I 
113TH CONGRESS 
1ST SESSION H. R. 2985 
To amend section 505 of the Federal Food, Drug, and Cosmetic Act to 
provide incentives for the development of new combination drugs. 
IN THE HOUSE OF REPRESENTATIVES 
AUGUST 2, 2013 
Mr. CHAFFETZ (for himself, Mr. COBLE, and Mr. SALMON) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
A BILL 
To amend section 505 of the Federal Food, Drug, and Cos-
metic Act to provide incentives for the development of 
new combination drugs. 
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 ‘‘Combination Drug De-
velopment Incentive Act of 2013’’. 
SEC. 2. APPLICABILITY TO COMBINATION DRUGS SUB-
MITTED UNDER A NEW DRUG APPLICATION. 
(a) IN GENERAL.—Clause (ii) of section 505(c)(3)(E) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(c)(3)(E)(ii)) is amended— 
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(1) by striking ‘‘(ii) If an application submitted 
under subsection (b) for a drug, no active ingredient 
(including any ester or salt of the active ingredient) 
of which has been approved in any other application 
under subsection (b),’’ and inserting ‘‘(ii)(I) If an 
application submitted under subsection (b) for a 
drug, and described in subclause (II) or (III),’’; and 
(2) by adding at the end the following: 
‘‘(II) An application is described in this sub-
clause if no active ingredient (including any ester or 
salt of the active ingredient) of the drug for which 
the application has been submitted has been ap-
proved in any other application under subsection (b). 
‘‘(III) An application is described in this sub-
clause if— 
‘‘(aa) the application contains reports of 
new clinical investigations (other than bio-
availability studies) essential to the approval of 
the application and conducted or sponsored by 
the applicant; 
‘‘(bb) the application is for a drug which 
contains a combination of active ingredients; 
and 
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‘‘(cc) no such combination of active ingre-
dients has been approved in any other applica-
tion under subsection (b).’’. 
(b) 
APPLICABILITY.—Subclause 
(I) 
of 
section 
505(c)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic 
Act, as designated by subsection (a)(1), is amended by 
striking ‘‘is approved after the date of the enactment of 
this clause’’ and inserting ‘‘is approved after January 1, 
2014, in the case of an application described in subclause 
(II) or subclause (III)’’. 
(c) CONFORMING AMENDMENT.—Clause (iii) of sec-
tion 505(c)(3)(E) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(c)(3)(E)) is amended by strik-
ing ‘‘If’’ and inserting ‘‘Except as provided in clause (ii), 
if’’. 
SEC. 3. APPLICABILITY TO COMBINATION DRUGS SUB-
MITTED UNDER AN ABBREVIATED NEW DRUG 
APPLICATION. 
(a) IN GENERAL.—Clause (ii) of section 505(j)(5)(F) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(5)(F)) is amended— 
(1) by striking ‘‘(ii) If an application submitted 
under subsection (b) for a drug, no active ingredient 
(including any ester or salt of the active ingredient) 
of which has been approved in any other application 
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under subsection (b),’’ and inserting ‘‘(ii)(I) If an 
application submitted under subsection (b) for a 
drug, and described in subclause (II) or (III),’’; and 
(2) by adding at the end the following: 
‘‘(II) An application is described in this subclause if 
no active ingredient (including any ester or salt of the ac-
tive ingredient) of the drug for which the application has 
been submitted has been approved in any other application 
under subsection (b). 
‘‘(III) An application is described in this subclause 
if— 
‘‘(aa) the application contains reports of new 
clinical investigations (other than bioavailability 
studies) essential to the approval of the application 
and conducted or sponsored by the applicant; 
‘‘(bb) the application is for a drug which con-
tains a combination of active ingredients; and 
‘‘(cc) no such combination of active ingredients 
has been approved in any other application under 
subsection (b).’’. 
(b) 
APPLICABILITY.—Subclause 
(I) 
of 
section 
505(j)(5)(F) of the Federal Food, Drug, and Cosmetic 
Act, as designated by subsection (a)(1), is amended by 
striking ‘‘is approved after the date of the enactment of 
this subsection’’ and inserting ‘‘is approved after January 
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1, 2014, in the case of an application described in sub-
clause (II) or subclause (III)’’. 
(c) CONFORMING AMENDMENT.—Clause (iii) of sec-
tion 505(j)(5)(F) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)(5)(F)) is amended by striking 
‘‘If’’ and inserting ‘‘Except as provided in clause (ii), if’’. 
Æ 
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