II 

112TH CONGRESS 

1ST SESSION S. 1734 

To provide incentives for the development of qualified infectious disease 

products. 

IN THE SENATE OF THE UNITED STATES 

OCTOBER 19, 2011 

Mr. BLUMENTHAL (for himself, Mr. CORKER, Mr. BENNET, Mr. HATCH, Mr. 

CASEY, Mr. ALEXANDER, and Mr. COONS) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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 2011’’. 

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 for drugs. 


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Sec. 4. Additional extension of exclusivity period for qualified infectious disease 

products for which a companion diagnostic test is cleared or 

approved. 

Sec. 5. Priority review. 

Sec. 6. Fast track product. 

Sec. 7. Study on incentives for qualified infectious disease biological products. 

Sec. 8. Clinical trials. 

1 SEC. 3. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS. 

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 of a drug 

8 pursuant to an application submitted under section 

9 505(b), the Secretary determines that the drug is a quali10 fied infectious disease product, then the four- and five11 year periods described in subsections (c)(3)(E)(ii) and 

12 (j)(5)(F)(ii) of section 505, the three-year periods de13 scribed in clauses (iii) and (iv) of subsection (c)(3)(E) and 

14 clauses (iii) and (iv) of subsection (j)(5)(F) of section 505, 

15 or the seven-year period described in section 527, as appli16 cable, shall be extended by five years. 

17 ‘‘(b) RELATION TO PEDIATRIC EXCLUSIVITY.—Any 

18 extension under subsection (a) of a period shall be in addi19 tion to any extension of the period under section 505A 

20 with respect to the drug. 

21 ‘‘(c) LIMITATIONS.—Subsection (a) does not apply to 

22 the approval of— 


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1 ‘‘(1) a supplement to an application under sec2 tion 505(b) for any qualified infectious disease prod3 uct for which an extension described in subsection 

4 (a) is in effect or has expired; or 

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

6 sponsor or manufacturer of a qualified infectious 

7 disease product described in paragraph (1) (or a li8 censor, predecessor in interest, or other related enti9 ty) for— 

10 ‘‘(A) a change (not including a modifica11 tion to the structure of the qualified infectious 

12 disease product) that results in a new indica13 tion, route of administration, dosing schedule, 

14 dosage form, delivery system, delivery device, or 

15 strength; or 

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

17 qualified infectious disease product that does 

18 not result in a change in safety or effectiveness. 

19 ‘‘(d) DETERMINATION.—The manufacturer or spon20 sor of a drug may request the Secretary to designate a 

21 drug as a qualified infectious disease product. Such a re22 quest for designation shall be made at least 45 days before 

23 the submission of an application under section 505(b) for 

24 such drug. The Secretary shall, not later than 30 days 


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1 after the submission of such request, determine whether 

2 the drug is a qualified infectious disease product. 

3 ‘‘(e) REGULATIONS.—The Secretary shall promulgate 

4 regulations for carrying out this section. The Secretary 

5 shall promulgate the initial regulations for carrying out 

6 this section not later than 12 months after the date of 

7 the enactment of this section. 

8 ‘‘(f) DEFINITIONS.—In this section: 

9 ‘‘(1) QUALIFIED INFECTIOUS DISEASE PROD10 UCT.—The term ‘qualified infectious disease prod11 uct’ means an antibiotic drug for treating, detecting, 

12 preventing, or identifying a qualifying pathogen. 

13 ‘‘(2) QUALIFYING PATHOGEN.—The term 

14 ‘qualifying pathogen’ means— 

15 ‘‘(A) resistant gram positive pathogens, in16 cluding methicillin-resistant Staphylococcus 

17 aureus (MRSA), vancomycin-resistant Staphy18 lococcus aureus (VRSA), and vancomycin-resist19 ant enterococcus (VRE); 

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

21 bacteria, including Acinetobacter, Klebsiella, 

22 Pseudomonas, and E. coli species; 

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


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1 ‘‘(D) any other infectious pathogen identi2 fied for purposes of this section by the Sec3 retary.’’. 

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

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

6 (a), applies only with respect to a drug that is first ap7 proved under section 505(c) of such Act (21 U.S.C. 

8 355(c)) on or after the date of the enactment of this Act. 

