What This Bill Does
This bill directs the Secretary of Health and Human Services to work with other officials to review how well the United States can manufacture biopharmaceuticals (medicines made from biological sources) domestically. The bill asks for recommendations on improving manufacturing technology and identifying ways to strengthen public health preparedness and the nation's ability to respond to medical emergencies. (Sec. 2)
Who It Affects
The Secretary of Health and Human Services. The Director of the Biomedical Advanced Research and Development Authority. The National Institute for Innovation in Manufacturing Biopharmaceuticals. The Department of Health and Human Services.
Key Provisions
• The National Institute for Innovation in Manufacturing Biopharmaceuticals will review the current capacity of the Department of Health and Human Services to manufacture biopharmaceuticals and how well it can adapt to different threats. (Sec. 2(b)(1))
• The institute will create recommendations for developing, demonstrating, deploying and advancing new domestic biopharmaceutical manufacturing technologies to fill gaps discovered during the review, including technologies developed by the federal government and private companies. (Sec. 2(b)(2))
• The institute will identify additional opportunities and priorities to improve United States public health, medical preparedness and response capabilities, and domestic biopharmaceutical manufacturing capabilities. (Sec. 2(b)(3))
What Changes
If this becomes law, the Secretary of Health and Human Services will enter into an agreement to have a comprehensive review conducted of domestic biopharmaceutical manufacturing capabilities and receive formal recommendations for improvements.
Important Definitions
None defined in bill text.
II
118TH CONGRESS
1ST SESSION
S. 36
To review domestic biopharmaceutical manufacturing capabilities in order
to improve public health and medical preparedness and response capabili-
ties and domestic biopharmaceutical manufacturing capabilities.
IN THE SENATE OF THE UNITED STATES
JANUARY 24 (legislative day, JANUARY 3), 2023
Mr. RUBIO (for himself and Mr. COONS) introduced the following bill; which
was read twice and referred to the Committee on Health, Education,
Labor, and Pensions
A BILL
To review domestic biopharmaceutical manufacturing capa-
bilities in order to improve public health and medical
preparedness and response capabilities and domestic bio-
pharmaceutical manufacturing capabilities.
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 ‘‘Agility in Manufac-
4
turing Preparedness Act of 2023’’.
5
VerDate Sep 11 2014
03:00 Jan 27, 2023
Jkt 039200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\S36.IS
S36
pbinns on DSKJLVW7X2PROD with $$_JOB
2
•S 36 IS
SEC. 2. REVIEW OF DOMESTIC BIOPHARMACEUTICAL MAN-
1
UFACTURING CAPABILITIES.
2
(a) IN GENERAL.—The Secretary of Health and
3
Human Services (referred to in this section as the ‘‘Sec-
4
retary’’), in cooperation with the Director of the Bio-
5
medical Advanced Research and Development Authority,
6
shall seek to enter into an agreement with the National
7
Institute for Innovation in Manufacturing Biopharma-
8
ceuticals to perform the services described in subsection
9
(b).
10
(b) REVIEW
AND RECOMMENDATIONS.—Under an
11
agreement described in subsection (a) between the Sec-
12
retary, the Director of the Biomedical Advanced Research
13
and Development Authority, and the National Institute for
14
Innovation in Manufacturing Biopharmaceuticals, the Na-
15
tional Institute for Innovation in Manufacturing Bio-
16
pharmaceuticals shall—
17
(1) review current domestic biopharmaceutical
18
manufacturing capacity at the Department of
19
Health and Human Services and such department’s
20
adaptability to various threats;
21
(2) draft recommendations for developing, dem-
22
onstrating, deploying, and advancing new domestic
23
biopharmaceutical manufacturing technologies that
24
address gaps identified under paragraph (1) and
25
align Federal technologies with technologies avail-
26
VerDate Sep 11 2014
03:00 Jan 27, 2023
Jkt 039200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\S36.IS
S36
pbinns on DSKJLVW7X2PROD with $$_JOB
3
•S 36 IS
able to the private sector, including through the new
1
BioMAP initiative of the Biomedical Advanced Re-
2
search and Development Authority; and
3
(3) identify other opportunities and priorities to
4
improve the United States public health and medical
5
preparedness and response capabilities and domestic
6
biopharmaceutical manufacturing capabilities.
7
Æ
VerDate Sep 11 2014
03:00 Jan 27, 2023
Jkt 039200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6301
E:\BILLS\S36.IS
S36
pbinns on DSKJLVW7X2PROD with $$_JOB