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. 
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 ‘‘Antibiotic Development 
to Advance Patient Treatment Act’’. 
SEC. 2. APPROVAL OF CERTAIN DRUGS FOR USE IN A LIM-
ITED POPULATION OF PATIENTS. 
(a) PURPOSE.—The purpose of this section is to help 
expedite the development and availability of treatments for 
serious or life-threatening bacterial or fungal infections in 
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patients with unmet needs, while maintaining safety and 
effectiveness standards for such treatments, taking into 
account the severity of the infection and the availability 
or lack of alternative treatments. 
(b) APPROVAL
OF CERTAIN ANTIBACTERIAL
AND 
ANTIFUNGAL DRUGS.—Section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by 
adding at the end the following new subsection: 
‘‘(x) APPROVAL OF CERTAIN ANTIBACTERIAL AND 
ANTIFUNGAL DRUGS
FOR USE
IN
A LIMITED POPU-
LATION OF PATIENTS.— 
‘‘(1) PROCESS.—At the request of the sponsor 
of an antibacterial or antifungal drug that is in-
tended to treat a serious or life-threatening infec-
tion, the Secretary— 
‘‘(A) may execute a written agreement 
with the sponsor on the process for developing 
data to support an application for approval of 
such drug, for use in a limited population of pa-
tients in accordance with this subsection; 
‘‘(B) shall proceed in accordance with this 
subsection only if a written agreement is 
reached under subparagraph (A); 
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‘‘(C) shall provide the sponsor with an op-
portunity to request meetings under paragraph 
(2); 
‘‘(D) if a written agreement is reached 
under subparagraph (A), may approve the drug 
under this subsection for such use— 
‘‘(i) in a limited population of patients 
for which there is an unmet medical need; 
‘‘(ii) based on a streamlined develop-
ment program; and 
‘‘(iii) only if the standards for ap-
proval under subsections (c) and (d) of this 
section or licensure under section 351 of 
the Public Health Service Act, as applica-
ble, are met; and 
‘‘(E) in approving a drug in accordance 
with this subsection, subject to subparagraph 
(D)(iii), may rely upon— 
‘‘(i) traditional endpoints, alternate 
endpoints, or a combination of traditional 
and alternate endpoints, and, as appro-
priate, data sets of a limited size; and 
‘‘(ii)(I) additional data, including pre-
clinical, pharmacologic, or pathophysiologic 
evidence; 
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‘‘(II) nonclinical susceptibility and 
pharmacokinetic data; 
‘‘(III) data from phase 2 clinical 
trials; and 
‘‘(IV) such other confirmatory evi-
dence as the Secretary determines appro-
priate to approve the drug. 
‘‘(2) FORMAL MEETINGS.— 
‘‘(A) IN GENERAL.—To help expedite and 
facilitate the development and review of a drug 
for which a sponsor intends to request approval 
in accordance with this subsection, the Sec-
retary may, at the request of the sponsor, con-
duct meetings that provide early consultation, 
timely advice, and sufficient opportunities to 
develop an agreement described in paragraph 
(1)(A) and help the sponsor design and conduct 
a drug development program as efficiently as 
possible, including the following types of meet-
ings: 
‘‘(i) An early consultation meeting. 
‘‘(ii) An assessment meeting. 
‘‘(iii) A postapproval meeting. 
‘‘(B) NO ALTERING OF GOALS.—Nothing 
in this paragraph shall be construed to alter 
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agreed upon goals and procedures identified in 
the letters described in section 101(b) of the 
Prescription Drug User Fee Amendments of 
2012. 
‘‘(C) BREAKTHROUGH THERAPIES.—In the 
case of a drug designated as a breakthrough 
therapy under section 506(a), the sponsor of 
such drug may elect to utilize meetings pro-
vided under such section with respect to such 
drug in lieu of meetings described in subpara-
graph (A). 
‘‘(3) LABELING
REQUIREMENT.—The labeling 
of an antibacterial or antifungal drug approved in 
accordance with this subsection shall contain the 
statement ‘Limited Population’ in a prominent man-
ner and adjacent to, and not more prominent than, 
the brand name of the product. The prescribing in-
formation for such antibacterial or antifungal drug 
required by section 201.57 of title 21, Code of Fed-
eral Regulations (or any successor regulation) shall 
also include the following statement: ‘This drug is 
indicated for use in a limited and specific population 
of patients.’. 
