Smith Introduces Legislation to Allow Drug Re-importation
Legislation Provides Immediate Benefits/Sets Timeline for Legalized Imports
Washington, DC - Today, Senator Gordon Smith (R-OR) and Chairman Judd Gregg (R-NH) of the Committee on Health Education, Labor, and Pensions introduced the Safe Importing of Medical Products and Rx Therapies (Safe IMPORT) Act to allow individuals, pharmacies, and wholesalers to safely import prescription drugs from Canada and as many as 15 Western European countries.
"Everyone agrees that we have to do something about the high cost of prescription drugs," said Smith. "The real question is how to do it safely and without destroying incentives to produce life-saving medicine. We've struck a good balance here - one that will quickly make imports legal while providing the same protection we have for drugs purchased in the United States."
Current law provides that individuals may import prescription drugs from other countries only when and if the U.S. Secretary of Health Human Services (HHS) certifies that such imports are safe. No HHS Secretary in the Bush or Clinton Administrations has made such a determination. The Safe IMPORT Act will create a specific timeline for the legalization of drug imports allowing the Food and Drug Administration (FDA) sufficient time to issue and implement necessary safety regulations.
The Safe IMPORT Act will:
allow individuals to legally import up to a 90-day supply of FDA-approved prescription drugs purchased from licensed pharmacies in Canada or any permitted country
permit pharmacies, wholesalers, and internet importers to import commercial quantities after meeting and maintaining strict requirements
ensure consumer safety by requiring commercial importers to register and maintain accurate supply chain records. It will also grant the FDA authorities similar to those currently in place for imported food.
be funded by a user fee program which will involve all businesses engaged in importation
Upon enactment of the Safe IMPORT Act, individuals will immediately be permitted to personally import pharmaceuticals from Canada. Pharmacy and wholesaler importation from Canada provisions become automatically effective within one year. Internet pharmacy provisions will become effective upon issuance of final regulations, which the FDA must complete within one year. Three years after enactment, the FDA may permit drug imports from countries admitted to the European Union prior to 2004.
