I 

113TH CONGRESS 

1ST SESSION H. R. 3742 

To provide for approval of certain drugs and biological products indicated 

for use in a limited population of patients in order to address increases 

in bacterial and fungal resistance to drugs and biological products, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 12, 2013 

Mr. GINGREY of Georgia (for himself, Mr. GENE GREEN of Texas, Mr. SHIMKUS, Ms. ESHOO, Mr. WHITFIELD, Ms. DEGETTE, Mrs. BLACKBURN, 

Mr. ENGEL, Mr. GRIFFITH of Virginia, and Mr. BUTTERFIELD) introduced the following bill; which was referred to the Committee on Energy 

and Commerce 

A BILL 

To provide for approval of certain drugs and biological products indicated for use in a limited population of patients 

in order to address increases in bacterial and fungal 

resistance to drugs and biological products, and for other 

purposes. 

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 ‘‘Antibiotic Development 

5 to Advance Patient Treatment Act of 2013’’. 

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1 SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A LIM2 ITED POPULATION OF PATIENTS. 

3 (a) APPROVAL OF CERTAIN ANTIBACTERIAL AND

4 ANTIFUNGAL DRUGS.—Section 505 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 

6 adding at the end the following: 

7 ‘‘(x) APPROVAL OF CERTAIN ANTIBACTERIAL AND

8 ANTIFUNGAL DRUGS FOR USE IN A LIMITED POPU9 LATION OF PATIENTS.— 

10 ‘‘(1) APPROVAL.—At the request of the sponsor 

11 of an antibacterial or antifungal drug that is in12 tended to treat a serious or life-threatening disease 

13 or condition, the Secretary— 

14 ‘‘(A) may approve the drug under sub15 section (c) to treat a limited population of pa16 tients for which there is an unmet medical 

17 need; 

18 ‘‘(B) in determining whether to grant such 

19 approval for a limited population of patients, 

20 may rely on traditional endpoints, alternative 

21 endpoints, or a combination of traditional and 

22 alternative endpoints; datasets of limited size; 

23 pharmacologic or pathophysiologic data; data 

24 from phase 2 clinical studies; and such other 

25 confirmatory evidence as the Secretary deems 

26 necessary; and 

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1 ‘‘(C) shall require the labeling of drugs ap2 proved pursuant to this subsection to promi3 nently include in the prescribing information re4 quired by section 201.57 of title 21, Code of 

5 Federal Regulations (or any successor regula6 tion) the following statement: ‘This drug is in7 dicated for use in a limited and specific popu8 lation of patients.’. 

9 ‘‘(2) PROMOTIONAL MATERIALS.—The provi10 sions of section 506(c)(2)(B) shall apply with re11 spect to approval under this subsection to the same 

12 extent and in the same manner as such provisions 

13 apply with respect to accelerated approval under sec14 tion 506(c)(1). 

15 ‘‘(3) WITHDRAWAL OF LIMITED POPULATION

16 APPROVAL REQUIREMENTS.—If a drug is approved 

17 pursuant to this subsection to treat a limited popu18 lation of patients and is subsequently approved or li19 censed under this section or section 351 of the Pub20 lic Health Service Act, respectively, without such a 

21 limitation, the Secretary may remove any labeling 

22 requirements or postmarketing conditions made ap23 plicable to the drug during the earlier approval proc24 ess. 

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1 ‘‘(4) RELATION TO OTHER PROVISIONS.—Noth2 ing in this subsection shall be construed to prohibit 

3 designation and expedited review of a drug as a 

4 breakthrough therapy under section 506(a), designa5 tion and treatment of a drug as a fast track product 

6 under section 506(b), or accelerated approval of the 

7 drug under section 506(c), in combination with ap8 proval of the drug for use in a limited population of 

9 patients under this subsection. 

10 ‘‘(5) RULE OF CONSTRUCTION.—Nothing in 

11 this subsection shall be construed to alter the stand12 ards of evidence under subsection (c) or (d) (includ13 ing the substantial evidence standard in subsection 

14 (d)). Subsections (c) and (d) and such standards of 

15 evidence apply to the review and approval of drugs 

16 under this subsection, including whether a drug is 

17 safe and effective. Nothing in this subsection shall 

18 be construed to limit the authority of the Secretary 

19 to approve products pursuant to this Act and the 

20 Public Health Service Act as authorized prior to the 

21 date of enactment of this subsection. 

22 ‘‘(6) EFFECTIVE IMMEDIATELY.—The Sec23 retary shall have the authorities vested in the Sec24 retary by this subsection beginning on the date of 

25 enactment of this subsection, irrespective of when 

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1 and whether the Secretary promulgates final regula2 tions to carry out this subsection.’’. 

3 (b) LICENSURE OF CERTAIN BIOLOGICAL PROD4 UCTS.—Section 351(j) of the Public Health Service Act 

5 (42 U.S.C. 262(j)) is amended— 

6 (1) by striking ‘‘(j)’’ and inserting ‘‘(j)(1)’’; 

7 (2) by inserting ‘‘505(x),’’ after ‘‘505(p),’’; and 

8 (3) by adding at the end the following: 

9 ‘‘(2) In applying section 505(x) of the Federal 

10 Food, Drug, and Cosmetic Act to the licensure of bi11 ological products under this section— 

12 ‘‘(A) references to an antibacterial or 

13 antifungal drug that is intended to treat a seri14 ous or life-threatening disease or condition shall 

15 be construed to refer to biological products in16 tended to treat a bacterial or fungal infection 

17 associated with a serious or life-threatening dis18 ease; and 

19 ‘‘(B) references to approval of a drug 

20 under section 505(c) of such Act shall be con21 strued to refer to licensure of a biological prod22 uct under subsection (a) of this section.’’. 

23 (c) MONITORING.—Title III of the Public Health 

24 Service Act is amended by inserting after section 317T 

25 (42 U.S.C. 247b–22) the following: 

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1 ‘‘SEC. 317U. MONITORING ANTIBACTERIAL AND 

2 ANTIFUNGAL DRUG USE AND RESISTANCE. 

3 ‘‘(a) MONITORING.—The Secretary, acting through 

4 the Director of the Centers for Disease Control and Pre5 vention, shall use the National Healthcare Safety Network 

6 or another appropriate monitoring system to monitor— 

7 ‘‘(1) the use of antibacterial and antifungal 

8 drugs, including those receiving approval or licensure 

9 for a limited population pursuant to section 505(x) 

10 of the Federal Food, Drug, and Cosmetic Act; and 

11 ‘‘(2) changes in bacterial and fungal resistance 

12 to drugs. 

13 ‘‘(b) PUBLIC AVAILABILITY OF DATA.—The Sec14 retary, acting through the Director of the Centers for Dis15 ease Control and Prevention, shall make the data derived 

16 from monitoring under this section publicly available for 

17 the purposes of— 

18 ‘‘(1) improving the monitoring of important 

19 trends in antibacterial and antifungal resistance; 

20 and 

21 ‘‘(2) ensuring appropriate stewardship of anti22 bacterial and antifungal drugs, including those re23 ceiving approval or licensure for a limited population 

24 pursuant to section 505(x) of the Federal Food, 

25 Drug, and Cosmetic Act.’’. 

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1 SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 

2 FOR MICROBIAL ORGANISMS. 

3 (a) IN GENERAL.—Section 511 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 360a) is amended to 

5 read as follows: 

6 ‘‘SEC. 511. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 

7 FOR MICROBIAL ORGANISMS. 

8 ‘‘(a) IN GENERAL.—The Secretary shall identify 

9 upon approval and subsequently update susceptibility test 

10 interpretive criteria for antibacterial drugs (including bio11 logical products intended to treat a bacterial infection and 

12 other types of antimicrobial drugs, as deemed appropriate 

13 by the Secretary), including qualified infectious disease 

14 products, by relying upon, to the extent available— 

15 ‘‘(1) preclinical and clinical data, including 

16 pharmacokinetic, pharmacodynamic, and epidemio17 logical data; 

18 ‘‘(2) Bayesian and pharmacometric statistical 

19 methodologies; and 

20 ‘‘(3) such other confirmatory evidence as the 

21 Secretary deems necessary. 

22 ‘‘(b) RESPONDING TO SUSCEPTIBILITY TEST INTER23 PRETIVE CRITERIA IDENTIFIED OR UPDATED BY PRI24 VATE ENTITIES.— 

25 ‘‘(1) IN GENERAL.—Each quarter of each fiscal 

26 year, the Secretary shall— 

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1 ‘‘(A) evaluate any appropriate new or up2 dated susceptibility test interpretive criteria 

3 published by a nationally or internationally rec4 ognized standard development organization; and 

5 ‘‘(B) publish on the public Website of the 

6 Food and Drug Administration a notice— 

7 ‘‘(i) adopting the new or updated in8 terpretive criteria; 

9 ‘‘(ii) declining to adopt the new or up10 dated interpretive criteria and explaining 

11 the reason for such decision; or 

12 ‘‘(iii) adopting one or more parts of 

13 the new or updated interpretive criteria, 

14 declining to adopt the remainder of such 

15 criteria, and explaining the reason for so 

16 declining. 

17 ‘‘(2) ANNUAL COMPILATION OF NOTICES.— 

18 Each year, the Secretary shall compile the notices 

19 published under paragraph (1)(B) and publish such 

20 compilation in the Federal Register. 

21 ‘‘(3) RELATION TO SECTION 514(c).—Any sus22 ceptibility test interpretive criterion for which an ap23 proval is in effect under paragraph (1) may be rec24 ognized as a standard by the Secretary under sec25 tion 514(c)(1). 

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1 ‘‘(4) USE OF NON-ADOPTED CRITERIA.—Noth2 ing in this section prohibits the sponsor of a drug 

3 or device from seeking approval or clearance of the 

4 drug or device, or changes to the drug, the device, 

5 or its labeling, on the basis of susceptibility test in6 terpretive criteria which differ from those adopted 

7 pursuant to paragraph (1). 

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

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

10 product’ means a qualified infectious disease product 

11 designated under 505E(d). 

12 ‘‘(2) The term ‘susceptibility test interpretive 

13 criteria’ means one or more specific values which 

14 characterize the degree to which bacteria or other 

15 microbes are resistant to the drug (or drugs) tested, 

16 such as clinically susceptible, intermediate, or resist17 ant.’’. 

18 (b) CONFORMING AMENDMENT.—Section 1111 of the 

19 Food and Drug Administration Amendments Act of 2007 

20 (42 U.S.C. 247d–5a; relating to identification of clinically 

21 susceptible concentrations of antimicrobials) is repealed. 

22 (c) REPORT TO CONGRESS.—Not later than one year 

23 after the date of enactment of this Act, the Secretary of 

24 Health and Human Services shall submit to the Com25 mittee on Energy and Commerce of the House of Repmaindgalligan on DSK5TPTVN1PROD with BILLS

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1 resentatives and the Committee on Health, Education, 

2 Labor, and Pensions of the Senate a report on the 

3 progress made in implementing section 511 of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as 

5 amended by this section. 

6 SEC. 4. NO EFFECT ON HEALTH CARE PRACTICE. 

7 Nothing in the Antibiotic Development to Advance 

8 Patient Treatment Act of 2013 (including the amend9 ments made thereby) shall be construed to restrict, in any 

10 manner, the prescribing of antibiotics or other products 

11 by health care professionals, or to limit the practice of 

12 health care. 

Æ 

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