The Slow War Against Rogue Rx Sites
Dr. Carlos Gustavo Levy practices osteopathic medicine in Sunrise, Fla,, more than 3,000 miles away from California. But that didn't stop him writing some 1,570 prescriptions for Californians. He made his diagnoses via an online questionnaire, prescribing medicines without ever seeing his patients.
It turns out that California Medical Board investigators were watching Levy. Snared in an online-prescription sting operation earlier this year, he was hit in February with the largest fine state regulators have imposed on a doctor for prescribing drugs online: $40 million.
Levy's attorney Robert Smoley calls the fine "a joke," adding that his client has no intention of paying it. But others hailed California's action, seeing the huge penalty as a potent message. "My guess is that it will get the attention of all doctors," says Dr. James Thompson, CEO of the Federation of State Medical Boards (FSMB). "This is a huge wake-up call."
For years, state and federal regulators have talked about better policing long-distance online pharmacies and the doctors who work for them. Now, they're starting to take action. But as the Levy case shows, this is a frontier area of the law, and it will probably take years to establish practices and precedents.
One problem is that many cyberpharmacies, such as the one run by senior lobbying group AARP are perfectly legitimate, selling medicines only after patients have been examined by their regular doctors. Seventeen states already have adopted a regulatory template developed by the FSMB. It says no doctor should write a prescription in a state where he's not licensed or for a patient he hasn't examined at least once. Yet some rogue sites continue to position themselves as prescription dispensers without observing standard medical practices, according to the state officials who track them.
In the past two years, 17 states have empowered their medical boards to punish doctors who prescribe drugs over the Net without examinations. "Three years ago, we didn't know what to do," says Texas State Pharmacist Karen Tannert, chief regulator of the Lone Star State's industry. "Now, we've got a clear mandate to hit these online pharmacies hard, and we are."
Tannert is also aware that making inroads against rogue online prescribers won't be easy. "Many of [the sites] operate outside our state and some outside the country," she notes. "It can be almost impossible to shut them down." Adds David Thornton, the California Medical Board's chief of enforcement: "It's new territory." The most shadowy operators are especially elusive targets, easily changing Web addresses and eluding regulators.
While Levy's attorney talks of his client simply ignoring the fine, other doctors are challenging punishments -- and some sites are winning partial victories in court. A Florida administrative judge recently fined Davie (Fla.)-based online pharmacy RX Network $24,000 and ordered it not to sell prescription drugs for a year. The site's operators refused to shut it down, saying state prosecutors failed to prove RX Network was a "public danger" under the law. If anything, "the judge validated RX Network's operations," says Sean Ellsworth, an attorney who represents the site.
Now, the local district attorney is pushing for the state pharmacy board to take more explicit action against RX Network. But even the lead prosecutor on the case, Rosanna Catalano, concedes, "It's very difficult to prosecute these sites."
Online pharmacies are garnering an estimated $1 billion to $3 billion of the $110 billion in annual retail drug sales, according to experts. Such success has spooked the bricks-and-mortar medical Establishment. As a result, pharmacists and doctors are some of the most effective advocates of cracking down on online pharmacies because these sites cut into their business.
More ominously, regulators fear that it's only a matter of time before a patient dies from a substandard or misprescribed drug bought online. "There's no horror story - yet," says Carmen Catizone, executive director of the National Association of Boards of Pharmacy. "But we all know it's coming."
The Golden State alone has 30 ongoing investigations. In February, it fined five other out-of-state doctors a total of $8 million, in addition to the $40 million fine against Levy. And a federal court jury in Alabama recently convicted Anton Pustai and Anita Yates, identified by prosecutors as operators of a rogue site, on charges of dispensing misbranded drugs and conspiracy to violate U.S. Food & Drug Administration regulations governing the sale of prescription drugs.
In its effort to choke off foreign supplies of prescriptions, the FDA has arrested 112 suspects, convicting 72 over the past two years on charges of illegally importing and selling prescription drugs, according to government records. This arduous battle is just beginning.
By Charles Haddad in Atlanta