Tag:importation

A number of state and municipal governments have encouraged American consumers to import prescription drugs from Canada as a way to lower drug costs. When operating through normal regulated distribution channels, Canada’s drug distribution system is very safe. But most Canadian mail-order distribution networks operate outside of regulated channels often relying on secondary or unlicensed or foreign suppliers. Safety issues, liability concerns and medical ethics are all impacted by the proliferation of unregulated importation of prescription drugs.

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According to a report recently released by the Government Accountability Office, over 2,000 foreign drug manufacturers subject to inspection by the U.S. Food and Drug Administration may never have been visited by agency inspectors.

This lack of oversight poses serious safety concerns for American patients, which are further compounded by the fact that a quarter (714) of these foreign drug manufacturers are from China. A recent article in the New York Times reported that pharmaceutical ingredients exported from China are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators. (1)

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A Congress out of touch with American consumers is considering making it easier to import drugs from other countries into the US. Yet according to recent data, internet drug sales from Canada have dropped 80 percent over the last 3 years. Growing concerns over the safety of mail-order drug imports and better access to drug benefits through programs like Medicare part D have caused many of the larger Canadian mail order pharmacies to close their doors.

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According to a story published in the Washington Post on June 17, 2007, “ Companies based in India were bit players in the American drug market 10 years ago, selling just eight generic drugs here. Today, almost 350 varieties and strengths of antidepressants, heart medicines, antibiotics and other drugs purchased by American consumers are made by Indian manufacturers. Five years ago, Chinese drug-makers exported about $300 million worth of products to the United States. Eager to meet Americans' demand for lower-cost medicines, they, too, have expanded rapidly. Last year, they sold more than $675 million in pharmaceutical ingredients and products in the U.S. market.”

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Patients need to have confidence in the quality, safety and effectiveness of their medicines. In developed countries, governments enact laws and regulations that provide stringent safeguards for drug approval, manufacturing, labelling and distribution.

Despite the obvious importance of such safeguards, some American lawmakers continue to promote the importation of cheap drugs by enabling foreign suppliers to evade the stringent oversight that protects America’s drug supply chain. One of the largest “Canadian” mail order pharmacies has been found to be shipping products from other countries to avoid the oversight of both American and Canadian regulators.

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The Medicare Modernization Act passed by Congress in 2003, contained a provision that would permit the importation of prescription drugs into the U.S. if the Department of Health and Human Services (HHS) certified that drugs imported from Canada posed no additional risk to public health and safety and that such imports provided significant cost savings to American consumers. H.H.S. released the results of its study of these issues on December 21, 2004.

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Because Canadian pharmaceutical production represents less than 5 percent of the American pharmaceutical market and Canadian price controls apply only to drugs manufactured for Canadian consumption, re-importing drugs from Canada will not meet the needs of uninsured Americans. In fact, far from meeting the needs of American consumers, the growth of unaccredited internet mail-order pharmacies in Canada is likely to create shortages for Canadian patients and force Canadian regulators to act to curtail mail order drug sales to the U.S.

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During the past year a handful of states including Minnesota, Wisconsin and New Hampshire have sanctioned websites to facilitate the importation of prescription drugs for their residents. In order to assure the safety and quality of foreign drug supplies, some states have imposed certain conditions on selected internet drug sellers.

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Most, if not all, cross-border drug sellers in Canada require American citizens to waive their right to the protection of American product liability laws. Differences in product liability laws between Canada and the United States is the largest single factor contributing to price differences between Canada and the United States.

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Currently there are a variety of initiatives from individuals, cities and states to import prescription drugs from Canada. Importing drugs from Canada can not meet the needs of the American pharmaceutical market because total Canadian pharmaceutical production represents less than 5% of the American pharmaceutical market.

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