II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Safeguarding Thera5 peutics Act of 2020’’. 

6 SEC. 2. AUTHORITY TO DESTROY COUNTERFEIT DEVICES. 

7 (a) IN GENERAL.—Section 801(a) of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is 

9 amended— 


kjohnson on DSK79L0C42PROD with BILLS
2 

•S 4225 IS

1 (1) in the fourth sentence, by inserting ‘‘or 

2 counterfeit device’’ after ‘‘counterfeit drug’’; and 

3 (2) by striking ‘‘The Secretary of the Treasury 

4 shall cause the destruction of’’ and all that follows 

5 through ‘‘liable for costs pursuant to subsection 

6 (c).’’ and inserting the following: ‘‘The Secretary of 

7 the Treasury shall cause the destruction of any such 

8 article refused admission unless such article is ex9 ported, under regulations prescribed by the Sec10 retary of the Treasury, within 90 days of the date 

11 of notice of such refusal or within such additional 

12 time as may be permitted pursuant to such regula13 tions, except that the Secretary of Health and 

14 Human Services may destroy, without the oppor15 tunity for export, any drug or device refused admis16 sion under this section, if such drug or device is val17 ued at an amount that is $2,500 or less (or such 

18 higher amount as the Secretary of the Treasury may 

19 set by regulation pursuant to section 498(a)(1) of 

20 the Tariff Act of 1930 (19 U.S.C. 1498(a)(1))) and 

21 was not brought into compliance as described under 

22 subsection (b). The Secretary of Health and Human 

23 Services shall issue regulations providing for notice 

24 and an opportunity to appear before the Secretary 

25 of Health and Human Services and introduce testiVerDate Sep 11 2014 03:08 Jul 25, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4225.IS S4225

kjohnson on DSK79L0C42PROD with BILLS
3 

•S 4225 IS

1 mony, as described in the first sentence of this sub2 section, on destruction of a drug or device under the 

3 seventh sentence of this subsection. The regulations 

4 shall provide that prior to destruction, appropriate 

5 due process is available to the owner or consignee 

6 seeking to challenge the decision to destroy the drug 

7 or device. Where the Secretary of Health and 

8 Human Services provides notice and an opportunity 

9 to appear and introduce testimony on the destruc10 tion of a drug or device, the Secretary of Health and 

11 Human Services shall store and, as applicable, dis12 pose of the drug or device after the issuance of the 

13 notice, except that the owner and consignee shall re14 main liable for costs pursuant to subsection (c).’’. 

15 (b) DEFINITION.—Section 201(h) of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is 

17 amended— 

18 (1) by redesignating subparagraphs (1), (2), 

19 and (3) as clauses (A), (B), and (C), respectively; 

20 and 

21 (2) after making such redesignations— 

22 (A) by striking ‘‘(h) The term’’ and insert23 ing ‘‘(h)(1) The term’’; and 

24 (B) by adding at the end the following: 


kjohnson on DSK79L0C42PROD with BILLS
4 

•S 4225 IS

1 ‘‘(2) The term ‘counterfeit device’ means a device 

2 which, or the container, packaging, or labeling of which, 

3 without authorization, bears a trademark, trade name, or 

4 other identifying mark, imprint, or symbol, or any likeness 

5 thereof, or is manufactured using a design, of a device 

6 manufacturer, packer, or distributor other than the person 

7 or persons who in fact manufactured, packed, or distrib8 uted such device and which thereby falsely purports or is 

9 represented to be the product of, or to have been packed 

10 or distributed by, such other device manufacturer, packer, 

11 or distributor. 

12 ‘‘(3) For purposes of subparagraph (2)— 

13 ‘‘(A) the term ‘manufactured’ refers to any of 

14 the following activities: manufacture, preparation, 

15 propagation, compounding, assembly, or processing; 

16 and 

17 ‘‘(B) the term ‘manufacturer’ means a person 

18 who is engaged in any of the activities listed in 

19 clause (A).’’. 

Æ 


kjohnson on DSK79L0C42PROD with BILLS