[Congressional Record Volume 166, Number 195 (Tuesday, November 17, 2020)]
[House]
[Pages H5816-H5818]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




      BLOCK, REPORT, AND SUSPEND SUSPICIOUS SHIPMENTS ACT OF 2020

  Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the 
bill (H.R. 3878) to amend the Controlled Substances Act to clarify the 
process for registrants to exercise due diligence upon discovering a 
suspicious order, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 3878

       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 ``Block, Report, And Suspend 
     Suspicious Shipments Act of 2020''.

     SEC. 2. CLARIFICATION OF PROCESS FOR REGISTRANTS TO EXERCISE 
                   DUE DILIGENCE UPON DISCOVERING A SUSPICIOUS 
                   ORDER.

       (a) In General.--Paragraph (3) of section 312(a) of the 
     Controlled Substances Act (21 U.S.C. 832(a)) is amended to 
     read as follows:
       ``(3) upon discovering a suspicious order or series of 
     orders--
       ``(A) exercise due diligence;
       ``(B) establish and maintain (for not less than a period to 
     be determined by the Administrator of the Drug Enforcement 
     Administration) a record of the due diligence that was 
     performed;
       ``(C) decline to fill the order or series of orders if the 
     due diligence fails to resolve all of the indicators that 
     gave rise to the suspicion that filling the order or series 
     of orders would cause a violation of this title by the 
     registrant or the prospective purchaser; and
       ``(D) notify the Administrator of the Drug Enforcement 
     Administration and the Special Agent in Charge of the 
     Division Office of the Drug Enforcement Administration for 
     the area in which the registrant is located or conducts 
     business of--
       ``(i) each suspicious order or series of orders discovered 
     by the registrant; and
       ``(ii) the indicators giving rise to the suspicion that 
     filling the order or series of orders would cause a violation 
     of this title by the registrant or the prospective 
     purchaser.''.
       (b) Regulations.--Not later than 1 year after the date of 
     enactment of this Act, for purposes of section 312(a)(3) of 
     the Controlled Substances Act, as amended by subsection (a), 
     the Attorney General of the United States shall promulgate a 
     final regulation specifying the indicators that give rise to 
     a suspicion that filling an order or series of orders would 
     cause a violation of the Controlled Substances Act (21 U.S.C. 
     801 et seq.) by a registrant or a prospective purchaser.
       (c) Applicability.--Section 312(a)(3) of the Controlled 
     Substances Act, as amended by

[[Page H5817]]

     subsection (a), shall apply beginning on the day that is 1 
     year after the date of enactment of this Act. Until such day, 
     section 312(a)(3) of the Controlled Substances Act shall 
     apply as such section 312(a)(3) was in effect on the day 
     before the date of enactment of this Act.

     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 gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Oregon (Mr. Walden) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members 
may have 5 legislative days within which to revise and extend their 
remarks and include extraneous material on H.R. 3878.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, I rise today in support of H.R. 3878, the Block, 
Report, And Suspend Suspicious Shipments Act of 2020. This bill will 
improve reporting an action on suspicious orders on controlled 
substances.
  Between 1999 and 2017, more than 700,000 Americans died from a drug 
overdose. Many of those Americans were caught in the first wave of what 
we typically describe as three waves of this epidemic.
  This first wave began in the 1990s with deaths involving prescription 
opioids. In 2010, we saw dramatic increases from heroin-involved 
deaths. And most recently, we are seeing a third wave involving 
synthetic opioids, like illicitly manufactured fentanyl.
  During that first wave, Americans across the country became addicted 
to opioids. Many of those opioids were prescribed to patients to treat 
pain. However, throughout the years, we have discovered that many of 
these opioids were diverted through a system meant to prevent 
diversion.
  The Drug Enforcement Administration requires entities that 
manufacture or distribute controlled substances to register and report 
their activities through ARCOS. This system is meant to track the 
manufacture, distribution, and dispensing of these substances. In this 
system, registrants are also expected to disclose suspicious orders of 
controlled substances, such as orders of unusual size, orders deviating 
from a normal pattern, or orders of unusual frequency.
  As an effort to improve reporting and action on suspicious orders, 
this bill would clarify the responsibilities of drug manufacturers and 
distributors when discovering a suspicious order, and require 
communications around that order to DEA. This will help all entities to 
better identify suspicious activity and root out bad actors.
  Madam Speaker, this is a commonsense bill that will make clear the 
responsibilities for all entities in our supply chain and, hopefully, 
help to deter opioid diversion and trafficking. I commend the lead 
sponsors of this bipartisan bill, Representatives Dingell and McKinley, 
and their staff for their work on this legislation. I also thank the 
Democratic and Republican members of our committee, as well as 
bipartisan staff for working together to move this bill.
  Madam Speaker, I urge my colleagues to support H.R. 3878, and I 
reserve the balance of my time.

