[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3478 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 3478

To require a report to assess, evaluate, and address the dependence of 
the United States on critical drugs and devices sourced or manufactured 
                     outside of the United States.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 12, 2020

 Mr. Durbin (for himself, Mr. Alexander, Mrs. Murray, Mr. Romney, Mr. 
Jones, Mr. Blunt, Ms. Smith, Ms. Baldwin, Mr. Reed, Ms. Klobuchar, and 
Mr. Blumenthal) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To require a report to assess, evaluate, and address the dependence of 
the United States on critical drugs and devices sourced or manufactured 
                     outside of the United States.

    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 ``Commission on America's Medical 
Security Act''.

SEC. 2. NATIONAL ACADEMIES REPORT ON AMERICA'S MEDICAL PRODUCT SUPPLY 
              CHAIN SECURITY.

    (a) In General.--Not later than 60 days after the date of enactment 
of this Act, the Secretary of Health and Human Services shall enter 
into an agreement with the National Academies of Sciences, Engineering, 
and Medicine (referred to in this section as the ``National 
Academies'') to examine, and, in a manner that does not compromise 
national security, report on, the security of the United States medical 
product supply chain.
    (b) Purposes.--The report developed under this section shall--
            (1) assess and evaluate the dependence of the United 
        States, including the private commercial sector, States, and 
        the Federal Government, on critical drugs and devices that are 
        sourced or manufactured outside of the United States, which may 
        include an analysis of--
                    (A) the supply chain of critical drugs and devices 
                of greatest priority to providing health care;
                    (B) any potential public health security or 
                national security risks associated with reliance on 
                critical drugs and devices sourced or manufactured 
                outside of the United States, which may include 
                responses to previous or existing shortages or public 
                health emergencies, such as infectious disease 
                outbreaks, bioterror attacks, and other public health 
                threats;
                    (C) any existing supply chain information gaps, as 
                applicable; and
                    (D) potential economic impact of increased domestic 
                manufacturing; and
            (2) provide recommendations, which may include a plan to 
        improve the resiliency of the supply chain for critical drugs 
        and devices as described in paragraph (1), and to address any 
        supply vulnerabilities or potential disruptions of such 
        products that would significantly affect or pose a threat to 
        public health security or national security, as appropriate, 
        which may include strategies to--
                    (A) promote supply chain redundancy and contingency 
                planning;
                    (B) encourage domestic manufacturing, including 
                consideration of economic impacts, if any;
                    (C) improve supply chain information gaps;
                    (D) improve planning considerations for medical 
                product supply chain capacity during public health 
                emergencies; and
                    (E) promote the accessibility of such drugs and 
                devices.
    (c) Input.--In conducting the study and developing the report under 
subsection (b), the National Academies shall--
            (1) consider input from the Department of Health and Human 
        Services, the Department of Homeland Security, the Department 
        of Defense, the Department of Commerce, the Department of 
        State, the Department of Veterans Affairs, the Department of 
        Justice, and any other Federal agencies as appropriate; and
            (2) consult with relevant stakeholders, which may include 
        conducting public meetings and other forms of engagement, as 
        appropriate, with health care providers, medical professional 
        societies, State-based societies, public health experts, State 
        and local public health departments, State medical boards, 
        patient groups, medical product manufacturers, health care 
        distributors, wholesalers and group purchasing organizations, 
        pharmacists, and other entities with experience in health care 
        and public health, as appropriate.
    (d) Definitions.--In this section, the terms ``device'' and 
``drug'' have the meanings given such terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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