FDAnews Drug Daily Bulletin

Four Former FDA Commissioners Advise Against Drug Importation

March 24, 2017

Four former FDA commissioners have called on Congress to abandon proposals that would allow drug imports, warning that such measures would come with substantial risks and only have a small effect on prescription drug costs and access.

In an open letter to Congress, former FDA commissioners Robert Califf, Margaret Hamburg, Mark McClellan and Andrew Von Eschenbach urged federal lawmakers to consider other measures — such as government negotiations or value-based payment models — that would directly drive down prescription drug costs and present fewer public health risks.

The letter cautioned that proposals to allow imported drugs — like the recently introduced bill that would allow U.S. wholesalers and pharmacies to import prescription drugs from certified Canadian sellers — could lead to unintended consequences.

Imported drugs could be substandard, adulterated and fake, and the FDA does not have the resources to oversee a drug importation program that could routinely verify the safety and effectiveness of imports, the former FDA commissioners said.

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