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 Cosmetic Act to provide incentives for the development of 

new combination drugs. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Combination Drug De5 velopment Incentive Act of 2013’’. 

6 SEC. 2. APPLICABILITY TO COMBINATION DRUGS SUB7 MITTED UNDER A NEW DRUG APPLICATION. 

8 (a) IN GENERAL.—Clause (ii) of section 505(c)(3)(E) 

9 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

10 355(c)(3)(E)(ii)) is amended— 

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1 (1) by striking ‘‘(ii) If an application submitted 

2 under subsection (b) for a drug, no active ingredient 

3 (including any ester or salt of the active ingredient) 

4 of which has been approved in any other application 

5 under subsection (b),’’ and inserting ‘‘(ii)(I) If an 

6 application submitted under subsection (b) for a 

7 drug, and described in subclause (II) or (III),’’; and 

8 (2) by adding at the end the following: 

9 ‘‘(II) An application is described in this sub10 clause if no active ingredient (including any ester or 

11 salt of the active ingredient) of the drug for which 

12 the application has been submitted has been ap13 proved in any other application under subsection (b). 

14 ‘‘(III) An application is described in this sub15 clause if— 

16 ‘‘(aa) the application contains reports of 

17 new clinical investigations (other than bio18 availability studies) essential to the approval of 

19 the application and conducted or sponsored by 

20 the applicant; 

21 ‘‘(bb) the application is for a drug which 

22 contains a combination of active ingredients; 

23 and 

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1 ‘‘(cc) no such combination of active ingre2 dients has been approved in any other applica3 tion under subsection (b).’’. 

4 (b) APPLICABILITY.—Subclause (I) of section 

5 505(c)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic 

6 Act, as designated by subsection (a)(1), is amended by 

7 striking ‘‘is approved after the date of the enactment of 

8 this clause’’ and inserting ‘‘is approved after January 1, 

9 2014, in the case of an application described in subclause 

10 (II) or subclause (III)’’. 

11 (c) CONFORMING AMENDMENT.—Clause (iii) of sec12 tion 505(c)(3)(E) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 355(c)(3)(E)) is amended by strik14 ing ‘‘If’’ and inserting ‘‘Except as provided in clause (ii), 

15 if’’. 

16 SEC. 3. APPLICABILITY TO COMBINATION DRUGS SUB17 MITTED UNDER AN ABBREVIATED NEW DRUG 

18 APPLICATION. 

19 (a) IN GENERAL.—Clause (ii) of section 505(j)(5)(F) 

20 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

21 355(j)(5)(F)) is amended— 

22 (1) by striking ‘‘(ii) If an application submitted 

23 under subsection (b) for a drug, no active ingredient 

24 (including any ester or salt of the active ingredient) 

25 of which has been approved in any other application 

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1 under subsection (b),’’ and inserting ‘‘(ii)(I) If an 

2 application submitted under subsection (b) for a 

3 drug, and described in subclause (II) or (III),’’; and 

4 (2) by adding at the end the following: 

5 ‘‘(II) An application is described in this subclause if 

6 no active ingredient (including any ester or salt of the ac7 tive ingredient) of the drug for which the application has 

8 been submitted has been approved in any other application 

9 under subsection (b). 

10 ‘‘(III) An application is described in this subclause 

11 if— 

12 ‘‘(aa) the application contains reports of new 

13 clinical investigations (other than bioavailability 

14 studies) essential to the approval of the application 

15 and conducted or sponsored by the applicant; 

16 ‘‘(bb) the application is for a drug which con17 tains a combination of active ingredients; and 

18 ‘‘(cc) no such combination of active ingredients 

19 has been approved in any other application under 

20 subsection (b).’’. 

21 (b) APPLICABILITY.—Subclause (I) of section 

22 505(j)(5)(F) of the Federal Food, Drug, and Cosmetic 

23 Act, as designated by subsection (a)(1), is amended by 

24 striking ‘‘is approved after the date of the enactment of 

25 this subsection’’ and inserting ‘‘is approved after January 

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1 1, 2014, in the case of an application described in sub2 clause (II) or subclause (III)’’. 

3 (c) CONFORMING AMENDMENT.—Clause (iii) of sec4 tion 505(j)(5)(F) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 355(j)(5)(F)) is amended by striking 

6 ‘‘If’’ and inserting ‘‘Except as provided in clause (ii), if’’. 

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