Safeguarding Therapeutics Act

Bill: 116-hr-5663
Sponsor: full_name: Rep. Guthrie, Brett [R-KY-2]
Introduced: 2020-01-21
Policy area: Health
Subjects: Administrative law and regulatory procedures

Administrative remedies

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Due process and equal protection

Evidence and witnesses

Health technology, devices, supplies

Product safety and quality

Trade restrictions
Latest action: action_date: 2021-01-05
text: Became Public Law No: 116-304.

Summaries:
action_date: 2020-01-21
action_desc: Introduced in House
text: <div><b><br /></b></div> <div><b>Safeguarding Therapeutics Act</b></div> <p>This bill authorizes the Food and Drug Administration to destroy imported counterfeit medical devices.</p>

action_date: 2021-01-05
action_desc: Public Law
text: <p><strong>Safeguarding Therapeutics Act</strong></p> <p>This bill authorizes the Food and Drug Administration to destroy imported counterfeit medical devices.</p>

tv_txt: I 116th CONGRESS 2d Session H. R. 5663 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.

1. Short title This Act may be cited as the Safeguarding Therapeutics Act . 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). .

tv_txt: I 116th CONGRESS 2d Session H. R. 5663 IN THE HOUSE OF REPRESENTATIVES AN ACT 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.

1. Short title This Act may be cited as the Safeguarding Therapeutics Act . 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). . 3. Determination of budgetary effects The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled Budgetary Effects of PAYGO Legislation for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.

Passed the House of Representatives September 21, 2020. Cheryl L. Johnson, Clerk.

tv_txt: IIB 116th CONGRESS 2d Session H. R. 5663 IN THE SENATE OF THE UNITED STATES September 22, 2020 Received; read twice and referred to the Committee on Health, Education, Labor, and Pensions AN ACT 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.

1. Short title This Act may be cited as the Safeguarding Therapeutics Act . 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). . 3. Determination of budgetary effects The budgetary effects of this Act, for the purpose of complying with the Statutory Pay-As-You-Go Act of 2010, shall be determined by reference to the latest statement titled Budgetary Effects of PAYGO Legislation for this Act, submitted for printing in the Congressional Record by the Chairman of the House Budget Committee, provided that such statement has been submitted prior to the vote on passage.

Passed the House of Representatives September 21, 2020. Cheryl L. Johnson, Clerk.

tv_txt: IB Union Calendar No. 412 116th CONGRESS 2d Session H. R. 5663 [Report No. 116–512] 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 September 17, 2020 Additional sponsor: Mr. Balderson September 17, 2020 Reported with an amendment; committed to the Committee of the Whole House on the State of the Union and ordered to be printed Strike out all after the enacting clause and insert the part printed in italic For text of introduced bill, see copy of bill as introduced on January 21, 2020 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.

1. Short title This Act may be cited as the Safeguarding Therapeutics Act . 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). .

September 17, 2020 Reported with an amendment; committed to the Committee of the Whole House on the State of the Union and ordered to be printed

tv_txt: I One Hundred Sixteenth Congress of the United States of America At the Second Session Begun and held at the City of Washington on Friday, the third day of January, two thousand and twenty H. R. 5663 AN ACT 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.

1. Short title This Act may be cited as the Safeguarding Therapeutics Act . 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. .

Speaker of the House of Representatives. Vice President of the United States and President of the Senate.

tv_txt: 116th CONGRESS 2d Session H.R. 5663 In the Senate of the United States, December 8, 2020. Amendment:

That the bill from the House of Representatives (H.R. 5663) entitled An Act 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. , do pass with the following Strike all after the enacting clause and insert the following: 1. Short title This Act may be cited as the Safeguarding Therapeutics Act . 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. .

Secretary