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 prod-
ucts indicated for use in a well-defined population of 
patients in order to address increases in bacterial resist-
ance to drugs and biological products, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Helping Effective Anti-
biotics Last Act of 2015’’ or the ‘‘HEAL Act’’. 
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SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A 
WELL-DEFINED POPULATION OF PATIENTS. 
(a) APPROVAL OF CERTAIN ANTIBACTERIAL.—Sec-
tion 505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) is amended by adding at the end the fol-
lowing: 
‘‘(x) APPROVAL OF CERTAIN ANTIBACTERIAL DRUGS 
FOR USE
IN
A WELL-DEFINED POPULATION
OF PA-
TIENTS.— 
‘‘(1) UNMET MEDICAL NEED DEFINED.—In this 
subsection, the term ‘unmet medical need’ means 
that the antibacterial drug involved— 
‘‘(A) has improved efficacy, as dem-
onstrated in adequate, well-controlled studies in 
humans, for specific diseases or conditions, 
where current therapies have been shown to be 
less effective; 
‘‘(B) has clinically meaningful decreased 
harms, demonstrated in adequate, well-con-
trolled studies in humans, for diseases or condi-
tions, where current therapies have unaccept-
able adverse effects; or 
‘‘(C) has improved convenience, as dem-
onstrated in adequate, well-controlled studies in 
humans, where improved convenience results in 
improved effectiveness or decreased harms. 
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‘‘(2) APPROVAL.—Upon receipt of an applica-
tion under subsection (b) for an antibacterial drug 
that is intended to treat a serious or life-threatening 
disease or condition, irrespective of whether the drug 
is intended to address an unmet medical need, the 
Secretary— 
‘‘(A) may approve the drug under sub-
section (c) only for treating a well-defined popu-
lation of patients, and based upon the results of 
clinical trials inclusive of human subjects rep-
resentative of such well-defined population; 
‘‘(B) in determining whether to grant such 
approval, shall rely on superior outcomes over 
available therapies based on direct measures of 
patient benefits, as demonstrated in adequate, 
well-controlled studies in the well-defined pa-
tient population, such as— 
‘‘(i) decreased mortality; 
‘‘(ii) irreversible morbidity; or 
‘‘(iii) validated surrogate endpoints 
that reflect mortality or irreversible mor-
bidity; and 
‘‘(C) shall require the labeling of drugs ap-
proved pursuant to this subsection to promi-
nently include in the prescribing information re-
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quired by section 201.57 of title 21, Code of 
Federal Regulations (or any successor regula-
tion)— 
‘‘(i) the population of patients with 
respect to which the added benefit over 
available therapies is expected as studied 
in adequate, well-controlled studies that 
form the basis for approval; and 
‘‘(ii) the method for identifying mem-
bers of that population. 
‘‘(3) 
RISK
EVALUATION
AND
MITIGATION 
STRATEGY.—The Secretary— 
‘‘(A) shall require a risk evaluation and 
mitigation strategy (REMS) under section 505– 
1 for each drug approved under this subsection; 
and 
‘‘(B) may include in any such strategy ad-
ditional elements to assure the safe use of the 
drug under subsections (e) and (f) of section 
505–1. 
‘‘(4) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed to alter the stand-
ards of evidence under subsection (c) or (d) (includ-
ing the substantial evidence standard in subsection 
(d)). Subsections (c) and (d) and such standards of 
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evidence apply to the review and approval of drugs 
under this subsection, including whether a drug is 
safe and effective. Nothing in this subsection shall 
be construed to limit the authority of the Secretary 
to approve products pursuant to this Act and the 
Public Health Service Act as authorized prior to the 
date of enactment of this subsection. 
‘‘(5) EFFECTIVE
IMMEDIATELY.—The Sec-
retary shall have the authorities vested in the Sec-
retary by this subsection beginning on the date of 
enactment of this subsection, irrespective of when 
and whether the Secretary promulgates final regula-
tions to carry out this subsection.’’. 
(b) LICENSURE
OF CERTAIN BIOLOGICAL PROD-
UCTS.—Section 351(j) of the Public Health Service Act 
(42 U.S.C. 262(j)) is amended— 
(1) by striking ‘‘(j)’’ and inserting ‘‘(j)(1)’’; 
(2) by inserting ‘‘505(x),’’ after ‘‘505(p),’’; and 
(3) by adding at the end the following: 
‘‘(2) In applying section 505(x) of the Federal Food, 
Drug, and Cosmetic Act to the licensure of biological prod-
ucts under this section— 
‘‘(A) references to an antibacterial drug with 
added benefits over available therapies for a well-de-
fined population that is intended to treat a serious 
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or life-threatening disease or condition shall be con-
strued to refer to biological products with added 
benefits over available therapies for a well-defined 
population intended to treat a bacterial infection as-
sociated with a serious or life-threatening disease; 
and 
‘‘(B) references to an application submitted 
under section 505(b) of such Act and to approval of 
a drug under section 505(c) of such Act shall be 
construed to refer to an application submitted under 
subsection (a) of this section and to licensure of a 
biological product under such subsection (a), respec-
tively.’’. 
