Preventing Essential Medical Device Shortages Act of 2020
This bill requires manufacturers to notify the Food and Drug Administration (FDA) of potential disruptions to the supply of essential medical devices. Specifically, a manufacturer of an essential medical device must notify the FDA of a permanent discontinuance or temporary interruption that is likely to lead to a meaningful disruption in the supply of the device in the United States.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3468 Introduced in Senate (IS)]
<DOC>
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.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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