June 17, 2004 Letter to Senators Warner and Allen
PO Box 8208
Alexandria, VA 22306-8208
June 17, 2004
The Honorable John William Warner
United States Senate
225 Russell Senate Office Building
Washington, DC 20510-4601
The Honorable George F. Allen
United States Senate
204 Russell Senate Office Building
Washington, DC 20510-4604
Dear Senators Warner and Allen:
As a constituent, I strongly urge you to support a substitute amendment to the Department of Defense Authorization Bill to be introduced by Sens. Tom Harkin and Orrin Hatch in regard to dietary supplements.
The second degree amendment from Sens. Harkin and Hatch, which expresses the sense of the Senate concerning reporting of serious adverse events related to dietary supplements, offers a comprehensive approach to ensuring the safety of all Americans, not just those on military bases. In addition, it calls for the Food and Drug Administration (FDA) to fully implement the Dietary Supplement Health and Education Act (DSHEA) and recommends that adequate resources be made available to ensure this happens.
The second degree amendment from Sens. Harkin and Hatch is a substitute for an amendment to be introduced by Sen. Richard Durbin, S.A. 3225. I believe this amendment from Sen. Durbin is not the right solution. It would effectively mandate reporting of serious adverse events without any consideration of the critical issues necessary to make such a reporting system effective. These include the appropriate balance between the value of the FDA knowing about serious adverse reactions and the cost to the industry and the consumer, as well as the cost to the agency itself.
Simply put, the amendment from Sens. Harkin and Hatch will set the stage for an industry-wide reporting system of serious adverse events for all Americans, not just one that’s applicable to the military. It will also help to ensure that the FDA gets the resources it needs to implement an effective system.
I urge you: Support the amendment from Sens. Harkin and Hatch and say no to Sen. Durbin’s amendment, S.A. 3225.
Sincerely,
James Landrith