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.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2985 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 2985
To amend section 505 of the Federal Food, Drug, and Cosmetic Act to
provide incentives for the development of new combination drugs.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
August 2, 2013
Mr. Chaffetz (for himself, Mr. Coble, and Mr. Salmon) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend section 505 of the Federal Food, Drug, and Cosmetic Act to
provide incentives for the development of new combination drugs.
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 ``Combination Drug Development
Incentive Act of 2013''.
SEC. 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)) is amended--
(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),'' and
inserting ``(ii)(I) If an application submitted under
subsection (b) for a drug, and described in subclause (II) or
(III),''; and
(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'' and inserting ``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)) 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.
(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)) is amended--
(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),'' and
inserting ``(ii)(I) If an application submitted under
subsection (b) for a drug, and described in subclause (II) or
(III),''; and
(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'' and inserting ``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)) is
amended by striking ``If'' and inserting ``Except as provided in clause
(ii), if''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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