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, during the 108 th Congress, the House of Representatives passed 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 the bill 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 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, some policymakers 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, lawmakers have introduced the following bills during the 109 th Congress: H.R. 328, H.R. 563, H.R. 578, H.R. 700, H.R. 753, H.R. 840, S. 109, S. 184, S. 334, and S. 399.Currently, the following federal and state agencies are involved in regulating aspects of prescription drug importation and Internet sales: the Food and Drug Administration, the U.S. Customs and Border Protection (CBP), the Drug Enforcement Agency (DEA), state boards of pharmacy, and state medical boards.Although this report is intended to focus on legal aspects of prescription drug importation and Internet sales, both legal and policy issues are addressed because they are closely linked.For a more complete analysis of policy issues, see CRS Report RL32511, Importing Prescription Drugs: Objectives, Options, and Outlook, by Susan Thaul and Donna U. Vogt. 1 Pub.L. No. 108-173 [hereinafter Medicare Act].The original certification provision was contained in the Medicine Equity and Drug Safety (MEDS) Act.Pub.L. No. 106-387.The new Medicare Act also requires HHS to conduct a study and issue a report on importing prescription drugs. Prescription Drug Importation and Internet Sales: A Legal OverviewThis report explores the legal issues raised by prescription drug importation and Internet sales.Although this report is intended to focus on legal analysis, both legal and policy issues are addressed because they are closely linked.For a more complete analysis of policy issues, see CRS Report RL32511, Importing Prescription Drugs: Objectives, Options, and Outlook, by Susan Thaul and Donna U. Vogt.

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