2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC31
Submitter : Ms. Celeste Kelley Date & Time: 05/03/2004 06:05:59
Organization : Kidney Cancer Association
Health Care Association
Category :
Issue Areas/Comments
GENERAL
GENERAL
The issues surrounding proposals to purchase medicines from Canadian and off-shore sources are difficult and complex. Most important is the concern for safety and the lack of U.S. Food & Drug Administration (FDA) oversight. Prescription drugs sold outside the US are not subject to FDA scrutiny. This scrutiny assures compliance with FDA rules for dosing and purity and thus, protects Americans from hazardous or unsafe medications. The United States currently stands as the world leader in the discovery of new theraputic agents for the treatment of all diseases, including kidney cancer. We should not adopt policies that undercut this ability to produce drugs that help people to live longer and healthier lives.Saving money on the cost of drugs does not imply or insure improved standard of care for patients. If plans to permit importation of drugs were approved - despite recent cautions from the FDA that they have no way of assuuring that foreign drugs are the same as U.S. drugs - at what risk and at what cost are we willing to save dollars? These same dollars may well be offset by damage awards because of harmful effects from impure or counterfeit drugs unitentionally imported. Who would bear this responsibility? And why, in an age of terrorism, would we even consider easing importation restrictions?