[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3793 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 3793

     To amend the Federal Food, Drug, and Cosmetic Act to require 
 manufacturers of life-saving drugs to submit data and information to 
assess the stability of the drugs and determine their longest supported 
                expiration date, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 5, 2023

 Ms. Slotkin 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 require 
 manufacturers of life-saving drugs to submit data and information to 
assess the stability of the drugs and determine their longest supported 
                expiration date, 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 ``Ensuring Access to Lifesaving Drugs 
Act of 2023''.

SEC. 2. EXTENDED EXPIRATION DATES FOR LIFE-SAVING DRUGS.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended by inserting after section 506L of such 
Act (21 U.S.C. 356l) the following new section:

``SEC. 506M. EXTENDED EXPIRATION DATES FOR LIFE-SAVING DRUGS.

    ``(a) In General.--A manufacturer of a life-saving drug shall--
            ``(1) submit to the Secretary data and information as 
        required by subsection (b)(1);
            ``(2) conduct and submit the results, data, and information 
        generated by any studies required under subsection (b)(2); and
            ``(3) make any labeling change described in subsection (c) 
        by the date specified by the Secretary pursuant to such 
        subsection.
    ``(b) Data and Information.--
            ``(1) In general.--The Secretary may issue an order 
        requiring the manufacturer of a life-saving drug to submit, in 
        such manner as the Secretary may prescribe, data and 
        information from any stage of development of the drug that are 
        adequate to assess the stability of the drug to determine the 
        longest supported expiration date.
            ``(2) Lack of data and information.--If the data and 
        information required pursuant to an order issued under 
        paragraph (1) are not available or are insufficient, as 
        determined by the Secretary, the Secretary may issue an order 
        requiring the manufacturer of the drug--
                    ``(A) to conduct studies, which may be a 
                continuation of ongoing studies, to provide data and 
                information adequate to assess the stability of the 
                drug and to determine the longest supported expiration 
                date; and
                    ``(B) to submit such data and information to the 
                Secretary in such manner as the Secretary may prescribe 
                in the order.
    ``(c) Labeling.--The Secretary may issue an order requiring the 
manufacturer of a life-saving drug, by a date determined by the 
Secretary in consultation with the sponsor of the drug, to make any 
labeling change regarding the expiration date or storage and handling 
of the drug that the Secretary determines to be appropriate based on 
the data and information required to be submitted under this section or 
any other data and information available to the Secretary.
    ``(d) Definitions.--In this section:
            ``(1) Life-saving drug.--The term `life-saving drug' means 
        a drug, that is--
                    ``(A)(i) a medical countermeasure; or
                    ``(ii) on the drug shortage list under section 506E 
                or determined by the Secretary to be at risk of 
                shortage; and
                    ``(B)(i) life-supporting;
                    ``(ii) life-sustaining; or
                    ``(iii) intended for use in the prevention or 
                treatment of a debilitating disease or condition in 
                humans or animals, 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.
            ``(2) Medical countermeasure.--The term `medical 
        countermeasure' means a countermeasure as defined in section 
        565(a).
    ``(e) Confidentiality.--Nothing in this section shall be construed 
as authorizing the Secretary to disclose any information that is a 
trade secret or confidential information subject to section 552(b)(4) 
of title 5, United States Code, or section 1905 of title 18, United 
States Code.''.
    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by section 3503(a)(1)(A) of 
division FF of Public Law 117-328, is amended by inserting at the end 
the following new subsection:
    ``(jjj) The failure to comply with any order issued under section 
506M.''.
    (c) Penalties.--Subsection (b) of section 303 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 333) is amended by inserting at the 
end the following:
    ``(9) If a manufacturer of a life-saving drug fails to submit data 
and information as required under section 506M(b)(1), fails to conduct 
or submit the data and information generated by studies as required 
under section 506M(b)(2), or fails to make a labeling change as 
required under section 506M(c), such manufacturer shall be subject to a 
civil penalty of not more than $10,000 for the first day on which the 
violation occurs and not more than $10,000 for each subsequent day on 
which the violation is not corrected.''.
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