Entitled the "Greater Access to Affordable Pharmaceuticals Act".
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.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Introduced in House
Introduced in House
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.
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
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