2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC41
Submitter : Mr. John Gorman Date & Time: 05/18/2004 11:05:59
Organization : Alzheimer's Aid Society
Consumer Group
Category :
Issue Areas/Comments
GENERAL
GENERAL
I respectfully submit great concern over the direction we are heading in this debate. While we applaud attempts to provide access to cost-effective treatments, we must take many critical factors into account: a) facilitating importing drugs is illegal because it poses a health and safety risk to the public (b)FDA, as well as Health Canada, do not and cannot guarantee the safety of imported drugs thru our ports of entry (c) When a patient with Alzheimer's is negatively impacted, adverse reaction, harm, who becomes liable in this "new world", of who's drug, what source of origin, etc?
Caregivers, families, and patients with Alzheimer's desire to have affordable prescriptions. Unless Canada pharmacies are required to stipulate country of origin, comply with each state's pharmacy law, and accepts full liability when and if harm comes our way, and safe guards provided our current US drug supply, I believe there are too many unanswered questions, too many unknowns, no guarantee of safety regulations and enforcement. Sincerely, John Gorman