Title: Safeguarding Therapeutics Act
Policy area: Health

Summary:
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]
[H.R. 5663 Introduced in House (IH)]

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116th CONGRESS
  2d Session
                                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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 21, 2020

Mr. Guthrie (for himself and Mr. Engel) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
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.

    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''.

SEC. 2. AUTHORITY TO DESTROY COUNTERFEIT DEVICES.

    Section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(a)) is amended--
            (1) in the fourth sentence insert ``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 ninety 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).''.
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