[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.

                          ____________________