H.R. 2182: Generating Antibiotic Incentives Now Act of 2011

112th Congress · introduced 2011-06-15 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

Where it came from: introduced 2011-06-15 · official record
Who proposed it: Rep. Gingrey, Phil [R-GA-11] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Generating Antibiotic Incentives Now Act of 2011

Plain 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.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

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If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Generating Antibiotic Incentives Now Act of 2011

Source: Congressional Research Service summary (Introduced in House)

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Gingrey, Phil [R-GA-11] · 46 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Diana DeGette (D-CO), Marsha Blackburn (R-TN), Robert E. Latta (R-OH), H. Morgan Griffith (R-VA), Christopher Murphy (D-CT), Edward J. Markey (D-MA), William R. Keating (D-MA), Brett Guthrie (R-KY), Michael T. McCaul (R-TX), Bill Cassidy (R-LA), James A. Himes (D-CT), Doris O. Matsui (D-CA)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)

Appropriation: Money a legislature sets aside by law for a specific purpose. Government agencies may spend public money only as it has been appropriated.

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in House)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-112hr2182.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/112/hr>

Record fed-us-cong112-hr2182 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112