Title: Safeguarding Therapeutics Act of 2020
Policy area: Health

Summary:
Safeguarding Therapeutics Act of 2020
This bill authorizes the Food and Drug Administration to destroy imported counterfeit medical devices.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4225 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 4225

   To establish authority to destroy counterfeit devices offered for 
                    import, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 20, 2020

 Mr. Enzi (for himself and Ms. Hassan) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To establish authority to destroy counterfeit devices offered for 
                    import, 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 ``Safeguarding Therapeutics Act of 
2020''.

SEC. 2. AUTHORITY TO DESTROY COUNTERFEIT DEVICES.

    (a) In General.--Section 801(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)) is amended--
            (1) in the fourth sentence, by inserting ``or counterfeit 
        device'' after ``counterfeit drug''; and
            (2) by striking ``The Secretary of the Treasury shall cause 
        the destruction of'' and all that follows through ``liable for 
        costs pursuant to subsection (c).'' and inserting the 
        following: ``The Secretary of the Treasury shall cause the 
        destruction of any such article refused admission unless such 
        article is exported, under regulations prescribed by the 
        Secretary of the Treasury, within 90 days of the date of notice 
        of such refusal or within such additional time as may be 
        permitted pursuant to such regulations, except that the 
        Secretary of Health and Human Services may destroy, without the 
        opportunity for export, any drug or device refused admission 
        under this section, if such drug or device is valued at an 
        amount that is $2,500 or less (or such higher amount as the 
        Secretary of the Treasury may set by regulation pursuant to 
        section 498(a)(1) of the Tariff Act of 1930 (19 U.S.C. 
        1498(a)(1))) and was not brought into compliance as described 
        under subsection (b). The Secretary of Health and Human 
        Services shall issue regulations providing for notice and an 
        opportunity to appear before the Secretary of Health and Human 
        Services and introduce testimony, as described in the first 
        sentence of this subsection, on destruction of a drug or device 
        under the seventh sentence of this subsection. The regulations 
        shall provide that prior to destruction, appropriate due 
        process is available to the owner or consignee seeking to 
        challenge the decision to destroy the drug or device. Where the 
        Secretary of Health and Human Services provides notice and an 
        opportunity to appear and introduce testimony on the 
        destruction of a drug or device, the Secretary of Health and 
        Human Services shall store and, as applicable, dispose of the 
        drug or device after the issuance of the notice, except that 
        the owner and consignee shall remain liable for costs pursuant 
        to subsection (c).''.
    (b) Definition.--Section 201(h) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(h)) is amended--
            (1) by redesignating subparagraphs (1), (2), and (3) as 
        clauses (A), (B), and (C), respectively; and
            (2) after making such redesignations--
                    (A) by striking ``(h) The term'' and inserting 
                ``(h)(1) The term''; and
                    (B) by adding at the end the following:
    ``(2) The term `counterfeit device' means a device which, or the 
container, packaging, or labeling of which, without authorization, 
bears a trademark, trade name, or other identifying mark, imprint, or 
symbol, or any likeness thereof, or is manufactured using a design, of 
a device manufacturer, packer, or distributor other than the person or 
persons who in fact manufactured, packed, or distributed such device 
and which thereby falsely purports or is represented to be the product 
of, or to have been packed or distributed by, such other device 
manufacturer, packer, or distributor.
    ``(3) For purposes of subparagraph (2)--
            ``(A) the term `manufactured' refers to any of the 
        following activities: manufacture, preparation, propagation, 
        compounding, assembly, or processing; and
            ``(B) the term `manufacturer' means a person who is engaged 
        in any of the activities listed in clause (A).''.
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