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Support for re-importation

September 20, 2000 7:00 AM UTC

The Clinton administration has signaled its strong support for the re-importation of prescription drugs, giving a boost to Congressional efforts to allow Americans to purchase drugs produced in countries with government-imposed price controls. In letters sent this week to members of Congress, Health and Human Services Secretary Donna Shalala and Office of Management and Budget Director Jacob Lew expressed support for a Senate effort to allow wholesalers and pharmacists to re-import or import FDA-approved drugs. However, both emphasized that the administration's support for re-importation is contingent on Congress appropriating sufficient funds for FDA to police imports.

An amendment to the agriculture appropriations bill allowing re-importation mandates extensive safeguards that are intended to prevent contaminated or counterfeit drugs from reaching American consumers. It also requires that the HHS Secretary certify that re-importation does not pose a risk to public health and safety and that it would result in significant reductions in costs to U.S. consumers. Shalala said she "would not be able to certify that there is no increased risk to public health and safety unless new and sufficient resources were provided to implement the new safety system." She and Lew noted that FDA estimates that $23 million will be needed to establish the system and several times that amount may be needed in future years to implement it. "If FDA is not provided with the necessary funding to implement and oversee this change in law, the borders would effectively be opened with no gatekeeper to provide protection from harm," Shalala wrote. Lew suggested that President Clinton would veto the agriculture appropriations bill if it contains the re-importation mandate without providing FDA new funds. Shalala also expressed firm opposition to re-importation bills that have passed the House of Representatives because they would prevent FDA from regulating imported drugs. ...