Prescription for change

President Clinton proposes the regulation of online drug sales.


Damien Cave
January 6, 2000 10:00PM (UTC)

At some Web sites, you can stock up on Prozac, steroids, Viagra and high-powered painkillers, all with nothing more than your fingers and a credit card. But not for long, if the White House gets its way.

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.

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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.

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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.

The White House plan mentions separate FDA seals, but according to Catizone, repetition will be minimized. "We prefer that there not be two seals. But what we've heard initially is that they will try and work with us to see that there isn't any overlap."

Clinton's key addition lies with enforcement, regulators say. More than 400 sites continue to sell drugs illegally. Most sell only Viagra and other lifestyle drugs such as Propecia for baldness. But others, such as Pharmagroup.com, offer more dangerous medications such as anabolic steroids and muscle relaxers that intensify with alcohol.

These sites can be prosecuted under current law. But it's no easy task. The present system relies on state legislation that was drafted when patients traveled only from their doctor's office to the corner pharmacy for their pills. That approach worked for decades. But with managed care, patients have begun to distrust the medical establishment, and the Web is filling that void. In 1999, 23 million Americans sought health and medical information on the Web, according to Cyber Dialogue, a Manhattan tracking firm. This year, 10 million more will be added.

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And many of these seekers want more than just information. By 2003, $2.4 billion in health products will be purchased online, according to Jupiter Communications. The majority of that cash -- 40 percent -- will go to prescriptions, chiefly regular refills such as Viagra, but also blood thinners and insulin.

In such a demand-swelling market, new entrants appear like mold. Meanwhile, regulators have a hard time finding the original spore, the brick and mortar base of an online store. Pharmagroup's site resembles bigger pharmacy sites, with shiny blue-green graphics, photos of drugs in what appear to be original boxes and friendly guarantees of quality and service. But click on the contact-us button and all you'll get is a Utah fax number, and some friendly words from the general manager/president. Names, addresses and phone numbers are conspicuously absent.

Many sites disappear before they can be prosecuted. Others have learned to give black screens when regulators log on to their sites. Even when suits are filed, and there have been several, fines hover at only $1,000 to $2,000.

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"Because of the way the Internet bridges [state boundaries] there is not a specific legal fit," says FDA spokesman Bill Hubbard. "A site in Arizona selling to 40 other states may not be something officials in Arizona care about. And officials in the 40 other states
may have no way to get at it. You need a law that fits the crime, and current law does not fit the crime."

Federal oversight, but especially financial punishment that amounts to more than a bruise, will help eliminate many of these structural problems, Catizone says. The 15 people now employed by the board are not enough to keep up. Forcing all pharmacies to submit to the FDA before operating would make it easier for investigators to catch violators. Federal laws will make them easier to punish.

Still, Clinton's plan may not be enough. About a third of the rogue drugstores are based abroad, many just over the border in Mexico. Sites such as mexicanpharmacies.com even offer a directory of the best and cheapest. Clinton's arsenal contains only one weapon against these: education. His plan includes money for a public-service campaign to teach consumers how to buy online.

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Critics say Clinton must do more or else a two-tiered system -- good Americans, bad foreigners -- will result and consumers will lose out.

"Given a choice, most Americans would prefer to buy from an American site," says Dr. Rick Williams, a Pearl City, Hawaii, gynecologist. In 1999 Williams began selling Viagra, Propecia, Xenical and basic birth control pills -- "all medications that do not typically require a physical examination," he says -- through his Web site, RickMD.com. He asked for medical information and refused those who did not fill out the online form.

"I really felt I was helping people," he says, citing appreciative letters from Viagra buyers such as the mayor of a small town, and the father of a town's only pharmacist. "They said I saved their marriages."

In all, he only sold to a few hundred customers, and barely made any money. But his altruism didn't keep the state of Kansas from suing him. As a result, Williams has stopped selling drugs online.

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"It's not worth the hassle," he says. "I was doing nothing wrong, not hurting anybody, and Kansas still had the right to come after me."

He says Clinton's plan, in its strictness and by adding another layer of bureaucracy, will only drive doctors like himself out of business. Or keep them from entering.

"It's an unrealistic barrier," he says, one that he can't afford to fight. "I have to pick which windmills to fight, and this one I have to let others battle."


Damien Cave

Damien Cave is an associate editor at Rolling Stone and a contributing writer at Salon.

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