I 

113TH CONGRESS 

1ST SESSION H. R. 486 

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

development of abuse-deterrent drugs. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 4, 2013 

Mr. KEATING (for himself, Mr. ROGERS of Kentucky, Mr. RAHALL, Mr. 

LYNCH, Ms. HANABUSA, and Mr. BUCHANAN) 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 2013’’. 

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-deterrent 

25 drug due to its physicochemical properties, informaVerDate Mar 15 2010 06:09 Feb 09, 2013 Jkt 029200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H486.IH H486

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1 tion from comparative in vitro, in vivo, or other test2 ing, or some combination thereof, as appropriate 

3 based on the type of data submitted for the listed 

4 drug, that demonstrates the new drug resists manip5 ulation or the effect of manipulation to a degree at 

6 least comparable to the listed drug.’’; and 

7 (iv) in the continuation text at the 

8 end of the subparagraph, by striking 

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

10 ‘‘clauses (i) through (ix)’’; 

11 (B) in subparagraph (C)— 

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

13 the end; 

14 (ii) in clause (ii), by striking the pe15 riod at the end and inserting ‘‘; or’’; and 

16 (iii) by adding at the end the fol17 lowing: 

18 ‘‘(iii) that the listed drug is an abuse-deterrent 

19 drug and one or more of the new drug’s active 

20 moieties differ in any material respect (in amount or 

21 otherwise) from those of the listed drug.’’; 

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

23 following: 

24 ‘‘(G) If a drug has been approved pursuant to an ap25 plication submitted under paragraph (2), and thereafter 


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1 the listed drug referred to in the application becomes an 

2 abuse-deterrent drug, the drug so approved shall not be 

3 considered to be bioequivalent to, or to have the same 

4 therapeutic effect as, the listed drug (as described in para5 graph (2)(A)(iv)) unless and until the drug so approved 

6 has been found by the Secretary to meet the requirements 

7 of paragraph (2)(A)(ix).’’; and 

8 (3) in paragraph (6)— 

9 (A) by striking ‘‘(6) If a drug’’ and insert10 ing ‘‘(6)(A) If a drug’’; 

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

12 ‘‘(i) for the’’; 

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

14 ‘‘(ii) if the’’; and 

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

16 ‘‘(B) For purposes of this paragraph and paragraph 

17 (7)(C), a withdrawal or suspension of a drug formulated 

18 for oral administration shall be considered to have been 

19 for safety or effectiveness reasons if— 

20 ‘‘(i) the approval of a listed drug, which is not 

21 an abuse-deterrent drug, is withdrawn or suspended, 

22 or a listed drug, which is not an abuse-deterrent 

23 drug, is withdrawn from sale; and 


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1 ‘‘(ii) the Secretary has previously approved pur2 suant to an application under subsection (b) a drug 

3 that— 

4 ‘‘(I) is in the same dosage form; 

5 ‘‘(II) contains the same controlled sub6 stance as an active moiety; 

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

8 ‘‘(IV) has not been discontinued from mar9 keting.’’. 

10 (e) WITHDRAWAL OF PREVIOUSLY APPROVED

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

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

13 355(e)) is amended— 

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

15 an active moiety a controlled substance that has 

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

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

18 102 of the Controlled Substances Act; (B) the drug 

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

20 is not an abuse-deterrent drug; and (D) the Sec21 retary has previously approved pursuant to an appli22 cation submitted under subsection (b) or (j) a drug 

23 that contains the same active moiety, is an abuse-de24 terrent drug, and has not been discontinued from 

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


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

2 Secretary may waive the application of paragraph 

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

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

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

6 the first sentence of this subsection) the approval of 

7 an application with respect to any drug, the Sec8 retary shall, on a case-by-case basis, delay the effec9 tive date of such withdrawal for a period deemed 

10 sufficient by the Secretary to give the sponsor an op11 portunity to obtain approval under this section for 

12 a formulation of the drug meeting the criteria de13 scribed in paragraph (2) of the definition of a 

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

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

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

17 amended by adding at the end the following: 

18 ‘‘(D) Beginning 60 days after the date of the enact19 ment of the Stop Tampering of Prescription Pills Act of 

20 2013, the Secretary shall— 

21 ‘‘(i) include in the list under subparagraph (A) 

22 a list of each drug or category of drugs which the 

23 Secretary has found to be abuse-deterrent drugs; 

24 and 

25 ‘‘(ii) update the list under subparagraph (A)— 


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1 ‘‘(I) to remove from the list of abuse-deter2 rent drugs any drug the Secretary later deter3 mines is not an abuse-deterrent drug; and 

4 ‘‘(II) as required by subparagraph (C) to 

5 reflect the application of paragraph (6)(B) to 

6 drugs that are withdrawn or suspended.’’. 

Æ 


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