[Congressional Record Volume 166, Number 163 (Monday, September 21, 2020)]
[House]
[Pages H4635-H4636]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                     SAFEGUARDING THERAPEUTICS ACT

  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.

  The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from 
Michigan (Mrs. Dingell) and the gentleman from Montana (Mr. Gianforte) 
each will control 20 minutes.
  The Chair recognizes the gentlewoman from Michigan.


                             General Leave

  Mrs. DINGELL. Madam Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on H.R. 5663.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentlewoman from Michigan?
  There was no objection.
  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

[[Page H4636]]

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.
  Madam Speaker, I reserve the balance of my time.
  Mr. GIANFORTE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, I rise today in support of H.R. 5663, the Safeguarding 
Therapeutics Act, introduced by Representatives Guthrie and Engel. This 
legislation would extend FDA's administrative destruction authority to 
counterfeit and other illegal medical devices.
  Under current law, the FDA is authorized to destroy certain imported 
drugs that may pose a threat to public health; however, this authority 
does not extend to medical devices.
  The passage of this legislation during the coronavirus pandemic is 
especially timely, as we have seen a surge in counterfeit COVID-19 test 
kits imported to the United States.
  But it is not only counterfeit COVID-19 test kits entering our 
borders and posing risks to U.S. consumers. International mail 
facilities have also intercepted shipments of illegal contact lenses 
and combination products in recent years.
  This additional authority will prevent shippers from trying to send 
illegal products back to the United States and may deter future illegal 
shipments of medical devices.
  Madam Speaker, I thank my colleagues, Representatives Guthrie and 
Engel, for working together in a bipartisan manner to advance this 
legislation to provide the FDA with the additional tool to protect 
American consumers against potentially dangerous medical products.
  Madam Speaker, I urge my colleagues to support this bipartisan 
legislation, and I reserve the balance of my time.
  Mrs. DINGELL. Madam Speaker, I reserve the balance of my time.
  Mr. GIANFORTE. Madam Speaker, I yield 3 minutes to the gentleman from 
Kentucky (Mr. Guthrie).
  Mr. GUTHRIE. Madam Speaker, I rise today in support of my bill, the 
Safeguarding Therapeutics Act.
  Last year, I had the opportunity to visit the international mail 
facility at JFK Airport in New York.
  When counterfeit drugs come through the mail facilities, the FDA has 
the authority to destroy it. However, if that counterfeit drug is 
attached to a syringe, it therefore constitutes a medical device, and 
the FDA does not currently have the authority to destroy counterfeit 
medical devices. Instead, in most cases, they are mailed back to where 
they came from, where they are repackaged and sent right back to the 
United States.
  After visiting the mail facility, I joined with my colleague, 
Representative Eliot Engel, to fix this, introducing the Safeguarding 
Therapeutics Act. This commonsense, bipartisan bill will give the FDA 
the authority to destroy counterfeit medical devices at entry points 
into our country. These include items such as combination products, 
like injections and vaccines. If allowed into the country, these 
products could end up on the black market and harm American patients.
  The Safeguarding Therapeutics Act has become especially important now 
that the country is facing the COVID-19 pandemic. We have already seen 
instances of counterfeit COVID-19 tests and products claiming to cure 
COVID being sent to the United States. Bad actors are marketing tests 
and treatments that have not been approved by the FDA or the CDC.
  We need to give the FDA the ability to destroy these products as they 
enter the United States. While our Nation continues to grapple with the 
coronavirus pandemic, the last thing we need is fake COVID-19 tests and 
products in our market.

  Also, in going to the JFK Airport, you are standing there with the 
personnel, men and women who are wearing the uniform of our country, 
receiving this mail moving forward. We gave them the authority: If it 
is a drug, they can destroy it if it is counterfeit; if it is a device, 
it is an interpretation, but they don't have the authority to move 
forward.
  They even told me that sometimes they open the package, see that it 
is counterfeit, and they have to return it. They close the package, 
return it, and they will see the same package come back through the 
exact way that they taped it.
  So we need to give them the authority. It doesn't make sense. It is a 
commonsense approach.
  Eliot Engel and I made this bipartisan. I think every American 
citizen says that is not the way we want to operate, and particularly 
in this time and this pandemic, and there are people trying to take 
advantage of this time and this pandemic.
  Madam Speaker, I appreciate bringing this to the floor today. I 
appreciate the hard work of the Committee on Energy and Commerce.
  I thank Representative Engel. I don't think he represents JFK, but he 
does represent the great city of New York.
  Madam Speaker, I look forward to continuing to work with my 
colleagues on the Committee on Energy and Commerce as they respond to 
the coronavirus pandemic.
  Mrs. DINGELL. Madam Speaker, I reserve the balance of my time.
  Mr. GIANFORTE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, I thank Mr. Guthrie for his leadership on this and 
taking the initiative to get out and understand the issue on the ground 
and crafting bipartisan legislation to solve this problem and protect 
American consumers.
  Madam Speaker, I urge adoption of this legislation, and I yield back 
the balance of my time.
  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.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentlewoman from Michigan (Mrs. Dingell) that the House suspend the 
rules and pass the bill, H.R. 5663, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

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