[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3468 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 3468

 To require the manufacturers of certain essential medical devices to 
notify the Food and Drug Administration when such manufacturers become 
aware of a circumstance that could lead to a shortage of such devices, 
                        and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 12, 2020

  Mrs. Loeffler (for herself and Mr. Casey) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To require the manufacturers of certain essential medical devices to 
notify the Food and Drug Administration when such manufacturers become 
aware of a circumstance that could lead to a shortage of such devices, 
                        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 ``Preventing Essential Medical Device 
Shortages Act of 2020''.

SEC. 2. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF ESSENTIAL 
              MEDICAL DEVICES.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 506I the following:

``SEC. 506J. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF 
              ESSENTIAL MEDICAL DEVICES.

    ``(a) In General.--The manufacturer of an essential device shall 
notify the Secretary, in accordance with subsection (b), of a permanent 
discontinuance in the manufacture of the essential device or an 
interruption of the manufacture of the essential device that is likely 
to lead to a meaningful disruption in the supply of that device in the 
United States, and the reasons for such discontinuance or interruption.
    ``(b) Timing.--A notice required under subsection (a) shall be 
submitted to the Secretary--
            ``(1) at least 6 months prior to the date of the 
        discontinuance or interruption; or
            ``(2) if compliance with paragraph (1) is not possible, as 
        soon as practicable.
    ``(c) Distribution.--
            ``(1) Public availability.--To the maximum extent 
        practicable, subject to paragraph (2), the Secretary shall 
        distribute, through such means as the Secretary determines 
        appropriate, information on the discontinuance or interruption 
        of the manufacture of essential devices reported under 
        subsection (a) to appropriate organizations, including 
        physician, health provider, and patient organizations, as 
        appropriate and applicable.
            ``(2) Public health exception.--The Secretary may choose 
        not to make information collected under this section publicly 
        available pursuant to this section if the Secretary determines 
        that disclosure of such information would adversely affect the 
        public health, such as by increasing the possibility of 
        hoarding or other disruption of the availability of drug 
        products to patients.
    ``(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) Failure To Meet Requirements.--If a person fails to submit 
information required under subsection (a) in accordance with subsection 
(b)--
            ``(1) the Secretary shall issue a letter to such person 
        informing such person of such failure;
            ``(2) not later than 30 calendar days after the issuance of 
        a letter under paragraph (1), the person who receives such 
        letter shall submit to the Secretary a written response to such 
        letter setting forth the basis for noncompliance and providing 
        information required under subsection (a); and
            ``(3) not later than 45 calendar days after the issuance of 
        a letter under paragraph (1), the Secretary shall make such 
        letter and any response to such letter under paragraph (2) 
        available to the public on the internet website of the Food and 
        Drug Administration, with appropriate redactions made to 
        protect information described in subsection (d), except that, 
        if the Secretary determines that the letter under paragraph (1) 
        was issued in error or, after review of such response, the 
        person had a reasonable basis for not notifying as required 
        under subsection (a), the requirements of this paragraph shall 
        not apply.
    ``(f) Expedited Inspections and Reviews.--If, based on 
notifications described in subsection (a) or any other relevant 
information, the Secretary concludes that there is, or is likely to be, 
a shortage of an essential device, the Secretary may--
            ``(1) expedite the review of an application for premarket 
        review under section 515 or review of a notification under 
        section 510(k) for a device that could help mitigate or prevent 
        such shortage; or
            ``(2) expedite an inspection or reinspection of an 
        establishment that could help mitigate or prevent such 
        shortage.
    ``(g) Definitions.--
            ``(1) Essential device.--
                    ``(A) In general.--Not later than 180 days after 
                the date of enactment of the Preventing Essential 
                Medical Device Shortages Act of 2020, the Secretary 
                shall, for the purposes of this section, promulgate a 
                notice of proposed rulemaking defining the term 
                `essential device' and shall, not later than 1 year 
                after such date of enactment, promulgate final 
                regulations defining such term.
                    ``(B) Essential devices during public health 
                emergencies.--Upon declaration by the Secretary of a 
                public health emergency under section 319 of the Public 
                Health Service Act, the Secretary shall issue a list of 
                devices deemed essential devices for the purpose of 
                ensuring the public health and safety for the duration 
                of the declared public health emergency.
            ``(2) Other definitions.--In this section--
                    ``(A) the term `meaningful disruption'--
                            ``(i) means a change in production that is 
                        reasonably likely to lead to a reduction in the 
                        supply of an essential device by a manufacturer 
                        that is more than negligible and affects the 
                        ability of the manufacturer to fill orders or 
                        meet expected demand for its product; and
                            ``(ii) does not include interruptions in 
                        manufacturing due to matters such as routine 
                        maintenance or insignificant changes in 
                        manufacturing so long as the manufacturer 
                        expects to resume operations in a short period 
                        of time; and
                    ``(B) the term `shortage', with respect to an 
                essential device, means a period of time when the 
                demand or projected demand for the device within the 
                United States exceeds the supply of the device.
    ``(h) Annual Report.--The Secretary shall publish a public list, 
updated annually, of medical devices--
            ``(1) approved under section 515, cleared under section 
        510(k), or for which an exemption is granted under subsection 
        (l) or (m) of section 510; and
            ``(2) meeting the definition of `essential device' as 
        described in subsection (g)(1).''.