9 SEC. 4. ADDITIONAL EXTENSION OF EXCLUSIVITY PERIOD 

10 FOR QUALIFIED INFECTIOUS DISEASE PROD11 UCTS FOR WHICH A COMPANION DIAGNOSTIC 

12 TEST IS CLEARED OR APPROVED. 

13 The Federal Food, Drug, and Cosmetic Act (21 

14 U.S.C. 301 et seq.), as amended by section 3, is further 

15 amended by inserting after section 505E the following: 

16 ‘‘SEC. 505E–1. ADDITIONAL EXTENSION OF EXCLUSIVITY 

17 FOR QUALIFIED INFECTIOUS DISEASE PROD18 UCTS FOR WHICH A COMPANION DIAGNOSTIC 

19 TEST IS CLEARED OR APPROVED. 

20 ‘‘(a) IN GENERAL.—If the sponsor or manufacturer 

21 of a qualified infectious disease product identifies in ac22 cordance with subsection (b) a companion diagnostic test 

23 described in subsection (c), any period extended under sec24 tion 505E(a) with respect to such product shall be further 

25 extended by 6 months. 


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1 ‘‘(b) IDENTIFICATION REQUIREMENTS.—For pur2 poses of subsection (a), the identification of a companion 

3 diagnostic test shall— 

4 ‘‘(1) be made in such manner as the Secretary 

5 may require; and 

6 ‘‘(2) occur before the expiration of the period to 

7 be extended under subsection (a), not counting any 

8 extension to such period under section 505E(a) or 

9 505A. 

10 ‘‘(c) COMPANION DIAGNOSTIC TEST.—For purposes 

11 of subsection (a), a device is a companion diagnostic test 

12 with respect to a qualified infectious disease product if 

13 each of the following is met: 

14 ‘‘(1) The device is determined by the Secretary 

15 under subsection (f) to be a test for diagnosis of a 

16 qualifying pathogen. 

17 ‘‘(2) The qualified infectious disease product 

18 has been determined under section 505E(d) to be for 

19 treating, detecting, preventing, or identifying such 

20 qualifying pathogen. 

21 ‘‘(3) The device is cleared under section 510(k) 

22 or approved under section 515. 

23 ‘‘(4) The sponsor or manufacturer, as applica24 ble, of the qualified infectious disease product has 


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1 the exclusive rights to submit an identification under 

2 subsection (a) with respect to the device. 

3 ‘‘(d) RELATION TO PEDIATRIC EXCLUSIVITY.—Any 

4 extension under subsection (a) of a period with respect 

5 to a qualified infectious disease product shall be in addi6 tion to any extension of the period under section 505A 

7 of this Act with respect to the product. 

8 ‘‘(e) LIMITATIONS.—After the extension of any pe9 riod under subsection (a) with respect to a qualified infec10 tious disease product pursuant to the identification of a 

11 device as a companion diagnostic test, subsection (a) does 

12 not authorize— 

13 ‘‘(1) any subsequent extension with respect to 

14 such product; or 

15 ‘‘(2) any extension with respect to any other 

16 product pursuant to identification of such device. 

17 ‘‘(f) DETERMINATION.—The sponsor or manufac18 turer of a drug may request the Secretary to determine 

19 that a device is a test for diagnosis of a qualifying patho20 gen. Such a request shall be made at least 45 days before 

21 the submission of a notification under section 510(k) or 

22 an application under section 515 for such device. The Sec23 retary shall, not later than 30 days after the submission 

24 of such request, determine whether the device is a test 

25 for diagnosis of a qualifying pathogen. 


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1 ‘‘(g) DEFINITIONS.—In this section: 

2 ‘‘(1) The term ‘qualified infectious disease 

3 product’ means a drug that is determined to be a 

4 qualified infectious disease product under section 

5 505E. 

6 ‘‘(2) The term ‘qualifying pathogen’ has the 

7 meaning given to such term in section 505E.’’. 

8 SEC. 5. PRIORITY REVIEW. 

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

10 Drug, and Cosmetic Act is amended by inserting after sec11 tion 524 (21 U.S.C. 360n) the following: 

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

13 DISEASE PRODUCTS. 

14 ‘‘(a) IN GENERAL.—If the Secretary makes a deter15 mination under section 505E(c) that a drug is a qualified 

16 infectious disease product, then the Secretary shall give 

17 priority review to any application submitted for approval 

18 for such drug under section 505(b). 

