HR 2182 · 112th Congress · Health
Generating Antibiotic Incentives Now Act of 2011
Bill Progress
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Introduced2
Committee3
House Vote4
Senate5
EnactedLatest: Referred to the Subcommittee on Health.(2011-06-16)
Plain Language Summary
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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 dise…
Summarized by Claude AI · Non-partisan · For informational purposes only
Cosponsors (20)
8 Democrats12 Republicans