SEC. 3. DRUG AND ESSENTIAL DEVICE SHORTAGE LIST.

    Section 506E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356e) is amended--
            (1) in the heading, by inserting ``and essential device'' 
        after ``drug'';
            (2) in subsection (a), by inserting ``and essential devices 
        (as such term is defined pursuant to section 506J(g)(1))'' 
        after ``drugs'';
            (3) in subsection (b)--
                    (A) in the matter preceding paragraph (1), by 
                inserting ``and each essential device'' after ``drug'';
                    (B) by amending paragraph (1) to read as follows:
            ``(1) The name of the drug or essential device in shortage, 
        including, with respect to a drug, the National Drug Code 
        number, or, with respect to an essential device, the unique 
        device identifier or national product code, if applicable.''; 
        and
                    (C) in paragraph (3)--
                            (i) by amending subparagraph (E) to read as 
                        follows:
                    ``(E) Discontinuance of the manufacture of the drug 
                or essential device.''; and
                            (ii) in each of subparagraphs (F) and (G), 
                        by inserting ``or essential device'' before the 
                        period; and
            (4) in subsection (c)(3)--
                    (A) by striking ``or section 506C(c)'' and 
                inserting ``, section 506C(c), or section 506J(c)''; 
                and
                    (B) by inserting ``or essential devices'' after 
                ``drug products''.

SEC. 4. GAO REPORT ON INTRA-AGENCY COORDINATION.

    (a) In General.--Not later than 18 months after the date of 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives a report examining the Food and Drug Administration's 
intra-agency coordination, communication, and decision making in 
assessing device shortages and risks associated with the supply of 
essential devices, and any efforts by the Food and Drug Administration 
to mitigate any essential device shortages or to take corrective 
actions.
    (b) Content.--The report shall include--
            (1) consideration of--
                    (A) risks associated with violations of current 
                good manufacturing practices;
                    (B) corrective and preventative actions with 
                respect to such violations requested by the Food and 
                Drug Administration;
                    (C) the effects of potential manufacturing 
                disruptions or shut-downs on potential essential device 
                shortages, including the discontinuance of essential 
                device manufacturing and marketing;
                    (D) efforts to prioritize review of applications 
                for essential devices that the Secretary has determined 
                under section 506E of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 356e) to be in shortage; and
                    (E) efforts to prioritize inspections of facilities 
                necessary for approval or clearance of essential 
                devices described in subparagraph (D);
            (2) a description of how the Food and Drug Administration 
        proactively coordinates strategies to mitigate the consequences 
        of the violations, slow-downs, and shut-downs described in 
        paragraph (1) across agencies; and
            (3) an evaluation of changes in relevant Food and Drug 
        Administration practices that such agency has proposed but not 
        yet implemented.
    (c) Definition.--In this section, the term ``essential device'' has 
the meaning given such term under section 506J(g)(1) of the Federal 
Food, Drug, and Cosmetic Act, as added by section 2.
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