Overseeing Online Sales

State medical boards regulate medical practice, while state pharmacy boards oversee pharmacy practice. The FDA and the Federal Trade Commission ensure that drug sellers make legal claims for their products. Numerous other agencies such as the U.S. Customs Service and the U.S. Postal Service enforce laws regarding the shipment of drug products.

The FDA regulates the safety, effectiveness and manufacturing of pharmaceutical drugs, as well as a part of the prescribing process. "It is a violation of the Food, Drug, and Cosmetic Act to sell a prescription drug without a valid prescription," says Shuren. "Therefore, FDA can take action against sites that bypass this requirement." He adds that the advantage of the FDA being involved is that states have difficulty enforcing their laws across state boundaries. If one state successfully shuts down sales of products by an illegal Web site within its borders, the site theoretically still has 49 other potential locales in which to sell. However, if the federal government shuts down an illegal Web site, that operation is out of business in all states.

In July 1999, the FDA announced that it was joining forces with state regulatory agencies and law enforcement groups to combat illegal domestic sales of prescription drugs. The agency signed agreements with the National Association of Boards of Pharmacy and the Federation of State Medical Boards. These organizations have made a commitment to help enforce federal and state laws against unlawful Internet sellers and prescribers of drugs in the United States.

Fraudulent Products

Though regulating Internet sales of health products is still fairly new, the FDA has successfully taken action in the past against illegal sites. For example, a California company called Lei-Home Access Care in 1996 and 1997 used the Internet to sell a home kit advertised as a blood test for the AIDS virus. Not only was the kit unapproved, but the maker also fabricated test results given to users who submitted a drop of blood. After an extensive FDA investigation, the site was shut down, and its operator, Lawrence Greene, was sentenced to more than five years in prison.

In July 1999, the Federal Trade Commission announced a program called "Operation Cure.All," which aims to stop bogus Internet claims for products and treatments touted as cures for various diseases. Over two years, the FTC identified about 800 sites and numerous Usenet newsgroups containing questionable promotions.

"Miracle cures, once thought to be laughed out of existence, have found a new medium," says Jodie Bernstein, director of the FTC's Bureau of Consumer Protection. "Consumers now spend millions on unproven, deceptively marketed products on the Web."

As part of the program, four companies settled FTC charges of deceptive health claims. These included sites that claimed to cure arthritis with a fatty acid derived from beef tallow, to treat cancer and AIDS with a Peruvian plant derivative, and to treat cancer and high blood pressure with magnetic devices. The FDA is working closely with the FTC on Operation Cure.All by issuing "cyber letters" to advise and educate operators of Web sites that may not know that the products they are marketing may not be in compliance with federal law. In addition to sending warning letters, the FDA has also taken more serious regulatory actions by seeking permanent injunctions against the marketing of four unapproved drug products being illegally promoted as treatments for cancer.

More than a dozen states also have taken some kind of action against Internet pharmacies, including Kansas, which in 1999 prohibited several pharmacies from operating illegal Web-based businesses within the state.

Industry Polices Itself

At the same time that regulatory agencies are stepping up enforcement efforts against illegal online drug sales, professional organizations are launching programs with the goal of cleaning house from within. In late 1999, the National Association of Boards of Pharmacy (NABP) unveiled its Verified Internet Pharmacy Practice Sites (VIPPS) program, which provides consumers valuable information about the credentials of online pharmacies.

VIPPS is a voluntary certification program. The fairly rigid conditions the online pharmacy must agree to for acceptance into the program include:

• maintaining all state licenses in good standing
• allowing information about the pharmacy to be posted and maintained on the VIPPS Web site
• allowing an NABP-sanctioned team to inspect its operations, given reasonable notice
• displaying and maintaining the VIPPS seal with a link to the VIPPS Web site

VIPPS officials say the program is especially beneficial to seniors. "There is particular concern among the elderly population, which is often the target of unscrupulous marketing ploys," says Kevin Kinkade, NABP executive committee chairman. "VIPPS will be of tremendous benefit to consumers who need to be certain that the prescription medications they receive are from legitimate online pharmacies."

