[Congressional Record Volume 172, Number 106 (Wednesday, June 24, 2026)]
[Senate]
[Pages S3436-S3437]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 6294. Ms. KLOBUCHAR submitted an amendment intended to be proposed
by her to the bill S. 4784, to authorize appropriations for fiscal year
2027 for military activities of the Department of Defense, for military
construction, and for defense activities of the Department of Energy,
to prescribe military personnel strengths for such fiscal year, and for
other purposes; which was ordered to lie on the table; as follows:
At the appropriate place in title X, insert the following:
SEC. __. 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) Notification and Distribution.--
``(1) 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.
``(2) Notification to the department of defense.--The
Secretary shall notify the Secretary of Defense each time a
notification is submitted to the Secretary under subsection
(a).'';
(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''.
[[Page S3437]]
(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);''.
(c) 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.''.
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