Combination Drug Development Incentive Act of 2013

To amend section 505 of the Federal Food, Drug, and Cosmetic Act to provide incentives for the development of new combination drugs. 1. Short title This Act may be cited as the Combination Drug Development Incentive Act of 2013 2. Applicability to combination drugs submitted under a new drug application (a) In general Clause (ii) of section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E)(ii) (1) by striking (ii) If an application submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), (ii)(I) If an application submitted under subsection (b) for a drug, and described in subclause (II) or (III), (2) by adding at the end the following: (II) An application is described in this subclause if no active ingredient (including any ester or salt of the active ingredient) of the drug for which the application has been submitted has been approved in any other application under subsection (b). (III) An application is described in this subclause if— (aa) the application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant; (bb) the application is for a drug which contains a combination of active ingredients; and (cc) no such combination of active ingredients has been approved in any other application under subsection (b). . (b) Applicability Subclause (I) of section 505(c)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act, as designated by subsection (a)(1), is amended by striking is approved after the date of the enactment of this clause is approved after January 1, 2014, in the case of an application described in subclause (II) or subclause (III) (c) Conforming amendment Clause (iii) of section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3)(E) If Except as provided in clause (ii), if 3. Applicability to combination drugs submitted under an abbreviated new drug application (a) In general Clause (ii) of section 505(j)(5)(F) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(F) (1) by striking (ii) If an application submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), (ii)(I) If an application submitted under subsection (b) for a drug, and described in subclause (II) or (III), (2) by adding at the end the following: (II) An application is described in this subclause if no active ingredient (including any ester or salt of the active ingredient) of the drug for which the application has been submitted has been approved in any other application under subsection (b). (III) An application is described in this subclause if— (aa) the application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant; (bb) the application is for a drug which contains a combination of active ingredients; and (cc) no such combination of active ingredients has been approved in any other application under subsection (b). . (b) Applicability Subclause (I) of section 505(j)(5)(F) of the Federal Food, Drug, and Cosmetic Act, as designated by subsection (a)(1), is amended by striking is approved after the date of the enactment of this subsection is approved after January 1, 2014, in the case of an application described in subclause (II) or subclause (III) (c) Conforming amendment Clause (iii) of section 505(j)(5)(F) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(F) If Except as provided in clause (ii), if

Summary: Combination Drug Development Incentive Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to the five-year bar on a new drug application (or abbreviated drug application) by anyone that has not obtained a right of reference or use from the original and approved drug approval applicant by or for whom investigations under the original, subsequently approved application were conducted. Applies this five-year bar, and the requirement of a grant of a right of reference or use, with respect to an approved drug application (or abbreviated drug application) if: (1) the application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, (2) the application is for a drug which contains a combination of active ingredients (combination drug), and (3) no such combination of active ingredients has been approved in any other application.