At its June 1999 annual meeting, the American Medical Association adopted guidelines for doctors that specifically address Internet prescriptions. These voluntary principles recommend that doctors who prescribe over the Internet follow minimum standards of care. This includes examining a patient to determine the medical problem, discussing the risks and benefits of a drug with the patient, and following up to ensure the patient does not experience serious side effects.

Many in the pharmaceutical industry back the AMA's action. "The relationship between physician and patient is critically important," says Martin Hirsch, public affairs director for Roche Laboratories Inc., maker of Xenical. "We support guidelines that will ensure that this relationship continues."

With regulatory and voluntary actions in full swing, it still will be hard to stay on top of illegal Internet drug sales. "Even if the state boards, FDA, and others do their jobs, consumers are going to need to be educated about the issue," says Wagner of the National Association of Chain Drug Stores.

The FDA has launched a public education campaign to increase consumer awareness of the risks and benefits of buying prescription drugs online. The campaign uses several different approaches — including the FDA Web site, radio and print public service announcements, a newspaper article, a brochure, and outreach by public affairs specialists based in the FDA's field offices around the country — to broadcast the FDA's message.

"Consumers need to know the risks of buying prescription drugs online so they can remain vigilant," says the FDA's Shuren. "The public also needs to know," he adds, "that there's a price to pay for operating an illegal Internet pharmacy. Even bringing a few highly publicized cases into the public eye will send a powerful message that these illegal sites will not be tolerated."

How Online Sales Work

In general, legitimate online pharmacies operate this way:

Users open an account with the pharmacy, submitting credit and insurance information. The pharmacy is licensed to sell prescription drugs by the state in which it operates and in those states to which it sells, if an out-of-state license is required.

After establishing an account, users must submit a valid prescription. Doctors can call it in or in some states e-mail it, or users can deliver it to the pharmacy by fax or mail. The site then verifies each prescription before dispensing the medication. A written verification policy is usually posted on the site.

Some online pharmacies send products from a central spot, while others allow users to pick the prescription up at a local drugstore. Prescriptions usually are delivered within three days, often for no shipping charge. For an extra fee, many sites will deliver overnight.

Sites typically have a mechanism for users to ask questions of the pharmacist, either through e-mail or a toll-free number.

What Consumers Can Do

With hundreds of drug-dispensing Web sites in business, how can consumers tell which sites are legitimate ones, especially when it is very easy to set up a site that is very professional-looking and promises deep discounts or a minimum of hassles?

"Consumers need to be cautious," says Jeffrey Shuren, M.D., medical officer in the FDA's Office of Policy, Planning and Legislation. "You should use the same kind of common sense you use when buying from any business. You look for a reputable dealer. You check the place out."

The FDA offers these tips to consumers who buy health products online:

• Check with the National Association of Boards of Pharmacy to determine if the site is a licensed pharmacy in good standing.
• Don't buy from sites that offer to prescribe a prescription drug for the first time without a physical exam, sell a prescription drug without a prescription, or sell drugs not approved by the FDA.
• Use sites that provide convenient access to a licensed pharmacist who can answer your questions.
• Avoid sites that do not identify with whom you are dealing and do not provide a U.S. address and phone number to contact if there's a problem.
• Beware of sites that advertise a "new cure" for a serious disorder or a quick cure-all for a wide range of ailments.
• Be careful of sites that use impressive-sounding terminology to disguise a lack of good science or those that claim the government, the medical profession, or research scientists have conspired to suppress a product.
• Steer clear of sites that include undocumented case histories claiming "amazing" medical results.
• Talk to your health-care practitioner before using any medication for the first time.

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Tags: Medicine

About the Author

FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.