Keeping It Real - Pharmaceutical Executive


Keeping It Real

Pharmaceutical Executive

One estimate of the scale of the problem comes from Rep. Steve Buyer (R-IN). In one day, he says, up to 360,000 packages containing counterfeit drugs enter the 12 international mail facilities. That's up to 10 million packages a month, and 130 million counterfeit drug packages in a year.

In the case of drugs, the word "counterfeit," includes far more than products made by someone other than the patent holder. Many of the products identified by FDA as counterfeit are authentic products that have been diverted from some other part of the drug distribution system. One key form of diversion: product intended for sale in countries, where prices are low, that is illegally reimported to the US as an exercise in illegal arbitrage—in order to gain a profitability advantage. Another type of counterfeit: Short-dated drugs intended for humanitarian efforts, long term care, group purchasing organizations, or specialty clinics that are smuggled back into the US, often with the expiration date altered.

"Many believe that diversion is often the catalyst for counterfeiting," says Dean Hart, executive vice president of NanoGuardian. "[They think] 'If I can get this diverted product through as easily as I can, if I really want to maximize my profits, maybe I go to that counterfeited level.'"

Viagra for Sale

Ironically, one company that is renowned for hunting down counterfeiters is also known for having the most forged drugs. Pfizer's heads of security have seen just about everything when it comes to counterfeiting, and the company is doing what it can to get a stranglehold on brand-jackers.

Since 2004, Pfizer's security crew has discovered approximately 42 million counterfeit products—mostly Viagra, but also Lipitor, Norvasc, and Celebrex. In addition, Pfizer has unearthed enough active pharmaceutical ingredient to manufacture probably another 63 million more tablets.

"We've also found ingredients that you would not normally want to ingest, such as boric acid; or people who take Viagra when it actually contains amphetamines or too much of the active ingredient, which can increase the possible side effects," says Rubie Mages, director of policy communications and programs at Pfizer. "While a number of these [drugs] do come in through the Internet, I think you need to take a look at the overall picture, which includes counterfeits that have been able to breach the security of even the most regulated of supply chains."

Mages is clear that even though the US pharmaceutical supply chain is one of the safest in the world, it isn't impenetrable. In 2003, 18 million pre-packaged Lipitor tablets were recalled from the legitimate supply chain after counterfeits slipped into the US. In that case, counterfeit product manufactured in Costa Rica was commingled with authentic product intended for another market—also smuggled into the United States—and then repackaged and delivered to pharmacy shelves throughout the country.

Pfizer has discovered counterfeit products in the supply chains of 26 other countries, including Canada and the UK. "While it's relatively safe, I think counterfeiters would love to get their product into our legitimate supply chain," says Patrick Ford, Pfizer's senior director of security for the Americas.

Pfizer's security team believes that the key defensive measure is conspicuous counterfeit protection on all packaging to help pharmacists and distributors distinguish counterfeit packaging from the real thing by simply looking for markers. "Counterfeiters, generally speaking, are very good at recognizing our overt authentication, and within six months they generally have counterfeited it," Ford said. "We've had other technologies that have lasted three years, four years, but we're always changing our overt features, depending on the product and whether or not it's been counterfeited."

For James Christian, head of security for Novartis, the best way to stop counterfeiters is the old-fashioned way—keep your ears to the floor, answer every report, and kick in the door in when necessary.


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