It used to be heroin or cocaine. But increasingly, authorities are finding counterfeit medications.
By Associated Press
Published June 12, 2003
WASHINGTON - Undercover agents staked out a Florida Chevron station, watching as a man handed $36,500 to his partner in a car before they pounced. But this was no ordinary drug bust - instead of cocaine or heroin, the men arrested sold fake versions of the anemia-fighting medicine Procrit.
Guilty pleas by three men in Miami on Wednesday highlight a growing problem: Fake medication, once a threat mostly in developing countries, now is increasingly turning up in the United States, involving schemes that can net counterfeiters millions.
The Food and Drug Administration believes that in this case, it intercepted all of the fake Procrit - some 1,800 vials filled with bacteria-tainted water - before any reached patients who depend on the blood-boosting injections.
Still under investigation is a far bigger counterfeiting case, involving more than 130,000 bottles containing fake Lipitor, the top-selling cholesterol medicine - counterfeits that did reach at least some patients.
Both cases illustrate a serious gap in drug security, said FDA Associate Commissioner John Taylor: These fakes made their way into the regular drug-distribution chain that stocks legitimate pharmacies.
"This is work of very good and very, very experienced counterfeiters," Miami U.S. Attorney Marcos Jimenez said of the Procrit scheme. "It was a very serious crime, very much a threat to their (patients') lives."
Counterfeit drugs have long been epidemic in parts of the world. One study found a third of malaria pills sampled in parts of Asia contained no trace of real medication.
There's no good data on how often counterfeits sell here, where pharmaceutical regulation is the world's strictest.
But while the vast majority of U.S. drugs are fine, "there has been an increase," Taylor said.
Since 1996, the FDA has investigated 71 counterfeit drug cases, resulting in 43 arrests.
Most U.S. counterfeiting has been of bulk ingredients shipped from overseas - but two years ago, FDA noticed a trend toward more counterfeit finished brands, including Procrit, Lipitor, the impotence pill Viagra and the AIDS-related drugs Serostim and Combivir.
The latest Procrit case began in April 2002, when manufacturer Amgen Inc. received a tip that a man in Miami named William Chavez was involved in a counterfeiting ring. Chavez pleaded guilty Wednesday.