[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6160 Introduced in House (IH)]

112th CONGRESS
  2d Session
                                H. R. 6160

 To amend the Federal Food, Drug, and Cosmetic Act to incentivize the 
                 development of tamper-resistant drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 19, 2012

 Mr. Keating (for himself, Mrs. Bono Mack, Mr. Rogers of Kentucky, Mr. 
Lynch, Mr. Rahall, Mr. Towns, and Mr. Tierney) 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 tamper-resistant 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 2012''.

SEC. 2. TAMPER-RESISTANT 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 `tamper-resistant 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) Tamper-resistant 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 a tamper-resistant 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 a tamper-resistant 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 a tamper-resistant 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 a tamper-resistant 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 a tamper-resistant 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 a tamper-
        resistant drug, is withdrawn or suspended, or a listed drug, 
        which is not a tamper-resistant 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 a tamper-resistant 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 a tamper-resistant 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 a tamper-resistant 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 `tamper-resistant 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 2012, 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 tamper-resistant drugs; and
            ``(ii) update the list under subparagraph (A)--
                    ``(I) to remove from the list of tamper-resistant 
                drugs any drug the Secretary later determines is not a 
                tamper-resistant drug; and
                    ``(II) as required by subparagraph (C) to reflect 
                the application of paragraph (6)(B) to drugs that are 
                withdrawn or suspended.''.
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