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II
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, Edu-
cation, 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 cir-
cumstance that could lead to a shortage of such devices,
and for other purposes.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Preventing Essential
4
Medical Device Shortages Act of 2020’’.
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•S 3468 IS
SEC. 2. DISCONTINUANCE OR INTERRUPTION IN THE PRO-
1
DUCTION OF ESSENTIAL MEDICAL DEVICES.
2
Chapter V of the Federal Food, Drug, and Cosmetic
3
Act (21 U.S.C. 351 et seq.) is amended by inserting after
4
section 506I the following:
5
‘‘SEC. 506J. DISCONTINUANCE OR INTERRUPTION IN THE
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PRODUCTION OF ESSENTIAL MEDICAL DE-
7
VICES.
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‘‘(a) IN GENERAL.—The manufacturer of an essen-
9
tial device shall notify the Secretary, in accordance with
10
subsection (b), of a permanent discontinuance in the man-
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ufacture of the essential device or an interruption of the
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manufacture of the essential device that is likely to lead
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to a meaningful disruption in the supply of that device
14
in the United States, and the reasons for such discontinu-
15
ance or interruption.
16
‘‘(b) TIMING.—A notice required under subsection (a)
17
shall be submitted to the Secretary—
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‘‘(1) at least 6 months prior to the date of the
19
discontinuance or interruption; or
20
‘‘(2) if compliance with paragraph (1) is not
21
possible, as soon as practicable.
22
‘‘(c) DISTRIBUTION.—
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‘‘(1) PUBLIC AVAILABILITY.—To the maximum
24
extent practicable, subject to paragraph (2), the Sec-
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retary shall distribute, through such means as the
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•S 3468 IS
Secretary determines appropriate, information on
1
the discontinuance or interruption of the manufac-
2
ture of essential devices reported under subsection
3
(a) to appropriate organizations, including physician,
4
health provider, and patient organizations, as appro-
5
priate and applicable.
6
‘‘(2) PUBLIC HEALTH EXCEPTION.—The Sec-
7
retary may choose not to make information collected
8
under this section publicly available pursuant to this
9
section if the Secretary determines that disclosure of
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such information would adversely affect the public
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health, such as by increasing the possibility of
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hoarding or other disruption of the availability of
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drug products to patients.
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‘‘(d) CONFIDENTIALITY.—Nothing in this section
15
shall be construed as authorizing the Secretary to disclose
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any information that is a trade secret or confidential infor-
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mation subject to section 552(b)(4) of title 5, United
18
States Code, or section 1905 of title 18, United States
19
Code.
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‘‘(e) FAILURE TO MEET REQUIREMENTS.—If a per-
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son fails to submit information required under subsection
22
(a) in accordance with subsection (b)—
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‘‘(1) the Secretary shall issue a letter to such
24
person informing such person of such failure;
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‘‘(2) not later than 30 calendar days after the
1
issuance of a letter under paragraph (1), the person
2
who receives such letter shall submit to the Sec-
3
retary a written response to such letter setting forth
4
the basis for noncompliance and providing informa-
5
tion required under subsection (a); and
6
‘‘(3) not later than 45 calendar days after the
7
issuance of a letter under paragraph (1), the Sec-
8
retary shall make such letter and any response to
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such letter under paragraph (2) available to the pub-
10
lic on the internet website of the Food and Drug Ad-
11
ministration, with appropriate redactions made to
12
protect information described in subsection (d), ex-
13
cept that, if the Secretary determines that the letter
14
under paragraph (1) was issued in error or, after re-
15
view of such response, the person had a reasonable
16
basis for not notifying as required under subsection
17
(a), the requirements of this paragraph shall not
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apply.
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‘‘(f) EXPEDITED INSPECTIONS AND REVIEWS.—If,
20
based on notifications described in subsection (a) or any
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other relevant information, the Secretary concludes that
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there is, or is likely to be, a shortage of an essential device,
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the Secretary may—
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‘‘(1) expedite the review of an application for
1
premarket review under section 515 or review of a
2
notification under section 510(k) for a device that
3
could help mitigate or prevent such shortage; or
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‘‘(2) expedite an inspection or reinspection of
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an establishment that could help mitigate or prevent
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such shortage.
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‘‘(g) DEFINITIONS.—
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‘‘(1) ESSENTIAL DEVICE.—
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‘‘(A) IN
GENERAL.—Not later than 180
10
days after the date of enactment of the Pre-
11
venting Essential Medical Device Shortages Act
12
of 2020, the Secretary shall, for the purposes of
13
this section, promulgate a notice of proposed
14
rulemaking defining the term ‘essential device’
15
and shall, not later than 1 year after such date
16
of enactment, promulgate final regulations de-
17
fining such term.
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‘‘(B) ESSENTIAL DEVICES DURING PUBLIC
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HEALTH EMERGENCIES.—Upon declaration by
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the Secretary of a public health emergency
21
under section 319 of the Public Health Service
22
Act, the Secretary shall issue a list of devices
23
deemed essential devices for the purpose of en-
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suring the public health and safety for the du-
1
ration of the declared public health emergency.
