How does the importation of drugs impact the U.S.?

Exposing the pharmaceutical distribution system to imported medicines raises the risk of counterfeit or substandard drugs creeping into our nation’s medicine supply. Even the Food and Drug Administration (FDA), under both Democratic and Republican administrations, has stated that it could not assure the safety of imported medicines from foreign countries and that they would present a risk to public health.

Countless reports suggest the worldwide counterfeit threat is knocking at America’s door. In fact, the Washington Post highlighted the counterfeit threat by stating, “counterfeit drugs are the latest -- and potentially most dangerous -- front in the long-running battle against intellectual-property crimes…[Out of all] counterfeit products seized by customs officials last year, pharmaceuticals are one of the fastest-growing categories.”

Outside the U.S., there is largely an open drug supply system, the counterfeit problem is growing worse by the day. In fact, a leading European Union (EU) commissioner, Gunter Verheugen, was quoted saying, “The number of counterfeit medicines arriving in Europe…is constantly growing. The European Commission is extremely worried. In just two months, the EU seized 34 million fake tablets at customs points in all member countries. This exceeded our worst fears.” Commissioner Verheugen was further quoted in the German newspaper Die Welt stating that, “Every faked drug is a potential massacre. Even when a medicine only contains an ineffective substance, this can lead to people dying because they think they are fighting their illness with a real drug.”

The alarming rate of counterfeit products being manufactured and sold around the world poses great challenges to federal agencies such as FDA,  Customs and Border Protection (CBP). In fact, according to CBP officials, seizures of counterfeit imports coming into the U.S. rose by 27 percent -- worth about $200 million in domestic value -- in 2007. Two years later, in 2009, CBP officials and U.S. Immigration and Customs Enforcement (ICE) officials made over 14,800 seizures of counterfeit and pirated goods, a total domestic value of $260.7 million. For this reason, PhRMA believes Congress should continue to maintain -- not weaken -- FDA’s closed drug supply system and also ensure that CBP and FDA have the resources to seize potentially dangerous and counterfeit products at our nation’s borders.

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Important: This content reflects information from various individuals and organizations and may offer alternative or opposing points of view. It should not be used for medical advice, diagnosis or treatment. As always, you should consult with your healthcare provider about your specific health needs.