‘‘(4) PROMOTIONAL
MATERIALS.—The provi-
sions of section 506(c)(2)(B) shall apply with re-
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spect to approval in accordance with this subsection 
to the same extent and in the same manner as such 
provisions apply with respect to accelerated approval 
in accordance with section 506(c)(1). 
‘‘(5) TERMINATION OF REQUIREMENTS OR CON-
DITIONS.—If a drug is approved in accordance with 
this subsection for an indication in a limited popu-
lation of patients and is subsequently approved or li-
censed under this section or section 351 of the Pub-
lic Health Service Act, other than in accordance with 
this subsection, for— 
‘‘(A) the same indication and the same 
conditions of use, the Secretary shall remove 
any labeling requirements or postmarketing 
conditions that were made applicable to the 
drug under this subsection; or 
‘‘(B) a different indication or condition of 
use, the Secretary shall not apply the labeling 
requirements and postmarketing conditions that 
were made applicable to the drug under this 
subsection to the subsequent approval of the 
drug for such different indication or condition 
of use. 
‘‘(6) RELATION TO OTHER PROVISIONS.—Noth-
ing in this subsection shall be construed to prohibit 
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the approval of a drug for use in a limited popu-
lation of patients in accordance with this subsection, 
in combination with— 
‘‘(A) an agreement on the design and size 
of a clinical trial pursuant to subparagraphs 
(B) and (C) of subsection (b)(5); 
‘‘(B) designation and treatment of the 
drug as a breakthrough therapy under section 
506(a); 
‘‘(C) designation and treatment of the 
drug as a fast track product under section 
506(b); or 
‘‘(D) accelerated approval of the drug in 
accordance with section 506(c). 
‘‘(7) RULE
OF
CONSTRUCTION.—Nothing in 
this subsection shall be construed— 
‘‘(A) to alter the standards of evidence 
under subsection (c) or (d) (including the sub-
stantial evidence standard in subsection (d)); 
‘‘(B) to waive or otherwise preclude the ap-
plication of requirements under subsection (o); 
‘‘(C) to otherwise, in any way, limit the au-
thority of the Secretary to approve products 
pursuant to this Act and the Public Health 
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Service Act as authorized prior to the date of 
enactment of this subsection; or 
‘‘(D) to restrict in any manner, the pre-
scribing of antibiotics or other products by 
health care providers, or to otherwise limit or 
restrict the practice of health care. 
‘‘(8) 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 or guidance. 
‘‘(9) DEFINITIONS.—In this subsection: 
‘‘(A) EARLY
CONSULTATION
MEETING.— 
The term ‘early consultation meeting’ means a 
pre-investigational new drug meeting or an end- 
of-phase 1 meeting that— 
‘‘(i) is conducted to review and reach 
a written agreement— 
‘‘(I) on the scope of the stream-
lined development plan for a drug for 
which a sponsor intends to request ap-
proval in accordance with this sub-
section; and 
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‘‘(II) which, as appropriate, may 
include agreement on the design and 
size of necessary preclinical and clin-
ical studies early in the development 
process, including clinical trials whose 
data are intended to form the primary 
basis for an effectiveness claim; and 
‘‘(ii) provides an opportunity to dis-
cuss expectations of the Secretary regard-
ing studies or other information that the 
Secretary deems appropriate for purposes 
of applying paragraph (5), relating to the 
termination of labeling requirements or 
postmarketing conditions. 
‘‘(B) ASSESSMENT
MEETING.—The term 
‘assessment meeting’ means an end-of-phase 2 
meeting, pre-new drug application meeting, or 
pre-biologics license application meeting con-
ducted to resolve questions and issues raised 
during the course of clinical investigations, and 
details addressed in the written agreement re-
garding postapproval commitments or expan-
sion of approved uses. 
‘‘(C) POSTAPPROVAL MEETING.—The term 
‘postapproval meeting’ means a meeting fol-
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lowing initial approval or licensure of the drug 
for use in a limited population, to discuss any 
issues identified by the Secretary or the sponsor 
regarding postapproval commitments or expan-
sion of approved uses.’’. 
