[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>