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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Generating Antibiotic 

5 Incentives Now Act of 2010’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 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. 

1 SEC. 3. EXTENSION OF EXCLUSIVITY PERIOD. 

2 (a) IN GENERAL.—The Federal Food, Drug, and 

3 Cosmetic Act is amended by inserting after section 505D 

4 (21 U.S.C. 355e) the following: 

5 ‘‘SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 

6 QUALIFIED INFECTIOUS DISEASE PRODUCTS. 

7 ‘‘(a) EXTENSION.—If, prior to approval or licensure 

8 of a drug or biological product pursuant to an application 

9 that is submitted under section 505(b) of this Act or sec10 tion 351(a) of the Public Health Service Act, the Sec11 retary determines that the drug or biological product is 

12 a qualified infectious disease product, then the exclusivity 

13 period for such qualified infectious disease product is 

14 deemed to be extended by 5 years. 

15 ‘‘(b) LIMITED TO FIRST LICENSURE.—Subsection 

16 (a) does not apply to the approval or licensure of— 

17 ‘‘(1) a supplement for the qualified infectious 

18 disease product; or 

19 ‘‘(2) a subsequent application filed by the same 

20 sponsor or manufacturer of the qualified infectious 

21 disease product (or a licensor, predecessor in inter22 est, or other related entity) for— 

23 ‘‘(A) a change (not including a modifica24 tion to the structure of the qualified infectious 


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1 disease product) that results in a new indica2 tion, route of administration, dosing schedule, 

3 dosage form, delivery system, delivery device, or 

4 strength; or 

5 ‘‘(B) a modification to the structure of the 

6 qualified infectious disease product that does 

7 not result in a change in— 

8 ‘‘(i) safety or effectiveness in the case 

9 of a drug; or 

10 ‘‘(ii) safety, purity, or potency in the 

11 case of a biological product. 

12 ‘‘(c) DETERMINATION.—At the request of any person 

13 submitting an application described in subsection (a), the 

14 Secretary shall, not later than 30 days after the submis15 sion of such request and prior to approval of the applica16 tion, determine whether the drug or biological product is 

17 a qualified infectious disease product. 

18 ‘‘(d) REGULATIONS.—The Secretary shall promul19 gate regulations for carrying out this section. The Sec20 retary shall promulgate the initial regulations for carrying 

21 out this section not later than 12 months after such date 

22 of enactment. 

23 ‘‘(e) DEFINITIONS.—In this section: 

24 ‘‘(1) EXCLUSIVITY PERIOD.—The term ‘exclu25 sivity period’ means, with respect to a qualified inVerDate Mar 15 2010 05:03 Oct 13, 2010 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6331.IH H6331

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1 fectious disease product approved or licensed under 

2 section 505 of this Act or section 351 of the Public 

3 Health Service Act, the period of time (as extended 

4 under section 505A or 527 of this Act or section 

5 351(m) of the Public Health Service Act) during 

6 which such section 505 or 351 prohibit the Sec7 retary from making effective the approval of another 

8 application under such section 505 or 351 for such 

9 product for a person who is not the holder of such 

10 approved application or of such approved license. 

11 ‘‘(2) QUALIFIED INFECTIOUS DISEASE PROD12 UCT.—The term ‘qualified infectious disease prod13 uct’ means an antibiotic drug, or a diagnostic test 

14 including a point-of-care diagnostic test, for treating, 

15 detecting, preventing, or identifying a qualifying 

16 pathogen. 

17 ‘‘(3) QUALIFYING PATHOGEN.—The term 

18 ‘qualifying pathogen’ means— 

19 ‘‘(A) resistant gram positive pathogens, in20 cluding methicillin-resistant Staphylococcus 

21 aureus (MRSA), vancomycin-resistant Staphy22 lococcus aureus (VRSA), and vancomycin-resist23 ant enterococcus (VRE); 


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1 ‘‘(B) multi-drug resistant gram negative 

2 bacteria, including Acinetobacter, Klebsiella, 

3 Pseudomonas, and E. coli species; 

4 ‘‘(C) multi-drug resistant tuberculosis; or 

5 ‘‘(D) any other infectious pathogen identi6 fied for purposes of this section by the Sec7 retary, in concurrence with infectious disease 

8 clinicians and appropriate professional associa9 tions, as a significant threat to public health 

10 because of drug resistance or other factors (or 

11 likely to become such a threat).’’. 

12 (b) APPLICATION.—Section 505E of the Federal 

13 Food, Drug, and Cosmetic Act, as added by subsection 

14 (a), shall apply with respect to any drug or biological prod15 uct that is first approved or licensed under section 505 

16 of such Act (21 U.S.C. 355) or section 351 of the Public 

17 Health Service Act (42 U.S.C. 262) on or after the date 

18 of the enactment of this Act. 

