[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.

                          ____________________