[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1961 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
1st Session
S. 1961
To require an interagency risk assessment of the pharmaceutical supply
chain to identify and mitigate health and national security risks, and
for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 13, 2023
Mr. Peters (for himself and Ms. Ernst) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To require an interagency risk assessment of the pharmaceutical supply
chain to identify and mitigate health and national security risks, 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 ``Pharmaceutical Supply Chain Risk
Assessment Act of 2023''.
SEC. 2. RISK ASSESSMENT.
(a) In General.--The Secretary of Health and Human Services shall
lead, in coordination with the Secretary of Defense, the Secretary of
Homeland Security, and the Director of the Office of Pandemic
Preparedness and Response Policy, a comprehensive risk assessment of
the United States pharmaceutical supply chain and report to the
relevant committees of Congress on the findings of each such
assessment. The assessment shall be completed not later than 18 months
after the date of enactment of this Act, and shall be updated annually
thereafter.
(b) Contents.--At a minimum, the risk assessment under subsection
(a) shall--
(1) use, as applicable, any drugs from the essential
medicines list developed by the Food and Drug Administration in
response to Executive Order 13944 (85 Fed. Reg. 49929) and any
other relevant assessments or lists, as appropriate, to
identify, in coordination with the private sector, a list of
essential medicines, to be updated regularly on a timeframe
that the Secretary of Health and Human Services, in
coordination with the Secretary of Defense and the Secretary of
Homeland Security, determines appropriate, which shall include
the active pharmaceutical ingredients and drugs that--
(A) are reasonably likely to be required to respond
to a public health emergency or to a chemical,
biological, radiological, or nuclear threat; or
(B) the shortage of which would pose a significant
threat to the United States health care system or at-
risk populations;
(2) identify, for each of the active pharmaceutical
ingredients and drugs that are identified under paragraph (1)--
(A) the active pharmaceutical ingredients and drugs
with vulnerable supply chains;
(B) the amount manufactured by each establishment
registered under section 510(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(b)), as reported
under section 510(j)(3) of such Act (21 U.S.C.
360(j)(3)), or, with respect to any active
pharmaceutical ingredient or drug for which such
information is unavailable, an explanation for why the
information is unavailable;
(C) the drugs that are sourced either exclusively
or primarily from foreign establishments, including
drugs manufactured domestically from active
pharmaceutical ingredients sourced exclusively or
primarily from foreign establishments; and
(D) the active pharmaceutical ingredients that are
sourced either exclusively or primarily from foreign
establishments;
(3) assess key starting materials and excipients used in
manufacturing the active pharmaceutical ingredients and drugs
identified under paragraph (1);
(4) assess current domestic manufacturing capabilities with
respect to drugs (including key starting materials, excipients,
and active pharmaceutical ingredients) identified under
paragraph (1), including advanced manufacturing capabilities;
(5) identify critical vulnerabilities, including
cybersecurity threats;
(6) identify the existing statutory authorities the
Department of Defense, the Department of Health and Human
Services, and the Department of Homeland Security have to
address public health or national security risks that may arise
as a result of vulnerabilities in the pharmaceutical supply
chain; and
(7) identify any deficiencies, lack of authorities, or
limitations in policy or process that limit the ability of any
of the departments described in paragraph (6) to address
vulnerabilities in the pharmaceutical supply chain identified
in the risk assessment, and describe the plans of the
departments described in paragraph (6) to mitigate such
vulnerabilities.
(c) Publication of Assessment.--The risk assessment under
subsection (a) (including any updates) shall be publicly available in
an unclassified form but may include a classified annex containing any
information that the Secretary of Health and Human Services determines
to be sensitive.
(d) Definitions.--In this section:
(1) Advanced manufacturing.--The term ``advanced
manufacturing'' has the meaning given the term ``advanced and
continuous pharmaceutical manufacturing'' in section 3016(h) of
the 21st Century Cures Act (21 U.S.C. 399h(h)).
(2) Cybersecurity threat.--The term ``cybersecurity
threat'' has the meaning given such term in section 2200 of the
Homeland Security Act of 2002 (6 U.S.C. 650).
(3) Drug.--The term ``drug'' has the meaning given such
term in section 201(g) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(g)).
(4) Relevant committees of congress.--The term ``relevant
committees of Congress'' means the Committee on Homeland
Security and Governmental Affairs, the Committee on Health,
Education, Labor, and Pensions, and the Committee on Armed
Services of the Senate and the Committee on Homeland Security,
the Committee on Energy and Commerce, and the Committee on
Armed Services of the House of Representatives.
(e) Clarification.--The participation of the Secretary of Health
and Human Services in developing and updating the list of essential
medicines under subsection (b)(1) shall be deemed to be full
satisfaction of the requirements applicable to such secretary under
section 3 of Executive Order 13944 (85 Fed. Reg. 49929).
<all>