[Congressional Record Volume 164, Number 97 (Tuesday, June 12, 2018)]
[House]
[Pages H5049-H5052]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
STOP COUNTERFEIT DRUGS BY REGULATING AND ENHANCING ENFORCEMENT NOW ACT
Mr. WALDEN. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 5228) to strengthen the authorities of the Food and Drug
Administration to address counterfeit drugs, illegal and synthetic
opioids, and opioid-like substances, and for other purposes, as
amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 5228
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
Counterfeit Drugs by Regulating and Enhancing Enforcement Now
Act'' or the ``SCREEN Act''.
(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. Notification, nondistribution, and recall of adulterated or
misbranded drug products.
Sec. 4. Single source pattern of shipments of adulterated or misbranded
drugs.
Sec. 5. Fund to strengthen efforts of FDA to combat the opioid and
substance use epidemic.
Sec. 6. Consideration of potential for misuse and abuse required for
drug approval.
SEC. 2. DETENTION, REFUSAL, AND DESTRUCTION OF DRUGS OFFERED
FOR IMPORTATION.
(a) Increasing the Maximum Dollar Amount of Drugs Subject
to Destruction.--The sixth sentence in section 801(a) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is
amended by striking ``except that the Secretary'' and all
that follows through the two periods at the end and inserting
``except that the Secretary of Health and Human Services may
destroy, without the opportunity for export, any drug refused
admission under this section, 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
such higher amount as the Commissioner of Food and Drugs may
set based on a finding by the Commissioner that the higher
amount is in the interest of public health), or if such drug
is entering the United States by mail, and was not brought
into compliance as described under subsection (b).''.
(b) Destruction of Articles of Concern.--The sixth sentence
of section 801(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 381(a)), as amended by subsection (a), is further
amended by inserting before the period at the end the
following: ``; and the Secretary of Health and Human Services
may destroy, without the opportunity for export, any article
refused admission under clause (6) of the third sentence of
this subsection''.
(c) Technical Amendments.--The seventh, eighth, and ninth
sentences of section 801(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381(a)) are amended--
(1) by striking ``a drug'' each place it appears and
inserting ``an article''; and
(2) by striking ``the drug'' each place it appears and
inserting ``the article''.
(d) Rule of Construction.--The last sentence in section
801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
381(a)) is amended to read as follows: ``Clauses (2), (5),
and (6) of the third sentence of this subsection shall not be
construed to prohibit the admission of narcotic or
nonnarcotic drugs or other substances, the importation of
which is permitted under the Controlled Substances Import and
Export Act.''.
SEC. 3. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF
ADULTERATED OR MISBRANDED DRUG PRODUCTS.
(a) Prohibited Acts.--Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding
at the end the following:
``(eee) The failure to comply with any order issued under
section 569D.''.
(b) Notification, Nondistribution, and Recall of
Adulterated or Misbranded Drugs.--Subchapter E of chapter V
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb
et seq.) is amended by adding at the end the following:
``SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF
ADULTERATED OR MISBRANDED DRUGS.
``(a) Order To Cease Distribution and Recall.--
``(1) In general.--Upon a determination that the use or
consumption of, or exposure to, a drug may present an
imminent or substantial hazard to the public health, the
Secretary shall issue an order requiring any person who
distributes the drug to immediately cease distribution of the
drug.
``(2) Hearing.--An order under paragraph (1) shall provide
the person subject to the order with an opportunity for an
informal hearing, to be held not later than 10 days after the
date of issuance of the order, on--
``(A) the actions required by the order; and
``(B) whether the order should be amended to require a
recall of the drug.
``(3) Inadequate grounds.--If, after providing an
opportunity for a hearing under paragraph (2), the Secretary
determines that inadequate grounds exist to support the
actions required by the order, the Secretary shall vacate the
order.
