HR 6160 IHCommentsClose CommentsPermalink

112th CONGRESSCommentsClose CommentsPermalink

2d SessionCommentsClose CommentsPermalink

H. R. 6160CommentsClose CommentsPermalink

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

IN THE HOUSE OF REPRESENTATIVESCommentsClose CommentsPermalink

July 19, 2012CommentsClose CommentsPermalink

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 CommerceCommentsClose CommentsPermalink

A BILLCommentsClose CommentsPermalink

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

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Stop Tampering of Prescription Pills Act of 2012’.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink





‘(ss) The term ‘tamper-resistant drug’ means a drug that--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(2) has been formulated for oral administration; andCommentsClose CommentsPermalink





‘(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; orCommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(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’;CommentsClose CommentsPermalink





(2) by striking ‘(7) based on fair’ and inserting ‘(8) based on fair’;CommentsClose CommentsPermalink





(3) by striking ‘clauses (1) through (6)’ and inserting ‘paragraphs (1) through (7)’; andCommentsClose CommentsPermalink





(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)’.CommentsClose CommentsPermalink





(d) Generic Drugs- Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended--CommentsClose CommentsPermalink





(1) in paragraph (2)--CommentsClose CommentsPermalink





(A) subparagraph (A)--CommentsClose CommentsPermalink





(i) in clause (vii), by striking ‘and’ at the end;CommentsClose CommentsPermalink





(ii) in clause (viii), by striking the period at the end and inserting ‘; and’;CommentsClose CommentsPermalink





(iii) by inserting after clause (viii) the following:CommentsClose CommentsPermalink





‘(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.’; andCommentsClose CommentsPermalink





(iv) in the continuation text at the end of the subparagraph, by striking ‘clauses (i) through (viii)’ and inserting ‘clauses (i) through (ix)’;CommentsClose CommentsPermalink





(B) in subparagraph (C)--CommentsClose CommentsPermalink





(i) in clause (i), by striking ‘or’ at the end;CommentsClose CommentsPermalink





(ii) in clause (ii), by striking the period at the end and inserting ‘; or’; andCommentsClose CommentsPermalink





(iii) by adding at the end the following:CommentsClose CommentsPermalink





‘(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.’;CommentsClose CommentsPermalink





(2) in paragraph (5), by adding at the end the following:CommentsClose CommentsPermalink





‘(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).’; andCommentsClose CommentsPermalink





(3) in paragraph (6)--CommentsClose CommentsPermalink





(A) by striking ‘(6) If a drug’ and inserting ‘(6)(A) If a drug’;CommentsClose CommentsPermalink





(B) by striking ‘(A) for the’ and inserting ‘(i) for the’;CommentsClose CommentsPermalink





(C) by striking ‘(B) if the’ and inserting ‘(ii) if the’; andCommentsClose CommentsPermalink





(D) by adding at the end the following:CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(ii) the Secretary has previously approved pursuant to an application under subsection (b) a drug that--CommentsClose CommentsPermalink





‘(I) is in the same dosage form;CommentsClose CommentsPermalink





‘(II) contains the same controlled substance as an active moiety;CommentsClose CommentsPermalink





‘(III) is a tamper-resistant drug; andCommentsClose CommentsPermalink





‘(IV) has not been discontinued from marketing.’.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(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,’; andCommentsClose CommentsPermalink





(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).’.CommentsClose CommentsPermalink





(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:CommentsClose CommentsPermalink





‘(D) Beginning 60 days after the date of the enactment of the Stop Tampering of Prescription Pills Act of 2012, the Secretary shall--CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(ii) update the list under subparagraph (A)--CommentsClose CommentsPermalink





‘(I) to remove from the list of tamper-resistant drugs any drug the Secretary later determines is not a tamper-resistant drug; andCommentsClose CommentsPermalink





‘(II) as required by subparagraph (C) to reflect the application of paragraph (6)(B) to drugs that are withdrawn or suspended.’.CommentsClose CommentsPermalink