```

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5127 Introduced in House (IH)]

<DOC>

114th CONGRESS
  2d Session
                                H. R. 5127

    To amend the Federal Food, Drug, and Cosmetic Act to extend the 
exclusivity period for certain drug products developed or labeled so as 
             to reduce drug abuse, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             April 29, 2016

Mr. Griffith (for himself, Mr. Connolly, and Mr. Bilirakis) 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 extend the 
exclusivity period for certain drug products developed or labeled so as 
             to reduce drug abuse, 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 ``Curb Opioid Misuse By Advancing 
Technology Act of 2016''.

SEC. 2. EXTENDED EXCLUSIVITY FOR CERTAIN DRUG PRODUCTS TO PROTECT THE 
              PUBLIC HEALTH.

    (a) New Drug Applications.--Section 505(c)(3)(E) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E)) is amended by 
adding at the end the following:
                            ``(vi) With respect to an application 
                        described in clause (iii) or a supplement to an 
                        application described in clause (iv), if such 
                        application or supplement is approved on or 
                        after the date of enactment of the Curb Opioid 
                        Misuse By Advancing Technology Act of 2016, the 
                        3-year period specified in each such clause 
                        shall be extended for an additional period of 
                        12 months if the person submitting such 
                        application or supplement provides 
                        documentation to the Secretary demonstrating 
                        that the drug that is the subject of the 
                        application or supplement--
                                    ``(I) is approved, in whole or in 
                                part, on the basis of one or more new 
                                clinical abuse potential studies; and
                                    ``(II) is approved with labeling 
                                that characterizes the abuse-deterrent 
                                properties of the drug product.''.
    (b) Abbreviated New Drug Applications.--Section 505(j)(5) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is amended--
            (1) in subparagraph (B), by adding at the end the 
        following:
                            ``(v) With respect to an abbreviated 
                        application described in clause (iv), if such 
                        application is approved on or after the date of 
                        enactment of the Curb Opioid Misuse By 
                        Advancing Technology Act of 2016, the 180-day 
                        period specified in such clause shall be 
                        extended for an additional period of 60 days if 
                        the first applicant submitting the abbreviated 
                        application provides documentation to the 
                        Secretary demonstrating that the listed drug 
                        referred to paragraph (2)(A)(i) and referenced 
                        in the abbreviated application--
                                    ``(I) is approved, in whole or in 
                                part, on the basis of one or more new 
                                clinical abuse potential studies; and
                                    ``(II) is approved with labeling 
                                that characterizes the abuse-deterrent 
                                properties of the drug product.''; and
            (2) in subparagraph (F), by adding at the end the 
        following:
                            ``(vi) With respect to an application 
                        described in clause (iii) or a supplement to an 
                        application described in clause (iv), if such 
                        application or supplement is approved on or 
                        after the date of enactment of the Curb Opioid 
                        Misuse By Advancing Technology Act of 2016, the 
                        3-year period specified in each such clause 
                        shall be extended for an additional period of 
                        12 months if the person submitting such 
                        application or supplement provides 
                        documentation to the Secretary demonstrating 
                        that the drug that is the subject of the 
                        application or supplement--
                                    ``(I) is approved, in whole or in 
                                part, on the basis of one or more new 
                                clinical abuse potential studies; and
                                    ``(II) is approved with labeling 
                                that characterizes the abuse-deterrent 
                                properties of that drug product.''.
    (c) Regulations.--
            (1) In general.--Not later than 2 years after the date of 
        the enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as ``the Secretary'') 
        shall adopt final regulations, which shall have been 
        promulgated in accordance with section 553 of title 5, United 
        States Code, to carry out the amendments made by this section.
            (2) Restrictions.--Notwithstanding any other provision of 
        law, the Secretary shall promulgate regulations implementing 
        this section only as described in paragraph (1), except that 
        the Secretary may issue interim guidance for persons claiming 
        eligibility for the extension provided by clause (vi) of 
        subsection (c)(3)(E) or (j)(5)(F) of section 505 of the Federal 
        Food, Drug, and Cosmetic Act (as added by subsections (a) and 
        (b)) prior to the promulgation of such regulations.
            (3) Exclusivity prior to regulations.--The Secretary shall 
        award the extensions provided by clause (vi) of subsection 
        (c)(3)(E) or (j)(5)(F) and by clause (v) of subsection 
        (j)(5)(B) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (as added by subsections (a) and (b)) prior to the 
        promulgation of regulations under this subsection, if an 
        application, supplement, or abbreviated application meets the 
        requirements for the applicable extension.
    (d) Definitions.--
            (1) The term ``new clinical investigations'' in subsections 
        (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(iii), and 
        (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) shall include new clinical abuse 
        potential studies intended to assess the impact of potentially 
        abuse-deterrent properties of drug products in human subjects.
            (2) The terms ``conditions of approval'' and ``change 
        approved in the supplement'' in subsections (c)(3)(E)(iii) and 
        (c)(3)(E)(iv) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) shall include any abuse-deterrent 
        properties of a drug product subject to the extension provided 
        by subsection (c)(3)(E)(vi) of such section 505 (as added by 
        subsection (a)), such that the Secretary may not make the 
        approval of an application submitted under subsection (b)(2) of 
        such section 505 effective before the expiration of 4 years 
        from the date of the approval of the application or supplement 
        under subsection (b) of such section 505, including the 
        extension under subsection (c)(3)(E)(vi) of such section 505, 
        unless the application submitted under subsection (b)(2) of 
        such section 505--
                    (A) is approved, in whole or in part, on the basis 
                of one or more new clinical abuse potential studies; 
                and
                    (B) is approved with labeling that characterizes 
                the abuse-deterrent properties of the drug product.
            (3) The terms ``conditions of approval'' and ``change 
        approved in the supplement'' in subsections (j)(5)(F)(iii) and 
        (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355) shall include any abuse-deterrent 
        properties of a drug product subject to the extension provided 
        by subsection (j)(5)(F)(vi) of such section 505 (as added by 
        subsection (b)), such that the Secretary may not make the 
        approval of an abbreviated application for a drug product 
        submitted under subsection (j) of such section 505 effective 
        before the expiration of 4 years from the date of the approval 
        of the application or supplement under subsection (b) of such 
        section 505, including the extension under subsection 
        (j)(5)(F)(vi) of such section 505.
    (e) Relation to Other Exclusivity Periods.--Any extension under 
clause (vi) in subsection (c)(3)(E) or (j)(5)(F) of section 505 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) (as added by 
subsections (a) and (b)) shall be in addition to any extensions under 
section 505A or 505E of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a; 21 U.S.C. 355f) with respect to the drug.
                                 <all>
```