[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2362 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 2362
To amend the Federal Food, Drug, and Cosmetic Act to provide for
notification by manufacturers of critical drugs of increased demand,
and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 18, 2023
Ms. Klobuchar (for herself, Ms. Collins, Ms. Smith, Ms. Murkowski, and
Ms. Warren) 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 to provide for
notification by manufacturers of critical drugs of increased demand,
and for other purposes.
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 ``Drug Shortage Prevention Act of
2023''.
SEC. 2. IMPROVING NOTIFICATION PROCEDURES IN CASE OF INCREASED DEMAND
FOR CRITICAL DRUGS.
(a) In General.--Section 506C of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356c) is amended--
(1) in the section heading, by striking ``discontinuance or
interruption in the production of life-saving drugs'' and
inserting ``notification of issues affecting domestic supply of
critical drugs'';
(2) by striking subsections (a), (b), and (c), and
inserting the following:
``(a) Notification Required.--
``(1) In general.--A manufacturer of a covered drug shall
notify the Secretary, in accordance with subsection (b), of--
``(A)(i) a permanent discontinuance in the
manufacture of the drug or an interruption of the
manufacture of the drug that is likely to lead to a
meaningful disruption in the supply of such drug in the
United States;
``(ii) a permanent discontinuance in the
manufacture of an active pharmaceutical ingredient of
such drug, or an interruption in the manufacture of an
active pharmaceutical ingredient of such drug that is
likely to lead to a meaningful disruption in the supply
of the active pharmaceutical ingredient of such drug;
or
``(iii) any other circumstance, such as an increase
in demand or export restriction, that is likely to
leave the manufacturer unable to meet demand for the
drug without a meaningful shortfall or delay; and
``(B) the reasons for such discontinuance,
interruption, or other circumstance, if known.
``(2) Contents.--Notification under this subsection with
respect to a covered drug shall include--
``(A) with respect to the reasons for the
discontinuation, interruption, or other circumstance
described in paragraph (1)(A)(iii), if an active
pharmaceutical ingredient is a reason for, or risk
factor in, such discontinuation, interruption, or other
circumstance, the source of the active pharmaceutical
ingredient and any alternative sources for the active
pharmaceutical ingredient known to the manufacturer;
``(B) whether any associated device used for
preparation or administration included in the drug is a
reason for, or a risk factor in, such discontinuation,
interruption, or other circumstance described in
paragraph (1)(A)(iii);
``(C) the expected duration of the interruption;
and
``(D) such other information as the Secretary may
require.
``(b) Timing.--A notice required under subsection (a) shall be
submitted to the Secretary--
``(1) at least 6 months prior to the date of the
discontinuance or interruption;
``(2) in the case of such a notice with respect to a
circumstance described in subsection (a)(1)(A)(iii), as soon as
practicable, or not later than 10 business days after the onset
of the circumstance; or
``(3) if compliance with paragraph (1) or (2) is not
possible, as soon as practicable.
``(c) Distribution.--To the maximum extent practicable, the
Secretary shall distribute, through such means as the Secretary
determines appropriate, information on the discontinuance or
interruption of the manufacture of, or other circumstance described in
subsection (a)(1)(A)(iii) that is likely to lead to a shortage or
meaningful disruption in the supply of, covered drugs to appropriate
organizations, including physician, health provider, and patient
organizations, as described in section 506E.'';
(3) in subsection (g), in the matter preceding paragraph
(1), by striking ``drug described in subsection (a)'' and
inserting ``covered drug''; and
(4) in subsection (j), by striking ``drug described in
subsection (a)'' and inserting ``covered drug''.
(b) Definitions.--Paragraph (1) of section 506C(h) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 356c(h)) is amended to read as
follows:
``(1) the term `covered drug' means a drug that is intended
for human use and that--
``(A) is--
``(i) life-supporting;
``(ii) life-sustaining; or
``(iii) intended for use in the prevention
or treatment of a debilitating disease or
condition, including any such drug used in
emergency medical care or during surgery or any
such drug that is critical to the public health
during a public health emergency declared by
the Secretary under section 319 of the Public
Health Service Act;
``(B) is not a radio pharmaceutical drug product or
any other product as designated by the Secretary; and
``(C) is not a biological product (as defined in
section 351(i) of the Public Health Service Act),
unless otherwise provided by the Secretary in the
regulations promulgated under subsection (i);''.
SEC. 3. REPORTING ON SUPPLY CHAINS.
Section 510(j)(3)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(j)(3)(A)) is amended--
(1) by striking ``annually to the Secretary'' in the first
sentence and inserting ``to the Secretary, once during the
month of March each year and once during the month of September
each year,'';
(2) by inserting ``, and the legal names of, and any
additional information the Secretary may require, regarding
suppliers of active pharmaceutical ingredients and intermediate
and in-process materials such person used for the manufacture,
preparation, propagation, compounding, or processing of such
drug, and the amount of such drug manufactured, prepared,
propagated, compounded, or processed using each such active
pharmaceutical ingredient or intermediate or in-process
material sourced from each such supplier'' before the period at
the end of the first sentence; and
(3) by inserting after the first sentence the following:
``In addition to the reporting required under the preceding
sentence, each person who registers with the Secretary under
this section with regard to a drug may voluntarily report on
the information described in the preceding sentence, at such
other times as the Secretary may specify.''.
<all>