US Congress House Bill 2182 (Prior Session Legislation)

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Sponsorship: Bipartisan Bill
Status: Introduced on June 15 2011 - 25% progression, died in committee
Action: 2011-06-16 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Generating Antibiotic Incentives Now Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for a new prescription drug by five years for a drug that the Secretary of Health and Human Services (HHS) determines to be a qualified infectious disease product. Defines "qualified infectious disease product" to mean an antibiotic drug for treating, detecting, preventing, or identifying a qualifying pathogen (certain pathogens that are resistant to antibiotics). Excludes drugs that are: (1) a supplement to a new drug application for which an extension is in effect or has expired; or (2) a subsequent application for a change that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or a modification to the structure of the product that does not result in a change in safety or effectiveness. Extends such period of exclusivity an additional six months for a sponsor or manufacturer of a qualified infectious disease product that identifies a companion diagnostic test. Requires the Secretary to give priority review to any drug determined to be a qualified infectious disease product. Includes qualified infectious disease products as fast track products for which the Secretary shall facilitate development and expedite review. Directs the Comptroller General to study the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products. Requires the Secretary to: (1) review Food and Drug Administration (FDA) guidelines for clinical trials of antibiotic drugs; and (2) revise such guidelines, as appropriate, to reflect developments in scientific and medical information and technology and to ensure clarity regarding the procedures and requirements for approval of an antibiotic drug.

Generating Antibiotic Incentives Now Act of 2011

Rep. Phil Gingrey [R-GA]	Rep. John Barrow [D-GA]	Rep. Dan Benishek [R-MI]	Rep. Brian Bilbray [R-CA]
Sen. Marsha Blackburn [R-TN]	Rep. Robert Brady [D-PA]	Rep. Mo Brooks [R-AL]	Rep. Paul Broun [R-GA]
Rep. Michael Burgess [R-TX]	Rep. Dan Burton [R-IN]	Rep. G. Butterfield [D-NC]	Rep. John Carney [D-DE]
Sen. Bill Cassidy [R-LA]	Rep. Donna Christensen [D-VI]	Rep. Diana DeGette [D-CO]	Rep. Anna Eshoo [D-CA]
Rep. Bob Filner [D-CA]	Rep. Charles Gonzalez [D-TX]	Rep. Gene Green [D-TX]	Rep. Morgan Griffith [R-VA]
Rep. Brett Guthrie [R-KY]	Rep. Gregg Harper [R-MS]	Rep. James Himes [D-CT]	Rep. Jay Inslee [D-WA]
Rep. William Keating [D-MA]	Rep. Adam Kinzinger [R-IL]	Rep. Leonard Lance [R-NJ]	Rep. Tom Latham [R-IA]
Rep. Robert Latta [R-OH]	Sen. Edward Markey [D-MA]	Rep. Jim Matheson [D-UT]	Rep. Doris Matsui [D-CA]
Rep. Michael McCaul [R-TX]	Rep. Patrick McHenry [R-NC]	Rep. Cathy McMorris Rodgers [R-WA]	Rep. Patrick Meehan [R-PA]
Rep. Brad Miller [D-NC]	Rep. Gary Miller [R-CA]	Sen. Christopher Murphy [D-CT]	Rep. Sue Myrick [R-NC]
Rep. Mike J. Rogers [R-MI]	Rep. Mike Ross [D-AR]	Rep. John Shimkus [R-IL]	Rep. John Sullivan [R-OK]
Rep. Niki Tsongas [D-MA]	Rep. Greg Walden [R-OR]	Rep. Ed Whitfield [R-KY]

Date	Chamber	Action
2011-06-16	House	Referred to the Subcommittee on Health.
2011-06-15	House	Referred to the House Committee on Energy and Commerce.

SB1734 (Same As) 2011-10-19 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/house-bill/2182/all-info
Text	https://www.congress.gov/112/bills/hr2182/BILLS-112hr2182ih.pdf