Risks in Ordering Drugs by Internet on the Rise

A report from the University of Maryland School of Pharmacy concludes that consumers are facing a growing risk of getting counterfeit drugs because of rising Internet sales of medical drugs, projected to reach upwards of $75 billion by 2010.

The report calls for stronger enforcement legislation than current proposals in Congress.

Counterfeit drugs get into the U.S. through different sources, but those through illegitimate Internet sites are of special concern, says report author Francis Palumbo, PhD, executive director of the School’s Center on Drugs and Public Policy at the University of Maryland, Baltimore.

“When consumers buy from those, it is definitely buyer beware. They are often not licensed anywhere we are aware of,” says Palumbo. He says the U.S. Food and Drug Administration (FDA) “has been pulling its hair out over the years trying to deal with rogue Internet sites, the terminology they [FDA] use.”

The report, “Policy Implications of Drug Importation,” published in the journal Clinical Therapeutics, tracks the growing “challenge” to U.S. drug regulators and pharmaceutical companies from the growth of imported drugs. The report also addresses the national debate over drug importation policies.

Personal drug importing used to be just a way for patients to continue therapy with medications that were not available in the U.S. and when all other options were exhausted, the report says. But the practice has changed because of pressure of high costs of branded drugs in this country and the desire of patients to find cheaper alternatives.

During the past 10 years, many people have been importing prescription drugs that were available for purchase in the U.S. and justifying the foreign purchases on the FDA’s policy of personal use exemption. “The policy was never intended to allow this practice to be institutionalized,” the report says. And it concludes that both FDA and U.S. Customs officials can’t handle the volume entering the country.

Blatantly ignoring historical policies on personal importing of drugs not sold in this country leaves the FDA “in a quandary,” the report states. The FDA, though, recognizes that there are many reputable Internet pharmacies, in the U.S. and licensed by states, that offer convenience, wide selections, and privacy, according to the agency’s Web site. Those pharmacies also provide easy access to medications for disabled patients “for whom a trip to the pharmacy can be difficult.”

The FDA also cooperates with other countries to try to stem the tide of illegal Internet sites that ship drugs to the U.S. See: www.fda.gov/buyonline/. Ilisa Bernstein, PharmD, FDA’s director of pharmacy affairs, says, “When we do hear about an incident…,we follow up. But to stop it entirely would be difficult.”

Another concern, says Palumbo, is that unlicensed and unregulated drugs may find their way into pharmacies. “We are trying to keep the wolf away from the door and yet there are ways counterfeiters can inject their products into the drug distribution system in the U.S. and may end up in some pharmacies. These are often introduced through the conduit of some secondary wholesalers.” He adds that many secondary distributors are “very legitimate”; they buy products from other wholesalers.