[Congressional Record Volume 164, Number 98 (Wednesday, June 13, 2018)]
[House]
[Pages H5117-H5119]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STOP ILLICIT DRUG IMPORTATION ACT OF 2018
Mrs. BLACKBURN. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 5752) to amend the Federal Food, Drug, and Cosmetic Act with
respect to the importation of certain drugs, and for other purposes, as
amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 5752
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Stop
Illicit Drug Importation Act of 2018''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Detention, refusal, and destruction of drugs offered for
importation.
Sec. 3. Seizure.
Sec. 4. Debarring violative individuals or companies.
SEC. 2. DETENTION, REFUSAL, AND DESTRUCTION OF DRUGS OFFERED
FOR IMPORTATION.
(a) Articles Treated as Drugs for Purposes of
Importation.--Section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by adding at the end
the following:
``(t) Articles Treated as Drugs for Purposes of This
Section.--
``(1) Labeled articles.--An article shall not be treated as
a drug pursuant to this subsection if--
``(A) an electronic import entry for such article is
submitted using an authorized electronic data interchange
system; and
``(B) such article is designated in such system as a drug,
device, dietary supplement, or other product that is
regulated under this Act.
``(2) Articles covered.--Subject to paragraph (1), for
purposes of this section, an article described in this
paragraph may be treated by the Secretary as a drug if it--
``(A) is or contains an ingredient that is an active
ingredient that is contained within--
``(i) a drug that has been approved under section 505 of
this Act; or
``(ii) a biological product that has been approved under
section 351 of the Public Health Service Act;
``(B) is or contains an ingredient that is an active
ingredient in a drug or biological product if--
``(i) an investigational use exemption has been authorized
for such drug or biological product under section 505(i) of
this Act or section 351(a) of the Public Health Service Act;
``(ii) substantial clinical investigation has been
instituted for such drug or biological product; and
``(iii) the existence of such clinical investigation has
been made public; or
``(C) is or contains a substance that has a chemical
structure that is substantially similar to the chemical
structure of an active ingredient in a drug or biological
product described in subparagraph (A) or (B).
``(3) Effect.--Except to the extent that an article may be
treated as a drug pursuant to paragraph (2), this subsection
shall not be construed as bearing on or being relevant to the
question of whether any article is a drug as defined in
section 201(g).''.
(b) Articles of Concern.--
(1) Delivery by treasury to hhs.--The first sentence of
section 801(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381(a)) is amended by striking ``and cosmetics''
and inserting ``cosmetics, and potential articles of concern
(as defined in subsection (u))''.
(2) Refused admission.--The third sentence of section
801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(a)) is amended by striking ``then such article shall be
refused admission'' and inserting ``or (5) such article is an
article of concern (as defined in subsection (u)), or (6)
such article is a drug that is being imported or offered for
import in violation of section 301(cc), then such article
shall be refused admission''.
(3) Definition of article of concern.--Section 801 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381), as
amended, is further amended by adding at the end the
following:
``(u) Article of Concern Defined.--For purposes of
subsection (a), the term `article of concern' means an
article that is or contains a drug or other substance--
``(1) for which, during the 24-month period prior to the
article being imported or offered for import, the Secretary
of Health and Human Services--
``(A) has requested that, based on a determination that the
drug or other substance appears to meet the requirements for
temporary or permanent scheduling pursuant to section 201 of
the Controlled Substances Act, the Attorney General initiate
the process to control the drug or other substance in
accordance with such Act; or
``(B) has, following the publication by the Attorney
General of a notice in the Federal Register of the intention
to issue an order temporarily scheduling such drug or
substance in schedule I of section 202 of the Controlled
Substances Act pursuant to section 201(h) of such Act, made a
determination that such article presents an imminent hazard
to public safety; and
``(2) with respect to which the Attorney General has not--
``(A) scheduled the drug or other substance under such Act;
or
``(B) notified the Secretary of Health and Human Services
that the Attorney General has made a determination not to
schedule the drug or other substance under such Act.''.
[[Page H5118]]
SEC. 3. SEIZURE.
