[Congressional Record Volume 166, Number 207 (Tuesday, December 8, 2020)]
[Senate]
[Page S7284]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           TEXT OF AMENDMENTS

  SA 2694. Mr. PORTMAN (for Mr. Alexander) proposed an amendment to the 
bill H.R. 5663, to amend the Federal Food, Drug, and Cosmetic Act to 
give authority to the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, to destroy counterfeit 
devices; as follows:

        Strike all after the enacting clause and insert the 
     following:

     SECTION 1. SHORT TITLE.

        This Act may be cited as the ``Safeguarding Therapeutics 
     Act''.

     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 or imprint, or any likeness thereof, or is 
     manufactured using a design, of a device manufacturer, 
     processor, packer, or distributor other than the person or 
     persons who in fact manufactured, processed, 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, processor, 
     packer, or distributor.''.

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