Pharmaceutical Market Access Act of 2005

Bill: 109-hr-328
Sponsor: Rep. Gutknecht, Gil [R-MN-1]
Introduced: 2005-01-25 in the House
Policy area: Health
Subjects: Administrative fees
Administrative procedure
Administrative remedies
Business records
Civil actions and liability
Commerce
Congress
Congressional reporting requirements
Consumer education
Consumer protection
Damages
Department of Health and Human Services
Drug approvals
Drug industry
Drugs
Economics and Public Finance
Electronic government information
Evidence (Law)
Federal Trade Commission
Federal-state relations
Foreign Trade and International Finance
Government Operations and Politics
Government paperwork
Government publicity
Governmental investigations
Identification devices
Import restrictions
Imports
Independent regulatory commissions
Injunctions
Intellectual property
Internet
Labeling
Law
Licenses
Limitation of actions
Packaging
Parties to actions
Patent infringement
Patents
Pharmacies
Pharmacists
Prescription pricing
Price discrimination
Product counterfeiting
Product safety
Punitive damages
Restrictive trade practices
Science, Technology, Communications
Telephone
Web sites
Wholesale trade

Summary:
action_date: 2005-01-25
text: 
Pharmaceutical Market Access Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to promulgate regulations permitting pharmacists, pharmacies, wholesalers, and individuals to import qualifying drugs from certain countries into the United States.
 
Sets forth registration requirements for exporters.
 
Requires the Secretary to: (1) educate consumers with regard to the availability of qualifying drugs for import for personal use; (2) inspect the facilities and records of importers and registered exporters to ensure compliance with this Act; and (3) establish a registration fee program to collect an annual fee from registered exporters.
 
Deems a prescription drug to be misbranded unless the packaging of such drug complies with the requirements for counterfeit-resistant technologies.
 
Prohibits: (1) failing to register in accordance with this Act; and (2) importing or offering to import a prescription drug in violation of a suspension order.
 
Declares that selling or importing a patented drug in the United States that was first sold abroad by or under authority of the owner or licensee of the patent is not patent infringement.
 
Prohibits drug manufacturers from discriminating against a person that engages in the importation of a prescription drug, including by charging higher prices or denying supplies of the drug.
 
Allows the Secretary to suspend or terminate the registration of an exporter for failing to maintain substantial compliance with all registration conditions.


Legislative actions:
action_date: 2005-06-21
text: Sponsor introductory remarks on measure. (CR H4861)
action_date: 2005-06-20
text: Sponsor introductory remarks on measure. (CR H4784-4785)
action_date: 2005-05-17
text: Sponsor introductory remarks on measure. (CR H3406-3407)
action_date: 2005-05-16
text: Sponsor introductory remarks on measure. (CR H3289-3290)
action_date: 2005-04-13
text: Sponsor introductory remarks on measure. (CR H1945-1946)
action_date: 2005-04-05
text: Sponsor introductory remarks on measure. (CR H1754)
action_date: 2005-03-02
text: Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
action_date: 2005-02-25
text: Referred to the Subcommittee on Health.
action_date: 2005-02-15
text: Sponsor introductory remarks on measure. (CR H606)
action_date: 2005-01-25
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2005-01-25
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2005-01-25
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
action_date: 2005-01-25
text: Introduced in House
action_date: 2005-01-25
text: Introduced in House