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The main concerns are that the drugs could be outdated, contaminated, too potent or not potent enough, improperly manufactured and handled, or counterfeit.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."

Regulation: State medical boards regulate medical practice and state pharmacy boards regulate pharmacy practice. It is generally unlawful to prescribe or dispense drugs without a legitimate relationship between the health care provider and the patient. Penalties may include fines and license suspensions.

When Internet operators violate the FD&C Act, the FDA, sometimes in collaboration with other law enforcement agencies, may take enforcement action against a firm. Enforcement actions might take the form of warning letters, cyber letters, import alerts, seizure actions, injunction actions, or criminal prosecution. A warning letter, usually sent by mail, advises a company that it may be engaged in illegal activities. A cyber letter is similar to a warning letter, but is sent electronically through the Internet to the operators of a Web site. If the violation continues, the FDA could take enforcement action. A seizure action removes products from the marketplace, and an injunction action results in a court document that orders the firm to cease violating the law. An import alert identifies products that violate the law so that FDA field personnel and U.S. Customs and Border Protection staff can stop their entry at the border.

Enforcement Examples:

• An emergency room physician from Kentucky was sentenced to a year in prison in October 2004 for conspiring to unlawfully distribute controlled substances over the Internet. The site's customers were able to obtain prescription drugs after filling out an online questionnaire. The FDA's Office of Criminal Investigations and the Federal Bureau of Investigation investigated the case.
• The FDA warned the public in February 2004 about Internet sites outside the United States selling counterfeit contraceptive patches that contained no active ingredients. With the cooperation of a U.S.-based Internet service provider, the FDA shut down service to the Web sites.
• In August 2004, the FDA announced the filing of a consent decree that stopped Rx Depot and Rx of Canada from facilitating the illegal importation of drugs. A judge found that the defendants' actions posed a public health threat.
• In September 2003, the FDA issued warning letters to Internet companies that were selling unapproved versions of Accutane (isotretinoin), a drug used to treat severe acne. Because of serious risks, including birth defects if taken by pregnant women, Accutane is available under a restricted distribution program that allows only certain doctors to prescribe the drug.

Tips: For consumers who want to buy prescription drugs online, the FDA recommends purchasing only from state-licensed pharmacies in the United States. This helps to assure that the consumer will receive drugs that are manufactured, packaged, distributed, and labeled properly. Some legitimate Internet pharmacies are extensions of traditional brick-and-mortar chain drug stores such as Walgreens, Eckerd, and CVS.

"There are also smaller, and still legitimate, Web sites that consumers can use with confidence," says Linda Silvers, who leads the Internet and health fraud team at the FDA's Center for Drug Evaluation and Research. "Legitimate sites require valid prescriptions."

"A Web site can look very sophisticated and legitimate, but actually be an illegal operation," Silvers says. "If there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required, consumers should be especially wary."

People should check with their state board of pharmacy or NABP to see if an online pharmacy has a valid pharmacy license and meets state quality standards. NABP's Verified Internet Pharmacy Practice Sites program, also known as VIPPS, is a voluntary program that verifies the legitimacy of Internet sites dispensing prescription drugs and gives a seal of approval to sites that apply and meet state licensure requirements and other VIPPS criteria.