to find the cheapest drugs available.  In recent years, consumers are turning to the Internet to comparison shop and buy the lowest cost drugs online.  The problem is that many Internet pharmacies are dispensing medicine illegally and, in some cases, selling counterfeit or unsafe drugs.  Because U.S. enforcement efforts are currently inadequate to stop the illegal operators, the high cost of U.S. prescription drugs is driving increasing numbers of Americans to play Russian roulette with Internet pharmacies, gambling their safety on the lure of more affordable prices.

 Over the past 4 years, U.S. prescription drugs have increased an average of nearly 20 percent annually.  Today, on average, Americans pay sixty percent more than the British or the Swiss for the same prescription drugs, two-thirds more than Canadians, eighty percent more than Germans and twice as much as Italians.  For poor and middle class individuals suffering chronic illnesses, high drug costs are forcing some to choose between taking their medicine on any given day, paying the bills, or even buying food.
 
 The GAO report before us today leads me to two conclusions.  First, Internet purchases of illegal pharmaceuticals are out of control, and we need to increase enforcement.  Second, medicines purchased from Canada are as safe or safer than those purchased in the United States.  I say that because 100% of the medicines purchased by GAO on the Internet from Canadian pharmacies required patient prescriptions compared to only five out of 29 or 17 percent of U.S. pharmacies. In addition, none of the Canadian or U.S. medicines were counterfeit.

 Internet pharmacies are a relatively new response to the problem of high cost medicines.  Some Internet pharmacies are completely legal operations, set up to offer clients convenience and cost savings.  They require patient prescriptions and deliver medications from U.S.-approved facilities.  Other internet pharmacies operate illegally, selling medications without prescriptions and using unapproved manufacturers either in the United States or offshore.  Some shadowy operations  send unsolicited offers to millions of Internet users, hawking medications like junk food bargains.  These illegal operators have begun to capture attention as a health and safety threat requiring criminal and civil enforcement action, and I commend Chairman Coleman for focusing on this problem and holding this inquiry today.

 Pharmacies and pharmaceutical sales involve a complex web of state and federal regulation to protect the public from unsafe or improperly prescribed drugs.  In the United States, the practice of pharmacy is regulated by state boards which license both pharmacists and pharmacies.  To legally dispense a prescription drug, a licensed pharmacist working in a licensed pharmacy must be presented with a valid prescription from a licensed health care professional before delivering the drug to the purchaser.  On the federal level, the Food and Drug Administration (FDA) is charged with ensuring the safety, effectiveness, and quality of domestic and imported drugs; the Bureau of Customs and Border Protection (Customs) is supposed to screen and stop unauthorized controlled substances at the border; and the Drug Enforcement Agency (DEA) is responsible for combating illegal narcotics and the abuse of controlled substances.

 To get a better sense of the enforcement problems associated with Internet pharmacies, at the request of this Subcommittee, the General Accounting Office (GAO) spent several months earlier this year buying prescription drugs online, tracking the Internet pharmacies and drugs delivered in response to their online orders, and then testing the delivered drugs to ascertain if they were actually the medications ordered.  GAO efforts focused on buying popular medications such as Celebrex, an anti-inflammatory pain reliever; Lipitor, a cholesterol lowering drug; Viagra, a medication for sexual dysfunction; and Zoloft, an antidepressant.

 GAO found that buying medications from Internet pharmacies was not difficult.  GAO placed 90 online orders for prescription drugs and received 68 samples, a success rate of 75 percent.  Of those 68 medications, 45 were shipped illegally, because there had been no patient-provided prescription.  Many were also shipped without FDA-required precautions such as patient instructions and temperature-controlled packaging.  Of the 68 samples, 48 were from U.S. or Canadian based Internet pharmacies, 18 were from foreign sites, and two could not be determined.  Of the 18 foreign samples, three were found to be counterfeit, including two that contained incorrect but not necessarily dangerous chemical compositions and one that had no active ingredients at all.  As mentioned earlier, GAO determined that none of the U.S. or Canadian samples were counterfeit, evidence suggesting that medications delivered from other foreign countries were less safe than those originating in the United States or Canada.

 The Subcommittee also examined operations at three U.S. ports of entry in New York, Chicago, and Miami to evaluate how federal agencies screen parcels containing pharmaceutical products and originating from foreign countries.  The investigation determined that tens of thousands of dangerous and addictive controlled substances are streaming into the United States on a daily basis from overseas and that, at ports of entry such as the John F. Kennedy International Airport (JFK) in New York and Miami International Airport, Customs agents are being overwhelmed as they attempt to prevent potentially hazardous materials from entering our borders. 

 For example, at JFK Airport, Customs officials estimated that over 40,000 parcels containing pharmaceutical products passed through its facility every day.  Miami International Airport saw 30,000 packages a day.  Neither facility had sufficient personnel to screen these parcels.  For example, JFK had an average of 50 Customs agents and just 6 FDA inspectors working at its facilities during the course of a day, which means each person was responsible for screening more than 700 pharmaceutical parcels every day.  And, remember, these agents and inspectors had lots of other responsibilities too – they were also charged, for example, with screening packages for firearms, nuclear material, counterfeit currency, and other contraband items.

 Millions of packages containing pharmaceutical products were imported into the United States last year and in 2003, and an estimated $1.1 billion worth of prescription drugs were imported into the U.S. solely from Canada.  Internet pharmacies have contributed to this increase and to the ongoing strain on our enforcement resources.  While some of these Internet pharmacies are based in the United States, many others are based in foreign countries which makes them harder to investigate, inspect, and shut down.  Recent research indicates, for example, that the top countries of origin for imported medications include Brazil, Canada, India, Mexico, the Netherlands, Pakistan, Portugal, Romania, and Spain.  While federal agencies such as FDA, Customs, DEA and the Department of Justice have successfully taken enforcement actions against both domestic and foreign Internet pharmacies and associated physicians in the past, these agencies face a host of enforcement issues with scarce resources.  In an age of global terrorism where these same agencies are charged with protecting the public from dirty bombs, heroin sales, and chemical and biological weapons, it is tough to believe that stopping Internet pharmacies will become a top priority.
 
 In addition, there is the larger issue of drug reimportation.  The importation of prescription drugs happens everyday in this country, whether is it through private individuals purchasing drugs through the Internet, or a busload of seniors traveling to Canada to buy cheaper drugs from their drug stores.  It is the exorbitant price of prescription drugs in the United States that is driving Americans to buy low cost medicine from foreign countries.

 I am one of many Senators who support the seniors’ bus trips to Canada.  Folks are doing what they have to in order to find and buy more affordable medicine.  It is an ironic but comforting fact that the GAO study found no counterfeit drugs among the medications imported from Canada, since so many Americans are now shopping there.  I am also one of many Senators who favor legalizing the importation of drugs from countries such as Canada as a way to bring down prices here at home and stop the current practice of forcing American taxpayers alone to bear the burden of subsidizing research and development costs for big drug companies.  While I support stronger enforcement action to shut down illegal Internet pharmacies and confiscate unsafe medications at the border, those actions won’t cure the larger problem of overpriced drugs here in the United States.  It is my hope that, this year, Congress will have an opportunity to vote on a real proposal, such as the Dorgan-McCain Pharmaceutical Market Access and Drug Safety Act, S.2428, that will legalize the importation of drugs and begin to address the real issue of high drug prices for Americans.

 Again, I commend Chairman Coleman for taking on this important and complicated safety issue, and I look forward to the testimony of the witnesses.