HR 2182 · 112th Congress 2011–2013, ended

Generating Antibiotic Incentives Now Act of 2011

Introduced Jun 15, 2011 Originated House Sponsor Phil Gingrey R-GA

Latest action · Jun 16, 2011 Referred to the Subcommittee on Health.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

IntroducedJun 15, 2011
Passed HouseNot reached
Passed SenateNot reached
To the PresidentNot reached
Became lawNot reached

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.

Cosponsors 46

Members who signed on, in the order they did. Signatures ran from Jun 15, 2011 to May 8, 2012; 6 are original cosponsors, there from the day it was introduced.

Seat	Cosponsor		Signed on
D-CA	Anna G. Eshoo	Original	Jun 15, 2011
D-CO	Diana DeGette	Original	Jun 15, 2011
R-KY	Ed Whitfield	Original	Jun 15, 2011
D-TX	Gene Green	Original	Jun 15, 2011
R-IL	John Shimkus	Original	Jun 15, 2011
R-MI	Mike Rogers	Original	Jun 15, 2011
R-CA	Brian P. Bilbray		Jul 6, 2011
R-MS	Gregg Harper		Jul 7, 2011
R-TN	Marsha Blackburn		Jul 8, 2011
R-NJ	Leonard Lance		Jul 12, 2011
R-NC	Sue Wilkins Myrick		Jul 15, 2011
R-OK	John Sullivan		Jul 20, 2011
R-TX	Michael C. Burgess		Jul 21, 2011
R-OH	Robert E. Latta		Jul 26, 2011
R-VA	H. Morgan Griffith		Jul 28, 2011
D-PA	Robert A. Brady		Sep 23, 2011
D-CT	Christopher Murphy		Oct 3, 2011
D-MA	Edward J. Markey		Oct 12, 2011
D-MA	William R. Keating		Oct 13, 2011
D-WA	Jay Inslee		Oct 25, 2011
D-DE	John C. Carney, Jr.		Oct 25, 2011
R-PA	Patrick Meehan		Oct 25, 2011
D-NC	Brad Miller		Oct 31, 2011
R-KY	Brett Guthrie		Nov 10, 2011
R-IN	Dan Burton		Nov 10, 2011
D-NC	G. K. Butterfield		Nov 10, 2011
R-LA	Bill Cassidy		Nov 16, 2011
R-TX	Michael T. McCaul		Nov 16, 2011
R-AL	Mo Brooks		Nov 30, 2011
R-GA	Paul C. Broun		Dec 2, 2011
R-WA	Cathy McMorris Rodgers		Dec 13, 2011
D-CT	James A. Himes		Dec 15, 2011
R-OR	Greg Walden		Dec 19, 2011
R-NC	Patrick T. McHenry		Dec 19, 2011
D-MA	Niki Tsongas		Feb 2, 2012
D-UT	Jim Matheson		Feb 7, 2012
D-TX	Charles A. Gonzalez		Feb 15, 2012
D-CA	Doris O. Matsui		Feb 29, 2012
R-IA	Tom Latham		Mar 5, 2012
D-CA	Bob Filner		Apr 17, 2012
R-CA	Gary G. Miller		Apr 17, 2012
D-GA	John Barrow		Apr 17, 2012
R-IL	Adam Kinzinger		Apr 24, 2012
R-MI	Dan Benishek		Apr 27, 2012
D-AR	Mike Ross		May 7, 2012
D-VI	Donna M. Christensen		May 8, 2012

Committees 1

Where it was sent and what each committee and subcommittee did with it, in order.

Chamber	Committee	What it did
House	Energy and Commerce Committee	Referred Jun 15, 2011
	Health Subcommittee	Referred Jun 16, 2011

Actions 3

Everything that happened, newest first.

Jun 16, 2011Referred to the Subcommittee on Health.
Jun 15, 2011Introduced in House
Jun 15, 2011Referred to the House Committee on Energy and Commerce.

In the Congressional Record 2

Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.

Where	In the Record	Members	Date
Senate	Debate and remarks S7028–S7030	Bob Corker R-TN, Richard Blumenthal D-CT	Nov 2, 2011
House	Lists H4278H.R. 2182-2203	—	Jun 15, 2011

Research

What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.

Constitutional authority

Congress has the power to enact this legislation pursuant to the following: The constitutional authority on which this legislation is based is found in article I, section 8, clause 18 granting Congress the power ``to make all Laws which shall be necessary and proper for carrying into Execution foregoing Powers, and all other Powers vested by this Constitution in the Government of the United States, or in any Department or Officer thereof.''

The sponsor’s statement, as printed in the page H4278.

Printed hearings 3

Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.

Number	Hearing	Committee	Held
Serial No. 112-126	FDA USER FEES 2012: ISSUES RELATED TO ACCELERATED APPROVAL, MEDICAL GAS, ANTIBIOTIC DEVELOPMENT, AND DOWNSTREAM PHARMACEUTICAL SUPPLY CHAIN218 pages	Energy and Commerce Committee	Mar 8, 2012
Serial No. 112-110	REAUTHORIZATION OF PDUFA: WHAT IT MEANS FOR JOBS, INNOVATION, AND PATIENTS261 pages	Energy and Commerce Committee	Feb 1, 2012
Serial No. 112-70	PDUFA V: MEDICAL INNOVATION, JOBS, AND PATIENTS169 pages	Energy and Commerce Committee	Jul 7, 2011

CRS reports 2

Congressional Research Service work that CRS links to this bill or the law it became, newest first.

Cite it 2

Products on other subjects that cite it, usually among other measures.

Product	Title	Kind	Published
R42680	The Food and Drug Administration Safety and Innovation Act (FDASIA, P.L. 112-144) Archived	Report	Feb 4, 2013
R42564	FDA User Fees and the Regulation of Drugs, Biologics, and Devices: Comparative Analysis of S. 3187 and H.R. 5651 Archived	Report	Jun 26, 2012

Related bills 1

Companion bills and other measures the record links to this one.

Bill	Title	Relationship	Latest action
S 1734	Generating Antibiotic Incentives Now Act of 2011	Identical bill	Oct 19, 2011

Titles 2

Every title it has carried, official and short, at each stage.

Official Title as Introduced: To provide incentives for the development of qualified infectious disease products.
Short Titles as Introduced: Generating Antibiotic Incentives Now Act of 2011

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

Jun 15, 2011Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.