Key facts
Important facts patients should know about cross-border internet salesThe medicines patients get through cross-border Internet sales may not always be what they expect, raising the very real issue of patient safety. Exporting prescription medicines to the US over the Internet essentially short-circuits the chain of accountability that is intended to help ensure drug safety. Governmental agencies like the US Food and Drug Administration (FDA) are established by every nation to ensure the safety and protection of its citizens. Almost all facets of the storage and distribution of medicines shipped within the US are under the jurisdiction and supervision of the FDA. Similar safety systems that protect consumers of medicines bought and sold domestically in the US are not in place to regulate cross-border sales. While medicines sold in Canada and the US may bear the same tradename, may contain the same active ingredient, and may even have been manufactured in the same plant, those entering the country from across the border are not the FDA approved versions and may differ in important respects like labeling, formulation, and dosage form.
Moreover, FDA has repeatedly warned that cross-border sales could be a back-door conduit for distributing counterfeit, contaminated, sub-potent or otherwise unsafe medicines to US customers. The FDA lists the following risks from imported medicines: See: http://www.fda.gov/cder/drug/consumer/buyonline/guide.htm
- Quality assurance concerns. Medications that have not been approved for sale in the United States may not have been manufactured under quality assurance procedures designed to produce a safe and effective product.
- Counterfeit potential. Some imported medications - even those that bear the name of a US-approved product - may, in fact, be counterfeit versions that are unsafe or even completely ineffective.
- Presence of untested substances. Imported medications and their ingredients, although legal in foreign countries, may not have been evaluated for safety and effectiveness in the United States. These products may be addictive or contain other dangerous substances.
- Risks of unsupervised use. Some medications, whether imported or not, are unsafe when taken without adequate medical supervision. Patients may need a medical evaluation to ensure that the medication is appropriate for them and their condition. Or, they may require medical checkups to make sure that they are taking the drug properly, it is working for them and that they are not having unexpected or life-threatening side effects.
- Labeling and language issues. The medication's label, including instructions for use and possible side effects, may be in a language the patient does not understand or may make medical claims and suggest specific uses that have not been adequately evaluated for safety and effectiveness in the US.
- Lack of information. An imported medication may lack information that would permit the patient to be promptly and correctly treated for a dangerous side effect caused by the drug.
The risk of counterfeiting in imported medicines is very real. The Senate Committee on Aging, July 9, 2002 hearing "Buyer beware: Public Health Concerns of Counterfeit Drugs" found that 8% of imported medicines into the US were counterfeit. The FDA has described an incident in 2002, where investigators from the Manhattan DA's office in New York obtained 25,000 counterfeit Viagra pills from China and India, that had been sold over the Internet to brokers and consumers in the US. When tested, all the pills contained active ingredient, but to varying potency. Another batch of counterfeit Viagra, seized in Los Angeles, had no active ingredient. This is a serious patient safety issue, particularly with regard to medicines that treat life-threatening diseases. See: Imported Drugs Raise Safety Concerns, FDA Consumer Magazine, reproduced on The National Association of Pharmacy Regulatory Authorities (NAPRA), Canada, Internet site. http://www.napra.org/pdfs/news/importeddrugs.PDF
In addition to genuine questions about the quality of medicines purchased across the border, cross-border Internet pharmacies may not conform to regulatory and non-governmental requirements for Pharmacy practice, raising still more concerns for patient safety. US mail order and US Internet pharmacies can be certified by the National Association of Boards of Pharmacy (NABP) and are fully regulated by the states in which the pharmacies are located, and in some cases the states in which patients receive medicines. The Verified Internet Pharmacy Practice Sites (VIPPS) program issues a non-governmental seal of approval for US Internet pharmacy sites. To be VIPPS certified, a US Internet pharmacy must, among other things, comply with the licensing and inspection requirements of their state and each state to which they mail pharmaceuticals. They must also comply with other important VIPPS criteria, providing adequate protection of patient rights to privacy, authenticating prescription orders and ensuring their security, ensuring quality of medicines, and providing meaningful consultation between patients and pharmacists.
In December of 2002, the Canadian National Association of Pharmacy Regulatory Authorities (NAPRA) announced that, in cooperation with the NABP, they would implement the VIPPS program in Canada. They stated that "on-line pharmacies that ship drugs into the United States will not be eligible for Canada's seal of approval." According to the FDA, if a Canadian Web-pharmacy sets up business to exclusively export outside Canada, Health Canada (Canada's counterpart to the US HHS) may not regulate the drugs or the company at all. Compliance with pharmacy practice standards designed to protect patients is a very real concern. For example, according to press reports, in May 2002, the Ontario College of Pharmacists, the regulatory body with responsibility for enforcing pharmacy practice standards in the Canadian province of Ontario, charged The Canadian Drugstore Inc. with 15 different violations, including operating an unlicensed Internet pharmacy without registered pharmacists from November 2001 to February 2002.
