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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Stop Tampering of 
Prescription Pills Act of 2015’’. 
SEC. 2. ABUSE-DETERRENT TECHNOLOGY. 
(a) DEFINITION.—Section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 
adding at the end the following: 
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‘‘(ss) The term ‘abuse-deterrent drug’ means a drug 
that— 
‘‘(1) contains as an active moiety a controlled 
substance that has been classified as opium, an opi-
ate, or a derivative thereof, as such terms are de-
fined or used in section 102 of the Controlled Sub-
stances Act; 
‘‘(2) has been formulated for oral administra-
tion; and 
‘‘(3)(A) exhibits physicochemical properties 
(demonstrated by in vitro, in vivo, or other testing, 
or some combination thereof, as determined appro-
priate by the Secretary) that make product manipu-
lation significantly more difficult or ineffective in al-
tering the characteristics of the drug for purposes of 
misuse or abuse when compared to drugs without 
such properties; or 
‘‘(B) contains one or more additional active or 
inactive ingredients that are intended to deter abuse 
through potential pharmacological effects, the effec-
tiveness of which has been demonstrated by at least 
one adequate and well-controlled investigation.’’. 
(b) REQUIRED INFORMATION IN APPLICATION FOR 
APPROVAL OF BRAND NAME DRUGS.—Section 505(b) of 
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the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)) is amended by adding at the end the following: 
‘‘(7) ABUSE-DETERRENT DRUGS.—If an appli-
cation submitted under this subsection is potentially 
subject to refusal under subsection (d)(7), the appli-
cation shall include such information as the Sec-
retary determines necessary to demonstrate that the 
application is not subject to such refusal.’’. 
(c) APPROVAL OF NEW BRAND NAME DRUGS.—Sec-
tion 505(d) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(d)) is amended— 
(1) by inserting ‘‘(7)(A) such drug has been 
formulated for oral administration; (B) such drug 
contains as an active moiety a controlled substance 
that has been classified as opium, an opiate, or a de-
rivative thereof, as such terms are defined or used 
in section 102 of the Controlled Substances Act; (C) 
such drug is not an abuse-deterrent drug; and (D) 
the Secretary has previously approved pursuant to 
an application submitted under subsection (b) or (j) 
a drug that (i) contains the same active moiety; (ii) 
is an abuse-deterrent drug, and (iii) has not been 
discontinued from marketing; or’’ after ‘‘(6) the ap-
plication failed to contain the patent information 
prescribed by subsection (b); or’’; 
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(2) by striking ‘‘(7) based on fair’’ and insert-
ing ‘‘(8) based on fair’’; 
(3) by striking ‘‘clauses (1) through (6)’’ and 
inserting ‘‘paragraphs (1) through (7)’’; and 
(4) by inserting ‘‘The Secretary may issue an 
order approving an application, even if paragraph 
(7) applies, upon a finding that paragraphs (1) 
through (6) and paragraph (8) do not apply and 
that such approval is necessary either to prevent or 
alleviate a drug shortage or to otherwise address a 
significant unmet public health need.’’ before ‘‘As 
used in this subsection and subsection (e)’’. 
