```

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2335 Introduced in House (IH)]

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 Representatives 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:
    ``(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 opiate, or a derivative 
        thereof, as such terms are defined or used in section 102 of 
        the Controlled Substances Act;
            ``(2) has been formulated for oral administration; and
            ``(3)(A) exhibits physicochemical properties (demonstrated 
        by in vitro, in vivo, or other testing, or some combination 
        thereof, as determined appropriate by the Secretary) that make 
        product manipulation significantly more difficult or 
        ineffective in altering 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 effectiveness 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 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 application submitted 
        under this subsection is potentially subject to refusal under 
        subsection (d)(7), the application shall include such 
        information as the Secretary determines necessary to 
        demonstrate that the application is not subject to such 
        refusal.''.
    (c) Approval of New Brand Name Drugs.--Section 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 derivative 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 application 
        failed to contain the patent information prescribed by 
        subsection (b); or'';
            (2) by striking ``(7) based on fair'' and inserting ``(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 
                        period at the end and inserting ``; and'';
                            (iii) by inserting after clause (viii) the 
                        following:
                    ``(ix) if the listed drug is an abuse-deterrent 
                drug due to its physicochemical properties, information 
                from comparative in vitro, in vivo, or other testing, 
                or some combination thereof, as appropriate based on 
                the type of data submitted 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 period 
                        at the end and inserting ``; or''; and
                            (iii) by adding at the end the following:
                    ``(iii) that the listed drug is an abuse-deterrent 
                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:
            ``(G) If a drug has been approved pursuant to an 
        application submitted under paragraph (2), and thereafter the 
        listed drug referred to in the application 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 inserting 
                ``(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 paragraph (7)(C), 
        a withdrawal or suspension of a drug formulated for oral 
        administration shall be considered 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 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 Secretary 
        has previously approved pursuant to an application submitted 
        under subsection (b) or (j) a drug that contains the same 
        active moiety, is an abuse-deterrent 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 Secretary shall, on a 
        case-by-case basis, delay the effective date of such withdrawal 
        for a period deemed sufficient by the Secretary to give the 
        sponsor an opportunity to obtain approval under this section 
        for a formulation of the drug meeting the criteria described 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 which the 
                Secretary has found to be abuse-deterrent 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 suspended.''.
                                 <all>
```