Protecting Access to Safe and Effective Medicines Act of 2021
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]
[H.R. 1857 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 1857
To amend the Federal Food, Drug, and Cosmetic Act to clarify the
meaning of a new chemical entity.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 11, 2021
Mr. Schrader (for himself and Mr. Guthrie) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to clarify the
meaning of a new chemical entity.
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 ``Protecting Access to Safe and
Effective Medicines Act of 2021''.
SEC. 2. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY.
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) (21 U.S.C.
360ff(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))''.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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