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HR 2640 108th Congress House Health 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

Prescription Affordability and Medicine Safety Act of 2003

Introduced: June 26, 2003 See on congress.gov
 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 11, 2003
Referred to the Subcommittee on Health.
Jul 2, 2003
Referred to the Subcommittee on Health.
Jun 26, 2003
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.
Jun 26, 2003
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now July 11, 2003

Referred to the Subcommittee on Health.

 Committees of jurisdiction 4