``(4) Amendment to order to require recall.--If, after
providing an opportunity for an informal hearing under
paragraph (2), the Secretary determines that the order should
be amended to include a recall of the drug with respect to
which the order was issued, the Secretary shall--
``(A) amend the order to require a recall; and
``(B) after consultation with the drug sponsor, specify a
timetable in which the recall will occur.
``(5) Notice to persons affected.--An order under this
subsection shall require any person who distributes the drug
to provide for notice, including to individuals as
appropriate, to persons who may be affected by the order to
cease distribution of or recall the drug, as applicable.
``(6) Action following order.--Any person who is subject to
an order under paragraph (1) or (4) shall immediately cease
distribution of or recall, as applicable, the drug and
provide notification as required by such order.
``(b) Notice to Consumers and Health Officials.--The
Secretary shall, as the Secretary determines to be necessary,
provide notice of a recall order under this section to--
``(1) consumers to whom the drug was, or may have been,
distributed; and
``(2) appropriate State and local health officials.
[[Page H5050]]
``(c) Order To Recall.--
``(1) Contents.--An order to recall a drug under subsection
(a) shall--
``(A) require periodic reports to the Secretary describing
the progress of the recall; and
``(B) provide for notice, including to individuals as
appropriate, to persons who may be affected by the recall.
``(2) Assistance allowed.--In providing for notice under
paragraph (1)(B), the Secretary may allow for the assistance
of health professionals, State or local officials, or other
individuals designated by the Secretary.
``(3) Nondelegation.--An order under this section shall be
ordered by the Secretary or an official designated by the
Secretary. An official may not be so designated under this
section unless the official is the Director of the Center for
Drug Evaluation and Research, is an official senior to such
Director, or is so designated by such Director.
``(d) Savings Clause.--Nothing contained in this section
shall be construed as limiting--
``(1) the authority of the Secretary to issue an order to
cease distribution of, or to recall, an drug under any other
provision of this Act or the Public Health Service Act; or
``(2) the ability of the Secretary to request any person to
perform a voluntary activity related to any drug subject to
this Act or the Public Health Service Act.''.
(c) Drugs Subject to Refusal.--The third sentence of
subsection (a) of section 801 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 381) is amended by inserting ``or (5)
in the case of a drug, such drug is subject to an order under
section 568 to cease distribution of or recall the drug,''
before ``then such article shall be refused admission''.
(d) Application.--Sections 301(eee) and 569D of the Federal
Food, Drug, and Cosmetic Act, as added by subsections (a) and
(b), shall apply with respect to a drug as of such date, not
later than 1 year after the date of the enactment of this
Act, as the Secretary of Health and Human Services shall
specify.
SEC. 4. SINGLE SOURCE PATTERN OF SHIPMENTS OF ADULTERATED OR
MISBRANDED DRUGS.
Section 801 of the Federal Food, Drug, and Cosmetic Act is
amended by adding at the end the following:
``(t) Single Source Pattern of Shipments of Adulterated or
Misbranded Drugs.--If the Secretary identifies a pattern of
adulterated or misbranded drugs being offered for import from
the same manufacturer, distributor, or importer, the
Secretary may by order choose to treat all drugs being
offered for import from such manufacturer, distributor, or
importer as adulterated or misbranded unless otherwise
demonstrated.''.
SEC. 5. FUND TO STRENGTHEN EFFORTS OF FDA TO COMBAT THE
OPIOID AND SUBSTANCE USE EPIDEMIC.
Chapter X of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 391 et seq.) is amended by adding at the end the
following:
``SEC. 1015. FUND TO STRENGTHEN EFFORTS OF FDA TO COMBAT THE
OPIOID AND SUBSTANCE USE EPIDEMIC.
``(a) In General.--The Commissioner of Food and Drugs shall
use any funds appropriated pursuant to the authorization of
appropriations under subsection (c) to carry out the programs
and activities described in subsection (d) to strengthen and
facilitate the Food and Drug Administration's efforts to
address the opioid and substance use epidemic. Such funds
shall be in addition to any funds which are otherwise
available to carry out such programs and activities.
