I 

114TH CONGRESS 

1ST SESSION H. R. 931 

To provide for approval of certain drugs and biological products indicated 

for use in a well-defined population of patients in order to address 

increases in bacterial resistance to drugs and biological products, and 

for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 12, 2015 

Ms. DELAURO (for herself, Ms. SLAUGHTER, and Ms. MENG) 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 well-defined population of 

patients in order to address increases in bacterial 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 ‘‘Helping Effective Anti5 biotics Last Act of 2015’’ or the ‘‘HEAL Act’’. 


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1 SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A 

2 WELL-DEFINED POPULATION OF PATIENTS. 

3 (a) APPROVAL OF CERTAIN ANTIBACTERIAL.—Sec4 tion 505 of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 355) is amended by adding at the end the fol6 lowing: 

7 ‘‘(x) APPROVAL OF CERTAIN ANTIBACTERIAL DRUGS

8 FOR USE IN A WELL-DEFINED POPULATION OF PA9 TIENTS.— 

10 ‘‘(1) UNMET MEDICAL NEED DEFINED.—In this 

11 subsection, the term ‘unmet medical need’ means 

12 that the antibacterial drug involved— 

13 ‘‘(A) has improved efficacy, as dem14 onstrated in adequate, well-controlled studies in 

15 humans, for specific diseases or conditions, 

16 where current therapies have been shown to be 

17 less effective; 

18 ‘‘(B) has clinically meaningful decreased 

19 harms, demonstrated in adequate, well-con20 trolled studies in humans, for diseases or condi21 tions, where current therapies have unaccept22 able adverse effects; or 

23 ‘‘(C) has improved convenience, as dem24 onstrated in adequate, well-controlled studies in 

25 humans, where improved convenience results in 

26 improved effectiveness or decreased harms. 


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1 ‘‘(2) APPROVAL.—Upon receipt of an applica2 tion under subsection (b) for an antibacterial drug 

3 that is intended to treat a serious or life-threatening 

4 disease or condition, irrespective of whether the drug 

5 is intended to address an unmet medical need, the 

6 Secretary— 

7 ‘‘(A) may approve the drug under sub8 section (c) only for treating a well-defined popu9 lation of patients, and based upon the results of 

10 clinical trials inclusive of human subjects rep11 resentative of such well-defined population; 

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

13 approval, shall rely on superior outcomes over 

14 available therapies based on direct measures of 

15 patient benefits, as demonstrated in adequate, 

16 well-controlled studies in the well-defined pa17 tient population, such as— 

18 ‘‘(i) decreased mortality; 

19 ‘‘(ii) irreversible morbidity; or 

20 ‘‘(iii) validated surrogate endpoints 

21 that reflect mortality or irreversible mor22 bidity; and 

23 ‘‘(C) shall require the labeling of drugs ap24 proved pursuant to this subsection to promi25 nently include in the prescribing information reVerDate Sep 11 2014 03:49 Feb 20, 2015 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H931.IH H931

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1 quired by section 201.57 of title 21, Code of 

2 Federal Regulations (or any successor regula3 tion)— 

4 ‘‘(i) the population of patients with 

5 respect to which the added benefit over 

6 available therapies is expected as studied 

7 in adequate, well-controlled studies that 

8 form the basis for approval; and 

9 ‘‘(ii) the method for identifying mem10 bers of that population. 

11 ‘‘(3) RISK EVALUATION AND MITIGATION

12 STRATEGY.—The Secretary— 

13 ‘‘(A) shall require a risk evaluation and 

14 mitigation strategy (REMS) under section 505– 

15 1 for each drug approved under this subsection; 

16 and 

17 ‘‘(B) may include in any such strategy ad18 ditional elements to assure the safe use of the 

19 drug under subsections (e) and (f) of section 

20 505–1. 

21 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in 

22 this subsection shall be construed to alter the stand23 ards of evidence under subsection (c) or (d) (includ24 ing the substantial evidence standard in subsection 

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


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1 evidence apply to the review and approval of drugs 

2 under this subsection, including whether a drug is 

3 safe and effective. Nothing in this subsection shall 

4 be construed to limit the authority of the Secretary 

5 to approve products pursuant to this Act and the 

6 Public Health Service Act as authorized prior to the 

7 date of enactment of this subsection. 

8 ‘‘(5) EFFECTIVE IMMEDIATELY.—The Sec9 retary shall have the authorities vested in the Sec10 retary by this subsection beginning on the date of 

11 enactment of this subsection, irrespective of when 

12 and whether the Secretary promulgates final regula13 tions to carry out this subsection.’’. 

14 (b) LICENSURE OF CERTAIN BIOLOGICAL PROD15 UCTS.—Section 351(j) of the Public Health Service Act 

16 (42 U.S.C. 262(j)) is amended— 

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

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

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

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

21 Drug, and Cosmetic Act to the licensure of biological prod22 ucts under this section— 

23 ‘‘(A) references to an antibacterial drug with 

24 added benefits over available therapies for a well-de25 fined population that is intended to treat a serious 


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1 or life-threatening disease or condition shall be con2 strued to refer to biological products with added 

3 benefits over available therapies for a well-defined 

4 population intended to treat a bacterial infection as5 sociated with a serious or life-threatening disease; 

6 and 

7 ‘‘(B) references to an application submitted 

8 under section 505(b) of such Act and to approval of 

9 a drug under section 505(c) of such Act shall be 

10 construed to refer to an application submitted under 

11 subsection (a) of this section and to licensure of a 

12 biological product under such subsection (a), respec13 tively.’’. 

