Importing Prescription Drugs: Objectives, Options, and Outlook (CRS Report for Congress)
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| Release Date |
Revised Jan. 26, 2007 |
| Report Number |
RL32511 |
| Report Type |
Report |
| Authors |
Susan Thaul, Domestic Social Policy Division |
| Source Agency |
Congressional Research Service |
| Older Revisions |
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Summary:
Can purchases from abroad lower the cost of prescription drugs to U.S. consumers? Current law allows pharmacists and wholesalers to import prescription drugs from Canada commercially, and codifies the Food and Drug Administration's (FDA) current practice of allowing imports of prescription drugs by individuals under certain defined circumstances. There is, however, one proviso. The Secretary of Health and Human Services (HHS) must first certify that the drugs to be imported under the program would "pose no additional risk to the public's health and safety; and result in a significant reduction in the cost of covered products to the American consumer"âa step no Secretary has been willing to take.
FDA has argued that it is impossible to monitor the millions of transactions and guarantee that these drugs would be safe. Meanwhile, some states and municipalities, looking at ways to control their expenditures for prescription drugs, have created websites to direct U.S. consumers to Canadian sources, and several state Governors have proposed pilot import programs. In October 2006, Congress took limited action regarding personal-use importation. The Department of Homeland Security Appropriations Act, 2007, blocks Customs and Border Protection from using those funds to stop an individual's importing, for personal use, a limited supply of a drug that meets FDA standards.
Drug importation was addressed in three pairs of comprehensive bills in the 109th Congress, none of which saw legislative action. To date, two revised versions have been introduced in the 110th (S. 242/H.R. 380 and S. 251). All would allow commercial and personal-use imports and replace the need for HHS Secretary certification with different ways to assure safety and effectiveness, among them requiring tamper-resistant and anti-counterfeit packaging; inspecting samples of imported drugs; requiring registration of importers, exporters, and Internet pharmacies; and enforcing extensive chain-of-custody monitoring and documentation. They also present different approaches for influencing industry response. Updates of this report will address bills and continuing discussions in the 110th Congress.
Opponents of the legislation raise concerns about safety, added costs, the feasibility of imports as a long-term solution to high domestic prices, and whether, beyond the short term, U.S. consumers would pay less for their prescription drugs. Other points of contention include issues of patent law and international trade agreements.
This report examines these issues, spells out how they are treated from bill to bill, and refers to the following alternatives to importation that might ease the burden of prescription drug costs on consumers: use of generics and disease management techniques; research and development incentives to industry; study of the drugs' comparative effectiveness and judicious application of the findings to benefit package and prescribing decisions; and assumption of some of the consumers' cost.