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                Washington, DC, November 16, 2020.
     Hon. Jerrold Nadler,
     Chair, Committee on Judiciary,
     Washington, DC.
       Dear Chairman Nadler: Thank you for consulting with the 
     Committee on Energy and Commerce and agreeing to be 
     discharged from further consideration of H.R. 3878, the 
     Block, Report, and Suspend Suspicious Shipments Act of 2020, 
     so that the bill may proceed expeditiously to the House 
     floor.
       I agree that your forgoing further action on this measure 
     does not in any way diminish or alter the jurisdiction of 
     your committee or prejudice its jurisdictional prerogatives 
     on this measure or similar legislation in the future. I would 
     support your effort to seek appointment of an appropriate 
     number of conferees from your committee to any House-Senate 
     conference on this legislation.
       I will seek to place our letters on H.R. 3878 into the 
     Congressional Record during floor consideration of the bill. 
     I appreciate your cooperation regarding this legislation and 
     look forward to continuing to work together as this measure 
     moves through the legislative process.
           Sincerely,
                                               Frank Pallone, Jr.,
     Chairman.
                                  ____

                                         House of Representatives,


                                   Committee on the Judiciary,

                                Washington, DC, November 16, 2020.
     Hon. Frank Pallone, Jr.,
     Chairman, Committee on Energy and Commerce,
     House of Representatives, Washington, DC.
       Dear Chairman Pallone: This is to advise you that the 
     Committee on the Judiciary has now had an opportunity to 
     review the provisions in H.R. 3878, the ``Block, Report, And 
     Suspend Suspicious Shipments Act of 2019,'' that fall within 
     our Rule jurisdiction. I appreciate your consulting with us 
     on those provisions. The Judiciary Committee has no objection 
     to your including them in the bill for consideration on the 
     House floor, and to expedite that consideration is willing to 
     forgo action on H.R. 3878, with the understanding that we do 
     not thereby waive any future jurisdictional claim over those 
     provisions or their subject matters.
       In the event a House-Senate conference on this or similar 
     legislation is convened, the Judiciary Committee reserves the 
     right to request an appropriate number of conferees to 
     address any concerns with these or similar provisions that 
     may arise in conference.
       Please place this letter into the Congressional Record 
     during consideration of the measure on the House floor. Thank 
     you for the cooperative spirit in which you have worked 
     regarding this matter and others between our committees.
           Sincerely,
                                                   Jerrold Nadler,
                                                         Chairman.

