Section 1 Short title
This Act may be cited as the “Combination Drug Development Incentive Act of 2015” .
Combination Drug Development Incentive Act of 2015
A BILL
To amend section 505 of the Federal Food, Drug, and Cosmetic Act to provide incentives for the development of new combination drugs.
Sec. 2 Applicability to combination drugs submitted under a new drug application
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)) is amended—
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),” and inserting “(ii)(I) If an application submitted under subsection (b) for a drug, and described in subclause (II) or (III),”; and
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).”
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” and inserting “is approved after January 1, 2016, in the case of an application described in subclause (II) or subclause (III)”.
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)) is amended by striking “If” and inserting “Except as provided in clause (ii), if”.
Sec. 3 Applicability to combination drugs submitted under an abbreviated new drug application
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)) is amended—
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),” and inserting “(ii)(I) If an application submitted under subsection (b) for a drug, and described in subclause (II) or (III),”; and
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).”
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” and inserting “is approved after January 1, 2016, in the case of an application described in subclause (II) or subclause (III)”.
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)) is amended by striking “If” and inserting “Except as provided in clause (ii), if”.