``(b) FDA Opioid and Substance Use Epidemic Response
Fund.--
``(1) Establishment of fund.--There is established in the
Treasury a fund, to be known as the FDA Opioid and Substance
Use Epidemic Response Fund (referred to in this subsection as
the `Fund'), for purposes of funding the programs and
activities described in subsection (d).
``(2) Transfer.--For the period of fiscal years 2019
through 2023, $110,000,000 shall be transferred to the Fund
from the general fund of the Treasury.
``(3) Amounts deposited.--Any amounts transferred under
paragraph (2) shall remain unavailable in the Fund until such
amounts are appropriated pursuant to subsection (c).
``(c) Appropriations.--
``(1) Authorization of appropriations.--For the period of
fiscal years 2019 through 2023, there is authorized to be
appropriated from the Fund to the Food and Drug
Administration, for the purpose of carrying out the programs
and activities described in subsection (d), an amount not to
exceed the total amount transferred to the Fund under
subsection (b)(2). Notwithstanding subsection (g), such funds
shall remain available until expended.
``(2) Offsetting future appropriations.--For any of fiscal
years 2019 through 2023, for any discretionary appropriation
out of the Fund to the Food and Drug Administration pursuant
to the authorization of appropriations under paragraph (1)
for the purpose of carrying out the programs and activities
described in subsection (d), the total amount of such
appropriations for the applicable fiscal year (not to exceed
the total amount remaining in the Fund) shall be subtracted
from the estimate of discretionary budget authority and the
resulting outlays for any estimate under the Congressional
Budget and Impoundment Control Act of 1974 or the Balanced
Budget and Emergency Deficit Control Act of 1985, and the
amount transferred to the Fund shall be reduced by the same
amount.
``(d) Food and Drug Administration.--The entirety of the
funds made available pursuant to subsection (c)(1) shall be
for the Commissioner of Food and Drugs, pursuant to
applicable authorities in the Public Health Service Act (42
U.S.C. 201 et seq.) or this Act and other applicable Federal
law, to support widespread innovation in non-opioid and non-
addictive medical products for pain treatment, access to
opioid addiction treatments, appropriate use of approved
opioids, and efforts to reduce illicit importation of
opioids. Such support may include the following programs and
activities:
``(1) Obligating contract funds beginning in fiscal year
2019 for an educational campaign that will--
``(A) educate patients and their families to differentiate
opioid medications;
``(B) raise awareness about preferred storage and disposal
methods; and
``(C) inform patients, families, and communities about
medication-assisted treatment options.
``(2) Building the Food and Drug Administration's presence
in international mail facilities, including through--
``(A) improvements in equipment and information technology
enhancements to identify unapproved, counterfeit, or other
unlawful pharmaceuticals for destruction;
``(B) increased and improved surveillance;
``(C) renovations at international mail facility locations;
and
``(D) the purchase of laboratory equipment.
``(3) Enhancing the identification and targeting of
entities offering products and products being offered by such
entities for import into the United States through review and
analysis of Internet websites, import data, and other sources
of intelligence for purposes of making the best use of the
Food and Drug Administration's inspection and analytical
resources.
``(4) Increasing the number of staff of the Food and Drug
Administration to increase the number of packages being
examined, ensuring the safety of the staff undertaking such
examinations, and ensuring that packages identified as
illegal, counterfeit, misbranded, or adulterated are removed
from commerce through available authorities, including
administrative destruction.
``(5) Enhancing the Food and Drug Administration's criminal
investigations resources (including full-time equivalent
employees and equipment), imports surveillance, and
international work.
``(6) Obtaining for the Food and Drug Administration
equipment and full-time equivalent employees needed to
efficiently screen and analyze products offered for import,
including by building data libraries of new substances and
analogues to facilitate identification and evaluation of
pharmaceutical-based agents and by purchasing screening
technologies for use at international mail facilities.
