Summary
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.
Lifecycle of the Bill
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