How FDA’s move on drug importation could shape medical marketing

It was a long time coming but the Food and Drug Administration greenlit Florida’s plan to import lower cost drugs from Canada.

The agency’s historic move toward drug pricing reform last week allows the Sunshine State to become the first state to buy drugs in bulk for its Medicaid program from Canada.

It’s estimated the action may save up to $150 million just in the first year of the initiative. Since Canada, like many other countries, can negotiate directly with drugmakers to set a lower cost for medications — prescription drugs are cheaper there as a whole than they are in the U.S.

Leslie Isenegger, who leads Real Chemistry’s corporate pricing and public affairs practice, says the decision is a significant one because people have been talking about drug reimportation for more than 20 years and it finally came to pass.

In the early 2000s, Congress passed a law that allowed drug importation under strictly defined circumstances — only if the Department of Health and Human Services (HHS) Secretary deemed importation safe for the American public, and if it would result in cost savings for patients.

However, the law was never implemented, largely due to pushback from industry groups, who argued that drug importation would raise safety issues.

“The fact that the FDA has given a nod to this, just in and of itself, is unprecedented,” Isenegger says.

Unsurprisingly, the pharma industry immediately expressed opposition to the FDA’s approval last week, with lobbying group PhRMA noting in a statement that the decision was “reckless” and that “the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health.”