Prescription Drug Importation: A Legal Overview (CRS Report for Congress)
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| Release Date |
Revised Dec. 1, 2008 |
| Report Number |
RL32191 |
| Report Type |
Report |
| Authors |
Vanessa K. Burrows, American Law Division |
| Source Agency |
Congressional Research Service |
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Summary:
High prescription drug prices have increased consumer interest in purchasing less costly medications abroad. Policymakers opposed to allowing prescription drugs to be imported from foreign countries argue that the Food and Drug Administration (FDA) cannot guarantee the safety or effectiveness of such drugs. 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. The importation debate continues.
In response to concerns about prescription drug imports, lawmakers have introduced multiple bills in this and previous Congresses. Bills introduced in the 110th Congress include H.R. 194, H.R. 380, H.R. 1218, H.R. 2638, H.R. 2900, H.R. 3161, H.R. 3580, S. 242, S. 251, S. 554, and S. 1082. In recent years, appropriations bills have contained restrictions on the use of funds by Customs and Border Protection (CBP) to prevent certain individuals from importing Canadian prescription drugs; however, such provisions appear to have limited effect.
The following federal and state agencies are involved in regulating aspects of prescription drug importation: FDA, CBP, the Drug Enforcement Agency (DEA), state boards of pharmacy, and state medical boards. This report, originally written by Jody Feder, Legislative Attorney, CRS, focuses on legal aspects of prescription drug importation, including antitrust law, international trade law, and patent law issues. However, policy issues are also 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. For more information regarding Internet pharmacies, see CRS Report RS21711, Legal Issues Related to Prescription Drug Sales on the Internet, by Vanessa K. Burrows.
