[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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