Drug Importation into the US from Canada — New Developments

In an effort to reduce the cost of prescription drugs for its citizens, some American states and cities have introduced Canadian drug importation plans. However, the US federal government has opposed such plans, often citing safety as a major concern. In developing their own state drug importation system, officials of the State of Oregon believe they have addressed the safety issues raised. Oregon's Pioneer Prescription Drug Project (PPD Project) includes a regulatory structure overseen by Oregon's Board of Pharmacy requiring, in addition to other things, that Canadian pharmaceutical wholesalers meet the same licensing requirements as US drug wholesaler outlets, that only approved manufacturing locations in Canada supply the drugs, and that inventories of imported medicines be stored separately from US product for tracking and recall purposes. Only licensed Oregon pharmacists may choose to participate in the PPD Project, and prescriptions filled from the imported drugs will not be eligible for insurance reimbursement. Since the Oregon officials believe that all of the concerns raised by the federal government have been addressed, an application has been made to federal government for a waiver to the current law, to allow the PPD Project to proceed legally. It seems unlikely, however, that the waiver will be granted as the FDA has yet to grant such a waiver despite the many requests it has already received. As a result, many States and cities have chosen to proceed with programs in defiance of the federal position. To date, the only response by the federal government has been to send warning letters. It should be noted that Vermont is the first state to have brought a legal action against the federal government in response to its refusal to grant a waiver. The result of the case may affect the future of US drug importation from Canada. For more information on Oregon's Pioneer Prescription Drug Project, see: http://governor.oregon.gov/Gov/press_081904.shtml. For more information on Vermont's legal action, visit: http://makeashorterlink.com/?O2BD25D29; http://www.vermont.gov/governor/priorities/FDA-complaint.pdf; or http://makeashorterlink.com/?D2CD52D29. Summary by: Sue Diaz