Curb Opioid Misuse By Advancing Technology Act of 2016

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. 1. Short title This Act may be cited as the Curb Opioid Misuse By Advancing Technology Act of 2016 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) (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 (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) (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 (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 (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 (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 21 U.S.C. 355 (2) The terms conditions of approval change approved in the supplement 21 U.S.C. 355 (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 change approved in the supplement 21 U.S.C. 355 (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 21 U.S.C. 355a 21 U.S.C. 355f

Summary: Curb Opioid Misuse By Advancing Technology Act of 2016 This bill amends the Federal Food, Drug, and Cosmetic Act to extend the marketing exclusivity period for certain brand name drugs that the Food and Drug Administration approves: (1) on the basis of new clinical abuse potential studies, and (2) with labeling that characterizes the drug's abuse-deterrent properties. This extension does not apply to the marketing exclusivity period for new chemical entities. The bill also extends the marketing exclusivity period for generics of these drugs.