Prescription Affordability and Medicine Safety Act of 2003

Bill: 108-hr-2640
Sponsor: Rep. Kennedy, Patrick J. [D-RI-1]
Introduced: 2003-06-26 in the House
Policy area: Health
Subjects: Administrative procedure
Administrative remedies
Civil actions and liability
Commerce
Consent decrees
Costs
Department of Health and Human Services
Drug advertising
Drug approvals
Drug industry
Drugs
Economics and Public Finance
Federal employees
Forfeiture
Generic drugs
Government Operations and Politics
Government paperwork
Government publicity
Government trust funds
Health education
Income tax
Injunctions
Intellectual property
Labor and Employment
Law
Medicare
Patent infringement
Patents
Pharmaceutical research
Pharmacies
Prescription pricing
Recruiting of employees
Research and development
Restrictive trade practices
Revolving funds
Science, Technology, Communications
Social Welfare
Tax deductions
Taxation
User charges

Summary:
action_date: 2003-06-26
text: 
Prescription Affordability and Medicine Safety Act of 2003 - Authorizes appropriations for the Food and Drug Administration (FDA) for generic drug application review and the continuation of the education program on the use and therapeutic equivalency of drugs.
 
Amends the Public Health Service Act to authorize the Secretary of Health and Human Services to make grants to States in support of State pharmacy benefit assistance programs. Requires a percentage of profits from the sale of certain drugs and biological products to be placed in a revolving fund and used to support the grants program. 
Limits the tax deductions for advertising for prescription drug manufacturers. 
Limits the extension of the 30-month stay of FDA approval for any new (generic) drug, as specified, thereby limiting the brand name drug's patent owner's period of exclusive sales. 
Makes a patent owner's failure to timely file a civil action for infringement a bar to later action.
Sets forth requirements for filing drug patent information with the FDA. Makes a patent owner's failure to timely file with the FDA a bar to civil actions for patent infringement. 
Requires the first generic drug applicant with a specified certification to forfeit the 180-day marketing exclusivity period to a subsequent generic drug applicant if the first generic drug applicant engages in certain behaviors which delay or prevent the marketing of the generic drug.

Legislative actions:
action_date: 2003-07-11
text: Referred to the Subcommittee on Health.
action_date: 2003-07-02
text: Referred to the Subcommittee on Health.
action_date: 2003-06-26
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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: 2003-06-26
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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: 2003-06-26
text: Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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: 2003-06-26
text: Introduced in House
action_date: 2003-06-26
text: Introduced in House