Safeguarding Therapeutics Act
Floor Speech
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Mrs. DINGELL. Madam Speaker, I move to suspend the rules and pass 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 amended.
The Clerk read the title of the bill.
The text of the bill is as follows: H.R. 5663
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.
(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).''. SEC. 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.
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Mrs. DINGELL. 5663.
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Mrs. DINGELL. Madam Speaker, I yield myself such time as I may consume.
Madam Speaker, I rise in strong support of H.R. 5663, the Safeguarding Therapeutics Act.
Madam Speaker, this legislation provides FDA additional authority to take action to protect public health and safety by extending the agency's administrative destruction authority for counterfeit medical devices, including diagnostic tests and surgical masks, as well as combination products, like vaccines, that may pose a threat to public health.
Given the global marketplace and extended supply chains for complex medical products, counterfeit medical devices are becoming increasingly common, both in the United States and abroad. These counterfeit products pose a significant risk to patient health and safety, and ensuring that FDA has the appropriate authority to take action by seizing and destroying counterfeit medical devices will help safeguard America's health.
Under current law, counterfeit medical devices and combination products are typically shipped back to the sender because of the limitations in FDA's existing authority. This allows dangerous counterfeit devices to remain in the supply chain, continuing to represent a significant risk to consumers. The Safeguarding Therapeutics Act is a straightforward, commonsense approach to this issue with bipartisan support that will provide FDA with authority it already possesses with respect to counterfeit drugs.
Given the deficiencies highlighted with certain aspects of the healthcare supply chain throughout the current pandemic, taking action to further safeguard the supply chain from potentially dangerous products is more important than ever.
Madam Speaker, I thank my colleagues on the Committee on Energy and Commerce, Representatives Guthrie and Engel, for their work on this legislation, and I urge my colleagues to support its passage.
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Mrs. DINGELL. Madam Speaker, I also thank Mr. Guthrie and Mr. Engel for their leadership.
I think the American people understand this issue more now than ever, unfortunately. I urge my colleagues to support this legislation.
Madam Speaker, I yield back the balance of my time.
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