[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>