Confusion and Contradiction: Untangling Drug Importation and Counterfeit Drugs

BACKGROUNDDrug importation first became big news in the United States when busloads of seniors began crossing the border to buy cheaper drugs from Canadian pharmacies.'Media reports soon followed that Americans were buying drugs from Canadian Internet pharmacies.Numerous bills were introduced in the House and Senate, each aimed at creating an importation scheme for prescription drugs. 2 At the same time, articles and books were being written about the problem of counterfeit drugs in America 3 and the fact that many Internet pharmacies claiming to be Canadian were not in fact based in Canada and were not selling Canadian-approved drug products.More broadly, Americans learned that a significant portion of the drugs available through the Internet were counterfeit.These two stories-importation and counterfeit drugs-have now become intertwined and inseparable.There is a growing perception that drugs imported into the United States have a much greater chance of being counterfeit.Underlying this belief appears to be a sort of xenophobic sentiment, a fear of drugs that are anything but homegrown.Yet, an important fact appears to have been forgotten: American drugs--drugs that are approved by the Food and Drug Administration (FDA) for sale in the United States-are manufactured all over the world.41. See IMS, RETAIL PRESCRIPTIONS GROW AT RECORD LEVEL IN 2003 (2004), http://www.imshealthcanada.con/htmen/1_09.htm.Although Food and Drug Administration (FDA) regulations currently prohibit retail pharmaceutical imports from Canada, a discretionary policy of the FDA and U.S. Customs Service allows a significant volume of imports to the United States.Total imports under the Customs Service personal use exemption totaled approximately $600 million in 2003.Id. 2. Safe Import Act of 2005, S. 184, 109th Cong.(2005); Pharmaceutical Market Access Act of 2005, H.R. 328, 109th Cong.(2005); Pharmaceutical Market Access and Drug Safety Act of 2005, S. 334, 109th Cong.(2005).These three bills are currently making their way through Congress and are commonly called the Gregg Bill (S. 184), the Gutknecht Bill (H.R. 328), and the Dorgan-Snowe Bill (S. 334).For more information on the progress of these bills, see Thomas: Legislative Information on the Internet, http://thomas.loc.gov(insert the above-mentioned bill numbers into a search of the 109th Congress). See, e.g., KATHERINE EBAN, DANGEROUS DOSES: How COUNTERFEITERS ARE CONTAMINATING AMERICA'S DRUG SUPPLY (2005).4.

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