Title: Ensuring Innovation Act
Policy area: Health

Summary:
Ensuring Innovation Act
This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases.
Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity.
The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1636 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  1st Session
                                S. 1636

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                   scope of new chemical exclusivity.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                 May 23 (legislative day, May 22), 2019

 Mr. Roberts (for himself, Ms. Smith, and Mr. Cassidy) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
                   scope of new chemical exclusivity.

    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 ``Ensuring Innovation Act''.

SEC. 2. NEW CHEMICAL EXCLUSIVITY SCOPE.

    Chapter V of the Federal Food, Drug, and Cosmetic Act is amended--
            (1) in section 505 (21 U.S.C. 355)--
                    (A) in subsection (c)(3)(E)--
                            (i) in clause (ii), by striking ``active 
                        ingredient (including any ester or salt of the 
                        active ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in section 
                        314.3 of title 21, Code of Federal Regulations 
                        (or any successor regulations))''; and
                            (ii) in clause (iii), by striking ``active 
                        ingredient (including any ester or salt of the 
                        active ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in section 
                        314.3 of title 21, Code of Federal Regulations 
                        (or any successor regulations))'';
                    (B) in subsection (j)(5)(F)--
                            (i) in clause (ii), by striking ``active 
                        ingredient (including any ester or salt of the 
                        active ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in section 
                        314.3 of title 21, Code of Federal Regulations 
                        (or any successor regulations))''; and
                            (ii) in clause (iii), by striking ``active 
                        ingredient (including any ester or salt of the 
                        active ingredient)'' and inserting ``active 
                        moiety (as defined by the Secretary in section 
                        314.3 of title 21, Code of Federal Regulations 
                        (or any successor regulations))'';
                    (C) in subsection (l)(2)(A)(i), by striking 
                ``active ingredient (including any ester or salt of the 
                active ingredient)'' and inserting ``active moiety (as 
                defined by the Secretary in section 314.3 of title 21, 
                Code of Federal Regulations (or any successor 
                regulations))'';
                    (D) in subsection (s), in the matter preceding 
                paragraph (1), by striking ``active ingredient 
                (including any ester or salt of the active 
                ingredient)'' and inserting ``active moiety (as defined 
                by the Secretary in section 314.3 of title 21, Code of 
                Federal Regulations (or any successor regulations))''; 
                and
                    (E) in subsection (u)(1), in the matter preceding 
                subparagraph (A)--
                            (i) by striking ``active ingredient 
                        (including any ester or salt of the active 
                        ingredient)'' and inserting ``active moiety (as 
                        defined by the Secretary in section 314.3 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations))''; and
                            (ii) by striking ``same active ingredient'' 
                        and inserting ``same active moiety'';
            (2) in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F))--
                    (A) in clause (i), by striking ``active ingredient 
                (including any ester or salt of the active 
                ingredient)'' and inserting ``active moiety (as defined 
                by the Secretary in section 314.3 of title 21, Code of 
                Federal Regulations (or any successor regulations))'';
                    (B) in clause (ii), by striking ``active ingredient 
                (including any ester or salt of the active 
                ingredient)'' and inserting ``active moiety (as defined 
                by the Secretary in section 314.3 of title 21, Code of 
                Federal Regulations (or any successor regulations))''; 
                and
                    (C) in clause (v), by striking ``active ingredient 
                (including any ester or salt of the active 
                ingredient)'' and inserting ``active moiety (as defined 
                by the Secretary in section 314.3 of title 21, Code of 
                Federal Regulations (or any successor regulations))'';
            (3) in section 524(a)(4)(C) (21 U.S.C. 360n(a)(4)(C)), by 
        striking ``active ingredient (including any ester or salt of 
        the active ingredient)'' and inserting ``active moiety (as 
        defined by the Secretary in section 314.3 of title 21, Code of 
        Federal Regulations (or any successor regulations))'';
            (4) in section 529(a)(4)(A)(ii), by striking ``active 
        ingredient (including any ester or salt of the active 
        ingredient)'' and inserting ``active moiety (as defined by the 
        Secretary in section 314.3 of title 21, Code of Federal 
        Regulations (or any successor regulations))''; and
            (5) in section 565A(a)(4)(D) (21 U.S.C. 360bbb-
        4a(a)(4)(D)), by striking ``active ingredient (including any 
        ester or salt of the active ingredient)'' and inserting 
        ``active moiety (as defined by the Secretary in section 314.3 
        of title 21, Code of Federal Regulations (or any successor 
        regulations))''.
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