[Congressional Record Volume 170, Number 115 (Thursday, July 11, 2024)]
[Senate]
[Pages S5067-S5068]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2843. Mr. CARDIN submitted an amendment intended to be proposed by 
him to the bill S. 4638, to authorize appropriations for fiscal year 
2025 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:


[[Page S5068]]


  

       At the end of subtitle H of title X, insert the following:

     SEC. 1095. DRUG SHORTAGES PREVENTION AND QUALITY IMPROVEMENT.

       (a) Short Title.--This section may be cited as the ``Drug 
     Shortages Prevention and Quality Improvement Act''.
       (b) Lengthen Expiration Dates to Mitigate Critical Drug 
     Shortages.--
       (1) In general.--The Federal Food, Drug, and Cosmetic Act 
     is amended by inserting after section 506C-1 (21 U.S.C. 356c-
     1) the following:

     ``SEC. 506C-2. 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 
     of 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) Notification.--
       ``(1) In general.--The Secretary may issue an order 
     requiring the manufacturer of any 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) Unavailable or insufficient data and information.--If 
     the data and information required pursuant to an order issued 
     under paragraph (1) are not available or are insufficient, 
     the Secretary may require the manufacturer of the drug to--
       ``(A) conduct studies adequate to provide the data and 
     information in accordance with section 211.166 of title 21, 
     Code of Federal Regulations (or any successor regulations); 
     and
       ``(B) submit to the Secretary the results, data, and 
     information generated by such studies when available.
       ``(c) Labeling.--The Secretary may issue an order requiring 
     the manufacturer of a life-saving drug to, by a specified 
     date, make any labeling change regarding the expiration date 
     that the Secretary determines to be appropriate based on the 
     data and information required to be submitted under this 
     section in accordance with labeling requirements under 
     subparts F and G of part 211 of title 21, Code of Federal 
     Regulations (or any successor regulations) or any other data 
     and information available to the Secretary.
       ``(d) 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.
       ``(e) Definition.--In this section, the term `life-saving 
     drug' means a drug described in section 506C(a).''.
       (2) Civil monetary penalty.--Section 303(b) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 333(b)) is amended by 
     adding at the end the following:
       ``(9)(A) If a manufacturer fails to submit data and 
     information as required under section 506C-2(b)(1), fails to 
     conduct or submit the results, data, and information 
     generated by studies as required under section 506C-2(b)(3), 
     or fails to make a labeling change as required under section 
     506C-2(c), such manufacturer shall be liable to the United 
     States for a civil penalty in an amount not to exceed $10,000 
     for each such violation.
       ``(B) If a violation described in subparagraph (A) is not 
     corrected within the 30-day period following notification by 
     the Secretary of a violation described in subparagraph (A), 
     the manufacturer shall, in addition to any penalty under 
     subparagraph (A), be subject to a civil monetary penalty of 
     not more than $10,000 for each day of the violation after 
     such period until the violation is corrected.''.
       (c) Reporting on Increases in Demand for a Drug.--
       (1) In general.--Section 506C of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 356c) is amended--
       (A) in the section heading, by inserting ``or increase in 
     demand for'' after ``production of'';
       (B) in subsection (a), in the matter following paragraph 
     (2), by striking ``drug, and the reasons for such 
     discontinuance or interruption'' and inserting ``drug, or 
     increase in the demand for such drug that is likely to lead 
     to a shortage of the drug, and the reasons for such 
     discontinuance, interruption, or increase in demand'';
       (C) in subsection (b)--
       (i) in paragraph (1), by striking ``; or'' and inserting a 
     semicolon;
       (ii) by redesignating paragraph (2) as paragraph (3);
       (iii) by inserting after paragraph (1) the following:
       ``(2) in the case of an increase in the demand for a drug, 
     not later than 30 days after the manufacture has knowledge of 
     such increase; or''; and
       (iv) in paragraph (3), as so redesignated, by striking 
     ``paragraph (1)'' and inserting ``paragraph (1) or (2)''; and
       (D) in subsection (c), by inserting ``, or increase in 
     demand for,'' after ``the manufacture of''.
       (2) Prohibited act.--
       (A) In general.--Section 301 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 331) is amended by adding at the end 
     the following:
       ``(jjj) The failure to notify the Secretary as required 
     under section 506C(a).''.
       (B) Enforcement.--Section 303 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 333(c)) is amended--
       (i) in paragraph (c), by adding before the period at the 
     end the following: ``; or (7) for having violated section 
     301(jjj) if such person acted in good faith and had a 
     reasonable basis for not notifying as required under section 
     506C''; and
       (ii) by adding at the end the following:
       ``(h) Notwithstanding subsection (a), any manufacturer who 
     violates section 301(jjj) shall be subject to a civil penalty 
     in an amount not to exceed $50,000 per violation.''.
                                 ______