(c) GUIDANCE.—Not later than 18 months after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall issue draft guidance describing cri-
teria, process, and other general considerations for dem-
onstrating the safety and effectiveness of antibacterial and 
antifungal drugs to be approved for use in a limited popu-
lation in accordance with section 505(x) of the Federal 
Food, Drug, and Cosmetic Act, as added by subsection 
(b). 
(d) CONFORMING AMENDMENTS.— 
(1) LICENSURE OF CERTAIN BIOLOGICAL PROD-
UCTS.—Section 351(j) of the Public Health Service 
Act (42 U.S.C. 262(j)) is amended— 
(A) 
by 
striking 
‘‘(j)’’ 
and 
inserting 
‘‘(j)(1)’’; 
(B) by inserting ‘‘505(x),’’ after ‘‘505(p),’’; 
and 
(C) by adding at the end the following new 
paragraph: 
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‘‘(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 or antifungal 
drug that is intended to treat a serious or life- 
threatening infection shall be construed to refer to 
a biological product intended to treat a serious or 
life-threatening bacterial or fungal infection; and 
‘‘(B) references to approval of a drug under 
section 505(c) of such Act shall be construed to 
refer to a licensure of a biological product under 
subsection (a) of this section.’’. 
(2) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is 
amended by adding at the end the following new 
subsection: 
‘‘(dd) If it is a drug approved in accordance with sec-
tion 505(x) and its labeling does not meet the require-
ments under paragraph (3) of such subsection, subject to 
paragraph (5) of such subsection.’’. 
(e) EVALUATION.— 
(1) ASSESSMENT.—Not later than 48 months 
after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall publish 
for public comment an assessment of the program 
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established under section 505(x) of the Federal 
Food, Drug, and Cosmetic Act, as added by sub-
section (b). Such assessment shall determine if the 
limited-use pathway established under such section 
505(x) has improved or is likely to improve patient 
access to novel antibacterial or antifungal treat-
ments and assess how the pathway could be ex-
panded to cover products for serious or life-threat-
ening diseases or conditions beyond bacterial and 
fungal infections. 
(2) MEETING.—Not later than 90 days after 
the date of the publication of such assessment, the 
Secretary, acting through the Commissioner of Food 
and Drugs shall hold a public meeting to discuss the 
findings of the assessment, during which public 
stakeholders may present their views on the success 
of the program established under section 505(x) of 
the Federal Food, Drug, and Cosmetic Act, as 
added by subsection (b), and the appropriateness of 
expanding such program. 
(f) EXPANSION OF PROGRAM.—If the Secretary of 
Health and Human Services determines, based on the as-
sessment under subsection (e)(1), evaluation of the assess-
ment, and any other relevant information, that the public 
health would benefit from expansion of the limited-use 
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pathway established under section 505(x) of the Federal 
Food, Drug, and Cosmetic Act (as added by subsection 
(b)) beyond the drugs approved in accordance with such 
section, the Secretary may expand such limited-use path-
way in accordance with such a determination. The ap-
proval of any drugs under any such expansion shall be 
subject to the considerations and requirements described 
in such section 505(x) for purposes of expansion to other 
serious or life-threatening diseases or conditions. 
(g) MONITORING.—The Public Health Service Act is 
amended by inserting after section 317T (42 U.S.C. 
247b–22) the following: 
‘‘SEC. 
317U. 
MONITORING 
ANTIBACTERIAL 
AND 
ANTIFUNGAL DRUG USE AND RESISTANCE. 
‘‘(a) MONITORING.—The Secretary shall use an ap-
propriate monitoring system to monitor— 
‘‘(1) the use of antibacterial and antifungal 
drugs, including those receiving approval or licensure 
for a limited population pursuant to section 505(x) 
of the Federal Food, Drug, and Cosmetic Act; and 
‘‘(2) changes in bacterial and fungal resistance 
to drugs. 
‘‘(b) PUBLIC AVAILABILITY
OF DATA.—The Sec-
retary shall make summaries of the data derived from 
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