Pharmaceutical Market Access and Drug Safety Act of 2005

Bill: 109-s-334
Sponsor: Sen. Dorgan, Byron L. [D-ND]
Introduced: 2005-02-09 in the Senate
Policy area: Health
Subjects: Accreditation (Medical care)
Administrative fees
Administrative procedure
Administrative remedies
Australia
Business records
Canada
Civil Rights and Liberties, Minority Issues
Civil actions and liability
Commerce
Congress
Congressional reporting requirements
Consumer education
Contracts
Crime and Law Enforcement
Customs administration
Damages
Defective products
Department of Health and Human Services
Directories
Drug advertising
Drug approvals
Drug industry
Drugs
East Asia
Economics and Public Finance
Education
Electronic commerce
Electronic data interchange
Electronic government information
Europe
European Union
Evidence (Law)
Export controls
Exports
Federal Trade Commission
Federal-state relations
Finance and Financial Sector
Fines (Penalties)
Food and Drug Administration (FDA)
Foreign Trade and International Finance
Forfeiture
Fraud
Government Operations and Politics
Government paperwork
Government publicity
Governmental investigations
Higher education
Identification devices
Import restrictions
Imports
Independent regulatory commissions
Injunctions
Intellectual property
Interactive media
Internet
Japan
Labeling
Law
Liability (Law)
Licenses
Medical associations
Medical education
Medical records
Medical tests
New Zealand
Oceania
Packaging
Parties to actions
Patent infringement
Patents
Pharmaceutical research
Pharmacies
Pharmacists
Physical examinations
Prescription pricing
Price discrimination
Product counterfeiting
Restrictive trade practices
Right of privacy
Science, Technology, Communications
Surety and fidelity
Switzerland
Telephone
User charges
Web sites
Wholesale trade

Summary:
action_date: 2005-02-09
text: 
Pharmaceutical Market Access and Drug Safety Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States.
 
Prohibits the importation of a qualifying drug unless such drug is imported by: (1) a registered importer; or (2) an individual for personal use.
 
Establishes registration conditions for importers and exporters. Requires the Secretary to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions.
 
Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences.
 
 Prohibits manufacturers from: (1) discriminating against registered exporters or importers; (2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; (3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or (4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person that engages or attempts to engage in the importation of a qualifying drug.
 
States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement.
 
Requires the Secretary to educate consumers regarding prescription drug importation.
 
Sets forth provisions governing the sale of prescription drugs through an Internet site. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under FFDCA.


Legislative actions:
action_date: 2005-04-19
text: Committee on Health, Education, Labor, and Pensions. Hearings held. Hearings printed: S.Hrg. 109-143.
action_date: 2005-02-10
text: Sponsor introductory remarks on measure. (CR S1253-1254)
action_date: 2005-02-09
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2005-02-09
text: Sponsor introductory remarks on measure. (CR S1206)
action_date: 2005-02-09
text: Introduced in Senate
action_date: 2005-01-26
text: Sponsor introductory remarks on measure. (CR S540-541)