When governments or individuals circumvent the regulatory gold standard of the FDA’s review and approval process to acquire unapproved prescription drugs from other countries outside of the United States’ secure drug distribution system – commonly referred to as importation – both individuals and the health care system suffer negative consequences.

Without proper Food and Drug Administration (FDA) oversight and enforcement of laws designed to protect patient safety, which importation schemes undermine, there is increased potential for counterfeit, substandard or adulterated products to infiltrate the U.S. pharmaceutical supply chain, putting lives in harm’s way.