Revisiting Reimportation

At what cost could FDA be forced to change its tune on reimportation?

“The Administration supports a program to allow Americans to buy safe and effective drugs from other countries and included $5 million in our FY 2010 budget request for the Food and Drug Administration (FDA or the Agency) to begin working with various stakeholders to develop policy options related to drug importation.”

This statement was included in a December 8 letter to U.S. Senator Tom Carper from FDA Commissioner Margaret Hamburg in response to Carper’s letter regarding reimportation. Carper was apparently asking for FDA’s views on an amendment presented by Senator Byron Dorgan.

FDA still seems uncomfortable with the idea, pointing out potential patient risks. “The Dorgan importation amendment seeks to address these risks,” Hamburg admits. “It would establish infrastructure governing the importation of qualifying drugs that are different from U.S. label drugs, by registered importers and by individuals for their personal use.”

But to pull it off, FDA seeks some form of regulatory oversight over these foreign manufacturers, and it says it could be costly. Hamburg writes that FDA would need to review both data and facilities. (An initial $5 million seems hardly enough to get started.)

So, “as currently written, the resulting structure would be logistically challenging to implement and resource intensive,” Hamburg concludes.

Given this conclusion, would the potential savings from the imports themselves be worth the costs of increasing FDA’s budget to give it sufficient international oversight?

And with healthcare reform potentially raising “taxes” on manufacturers (or at least some sort of “support”), could U.S. drug manufacturers actually be forced to pay for reimportation?

Daphne Allen