SEC. 2. PROMOTING THE DEVELOPMENT OF COMBINA-
TIONS OF INVESTIGATIONAL NEW DRUGS 
FOR SERIOUS DISEASES. 
(a) IN GENERAL.—Subchapter A of chapter 5 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by inserting, after section 505, the 
following new section: 
‘‘SEC. 505E. MARKETING EXCLUSIVITY AND PRIORITY RE-
VIEW FOR SIGNIFICANT DRUG COMBINA-
TIONS. 
‘‘(a) SIGNIFICANT DRUG COMBINATION DESIGNA-
TION.— 
‘‘(1) IN
GENERAL.—The Secretary may des-
ignate a combination of drugs as a significant drug 
combination if such combination of drugs— 
‘‘(A) includes 2 or more drugs (which may 
include one or more biologics subject to licen-
sure under section 351 of the Public Health 
Service Act) that— 
‘‘(i) when used in combination, offer 
the potential to significantly advance treat-
ment for a serious or life-threatening dis-
ease; and 
‘‘(ii) in combination, meet the criteria 
for codevelopment of drug combinations, as 
specified in the Food and Drug Adminis-
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tration’s guidance document entitled ‘Guid-
ance for Industry: Codevelopment of Two 
or More Unmarketed Investigational Drugs 
for Use in Combination’ or a successor 
document; and 
‘‘(B) includes at least 2 drugs that, as of 
the date on which such designation is made, are 
not approved under section 505 of this Act or 
licensed under section 351 of the Public Health 
Service Act. 
‘‘(2) PURPOSE.—The purpose of the designa-
tion under paragraph (1) is to encourage the code-
velopment of such drug combinations. 
‘‘(3) TASK
FORCE
RECOMMENDATIONS.—In 
making designations under paragraph (1), the Sec-
retary shall take into account the recommendations 
submitted by the codevelopment task force under 
section 3(c)(1) of the Life-Threatening Diseases 
Compassion through Combination Therapy Act of 
2012. 
‘‘(4) REQUESTS.— 
‘‘(A) IN GENERAL.—The manufacturer or 
sponsor of a drug may request that the Sec-
retary determine whether a combination of 2 or 
more drugs is a significant drug combination. 
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‘‘(B) RESPONSE TO REQUEST.—Not later 
than 30 days after the submission of the re-
quest under subparagraph (A), the Secretary 
shall review the request and— 
‘‘(i) if the combination of drugs sub-
ject to the request has previously been des-
ignated under paragraph (1) and the com-
bination of drugs continues to meet the re-
quirements for such a designation, the Sec-
retary shall provide notice to the person 
who submitted the request that such com-
bination of drugs is a significant drug 
combination; 
‘‘(ii) if the combination of drugs sub-
ject to the request has not previously been 
designated under paragraph (1), but the 
combination of drugs meets the require-
ments for such a designation, the Sec-
retary shall designate such drug as a sig-
nificant drug combination under paragraph 
(1) and provide notice to the person who 
submitted the request that such combina-
tion of drugs is a significant drug com-
bination; or 
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‘‘(iii) if the combination of drugs sub-
ject to the request does not meet the re-
quirements for designation as a significant 
drug combination under paragraph (1), the 
Secretary shall provide notice to the person 
who submitted the request that such com-
bination of drugs is not a significant drug 
combination. 
‘‘(C) DEADLINE.—A request for designa-
tion under subparagraph (A) shall be made con-
currently with, or after, submission of an appli-
cation for the investigation of the drug under 
section 505(i) or section 351(a)(3) of the Public 
Health Service Act, but not later than the first 
date on which phase I trials for any of the 
drugs involved in the drug combination are 
completed. 
‘‘(b) LIST OF SIGNIFICANT DRUG COMBINATIONS.— 
‘‘(1) INITIAL LIST.—Not later than 180 days 
after the date of enactment of the Life-Threatening 
Diseases Compassion through Combination Therapy 
Act of 2012, the Secretary shall develop, and shall 
publish on the public Web site of the Food and Drug 
Administration, an initial list of combinations of 2 
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or more drugs that the Secretary has designated as 
significant drug combinations under subsection (a). 
‘‘(2) UPDATE.—The Secretary shall revise and 
update the list under paragraph (1) on an annual 
basis— 
‘‘(A) to include additional drug combina-
tions that the Secretary has designated as sig-
nificant drug combinations under subsection 
(a); and 
‘‘(B) to exclude drug combinations which 
were previously designated as significant drug 
combinations under subsection (a), but which 
no longer meet the requirements of subsection 
(a)(1)(B) (relating to the minimum number of 
unapproved drugs in a significant drug com-
bination). 
‘‘(c) EXTENSION OF MARKET EXCLUSIVITY.— 
‘‘(1) IN GENERAL.—If, prior to approval of a 
drug pursuant to an application submitted under 
section 505(b), the Secretary designated a signifi-
cant drug combination under subsection (a) that in-
cludes such drug, then the four- and five-year peri-
ods described in subsections (c)(3)(E)(ii) and 
(j)(5)(F)(ii) of section 505, the three-year periods 
described in clauses (iii) and (iv) of subsection 
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