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

15 Service Act is amended by inserting after section 317T 

16 (42 U.S.C. 247b–22) the following: 

17 ‘‘SEC. 317U. MONITORING OF ANTIBACTERIAL DRUG USE, 

18 PATIENT OUTCOMES, AND RESISTANCE. 

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

20 the Director of the Centers for Disease Control and Pre21 vention, shall use the National Healthcare Safety Network 

22 or another appropriate monitoring system to monitor— 

23 ‘‘(1) changes in patient outcomes such as mor24 tality and irreversible morbidity causally related to 

25 antibacterial resistance; and 


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1 ‘‘(2) changes in bacterial resistance to drugs in 

2 relation to patient outcomes. 

3 ‘‘(b) PUBLIC AVAILABILITY OF DATA.—The Sec4 retary, acting through the Director of the Centers for Dis5 ease Control and Prevention, shall make the data derived 

6 from monitoring under this section publicly available for 

7 the purposes of— 

8 ‘‘(1) improving the monitoring of important 

9 trends in patient outcomes in relation to anti10 bacterial resistance; and 

11 ‘‘(2) ensuring appropriate stewardship of anti12 bacterial drugs, including those receiving approval or 

13 licensure for a well-defined population pursuant to 

14 section 505(x) of the Federal Food, Drug, and Cos15 metic Act.’’. 

16 SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 

17 FOR MICROBIAL ORGANISMS. 

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

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

20 read as follows: 

21 ‘‘SEC. 511. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 

22 FOR MICROBIAL ORGANISMS. 

23 ‘‘(a) IN GENERAL.—The Secretary shall— 

24 ‘‘(1) identify upon approval or licensing of anti25 bacterial drugs (including biological products inVerDate Sep 11 2014 03:49 Feb 20, 2015 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H931.IH H931

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1 tended to treat a bacterial infection and other types 

2 of antimicrobial drugs, as deemed appropriate by the 

3 Secretary), including qualified infectious disease 

4 products, susceptibility test interpretive criteria for 

5 such drugs based upon patient outcomes of mortality 

6 and morbidity from adequate and well-controlled 

7 studies and such other confirmatory evidence as the 

8 Secretary deems necessary; and 

9 ‘‘(2) update, consistent with subsection (b), 

10 such criteria as needed based upon scientific evi11 dence of changes in patient outcomes. 

12 ‘‘(b) RESPONDING TO CHANGES IN PATIENT OUT13 COMES TO EVALUATE SUSCEPTIBILITY TEST INTERPRE14 TIVE CRITERIA.— 

15 ‘‘(1) IN GENERAL.—As needed based on evi16 dence related to changes in patient outcomes, the 

17 Secretary shall— 

18 ‘‘(A) evaluate any new scientific studies on 

19 changes in patient outcomes in relation to sus20 ceptibility test interpretive criteria; and 

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

22 Food and Drug Administration a notice— 

23 ‘‘(i) presenting suggested new or up24 dated interpretive criteria; and 


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1 ‘‘(ii) if needed, hold a public advisory 

2 committee to discuss scientific evidence re3 lated to changes in interpretative criteria. 

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

5 Each year, the Secretary shall compile the notices 

6 published under paragraph (1)(B) noting any 

7 changes from prior notices and publish such com8 pilation in the Federal Register. 

9 ‘‘(c) DEFINITION.—In this section, the term ‘suscep10 tibility test interpretive criteria’ means one or more spe11 cific values which characterize patient outcomes in relation 

12 to the degree to which bacteria or other microbes are more 

13 resistant to treatment as measured by patient outcomes.’’. 

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

15 Food and Drug Administration Amendments Act of 2007 

16 (42 U.S.C. 247d–5a; relating to identification of clinically 

17 susceptible concentrations of antimicrobials) is repealed. 

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

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

20 Health and Human Services shall submit to the Com21 mittee on Energy and Commerce of the House of Rep22 resentatives and the Committee on Health, Education, 

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

24 progress made in implementing section 511 of the Federal 


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

2 amended by this section. 

3 SEC. 4. REQUIRING DEMONSTRATION OF SUPERIOR OUT4 COMES FOR QUALIFIED INFECTIOUS DISEASE 

5 PRODUCTS TO RECEIVE AN EXTENDED EX6 CLUSIVITY PERIOD. 

7 Section 505E(g) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 355f(g)) is amended by striking 

9 ‘‘means an antibacterial or antifungal drug for human use 

10 intended to treat’’ and inserting ‘‘means an antibacterial 

11 or antifungal drug for human use that is demonstrated 

12 to produce superior outcomes over available therapies, 

13 based on direct measures of patient benefits in clinical 

14 trials, and that is intended to treat’’. 

15 SEC. 5. GUIDANCE ON TARGET PRODUCT PROFILES. 

16 Not later than 18 months after the date of enactment 

17 of this Act, the Commissioner of Food and Drugs, in con18 sultation with the Administrator of the Centers for Medi19 care & Medicaid Services, the Director of the Indian 

20 Health Service, the Secretary of Defense, and the Sec21 retary of Veterans Affairs, shall issue guidance on the de22 velopment of target product profiles for novel antibacterial 

23 drugs focused on public health priorities. 

Æ 


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