Safeguarding Therapeutics Act of 2020

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. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Safeguarding Thera- 4 peutics Act of 2020’’. 5 SEC. 2. AUTHORITY TO DESTROY COUNTERFEIT DEVICES. 6 (a) IN GENERAL.—Section 801(a) of the Federal 7 Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is 8 amended— 9 VerDate Sep 11 2014 03:08 Jul 25, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4225.IS S4225 kjohnson on DSK79L0C42PROD with BILLS 2 •S 4225 IS (1) in the fourth sentence, by inserting ‘‘or 1 counterfeit device’’ after ‘‘counterfeit drug’’; and 2 (2) by striking ‘‘The Secretary of the Treasury 3 shall cause the destruction of’’ and all that follows 4 through ‘‘liable for costs pursuant to subsection 5 (c).’’ and inserting the following: ‘‘The Secretary of 6 the Treasury shall cause the destruction of any such 7 article refused admission unless such article is ex- 8 ported, under regulations prescribed by the Sec- 9 retary of the Treasury, within 90 days of the date 10 of notice of such refusal or within such additional 11 time as may be permitted pursuant to such regula- 12 tions, except that the Secretary of Health and 13 Human Services may destroy, without the oppor- 14 tunity for export, any drug or device refused admis- 15 sion under this section, if such drug or device is val- 16 ued at an amount that is $2,500 or less (or such 17 higher amount as the Secretary of the Treasury may 18 set by regulation pursuant to section 498(a)(1) of 19 the Tariff Act of 1930 (19 U.S.C. 1498(a)(1))) and 20 was not brought into compliance as described under 21 subsection (b). The Secretary of Health and Human 22 Services shall issue regulations providing for notice 23 and an opportunity to appear before the Secretary 24 of Health and Human Services and introduce testi- 25 VerDate 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 mony, as described in the first sentence of this sub- 1 section, on destruction of a drug or device under the 2 seventh sentence of this subsection. The regulations 3 shall provide that prior to destruction, appropriate 4 due process is available to the owner or consignee 5 seeking to challenge the decision to destroy the drug 6 or device. Where the Secretary of Health and 7 Human Services provides notice and an opportunity 8 to appear and introduce testimony on the destruc- 9 tion of a drug or device, the Secretary of Health and 10 Human Services shall store and, as applicable, dis- 11 pose of the drug or device after the issuance of the 12 notice, except that the owner and consignee shall re- 13 main liable for costs pursuant to subsection (c).’’. 14 (b) DEFINITION.—Section 201(h) of the Federal 15 Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)) is 16 amended— 17 (1) by redesignating subparagraphs (1), (2), 18 and (3) as clauses (A), (B), and (C), respectively; 19 and 20 (2) after making such redesignations— 21 (A) by striking ‘‘(h) The term’’ and insert- 22 ing ‘‘(h)(1) The term’’; and 23 (B) by adding at the end the following: 24 VerDate Sep 11 2014 03:08 Jul 25, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4225.IS S4225 kjohnson on DSK79L0C42PROD with BILLS 4 •S 4225 IS ‘‘(2) The term ‘counterfeit device’ means a device 1 which, or the container, packaging, or labeling of which, 2 without authorization, bears a trademark, trade name, or 3 other identifying mark, imprint, or symbol, or any likeness 4 thereof, or is manufactured using a design, of a device 5 manufacturer, packer, or distributor other than the person 6 or persons who in fact manufactured, packed, or distrib- 7 uted such device and which thereby falsely purports or is 8 represented to be the product of, or to have been packed 9 or distributed by, such other device manufacturer, packer, 10 or distributor. 11 ‘‘(3) For purposes of subparagraph (2)— 12 ‘‘(A) the term ‘manufactured’ refers to any of 13 the following activities: manufacture, preparation, 14 propagation, compounding, assembly, or processing; 15 and 16 ‘‘(B) the term ‘manufacturer’ means a person 17 who is engaged in any of the activities listed in 18 clause (A).’’. 19 Æ VerDate Sep 11 2014 03:08 Jul 25, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S4225.IS S4225 kjohnson on DSK79L0C42PROD with BILLS