  Mr. WALDEN. Madam Speaker, I rise to support H.R. 3878, the Block, 
Report, And Suspend Suspicious Shipments Act, which was led by my 
Energy and Commerce Committee colleagues, Representatives McKinley and 
Dingell.
  This legislation addresses an alarming problem that was identified in 
the committee's 2018 bipartisan investigation in the distribution of 
prescription opioids by wholesale drug distributors. The committee 
found that when millions of prescription opioids were dumped into 
communities, large and small, across the country, the distributors 
flagged the orders for the DEA, but shipped the orders anyway, even 
after notifying the authorities that the orders were suspicious.
  H.R. 3878 would place additional commonsense obligations on drug 
manufacturers and distributors who discover a controlled substance 
suspicious order. In addition to reporting the suspicious order to the 
DEA, this legislation requires the manufacturer or distributor to 
exercise due diligence, to decline to fill the order, and to provide 
information to the Drug Enforcement Administration on the indicators 
that led to the belief that filling the order would violate the 
Substances Controlled Act.
  We all have a part to play in the fight against the opioid epidemic, 
and it is critical that pharmaceutical manufacturers and distributors 
step up in stopping pill dumping.
  Madam Speaker, I thank my colleagues, Representatives Dingell and 
McKinley, for their extra effort on this legislation. It is a fine 
piece of work moving forward, and I commend them for their work.
  Madam Speaker, I don't believe I have any speakers on this one, so I 
yield back the balance of my time.
  Mr. PALLONE. Madam Speaker, I yield 3 minutes to the gentlewoman from 
Michigan (Mrs. Dingell), the Democratic sponsor of the bill.
  Mrs. DINGELL. Madam Speaker, I rise in support of the Block, Report, 
And Suspend Suspicious Shipments Act, which would crack down on pill 
dumping and other abusive practices to address the ongoing opioid 
epidemic, which still remains one of the most significant public health 
challenges facing our country.
  In 2018, over 67,000 Americans still lost their lives to drug 
overdoses, and preliminary data for 2019 suggests that deaths are 
rising again.
  My home State of Michigan has been hit hard by the opioid epidemic, 
which has been exacerbated by COVID-19. We have seen a 15 percent year-
over-year increase in fatal overdoses across the entire State since 
March of this year.
  New tools to address pill dumping and other dodgy practices that have

[[Page H5818]]

perpetuated the opioid crisis are needed more now than ever. The Block, 
Report, And Suspend Suspicious Shipments Act will crack down on these 
abuses. It will improve oversight of the opioid supply chain by 
mandating that the drug manufacturers and distributors exercise due 
diligence when they receive a suspicious order for controlled 
substances. This includes blocking or declining to fill the suspicious 
order, and providing the DEA with additional data and background on the 
indicators on the order in question.
  Distributors and manufacturers should be active partners in 
addressing these abuses, and this legislation's commonsense protections 
will save lives in Michigan and the country.
  Madam Speaker, I want to recognize my colleague, Congressman 
McKinley, for his years of leadership and work in highlighting this 
issue and driving action to address the role bad actors continue to 
play in perpetuating the opioid crisis. I also thank Chairman Pallone 
and Ranking Member Walden, who I am going to miss greatly, as well as 
the Democratic and Republican committee staff for working tirelessly to 
advance this important bipartisan priority.
  Madam Speaker, I urge my colleagues to support this legislation.
  Mr. PALLONE. Madam Speaker, I have no additional speakers. I urge my 
colleagues to support this bill, and I yield back the balance of my 
time.
  Mr. McKINLEY. Madam Speaker, I rise in support of H.R. 3878. While 
Congress has understandably been focused on the COVID-19 pandemic, the 
opioid epidemic has not gone away. In fact, across the nation overdose 
deaths are up 13 percent from this time last year.
  In West Virginia, nearly twice as many people have died from drug 
abuse than from COVID.
  Last Congress, the Energy and Commerce Committee conducted an 
investigation that found massive evidence of pill dumping. One example 
in the report was that nearly 9 million pills were distributed in just 
two years to a single pharmacy in West Virginia. Finally, two years 
later we're passing legislation that would help address the problem.
  I am proud to work with Mrs. Dingell on this nonpartisan bill. The 
Block, Report, and Suspend Suspicious Shipments Act would require drug 
wholesalers and manufacturers to report and stop unusually large 
orders. We are hopeful this bill will be another positive step in 
addressing America's opioid epidemic.
  I urge my colleagues to support the passage of H.R. 3878.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 3878, 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.

                          ____________________