``(7) Operating the Food and Drug Administration's forensic
laboratory facility to ensure adequate laboratory space and
functionality for additional work and full-time equivalent
employees.
``(e) Accountability and Oversight.--
``(1) Work plan.--
``(A) In general.--Not later than 180 days after the date
of enactment of this Act, the Commissioner of Food and Drugs
shall submit to the Committee on Health, Education, Labor and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, a work plan
including the proposed allocation of funds appropriated
pursuant to the authorization of appropriations under
subsection (c) for each of fiscal years 2019 through 2023 and
the contents described in subparagraph (B).
``(B) Contents.--The work plan submitted under subparagraph
(A) shall include--
``(i) the amount of money to be obligated or expended out
of the Fund in each fiscal year for each program and activity
described in subsection (d); and
``(ii) a description and justification of each such program
and activity.
``(2) Reports.--
``(A) Annual reports.--Not later than October 1 of each of
fiscal years 2020 through 2024, the Secretary of Health and
Human Services shall submit to the Committee on Health,
Education, Labor and Pensions of the Senate and the Committee
on Energy and Commerce of the House of Representatives a
report that includes--
``(i) the amount of money obligated or expended out of the
Fund in the prior fiscal year for each program and activity
described in subsection (d);
``(ii) a description of all programs and activities using
funds provided pursuant to the authorization of
appropriations under subsection (c); and
``(iii) how the programs and activities are advancing
public health.
``(B) Additional reports.--At the request of the Committee
on Health, Education, Labor and Pensions of the Senate or the
Committee on Energy and Commerce of the House of
Representatives, the Commissioner shall provide an update in
the form of testimony and any additional reports to the
respective congressional committee regarding the allocation
of funding under this section or the description of the
programs and activities undertaken with such funding.
``(f) Limitations.--Notwithstanding any transfer authority
authorized by this section or any appropriations Act, any
funds made available pursuant to the authorization of
appropriations under subsection (c) may not be used for any
purpose other than the programs and activities described in
subsection
[[Page H5051]]
(d) to strengthen and facilitate the Food and Drug
Administration's efforts to address the opioid and substance
use epidemic.
``(g) Sunset.--This section shall expire on September 30,
2022, except that--
``(1) this subsection does not apply to reporting under
subsection (e)(2); and
``(2) this section shall remain in effect until such time,
and to such extent, as may be necessary for the funds
transferred by subsection (b)(2) to be fully expended.''.
SEC. 6. CONSIDERATION OF POTENTIAL FOR MISUSE AND ABUSE
REQUIRED FOR DRUG APPROVAL.
(a) In General.--Section 505(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(d)) is amended--
(1) in the first sentence--
(A) by striking ``or (7)'' and inserting ``(7)''; and
(B) by inserting ``or (8) if the drug is or contains a
controlled substance for which a listing in any schedule is
in effect under the Controlled Substances Act or that is
permanently scheduled pursuant to section 201 of such Act, on
the basis of information submitted to him as part of the
application, or upon the basis of any other information
before him with respect to such drug, the drug is unsafe for
use due to the risks of abuse or misuse or there is
insufficient information to show that the drug is safe for
use considering such risks;'' before ``he shall issue an
order refusing to approve the application''; and
(2) in the second sentence, by striking ``(6)'' and
inserting ``(8)''.
(b) Withdrawal Authority.--Section 505(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended in
the first sentence--
(1) by striking ``or (5)'' and inserting ``(5)''; and
(2) by inserting the following: ``; or (6) that, in the
case of a drug that is or contains a controlled substance for
which a listing in any schedule is in effect under the
Controlled Substances Act or that is permanently scheduled
pursuant to section 201 of such Act, on the basis of new
information before him with respect to such drug, evaluated
together with the information available to him when the
application was approved, that the drug is unsafe for use due
to the risks of abuse or misuse'' after ``of a material
fact''.
