(c)(3)(E) and clauses (iii) and (iv) of subsection 
(j)(5)(F) of section 505, or the seven-year period de-
scribed in section 527, as applicable, shall be ex-
tended by 6 months for such drug. 
‘‘(2) LIMITATIONS.—Paragraph (1) does not 
apply to the approval of— 
‘‘(A) a supplement to an application under 
section 505(b) for a drug in a designated sig-
nificant drug combination, if an extension de-
scribed in paragraph (1) is in effect or has ex-
pired for the original application (or a prior 
supplement to such application); or 
‘‘(B) a subsequent application filed by the 
same sponsor or manufacturer of a drug in a 
designated significant drug combination de-
scribed in subparagraph (A) (or a licensor, 
predecessor in interest, or other related entity) 
for— 
‘‘(i) a change (not including a modi-
fication to the structure of the drug) that 
results in a new indication, route of admin-
istration, dosing schedule, dosage form, de-
livery system, delivery device, or strength; 
or 
VerDate Mar 15 2010 
04:28 Oct 03, 2012
Jkt 029200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H6502.IH
H6502
tjames on DSK6SPTVN1PROD with BILLS
‘‘(ii) a modification to the structure of 
the drug that does not result in a change 
in safety or effectiveness. 
‘‘(d) PRIORITY REVIEW.—If a drug is a drug in a 
significant drug combination designated under subsection 
(a), the Secretary shall review and take action on any ap-
plication submitted for such drug under section 505(b) or 
section 351(k) not later than 6 months after receipt by 
the Secretary of such application. 
‘‘(e) SIGNIFICANTLY ADVANCE TREATMENT DEFINI-
TION.—For purposes of this section, the phrase ‘signifi-
cantly advance treatment’ means, with respect to a drug 
combination— 
‘‘(1) the drug combination provides for the 
treatment of one or more life-threatening or other 
serious diseases or conditions for which no therapy 
exists; or 
‘‘(2) if one or more therapies are available for 
the treatment of such a disease or condition, the 
drug combination is demonstrated, through clinical 
investigations to cause one or more improved effects 
on serious outcomes of the disease or condition that 
are affected by alternative therapies, such as— 
‘‘(A) superiority of the drug combination; 
or 
VerDate Mar 15 2010 
04:28 Oct 03, 2012
Jkt 029200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H6502.IH
H6502
tjames on DSK6SPTVN1PROD with BILLS
‘‘(B) the drug combination minimizes the 
development of drug resistance, 
in an active controlled trial assessing an endpoint re-
flecting serious morbidity.’’. 
(b) FAST TRACK PRODUCT.—Paragraph (1) of sec-
tion 506(a) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 356(a)) is amended by inserting after ‘‘if it 
is intended for the treatment of a serious or life-threat-
ening condition and it demonstrates the potential to ad-
dress unmet medical needs for such a condition’’ the fol-
lowing: ‘‘or if such drug is a drug in a significant drug 
combination designated under section 505E(a)’’. 
SEC. 3. CODEVELOPMENT TASK FORCE. 
(a) ESTABLISHMENT.—Not later than 6 months after 
the date of enactment of this Act, the Secretary of Health 
and Human Services shall establish an interagency task 
force for the purpose of encouraging the codevelopment 
of drugs in significant drug combinations. 
(b) MEMBERSHIP.—The membership of the task 
force under subsection (a) shall include experts on— 
(1) basic and translational research; and 
(2) preclinical and clinical drug development re-
lated to serious and life-threatening diseases, includ-
ing cancer. 
VerDate Mar 15 2010 
04:28 Oct 03, 2012
Jkt 029200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H6502.IH
H6502
tjames on DSK6SPTVN1PROD with BILLS
(c) DUTIES.—The task force under subsection (a) 
shall have the following duties: 
(1) RECOMMENDED
SIGNIFICANT
DRUG
COM-
BINATION LIST.— 
(A) 
INITIAL
RECOMMENDATIONS.—The 
task force shall develop a list of types of drug 
combinations that the task force recommends 
that the Secretary designate as significant drug 
combinations under section 505E of the Fed-
eral Food, Drug, and Cosmetic Act. 
(B) PUBLIC
COMMENT.—The task force 
shall make the list developed under subpara-
graph (A) publicly available, and shall provide 
an opportunity for members of the public to 
comment on the content of such list. 
(C) REVISED
RECOMMENDATIONS.—Not 
later than 60 days after making the list publicly 
available under subparagraph (B), the task 
force shall revise the list under subparagraph 
(A) in response to the comments received under 
subparagraph (B) and shall submit such revised 
list to the Secretary and the Congress. 
(D) UPDATES.—On an annual basis, the 
task force shall submit to the Secretary and the 
Congress updates to the list under subpara-
VerDate Mar 15 2010 
04:28 Oct 03, 2012
Jkt 029200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H6502.IH
H6502
tjames on DSK6SPTVN1PROD with BILLS
graph (C), after making such updates publicly 
available and providing an opportunity for pub-
lic comment. 
(2) POLICY REPORT.— 
(A) IN GENERAL.—Not later than one year 
after the date of enactment of this Act, and an-
nually thereafter, the task force shall submit to 
the Secretary and the Congress a report that— 
(i) identifies— 
(I) issues that present challenges 
to the codevelopment of drugs in sig-
nificant drug combinations; and 
(II) opportunities to further sup-
port the codevelopment of drugs in 
significant drug combinations; and 
(ii) contains recommendations to the 
Secretary and the Congress on policy 
changes that could provide additional sup-
port for the codevelopment of drugs in sig-
nificant drug combinations. 
(B) PUBLIC
COMMENT.—Before submit-
ting the report under subparagraph (A), the 
task force shall make a draft of the report pub-
licly available, and shall provide an opportunity 
VerDate Mar 15 2010 
04:28 Oct 03, 2012
Jkt 029200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H6502.IH
H6502
tjames on DSK6SPTVN1PROD with BILLS
for members of the public to comment on such 
report. 
(d) APPLICATION OF FACA.—Section 14 of the Fed-
eral Advisory Committee Act shall not apply to the dura-
tion of the task force under subsection (a). 
(e) SIGNIFICANT DRUG COMBINATION DEFINED.— 
For purposes of this section, the term ‘‘significant drug 
combination’’ means a combination of 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— 
(1) when used in combination, offer the poten-
tial to significantly advance treatment for a serious 
or life-threatening disease; 
(2) in combination, meet the criteria for code-
velopment of drug combinations, as specified in the 
Food and Drug Administration’s guidance document 
entitled ‘‘Guidance for Industry: Codevelopment of 
Two or More Unmarketed Investigational Drugs for 
Use in Combination’’ or a successor document; and 
(3) includes at least 2 drugs that are not ap-
proved under section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) or licensed 
under section 351 of the Public Health Service Act 
(42 U.S.C. 262). 
VerDate Mar 15 2010 
04:28 Oct 03, 2012
Jkt 029200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H6502.IH
H6502
tjames on DSK6SPTVN1PROD with BILLS