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

20 review’, with respect to an application described in sub21 section (a), means review and action by the Secretary on 

22 such application not later than 6 months after receipt by 

23 the Secretary of such application.’’. 

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

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


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1 (a), applies only with respect to an application that is sub2 mitted under section 505(b) (21 U.S.C. 355(b)) on or 

3 after the date of the enactment of this Act. 

4 SEC. 6. FAST TRACK PRODUCT. 

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

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

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

8 a serious or life-threatening condition and it demonstrates 

9 the potential to address unmet medical needs for such a 

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

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

12 disease product’’. 

13 SEC. 7. STUDY ON INCENTIVES FOR QUALIFIED INFEC14 TIOUS DISEASE BIOLOGICAL PRODUCTS. 

15 (a) IN GENERAL.—The Comptroller General of the 

16 United States shall— 

17 (1) conduct a study on the need for incentives 

18 to encourage the research, development, and mar19 keting of qualified infectious disease biological prod20 ucts; and 

21 (2) not later than 1 year after the date of the 

22 enactment of this Act, submit a report to the Con23 gress on the results of such study, including any rec24 ommendations of the Comptroller General on appro25 priate incentives for addressing such need. 


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1 (b) DEFINITIONS.—In this section: 

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

3 meaning given to such term in section 351 of the 

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

5 (2) The term ‘‘qualified infectious disease bio6 logical product’’ means a biological product for 

7 treating, detecting, preventing, or identifying a 

8 qualifying pathogen. 

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

10 meaning given to such term in section 505E of the 

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

12 section 3 of this Act. 

13 SEC. 8. CLINICAL TRIALS. 

14 (a) REVIEW AND REVISION OF GUIDELINES.— 

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

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

17 than 4 years thereafter, the Secretary shall— 

18 (A) review the guidelines of the Food and 

19 Drug Administration for the conduct of clinical 

20 trials with respect to antibiotic drugs; and 

21 (B) as appropriate, revise such guidelines 

22 to reflect developments in scientific and medical 

23 information and technology and to ensure clar24 ity regarding the procedures and requirements 

25 for approval of an antibiotic drug under chapter 


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

2 (21 U.S.C. 351 et seq.). 

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

4 review under paragraph (1) shall address the appro5 priate animal models of infection, in vitro tech6 niques, valid micro-biological surrogate markers, the 

7 use of non-inferiority versus superiority trials, and 

8 appropriate delta values for non-inferiority trials. 

9 (3) RULE OF CONSTRUCTION.—Except to the 

10 extent to which the Secretary of Health and Human 

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

12 nothing in this section shall be construed to repeal 

13 or otherwise affect the guidelines of the Food and 

14 Drug Administration. 

15 (b) RECOMMENDATIONS FOR INVESTIGATIONS.— 

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

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

18 qualifying pathogen may request that the Secretary 

19 provide written recommendations for nonclinical and 

20 clinical investigations which may be conducted with 

21 the drug before it may be approved for such use 

22 under section 505 of the Federal Food, Drug, and 

23 Cosmetic Act (21 U.S.C. 355). 

24 (2) RECOMMENDATIONS.—If the Secretary has 

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


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1 made under this subsection is a qualified infections 

2 disease product, the Secretary shall provide the per3 son making the request written recommendations for 

4 the nonclinical and clinical investigations which the 

5 Secretary believes, on the basis of information avail6 able to the Secretary at the time of the request, 

7 would be necessary for approval under section 505 

8 of the Federal Food, Drug, and Cosmetic Act (21 

9 U.S.C. 355) of such drug for the use described in 

10 paragraph (1). 

11 (c) DEFINITIONS.—In this section: 

12 (1) The term ‘‘drug’’ has the meaning given to 

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

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

15 (2) The term ‘‘qualifying pathogen’’ has the 

16 meaning given to such term in section 505E of the 

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

18 section 3 of this Act. 

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

20 of Health and Human Services, acting through the 

21 Commissioner of Food and Drugs. 

Æ 


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