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Last week, President Clinton called for legislation forcing all online pharmacies to get approval from the Food and Drug Administration before selling pharmaceuticals without a prescription. The plan also seeks $10 million to upgrade computers and hire 100 investigators who would have the power to subpoena company documents. They could also levy fines of up to $500,000 for several offenses: selling drugs without a prescription, unapproved drugs, counterfeit drugs and expired or illegally diverted drugs.

Congress still has to pass the plan -- and Clinton's health plans have a history of terminal illness -- but if the proposal becomes a reality, it would be the first federal foray into regulating anything other than child pornography on the Web. Internet freedom fighters, including Virginia Postrel, editor of Reason, a libertarian magazine, have decried the plan as intrusive and an unnecessary bureaucratic barrier to creativity.

But regulation veterans -- pharmaceutical companies, the FDA, and state pharmacy boards -- say critics are overestimating Clinton's ambition. Despite claims that the Web is unique, the FDA already has prosecuted other non-traditional pharmacies, such as truck stops that used to distribute amphetamines, says Jeff Truitt, spokesman for the Pharmaceutical Researchers and Manufacturers of America, a Washington-based trade group.

And Clinton's "rapid response team" is no army. One hundred investigators represents only a fraction of the FDA's total manpower, and $10 million rings like a copper penny when compared to the agency's $1.1 billion budget.

According to Carmen Catizone, executive director of the National Association of the Boards of Pharmacy, Clinton's plan will simply add the teeth of punishment -- and some much-needed cash -- to the system of online self-regulation that has already begun to form.

"Clinton's plan will simply help fill the regulatory gap," he says.

Catizone's group, an Illinois association of state and international pharmacy boards, spearheaded the trend toward self-regulation. In January, a few months after a Lisle, Ill., man died of a heart attack after taking Viagra that he bought online without a prescription, it began to offer its own seals of approval.

In June, after scrutinizing proposals and visiting several online pharmacies' physical headquarters to ensure that the drugstores complied with all relevant state laws, the board awarded seals to five sites. The winners represented the biggest and best-known such as PlanetRX.com, CVS.com and Drugstore.com. But now, 15 more are being considered and 80 sites from across the world have requested applications, Catizone says.

Next page | "They said I saved their marriages," says a former online salesman