Section 304(b) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 334(b)) is amended by striking the first sentence
and inserting the following: ``The article, equipment, or
other thing proceeded against shall be liable to seizure by
process pursuant to the libel, and the procedure in cases
under this section shall conform, as nearly as may be, to the
procedure in admiralty rather than the procedure used for
civil asset forfeiture proceedings set forth in section 983
of title 18, United States Code. On demand of either party
any issue of fact joined in any such a case brought under
this section shall be tried by jury. A seizure brought under
this section is not governed by Rule G of the Supplemental
Rules of Admiralty or Maritime Claims and Asset Forfeiture
Actions. Exigent circumstances shall be deemed to exist for
all seizures brought under this section, and in such cases,
the summons and arrest warrant shall be issued by the clerk
of the court without court review.''.
SEC. 4. DEBARRING VIOLATIVE INDIVIDUALS OR COMPANIES.
(a) Prohibited Act.--Section 301(cc) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331(cc)) is amended--
(1) by inserting after ``an article of food'' the
following: ``or a drug''; and
(2) by inserting after ``a person debarred'' the following:
``from such activity''.
(b) Debarment.--Section 306(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 335a(b)) is amended--
(1) in paragraph (1)--
(A) in the matter preceding subparagraph (A), by striking
``paragraph (2)'' and inserting ``paragraph (2) or (3)'';
(B) in subparagraph (B), by striking ``or'' at the end;
(C) in subparagraph (C), by striking the period at the end
and inserting ``, or''; and
(D) by adding at the end the following:
``(D) a person from importing or offering to import into
the United States--
``(i) a controlled substance as defined in section 102(6)
of the Controlled Substances Act; or
``(ii) any drug, if such drug is declared to be 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), or if such
drug is entering the United States by mail.''; and
(2) in paragraph (3)--
(A) in the paragraph heading after ``food'' by inserting
``or drug'';
(B) by redesignating subparagraphs (A) and (B) as clauses
(i) and (ii), respectively, and moving the indentation of
each such clause 2 ems to the right;
(C) after making the amendments required by subparagraph
(B), by striking ``A person is subject'' and inserting the
following:
``(A) Food.--A person is subject''; and
(D) by adding at the end the following:
``(B) Importation of drugs.--A person is subject to
debarment under paragraph (1)(D) if--
``(i) the person has been convicted of a felony for conduct
relating to the importation into the United States of any
drug or controlled substance (as defined in section 102 of
the Controlled Substances Act); or
``(ii) the person has engaged in a pattern of importing or
offering for import articles of drug that are--
``(I)(aa) adulterated, misbranded, or in violation of
section 505; and
``(bb) present a threat of serious adverse health
consequences or death to humans or animals; or
``(II) controlled substances whose importation is
prohibited pursuant to section 401(m) of the Tariff Act of
1930.
``(C) Definition.--For purposes of subparagraph (B), the
term `pattern of importing or offering for import articles of
drug' means importing or offering for import articles of drug
described in subclause (I) or (II) of subparagraph (B)(ii) in
an amount, frequency, or dosage that is inconsistent with
personal or household use by the importer.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentlewoman from
Tennessee (Mrs. Blackburn) and the gentleman from Texas (Mr. Gene
Green) each will control 20 minutes.
The Chair recognizes the gentlewoman from Tennessee.
General Leave
Mrs. BLACKBURN. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days in which to revise and extend their remarks
and insert extraneous materials in the Record on this bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentlewoman from Tennessee?
There was no objection.
Mrs. BLACKBURN. Mr. Speaker, I yield myself such time as I may
consume.
I rise in support of this important piece of legislation. This bill
will get FDA the tools the agency needs to intercept illicit substances
coming through our country's international mail facilities. Illicit and
unapproved drugs entering the U.S. supply chain through these
facilities pose serious public health threats.
Hundreds of millions of parcels go through the IMF facilities each
year, and it has been reported that the number of packages processed by
the Nation's nine IMFs nearly doubled from 2013 to 2015. These
facilities now receive more than 275 million packages annually.
Although the FDA has increased the number of investigators it has in
the facilities, it is estimated that the FDA can only physically
inspect less than 0.06 percent of the packages that might contain drugs
or drug products.
