[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2586 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2586

   To address prescription drug shortages and improve the quality of 
              prescription drugs, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 27, 2023

Mr. Cardin (for himself, Ms. Smith, and Mr. Blumenthal) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To address prescription drug shortages and improve the quality of 
              prescription 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 Shortages Prevention and 
Quality Improvement Act''.

SEC. 2. LENGTHEN EXPIRATION DATES TO MITIGATE CRITICAL DRUG SHORTAGES.

    (a) 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).''.
    (b) 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.''.

SEC. 3. REPORTING ON INCREASES IN DEMAND FOR A DRUG.

    (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 inserting ``or increase in 
        demand for'' after ``production of'';
            (2) 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'';
            (3) in subsection (b)--
                    (A) in paragraph (1), by striking ``; or'' and 
                inserting a semicolon;
                    (B) by redesignating paragraph (2) as paragraph 
                (3);
                    (C) 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
                    (D) in paragraph (3), as so redesignated, by 
                striking ``paragraph (1)'' and inserting ``paragraph 
                (1) or (2)''; and
            (4) in subsection (c), by inserting ``, or increase in 
        demand for,'' after ``the manufacture of''.
    (b) Prohibited Act.--
            (1) 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).''.
            (2) Enforcement.--Section 303 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 333(c)) is amended--
                    (A) 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
                    (B) 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.''.

SEC. 4. SUPPORTING CONTINUOUS MANUFACTURING TO PREVENT SHORTAGES FOR 
              SUSCEPTIBLE DRUGS.

    (a) In General.--Subtitle B of title III of the 21st Century Cures 
Act is amended by inserting after section 3016 (21 U.S.C. 399h) the 
following:

``SEC. 3017. GRANTS FOR CONTINUOUS MANUFACTURING TO PREVENT DRUG 
              SHORTAGES.

    ``(a) In General.--The Secretary of Health and Human Services shall 
solicit and, beginning not later than one year after the date of 
enactment of the Drug Shortages Prevention and Quality Improvement Act, 
receive, requests for grants from institutions of higher education or 
nonprofit entities engaged in the manufacture of sterile injectable 
drugs for the purpose of upgrading drug establishment to continuous 
manufacturing or other advanced manufacturing capabilities.
    ``(b) Grant Criteria.--An institution of higher education or a 
nonprofit entity shall be eligible for a grant under this section if 
such institution or entity manufactures a drug that--
            ``(1) is categorized as an essential medicine under 
        Executive Order 13944;
            ``(2) is a sterile injectable drug; and
            ``(3) is vulnerable to shortage, including as determined 
        through notifications submitted to the Secretary under section 
        506C.
    ``(c) Grant Selection.--As a condition for accepting a grant under 
this section, an institution of higher education and nonprofit entity 
shall agree to develop and carrying out a robust plan focused on 
sustainability of the continuous manufacturing or other advanced 
manufacturing capabilities supported by the grant.
    ``(d) Authorization of Appropriations.--To carry out this section, 
in additional to amounts otherwise made available for such purposes, 
there is authorized to be appropriated $1,000,000,000 for the period of 
fiscal years 2024 through 2029.
    ``(e) Definitions.--In this section:
            ``(1) Advanced manufacturing.--The term `advanced 
        manufacturing' means an approach for the manufacturing of drugs 
        that incorporates novel technology, or uses an established 
        technique or technology in a new or innovative that enhances 
        drug quality or improves the manufacturing process.
            ``(2) Continuous manufacturing.--The term `continuous 
        manufacturing'--
                    ``(A) means a process where the input materials are 
                continuously fed into and transformed within the 
                process, and the processed output materials are 
                continuously removed from the system; and
                    ``(B) consists of an integrated process that 
                consists of a series of 2 or more unit operations.
            ``(3) Sterile injectable drug.--The term `sterile 
        injectable drug' means a drug approved under section 505 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), a 
        biological product licensed under section 351 of the Public 
        Health Service Act (42 U.S.C. 262), or a combination product 
        (as described in section 503(g) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 353(g)) whose primary mode of action is 
        that of a drug or biological product, that is intended for 
        injection for intravenous use of infusion and whose 
        manufacturing, distribution, and administration processes 
        require sterile conditions.''.
    (b) GAO Study on Quality Management Purchasing.--The Comptroller 
General of the United States shall conduct a study on including quality 
management maturity as a factor in prescription drug purchasing by 
Federal health care programs (as defined in section 1128B(f) of the 
Social Security Act (42 U.S.C. 1320a-7b(f))), and not later than 2 
years after the date of enactment of this Act, shall submit a report on 
such study to Congress.

