Counterfeit Drug Volume Coming Into U.S. is “Huge” Says FDA Commissioner

March 1, 2024

The problem of potentially illicit, contaminated or low-potency counterfeit drugs coming into the U.S. from other countries is “huge,” but the government doesn't have a handle on the true numbers, said FDA Commissioner Robert Califf on Wednesday during a Reuters Newsmakers webinar.

“The total picture of illicit drugs being sold on the Internet — it’s almost certainly much bigger than what we see,” said Califf. “If you want an eye-opening experience, you should see the international mail coming into JFK airport.”

The numbers remain elusive, Califf said, because regulators in the U.S. can only rely on spontaneous adverse event reporting from people who had a problem with a counterfeit drug and decided to report it. Naturally, then, the true numbers go vastly underreported.

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