(c) MONITORING.—Title III of the Public Health 
Service Act is amended by inserting after section 317T 
(42 U.S.C. 247b–22) the following: 
‘‘SEC. 317U. MONITORING OF ANTIBACTERIAL DRUG USE, 
PATIENT OUTCOMES, AND RESISTANCE. 
‘‘(a) MONITORING.—The Secretary, acting through 
the Director of the Centers for Disease Control and Pre-
vention, shall use the National Healthcare Safety Network 
or another appropriate monitoring system to monitor— 
‘‘(1) changes in patient outcomes such as mor-
tality and irreversible morbidity causally related to 
antibacterial resistance; and 
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‘‘(2) changes in bacterial resistance to drugs in 
relation to patient outcomes. 
‘‘(b) PUBLIC AVAILABILITY
OF DATA.—The Sec-
retary, acting through the Director of the Centers for Dis-
ease Control and Prevention, shall make the data derived 
from monitoring under this section publicly available for 
the purposes of— 
‘‘(1) improving the monitoring of important 
trends in patient outcomes in relation to anti-
bacterial resistance; and 
‘‘(2) ensuring appropriate stewardship of anti-
bacterial drugs, including those receiving approval or 
licensure for a well-defined population pursuant to 
section 505(x) of the Federal Food, Drug, and Cos-
metic Act.’’. 
SEC. 3. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 
FOR MICROBIAL ORGANISMS. 
(a) IN GENERAL.—Section 511 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360a) is amended to 
read as follows: 
‘‘SEC. 511. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA 
FOR MICROBIAL ORGANISMS. 
‘‘(a) IN GENERAL.—The Secretary shall— 
‘‘(1) identify upon approval or licensing of anti-
bacterial drugs (including biological products in-
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tended to treat a bacterial infection and other types 
of antimicrobial drugs, as deemed appropriate by the 
Secretary), including qualified infectious disease 
products, susceptibility test interpretive criteria for 
such drugs based upon patient outcomes of mortality 
and morbidity from adequate and well-controlled 
studies and such other confirmatory evidence as the 
Secretary deems necessary; and 
‘‘(2) update, consistent with subsection (b), 
such criteria as needed based upon scientific evi-
dence of changes in patient outcomes. 
‘‘(b) RESPONDING TO CHANGES IN PATIENT OUT-
COMES TO EVALUATE SUSCEPTIBILITY TEST INTERPRE-
TIVE CRITERIA.— 
‘‘(1) IN GENERAL.—As needed based on evi-
dence related to changes in patient outcomes, the 
Secretary shall— 
‘‘(A) evaluate any new scientific studies on 
changes in patient outcomes in relation to sus-
ceptibility test interpretive criteria; and 
‘‘(B) publish on the public Website of the 
Food and Drug Administration a notice— 
‘‘(i) presenting suggested new or up-
dated interpretive criteria; and 
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‘‘(ii) if needed, hold a public advisory 
committee to discuss scientific evidence re-
lated to changes in interpretative criteria. 
‘‘(2) ANNUAL
COMPILATION
OF
NOTICES.— 
Each year, the Secretary shall compile the notices 
published under paragraph (1)(B) noting any 
changes from prior notices and publish such com-
pilation in the Federal Register. 
‘‘(c) DEFINITION.—In this section, the term ‘suscep-
tibility test interpretive criteria’ means one or more spe-
cific values which characterize patient outcomes in relation 
to the degree to which bacteria or other microbes are more 
resistant to treatment as measured by patient outcomes.’’. 
(b) CONFORMING AMENDMENT.—Section 1111 of the 
Food and Drug Administration Amendments Act of 2007 
(42 U.S.C. 247d–5a; relating to identification of clinically 
susceptible concentrations of antimicrobials) is repealed. 
(c) REPORT TO CONGRESS.—Not later than one year 
after the date of enactment of this Act, the Secretary of 
Health and Human Services shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the 
progress made in implementing section 511 of the Federal 
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Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as 
amended by this section. 
SEC. 4. REQUIRING DEMONSTRATION OF SUPERIOR OUT-
COMES FOR QUALIFIED INFECTIOUS DISEASE 
PRODUCTS TO RECEIVE AN EXTENDED EX-
CLUSIVITY PERIOD. 
Section 505E(g) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355f(g)) is amended by striking 
‘‘means an antibacterial or antifungal drug for human use 
intended to treat’’ and inserting ‘‘means an antibacterial 
or antifungal drug for human use that is demonstrated 
to produce superior outcomes over available therapies, 
based on direct measures of patient benefits in clinical 
trials, and that is intended to treat’’. 
SEC. 5. GUIDANCE ON TARGET PRODUCT PROFILES. 
Not later than 18 months after the date of enactment 
of this Act, the Commissioner of Food and Drugs, in con-
sultation with the Administrator of the Centers for Medi-
care & Medicaid Services, the Director of the Indian 
Health Service, the Secretary of Defense, and the Sec-
retary of Veterans Affairs, shall issue guidance on the de-
velopment of target product profiles for novel antibacterial 
drugs focused on public health priorities. 
Æ 
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