Whether new legislation will improve oversight of online pharmacies remains to be seen. For the moment, regulators have entered what FDA's Shuren calls "a whole new ball game" that cuts across the limited jurisdictions of several federal and state agencies. State medical boards regulate medical practice, while state pharmacy boards oversee pharmacy practice. 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.
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 FDA being involved is that states have difficulty enforcing their laws across state boundaries. If one state successfully shuts down an illegal Website 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 Website, that operation is out of business.
In July 1999, 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.
Though regulating Internet sales of health products is still fairly new, 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 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. FDA is working closely with FTC on Operation Cure.All and has taken its own regulatory actions, such as sending warning letters to help ensure that false and misleading statements are removed from the Internet.
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.
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