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

Pharmacy Times, Volume 0, 0

Former FDA Commissioner DavidA. Kessler, MD, has called on Congressto grant the agency unprecedentednew authority to ensure the safety andeffectiveness of prescription drugsimported from Canada and othercountries. Dr. Kessler, who was often athorn in pharmacy's side during histenure at the FDA in both the Bush andClinton administrations, warned thatthe "current system of uncontrolleddrug importation" has created "uncontrolledrisks to the American public."

Yet, unlike many pharmacy leadersand other critics of Rx importation, Dr.Kessler told Congress that the solutionis not to prohibit prescription importsbut to grant the FDA new regulatorytools "to efficiently police the marketplace"beyond US borders. Testifying insupport of the pending PharmaceuticalMarket Access and Drug Safety Act of2005, Dr. Kessler told Senate leadersthat this bill would "create a safe systemfor drug importation" and "makeit possible for consumers to safelyimport drugs for their own use."

To reach this point, he said, the FDAneeds new authority to inspect foreigndrug-manufacturing facilities thatmake products shipped to the UnitedStates, as well as the power to verify the"chain of custody" of all importeddrugs "all the way back to the source ofmanufacture."

Mr. Rankin is a freelance medical writer.