I 

114TH CONGRESS 

2D SESSION H. R. 5127 

To amend the Federal Food, Drug, and Cosmetic Act to extend the exclusivity 

period for certain drug products developed or labeled so as to reduce 

drug abuse, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 29, 2016 

Mr. GRIFFITH (for himself, Mr. CONNOLLY, and Mr. BILIRAKIS) 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 to 

extend the exclusivity period for certain drug products 

developed or labeled so as to reduce drug abuse, and 

for other purposes. 

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 ‘‘Curb Opioid Misuse 

5 By Advancing Technology Act of 2016’’. 


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1 SEC. 2. EXTENDED EXCLUSIVITY FOR CERTAIN DRUG 

2 PRODUCTS TO PROTECT THE PUBLIC 

3 HEALTH. 

4 (a) NEW DRUG APPLICATIONS.—Section 

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

6 Act (21 U.S.C. 355(c)(3)(E)) is amended by adding at 

7 the end the following: 

8 ‘‘(vi) With respect to an application 

9 described in clause (iii) or a supplement to 

10 an application described in clause (iv), if 

11 such application or supplement is approved 

12 on or after the date of enactment of the 

13 Curb Opioid Misuse By Advancing Tech14 nology Act of 2016, the 3-year period spec15 ified in each such clause shall be extended 

16 for an additional period of 12 months if 

17 the person submitting such application or 

18 supplement provides documentation to the 

19 Secretary demonstrating that the drug 

20 that is the subject of the application or 

21 supplement— 

22 ‘‘(I) is approved, in whole or in 

23 part, on the basis of one or more new 

24 clinical abuse potential studies; and 


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1 ‘‘(II) is approved with labeling 

2 that characterizes the abuse-deterrent 

3 properties of the drug product.’’. 

4 (b) ABBREVIATED NEW DRUG APPLICATIONS.—Sec5 tion 505(j)(5) of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 355(j)(5)) is amended— 

7 (1) in subparagraph (B), by adding at the end 

8 the following: 

9 ‘‘(v) With respect to an abbreviated 

10 application described in clause (iv), if such 

11 application is approved on or after the date 

12 of enactment of the Curb Opioid Misuse 

13 By Advancing Technology Act of 2016, the 

14 180-day period specified in such clause 

15 shall be extended for an additional period 

16 of 60 days if the first applicant submitting 

17 the abbreviated application provides docu18 mentation to the Secretary demonstrating 

19 that the listed drug referred to paragraph 

20 (2)(A)(i) and referenced in the abbreviated 

21 application— 

22 ‘‘(I) is approved, in whole or in 

23 part, on the basis of one or more new 

24 clinical abuse potential studies; and 


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1 ‘‘(II) is approved with labeling 

2 that characterizes the abuse-deterrent 

3 properties of the drug product.’’; and 

4 (2) in subparagraph (F), by adding at the end 

5 the following: 

6 ‘‘(vi) With respect to an application 

7 described in clause (iii) or a supplement to 

8 an application described in clause (iv), if 

9 such application or supplement is approved 

10 on or after the date of enactment of the 

11 Curb Opioid Misuse By Advancing Tech12 nology Act of 2016, the 3-year period spec13 ified in each such clause shall be extended 

14 for an additional period of 12 months if 

15 the person submitting such application or 

16 supplement provides documentation to the 

17 Secretary demonstrating that the drug 

18 that is the subject of the application or 

19 supplement— 

20 ‘‘(I) is approved, in whole or in 

21 part, on the basis of one or more new 

22 clinical abuse potential studies; and 

23 ‘‘(II) is approved with labeling 

24 that characterizes the abuse-deterrent 

25 properties of that drug product.’’. 


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1 (c) REGULATIONS.— 

2 (1) IN GENERAL.—Not later than 2 years after 

3 the date of the enactment of this Act, the Secretary 

4 of Health and Human Services (referred to in this 

5 section as ‘‘the Secretary’’) shall adopt final regula6 tions, which shall have been promulgated in accord7 ance with section 553 of title 5, United States Code, 

8 to carry out the amendments made by this section. 

