Press Release

PhRMA Statement on Prescription Drug Importation

PhRMA July 10, 2009

Washington, D.C. (July 10, 2009) — Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding the worldwide counterfeit threat and prescription drug importation:

“It is critical that we maintain our focus on comprehensive health reform to help all Americans access high-quality and affordable healthcare coverage and services. The Congress should not pursue policies that could expose Americans to counterfeit and substandard drug products and potentially weaken the Food and Drug Administration (FDA) and the Department of Homeland Security (DHS) by crippling their ability to fulfill their mission in protecting public health and safety.

“The worldwide counterfeit threat is knocking at America’s door and will soon be greeted if prescription drug importation proposals move forward. According to European Union (EU) custom officials, 8.9 million counterfeit medicines were seized in the EU in 2008, an increase of 118 percent compared to 2007. In other parts of the world – such as countries in Africa and Southeast Asia – the situation is even worse with up to 30 percent of medicines being counterfeit, according to the World Health Organization.

“Now, more than ever, patients should know that the FDA has stated that so-called ‘Canadian’ Internet pharmacy sites bearing the Canadian flag often are operated out of other foreign countries around the world. In fact, an FDA investigation found that mail packages containing prescription drugs from ‘Canada’ came from 27 countries globally – such countries include India, Costa Rica and Vanuatu.

“The alarming rate of counterfeit products being manufactured and sold around the world poses great challenges to federal agencies such as FDA and Customs and Border Protection (CBP), which falls under the DHS. In fact, public statements by DHS suggest that there has been a significant increase in seizures of counterfeit imports at U.S. borders. For this reason, PhRMA believes that Congress should continue to maintain – not weaken – FDA’s relatively 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. For more information about the worldwide counterfeit threat, go to

“The counterfeit threat also poses significant challenges to America’s pharmaceutical research and biotechnology companies, whose lifeblood is the safety and integrity of the products they develop. For all of these reasons, we look forward to continuing our dialogue with Congress and the Administration to help ensure that patient health and safety is protected and to help prevent the proliferation of counterfeit medicines in the U.S.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

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For information on the danger of imported drugs, visit: