I 

114TH CONGRESS 

1ST SESSION H. R. 2629 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

approval of certain antibacterial and antifungal drugs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 3, 2015 

Mr. SHIMKUS (for himself and Mr. GENE GREEN of Texas) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to the approval of certain antibacterial and 

antifungal drugs, 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’’. 

6 SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A LIM7 ITED POPULATION OF PATIENTS. 

8 (a) PURPOSE.—The purpose of this section is to help 

9 expedite the development and availability of treatments for 

10 serious or life-threatening bacterial or fungal infections in 


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1 patients with unmet needs, while maintaining safety and 

2 effectiveness standards for such treatments, taking into 

3 account the severity of the infection and the availability 

4 or lack of alternative treatments. 

5 (b) APPROVAL OF CERTAIN ANTIBACTERIAL AND

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

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

8 adding at the end the following new subsection: 

9 ‘‘(x) APPROVAL OF CERTAIN ANTIBACTERIAL AND

10 ANTIFUNGAL DRUGS FOR USE IN A LIMITED POPU11 LATION OF PATIENTS.— 

12 ‘‘(1) PROCESS.—At the request of the sponsor 

13 of an antibacterial or antifungal drug that is in14 tended to treat a serious or life-threatening infec15 tion, the Secretary— 

16 ‘‘(A) may execute a written agreement 

17 with the sponsor on the process for developing 

18 data to support an application for approval of 

19 such drug, for use in a limited population of pa20 tients in accordance with this subsection; 

21 ‘‘(B) shall proceed in accordance with this 

22 subsection only if a written agreement is 

23 reached under subparagraph (A); 


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1 ‘‘(C) shall provide the sponsor with an op2 portunity to request meetings under paragraph 

3 (2); 

4 ‘‘(D) if a written agreement is reached 

5 under subparagraph (A), may approve the drug 

6 under this subsection for such use— 

7 ‘‘(i) in a limited population of patients 

8 for which there is an unmet medical need; 

9 ‘‘(ii) based on a streamlined develop10 ment program; and 

11 ‘‘(iii) only if the standards for ap12 proval under subsections (c) and (d) of this 

13 section or licensure under section 351 of 

14 the Public Health Service Act, as applica15 ble, are met; and 

16 ‘‘(E) in approving a drug in accordance 

17 with this subsection, subject to subparagraph 

18 (D)(iii), may rely upon— 

19 ‘‘(i) traditional endpoints, alternate 

20 endpoints, or a combination of traditional 

21 and alternate endpoints, and, as appro22 priate, data sets of a limited size; and 

23 ‘‘(ii)(I) additional data, including pre24 clinical, pharmacologic, or pathophysiologic 

25 evidence; 


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1 ‘‘(II) nonclinical susceptibility and 

2 pharmacokinetic data; 

3 ‘‘(III) data from phase 2 clinical 

4 trials; and 

5 ‘‘(IV) such other confirmatory evi6 dence as the Secretary determines appro7 priate to approve the drug. 

8 ‘‘(2) FORMAL MEETINGS.— 

9 ‘‘(A) IN GENERAL.—To help expedite and 

10 facilitate the development and review of a drug 

11 for which a sponsor intends to request approval 

12 in accordance with this subsection, the Sec13 retary may, at the request of the sponsor, con14 duct meetings that provide early consultation, 

15 timely advice, and sufficient opportunities to 

16 develop an agreement described in paragraph 

17 (1)(A) and help the sponsor design and conduct 

18 a drug development program as efficiently as 

19 possible, including the following types of meet20 ings: 

21 ‘‘(i) An early consultation meeting. 

22 ‘‘(ii) An assessment meeting. 

23 ‘‘(iii) A postapproval meeting. 

24 ‘‘(B) NO ALTERING OF GOALS.—Nothing 

25 in this paragraph shall be construed to alter 


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1 agreed upon goals and procedures identified in 

2 the letters described in section 101(b) of the 

3 Prescription Drug User Fee Amendments of 

4 2012. 

5 ‘‘(C) BREAKTHROUGH THERAPIES.—In the 

6 case of a drug designated as a breakthrough 

7 therapy under section 506(a), the sponsor of 

8 such drug may elect to utilize meetings pro9 vided under such section with respect to such 

10 drug in lieu of meetings described in subpara11 graph (A). 

12 ‘‘(3) LABELING REQUIREMENT.—The labeling 

13 of an antibacterial or antifungal drug approved in 

14 accordance with this subsection shall contain the 

15 statement ‘Limited Population’ in a prominent man16 ner and adjacent to, and not more prominent than, 

17 the brand name of the product. The prescribing in18 formation for such antibacterial or antifungal drug 

19 required by section 201.57 of title 21, Code of Fed20 eral Regulations (or any successor regulation) shall 

21 also include the following statement: ‘This drug is 

22 indicated for use in a limited and specific population 

23 of patients.’. 

24 ‘‘(4) PROMOTIONAL MATERIALS.—The provi25 sions of section 506(c)(2)(B) shall apply with reVerDate Sep 11 2014 06:19 Jun 04, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2629.IH H2629

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1 spect to approval in accordance with this subsection 

2 to the same extent and in the same manner as such 

3 provisions apply with respect to accelerated approval 

4 in accordance with section 506(c)(1). 

5 ‘‘(5) TERMINATION OF REQUIREMENTS OR CON6 DITIONS.—If a drug is approved in accordance with 

7 this subsection for an indication in a limited popu8 lation of patients and is subsequently approved or li9 censed under this section or section 351 of the Pub10 lic Health Service Act, other than in accordance with 

11 this subsection, for— 

12 ‘‘(A) the same indication and the same 

13 conditions of use, the Secretary shall remove 

14 any labeling requirements or postmarketing 

15 conditions that were made applicable to the 

16 drug under this subsection; or 

17 ‘‘(B) a different indication or condition of 

18 use, the Secretary shall not apply the labeling 

19 requirements and postmarketing conditions that 

20 were made applicable to the drug under this 

21 subsection to the subsequent approval of the 

22 drug for such different indication or condition 

23 of use. 

24 ‘‘(6) RELATION TO OTHER PROVISIONS.—Noth25 ing in this subsection shall be construed to prohibit 


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1 the approval of a drug for use in a limited popu2 lation of patients in accordance with this subsection, 

3 in combination with— 

4 ‘‘(A) an agreement on the design and size 

5 of a clinical trial pursuant to subparagraphs 

6 (B) and (C) of subsection (b)(5); 

7 ‘‘(B) designation and treatment of the 

8 drug as a breakthrough therapy under section 

9 506(a); 

10 ‘‘(C) designation and treatment of the 

11 drug as a fast track product under section 

12 506(b); or 

13 ‘‘(D) accelerated approval of the drug in 

14 accordance with section 506(c). 

15 ‘‘(7) RULE OF CONSTRUCTION.—Nothing in 

16 this subsection shall be construed— 

17 ‘‘(A) to alter the standards of evidence 

18 under subsection (c) or (d) (including the sub19 stantial evidence standard in subsection (d)); 

20 ‘‘(B) to waive or otherwise preclude the ap21 plication of requirements under subsection (o); 

22 ‘‘(C) to otherwise, in any way, limit the au23 thority of the Secretary to approve products 

24 pursuant to this Act and the Public Health 


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1 Service Act as authorized prior to the date of 

2 enactment of this subsection; or 

3 ‘‘(D) to restrict in any manner, the pre4 scribing of antibiotics or other products by 

5 health care providers, or to otherwise limit or 

6 restrict the practice of health care. 

7 ‘‘(8) EFFECTIVE IMMEDIATELY.—The Sec8 retary shall have the authorities vested in the Sec9 retary by this subsection beginning on the date of 

10 enactment of this subsection, irrespective of when 

11 and whether the Secretary promulgates final regula12 tions or guidance. 

13 ‘‘(9) DEFINITIONS.—In this subsection: 

14 ‘‘(A) EARLY CONSULTATION MEETING.— 

15 The term ‘early consultation meeting’ means a 

16 pre-investigational new drug meeting or an end17 of-phase 1 meeting that— 

18 ‘‘(i) is conducted to review and reach 

19 a written agreement— 

20 ‘‘(I) on the scope of the stream21 lined development plan for a drug for 

22 which a sponsor intends to request ap23 proval in accordance with this sub24 section; and 


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1 ‘‘(II) which, as appropriate, may 

2 include agreement on the design and 

3 size of necessary preclinical and clin4 ical studies early in the development 

5 process, including clinical trials whose 

6 data are intended to form the primary 

7 basis for an effectiveness claim; and 

8 ‘‘(ii) provides an opportunity to dis9 cuss expectations of the Secretary regard10 ing studies or other information that the 

11 Secretary deems appropriate for purposes 

12 of applying paragraph (5), relating to the 

13 termination of labeling requirements or 

14 postmarketing conditions. 

15 ‘‘(B) ASSESSMENT MEETING.—The term 

16 ‘assessment meeting’ means an end-of-phase 2 

17 meeting, pre-new drug application meeting, or 

18 pre-biologics license application meeting con19 ducted to resolve questions and issues raised 

20 during the course of clinical investigations, and 

21 details addressed in the written agreement re22 garding postapproval commitments or expan23 sion of approved uses. 

24 ‘‘(C) POSTAPPROVAL MEETING.—The term 

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1 lowing initial approval or licensure of the drug 

2 for use in a limited population, to discuss any 

3 issues identified by the Secretary or the sponsor 

4 regarding postapproval commitments or expan5 sion of approved uses.’’. 

6 (c) GUIDANCE.—Not later than 18 months after the 

7 date of enactment of this Act, the Secretary of Health and 

8 Human Services, acting through the Commissioner of 

9 Food and Drugs, shall issue draft guidance describing cri10 teria, process, and other general considerations for dem11 onstrating the safety and effectiveness of antibacterial and 

12 antifungal drugs to be approved for use in a limited popu13 lation in accordance with section 505(x) of the Federal 

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

15 (b). 

16 (d) CONFORMING AMENDMENTS.— 

17 (1) LICENSURE OF CERTAIN BIOLOGICAL PROD18 UCTS.—Section 351(j) of the Public Health Service 

19 Act (42 U.S.C. 262(j)) is amended— 

20 (A) by striking ‘‘(j)’’ and inserting 

21 ‘‘(j)(1)’’; 

22 (B) by inserting ‘‘505(x),’’ after ‘‘505(p),’’; 

23 and 

24 (C) by adding at the end the following new 

25 paragraph: 


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1 ‘‘(2) In applying section 505(x) of the Federal Food, 

2 Drug, and Cosmetic Act to the licensure of biological prod3 ucts under this section— 

4 ‘‘(A) references to an antibacterial or antifungal 

5 drug that is intended to treat a serious or life6 threatening infection shall be construed to refer to 

7 a biological product intended to treat a serious or 

8 life-threatening bacterial or fungal infection; and 

9 ‘‘(B) references to approval of a drug under 

10 section 505(c) of such Act shall be construed to 

11 refer to a licensure of a biological product under 

12 subsection (a) of this section.’’. 

13 (2) MISBRANDING.—Section 502 of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is 

15 amended by adding at the end the following new 

16 subsection: 

17 ‘‘(dd) If it is a drug approved in accordance with sec18 tion 505(x) and its labeling does not meet the require19 ments under paragraph (3) of such subsection, subject to 

20 paragraph (5) of such subsection.’’. 

21 (e) EVALUATION.— 

22 (1) ASSESSMENT.—Not later than 48 months 

23 after the date of enactment of this Act, the Sec24 retary of Health and Human Services shall publish 

25 for public comment an assessment of the program 


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1 established under section 505(x) of the Federal 

2 Food, Drug, and Cosmetic Act, as added by sub3 section (b). Such assessment shall determine if the 

4 limited-use pathway established under such section 

5 505(x) has improved or is likely to improve patient 

6 access to novel antibacterial or antifungal treat7 ments and assess how the pathway could be ex8 panded to cover products for serious or life-threat9 ening diseases or conditions beyond bacterial and 

10 fungal infections. 

11 (2) MEETING.—Not later than 90 days after 

12 the date of the publication of such assessment, the 

13 Secretary, acting through the Commissioner of Food 

14 and Drugs shall hold a public meeting to discuss the 

15 findings of the assessment, during which public 

16 stakeholders may present their views on the success 

17 of the program established under section 505(x) of 

18 the Federal Food, Drug, and Cosmetic Act, as 

19 added by subsection (b), and the appropriateness of 

20 expanding such program. 

21 (f) EXPANSION OF PROGRAM.—If the Secretary of 

22 Health and Human Services determines, based on the as23 sessment under subsection (e)(1), evaluation of the assess24 ment, and any other relevant information, that the public 

25 health would benefit from expansion of the limited-use 


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1 pathway established under section 505(x) of the Federal 

2 Food, Drug, and Cosmetic Act (as added by subsection 

3 (b)) beyond the drugs approved in accordance with such 

4 section, the Secretary may expand such limited-use path5 way in accordance with such a determination. The ap6 proval of any drugs under any such expansion shall be 

7 subject to the considerations and requirements described 

8 in such section 505(x) for purposes of expansion to other 

9 serious or life-threatening diseases or conditions. 

10 (g) MONITORING.—The Public Health Service Act is 

11 amended by inserting after section 317T (42 U.S.C. 

12 247b–22) the following: 

13 ‘‘SEC. 317U. MONITORING ANTIBACTERIAL AND 

14 ANTIFUNGAL DRUG USE AND RESISTANCE. 

15 ‘‘(a) MONITORING.—The Secretary shall use an ap16 propriate monitoring system to monitor— 

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

18 drugs, including those receiving approval or licensure 

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

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

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

22 to drugs. 

23 ‘‘(b) PUBLIC AVAILABILITY OF DATA.—The Sec24 retary shall make summaries of the data derived from 


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1 monitoring under this section publicly available for the 

2 purposes of— 

3 ‘‘(1) improving the monitoring of important 

4 trends in antibacterial and antifungal resistance; 

5 and 

6 ‘‘(2) ensuring appropriate stewardship of anti7 bacterial and antifungal drugs, including those re8 ceiving approval or licensure for a limited population 

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

10 Drug, and Cosmetic Act.’’. 

11 SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 

12 FOR MICROORGANISMS. 

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

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

15 read as follows: 

16 ‘‘SEC. 511. IDENTIFYING AND UPDATING SUSCEPTIBILITY 

17 TEST INTERPRETIVE CRITERIA FOR MICRO18 ORGANISMS. 

19 ‘‘(a) PURPOSE; IDENTIFICATION OF CRITERIA.— 

20 ‘‘(1) PURPOSE.—The purpose of this section is 

21 to provide the Secretary with an expedited, flexible 

22 method for— 

23 ‘‘(A) clearance or premarket approval of 

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1 terpretive criteria to characterize the in vitro 

2 susceptibility of particular bacteria, fungi, or 

3 other microorganisms to antimicrobial drugs; 

4 and 

5 ‘‘(B) providing public notice of the avail6 ability of recognized interpretive criteria to 

7 meet premarket submission requirements or 

8 other requirements under this Act for anti9 microbial susceptibility testing devices. 

10 ‘‘(2) IN GENERAL.—The Secretary shall iden11 tify appropriate susceptibility test interpretive cri12 teria with respect to antimicrobial drugs— 

13 ‘‘(A) if such criteria are available on the 

14 date of approval of the drug under section 505 

15 of this Act or licensure of the drug under sec16 tion 351 of the Public Health Service Act (as 

17 applicable), upon such approval or licensure; or 

18 ‘‘(B) if such criteria are unavailable on 

19 such date, on the date on which such criteria 

20 are available for such drug. 

21 ‘‘(3) BASES FOR INITIAL IDENTIFICATION.— 

22 The Secretary shall identify appropriate suscepti23 bility test interpretive criteria under paragraph (2), 

24 based on the Secretary’s review of, to the extent 

25 available and relevant— 


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

2 pharmacokinetic, pharmacodynamic, and epide3 miological data; 

4 ‘‘(B) Bayesian and pharmacometric statis5 tical methodologies; and 

6 ‘‘(C) such other evidence and information 

7 as the Secretary considers appropriate. 

8 ‘‘(b) SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA

9 WEBSITE.— 

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

11 the date of the enactment of the Antibiotic Develop12 ment to Advance Patient Treatment Act, the Sec13 retary shall establish, and maintain thereafter, on 

14 the website of the Food and Drug Administration, a 

15 dedicated website that contains a list of any appro16 priate new or updated susceptibility test interpretive 

17 criteria standards in accordance with paragraph (2) 

18 (referred to in this section as the ‘Interpretive Cri19 teria Website’). 

20 ‘‘(2) LISTING OF SUSCEPTIBILITY TEST INTER21 PRETIVE CRITERIA STANDARDS.— 

22 ‘‘(A) IN GENERAL.—The list described in 

23 paragraph (1) shall consist of any new or up24 dated susceptibility test interpretive criteria 

25 standards that are— 


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1 ‘‘(i) established by a nationally or 

2 internationally recognized standard devel3 opment organization that— 

4 ‘‘(I) establishes and maintains 

5 procedures to address potential con6 flicts of interest and ensure trans7 parent decisionmaking; 

8 ‘‘(II) holds open meetings to en9 sure that there is an opportunity for 

10 public input by interested parties, and 

11 establishes and maintains processes to 

12 ensure that such input is considered 

13 in decisionmaking; and 

14 ‘‘(III) permits its standards to be 

15 made publicly available, through the 

16 National Library of Medicine or an17 other similar source acceptable to the 

18 Secretary; and 

19 ‘‘(ii) recognized in whole, or in part, 

20 by the Secretary under subsection (c). 

21 ‘‘(B) OTHER LIST.—The Interpretive Cri22 teria Website shall, in addition to the list de23 scribed in subparagraph (A), include a list of 

24 interpretive criteria, if any, that the Secretary 

25 has determined to be appropriate with respect 


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1 to legally marketed antimicrobial drugs, 

2 where— 

3 ‘‘(i) the Secretary does not recognize, 

4 in whole or in part, an interpretive criteria 

5 standard described under subparagraph 

6 (A) otherwise applicable to such a drug; 

7 ‘‘(ii) the Secretary withdraws under 

8 subsection (c)(1)(B) recognition of a 

9 standard, in whole or in part, otherwise 

10 applicable to such a drug; 

11 ‘‘(iii) the Secretary approves an appli12 cation under section 505 of this Act or sec13 tion 351 of the Public Health Service Act, 

14 as applicable, with respect to marketing of 

15 such a drug for which there are no rel16 evant interpretive criteria included in a 

17 standard recognized by the Secretary 

18 under subsection (c); or 

19 ‘‘(iv) because the characteristics of 

20 such a drug differ from other drugs with 

21 the same active ingredient, the interpretive 

22 criteria with respect to such drug— 

23 ‘‘(I) differ from otherwise appli24 cable interpretive criteria included in 

25 a standard listed under subparagraph 


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1 (A) or interpretive criteria otherwise 

2 listed under this subparagraph; and 

3 ‘‘(II) are determined by the Sec4 retary to be appropriate for the drug. 

5 ‘‘(C) REQUIRED STATEMENTS OF LIMITA6 TIONS OF INFORMATION.—The Interpretive Cri7 teria Website shall include the following: 

8 ‘‘(i) A statement that— 

9 ‘‘(I) the website provides infor10 mation about the susceptibility of bac11 teria, fungi, or other microorganisms 

12 to a certain drug (or drugs); and 

13 ‘‘(II) the safety and efficacy of 

14 the drug in treating clinical infections 

15 due to such bacteria, fungi, or other 

16 microorganisms may not have been es17 tablished in adequate and well-con18 trolled clinical trials and the clinical 

19 significance of such susceptibility in20 formation in such trials is unknown. 

21 ‘‘(ii) A statement that directs health 

22 care practitioners to consult the approved 

23 product labeling for specific drugs to deter24 mine the uses for which the Food and 


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1 Drug Administration has approved the 

2 product. 

3 ‘‘(iii) Any other statement that the 

4 Secretary determines appropriate to ade5 quately convey the limitations of the data 

6 supporting susceptibility test interpretive 

7 criteria standard listed on the website. 

8 ‘‘(3) NOTICE.—Not later than the date on 

9 which the Interpretive Criteria Website is estab10 lished, the Secretary shall publish a notice of that 

11 establishment in the Federal Register. 

12 ‘‘(4) INAPPLICABILITY OF MISBRANDING PROVI13 SION.—The inclusion in the approved labeling of an 

14 antimicrobial drug of a reference or hyperlink to the 

15 Interpretive Criteria Website, in and of itself, shall 

16 not cause the drug to be misbranded in violation of 

17 section 502, or the regulations promulgated there18 under. 

19 ‘‘(5) TRADE SECRETS AND CONFIDENTIAL IN20 FORMATION.—Nothing in this section shall be con21 strued as authorizing the Secretary to disclose any 

22 information that is a trade secret or confidential in23 formation subject to section 552(b)(4) of title 5, 

24 United States Code. 


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1 ‘‘(c) RECOGNITION OF SUSCEPTIBILITY TEST INTER2 PRETIVE CRITERIA FROM STANDARD DEVELOPMENT OR3 GANIZATIONS.— 

4 ‘‘(1) IN GENERAL.—Beginning on the date of 

5 the establishment of the Interpretive Criteria 

6 Website, and at least every 6 months thereafter, the 

7 Secretary shall— 

8 ‘‘(A) evaluate any appropriate new or up9 dated susceptibility test interpretive criteria 

10 standards established by a nationally or inter11 nationally recognized standard development or12 ganization described in subsection (b)(2)(A)(i); 

13 and 

14 ‘‘(B) publish on the public website of the 

15 Food and Drug Administration a notice— 

16 ‘‘(i) withdrawing recognition of any 

17 different susceptibility test interpretive cri18 teria standard, in whole or in part; 

19 ‘‘(ii) recognizing the new or updated 

20 standards; 

21 ‘‘(iii) recognizing one or more parts of 

22 the new or updated interpretive criteria 

23 specified in such a standard and declining 

24 to recognize the remainder of such stand25 ard; and 


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1 ‘‘(iv) making any necessary updates to 

2 the lists under subsection (b)(2). 

3 ‘‘(2) BASES FOR UPDATING INTERPRETIVE CRI4 TERIA STANDARDS.—In evaluating new or updated 

5 susceptibility test interpretive criteria standards 

6 under paragraph (1)(A), the Secretary may con7 sider— 

8 ‘‘(A) the Secretary’s determination that 

9 such a standard is not applicable to a particular 

10 drug because the characteristics of the drug dif11 fer from other drugs with the same active in12 gredient; 

13 ‘‘(B) information provided by interested 

14 third parties, including public comment on the 

15 annual compilation of notices published under 

16 paragraph (3); 

17 ‘‘(C) any bases used to identify suscepti18 bility test interpretive criteria under subsection 

19 (a)(2); and 

20 ‘‘(D) such other information or factors as 

21 the Secretary determines appropriate. 

22 ‘‘(3) ANNUAL COMPILATION OF NOTICES.— 

23 Each year, the Secretary shall compile the notices 

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

25 compilation in the Federal Register and provide for 


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1 public comment. If the Secretary receives comments, 

2 the Secretary will review such comments and, if the 

3 Secretary determines appropriate, update pursuant 

4 to this subsection susceptibility test interpretive cri5 teria standards— 

6 ‘‘(A) recognized by the Secretary under 

7 this subsection; or 

8 ‘‘(B) otherwise listed on the Interpretive 

9 Criteria Website under subsection (b)(2). 

10 ‘‘(4) RELATION TO SECTION 514(c).—Any sus11 ceptibility test interpretive standard recognized 

12 under this subsection or any criteria otherwise listed 

13 under subsection (b)(2)(B) shall be deemed to be 

14 recognized as a standard by the Secretary under sec15 tion 514(c)(1). 

16 ‘‘(5) VOLUNTARY USE OF INTERPRETIVE CRI17 TERIA.—Nothing in this section prohibits a person 

18 from seeking approval or clearance of a drug or de19 vice, or changes to the drug or the device, on the 

20 basis of susceptibility test interpretive criteria stand21 ards which differ from those recognized pursuant to 

22 paragraph (1). 

23 ‘‘(d) ANTIMICROBIAL DRUG LABELING.— 

24 ‘‘(1) DRUGS MARKETED PRIOR TO ESTABLISH25 MENT OF INTERPRETIVE CRITERIA WEBSITE.—With 


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1 respect to an antimicrobial drug lawfully introduced 

2 or delivered for introduction into interstate com3 merce for commercial distribution before the estab4 lishment of the Interpretive Criteria Website, a hold5 er of an approved application under section 505 or 

6 section 351 of the Public Health Service Act, as ap7 plicable, for each such drug— 

8 ‘‘(A) not later than 1 year after establish9 ment of the Interpretive Criteria Website, shall 

10 submit to the Secretary a supplemental applica11 tion for purposes of changing the drug’s label12 ing to substitute a reference or hyperlink to 

13 such Website for any susceptibility test inter14 pretive criteria and related information; and 

15 ‘‘(B) may begin distribution of the drug in16 volved upon receipt by the Secretary of the sup17 plemental application for such change. 

18 ‘‘(2) DRUGS MARKETED SUBSEQUENT TO ES19 TABLISHMENT OF INTERPRETIVE CRITERIA

20 WEBSITE.—With respect to antimicrobial drugs law21 fully introduced or delivered for introduction into 

22 interstate commerce for commercial distribution on 

23 or after the date of the establishment of the Inter24 pretive Criteria Website, the labeling for such a drug 

25 shall include, in lieu of susceptibility test interpretive 


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1 criteria and related information, a reference to such 

2 Website. 

3 ‘‘(e) SPECIAL CONDITION FOR MARKETING OF ANTI4 MICROBIAL SUSCEPTIBILITY TESTING DEVICES.— 

5 ‘‘(1) IN GENERAL.—Notwithstanding sections 

6 501, 502, 510, 513, and 515, if the conditions speci7 fied in paragraph (2) are met (in addition to other 

8 applicable provisions under this chapter) with re9 spect to an antimicrobial susceptibility testing device 

10 described in subsection (f)(1), the Secretary may au11 thorize the marketing of such device for a use de12 scribed in such subsection. 

13 ‘‘(2) CONDITIONS APPLICABLE TO ANTI14 MICROBIAL SUSCEPTIBILITY TESTING DEVICES.— 

15 The conditions specified in this paragraph are the 

16 following: 

17 ‘‘(A) The device is used to make a deter18 mination of susceptibility using susceptibility 

19 test interpretive criteria that are— 

20 ‘‘(i) included in a standard recognized 

21 by the Secretary under subsection (c); or 

22 ‘‘(ii) otherwise listed on the Interpre23 tive Criteria Website under subsection 

24 (b)(2). 


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1 ‘‘(B) The labeling of such device promi2 nently and conspicuously— 

3 ‘‘(i) includes a statement that— 

4 ‘‘(I) the device provides informa5 tion about the susceptibility of bac6 teria and fungi to certain drugs; and 

7 ‘‘(II) the safety and efficacy of 

8 such drugs in treating clinical infec9 tions due to such bacteria or fungi 

10 may not have been established in ade11 quate and well-controlled clinical trials 

12 and the clinical significance of such 

13 susceptibility information in those in14 stances is unknown; 

15 ‘‘(ii) includes a statement directing 

16 health care practitioners to consult the ap17 proved labeling for drugs tested using such 

18 a device, to determine the uses for which 

19 the Food and Drug Administration has ap20 proved such drugs; and 

21 ‘‘(iii) includes any other statement the 

22 Secretary determines appropriate to ade23 quately convey the limitations of the data 

24 supporting the interpretive criteria de25 scribed in subparagraph (A). 


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

2 ‘‘(1) The term ‘antimicrobial susceptibility test3 ing device’ means a device that utilizes susceptibility 

4 test interpretive criteria to determine and report the 

5 in vitro susceptibility of certain microorganisms to a 

6 drug (or drugs). 

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

8 product’ means a qualified infectious disease product 

9 designated under section 505E(d). 

10 ‘‘(3) The term ‘susceptibility test interpretive 

11 criteria’ means— 

12 ‘‘(A) one or more specific numerical values 

13 which characterize the susceptibility of bacteria 

14 or other microorganisms to the drug tested; and 

15 ‘‘(B) related categorizations of such sus16 ceptibility, including categorization of the drug 

17 as susceptible, intermediate, resistant, or such 

18 other term as the Secretary determines appro19 priate. 

20 ‘‘(4)(A) The term ‘antimicrobial drug’ means, 

21 subject to subparagraph (B), a systemic anti22 bacterial or antifungal drug that— 

23 ‘‘(i) is intended for human use in the treat24 ment of a disease or condition caused by a bac25 terium or fungus; 


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1 ‘‘(ii) may include a qualified infectious dis2 ease product designated under section 505E(d); 

3 and 

4 ‘‘(iii) is subject to section 503(b)(1). 

5 ‘‘(B) If provided by the Secretary through regu6 lations, such term may include— 

7 ‘‘(i) drugs other than systemic anti8 bacterial and antifungal drugs; and 

9 ‘‘(ii) biological products (as such term is 

10 defined in section 351 of the Public Health 

11 Service Act) to the extent such products exhibit 

12 antimicrobial activity. 

13 ‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec14 tion shall be construed— 

15 ‘‘(1) to alter the standards of evidence— 

16 ‘‘(A) under subsection (c) or (d) of section 

17 505, including the substantial evidence stand18 ard in section 505(d), or under section 351 of 

19 the Public Health Service Act (as applicable); 

20 or 

21 ‘‘(B) with respect to marketing authoriza22 tion for devices, under section 510, 513, or 515; 

23 ‘‘(2) to apply with respect to any drug, device, 

24 or biological product, in any context other than— 

25 ‘‘(A) an antimicrobial drug; or 


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1 ‘‘(B) an antimicrobial susceptibility testing 

2 device that uses susceptibility test interpretive 

3 criteria to characterize and report the in vitro 

4 susceptibility of certain bacteria, fungi, or other 

5 microorganisms to antimicrobial drugs in ac6 cordance with this section; or 

7 ‘‘(3) unless specifically stated, to have any ef8 fect on authorities provided under other sections of 

9 this Act, including any regulations issued under such 

10 sections.’’. 

11 (b) CONFORMING AMENDMENTS.— 

12 (1) REPEAL OF RELATED AUTHORITY.—Section 

13 1111 of the Food and Drug Administration Amend14 ments Act of 2007 (42 U.S.C. 247d–5a; relating to 

15 identification of clinically susceptible concentrations 

16 of antimicrobials) is repealed. 

17 (2) MISBRANDING.—Section 502 of the Federal 

18 Food, Drug, and Cosmetic Act (21 U.S.C. 352), as 

19 amended by section 1, is further amended by adding 

20 at the end the following: 

21 ‘‘(ee) If it is an antimicrobial drug and its labeling 

22 fails to conform with the requirements under section 

23 511(d).’’. 

24 (3) RECOGNITION OF INTERPRETIVE CRITERIA

25 AS DEVICE STANDARD.—Section 514(c)(1)(A) of the 


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1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

2 360d(c)(1)(A)) is amended by inserting after ‘‘the 

3 Secretary shall, by publication in the Federal Reg4 ister’’ the following: ‘‘(or, with respect to suscepti5 bility test interpretive criteria or standards recog6 nized or otherwise listed under section 511, by post7 ing on the Interpretive Criteria Website in accord8 ance with such section)’’. 

9 (c) REPORT TO CONGRESS.—Not later than two 

10 years after the date of enactment of this Act, the Sec11 retary of Health and Human Services shall submit to the 

12 Committee on Energy and Commerce of the House of 

13 Representatives and the Committee on Health, Education, 

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

15 progress made in implementing section 511 of the Federal 

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

17 amended by this section. 

18 (d) REQUESTS FOR UPDATES TO INTERPRETIVE CRI19 TERIA WEBSITE.—Chapter 35 of title 44, United States 

20 Code, shall not apply to the collection of information from 

21 interested parties regarding the updating of lists under 

22 paragraph (2) of subsection (b) of section 511 of the Fed23 eral Food, Drug, and Cosmetic Act (as amended by sub24 section (a)) and posted on the Interpretive Criteria 


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1 Website established under paragraph (1) of such sub2 section (b). 

3 (e) NO EFFECT ON HEALTH CARE PRACTICE.— 

4 Nothing in this Act (including the amendments made by 

5 this Act) shall be construed to restrict, in any manner, 

6 the prescribing or administering of antibiotics or other 

7 products by health care practitioners, or to limit the prac8 tice of health care. 

Æ 


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