Counterfeiters and middlemen have targeted some of Roche's best selling cancer drugs in the U.S., selling fakes and unapproved foreign versions at deep discounts while still reaping substantial payoffs. Now Europe is facing the problem, with the authorities warning that vials of Roche's cancer med Herceptin that were stolen in Italy are now showing up across the continent with little or none of its active ingredient.
On Wednesday, the European Medicines Agency (EMA) issued an alert to healthcare professionals to be on the lookout for the vials, which may show signs of tampering. Herceptin maker Roche ($RHHBY) decided to recall all of the batches from which the stolen drugs came even though only a small number were thought to be affected. The EMA said none of the stolen vials have been found in hospitals, and there have been no reports that any patients have been harmed. It said some of the vials were stolen from hospitals in Italy and that authorities there are investigating. It did not indicate how much of the drug was stolen, but 9 batch numbers were listed by the agency.
So far, counterfeit Herceptin has been discovered in Britain, Finland and Germany, Roche told Reuters. The company said testing found that some of the vials, which come with falsified records, did not contain the injectable cancer drugs' active ingredient. Others had it but showed signs of tampering or dilution. "Such tampering could compromise the sterility or efficacy of the product putting the health and well-being of patients at risk," Roche said in a statement.
The faked vials are labeled as Italian Herceptin® 150 mg, according to the EMA, but batch numbers and expiry dates on most vials do not match those on the outer package. Some of the packages of powder have liquid in them, and "evidence of tampering with the rubber stoppers, crimping caps or lids" was apparent on some.
Counterfeit and unapproved drugs have become an increasing problem in the U.S. and Europe as counterfeiters begin to target higher priced and sometimes lifesaving drugs. A counterfeit version of Allergan's ($AGN) cosmetic drug Botox was found in the U.S. last year, and in 2012, the FDA found that fraudulent versions of Roche's cancer treatment Avastin had been sold to physician practices throughout the U.S. The FDA and Department of Justice have also been prosecuting a number of cases in which versions of drugs manufactured for foreign markets but unapproved in the U.S. have been sold to American physician practices--including some of Roche's cancer meds. In some cases doctors knowingly bought the unapproved products because of the deep discounts offered on them, and the feds have charged some of them.
In an effort to better protect the U.S. supply chain, Congress approved a new law last year that over time requires the creation of a national track-and-trace system. Under the new law, drugmakers are required to begin tracking prescription drug lots in 2015. Two years later, industry players must begin assigning serial numbers to individual "saleable units" of every prescription product sold in the U.S., government deadlines mandate. The EU is working on similar requirements, and drugmakers are responding. Eli Lilly ($LLY), for example, is investing $110 million into stamping unique codes and serial numbers on every drug package it sells worldwide to help protect against fakes.
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