119-s2665

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2665 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 2665

 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

 August 1, 2025

Ms. Klobuchar (for herself, Ms. Collins, Ms. Warren, Ms. Murkowski, Ms. 
 Smith, and Mr. Peters) 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 
2025''.

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.''.
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