The drug importation debate has once again heated up, with both Members of Congress and industry insiders stating their belief that reimportation will become a reality this year.

At a seminar on the topic put on by the Center for Medicare Use, Policy and Economics of the University of Michigan School of Pharmacy (sponsored, in part, by a grant by AstraZeneca Pharmaceuticals), industry and academic sources speculated that drug reimportation will either pass as legislation in some form or that government will provide guidelines under which reimportation will be allowed.

Concurrently, a bipartisan group of Senators announced a new reimportation bill (S.2328) that they say addresses current concerns to include safety and other issues. The group, which includes Senators Byron Dorgan, Olympia Snowe, John McCain, Edward Kennedy, Minority Leader Tom Daschle, and others, unveiled their proposal at a news conference on April 21st. Senator Snowe stated that the new legislation makes reimportation “doable and achievable” this year, according to the April 21st edition of The Hill, a magazine dedicated to legislative and political news. In addition to the bill just introduced by this bipartisan group, Senators Dorgan and McCain earlier introduced a bill, S.1781, on which TSCL Legislative Consultant David Funderburk testified before the Senate Commerce Committee in November 2003.

In other Senate action, Senator Judd Gregg – Chairman of the Senate Health, Labor, Education and Pension Committee (HELP) – is crafting a framework for legislation. As of this writing, hearings were recently held on the issue in that committee. Majority Leader Bill Frist has made known his desire in having any reimportation pass through the HELP Committee. Finance Committee Chairman Charles Grassley has his own reimportation bill, and legislation on Social Security and Medicare is often referred to the Finance Committee. Legislation is not expected to be considered before the full Senate prior to September.

A strong reimportation bill (H.R.2427), that TSCL supports – was introduced by Congressman Gil Gutknecht and Representative Rahm Emanuel – and agreed to by the House of Representatives in July 2003. When we meet with Members of Congress on both sides of the aisle, we are increasingly hearing of support for reimportation, including from among those who voted against the Gutknecht bill last July.

We hope to work further with Senate leaders on this issue. If differing versions of prescription drug reimportation pass the two bodies of Congress, a conference committee will meet to iron out the differences. In addition, a task force – mandated by the Medicare prescription drug bill that passed Congress and was signed into law in December 2003 – is meeting and may recommend means to allow reimportation through guidelines and regulations handled within the Food and Drug Administration and Health and Human Services.

May 2004