Stop Tampering of Prescription Pills Act of 2013

Bill: 113-hr-486
Sponsor: full_name: Rep. Keating, William R. [D-MA-9]
Introduced: 2013-02-04
Policy area: Health
Subjects: Administrative law and regulatory procedures

Administrative remedies

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Drug, alcohol, tobacco use

Food and Drug Administration (FDA)

Prescription drugs
Latest action: action_date: 2013-02-08
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2013-02-04
action_desc: Introduced in House
text: <p>Stop Tampering of Prescription Pills Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for abuse-deterrent drugs: (1) containing as an active moiety (the part of the drug that makes it work the way it does) a controlled substance classified as opium, an opiate, or a derivative; (2) formulated for oral administration; (3) exhibiting physicochemical properties making them significantly more difficult or ineffective in altering the drug's characteristics for purposes of misuse or abuse; and (4) containing one or more additional ingredients intended to deter abuse through potential pharmacological effects.</p> <p>Requires the Secretary to refuse a new drug application for any new (brand name) drug containing opium, an opiate, or a derivative as an active moiety that is not abuse-deterrent if an abuse-deterrent drug containing the same active moiety has been approved and has not been discontinued from marketing. Authorizes the Secretary to approve an application failing to meet such requirements, however, if approval is necessary to prevent or alleviate a drug shortage or otherwise address a significant unmet public health need.</p> <p>Requires an abbreviated new (generic) drug application for an abuse-deterrent drug to include testing information demonstrating that the generic drug resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Authorizes the Secretary to deny approval of a generic application if the listed drug is abuse-deterrent and one or more of the generic drug's active moieties differ in any material respect from those of the listed drug.</p> <p>Declares that an approved generic drug shall not be considered bioequivalent to, or as having the same therapeutic effect as, a listed drug if the listed drug becomes abuse-deterrent unless and until the generic drug demonstrates that it resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug.</p> <p>Prescribes requirements governing when a drug which is not abuse-deterrent may have its approval withdrawn or suspended.</p>

tv_txt: I 113th CONGRESS 1st Session H. R. 486 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. Short title This Act may be cited as the Stop Tampering of Prescription Pills Act of 2013 . 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 2013 , 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. .