Lineage

Dec 14, 2020viewing Engrossed in Senate See what changed
May 23, 2019 Introduced in Senate 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

S. 1636 — what changed

Ensuring Innovation Act

From Introduced in Senate to Engrossed in Senate. 1 section amended and 1 removed between Introduced in Senate and Engrossed in Senate.

Section 1 Clarifying the meaning of new chemical entity

(a)

added In general— Chapter V of the Federal Food, Drug, and Cosmetic Act is amended—

(1)

added in section 505 (21 U.S.C. 355)—

(A)

added 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)

added 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)

added in subsection (l)(2)(A)—

(i)

added by amending clause (i) to read as follows:

added “(i) not later than 30 days after the date of approval of such applications—

added “(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

added “(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”

(ii)

added in clause (ii), by inserting “or biological product” before the period;

(D)

added by amending subsection (s) to read as follows:

added “(s) Referral to advisory committee—The Secretary shall—

added “(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—

added “(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

added “(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

added “(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.”

(E)

added in subsection (u)(1), in the matter preceding subparagraph (A)—

(i)

added 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)

added by striking “same active ingredient” and inserting “same active moiety”;

(2)

added 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)

added in section 524(a)(4) (21 U.S.C. 360n(a)(4)), by amending subparagraph (C) to read as follows:

added “(C) is for—

added “(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

added “(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)

added in section 529(a)(4) (21 U.S.C. 21 U.S.C. 360ff(a)(4)), by striking subparagraphs (A) and (B) and inserting the following:

added “(A) is for a drug or biological product that is for the prevention or treatment of a rare pediatric disease;

added “(B)

added “(i) is for such a drug—

added “(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

added “(II) that is the subject of an application submitted under section 505(b)(1); or

added “(ii) is for such a biological product—

added “(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

added “(II) that is the subject of an application submitted under section 351(a) of the Public Health Service Act;”

(5)

added in section 565A(a)(4) (21 U.S.C. 360bbb–4a(a)(4)), by amending subparagraph (D) to read as follows:

added “(D) is for—

added “(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)

added Technical corrections— Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq) is amended—

(1)

added in section 505 (21 U.S.C. 355)—

(A)

added in subsection (c)(3)(E), by repealing clause (i); and

(B)

added in subsection (j)(5)(F), by repealing clause (i); and

(2)

added 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)”.

removed ~~This Act may be cited as the “Ensuring Innovation Act”.~~

Sec. 2 New chemical exclusivity scope

removed

removed ~~Chapter V of the Federal Food, Drug, and Cosmetic Act is amended—~~

(1)

removed ~~in section 505 (21 U.S.C. 355)—~~

(A)

removed ~~in subsection (c)(3)(E)—~~

(i)

removed 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)

removed 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)

removed ~~in subsection (j)(5)(F)—~~

(i)

(ii)

(C)

removed 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)

removed 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)

removed ~~in subsection (u)(1), in the matter preceding subparagraph (A)—~~

(i)

removed 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)

removed ~~by striking “same active ingredient” and inserting “same active moiety”;~~

(2)

removed ~~in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F))—~~

(A)

removed 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)

(C)

removed 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)

removed 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)

removed 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)

removed 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))”.

S. 1636 — what changed

Section 1 Clarifying the meaning of new chemical entity

Sec. 2 New chemical exclusivity scope

Cite this provision

Incoming references