2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC62
Submitter : Mr. Doug Getter Date & Time: 06/03/2004 04:06:41
Organization : Iowa Healthcare Access Network
Health Care Association
Category :
Issue Areas/Comments
The members of the Iowa Healthcare Access Network are anxious to make affordable prescription drugs available to all people; however, there are many uncertainties about the integrity and safety of drugs obtained from other counties and websites. There are too many life threatening risks involved in obtaining these drugs with no safety nets or accountability.

Importation is an attempt at a quick fix to a problem that requires a long term solution. But even more pressing are the adverse consequences that this shortsighted legislation will have on people living with debilitating and life threatening diseases.

We must respectfully ask you to oppose prescription drug importation legislation. While we applauding your attempt to provide access to cost- effective treatments, we must ask you to take many critical factors into account:

? Facilitating importing drugs from Canada is currently illegal under Federal Law unless the Secretary of HHS clearly certifies that importation poses no risk to the public?s health and safety. We are concerned there are inadequate guarantees in place to do so.

? Under Canadian law it is illegal to ship drugs to the US. Canadian citizens do not support exporting their drugs to the US. Canada only uses 2 percent of the world?s drug supply compared to 50 percent used by people in the US.

? FDA and Health Canada do not and cannot guarantee safety of imported drugs. Recent random searches by FDA had continued to reinforce the lack of safety of incoming imported prescriptions at our US ports of entry (see FDA website).

? There is absolutely no effective way to prevent transshipment of drugs ? legitimate or otherwise ? from Third World countries into Canada. In fact, an FDA study in 2000 found up to 400 Internet pharmacies, evenly split between domestic and foreign locations. Since then, this cottage industry has exploded.

? Based on FDA spot checks of mail facilities, 88% of mail order drugs coming into the U.S. have serious safety problems including, prescriptions being incorrectly labeled, diluted drugs, improper storage and handling of drugs, etc.

? Who is liable when the state facilitates importation activity?
-----is the Federal Government liable?
-----is the Canadian medical doctor and Canadian pharmacist?
-----is the US doctor, who?s prescription is rewritten by Canadian doctor who never saw the US patient?
-----why are US citizens required to waive their rights of liability to Canadian internet pharmacies?

The members of our coalition are advocates for healthcare in Iowa. We represent Iowans who use all facets of the healthcare system who desire to have affordable prescriptions for our community and families. When it comes to healthcare Iowans have a reputation for expecting nothing but the best and we want the newest and best drugs available. We want it all at a cheap price and most important we want it now. We understand that it may not be possible to have it all to ensure safety to all patients.

IHAN takes into account the value of new innovative medicines and understands that the may cost more but provide value in the form of improved quality of life for the patient as well as savings by lowering costs in other areas of the healthcare system.

As you can see, there are too many unknown questions, and unknown answers to legislate toward this means to provide affordable prescription drugs. We know this is among the most important issues facing you today. We encourage you to continue discussing the critical issue of the cost of prescription drugs, but ask you to explore other ways to deal with this issue.