2
‘‘(2) OTHER DEFINITIONS.—In this section—
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‘‘(A) the term ‘meaningful disruption’—
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‘‘(i) means a change in production
5
that is reasonably likely to lead to a reduc-
6
tion in the supply of an essential device by
7
a manufacturer that is more than neg-
8
ligible and affects the ability of the manu-
9
facturer to fill orders or meet expected de-
10
mand for its product; and
11
‘‘(ii) does not include interruptions in
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manufacturing due to matters such as rou-
13
tine maintenance or insignificant changes
14
in manufacturing so long as the manufac-
15
turer expects to resume operations in a
16
short period of time; and
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‘‘(B) the term ‘shortage’, with respect to
18
an essential device, means a period of time
19
when the demand or projected demand for the
20
device within the United States exceeds the
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supply of the device.
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‘‘(h) ANNUAL REPORT.—The Secretary shall publish
23
a public list, updated annually, of medical devices—
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‘‘(1) approved under section 515, cleared under
1
section 510(k), or for which an exemption is granted
2
under subsection (l) or (m) of section 510; and
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‘‘(2) meeting the definition of ‘essential device’
4
as described in subsection (g)(1).’’.
5
SEC. 3. DRUG AND ESSENTIAL DEVICE SHORTAGE LIST.
6
Section 506E of the Federal Food, Drug, and Cos-
7
metic Act (21 U.S.C. 356e) is amended—
8
(1) in the heading, by inserting ‘‘AND ESSEN-
9
TIAL DEVICE’’ after ‘‘DRUG’’;
10
(2) in subsection (a), by inserting ‘‘and essen-
11
tial devices (as such term is defined pursuant to sec-
12
tion 506J(g)(1))’’ after ‘‘drugs’’;
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(3) in subsection (b)—
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(A) in the matter preceding paragraph (1),
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by inserting ‘‘and each essential device’’ after
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‘‘drug’’;
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(B) by amending paragraph (1) to read as
18
follows:
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‘‘(1) The name of the drug or essential device
20
in shortage, including, with respect to a drug, the
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National Drug Code number, or, with respect to an
22
essential device, the unique device identifier or na-
23
tional product code, if applicable.’’; and
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(C) in paragraph (3)—
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(i) by amending subparagraph (E) to
1
read as follows:
2
‘‘(E) Discontinuance of the manufacture of
3
the drug or essential device.’’; and
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(ii) in each of subparagraphs (F) and
5
(G), by inserting ‘‘or essential device’’ be-
6
fore the period; and
7
(4) in subsection (c)(3)—
8
(A) by striking ‘‘or section 506C(c)’’ and
9
inserting
‘‘,
section
506C(c),
or
section
10
506J(c)’’; and
11
(B) by inserting ‘‘or essential devices’’
12
after ‘‘drug products’’.
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SEC. 4. GAO REPORT ON INTRA-AGENCY COORDINATION.
14
(a) IN GENERAL.—Not later than 18 months after
15
the date of enactment of this Act, the Comptroller General
16
of the United States shall submit to the Committee on
17
Health, Education, Labor, and Pensions of the Senate and
18
the Committee on Energy and Commerce of the House
19
of Representatives a report examining the Food and Drug
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Administration’s intra-agency coordination, communica-
21
tion, and decision making in assessing device shortages
22
and risks associated with the supply of essential devices,
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and any efforts by the Food and Drug Administration to
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mitigate any essential device shortages or to take correc-
1
tive actions.
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(b) CONTENT.—The report shall include—
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(1) consideration of—
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(A) risks associated with violations of cur-
5
rent good manufacturing practices;
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(B) corrective and preventative actions
7
with respect to such violations requested by the
8
Food and Drug Administration;
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(C) the effects of potential manufacturing
10
disruptions or shut-downs on potential essential
11
device shortages, including the discontinuance
12
of essential device manufacturing and mar-
13
keting;
14
(D) efforts to prioritize review of applica-
15
tions for essential devices that the Secretary
16
has determined under section 506E of the Fed-
17
eral Food, Drug, and Cosmetic Act (21 U.S.C.
18
356e) to be in shortage; and
19
(E) efforts to prioritize inspections of fa-
20
cilities necessary for approval or clearance of
21
essential devices described in subparagraph (D);
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(2) a description of how the Food and Drug
23
Administration proactively coordinates strategies to
24
mitigate the consequences of the violations, slow-
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downs, and shut-downs described in paragraph (1)
1
across agencies; and
2
(3) an evaluation of changes in relevant Food
3
and Drug Administration practices that such agency
4
has proposed but not yet implemented.
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(c) DEFINITION.—In this section, the term ‘‘essential
6
device’’ has the meaning given such term under section
7
506J(g)(1) of the Federal Food, Drug, and Cosmetic Act,
8
as added by section 2.
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Æ
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