[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2025 Introduced in House (IH)]

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115th CONGRESS
  1st Session
                                H. R. 2025

 To amend section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic 
 Act to prevent certain applications from being considered ineligible 
  for approval under section 505(c) of such Act on the basis that the 
   proposed labeling includes information describing abuse-deterrent 
properties that otherwise would be blocked by exclusivity under clause 
   (iii) or (iv) of section 503(c)(3)(E) of such Act, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 6, 2017

Mr. Griffith (for himself and Mr. Costello of Pennsylvania) introduced 
 the following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic 
 Act to prevent certain applications from being considered ineligible 
  for approval under section 505(c) of such Act on the basis that the 
   proposed labeling includes information describing abuse-deterrent 
properties that otherwise would be blocked by exclusivity under clause 
   (iii) or (iv) of section 503(c)(3)(E) of such Act, and for other 
                               purposes.

    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 ``Abuse-Deterrent Opioids Plan for 
Tomorrow Act of 2017''.

SEC. 2. LABELING INFORMATION DESCRIBING ABUSE-DETERRENT PROPERTIES.

    (a) In General.--Subparagraph (E) of section 505(c)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)) is amended 
by adding at the end the following new clause:
            ``(vi) A drug for which an application (or a supplement to 
        an application) described in subsection (b)(2) is submitted 
        shall not be considered ineligible for approval under this 
        subsection on the basis that its labeling includes information 
        describing the abuse-deterrent properties of the drug 
        (including abuse-deterrent claims) that otherwise would be 
        blocked by exclusivity under clause (iii) or (iv) of this 
        subparagraph if--
                    ``(I) the investigation or investigations relied 
                upon by the applicant for approval of the labeling 
                information were conducted by or for the applicant or 
                the applicant has obtained a right of reference or use 
                from the person by or for whom the investigation or 
                investigations were conducted; and
                    ``(II) the drug has meaningful technological 
                differences compared to the drug otherwise protected by 
                exclusivity under clause (iii) or (iv) of this 
                subparagraph.''.
    (b) Guidance.--The Secretary of Health and Human Services shall--
            (1) not later than 18 months after the date of enactment of 
        this Act, issue draft guidance regarding the award and scope of 
        exclusivity under clauses (iii) and (iv) of section 
        505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(c)(3)(E)) for drugs with properties designed to 
        deter abuse and the exception to such exclusivity described in 
        clause (vi) of such section 505(c)(3)(E), as added by 
        subsection (a); and
            (2) not later than 18 months after the close of the period 
        for receiving public comments on such draft guidance, publish 
        final guidance on the topics described in paragraph (1).
    (c) Effective Date.--The amendment made by subsection (a) applies 
with respect to applications, and supplements to applications, that are 
submitted or pending under section 505(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355(b)) on or after January 1, 2017.
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