2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC30
Submitter : Ms. William Bro Date & Time: 05/03/2004 06:05:50
Organization : Kidney Cancer Association
Health Care Association
Category :
Issue Areas/Comments
There are difficult issues surrounding the various proposals to purchase medications from Canadian and off-shore sources, the most important of which is the lack of U.S. Food & Drug Administration (FDA) oversight. Prescription medicines sold outside our country are not subject to FDA scrutiny. It is important that medications comply with FDA rules for dosing, purity, etc.

The U.S. leads the world in the discovery of new medicines. We should not adopt policies that undercut profits that fund our ability to produce drugs that allow people to live longer and healthier lives.

In our office we hear regularly from Canadian patients who want to come to the U.S. for treatment of their cancer. The lack of understanding about Canada's inferior health care system could result in needless hardship for people who are sick here in the U.S. Merely saving money on the cost of drugs does not imply an improved standard of care for people who are ill.

If plans to permit importation of drugs from Canadian or off-shores sources were approved, who would be held responsible for possible adverse events due to the unintended importation of impure or counterfeit drugs? If states must bear this responsibilty, damage awards to people who were harmed might more than offset any potential savings.