Prescription Drug Importation and Internet Sales: A Legal Overview

As prescription drug prices have escalated in recent years, so too has consumer interest in purchasing less costly medications abroad.Meanwhile, in July, 2003, the House of Representatives passed H.R. 2427, a bill that would allow wholesalers, pharmacists, and consumers to import certain prescription drugs from 25 different countries, including Canada, where drug prices are often lower than in the United States.Although H.R. 2427 passed the House, the provisions allowing drug importation faced opposition in the Senate and were not included in the conference agreement on Medicare prescription drug benefits.Instead, the final Medicare bill, H.R. 1, modified a provision of existing law that authorizes the Food and Drug Administration (FDA) to allow the importation of prescription drugs if the Secretary of Health and Human Services certifies that implementing such a program is safe and reduces costs, a determination that no Secretary has made in the years since a similar certification requirement was established in 2000.Despite the compromise reached in the final Medicare bill, the debate about drug importation continues.On the one hand, the FDA and some lawmakers remain opposed to allowing prescription drugs to be imported from foreign countries, arguing that the FDA cannot guarantee the safety of such drugs.On the other hand, importation proponents, who claim that importation would result in significantly lower prices for U.S. consumers, say that safety concerns are overblown and would recede if additional precautions were implemented.Just as the FDA has expressed concerns about the safety of imported drugs, federal regulators have become increasingly worried about the risks posed by some online pharmacies and Internet drug sales.Indeed, the regulation of prescription drug importation and the oversight of online pharmacies often overlap because many consumers use online pharmacies to purchase imported drugs.Regardless of whether or not drugs purchased online are imported, the FDA is worried about the safety of such medications because of its concern that a small number of online doctors and pharmacies are exploiting regulatory gaps to prescribe and dispense illegal, addictive, or unsafe drugs.In response to concerns about prescription drug imports and Internet sales, several congressional lawmakers have introduced the following bills: H.

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