(d) GENERIC DRUGS.—Section 505(j) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is 
amended— 
(1) in paragraph (2)— 
(A) subparagraph (A)— 
(i) in clause (vii), by striking ‘‘and’’ at 
the end; 
(ii) in clause (viii), by striking the pe-
riod at the end and inserting ‘‘; and’’; 
(iii) by inserting after clause (viii) the 
following: 
‘‘(ix) if the listed drug is an abuse-deter-
rent drug due to its physicochemical properties, 
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information from comparative in vitro, in vivo, 
or other testing, or some combination thereof, 
as appropriate based on the type of data sub-
mitted for the listed drug, that demonstrates 
the new drug resists manipulation or the effect 
of manipulation to a degree at least comparable 
to the listed drug.’’; and 
(iv) in the continuation text at the 
end of the subparagraph, by striking 
‘‘clauses (i) through (viii)’’ and inserting 
‘‘clauses (i) through (ix)’’; 
(B) in subparagraph (C)— 
(i) in clause (i), by striking ‘‘or’’ at 
the end; 
(ii) in clause (ii), by striking the pe-
riod at the end and inserting ‘‘; or’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(iii) that the listed drug is an abuse-de-
terrent drug and one or more of the new drug’s 
active moieties differ in any material respect (in 
amount or otherwise) from those of the listed 
drug.’’; 
(2) in paragraph (5), by adding at the end the 
following: 
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‘‘(G) If a drug has been approved pursuant to 
an application submitted under paragraph (2), and 
thereafter the listed drug referred to in the applica-
tion becomes an abuse-deterrent drug, the drug so 
approved shall not be considered to be bioequivalent 
to, or to have the same therapeutic effect as, the 
listed drug (as described in paragraph (2)(A)(iv)) 
unless and until the drug so approved has been 
found by the Secretary to meet the requirements of 
paragraph (2)(A)(ix).’’; and 
(3) in paragraph (6)— 
(A) by striking ‘‘(6) If a drug’’ and insert-
ing ‘‘(6)(A) If a drug’’; 
(B) by striking ‘‘(A) for the’’ and inserting 
‘‘(i) for the’’; 
(C) by striking ‘‘(B) if the’’ and inserting 
‘‘(ii) if the’’; and 
(D) by adding at the end the following: 
‘‘(B) For purposes of this paragraph and para-
graph (7)(C), a withdrawal or suspension of a drug 
formulated for oral administration shall be consid-
ered to have been for safety or effectiveness reasons 
if— 
‘‘(i) the approval of a listed drug, which is 
not an abuse-deterrent drug, is withdrawn or 
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suspended, or a listed drug, which is not an 
abuse-deterrent drug, is withdrawn from sale; 
and 
‘‘(ii) the Secretary has previously approved 
pursuant to an application under subsection (b) 
a drug that— 
‘‘(I) is in the same dosage form; 
‘‘(II) contains the same controlled 
substance as an active moiety; 
‘‘(III) is an abuse-deterrent drug; and 
‘‘(IV) has not been discontinued from 
marketing.’’. 
(e) 
WITHDRAWAL
OF
PREVIOUSLY
APPROVED 
BRAND NAME AND GENERIC DRUGS.—Section 505(e) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(e)) is amended— 
(1) by inserting ‘‘or (6)(A) the drug contains as 
an active moiety a controlled substance that has 
been classified as opium, an opiate, or a derivative 
thereof, as such terms are defined or used in section 
102 of the Controlled Substances Act; (B) the drug 
is formulated for oral administration; (C) the drug 
is not an abuse-deterrent drug; and (D) the Sec-
retary has previously approved pursuant to an appli-
cation submitted under subsection (b) or (j) a drug 
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that contains the same active moiety, is an abuse-de-
terrent drug, and has not been discontinued from 
marketing’’ before ‘‘: Provided,’’; and 
(2) by adding at the end the following: ‘‘The 
Secretary may waive the application of paragraph 
(6) of the first sentence of this subsection in the 
case of a drug intended for use in a special needs 
population. In withdrawing (under paragraph (6) of 
the first sentence of this subsection) the approval of 
an application with respect to any drug, the Sec-
retary shall, on a case-by-case basis, delay the effec-
tive date of such withdrawal for a period deemed 
sufficient by the Secretary to give the sponsor an op-
portunity to obtain approval under this section for 
a formulation of the drug meeting the criteria de-
scribed in paragraph (2) of the definition of 
a’’abuse-deterrent drug‘‘ in section 201(ss).’’. 
(f) LISTED DRUGS.—Section 505(j)(7) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)) is 
amended by adding at the end the following: 
‘‘(D) Beginning 60 days after the date of the 
enactment of the Stop Tampering of Prescription 
Pills Act of 2015, the Secretary shall— 
‘‘(i) include in the list under subparagraph 
(A) a list of each drug or category of drugs 
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which the Secretary has found to be abuse-de-
terrent drugs; and 
‘‘(ii) update the list under subparagraph 
(A)— 
‘‘(I) to remove from the list of abuse- 
deterrent drugs any drug the Secretary 
later determines is not an abuse-deterrent 
drug; and 
‘‘(II) as required by subparagraph (C) 
to reflect the application of paragraph 
(6)(B) to drugs that are withdrawn or sus-
pended.’’. 
Æ 
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