19 SEC. 4. PRIORITY REVIEW. 

20 (a) AMENDMENT.—Chapter V of the Federal Food, 

21 Drug, and Cosmetic Act is amended by inserting after sec22 tion 524 (21 U.S.C. 360n) the following: 


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1 ‘‘SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS 

2 DISEASE PRODUCTS. 

3 ‘‘(a) IN GENERAL.—If the Secretary determines 

4 under section 505E that a drug is a qualified infectious 

5 disease product, the Secretary shall give priority review 

6 to the application for approval or licensure of such product 

7 submitted under section 505(b) of this Act or section 

8 351(a) of the Public Health Service Act. 

9 ‘‘(b) DEFINITION.—In this section, the term ‘priority 

10 review’, with respect to an application described in sub11 section (b), means review and action by the Secretary on 

12 such application not later than 6 months after receipt by 

13 the Secretary of such application.’’. 

14 (b) APPLICATION.—Section 524A of the Federal 

15 Food, Drug, and Cosmetic Act, as added by subsection 

16 (a), shall apply with respect to an application that is sub17 mitted under section 505(b) of such Act (21 U.S.C. 

18 355(b)) or section 351(a) of the Public Health Service Act 

19 (42 U.S.C. 262(a)) on or after the date of the enactment 

20 of this Act. 

21 SEC. 5. FAST TRACK PRODUCT. 

22 Paragraph (1) of section 506(a) of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 356(a)) is amended 

24 by inserting after ‘‘if it is intended for the treatment of 

25 a serious or life-threatening condition and it demonstrates 

26 the potential to address unmet medical needs for such a 


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1 condition’’ the following: ‘‘or if the Secretary determines 

2 under section 505E that the drug is a qualified infectious 

3 disease product’’. 

4 SEC. 6. CLINICAL TRIALS. 

5 (a) REVIEW AND REVISION OF GUIDELINES.— 

6 (1) IN GENERAL.—Not later than 1 year after 

7 the date of the enactment of this Act, and not later 

8 than 4 years thereafter, the Secretary shall— 

9 (A) review the guidelines of the Food and 

10 Drug Administration for the conduct of clinical 

11 trials with respect to antibiotic drugs; and 

12 (B) as appropriate, revise such guidelines 

13 to reflect developments in scientific and medical 

14 information and technology and to ensure clar15 ity regarding the procedures and requirements 

16 for approval of an antibiotic drug under chapter 

17 V of the Federal Food, Drug, and Cosmetic Act 

18 (21 U.S.C. 351 et seq.) or section 351 of the 

19 Public Health Service Act (42 U.S.C. 262). 

20 (2) ISSUES FOR REVIEW.—At a minimum, the 

21 review under paragraph (1) shall address the appro22 priate animal models of infection, in vitro tech23 niques, valid micro-biological surrogate markers, the 

24 use of non-inferiority versus superiority trials, and 

25 appropriate delta values for non-inferiority trials. 


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1 (3) REPORTS TO CONGRESS.—Not later than 1 

2 year after the date of the enactment of this Act, and 

3 annually thereafter for the next 4 years, the Sec4 retary shall submit a report to the Congress on the 

5 progress of the review under paragraph (1). 

6 (4) RULE OF CONSTRUCTION.—Except to the 

7 extent to which the Secretary of Health and Human 

8 Services makes revisions under paragraph (1)(B), 

9 nothing in this section shall be construed to repeal 

10 or otherwise affect the guidelines of the Food and 

11 Drug Administration. 

12 (b) RECOMMENDATIONS FOR INVESTIGATIONS.— 

13 (1) REQUEST.—The sponsor of a drug intended 

14 to be used to treat, detect, prevent, or identify a 

15 qualifying pathogen may request that the Secretary 

16 provide written recommendations for nonclinical and 

17 clinical investigations which may be conducted with 

18 the drug before— 

19 (A) it may be approved for such use under 

20 section 505 of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 355); or 

22 (B) if the drug is a biological product, it 

23 may be licensed for such use under section 351 

24 of the Public Health Service Act. 


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1 (2) RECOMMENDATIONS.—If the Secretary has 

2 reason to believe that a drug for which a request is 

3 made under this subsection is a qualified infectious 

4 disease product, the Secretary shall provide the per5 son making the request written recommendations for 

6 the nonclinical and clinical investigations which the 

7 Secretary believes, on the basis of information avail8 able to the Secretary at the time of the request, 

9 would be necessary for— 

10 (A) approval under section 505 of the Fed11 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

12 355) of such drug for the use described in para13 graph (1); or 

14 (B) licensing under section 351 of the 

15 Public Health Service Act (42 U.S.C. 262) of 

16 such drug for such use. 

17 (c) DEFINITIONS.—In this section: 

18 (1) The term ‘‘biological product’’ has the 

19 meaning given to such term in section 351 of the 

20 Public Health Service Act (42 U.S.C. 262). 

21 (2) The term ‘‘drug’’ has the meaning given to 

22 such term in section 201 of the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 321). 

24 (3) The term ‘‘qualifying pathogen’’ has the 

25 meaning given such term in section 505E of the 


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1 Federal Food, Drug, and Cosmetic Act, as added by 

2 section 3. 

3 (4) The term ‘‘Secretary’’ means the Secretary 

4 of Health and Human Services, acting through the 

5 Commissioner of Food and Drugs. 

Æ 


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