(c) Rule of Construction.--Nothing in the amendments made
by this section shall be construed to limit or narrow, in any
manner, the meaning or application of the provisions of
paragraphs (1), (2), (3), (4), (5), and (7) of section 505(d)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(d)) or paragraphs (1) and (2) of section 505(e) of such
Act (21 U.S.C. 355(e)).
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Oregon (Mr. Walden) and the gentleman from New Jersey (Mr. Pallone)
each will control 20 minutes.
The Chair recognizes the gentleman from Oregon.
General Leave
Mr. WALDEN. 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 the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Oregon?
There was no objection.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise to speak in support of this legislation, and I
want to commend my friend and ranking member of the Energy and Commerce
Committee, Representative Frank Pallone of New Jersey. He has worked
tirelessly on this very important policy.
Hundreds of millions of parcels containing illicit or unapproved
drugs enter the United States supply chain each year, and they do it
through international mail facilities. Through the mail, Mr. Speaker.
That poses a major threat to public health. These parcels are often
difficult to identify as they contain little or no labeling, and the
Food and Drug Administration's current detention and destruction
authorities over these parcels, turns out, it is pretty limited.
H.R. 5228 seeks to strengthen FDA's authority to refuse and destroy
substances identified through these international mail facilities and
improve enforcement mechanisms available to the agency to combat the
influx of illegally manufactured opioids into the country.
I know, in my conversations with Dr. Scott Gottlieb, who heads the
FDA, he has added the resources he could find within his agency and has
brought many of these issues to our attention. He has been a real
leader on this issue for the Trump administration, and I thank him for
his work.
But it is clear this bipartisan legislation that Mr. Pallone brings
to us today is essential as we join together to interdict and stop the
flow of illegal drugs into the United States of America.
Mr. Speaker, I encourage passage of this bill, and I reserve the
balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise to voice my strong support for H.R. 5228,
legislation that I authored that will strengthen FDA's ability to
prevent illicit opioids from coming in through our international mail
facilities by providing the agency with additional enforcement
authority and financial resources.
In April, Mr. Speaker, I had the opportunity to visit an
international mail facility in my home State of New Jersey with the
Food and Drug Administration, Customs and Border Patrol, and the U.S.
Postal Service, and to see firsthand the problems that these agencies
are facing when it comes to illegal, unapproved drugs entering our
country through international mail facilities.
FDA staff showed us boxes of pills that had limited labeling,
labeling in foreign languages, or no labeling at all, and were sent
from unknown and unregistered facilities. FDA staff explained that it
takes the agency days to catalog these boxes, identify what products
contained inside are legitimate, and identify what products, under
current law, the agency can destroy.
FDA then had no other option but to return that box to the sender.
This leaves open the possibility that the sender will just drop the box
of illegal pills back in the mail and try to enter the country again
through another international mail facility.
The agency also showed me a series of similarly wrapped and marked
packages that contained little labeling and were misidentified as
gifts. Upon inspection, these packages included bags of drugs, some
labeled and some labeled in another language. Again, the agency faced
the task of trying to identify if the product was a drug before it
could take further action.
Now, the SCREEN Act, the bill before us, which passed the Energy and
Commerce Committee by a voice vote, would give FDA authority to act in
these situations to stop illicit drugs from entering the marketplace
and allow the agency to better target their resources.
Specifically, the SCREEN Act would, first, expand FDA's authority to
refuse or destroy illegal drugs; second, provide FDA with the ability
to order manufacturers to cease distribution or to recall drugs that
pose an imminent or substantial hazard to the public health. Third, it
would allow FDA to refuse admission or to destroy bulk shipments of
drugs from manufacturers, distributors, or importers, if they are found
to be misbranded or adulterated. Then it would authorize new resources
to help provide additional capacity at international mail facilities
and to upgrade infrastructure, equipment, and other needed technology
for screening purposes.
Mr. Speaker, having worked closely with FDA on this legislation, I
know that the authorities outlined in the SCREEN Act will go a long way
toward empowering the agency to take on repeated illicit drug
traffickers and ensure that dangerous, unapproved drugs are stopped at
our ports and at our mail facilities.