SEC. 5. AUTHORITY TO USE ALTERNATIVE PAYMENT UNDER THE MEDICARE PROGRAM 
              FOR DRUGS AND BIOLOGICALS TO PREVENT POTENTIAL DRUG 
              SHORTAGES.

    (a) Payment Under Part B.--Section 1847A(e) of the Social Security 
Act (42 U.S.C. 1395w-3a(e)) is amended--
            (1) by striking ``Payment in Response to Public Health 
        Emergency.--In the case'' and inserting ``Payments.--
            ``(1) In response to public health emergency.--In the 
        case''; and
            (2) by adding at the end the following new paragraph:
            ``(2) Preventing potential drug shortages.--
                    ``(A) In general.--In the case of a drug or 
                biological described in subparagraph (B), the Secretary 
                may use the wholesale acquisition cost (or other 
                reasonable measure of a drug or biological price) 
                instead of the manufacturer's average sales price for 
                quarters beginning on or after the date on which the 
                Secretary determines the drug or biological is 
                described in such subparagraph and for subsequent 
                quarters until the end of the quarter in which such 
                drug or biological is removed from the drug shortage 
                list under section 506E of the Federal Food, Drug, and 
                Cosmetic Act, or in the case of a drug or biological 
                described in subparagraph (B)(ii)(II), the date on 
                which the Secretary determines the manufacturing 
                capacity or the number of manufacturers of such drug or 
                biological is sufficient to prevent a potential 
                shortage of the drug or biological.
                    ``(B) Drug or biological described.--For purposes 
                of subparagraph (A), a drug or biological described in 
                this subparagraph is a drug or biological--
                            ``(i) that is life-supporting, life-
                        sustaining, or intended for use in the 
                        prevention or treatment of a debilitating 
                        disease or condition (as those terms are 
                        defined for purposes of section 506C of the 
                        Federal Food, Drug, and Cosmetic Act and is 
                        subject to the reporting requirements under 
                        section 506C(b) of such Act), including any 
                        such drug or biological that is used in 
                        emergency medical care or during surgery; and
                            ``(ii)(I) that is listed on the drug and 
                        biological shortage list maintained by the Food 
                        and Drug Administration pursuant to section 
                        506E of the Federal Food, Drug, and Cosmetic 
                        Act, and for which the manufacturer of such 
                        drug or biological notifies the Secretary of a 
                        permanent discontinuance or an interruption 
                        that is likely to lead to a meaningful 
                        disruption in the manufacturer's supply of that 
                        drug or biological pursuant to section 
                        506C(b)(1) of such Act; or
                            ``(II) that was listed on such drug and 
                        biological shortage list within the preceding 5 
                        years and for which the manufacturing capacity 
                        of manufacturers with an approved application 
                        for such drug or biological, or the number of 
                        manufacturers with an approved application for 
                        such drug or biological, declines during a 6-
                        month period, as determined by the Secretary.
                    ``(C) Provision of additional information.--For 
                each quarter in which the amount of payment for a drug 
                or biological described in subparagraph (B) pursuant to 
                subparagraph (A) exceeds the amount of payment for the 
                drug or biological otherwise applicable under this 
                section, the manufacturer of such drug or biological 
                shall provide to the Secretary information related to 
                the potential cause or causes of the shortage and the 
                expected length of the shortage with respect to such 
                drug.''.
    (b) Additional Payment Under IPPS.--Section 1886(d)(5) of the 
Social Security Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at 
the end the following new subparagraph:
    ``(N) The Secretary shall establish a modifier or other mechanism 
for purposes of tracking utilization of drugs on the shortage list 
pursuant to section 506E of the Federal Food, Drug, and Cosmetic Act, 
and update the modifier to reflect the drugs on such list each calendar 
year.''.
    (c) GAO Study on Drug Shortages.--Not later than 2 years after the 
date of enactment of this Act, the Comptroller General of the United 
States shall--
            (1) conduct a study on--
                    (A) drugs and biologicals for which payment is made 
                under the inpatient prospective payment system (IPPS) 
                under section 1886 of the Social Security Act (42 
                U.S.C. 1395ww) and the hospital outpatient prospective 
                payment system (OPPS) under section 1833(t) of the 
                Social Security Act (42 U.S.C. 1395l(t)) that have been 
                on the shortage list under section 506E of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 356e(c)(2)) in 
                the last 5 years; and
                    (B) whether any changes to payment under such 
                payment systems would decrease--
                            (i) the number of drugs and biologicals on 
                        such shortage list; or
                            (ii) the frequency with which the drugs and 
                        biologicals appear on such shortage list; and
            (2) submit to Congress recommendations for legislation and 
        administrative actions with respect to the matters described in 
        subparagraphs (A) and (B) of paragraph (1).
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