Cross-border Internet commerce may also compromise relationships between physicians, pharmacists and patients. When a doctor, pharmacist and patient live in different countries, there are no assurances that patients who take prescription medications bought from Internet pharmacies outside the country are in the care of a doctor who has the necessary medical history and geographic proximity to care for the patient adequately. There is also no assurance that patients have appropriate access to the dispensing pharmacist, who provides an essential role that is a safety check on dosage, prescribing, and drug interaction.
If patients experience a problem, they may have no legal recourse against Internet pharmacies. In addition to lacking regulatory protection usually afforded by US state pharmacy practice acts and boards, US patients are required by some, if not all, Canadian web pharmacists to execute "waivers" of liability. If these waivers were respected by Canadian courts, remedies and the protection usually available through private litigation could be lost to the patient.
Cross-border commercial sale of non-FDA approved medicines is illegal, in the United States. According to The United States Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. section 331) the interstate shipment of any prescription drug that lacks required FDA approval is illegal. Interstate shipment includes passage of drugs from a foreign country to any state. Drugs sold in the US also must have proper labeling that conforms to the FDA's requirements.
The exportation to the US of medicines approved for Canadian use risks depletion of supply for Canadian patients. Canadian Internet pharmacies engaged in export of medicines to the United States present a threat to Canada's healthcare system, and more specifically to the supply of medicines for Canadians. Canada's drug supply is calculated based on the domestic patient population and cannot withstand demand from a market ten times the size.
The FDA, the National Association of Chain Drug Stores, the National Association of Community Pharmacists, many state pharmacy associations, and numerous Canadian pharmacy and medical associations oppose the cross-border shipments of prescription drugs. The National Community Pharmacists Association, for example, has stated: "We emphatically reiterate the need for US law enforcement officials to take immediate action to prevent the illegal importation of prescription drugs prevent the promotion, including advertising of these illegal activities…The importation of prescription drugs from other countries, including through internet sales sites, is illegal and poses a number of risks to patients."
Also addressing concerns over cross-border Internet sales, National Medical Association President L. Natalie Carroll, M.D., has stated "Many drugs are for complex serious, chronic diseases such as HIV/AIDS, diabetes, asthma, depression and congestive heart failure. The health of patients with conditions such as these should not be risked by use of potentially substandard drugs, under uncertain medical supervision."
The sale of non-FDA approved medicines to US customers via the Internet, with all the attendant safety issues, is not the way to resolve the issue of affordability of medicines in the US. Passage of a Medicare prescription drug benefit is the appropriate way to help ensure affordable access to medication for seniors in the US. Instead of supporting illegal trade and poorly regulated and potentially unsafe business practices, activists in the US should be encouraging their representatives in Congress to pass a Medicare prescription drug benefit.
In the absence of a Medicare drug benefit, GSK is committed to helping seniors and US citizens of modest income through the GSK Orange Card and the Together Rx Card. Those cards provide up to 40% off the price of GSK medicines. At these prices, the cost of the drugs can be comparable to the cost of non-FDA-approved versions offered for sale on the Internet for export from Canada. For example: Avandia 4 mg 30 tablets would cost an average of $60.76 with the Orange Card compared to $57 plus shipping for a non-FDA-approved version offered for sale at a Canadian Internet pharmacy.
For those with more limited means, the GSK Patient Assistance Program provides medicine free of charge or at a minimum co-pay for 400,000 low-income patients - a value of more than $160 million dollars annually.
Prescription drugs are generally cheaper in Canada primarily because prices are capped by the Canada's Patented Medicines Prices Review Board. The price of Canadian medicines is controlled by the government of Canada through the Patented Medicines Prices Review Board. Using this system to provide patients outside of Canada with low-price pharmaceuticals comes at the cost of Canadians.
Even without price controls, prescription medicines, like most other products, would probably still be cheaper in Canada due to lower wages and buying power there. An article last year in the Associated Press revealed that a Dodge Caravan costs $31,000 in the U.S. but just $21,000 in US dollars in Canada. In response to dealers importing cars from Canada to re-sell, some U.S. auto-makers threatened to void their warranties or hold back other incentives for these dealers.
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