“Our awareness of the extent of counterfeiting came about mainly as a result of Cialis,” says Lechleiter of Indianapolis-based Lilly. “But the problem is not restricted to Cialis. We’ve seen counterfeit versions of other Lilly products emerge in markets around the world.”
Counterfeits of Lilly’s top seven products, led by the anti-psychotic drug Zyprexa, and more than two million tablets of Cialis, were seized in 800 raids around the world last year, Lilly security officials say. The top seven drugs made by Lilly generated 68% of the company’s $17.6 billion in sales of human medicine in 2007. Seizures in 45 countries last year found counterfeits of Pfizer’s nine best-selling drugs, including fakes of Lipitor, the cholesterol pill that accounts for one-quarter of Pfizer’s $48 billion in sales. Illegal copies of Pfizer’s eight other top drugs, which account for another 30% of sales, also were seized.
Pfizer’s Mages says Viagra remains the world’s most counterfeited drug and accounted by volume for almost three-quarters of the illicit copies of Pfizer brands seized last year in 45 countries. The drugs are marketed on Internet sites whose operations are also global, she says.
US Food and Drug Administration (FDA) officials say they are unable to stop the flow of illegal drugs sold on the Internet. “There are counterfeiters circulating all over the world,” says Ilisa Bernstein, director of pharmacy affairs at the Rockville, Maryland-based FDA. “It’s hard to tell how many there are because the counterfeiters are just so good at what they do.”
The agency can’t police all the international drug shipments referred to FDA by US Customs and Border Protection Inspectors at post offices, she says.
“There are millions and millions and millions of these packages coming in at international mail facilities each year,” Bernstein says.
“It’s very difficult to find and catch all of these drugs that are coming in to protect patients from all these very risky drugs.”
The FDA’s claim that it can’t destroy counterfeits is disputed by representative Steven Buyer, an Indiana Republican. “The FDA does not destroy it, the FDA becomes the enabler of the counterfeiters,” says Buyer, who predicts counterfeit drugs will be a $100 billion global business in five years.
Representative Bart Stupak, a Michigan Democrat who chairs the house energy and commerce subcommittee on oversight and investigations, says the FDA’s failure to act has contributed to the flow of counterfeit drugs into the US. Stupak says he has repeatedly asked the FDA if it needs new laws passed to strengthen enforcement and they “have remained silent”.
Few law enforcement agencies make stopping counterfeit drugs a priority, says James Christian, vice-president for corporate security for Basel, Switzerland-based Novartis AG, which is investigating sales of counterfeit versions of its hypertension drug, Diovan.
“When you are talking about where manufacturing is taking place, where distribution is taking place, where the printing of the counterfeit inserts and packaging is taking place, these cases are 99% made by the industry,” says Christian.