Medicine SafetyImportation & Counterfeits

Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, is the wrong answer. 

Due to the U.S. Food and Drug Administration’s (FDA) comprehensive drug approval process, medicines on the U.S. market are widely regarded as the safest in the world. The U.S.’s relatively closed distribution system plays a critical role in helping to keep the global proliferation of counterfeit medicines from infiltrating the U.S. prescription medicine system. 

The World Health Organization (WHO) estimates 10 percent of medicines worldwide – and up to 50 percent of the drugs consumed in developing nations – are counterfeit.  Without proper FDA oversight and enforcement of laws designed to protect patient safety—which importation undermines— these products could infiltrate the U.S. pharmaceutical supply chain, with life threatening consequences.  Under both democratic and republican administrations, the FDA has stated it cannot assure the safety of imported medicines from foreign countries and they would present a risk to public health.

There are many other safe alternatives available for patients unable to access needed medicines. Patient assistance programs sponsored by America’s biopharmaceutical research companies are one option to help patients. Learn more about the Partnership for Prescription Assistance (PPA) by visiting

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