[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3008 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 3008

   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
   notification by manufacturers of critical essential medicines of 
        increased demand of such drugs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 28, 2023

   Ms. Jacobs (for herself, Mr. Allred, Ms. Clarke of New York, Mr. 
Doggett, Mr. Garcia of Illinois, Mr. Grijalva, Mr. Huffman, Mr. Khanna, 
  Mr. Larson of Connecticut, Ms. Lee of California, Mr. McGovern, Ms. 
  Ocasio-Cortez, Ms. Pressley, Mr. Veasey, Ms. Velazquez, Mrs. Watson 
 Coleman, Mr. Carter of Louisiana, Ms. Norton, Mr. Cohen, Mr. Cleaver, 
Mr. Smith of Washington, Ms. Blunt Rochester, Ms. Crockett, Ms. Kuster, 
 Ms. Tokuda, Ms. Caraveo, Mr. Schiff, Ms. Jackson Lee, Mr. Kim of New 
    Jersey, and Mr. Mills) 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 provide for 
   notification by manufacturers of critical essential medicines of 
        increased demand of such drugs, 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 ESSENTIAL MEDICINES.

    (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 essential medicines'';
            (2) by striking subsections (a), (b), and (c), and 
        inserting the following:
    ``(a) Notification Required.--
            ``(1) In general.--A manufacturer of a critical essential 
        medicine 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, an 
                excipient, or any other input in the final dosage form 
                of such drug or an interruption in the manufacture of 
                the active pharmaceutical ingredient, an excipient, or 
                any other input in the final dosage form of such drug 
                of such drug that is likely to lead to a meaningful 
                disruption in the supply of the active pharmaceutical 
                ingredient of such drug;
                    ``(iii) an increased demand (other than an 
                anticipated seasonal surge) for such drug or an active 
                pharmaceutical ingredient, an excipient, or any other 
                input in the final dosage form of such drug that is 
                likely to lead to a shortage of the drug or the active 
                pharmaceutical ingredient, an excipient, or any other 
                input in the final dosage form of such drug; and
                    ``(B) the reasons for such discontinuance, 
                interruption, or increased demand.
            ``(2) Contents.--Notification under this subsection with 
        respect to a critical essential medicine shall include--
                    ``(A) with respect to the reasons for the 
                discontinuation, interruption, or increased demand 
                referred to in paragraph (1)(C), if an active 
                pharmaceutical ingredient, an excipient, or any other 
                input in the final dosage form of such drug is a reason 
                for, or risk factor in, such discontinuation, 
                interruption, or increased demand, the source of the 
                active pharmaceutical ingredient, excipient, or other 
                input and any alternative sources for the an active 
                pharmaceutical ingredient, an excipient, or any other 
                input by 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 increased demand;
                    ``(C) the expected duration of the interruption or 
                increased demand; and
                    ``(D) such other information as the Secretary may 
                require.
    ``(b) Timing.--
            ``(1) In general.--A notice required under subsection (a) 
        shall be submitted to the Secretary--
                    ``(A) at least 6 months prior to the date of the 
                discontinuance or interruption;
                    ``(B) in the case of such a notice with respect to 
                increased demand for a critical essential medicine, not 
                later than 30 days after the submission of the initial 
                notification under paragraph (2); or
                    ``(C) if compliance with subparagraph (A) or (B) is 
                not possible, as soon as practicable.
            ``(2) Initial notification with respect to increased 
        demand.--In the case a notification required under subsection 
        (a) with respect to increased demand for a critical essential 
        medicine, the manufacturer of the drug involved shall submit to 
        the Secretary an initial notification not later than 48 hours 
        after the date on which there has been increased demand for the 
        critical essential medicine for a period of at least 6 
        consecutive weeks.
    ``(c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute, through such means as the Secretary deems 
appropriate, information on the discontinuance or interruption of the 
manufacture of, or the increased demand for, critical essential 
medicines 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 ``critical essential medicine''; and
            (4) in subsection (j), by striking ``drug described in 
        subsection (a)'' and inserting ``critical essential medicine''.
    (b) Application to Nonprescription Drugs.--Section 506C(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(h)) is amended--
            (1) by redesignating paragraphs (1), (2), and (3) as 
        paragraphs (2), (3), and (4), respectively;
            (2) in paragraph (2)(A) (as so redesignated), by striking 
        ``and that is subject to section 503(b)(1)'' and inserting ``, 
        including a drug that is not subject to section 503(b)(1)''; 
        and
            (3) by inserting before paragraph (2) (as so redesignated) 
        the following:
            ``(1) the term `critical essential medicine' means a drug 
        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; and
                    ``(B) is not a radio pharmaceutical drug product or 
                any other product as designated by the Secretary;''.
    (c) Regulations.--Not later than 18 months after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
issue final regulations to implement the amendments made by subsections 
(a) and (b).
    (d) Guidance.--
            (1) In general.--The Secretary of Health and Human 
        Services, acting through the Commissioner of Food and Drugs, 
        shall issue guidance on the requirements for notifications 
        required to be submitted under section 506C of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 356c), as amended by 
        subsections (a) and (b), with respect to increased demand for 
        critical essential medicines (as defined in such section 506C). 
        Such guidance shall specifically address--
                    (A) the ways in which manufacturers of critical 
                essential medicines can improve demand predictability;
                    (B) what information manufacturers of critical 
                essential medicines should send to the Secretary; and
                    (C) what communications from the manufacturer the 
                Secretary would request with respect to increases in 
                demand following such notifications.
            (2) Consultation.--In developing such guidance, the 
        Secretary shall consult with relevant stakeholders, including 
        manufacturers of critical essential medicines and local, State, 
        or Federal public health officials.
            (3) Timing.--The Secretary of Health and Human Services, 
        acting through the Commissioner of Food and Drugs, shall 
        issue--
                    (A) draft guidance under paragraph (1) not later 
                than 120 days after the date of the enactment of this 
                Act; and
                    (B) final guidance under such paragraph not later 
                than 180 days after the date of the enactment of this 
                Act.
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