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28 March 2013Big Pharma

Confidence in the face of counterfeits

When you think of counterfeit goods, what comes to mind? Many would say fake purses, fake watches and other similar products you might find being hawked on street corners. What about counterfeit drugs? Would counterfeiters dare to enter such a highly regulated industry? Or attempt to replicate a product that is potentially life-changing and even life-saving, and so difficult to manufacture and distribute safely and correctly? Sadly, yes—drugs are among the many types of products targeted by counterfeiters.

Across the planet, drugs in all major therapeutic categories have been counterfeited. Annual counterfeit drug sales were estimated to generate $200 billion in 2011. And incidences of counterfeit medicines continue to rise on a global level as the technology to copy drugs and to reach patients advances.

Genuine medicines are manufactured and packaged under strict regulations to meet quality standards that ensure safety and efficacy. Counterfeit drugs are manufactured outside of that safety net, may be contaminated, or may contain the wrong active ingredients, harmful ingredients, or no active ingredients—all of which compromise the drugs’ safety and efficacy.

In February of this year, the US Food and Drug Administration (FDA) warned that counterfeit versions of a cancer drug used to treat cancers of the colon, lung, kidney and brain had been found in the US market. The counterfeit product did not contain any of the active ingredients of the genuine product.

But even if some counterfeit drugs turn out not to be harmful, they are still illegal. The bottom line is there are no ‘good’ counterfeit drugs. They pose a serious public health risk and have caused serious injury—and even death—around the globe.

Counterfeits and the Internet

The Internet has further complicated the battle against drug counterfeiting. As a semi-unregulated environment, with virtual anonymity and a direct link to the public, the Internet has become a widely used channel for the distribution of counterfeit drugs.

Search engines are the gateway for navigating the Internet for most consumers. Counterfeiters infiltrate search results with websites selling counterfeit drugs to unsuspecting consumers. Many websites are difficult to monitor because they can be activated and deactivated at the click of a button. Moreover, the actual operators of these sites can be difficult to locate and often these cybercrimes go unresolved.

A review by the National Association of Boards of Pharmacy (NABP) of more than 10,000 websites offering drugs to the US market found that 97 percent operate out of compliance with US pharmacy laws. Specifically, the review found that:

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