S 1636 — Ensuring Innovation Act

1636 IntroducedEngrossed in Senate (IS)](ES)] <DOC> 116th CONGRESS 1st2d Session S.

1636 _______________________________________________________________________ AN ACT 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.

SHORTCLARIFYING TITLE.THE MEANING OF NEW CHEMICAL ENTITY.

This(a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic Act mayis beamended-- cited(1) asin thesection ``Ensuring505 Innovation(21 Act''.U.S.C.

SEC.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))'';

2.(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))'';

NEW(C) CHEMICALin EXCLUSIVITYsubsection SCOPE.(l)(2)(A)-- (i) by amending clause (i) to read as follows:

Chapter``(i) Vnot 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 Food,Regulations Drug,(or andany Cosmeticsuccessor Actregulations)) isof amended--which (1)has been approved in sectionany 505other (21application U.S.C.under this section;

355)--or (A)``(II) infor subsectiona (c)(3)(E)--biological (i)product, inno clauseactive (ii), by striking ``active ingredient (including any ester or salt of thewhich activehas ingredient)''been andapproved insertingin ``activeany moietyother (asapplication definedunder by the Secretary in section 314.3351 of titlethe 21,Public CodeHealth ofService FederalAct; Regulations (or any successor regulations))'';

andand''; (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)and in(ii) subsection (j)(5)(F)-- (i) in clause (ii), by striking ``active ingredient (including any ester or salt of the active ingredient)'' and inserting ``active``or moietybiological (asproduct'' definedbefore by the Secretaryperiod; in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))'';

and(D) (ii) in clause (iii), by strikingamending ``activesubsection ingredient(s) (includingto anyread esteras orfollows: 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)``(s) inReferral subsectionto (l)(2)(A)(i),Advisory byCommittee.--The strikingSecretary ``activeshall-- ingredient``(1) (includingrefer anya esterdrug or saltbiological product to a Food and Drug Administration advisory committee for review at a meeting of such advisory committee prior to the activeapproval ingredient)''of andsuch insertingdrug ``activeor 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))'';regulations)) of which has been approved in any other application under this section;

(D)or in``(B) subsectiona (s),biological inproduct, theno matteractive preceding paragraph (1), by striking ``active ingredient (including any ester or salt of thewhich activehas ingredient)''been andapproved insertingin ``activeany moietyother (asapplication definedunder by the Secretary in section 314.3351 of titlethe 21,Public CodeHealth ofService FederalAct; Regulations (or any successor regulations))'';

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.'';

360b(c)(2)(F))--360b(c)(2)(F)), (A) in clause (i), 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)(3) 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 314.3524(a)(4) of(21 titleU.S.C. 21, Code of Federal Regulations (or any successor regulations))'';

and360n(a)(4)), (C) in clause (v), by strikingamending ``activesubparagraph ingredient(C) (includingto anyread esteras orfollows: 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)``(C) is for-- ``(i) a human drug, no active moiety (as defined by the Secretary in section 524(a)(4)(C)314.3 (21of U.S.C.title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under section 505(b)(1);

360n(a)(4)(C)),or by``(ii) strikinga ``activebiological ingredientproduct, (includingno anyactive esteringredient or salt of thewhich activehas ingredient)''been andapproved insertingin ``activeany moietyother (asapplication definedunder by the Secretary in section 314.3351 of titlethe 21,Public CodeHealth ofService FederalAct.''; Regulations (or any successor regulations))'';

(4) in section 529(a)(4)(A)(ii),529(a)(4) by(21 strikingU.S.C. ``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))'';

and21 (5) in section 565A(a)(4)(D) (21 U.S.C.

360bbb-360ff(a)(4)), 4a(a)(4)(D)), by striking ``activesubparagraphs ingredient(A) (includingand any(B) ester or salt of the active ingredient)'' and inserting ``active moiety (as defined by the Secretaryfollowing: in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))''.

<all>``(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);