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Four FDA Commissioners Write Letter to Trump on Drug Importation

March 16, 2017
By Robert M. Califf, Margaret A. Hamburg, Mark B. McClellan, Andrew Von Eschenbach

Four former FDA commissioners wrote an open letter asking President Donald Trump to resist a policy of importing drugs from foreign countries.

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The letter states the following:

"The American public and members of Congress have expressed serious concerns about access to and costs of prescription drugs, particularly innovative therapies with major benefits for people with serious diseases. We share these concerns, and believe we need better systems that enable affordable access to life-saving medicines.

"However, routine importation from foreign countries is not the right approach. Allowing importation of drugs purported to be manufactured overseas in FDA-inspected facilities and drugs purported to be manufactured domestically for export to other countries and reimported from those countries to the United States cannot meet the requirements under the existing closed drug manufacturing and distribution system because the drugs could not be tracked and certified by the manufacturer.

"Such a program would be very different from importation of consumer products like watches or clothing, where consumers can more easily discern quality and where there are no health consequences of fake products. It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs. It could also undermine American confidence in what has proven to be a highly successful system for assuring drug safety."

The letter continues.