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HR 2491 108th Congress House Health Administrative procedure Administrative remedies Antitrust law Civil actions and liability Commerce Consent decrees Department of Health and Human Services Drug approvals Drug industry Drugs Generic drugs Government Operations and Politics Intellectual property Law Marketing Patent infringement Patents Pharmaceutical research Punitive damages

Greater Access to Affordable Pharmaceuticals Act

Introduced: June 17, 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
Jun 25, 2003
Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
Jun 24, 2003
Referred to the Subcommittee on Health.
Jun 17, 2003
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.
Jun 17, 2003
Introduced in House
 Plain-English summary Congressional Research Service

Greater Access to Affordable Pharmaceuticals Act - Amends the Federal Food, Drug, and Cosmetic Act to: (1) limit a brand name drug manufacturer to one Food and Drug Administration (FDA) 30-month stay of competition in a patent infringement suit against a generic drug applicant; (2) permit a generic applicant being sued to file a counterclaim to correct or delete patent information; (3) limit damages that a brand name manufacturer may recover in an instance where such manufacturer failed to file certain patent information; (4) permit a generic drug applicant to seek declaratory judgment regarding patent infringement prior to marketing a drug; (5) forfeit the180-day market exclusivity period for a first generic drug applicant to a subsequent generic applicant if the first applicant engages in certain activities which impede such drug's timely marketing; and (6) permit alternative means to determine bioequivalence for drugs that are not absorbed into the bloodstream.

What's happening now June 25, 2003

Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.

 Committees of jurisdiction 4