Former FDA heads warn against dangers of drug importation

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Four former Food and Drug Administration commissioners are warning lawmakers about the dangers associated with importing cheaper medications from other countries.

Robert Califf, MD, Margaret Hamburg, MD, Mark McClellan, MD, PhD, and Andrew Von Eschenbach, MD, sent a letter to members of Congress highlighting their concerns with drug importation.

"The American public and members of Congress have expressed serious concerns about access to and cost of prescription drugs…We share these concerns and believe we need better systems that enable affordable access to life-saving medicines," they wrote in the letter. "However, routine importation from foreign countries is not the right approach."

The former FDA leaders cited the following concerns with dug importation.

1. Drugs purchased from other countries may be substandard, unsafe, adulterated or fake.

2. The system opens up patients and consumers to serious risks.

3. The FDA lacks resources necessary to oversee a large drug importation program.

4. The global drug supply system will limit improvements in access, meaning a limited supply of drugs would be available for importation.

5. Importation would likely achieve minimal cost savings and only a slight improvement to access.

"We urge Congress and the many others concerned about the cost of drugs to deal directly with the issues driving the cost of medicines and not to place false hope in measures that will place patients who need treatment at risk and jeopardize public health," the former FDA leaders wrote.

They advocated for more direct tactics to lower drug costs, such as value-based drug pricing and streamlined approvals for generics and biosimilars.

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