9 (2) RESTRICTIONS.—Notwithstanding any other 

10 provision of law, the Secretary shall promulgate reg11 ulations implementing this section only as described 

12 in paragraph (1), except that the Secretary may 

13 issue interim guidance for persons claiming eligi14 bility for the extension provided by clause (vi) of 

15 subsection (c)(3)(E) or (j)(5)(F) of section 505 of 

16 the Federal Food, Drug, and Cosmetic Act (as 

17 added by subsections (a) and (b)) prior to the pro18 mulgation of such regulations. 

19 (3) EXCLUSIVITY PRIOR TO REGULATIONS.— 

20 The Secretary shall award the extensions provided 

21 by clause (vi) of subsection (c)(3)(E) or (j)(5)(F) 

22 and by clause (v) of subsection (j)(5)(B) of section 

23 505 of the Federal Food, Drug, and Cosmetic Act 

24 (as added by subsections (a) and (b)) prior to the 

25 promulgation of regulations under this subsection, if 


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1 an application, supplement, or abbreviated applica2 tion meets the requirements for the applicable exten3 sion. 

4 (d) DEFINITIONS.— 

5 (1) The term ‘‘new clinical investigations’’ in 

6 subsections (c)(3)(E)(iii), (c)(3)(E)(iv), 

7 (j)(5)(F)(iii), and (j)(5)(F)(iv) of section 505 of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

9 355) shall include new clinical abuse potential stud10 ies intended to assess the impact of potentially 

11 abuse-deterrent properties of drug products in 

12 human subjects. 

13 (2) The terms ‘‘conditions of approval’’ and 

14 ‘‘change approved in the supplement’’ in subsections 

15 (c)(3)(E)(iii) and (c)(3)(E)(iv) of section 505 of the 

16 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

17 355) shall include any abuse-deterrent properties of 

18 a drug product subject to the extension provided by 

19 subsection (c)(3)(E)(vi) of such section 505 (as 

20 added by subsection (a)), such that the Secretary 

21 may not make the approval of an application sub22 mitted under subsection (b)(2) of such section 505 

23 effective before the expiration of 4 years from the 

24 date of the approval of the application or supple25 ment under subsection (b) of such section 505, inVerDate Sep 11 2014 04:02 May 05, 2016 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5127.IH H5127

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1 cluding the extension under subsection (c)(3)(E)(vi) 

2 of such section 505, unless the application submitted 

3 under subsection (b)(2) of such section 505— 

4 (A) is approved, in whole or in part, on the 

5 basis of one or more new clinical abuse poten6 tial studies; and 

7 (B) is approved with labeling that charac8 terizes the abuse-deterrent properties of the 

9 drug product. 

10 (3) The terms ‘‘conditions of approval’’ and 

11 ‘‘change approved in the supplement’’ in subsections 

12 (j)(5)(F)(iii) and (j)(5)(F)(iv) of section 505 of the 

13 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

14 355) shall include any abuse-deterrent properties of 

15 a drug product subject to the extension provided by 

16 subsection (j)(5)(F)(vi) of such section 505 (as 

17 added by subsection (b)), such that the Secretary 

18 may not make the approval of an abbreviated appli19 cation for a drug product submitted under sub20 section (j) of such section 505 effective before the 

21 expiration of 4 years from the date of the approval 

22 of the application or supplement under subsection 

23 (b) of such section 505, including the extension 

24 under subsection (j)(5)(F)(vi) of such section 505. 


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1 (e) RELATION TO OTHER EXCLUSIVITY PERIODS.— 

2 Any extension under clause (vi) in subsection (c)(3)(E) or 

3 (j)(5)(F) of section 505 of the Federal Food, Drug, and 

4 Cosmetic Act (21 U.S.C. 355) (as added by subsections 

5 (a) and (b)) shall be in addition to any extensions under 

6 section 505A or 505E of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 355a; 21 U.S.C. 355f) with re8 spect to the drug. 

Æ 


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