I 

114TH CONGRESS 

1ST SESSION H. R. 2335 

To amend the Federal Food, Drug, and Cosmetic Act to incentivize the 

development of abuse-deterrent drugs. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 14, 2015 

Mr. KEATING (for himself, Mr. ROGERS of Kentucky, Mr. ROONEY of Florida, 

Mr. LYNCH, Mr. ADERHOLT, Mr. BUCHANAN, Mr. KENNEDY, Mr. 

MCGOVERN, and Ms. SCHAKOWSKY) 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 

incentivize the development of abuse-deterrent 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 ‘‘Stop Tampering of 

5 Prescription Pills Act of 2015’’. 

6 SEC. 2. ABUSE-DETERRENT TECHNOLOGY. 

7 (a) DEFINITION.—Section 201 of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 

9 adding at the end the following: 


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1 ‘‘(ss) The term ‘abuse-deterrent drug’ means a drug 

2 that— 

3 ‘‘(1) contains as an active moiety a controlled 

4 substance that has been classified as opium, an opi5 ate, or a derivative thereof, as such terms are de6 fined or used in section 102 of the Controlled Sub7 stances Act; 

8 ‘‘(2) has been formulated for oral administra9 tion; and 

10 ‘‘(3)(A) exhibits physicochemical properties 

11 (demonstrated by in vitro, in vivo, or other testing, 

12 or some combination thereof, as determined appro13 priate by the Secretary) that make product manipu14 lation significantly more difficult or ineffective in al15 tering the characteristics of the drug for purposes of 

16 misuse or abuse when compared to drugs without 

17 such properties; or 

18 ‘‘(B) contains one or more additional active or 

19 inactive ingredients that are intended to deter abuse 

20 through potential pharmacological effects, the effec21 tiveness of which has been demonstrated by at least 

22 one adequate and well-controlled investigation.’’. 

23 (b) REQUIRED INFORMATION IN APPLICATION FOR

24 APPROVAL OF BRAND NAME DRUGS.—Section 505(b) of 


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

2 355(b)) is amended by adding at the end the following: 

3 ‘‘(7) ABUSE-DETERRENT DRUGS.—If an appli4 cation submitted under this subsection is potentially 

5 subject to refusal under subsection (d)(7), the appli6 cation shall include such information as the Sec7 retary determines necessary to demonstrate that the 

8 application is not subject to such refusal.’’. 

9 (c) APPROVAL OF NEW BRAND NAME DRUGS.—Sec10 tion 505(d) of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 355(d)) is amended— 

12 (1) by inserting ‘‘(7)(A) such drug has been 

13 formulated for oral administration; (B) such drug 

14 contains as an active moiety a controlled substance 

15 that has been classified as opium, an opiate, or a de16 rivative thereof, as such terms are defined or used 

17 in section 102 of the Controlled Substances Act; (C) 

18 such drug is not an abuse-deterrent drug; and (D) 

19 the Secretary has previously approved pursuant to 

20 an application submitted under subsection (b) or (j) 

21 a drug that (i) contains the same active moiety; (ii) 

22 is an abuse-deterrent drug, and (iii) has not been 

23 discontinued from marketing; or’’ after ‘‘(6) the ap24 plication failed to contain the patent information 

25 prescribed by subsection (b); or’’; 


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1 (2) by striking ‘‘(7) based on fair’’ and insert2 ing ‘‘(8) based on fair’’; 

3 (3) by striking ‘‘clauses (1) through (6)’’ and 

4 inserting ‘‘paragraphs (1) through (7)’’; and 

5 (4) by inserting ‘‘The Secretary may issue an 

6 order approving an application, even if paragraph 

7 (7) applies, upon a finding that paragraphs (1) 

8 through (6) and paragraph (8) do not apply and 

9 that such approval is necessary either to prevent or 

10 alleviate a drug shortage or to otherwise address a 

11 significant unmet public health need.’’ before ‘‘As 

12 used in this subsection and subsection (e)’’. 

13 (d) GENERIC DRUGS.—Section 505(j) of the Federal 

14 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is 

15 amended— 

16 (1) in paragraph (2)— 

17 (A) subparagraph (A)— 

18 (i) in clause (vii), by striking ‘‘and’’ at 

19 the end; 

20 (ii) in clause (viii), by striking the pe21 riod at the end and inserting ‘‘; and’’; 

22 (iii) by inserting after clause (viii) the 

23 following: 

24 ‘‘(ix) if the listed drug is an abuse-deter25 rent drug due to its physicochemical properties, 


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1 information from comparative in vitro, in vivo, 

2 or other testing, or some combination thereof, 

3 as appropriate based on the type of data sub4 mitted for the listed drug, that demonstrates 

5 the new drug resists manipulation or the effect 

6 of manipulation to a degree at least comparable 

7 to the listed drug.’’; and 

8 (iv) in the continuation text at the 

9 end of the subparagraph, by striking 

10 ‘‘clauses (i) through (viii)’’ and inserting 

11 ‘‘clauses (i) through (ix)’’; 

