Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004
Read twice and referred to the Committee on Finance.
Congressional Research Service
Official summary
Version 00 · Introduced in Senate · Apr 8, 2004
Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions governing the importation of prescription drugs. Requires the Secretary of Health and Human Services to promulgate regulations allowing the importation of qualifying prescription drugs from permitted countries (defined as Canada, other countries that may be designated by the Secretary as meeting qualifying requirements, and, after a specified report due within 18 months is published, Australia, European Union countries, Japan and New Zealand). Allows such importation only from registered exporters by importers or by individuals for personal use.
Sets conditions on registered exporters, including that they must: (1) submit to the jurisdiction of U.S. courts; (2) export only qualifiying drugs manufactured in and obtained from registered establishments; (3) permit facility and record inspections and place of business monitoring; (4) pay user fees to cover the costs of administering this Act; and (5) be authorized under foreign law to dispense drugs that are only safe for use under supervision of a licensed practitioner.
Requires the Secretary to regulate such importation, including by verifying the chain of custody of drugs from the manufacturer to the exporter, conducting random sampling of exports for personal use to determine whether all conditions are being met, and listing registered exporters on the Food and Drug Administration (FDA) web site.
Showing the opening paragraphs of the official summary.
Read full official summaryShow less
Allows non-FDA approved drugs to be imported if the drugs have the same manufacturer and the same active ingredients, route of administration, dosage form, and strength as FDA approved drugs, with specific limitations.
Bars importation of qualifying drugs supplied for free or for a nominal cost by a manufacturer to a charitable or humanitarian organization or a foreign government.
Allows for the immediate importation for personal use under certain conditions.
Provides for penalties for violations of this Act, including the destruction without notice of drug shipments.
Amends the Controlled Substances Import and Export Act to repeal the exemption that permitted individuals to import controlled substances for personal medical use.
Amends the Internal Revenue Code to: (1) disallow any deduction for advertising expenditures of a drug manufacturer that does not certify that it has not taken any action to prevent authorized importation; and (2) provide a 20 percent increase in the tax credit for research activities for a drug manufacturer that makes such certification.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Aug 18, 2025. Consult Congress.gov for the current record.
AI Conversation Starters
Explore the bill from different angles
Choose a perspective, copy a prompt, and paste it into your preferred AI. Each prompt includes the bill version and available official source links, and asks for counterarguments as well as supporting evidence.
Neutral evidence review
Objective
Analyze S.2307 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
View full prompt & sources
Fairness and public impact
Progressive lens
Examine S.2307 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
View full prompt & sources
Institutions and government scope
Conservative lens
Examine S.2307 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.
View full prompt & sources
Individual rights and government power
Liberty lens
Examine S.2307 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.