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.
[117th Congress Public Law 9]
[From the U.S. Government Publishing Office]



[[Page 254]]

                                     

[[Page 135 STAT. 255]]

Public Law 117-9
117th Congress

                                 An Act


 
 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
 scope of new chemical exclusivity. <<NOTE: Apr. 23, 2021 -  [S. 415]>> 

    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) <<NOTE: Deadline.>>  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) <<NOTE: Review.>>  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

[[Page 135 STAT. 256]]

                    ``(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) <<NOTE: Summary.>>  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

[[Page 135 STAT. 257]]

            (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)''.

    Approved April 23, 2021.

LEGISLATIVE HISTORY--S. 415:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 167 (2021):
            Mar. 10, considered and passed Senate.
            Apr. 14, considered and passed House.

                                  <all>
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.
Official Titles - Senate
Official Title as Introduced
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity.
Sen. Cassidy, Bill