United States · Bill · HR
H.R. 2182 (112th)
Generating Antibiotic Incentives Now Act of 2011
Introduced
15 June 2011
Last action
16 June 2011 · Referred
Status
Referred to the Subcommittee on Health.
Sponsors
Rep. Gingrey, Phil [R-GA-11], Rep. Green, Gene [D-TX-29], Rep. Whitfield, Ed [R-KY-1], Rep. DeGette, Diana [D-CO-1], Rep. Rogers, Mike J. [R-MI-8], Rep. Eshoo, Anna G. [D-CA-18], Rep. Shimkus, John [R-IL-15], Rep. Bilbray, Brian P. [R-CA-50], Rep. Harper, Gregg [R-MS-3], Sen. Blackburn, Marsha [R-TN], Rep. Lance, Leonard [R-NJ-7], Rep. Myrick, Sue Wilkins [R-NC-9], Rep. Sullivan, John [R-OK-1], Rep. Burgess, Michael C. [R-TX-26], Rep. Latta, Robert E. [R-OH-5], Rep. Griffith, H. Morgan [R-VA-9], ROBERT BRADY, Sen. Murphy, Christopher [D-CT], Sen. Markey, Edward J. [D-MA], Rep. Keating, William R. [D-MA-9], Rep. Inslee, Jay [D-WA-1], Rep. Meehan, Patrick [R-PA-7], Rep. Carney, John C., Jr. [D-DE-At Large], Rep. Miller, Brad [D-NC-13], Rep. Burton, Dan [R-IN-5], Rep. Butterfield, G. K. [D-NC-1], Rep. Guthrie, Brett [R-KY-2], Rep. McCaul, Michael T. [R-TX-10], Sen. Cassidy, Bill [R-LA], Rep. Brooks, Mo [R-AL-5], Rep. Broun, Paul C. [R-GA-10], Rep. McMorris Rodgers, Cathy [R-WA-5], Rep. Himes, James A. [D-CT-4], Rep. McHenry, Patrick T. [R-NC-10], Rep. Walden, Greg [R-OR-2], Rep. Tsongas, Niki [D-MA-3], Rep. Matheson, Jim [D-UT-2], Rep. Gonzalez, Charles A. [D-TX-20], Rep. Matsui, Doris O. [D-CA-7], Rep. Latham, Tom [R-IA-3], Rep. Filner, Bob [D-CA-51], Rep. Miller, Gary G. [R-CA-42], Rep. Barrow, John [D-GA-12], Rep. Kinzinger, Adam [R-IL-16], Rep. Benishek, Dan [R-MI-1], Rep. Ross, Mike [D-AR-4], Del. Christensen, Donna M. [D-VI-At Large]
Subjects
Healthcare
Source updated
5 December 2025
Summary
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.
This text is taken from the official record. PoliticalRepo does not editorialize.
Timeline
15 June 2011
Introduced
Referred to the House Committee on Energy and Commerce.
Source: IntroReferral
15 June 2011
Introduced
Introduced in House
Source: IntroReferral
15 June 2011
Introduced
Introduced in House
Source: IntroReferral
16 June 2011
Referred
Referred to the Subcommittee on Health.
Source: Committee
Votes
No vote records are attached yet.
Versions
- Introduced in House · 15 June 2011 · Download file
Documents
3 official files
Introduced in House (text)
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Introduced in House (text)
Introduced in House · EN · 15 June 2011
Introduced in House (PDF)
Introduced in House · EN · 15 June 2011
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Introduced in House
summary · EN · 15 June 2011
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Sponsors
- Rep. Gingrey, Phil [R-GA-11] · R · Sponsor
- Rep. Green, Gene [D-TX-29] · D · Sponsor
- Rep. Whitfield, Ed [R-KY-1] · R · Sponsor
- Rep. DeGette, Diana [D-CO-1] · D · Sponsor
- Rep. Rogers, Mike J. [R-MI-8] · R · Sponsor
- Rep. Eshoo, Anna G. [D-CA-18] · D · Sponsor
- Rep. Shimkus, John [R-IL-15] · R · Sponsor
- Rep. Bilbray, Brian P. [R-CA-50] · R · Cosponsor
- Rep. Harper, Gregg [R-MS-3] · R · Cosponsor
- Sen. Blackburn, Marsha [R-TN] · R · Cosponsor
- Rep. Lance, Leonard [R-NJ-7] · R · Cosponsor
- Rep. Myrick, Sue Wilkins [R-NC-9] · R · Cosponsor
- Rep. Sullivan, John [R-OK-1] · R · Cosponsor
- Rep. Burgess, Michael C. [R-TX-26] · R · Cosponsor
- Rep. Latta, Robert E. [R-OH-5] · R · Cosponsor
- Rep. Griffith, H. Morgan [R-VA-9] · R · Cosponsor
- ROBERT BRADY · D · Cosponsor
- Sen. Murphy, Christopher [D-CT] · D · Cosponsor
- Sen. Markey, Edward J. [D-MA] · D · Cosponsor
- Rep. Keating, William R. [D-MA-9] · D · Cosponsor
- Rep. Inslee, Jay [D-WA-1] · D · Cosponsor
- Rep. Meehan, Patrick [R-PA-7] · R · Cosponsor
- Rep. Carney, John C., Jr. [D-DE-At Large] · D · Cosponsor
- Rep. Miller, Brad [D-NC-13] · D · Cosponsor
- Rep. Burton, Dan [R-IN-5] · R · Cosponsor
- Rep. Butterfield, G. K. [D-NC-1] · D · Cosponsor
- Rep. Guthrie, Brett [R-KY-2] · R · Cosponsor
- Rep. McCaul, Michael T. [R-TX-10] · R · Cosponsor
- Sen. Cassidy, Bill [R-LA] · R · Cosponsor
- Rep. Brooks, Mo [R-AL-5] · R · Cosponsor
- Rep. Broun, Paul C. [R-GA-10] · R · Cosponsor
- Rep. McMorris Rodgers, Cathy [R-WA-5] · R · Cosponsor
- Rep. Himes, James A. [D-CT-4] · D · Cosponsor
- Rep. McHenry, Patrick T. [R-NC-10] · R · Cosponsor
- Rep. Walden, Greg [R-OR-2] · R · Cosponsor
- Rep. Tsongas, Niki [D-MA-3] · D · Cosponsor
- Rep. Matheson, Jim [D-UT-2] · D · Cosponsor
- Rep. Gonzalez, Charles A. [D-TX-20] · D · Cosponsor
- Rep. Matsui, Doris O. [D-CA-7] · D · Cosponsor
- Rep. Latham, Tom [R-IA-3] · R · Cosponsor
- Rep. Filner, Bob [D-CA-51] · D · Cosponsor
- Rep. Miller, Gary G. [R-CA-42] · R · Cosponsor
- Rep. Barrow, John [D-GA-12] · D · Cosponsor
- Rep. Kinzinger, Adam [R-IL-16] · R · Cosponsor
- Rep. Benishek, Dan [R-MI-1] · R · Cosponsor
- Rep. Ross, Mike [D-AR-4] · D · Cosponsor
- Del. Christensen, Donna M. [D-VI-At Large] · D · Cosponsor
- · hsif00 · Standing
Related records
- related to ← Generating Antibiotic Incentives Now Act of 2011
Sources
PoliticalRepo is an index and interpretation layer, not the authoritative legal source.
- Official source: https://www.congress.gov/bill/112th-congress/house-bill/2182
- Open data entity: https://api.congress.gov/v3/bill/112/hr/2182
- us · 112-hr-2182 · source updated 5 December 2025