Title: Medical Supply Chain Security Act
Policy area: Health

Summary:
Medical Supply Chain Security Act
This bill requires manufacturers of essential medical devices (i.e., those that are life supporting, life-sustaining, or intended for use for a debilitating disease or condition) to notify the Food and Drug Administration (FDA) if the device is discontinued or if there is any meaningful disruption to the device's manufacturing. The bill also authorizes the FDA to expedite review of such a device to mitigate or prevent a shortage.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3343 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 3343

 To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced 
                 security for the medical supply chain.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           February 27, 2020

  Mr. Hawley introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced 
                 security for the medical supply chain.

    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 ``Medical Supply Chain Security Act''.

SEC. 2. MEDICAL SUPPLY CHAIN SECURITY.

    (a) Additional Manufacturer Reporting for Essential Medical 
Devices.--Section 506C of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 356c) is amended--
            (1) in subsection (a)--
                    (A) in the matter preceding paragraph (1), by 
                inserting ``or device'' after ``a drug''; and
                    (B) in the flush matter by inserting ``or device'' 
                after ``drug'' each place such term appears;
            (2) in subsection (c), by inserting ``and devices'' after 
        ``drugs'';
            (3) in subsection (g)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``drug shortage of a drug'' and inserting 
                ``shortage of a drug or device'';
                    (B) in paragraph (1), by striking ``; or'' and 
                inserting a semicolon;
                    (C) by redesignating paragraph (2) as paragraph 
                (3);
                    (D) by inserting after paragraph (1) the following:
            ``(2) expedite the review of a device subject to premarket 
        approval under section 515 that could help mitigate or prevent 
        such shortage; or''; and
                    (E) in paragraph (3), as so redesignated, by 
                striking ``drug shortage'' and inserting ``shortage'';
            (4) in subsection (h)--
                    (A) by amending paragraph (2) to read as follows:
            ``(2) the term `shortage', with respect to a drug or 
        device, means a period of time when the demand or projected 
        demand for the drug or device within the United States exceeds 
        the supply of the drug or device; and''; and
                    (B) in paragraph (3)(A), by inserting ``or device'' 
                after ``drug''; and
            (5) by adding at the end the following:
    ``(j) Additional Manufacturer Reporting for Essential Drugs and 
Devices.--Each manufacturer of a drug or device described in subsection 
(a) shall provide to the Food and Drug Administration, on an annual 
basis, or more frequently at the request of the Secretary, information 
related to the manufacturing capacity of such drug or device. Such 
information shall include--
            ``(1) details about--
                    ``(A) all locations of production;
                    ``(B) the sourcing of all component parts;
                    ``(C) the sourcing of any active pharmaceutical 
                ingredients; and
                    ``(D) the use of any scarce raw materials; and
            ``(2) any other information determined by the Secretary to 
        be relevant to the security of the supply chain of the drug or 
        device.''.
    (b) Provision of Additional Information.--Section 506C-1 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c-1) is amended--
            (1) in the heading, by striking ``drug shortages'' and 
        inserting ``drug or device shortages'';
            (2) by striking ``drug shortages'' each place it appears 
        and inserting ``drug or device shortages'';
            (3) in subsection (a)--
                    (A) in paragraph (3)(B)--
                            (i) in clause (i), by striking ``section 
                        506C(g)(1)'' and inserting ``paragraph (1) or 
                        (2) of section 506C(g)''; and
                            (ii) in clause (ii), by striking ``section 
                        506C(g)(2)'' and inserting ``section 
                        506C(g)(3)''; and
                    (B) in paragraph (5), by striking ``drug shortage'' 
                and inserting ``drug or device shortage''; and
            (4) in subsection (c), by striking ```drug shortage' or''.
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