I urge my colleagues to vote in support of this bill, and I reserve
the balance of my time.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume. I
just want to again say, as my friend and colleague from New Jersey has
outlined, you understand the importance of why we need to make these
changes under the law. I again commend him for his work on this.
I encourage all my colleagues to support this very critical piece of
legislation. This could do more to stop the flow of this illegal
fentanyl and the death it brings to our country than any other thing we
can do.
I commend the gentleman for his work on this. I encourage support of
the bill, and I yield back the balance of my time.
Mr. PALLONE. Mr. Speaker, I have no additional speakers. I urge my
colleagues to support the bill, and I yield back the balance of my
time.
Ms. JACKSON LEE. Mr. Speaker, I rise in strong support of H.R. 5228,
the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now
Act, or the SCREEN Act.
[[Page H5052]]
Mr. Speaker, one way the nation can express its concern for our
citizens' health is by addressing the issue regarding counterfeit drugs
and synthetic opioids.
Among other things, H.R. 5228 will strengthen the ability of the Food
and Drug Administration to combat counterfeit drugs, illegal and
synthetic opioids, and opioid-like substances.
Because the capabilities of counterfeit drugs and opioids are rapidly
and continuously evolving, there is no ``single'' technology that
provides long-term assurance of drug security.
H.R. 5228 will implement new, holistic technology to better protect
our drug supply.
Opioids are a class of drugs that include the illegal drug heroin.
All opioids are chemically related and interact with opioid receptors
on nerve cells in the body and brain.
According to a recent study, Centers for Disease Control and
Prevention (CDC) report there were 63,632 drug overdose deaths in 2016
in America, 42,249 of which were related to opioid overdoses.
This issue directly affects my state of Texas, because in 2016, there
were 1,375 opioid-related overdose deaths, according to the National
Institute on Drug Abuse.
In the city of Houston alone, there were 364 drug-related overdose
deaths.
Another issue that H.R. 5228 will address is the prevalence of
counterfeits, or fake medicines which are produced and sold with the
intent to deceptively represent its authenticity or effectiveness.
Fake medicine may contain harmful or inactive ingredients that harm
users, or might have the right active ingredient but at the wrong
dosage.
Counterfeit drugs are illegal and can be harmful to your health.
Mr. Speaker, critics of the FDA say the entire screening system is
underutilized and filled with incomplete and late information.
By enacting H.R. 5228, the FDA will have the authority to combat the
scourge of opioids and counterfeit drugs.
I urge my colleagues to join me in supporting H.R. 5228.
Mr. GENE GREEN of Texas. Mr. Speaker, I rise in support of H.R. 5228,
the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now
Act, or SCREEN Act.
I am proud to champion an important provision that was added to the
SCREEN Act during the Energy and Commerce Committee's markup that
clarifies the U.S. Food and Drug Administration's authority to consider
the potential for misuse and abuse as part of the approval process.
In March, the Health Subcommittee received testimony from FDA
Commissioner Scott Gottlieb that opioid misuse and abuse is one of the
agency's highest priorities.
Last year, the FDA acted when it requested the withdrawal of the
opioid pain medication Opana ER, finding, ``the benefits of the drug
may no longer outweigh its risks.''
Clarifying the FDA's authority to examine the potential risks for
abuse and misuse as a consideration in the approval process is an
important step in combatting the opioid crisis.
I thank our committee's chairman, Greg Walden, and our Ranking
Member, Frank Pallone, for supporting the inclusion of this important
provision.
I ask my colleagues to join me in supporting the underlining bill,
which will strengthen the FDA's authority to stop and destroy illicit
substances identified through international mail facilities, and my
misuse and abuse language which will help protect Americans from opioid
and substance use abuse.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Oregon (Mr. Walden) that the House suspend the rules and
pass the bill, H.R. 5228, 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.
____________________