/publications/issue/2005/2005-06/2005-06-9624

Ex-FDA Commissioner Kessler Calls for "Safer" Rx Imports

Author: Ken Rankin

Former FDA Commissioner David A. Kessler, MD, has called on Congress to grant the agency unprecedented new authority to ensure the safety and effectiveness of prescription drugs imported from Canada and other countries. Dr. Kessler, who was often a thorn in pharmacy's side during his tenure at the FDA in both the Bush and Clinton administrations, warned that the "current system of uncontrolled drug importation" has created "uncontrolled risks to the American public."

Yet, unlike many pharmacy leaders and other critics of Rx importation, Dr. Kessler told Congress that the solution is not to prohibit prescription imports but to grant the FDA new regulatory tools "to efficiently police the marketplace" beyond US borders. Testifying in support of the pending Pharmaceutical Market Access and Drug Safety Act of 2005, Dr. Kessler told Senate leaders that this bill would "create a safe system for drug importation" and "make it possible for consumers to safely import drugs for their own use."

To reach this point, he said, the FDA needs new authority to inspect foreign drug-manufacturing facilities that make products shipped to the United States, as well as the power to verify the "chain of custody" of all imported drugs "all the way back to the source of manufacture."

Mr. Rankin is a freelance medical writer.