Title: Drug Shortages Prevention and Quality Improvement Act
Policy area: Health

Summary:
Drug Shortages Prevention and Quality Improvement Act
This bill addresses shortages of essential drugs and related issues. (Generally, an essential drug is one that is life-supporting, life-sustaining, or intended to treat or prevent a debilitating condition.)
The Food and Drug Administration (FDA) may require a manufacturer of an essential drug to (1) submit data, or conduct studies to gather data, to determine the longest supported expiration date of a drug; or (2) make labeling changes regarding a drug's expiration period based on data provided under this bill or otherwise available to the FDA.
The bill establishes civil monetary penalties for a manufacturer that (1) refuses such a request to provide data or modify a drug label's expiration information, or (2) fails to meet certain requirements to provide to the FDA timely information about essential drug shortages.
The Government Accountability Office must conduct a study examining the process by which prescription drug manufacturers provide shelf life data to the FDA.
The FDA must establish a pilot program to assess the facilities and processes of participating manufacturers of prescription sterile injectable drugs that have been deemed essential under a specified executive order. The assessment shall cover topics including supply chain management, manufacturing strategy and operations, and workforce management.
Furthermore, the FDA must provide grants to certain nonprofit entities and institutions of higher education that agree to participate in the above pilot program. The grant funds must be used to upgrade the recipient's drug manufacturing facilities to utilize advanced manufacturing capabilities.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 2595 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 2595

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             August 4, 2021

 Mr. Cardin (for himself and Ms. Smith) 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 SHELF LIFE DATES FOR ESSENTIAL DRUGS.

    ``(a) In General.--A manufacturer of a drug subject to notification 
requirements under section 506C(a) (referred to in this section as an 
`essential drug') shall--
            ``(1) submit to the Secretary data and information as 
        required by subsection (b)(1);
            ``(2) conduct and submit the results 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 essential 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 shelf life 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 an essential drug to, by a specified date, make any 
labeling change regarding the expiration period 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 in accordance with labeling requirements 
under subpart G of part 211 of title 21, Code of Federal Regulations 
(or any successor regulations).
    ``(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.''.
    (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) If a drug manufacturer fails to submit data and information 
as required under section 506C-2(b)(1), fails to conduct or submit the 
results of 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.''.
    (c) GAO Study of Shelf Life Data.--Not later than 2 years after the 
date of enactment of this Act, the Comptroller General of the United 
States shall conduct a study examining the process by which 
prescription drug manufacturers submit data on shelf life to the Food 
and Drug Administration. In carrying out this study, the Comptroller 
General shall consider whether manufacturers adequately test the shelf 
life stability of their drug products subject to section 211.166 of 
title 21, Code of Federal Regulations (or any successor regulations).
    (d) Shelf Life Stability Guidance.--Not later than 6 months after 
the date of enactment of this Act, the Secretary shall publish for 
notice and comment in the Federal Register updates to stability testing 
under section 211.166 of title 21, Code of Federal Regulations (or any 
successor regulations).

SEC. 3. QUALITY MANAGEMENT MATURITY STERILE INJECTABLE DRUG PILOT 
              PROGRAM.

