FDA: Cost of Enforcement Would Exceed Benefits of Importation

Published February 1, 2004

As millions of Americans turn to Canada and even borderless Internet drug stores for less-expensive medicines, the FDA’s pharmacy affairs director, Tom McGinnis, said it would take hundreds of millions of dollars to set up a legal, safe program to import the medicines. Despite pressure from Congress, state governors, and municipal officials, he insisted the FDA would never rely on Canada’s safety assurances for drugs shipped out of that country.

In the international mail facility at New York’s John F. Kennedy International Airport, packages of confiscated prescription drugs are stacked floor-to-ceiling. The thousands of such illegal mail-order drugs stopped at America’s entry points, however, are a small fraction of the multimillion-dollar business that federal regulators are struggling to control.

McGinnis told the Associated Press the FDA would not piggyback its inspections on the Canadian system because the United States inspects drug manufacturers around the world, while Health Canada often relies on inspections done by the drug maker’s host country. “We want to see everything with our own eyes. We’ve never accepted inspection results from another country,” said McGinnis.

The FDA’s stubborn stand on illegal cross-border drug sales sets the tone for a Health and Human Services study on the safety of Canadian drug imports. The study, required by the Medicare reform measure President George W. Bush signed in December, was included as a way to appease lawmakers bent on legalizing imported drugs.

McGinnis, who was surveying the illegal take at Kennedy Airport in late December, said, “Anything can be done with enough resources and the authority to do inspections. … You’re talking about a lot of resources, and when is cost going to outweigh benefit?”