1. Cross-Border Internet Pharmacy: No Place to Buy Drugs Durhane Wong-Rieger, PhD Consumer Advocare Network

2. Importation and the Safety of the Drug Supply Chain Government agencies in Canada and the United States will not attest to the safety of drugs re-imported into the United States. “The Government of Canada has never stated that it would be responsible for the safety and quality of prescription drugs exported from Canada into the United States, or any other country for that matter.” Diane Gorman Assistant Deputy Minister, Health Canada Letter to Washington Post, May 9, 2003 “A growing number of Americans are obtaining their prescription medications from foreign locations. They often seek out Canadian suppliers, or sources that purport to be Canadian. As we have said in the past, FDA cannot ensure the safety of drugs purchased from foreign sources.” Wm. K Hubbard Senior Associate Commissioner FDA Testimony Before Senate Committee on Commerce, Science and Transportation, Sept. 2001

3. Safeguards that Ensure the Safety & Efficacy of the Canada’s Drug Supply The submission review process for individual products The regulation of marketing and advertising practices Establishment licenses for legal importers Record retention and recall mechanisms Mutual recognition agreements for pharmaceutical GMP requirements Packaging and labeling requirements Cross-border Internet pharmacies evade the safeguards that ensure the high standards of safety and efficacy of Canada’s drug supply.

4. Positions Canadian Pharmacists Association (CPhA): “CPhA opposes the cross-border prescription drug trade based upon our concerns of the negative impact of this trade on Canadians, including access to quality care, access to prescription drugs and the threat to drug prices in Canada. The health and safety of patients is the overriding principle upon which this position is based.” Canadian Medical Association: “If a physician wishes to sign a prescription for an individual who has not previously been his/her patient or a patient of his/her group practice or shared call group, basic principles of assessment and diagnosis must be applied. It is incumbent upon the physician to obtain an adequate history and perform an appropriate physical examination to reach a diagnosis which will ensure that the prescribed medications are appropriate. It is not acceptable for a physician to sign a prescription without properly assessing the patient.” Consumer Groups: “Cross-border internet pharmacies are having an adverse impact on the lives of Canadians and this impact will escalate if left unchecked. Cross-border internet pharmacies must be banned.”

5. Results of 2003 FDA Blitz at the Buffalo, Dallas, Chicago and Seattle mail facilities and the Memphis and Cincinnati courier hubs : “foreign versions” of FDA-approved drugs drugs requiring careful dosing drugs with inadequate labeling drugs inappropriately packaged drugs withdrawn from the market drugs with dangerous interactions drugs requiring initial screening and/or periodic patient monitoring drugs containing addictive controlled substances The Reality of Safety Issues Associated with Mail Order Importation

6. Patients Loss of Faith Patients on both sides of the border are losing faith that governments and healthcare professionals will protect their interests and safety. By continuing to allow Internet pharmacies to practice illegally and to sell drugs through unregulated channels, we are putting the safety of all patients at risk. The US FDA has stated that it is unable to regulate the business and is under-resourced to inspect individual shipments. Health Canada should not be using Canadian healthcare dollars to monitor a practice that does not benefit Canadian patients and, indeed, puts Canadian patients at risk for having access to safe, affordable prescription medication.