In conjunction with H.R. 5228, led by Representative Pallone and
passed by the House yesterday, this bill will give the FDA the
flexibility and the tools the agency needs to effectively and
efficiently seize illicit or unapproved drugs, and to prohibit bad
actors from continuing to ship these deadly products into the country.
I urge my colleagues to support this bill and to help stop the
entrance of illegal opioids and other drugs that might harm Americans.
Mr. Speaker, I reserve the balance of my time.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I
may consume.
Mr. Speaker, I rise in support of H.R. 5752, the Stop Illicit Drug
Importation Act of 2018.
In 2016, 42,000 Americans died from opioid-related overdoses alone,
including more than 2,800 victims of opioid addiction in my home State
of Texas.
One of the contributing factors to the opioid epidemic is the illicit
importation of opioid drugs. According to Commissioner Gottlieb: ``FDA
investigators are the last line of defense at the international mail
facilities'' when it comes to preventing illicit drugs from entering
our country.
Despite the fact that more than 2 million packages are received each
day at our international mail facilities, FDA only has the capacity and
resources to inspect 40,000 of these. More must be done to equip the
FDA, both from the resource perspective but also with the law
enforcement perspective.
This is why I was also pleased to support the SCREEN Act, which was
passed yesterday, and would authorize additional resources for FDA to
take on this fight and grant FDA greater authority to destroy and
recall drugs that pose harm to public health.
The Stop Illicit Drug Importation Act of 2018 empowers the FDA to
refuse admission and destroy imports identified as items of concern by
the FDA and the Drug Enforcement Administration.
The bill will also help streamline seizure procedures and debar
individuals and companies that repeatedly violate Federal law from
being able to import in the United States.
This commonsense measure passed by the Energy and Commerce Committee
by voice vote last month will help stem the tide of illegal and illicit
products, including opioids, from entering our country from
international mail facilities. I urge my colleagues to support this
legislation.
Mr. Speaker, I reserve the balance of my time.
Mrs. BLACKBURN. Mr. Speaker, I yield such time as he may consume to
the gentleman from Oregon (Mr. Walden), the chairman of the Energy and
Commerce Committee.
Mr. WALDEN. Mr. Speaker, I say to my colleagues on the Energy and
Commerce Committee on both sides of the aisle, thanks for your great
work on this bill. My colleague, Congresswoman Blackburn from
Tennessee, this is an issue she has worked on for a long time--we will
just say a long time--with great passion and great diligence.
We had the subcommittee chair of the Health Subcommittee, Dr.
Burgess, go up to the facility in New Jersey recently and observe
firsthand what happens, what transpires there.
My colleague, Mr. Green, and others have talked about the number of
packages that go through the facility versus the number that are
actually inspected.
Then, I know we have all had pretty good conversations with Dr. Scott
Gottlieb, the now-Commissioner of the Food and Drug Administration, and
he has done marvelous work with the limited tools that he has to really
ramp up their ability to try to stop these shipments of illegal
fentanyl.
For those here in the Chamber, you have to understand illegal
fentanyl. If you took a salt shaker and put, I don't know, half a dozen
grains of salt on
[[Page H5119]]
this podium and put your finger on it, it would likely go through your
skin and you would pass out and die, unless my colleague from Texas or
Tennessee here, or the House Physician, had some naloxone they could
come and revive you. It is that potent; it is that dangerous; it is
that deadly; and that is what is getting cut into heroin.
By the way, you can always trust your local heroin dealer to get the
right mixture. They are good chemists, I am sure. No, not. But that is
what is getting cut in.
That is what we are trying to stop with this legislation, this
illegal fentanyl coming in through the mail system from foreign
countries, mainly China, stop it from getting into our country.
That is why I want to commend Mrs. Blackburn, Mr. Green, and others,
everybody who was involved in this legislation.
Mr. Speaker, I also take the floor because, over the course of this
week and next week, we will deal with more than 57 different opioid-
related bills. We have heard from Republicans and Democrats. This is an
epidemic that doesn't check your party registration before it sickens
or kills or addicts somebody in your family or your community.
Throughout all this, we have had terrific support, not only from our
Members, but also from our staff and on both sides of the aisle.