12 (B) in subparagraph (C)— 

13 (i) in clause (i), by striking ‘‘or’’ at 

14 the end; 

15 (ii) in clause (ii), by striking the pe16 riod at the end and inserting ‘‘; or’’; and 

17 (iii) by adding at the end the fol18 lowing: 

19 ‘‘(iii) that the listed drug is an abuse-de20 terrent drug and one or more of the new drug’s 

21 active moieties differ in any material respect (in 

22 amount or otherwise) from those of the listed 

23 drug.’’; 

24 (2) in paragraph (5), by adding at the end the 

25 following: 


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1 ‘‘(G) If a drug has been approved pursuant to 

2 an application submitted under paragraph (2), and 

3 thereafter the listed drug referred to in the applica4 tion becomes an abuse-deterrent drug, the drug so 

5 approved shall not be considered to be bioequivalent 

6 to, or to have the same therapeutic effect as, the 

7 listed drug (as described in paragraph (2)(A)(iv)) 

8 unless and until the drug so approved has been 

9 found by the Secretary to meet the requirements of 

10 paragraph (2)(A)(ix).’’; and 

11 (3) in paragraph (6)— 

12 (A) by striking ‘‘(6) If a drug’’ and insert13 ing ‘‘(6)(A) If a drug’’; 

14 (B) by striking ‘‘(A) for the’’ and inserting 

15 ‘‘(i) for the’’; 

16 (C) by striking ‘‘(B) if the’’ and inserting 

17 ‘‘(ii) if the’’; and 

18 (D) by adding at the end the following: 

19 ‘‘(B) For purposes of this paragraph and para20 graph (7)(C), a withdrawal or suspension of a drug 

21 formulated for oral administration shall be consid22 ered to have been for safety or effectiveness reasons 

23 if— 

24 ‘‘(i) the approval of a listed drug, which is 

25 not an abuse-deterrent drug, is withdrawn or 


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1 suspended, or a listed drug, which is not an 

2 abuse-deterrent drug, is withdrawn from sale; 

3 and 

4 ‘‘(ii) the Secretary has previously approved 

5 pursuant to an application under subsection (b) 

6 a drug that— 

7 ‘‘(I) is in the same dosage form; 

8 ‘‘(II) contains the same controlled 

9 substance as an active moiety; 

10 ‘‘(III) is an abuse-deterrent drug; and 

11 ‘‘(IV) has not been discontinued from 

12 marketing.’’. 

13 (e) WITHDRAWAL OF PREVIOUSLY APPROVED

14 BRAND NAME AND GENERIC DRUGS.—Section 505(e) of 

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

16 355(e)) is amended— 

17 (1) by inserting ‘‘or (6)(A) the drug contains as 

18 an active moiety a controlled substance that has 

19 been classified as opium, an opiate, or a derivative 

20 thereof, as such terms are defined or used in section 

21 102 of the Controlled Substances Act; (B) the drug 

22 is formulated for oral administration; (C) the drug 

23 is not an abuse-deterrent drug; and (D) the Sec24 retary has previously approved pursuant to an appli25 cation submitted under subsection (b) or (j) a drug 


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1 that contains the same active moiety, is an abuse-de2 terrent drug, and has not been discontinued from 

3 marketing’’ before ‘‘: Provided,’’; and 

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

5 Secretary may waive the application of paragraph 

6 (6) of the first sentence of this subsection in the 

7 case of a drug intended for use in a special needs 

8 population. In withdrawing (under paragraph (6) of 

9 the first sentence of this subsection) the approval of 

10 an application with respect to any drug, the Sec11 retary shall, on a case-by-case basis, delay the effec12 tive date of such withdrawal for a period deemed 

13 sufficient by the Secretary to give the sponsor an op14 portunity to obtain approval under this section for 

15 a formulation of the drug meeting the criteria de16 scribed in paragraph (2) of the definition of 

17 a’’abuse-deterrent drug‘‘ in section 201(ss).’’. 

18 (f) LISTED DRUGS.—Section 505(j)(7) of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is 

20 amended by adding at the end the following: 

21 ‘‘(D) Beginning 60 days after the date of the 

22 enactment of the Stop Tampering of Prescription 

23 Pills Act of 2015, the Secretary shall— 

24 ‘‘(i) include in the list under subparagraph 

25 (A) a list of each drug or category of drugs 


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1 which the Secretary has found to be abuse-de2 terrent drugs; and 

3 ‘‘(ii) update the list under subparagraph 

4 (A)— 

5 ‘‘(I) to remove from the list of abuse6 deterrent drugs any drug the Secretary 

7 later determines is not an abuse-deterrent 

8 drug; and 

9 ‘‘(II) as required by subparagraph (C) 

10 to reflect the application of paragraph 

11 (6)(B) to drugs that are withdrawn or sus12 pended.’’. 

Æ 


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