    (a) Quality Management Maturity Sterile Injectable Drug Pilot 
Program.--
            (1) In general.--Not later than 6 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary''), 
        acting through the Commissioner of Food and Drugs, shall 
        commence the Quality Management Maturity (QMM) Sterile 
        Injectable Drug Pilot Program (referred to in this section as 
        the ``pilot program'') under this section. Under such program, 
        the Secretary shall--
                    (A) select eligible drug manufacturers to 
                participate in the program in accordance with paragraph 
                (2); and
                    (B) contract with a third-party contractor to 
                develop a QMM assessment tool and conduct assessments, 
                in cooperation with staff of the Food and Drug 
                Administration, of each participant's quality 
                management system.
            (2) Eligibility.--To be eligible to participate in the 
        pilot program under this section, a manufacturer shall--
                    (A) be a for-profit or nonprofit entity;
                    (B) manufacture a prescription drug that is a 
                sterile injectable drug;
                    (C) manufacture a drug that is deemed an essential 
                medicine under Executive Order 13944 (85 Fed. Reg. 
                49929);
                    (D) have received a final classification of ``No 
                Action Indicated'' or ``Voluntary Action Indicated'' 
                with respect to all inspections of all manufacturing 
                facilities of the entity conducted by the Food and Drug 
                Administration within the 5-year period immediately 
                preceding the date of enactment of this Act;
                    (E) be a person who has registered one or more 
                establishments under subsection (b)(1) or (i)(1) of 
                section 510 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 360), with respect to the manufacture of a 
                prescription drug described in subparagraph (B); and
                    (F) agree to--
                            (i) permit a third-party contractor to 
                        conduct regular assessments under the QMM pilot 
                        program, as described in paragraph (3), either 
                        on-site or remotely;
                            (ii) collect and submit metrics data to the 
                        Food and Drug Administration and the contractor 
                        by an agreed upon date, prior to each 
                        assessment described in clause (i); and
                            (iii) be available for consultations with 
                        the third-party contractor and the Food and 
                        Drug Administration prior to and after each 
                        assessment described in clause (i), including 
                        discussions regarding the participant's 
                        established QMM-related activities and the 
                        contractor's post-assessment recommendations 
                        regarding these activities.
            (3) Assessments.--Assessments that are conducted jointly by 
        a third-party contractor, in cooperation with staff of the Food 
        and Drug Administration, will regularly conduct manufacturer 
        facility assessments to determine the manufacturer's quality 
        management maturity progress or status. Pilot program 
        assessments will cover multiple topics and shall include--
                    (A) supply chain management;
                    (B) manufacturing strategy and operations;
                    (C) safety, environmental, and regulatory 
                compliance;
                    (D) inventory management;
                    (E) performance management and continual 
                improvement;
                    (F) risk management;
                    (G) management review and responsibility;
                    (H) planning;
                    (I) workforce management;
                    (J) quality culture; and
                    (K) customer experience.
            (4) Program duration.--Not later than 6 months after the 
        date of enactment of this Act, the Secretary shall publish 
        instructions for applicants in the Federal Register. Such 
        instructions shall include a timeline for the application 
        period for such program, and a 1-year timeline for the pilot 
        program following such application period.
    (b) Report to Congress.--Not later than 6 months after the 
completion of the pilot program, the Secretary shall submit a report to 
Congress on such pilot program. Such report shall include--
            (1) a summary of third-party assessments of each 
        participating manufacturer's quality management system;
            (2) recommendations on next steps towards developing a 
        publicly available Food and Drug Administration rating system 
        for quality management maturity systems of sterile injectable 
        drug manufacturing facilities, including specific drugs 
        manufactured at each facility;
            (3) considerations the Food and Drug Administration may 
        take in updating guidance of current good manufacturing 
        practice of sterile injectable drug products; and
            (4) recommendations on incorporating pilot programs (or 
        related work) described in the guidances entitled, ``Quality 
        Management Maturity for Finished Dosage Forms Pilot Program for 
        Domestic Drug Product Manufacturers; Program Announcement'', 
        issued by the Food and Drug Administration on October 16, 2020 
        (85 Fed. Reg. 65824), and ``Quality Management Maturity for 
        Active Pharmaceutical Ingredients Pilot Program for Foreign 
        Facilities; Program Announcement'', issued by the Food and Drug 
        Administration on October 16, 2020 (85 Fed. Reg. 65828), into 
        publicly available Food and Drug Administration rating systems 
        for overall quality management maturity systems.
    (c) Definition.--In this section, 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, whose manufacturing, 
distribution, and administration processes require sterile conditions.

SEC. 4. IMPROVED DATA SHARING: ENSURING TIMELY AND INFORMATIVE 
              NOTIFICATION.

    (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:
    ``(fff) Failure To Provide Timely and Informative Notification.--
Any manufacturer who violates a requirement of this Act that relates to 
critical drugs by failing to provide timely, adequate information 
related to drug shortages pursuant to section 506C(a) shall be subject 
to a civil penalty in an amount not to exceed $50,000 per violation.''.
    (b) Regulations.--Not later than 1 year after the date of the 
enactment of this Act, the Secretary shall promulgate final regulations 
to carry out section 301(fff) of the Federal Food, Drug, and Cosmetic 
Act, as added by subsection (a).

SEC. 5. SUPPORTING CONTINUOUS MANUFACTURING TO PREVENT SHORTAGES FOR 
              SUSCEPTIBLE DRUGS.

    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, 
acting through the Commissioner of Food and Drugs, 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 from institutions of higher education and 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.
    ``(c) Grant Selection.--As a condition for accepting a grant under 
this section, an institution of higher education and nonprofit entity 
shall agree to participate in the Quality Management Maturity Sterile 
Injectable Drug Pilot Program established under section 3 of the Drug 
Shortages Prevention and Quality Improvement Act.
    ``(d) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $1,000,000,000 for the period of 
fiscal years 2022 through 2027.
    ``(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 way (such as 
        continuous manufacturing where the input materials are 
        continuously transformed within the process by 2 or more unit 
        operations) 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, whose manufacturing, 
        distribution, and administration processes require sterile 
        conditions.''.
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