[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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