There is somebody I want to single out today on our side of the aisle
who, unfortunately, has decided to pursue other endeavors. Paul Edattel
has served as the chief counsel for our Health Subcommittee since 2016
under then-Chairman Fred Upton.
{time} 1415
Prior to that, he served our Health Subcommittee on an abundance of
healthcare issues, as well as being hired to be Speaker Boehner's top
health policy staffer. But timing has a funny way of getting in the way
of things, and following Speaker Boehner's decision to leave the
Congress, we were able to persuade Paul Edattel to come back to the
Energy and Commerce Committee.
In fact, when I became chairman of the committee, I remember meeting
in Speaker Ryan's office when we were just getting started, and I was
choosing the final staff and Speaker Ryan looked at me and said: I
don't care who else you keep or don't keep, but that guy over there is
the brightest guy around on health policy.
I said: I agree, and we have already reached our agreement that he
would continue on.
His service has been our gain and that of the country's. Paul has
helped lead our push on the floor on these issues with his very
talented team; and just as my colleagues and I have made this our top
issue, so has Paul. At the same time, he has ensured other critical
healthcare policy priorities continue to move through our processes.
Paul is one of the best. He is also a machine. He has been guiding
this committee on the Nation's top healthcare issues for many years,
including our comprehensive review of America's mental health laws that
we passed in, I think, a big bipartisan vote last Congress, helped
engineer through the 21st Century Cures Act, our opioids act, and so
many other pieces of legislation.
Paul is also a wonderful family man, a great individual with
tremendous integrity and insight, and we will miss his friendly smile
and unmatched understanding of how this place works. We will even miss
his unwavering support for the Buffalo Bills, if you are a Buffalo
Bills fan. If you are not, you will be glad to see him go, probably. It
has been an honor to work with Paul and call him a trusted adviser and,
moreover, a friend.
So, Paul, as you begin your new chapter in your new career, I join
with all of our Energy and Commerce Committee members and staff, I
think, on both sides of the aisle in wishing you the very best and
thanking you for your service, Paul Edattel.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I
may consume.
I want to join our chairman in thanking our staff. We couldn't be
here today without our staff working on these.
But this bill is so important. I have been on the docks of the Port
of Houston and watched these containers come in off the ships and them
being inspected. The FDA agents there are frustrated with it, even in
our international mail facilities that are actually in our district in
Texas. So that is why this bill is so important, and I am glad for my
colleague from Tennessee to be sponsoring this bill.
I have no other speakers, Mr. Speaker, and I yield back the balance
of my time.
Mrs. BLACKBURN. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, you have heard the mention of bipartisan work and
bipartisan support on these issues, and Chairman Walden is exactly
right.
Not only have Members worked in a bipartisan way, but also our staffs
have to answer the questions: How do we help to get the resources to
our local and our State officials? How do we help to remove barriers so
we can end this epidemic in our country?
Last year, 63,632 Americans lost their lives to drug abuse and drug
overdose, and 1,600 of those were Tennesseans. We can all tell you
these stories, and I tell you as a mom and as a friend, so many times
when you talk to families and talk to people who have been so affected
and so impacted by this, they talk about family members and coworkers
and individuals that they are in contact with every single day and how
we need to work on this issue with opioids, with fentanyl, with heroin,
with cocaine, these illicit drugs that are flooding our streets, as
well as the pills.
Now, last October, during a hearing when Dr. Gottlieb was before us
and we were conducting oversight with the FDA, one of the things that
he mentioned was there were some changes that they needed to see in
Federal law. The number one change they needed was permission to work
some changes in Federal statute for how they would work in these
international mail facilities.
As we have said, there are hundreds of millions of packages. As
Congressman Green said, they cannot get ahead of the work. So we have
come together. The Stop Illicit Drug Importation Act is something that
will be helpful to getting the job done and getting these drugs off the
streets. Indeed, they will never get to the streets. They will never
get to the streets because there will be the ability to stop them and
dispose of these drugs before they ever get to the streets.
Mr. Speaker, I encourage my colleagues to support this bill, and I
yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the
gentlewoman from Tennessee (Mrs. Blackburn) that the House suspend the
rules and pass the bill, H.R. 5752, 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.
____________________