[Congressional Record Volume 167, Number 81 (Tuesday, May 11, 2021)]
[House]
[Pages H2180-H2181]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




      BLOCK, REPORT, AND SUSPEND SUSPICIOUS SHIPMENTS ACT OF 2021

  Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the 
bill (H.R. 768) 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.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                                H.R. 768

       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 2021''.

     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 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 Kentucky (Mr. Guthrie) 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 in which to revise and extend their remarks 
and include extraneous material on H.R. 768.
  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. 768, the Block, 
Report, And Suspend Suspicious Shipments Act of 2021.
  Since 1999, more than 841,000 Americans have died from a drug 
overdose. In the early years of this epidemic, many of these deaths 
involved prescription opioids. Then in 2010 we began seeing dramatic 
increases from heroin-involved deaths, and now we are seeing a third 
wave, Madam Speaker, involving synthetic opioids like illicitly 
manufactured fentanyl.
  In those earlier years, 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, a system 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 an unusual frequency.
  H.R. 768 will improve reporting and action on suspicious orders by 
clarifying the responsibilities of drug manufacturers and distributors 
when discovering a suspicious order. The legislation also requires that 
this discovery be reported to DEA, which will help all entities to 
better identify suspicious activity and root out bad actors.
  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 legislation, Representatives 
Dingell and McKinley, and their staff, for their work on this bill.
  Madam Speaker, I urge my colleagues to support the bill, and I 
reserve the balance of my time.
                                         House of Representatives,


                                   Committee on the Judiciary,

                                      Washington, DC, May 5, 2021.
     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. 768, the ``Block, Report, And 
     Suspend Suspicious Shipments Act of 2021,'' that fall within 
     our Rule X 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. 768, 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.
                                  ____

                                         House of Representatives,


                             Committee on Energy and Commerce,

                                      Washington, DC, May 7, 2021.
     Hon. Jerrold Nadler,
     Chairman, Committee on the 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. 768, the 
     ``Block, Report, And Suspend Suspicious Shipments Act of 
     2021,'' 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. 768 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.

  Mr. GUTHRIE. Madam Speaker, I yield myself such time as I may 
consume.
  Madam Speaker, I rise today to express my strong support for H.R. 
768, the Block, Report, And Suspend Shipments Act of 2021, which was 
led by my

[[Page H2181]]

Energy and Commerce Committee colleagues, McKinley and Dingell.
  This bill addresses an alarming problem that was identified in the 
Energy and Commerce Committee's 2018 bipartisan investigation into 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.

                              {time}  1600

  This bill places additional obligations on drug manufacturers and 
distributors that discover a controlled substance suspicious order.
  In addition to reporting the suspicious order to the DEA, H.R. 768 
requires the manufacturer or distributor to exercise due diligence, 
decline to fill the order, and provide information to the DEA on the 
indicators that led to the belief that filling the order would violate 
the Controlled Substances Act.
  All stakeholders have important roles to play in preventing substance 
use disorders, and it is critical that our pharmaceutical manufacturers 
and distributors step up in stopping pill dumping.
  I urge a ``yes'' vote, and I reserve the balance of my time.
  Mr. PALLONE. Madam Speaker, I yield such time as she may consume to 
the gentlewoman from Michigan (Mrs. Dingell), who is the author of this 
bill and oftentimes presents to the House commonsense action plans on 
important issues.
  Mrs. DINGELL. Madam Speaker, I thank the gentleman for being a very 
good and fair chairman.
  I rise in support of the Block, Report, And Suspend Suspicious 
Shipments Act. This bipartisan legislation would implement safeguards 
against pill dumping and other abusive practices to address the ongoing 
opioid epidemic, which remains one of the most pressing public health 
threats facing our country.
  Last year, over 88,000 Americans lost their lives as a result of the 
opioid crisis, including 2,650 individuals in my home State of 
Michigan. Communities across the country are hurting, and new tools to 
address pill dumping and other dodgy practices that have exacerbated 
the opioid crisis are needed now more than ever.
  The Block, Report, And Suspend Suspicious Shipments Act will 
strengthen oversight and integrity of the opioid supply chain by 
requiring that 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 DEA additional data and background on the 
indicators of the order in question.
  This legislation's commonsense protection will save lives in Michigan 
and all around this country by making distributors and manufacturers 
active partners in curbing these abuses.
  I would like to recognize my colleague, Congressman McKinley, for his 
record of leadership, concern, empathy, compassion, and working to 
address this longstanding issue that has helped perpetuate the opioid 
crisis.
  I would also like to thank Chairman Pallone and Ranking Member 
Rodgers, as well as the Democratic and Republican committee staff, for 
their hard work to build consensus and advance this important 
bipartisan priority.
  I urge my colleagues to support this legislation.
  Mr. GUTHRIE. Madam Speaker, I yield myself the balance of my time.
  My good friend from Michigan thanked the Republican and Democratic 
staff. We have gone through a series of bills and have another one to 
go, most dealing with substance use disorders, mental health, and 
suicide prevention, and all of them brought to the floor in a 
bipartisan way. That happens with Members working together, but it also 
happens with staff working long hours together. We certainly appreciate 
all of them who are here with us on the floor or not on the floor this 
afternoon.
  This is important. We did an oversight investigation. We did a 
committee investigation and saw what seemed to us obvious quantities of 
pills being distributed that should be raised to the attention of 
people.
  I think my friend from Michigan said it best when she said this is 
common sense, so we want to make sure we clarify the role of 
pharmaceutical manufacturers and distributors.
  This is a good bill, and I urge its support.
  Madam Speaker, I yield back the balance of my time.
  Mr. PALLONE. Madam Speaker, I yield myself the balance of my time.
  I appreciate my colleague from Kentucky referencing the investigation 
that was done that led to this bill and other legislation. Many times, 
I think the public doesn't realize that our committees do a lot of 
investigative work that leads to important legislation. This is 
certainly an example.
  Again, I thank Mrs. Dingell, in particular, because this is something 
that I think will help us with the supply chain and, hopefully, deter 
opioid diversion and trafficking.
  Madam Speaker, I urge bipartisan support, and I yield back the 
balance of my time.
  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. 768.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. ROY. Madam Speaker, on that I demand the yeas and nays.
  The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution 
8, the yeas and nays are ordered.
  Pursuant to clause 8 of rule XX, further proceedings on this motion 
are postponed.

                          ____________________