[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.
____________________