FDA to Halt Cipro Imports in Bid to Stop Illegal Sales Over Internet
The Food and Drug Administration announced Friday that it would halt private imports of the antibiotic Cipro in an effort to curb illegal Internet sales of the drug used to treat anthrax.
A swarm of new Internet sites has appeared in recent weeks with pitches to sell the antibiotic without requiring a doctor’s prescription, which is illegal. The FDA said it also is investigating pharmacists’ and consumers’ suspicions that some Internet sites are selling counterfeit medications instead of authentic Cipro, made only by Bayer AG, a German company.
Because some of the Web sites are based overseas, the FDA has asked the U.S. Customs Service to stop the shipments.
“When you’re ordering products from overseas, nobody has any idea of the strength, quality and purity of the stuff coming in,” said Tom McGinnis, the FDA’s director of pharmacy affairs. “The FDA has no jurisdiction--you may be getting a counterfeit product, a sub-potent product or sugar pills. Consumers really are at risk.”
The FDA action comes as federal officials scramble to contain the run on Cipro, an antibiotic made by Bayer under exclusive patent in this country. Canadian officials announced Thursday that they would override Bayer’s patent and order another company to make a generic version. The Bush administration has said it is not considering following Canada’s lead, but a congressional source said Friday that the administration is holding talks with Bayer officials aimed at making the drug more available.
Bayer condemned Canada’s move as unnecessary, saying it could meet the growing demand for Cipro without help.
Doctors can use several other drugs to treat anthrax exposure, including penicillin, doxycycline and Levaquin. But Cipro generally is the preferred treatment because anthrax in the past has shown some resistance to other drugs, said Jennifer Cupo Abbott, an assistant professor at the USC School of Pharmacy.
The online demand for Cipro currently is rivaling other top sellers such as Prozac, the antidepressant, and Lipitor, a cholesterol drug, Internet retailers report. Some sites have been getting 50 to 100 orders an hour for Cipro since news of anthrax infections broke.
Online costs of the drug were on average $5 a pill and rose quickly to as much as $7 each at some sites. The sites often charge a “consultation” fee of about $75 as well. Consumers fill out a brief medical history form electronically, which is then “reviewed,” the Web sites say, by a medical professional, who never sees the purchaser.
Also, many of the sites advertising on popular search engines such as Google.com have registered their domain names only in the last few weeks or days, according to Network Solutions, which tracks registration. Some are making confusing claims.
Last week, one Web site was advertising that it had anthrax vaccine. But Cipro is a treatment for anthrax exposure, and government officials say a vaccine against the bacterium is not available for consumers. Another site has been advertising three-day and seven-day “packages” of the medicine. Doctors say that treating anthrax exposure properly requires taking two 500-milligram tablets a day for four to six weeks or more.
“Where there’s hysteria, people are going to try to make a profit,” said Daniel Albrant, president of Pharmacy Dynamic in Arlington, Va., and a spokesman for the American Pharmaceutical Assn. “I think it’s ludicrous to go online to get this stuff right now. The likelihood of exposure is extremely low. . . . And in the end, you really don’t know what you’re getting.”
FDA sources and state medical board officials say they are unaware of counterfeit products or fraud. Multinational drug firms such as Bayer often manufacture products at facilities worldwide, and the vast majority of imported drugs are identical to what’s available in the United States, experts say.
Still, anyone buying online should have the drugs checked by a pharmacist, Albrant said. The 500-milligram dose of Cipro comes in white oblong tablets that have the word “Cipro” on one side and “500” on the other, he said.
The FDA long has sought to crack down on online sales of prescription drugs from foreign sources. The Clinton administration sought authority to cut off credit card sales to rogue pharmacies overseas, but legislation introduced in Congress went nowhere.
The agency’s next step will be to send foreign Web sites warning letters telling them to immediately cease shipping Cipro to the United States, the FDA said. If the companies continue to sell the products, the agency will ask foreign health regulators to intervene, an action that was effective two years ago in a similar FDA crackdown on foreign online drug sales.
Meanwhile, there is at least one way to gauge the legitimacy of an online drug retailer. The National Assn. of Boards of Pharmacy evaluates sites and bestows a seal of approval; the results are on the board’s Web site at https://www.nabp.net.
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Times health writer Jane E. Allen contributed to this report.
