Few Online 'Canadian Pharmacies' Based in Canada, FDA Says; Study Finds Most Sites Are Linked to U.S. Entities

Byline: Brian Krebs

Most Web sites that purport to sell quality, discounted prescription drugs from online stores in Canada appear to be controlled or owned by individuals or companies located outside Canada, including many in the United States, according to a study commissioned by the Food and Drug Administration.

The study examined some 11,000 Internet pharmacies, finding that only about a thousand of those Web sites actually sold prescription drugs and that fewer than 25 percent were registered to or hosted by companies or individuals in Canada.

Rather, the report concluded that most of the sites referred visitors to 1,009 online stores, 86 percent of which are currently hosted by companies located in the United States. Nearly 70 percent of the sites also were registered to U.S. citizens, and more than half of those sites are registered to a single Web design firm based in New England, which the publicly released version of the study did not identify.

Many of the apparently fraudulent sites referenced in the study were not reachable through traditional Internet search methods, said Tom McGinnis, director of pharmacy affairs for the FDA. Instead, most could only be found by clicking on links in junk "spam" e-mails, he said.

"We want consumers to be aware that when they order online from these sites ... for the most part no one is overseeing that -- not the state boards of pharmacy, not the FDA -- and that they're the ones responsible for taking a look at the quality of these sites and their offerings," McGinnis said.

The study is the latest salvo in the ongoing debate over whether Americans should be able to have less expensive prescription drugs shipped from outside the country. A number of states and localities have recently taken steps to help government employees and residents buy imported drugs in defiance of federal law. Although the FDA contends that importing prescription medicines is illegal, the agency has never gone to court to block a state or local government from referring people to Canadian Internet pharmacies, calling such efforts an inefficient use of regulatory resources.

The pharmaceutical industry has strongly opposed efforts in Congress and in several states to make it easier to import prescription drugs from other countries, citing concerns over possible counterfeiting or tampering as well as the impact on revenue streams that support research and development.

The new report was commissioned by the FDA's Office of Criminal Investigations and conducted by Arlington, Va.-based Cyveillance, a company whose clients include three of the nation's top four pharmaceutical manufacturers. The version released to the public spanned less than two pages and did not include information on any of the 214 pharmacy sites identified as connected to a legitimate business or individual in Canada. FDA's McGinnis said the agency is withholding that information until its investigation is complete.

"I'd hate to give consumers a false sense that these 214 sites are all legitimate if they aren't," McGinnis said.

According to the FDA, two-thirds of the online pharmacies identified in the study explicitly stated on their Web sites that potential customers did not need a prescription to purchase medicines that otherwise would require a doctor's written permission and a prior, legitimate doctor-patient relationship for U.S. residents.

Andy Troszok, president of the Canadian International Pharmacy Association, said the study was likely to instill fear and uncertainty into the minds of Americans who are considering buying drugs from Canadian online pharmacies.

Fewer than 300 legitimate pharmacies in Canada ship prescription drugs into the United States, and all of those pharmacies require customers to have a prescription before ordering, Troszok said.

A U.S. Government Accountability Office investigation in June 2004 also found that legitimate Canadian online stores were requiring U.S. citizens to provide a doctor's prescription. GAO investigators purchased drugs from more than 60 online pharmacies -- including 18 in Canada -- and found that all of the Canadian sites required a patient-provided prescription. Most of the troublesome online pharmacies examined in the GAO study were located in the United States and countries other than Canada.

Eighty-seven of the online stores identified in the FDA study are hosted in Barbados, but many of those list their mailing address and phone numbers at offices in Las Vegas. Eric Olson, vice president of client services for Cyveillance, said that from an investigatory standpoint, the Barbados-Las Vegas connections were the most interesting because they indicate the involvement of a U.S-based company.

Cyveillance also found many of the online pharmacy sites claiming to be based in Canada were actually registered to individuals or companies in other countries, such Australia, the Czech Republic, El Salvador, Germany, Mexico and Vietnam.

Online and mail-order pharmacies in Canada and the United States point out that roughly 80 percent of all drugs imported into the United States from Canada come from about 30 pharmacies that have met the health and safety requirements set by CIPA.

In the United States, there is the Verified Internet Pharmacy Practice Sites program, which has certified 15 online pharmacies -- all of them U.S.-based -- as having met the FDA's safety and health guidelines.

But CIPA's Troszok said VIPPS -- which is operated by the National Associations of Boards of Pharmacy -- has refused to certify Canadian pharmacies that sell into the United States, and that many legitimate Canadian pharmacies are reluctant to advertise that they sell to U.S. customers for fear that the U.S.-based pharmaceutical industry will seek to cut their supplies.

"It's somewhat ironic that the FDA is doing this study to find out how many legitimate online pharmacies there are in Canada, but it is not willing to work with us on an accreditation plan to find and certify legitimate sites," Troszok said.

Accrediting Canadian pharmacies would be akin to aiding and abetting a crime so long as federal law banning importation of prescription drugs remains on the books, said Carmen Catizone, executive director of the NABP.

In June 2004, the NABP adopted a resolution calling on the FDA to pursue legal action against U.S. states and localities "for endorsing, promoting or engaging in the illegal importation of medications."

That hasn't deterred local lawmakers in the FDA's own backyard. Last year Montgomery County Council President Tom Perez (D) led a successful effort to get the county to approve buying prescription drugs from Canada. The county will soon sign a contract with a pharmacy in Canada that should allow current and retired county employees to purchase discounted drugs, Perez said.

"Rather than wasting taxpayer dollars on reports written by organizations fronting for the [pharmaceutical] industry, let's have an objective review that shows that this can be done in a safe manner," Perez said. "The fact is, if you have the political will to do something, you can get it done. And if you have political will to tank something, you can do that too."

Several states -- including Illinois, Kansas, Missouri, Wisconsin and Vermont -- have formed a cartel to buy prescription drugs from pharmacies in Ireland, Britain and Canada. That program, at Isaverx.net, requires some 60 approved pharmacies abroad to meet each state's own safety rules and regulations for dispensing prescription drugs.

"We started this program because we know there are many people who can no longer afford to buy their medications here and have to look elsewhere because the FDA has refused to get involved in monitoring the safety of drugs being brought in from outside the country," said Abby Ottenhoff, spokeswoman for Illinois Gov. Rod Blagojevich (D).

The FDA's McGinnis said the agency is not aware of any data suggesting that a single U.S. citizen has been harmed or killed by prescription drugs ordered from any legitimate Canadian pharmacy. Still, McGinnis said, as long as shipping medications into the United States remains illegal, the agency would continue to refuse to work with any entity supporting that activity.

"The FDA doesn't make the laws [on prescription drugs], it just enforces them, and we'll do whatever the law tells us to do."

Americans spent an estimated $1.1 billion buying medicine online in 2003, according to consulting firm IMSHealth Inc., which tracks pharmaceutical industry trends.

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