Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004

Bill: 108-s-2307
Sponsor: Sen. Grassley, Chuck [R-IA]
Introduced: 2004-04-08 in the Senate
Policy area: Health
Subjects: Administrative fees
Administrative procedure
Administrative remedies
Australia
Business records
Canada
Civil actions and liability
Commerce
Congress
Congressional reporting requirements
Crime and Law Enforcement
Department of Health and Human Services
Directories
Drug advertising
Drug approvals
Drug industry
Drug therapy
Drugs
EEC countries
East Asia
Economics and Public Finance
Electronic government information
Europe
Evidence (Law)
Export controls
Exports
Fines (Penalties)
Food and Drug Administration (FDA)
Foreign Trade and International Finance
Forfeiture
Gifts
Government Operations and Politics
Government paperwork
Government publicity
Governmental investigations
Health care fraud
Import restrictions
Imports
Income tax
Injunctions
Internet
Japan
Labeling
Law
Legislation
Licenses
New Zealand
Oceania
Packaging
Pharmaceutical research
Pharmacies
Pharmacists
Prescription pricing
Product counterfeiting
Product safety
Quality control
Research and development tax credit
Restrictive trade practices
Science, Technology, Communications
Tax deductions
Taxation
Web sites
Wholesale trade

Summary:
action_date: 2004-04-08
text: 
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.
 
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.


Legislative actions:
action_date: 2004-04-08
text: Read twice and referred to the Committee on Finance.
action_date: 2004-04-08
text: Sponsor introductory remarks on measure. (CR S4042-4046)
action_date: 2004-04-08
text: Introduced in Senate