Looking Under the Hood of Prescription Drug Reimportation

Congressional interest in prescription drugs was by no means exhausted once the Medicare drug bill passed in December 2003. A continuing focus on the Hill is whether to encourage reimportation of drugs to the U.S. from other countries, notably Canada. The secretary of Health and Human Services has had the right to authorize reimportation since the Clinton administration, but no secretary has yet exercised the right, citing safety concerns.

What does current law say about reimportation of prescription drugs by individuals and commercial entities? How does this affect FDA enforcement? Are drugs that are manufactured in Canada and other countries comparable in every respect to FDA-approved products? What are the key changes that leading congressional proposals would make to current law? What changes are states seeking, and why?

To discuss the potential gains, limitations and risks associated with reimportation, the Alliance for Health Reform and the Kaiser Family Foundation sponsored a July 22, 2004 briefing. Panelists included: Tom McGinnis, director of pharmacy affairs in the commissioner’s office at the Food and Drug Administration; Donna Vogt and Susan Thaul, specialists in social legislation at the Congressional Research Service, and Cal Ludeman, commissioner for the Minnesota Department of Employee Relations, who highlighted growing interest among state employees in purchasing prescription drugs from Canada. Diane Rowland of Kaiser made brief remarks and Ed Howard of the Alliance moderated the discussion.