I 
111TH CONGRESS 
2D SESSION 
H. R. 6331 
To provide incentives for the development of qualified infectious disease 
products. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 29, 2010 
Mr. GINGREY of Georgia (for himself, Mr. GENE GREEN of Texas, Mr. 
WHITFIELD, Mr. ROGERS of Michigan, and Ms. DEGETTE) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To provide incentives for the development of qualified 
infectious disease products. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Generating Antibiotic 
Incentives Now Act of 2010’’. 
SEC. 2. TABLE OF CONTENTS. 
The table of contents of this Act is as follows: 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
Sec. 3. Extension of exclusivity period. 
Sec. 4. Priority review. 
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Sec. 5. Fast track product. 
Sec. 6. Clinical trials. 
SEC. 3. EXTENSION OF EXCLUSIVITY PERIOD. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 505D 
(21 U.S.C. 355e) the following: 
‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 
QUALIFIED INFECTIOUS DISEASE PRODUCTS. 
‘‘(a) EXTENSION.—If, prior to approval or licensure 
of a drug or biological product pursuant to an application 
that is submitted under section 505(b) of this Act or sec-
tion 351(a) of the Public Health Service Act, the Sec-
retary determines that the drug or biological product is 
a qualified infectious disease product, then the exclusivity 
period for such qualified infectious disease product is 
deemed to be extended by 5 years. 
‘‘(b) LIMITED
TO FIRST LICENSURE.—Subsection 
(a) does not apply to the approval or licensure of— 
‘‘(1) a supplement for the qualified infectious 
disease product; or 
‘‘(2) a subsequent application filed by the same 
sponsor or manufacturer of the qualified infectious 
disease product (or a licensor, predecessor in inter-
est, or other related entity) for— 
‘‘(A) a change (not including a modifica-
tion to the structure of the qualified infectious 
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disease product) that results in a new indica-
tion, route of administration, dosing schedule, 
dosage form, delivery system, delivery device, or 
strength; or 
‘‘(B) a modification to the structure of the 
qualified infectious disease product that does 
not result in a change in— 
‘‘(i) safety or effectiveness in the case 
of a drug; or 
‘‘(ii) safety, purity, or potency in the 
case of a biological product. 
‘‘(c) DETERMINATION.—At the request of any person 
submitting an application described in subsection (a), the 
Secretary shall, not later than 30 days after the submis-
sion of such request and prior to approval of the applica-
tion, determine whether the drug or biological product is 
a qualified infectious disease product. 
‘‘(d) REGULATIONS.—The Secretary shall promul-
gate regulations for carrying out this section. The Sec-
retary shall promulgate the initial regulations for carrying 
out this section not later than 12 months after such date 
of enactment. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) EXCLUSIVITY PERIOD.—The term ‘exclu-
sivity period’ means, with respect to a qualified in-
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fectious disease product approved or licensed under 
section 505 of this Act or section 351 of the Public 
Health Service Act, the period of time (as extended 
under section 505A or 527 of this Act or section 
351(m) of the Public Health Service Act) during 
which such section 505 or 351 prohibit the Sec-
retary from making effective the approval of another 
application under such section 505 or 351 for such 
product for a person who is not the holder of such 
approved application or of such approved license. 
‘‘(2) QUALIFIED
INFECTIOUS
DISEASE
PROD-
UCT.—The term ‘qualified infectious disease prod-
uct’ means an antibiotic drug, or a diagnostic test 
including a point-of-care diagnostic test, for treating, 
detecting, preventing, or identifying a qualifying 
pathogen. 
‘‘(3) 
QUALIFYING
PATHOGEN.—The 
term 
‘qualifying pathogen’ means— 
‘‘(A) resistant gram positive pathogens, in-
cluding 
methicillin-resistant 
Staphylococcus 
aureus (MRSA), vancomycin-resistant Staphy-
lococcus aureus (VRSA), and vancomycin-resist-
ant enterococcus (VRE); 
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‘‘(B) multi-drug resistant gram negative 
bacteria, including Acinetobacter, Klebsiella, 
Pseudomonas, and E. coli species; 
‘‘(C) multi-drug resistant tuberculosis; or 
‘‘(D) any other infectious pathogen identi-
fied for purposes of this section by the Sec-
retary, in concurrence with infectious disease 
clinicians and appropriate professional associa-
tions, as a significant threat to public health 
because of drug resistance or other factors (or 
likely to become such a threat).’’. 
(b) APPLICATION.—Section 505E of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a), shall apply with respect to any drug or biological prod-
uct that is first approved or licensed under section 505 
of such Act (21 U.S.C. 355) or section 351 of the Public 
Health Service Act (42 U.S.C. 262) on or after the date 
of the enactment of this Act. 
SEC. 4. PRIORITY REVIEW. 
(a) AMENDMENT.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act is amended by inserting after sec-
tion 524 (21 U.S.C. 360n) the following: 
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‘‘SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS 
DISEASE PRODUCTS. 
‘‘(a) IN GENERAL.—If the Secretary determines 
under section 505E that a drug is a qualified infectious 
disease product, the Secretary shall give priority review 
to the application for approval or licensure of such product 
submitted under section 505(b) of this Act or section 
351(a) of the Public Health Service Act. 
‘‘(b) DEFINITION.—In this section, the term ‘priority 
review’, with respect to an application described in sub-
section (b), means review and action by the Secretary on 
such application not later than 6 months after receipt by 
the Secretary of such application.’’. 
(b) APPLICATION.—Section 524A of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(a), shall apply with respect to an application that is sub-
mitted under section 505(b) of such Act (21 U.S.C. 
355(b)) or section 351(a) of the Public Health Service Act 
(42 U.S.C. 262(a)) on or after the date of the enactment 
of this Act. 
SEC. 5. FAST TRACK PRODUCT. 
Paragraph (1) of section 506(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356(a)) is amended 
by inserting after ‘‘if it is intended for the treatment of 
a serious or life-threatening condition and it demonstrates 
the potential to address unmet medical needs for such a 
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