DOJ settlement targets unlawful importation

Google agreed yesterday to forfeit $500 million for “allowing online Canadian pharmacies to place advertisements … targeting consumers in the United States, resulting in the unlawful importation of controlled and non-controlled prescription drugs into the United States.”

The U.S. Department of Justice gets to the heart of the underlying issue in its news release:

The importation of prescription drugs to consumers in the United States is almost always unlawful because the FDA cannot ensure the safety and effectiveness of foreign prescription drugs that are not FDA-approved because the drugs may not meet FDA’s labeling requirements; may not have been manufactured, stored and distributed under proper conditions; and may not have been dispensed in accordance with a valid prescription.

Also:

While Canada has its own regulatory rules for prescription drugs, Canadian pharmacies that ship prescription drugs to U.S. residents are not subject to Canadian regulatory authority, and many sell drugs obtained from countries other than Canada which lack adequate pharmacy regulations.

AstraZeneca agrees. We believe the importation of medicines from outside the US drug regulatory system places the public health at risk because the safety of the medicines cannot be monitored or authenticated by the FDA, US Customs, or other foreign regulatory bodies. This lack of oversight can result in mishandled, tainted, or counterfeit products entering the US drug supply.

See what PhRMA has to say on the settlement here.

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