I 

115TH CONGRESS 

1ST SESSION H. R. 2025 

To amend section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic 

Act to prevent certain applications from being considered ineligible for 

approval under section 505(c) of such Act on the basis that the proposed 

labeling includes information describing abuse-deterrent properties that 

otherwise would be blocked by exclusivity under clause (iii) or (iv) of 

section 503(c)(3)(E) of such Act, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 6, 2017 

Mr. GRIFFITH (for himself and Mr. COSTELLO of Pennsylvania) introduced 

the following bill; which was referred to the Committee on Energy and 

Commerce 

A BILL 

To amend section 505(c)(3)(E) of the Federal Food, Drug, 

and Cosmetic Act to prevent certain applications from 

being considered ineligible for approval under section 

505(c) of such Act on the basis that the proposed labeling includes information describing abuse-deterrent properties that otherwise would be blocked by exclusivity 

under clause (iii) or (iv) of section 503(c)(3)(E) of such 

Act, 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Abuse-Deterrent 

3 Opioids Plan for Tomorrow Act of 2017’’. 

4 SEC. 2. LABELING INFORMATION DESCRIBING ABUSE-DE5 TERRENT PROPERTIES. 

6 (a) IN GENERAL.—Subparagraph (E) of section 

7 505(c)(3) of the Federal Food, Drug, and Cosmetic Act 

8 (21 U.S.C. 355(c)(3)) is amended by adding at the end 

9 the following new clause: 

10 ‘‘(vi) A drug for which an application (or a sup11 plement to an application) described in subsection 

12 (b)(2) is submitted shall not be considered ineligible 

13 for approval under this subsection on the basis that 

14 its labeling includes information describing the 

15 abuse-deterrent properties of the drug (including 

16 abuse-deterrent claims) that otherwise would be 

17 blocked by exclusivity under clause (iii) or (iv) of 

18 this subparagraph if— 

19 ‘‘(I) the investigation or investigations re20 lied upon by the applicant for approval of the 

21 labeling information were conducted by or for 

22 the applicant or the applicant has obtained a 

23 right of reference or use from the person by or 

24 for whom the investigation or investigations 

25 were conducted; and 


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1 ‘‘(II) the drug has meaningful techno2 logical differences compared to the drug other3 wise protected by exclusivity under clause (iii) 

4 or (iv) of this subparagraph.’’. 

5 (b) GUIDANCE.—The Secretary of Health and 

6 Human Services shall— 

7 (1) not later than 18 months after the date of 

8 enactment of this Act, issue draft guidance regard9 ing the award and scope of exclusivity under clauses 

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

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

12 355(c)(3)(E)) for drugs with properties designed to 

13 deter abuse and the exception to such exclusivity de14 scribed in clause (vi) of such section 505(c)(3)(E), 

15 as added by subsection (a); and 

16 (2) not later than 18 months after the close of 

17 the period for receiving public comments on such 

18 draft guidance, publish final guidance on the topics 

19 described in paragraph (1). 

20 (c) EFFECTIVE DATE.—The amendment made by 

21 subsection (a) applies with respect to applications, and 

22 supplements to applications, that are submitted or pend23 ing under section 505(b) of the Federal Food, Drug, and 


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1 Cosmetic Act (21 U.S.C. 355(b)) on or after January 1, 

2 2017. 

Æ 


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