Title: A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.
Policy area: Health

Summary:
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 117th Congress]
[From the U.S. Government Publishing Office]
[S. 415 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                 S. 415

 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

                           February 24, 2021

 Mr. Cassidy (for himself, Ms. Smith, and Mr. Marshall) 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. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY.

    (a) In General.--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), by striking ``active 
                ingredient (including any ester or salt of the active 
                ingredient)'' each place it appears 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), by striking ``active 
                ingredient (including any ester or salt of the active 
                ingredient)'' each place it appears 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 amending clause (i) to read as 
                        follows:
                    ``(i) not later than 30 days after the date of 
                approval of such applications--
                            ``(I) for a drug, no active moiety (as 
                        defined by the Secretary in section 314.3 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations)) of which has been 
                        approved in any other application under this 
                        section; or
                            ``(II) for a biological product, no active 
                        ingredient of which has been approved in any 
                        other application under section 351 of the 
                        Public Health Service Act; and''; and
                            (ii) in clause (ii), by inserting ``or 
                        biological product'' before the period;
                    (D) by amending subsection (s) to read as follows:
    ``(s) Referral to Advisory Committee.--The Secretary shall--
            ``(1) refer a drug or biological product to a Food and Drug 
        Administration advisory committee for review at a meeting of 
        such advisory committee prior to the approval of such drug or 
        biological if it is--
                    ``(A) a drug, no active moiety (as defined by the 
                Secretary in section 314.3 of title 21, Code of Federal 
                Regulations (or any successor regulations)) of which 
                has been approved in any other application under this 
                section; or
                    ``(B) a biological product, no active ingredient of 
                which has been approved in any other application under 
                section 351 of the Public Health Service Act; or
            ``(2) if the Secretary does not refer a drug or biological 
        product described in paragraph (1) to a Food and Drug 
        Administration advisory committee prior to such approval, 
        provide in the action letter on the application for the drug or 
        biological product a summary of the reasons why the Secretary 
        did not refer the drug or biological product to an advisory 
        committee prior to approval.''; 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)), by 
        striking ``active ingredient (including any ester or salt of 
        the active ingredient)'' each place it appears 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) (21 U.S.C. 360n(a)(4)), by 
        amending subparagraph (C) to read as follows:
                    ``(C) is for--
                            ``(i) a human drug, no active moiety (as 
                        defined by the Secretary in section 314.3 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations)) of which has been 
                        approved in any other application under section 
                        505(b)(1); or
                            ``(ii) a biological product, no active 
                        ingredient of which has been approved in any 
                        other application under section 351 of the 
                        Public Health Service Act.'';
            (4) in section 529(a)(4) (21 U.S.C. 360ff(a)(4)), by 
        striking subparagraphs (A) and (B) and inserting the following:
                    ``(A) is for a drug or biological product that is 
                for the prevention or treatment of a rare pediatric 
                disease;
                    ``(B)(i) is for such a drug--
                            ``(I) that contains no active moiety (as 
                        defined by the Secretary in section 314.3 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations)) that has been 
                        previously approved in any other application 
                        under subsection (b)(1), (b)(2), or (j) of 
                        section 505; and
                            ``(II) that is the subject of an 
                        application submitted under section 505(b)(1); 
                        or
                    ``(ii) is for such a biological product--
                            ``(I) that contains no active ingredient 
                        that has been previously approved in any other 
                        application under section 351(a) or 351(k) of 
                        the Public Health Service Act; and
                            ``(II) that is the subject of an 
                        application submitted under section 351(a) of 
                        the Public Health Service Act;''; and
            (5) in section 565A(a)(4) (21 U.S.C. 360bbb-4a(a)(4)), by 
        amending subparagraph (D) to read as follows:
                    ``(D) is for--
                            ``(i) a human drug, no active moiety (as 
                        defined by the Secretary in section 314.3 of 
                        title 21, Code of Federal Regulations (or any 
                        successor regulations)) of which has been 
                        approved in any other application under section 
                        505(b)(1); or
                            ``(ii) a biological product, no active 
                        ingredient of which has been approved in any 
                        other application under section 351 of the 
                        Public Health Service Act.''.
    (b) Technical Corrections.--Chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 351 et seq.) is amended--
            (1) in section 505 (21 U.S.C. 355)--
                    (A) in subsection (c)(3)(E), by repealing clause 
                (i); and
                    (B) in subsection (j)(5)(F), by repealing clause 
                (i); and
            (2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 
        355a(c)(1)(A)(i)(II)), by striking ``(c)(3)(D)'' and inserting 
        ``(c)(3)(E)''.
                                 <all>