Use caution buying medical products online

FDA Consumer, Jan-Feb, 2005 by Michelle Meadows

Get prescription drugs fast no doctor needed! Cure cancer with herbs! Zap your pain away with an amazing device! Absolutely safe--pull out your credit card NOW, and get rock-bottom prices.

It's not hard to find statements like these floating around in cyberspace. "And if they sound too good to be true, it's because they usually are," says Rich Cleland, assistant director of the Division of Advertising Practices at the Federal Trade Commission (FTC).

Many legitimate Web sites bring customers health products with the benefits of convenience, privacy, and, sometimes, cheaper prices. "But consumers need to be aware that the Internet has also created a marketplace for unapproved medical products, illegal prescribing, and products marketed with fraudulent health claims," says William Hubbard, associate commissioner for policy and planning at the Food and Drug Administration.

"And the unique qualities of the Internet, including its broad reach, relative anonymity, and the ease of creating and removing Web sites, pose challenges for enforcing federal and state laws," Hubbard says. "Many sites are connected to other sites and have multiple links, which makes investigations more complex. And there are jurisdictional challenges because the regulatory and enforcement issues cross state, federal, and international lines."

Government agencies work together to shut down illegal Web sites and prosecute criminals, but enforcement resources are limited. "Consumers need to take some responsibility for recognizing suspicious sites and turning the other way," Hubbard says. So how can you spot the red flags? Here's a guide to help you protect your health and your wallet.

Prescription Drugs

What are they? Prescription drugs are substances that are intended to diagnose, cure, treat, or prevent medical conditions or diseases. Before they can be legally marketed, they must undergo clinical studies on their safety and effectiveness and be approved by the FDA. The agency approves a drug if its experts determine that the benefits of the drug outweigh the risks associated with it. But no drug is absolutely safe; there is always some level of risk.

Problem sites: One way that illegitimate Web sites violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) is by dispensing prescription drugs without a valid prescription, says Steven Silverman, director of the Division of New Drugs and Labeling Compliance in the FDA's Center for Drug Evaluation and Research. "FDA leaves it to individual states to decide what is a valid prescription. Web sites cannot dispense drugs in violation of those laws or with no prescription at all."

In general, to be valid, a prescription must address a legitimate medical purpose, be written by a physician or other health care provider authorized to prescribe medicine, and be based on a legitimate doctor-patient relationship. But some Web sites dispense drugs after customers simply fill out an online questionnaire or engage in some other similar cyber "consultation."

In June 2004, experts at the Government Accountability Office, formerly the General Accounting Office, reported that, as part of an investigation, they were able to obtain most of the prescription drugs they set out to order from various Internet pharmacy sites without needing to provide a prescription. Some of the drugs had special safety restrictions or were addictive narcotic painkillers.

"The FDA has taken action against Web sites selling drug products that are unapproved, misbranded, or that make fraudulent health claims," Silverman says. Misbranded drugs include those with misleading labeling and those that aren't adequately labeled with directions for use of the product.

Risks: "When you buy drugs from a questionable Web site, you just don't know what you're actually getting," says Carmen Catizone, executive director of the National Association of Boards of Pharmacy (NABP).

The main concerns are that the drugs could be outdated, contaminated, too potent or not potent enough, improperly manufactured and handled, or counterfeit. "We have seen some reports of cases where people thought they ordered prescription drugs, but they received some kind of dietary supplement," Catizone says.

Between February 2004 and August 2004, the NABP received more than 100 consumer complaints alleging harm related to buying drugs online. Consumers paid money but never received products, received medications different from what they ordered, or experienced worsening symptoms after taking the drugs they ordered online.

As for drugs imported from countries outside of the United States, the FDA can't assure their safety. In July 2004, the FDA announced that its investigators bought three commonly prescribed drugs--Viagra, Lipitor, and Ambien--from a Web site advertising "Canadian generics," and found that the drugs were fake and potentially dangerous.

"What's creating consumer confusion is that several governors and mayors are pushing for importation and some have established pharmacy programs that allow their constituents to purchase drugs from foreign sources, leading the public to believe the practice is safe," Catizone says. "But importation just opens the door to counterfeit drugs and other risks."