[Congressional Record Volume 164, Number 102 (Tuesday, June 19, 2018)]
[House]
[Pages H5234-H5237]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




  SECURING OPIOIDS AND UNUSED NARCOTICS WITH DELIBERATE DISPOSAL AND 
                         PACKAGING ACT OF 2018

  Mr. WALDEN. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 5687) to amend the Federal Food, Drug, and Cosmetic Act to 
require improved packaging and disposal methods with respect to certain 
drugs, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 5687

       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 ``Securing Opioids and Unused 
     Narcotics with Deliberate Disposal and Packaging Act of 
     2018'' or the ``SOUND Disposal and Packaging Act''.

     SEC. 2. IMPROVED TECHNOLOGIES, CONTROLS, OR MEASURES WITH 
                   RESPECT TO THE PACKAGING OR DISPOSAL OF CERTAIN 
                   DRUGS.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act is amended by inserting after section 505-1 (21 
     U.S.C. 355-1) the following new section:

     ``SEC. 505-2. SAFETY-ENHANCING PACKAGING AND DISPOSAL 
                   FEATURES.

       ``(a) Orders.--
       ``(1) In general.--The Secretary may issue an order 
     requiring the holder of a covered application to implement or 
     modify one or more technologies, controls, or measures with 
     respect to the packaging or disposal of one or more drugs 
     identified in the covered application, if the Secretary 
     determines such technologies, controls, or measures to be 
     appropriate to help mitigate the risk of abuse or misuse of 
     such drug or drugs, which may include by reducing the 
     availability of unused drugs.
       ``(2) Prior consultation.--The Secretary may not issue an 
     order under paragraph (1) unless the Secretary has consulted 
     with relevant stakeholders, through a public meeting, 
     workshop, or otherwise, about matters that are relevant to 
     the subject of the order.
       ``(3) Assuring access and minimizing burden.--Technologies, 
     controls, or measures required under paragraph (1) shall--
       ``(A) be commensurate with the specific risk of abuse or 
     misuse of the drug listed in the covered application;
       ``(B) considering such risk, not be unduly burdensome on 
     patient access to the drug, considering in particular any 
     available evidence regarding the expected or demonstrated 
     public health impact of such technologies, controls, or 
     measures; and
       ``(C) reduce the risk of abuse or misuse of such drug.
       ``(4) Order contents.--An order issued under paragraph (1) 
     may--
       ``(A) provide for a range of options for implementing or 
     modifying the technologies, controls, or measures required to 
     be implemented by such order; and
       ``(B) incorporate by reference standards regarding 
     packaging or disposal set forth in an official compendium, 
     established by a nationally or internationally recognized 
     standard development organization, or described

[[Page H5235]]

     on the public website of the Food and Drug Administration, so 
     long as the order includes the rationale for incorporation of 
     such standard.
       ``(5) Orders applicable to drug class.--When a concern 
     about the risk of abuse or misuse of a drug relates to a 
     pharmacological class, the Secretary may, after consultation 
     with relevant stakeholders, issue an order under paragraph 
     (1) which applies to the pharmacological class.
       ``(b) Compliance.--The holder of a covered application 
     shall--
       ``(1) submit a supplement containing proposed changes to 
     the covered application to comply with an order issued under 
     subsection (a) not later than--
       ``(A) 180 calendar days after the date on which the order 
     is issued; or
       ``(B)(i) such longer time period as specified by the 
     Secretary in such order; or
       ``(ii) if a request for an alternative date is submitted by 
     the holder of such application not later than 60 calendar 
     days after the date on which such order is issued--
       ``(I) such requested alternative date if agreed to by the 
     Secretary; or
       ``(II) another date as specified by the Secretary; and
       ``(2) implement the changes approved pursuant to such 
     supplement not later than the later of--
       ``(A) 90 calendar days after the date on which the 
     supplement is approved; or
       ``(B) the end of such longer period as is--
       ``(i) determined to be appropriate by the Secretary; or
       ``(ii) approved by the Secretary pursuant to a request by 
     the holder of the covered application that explains why such 
     longer period is needed, including to satisfy any other 
     applicable Federal statutory or regulatory requirements.
       ``(c) Alternative Measures.--The holder of the covered 
     application may propose, and the Secretary shall approve, 
     technologies, controls, or measures regarding packaging, 
     storage, or disposal other than those specified in the 
     applicable order issued under subsection (a), if such 
     technologies, controls, or measures are supported by data and 
     information demonstrating that such alternative technologies, 
     controls, or measures can be expected to mitigate the risk of 
     abuse or misuse of the drug or drugs involved, including by 
     reducing the availability of unused drugs, to at least the 
     same extent as the technologies, controls, or measures 
     specified in such order.
       ``(d) Dispute Resolution.--If a dispute arises in 
     connection with a supplement submitted under subsection (b), 
     the holder of the covered application may appeal a 
     determination made with respect to such supplement using 
     applicable dispute resolution procedures specified by the 
     Secretary in regulations or guidance.
       ``(e) Definitions.--In this section--
       ``(1) the term `covered application' means an application 
     submitted under subsection (b) or (j) of section 505 for 
     approval under such section or an application submitted under 
     section 351 of Public Health Service Act for approval under 
     such section, with respect to a drug that is or contains an 
     opioid for which a listing in schedule II or III (on a 
     temporary or permanent basis) is in effect under section 202 
     of the Controlled Substances Act; and
       ``(2) the term `relevant stakeholders' may include 
     scientific experts within the drug manufacturing industry; 
     brand and generic drug manufacturers; standard development 
     organizations; wholesalers and distributors; payers; health 
     care providers; pharmacists; pharmacies; manufacturers; 
     poison centers; and representatives of the National Institute 
     on Drug Abuse, the National Institutes of Health, the Centers 
     for Disease Control and Prevention, the Centers for Medicare 
     & Medicaid Services, the Drug Enforcement Agency, the 
     Consumer Product Safety Commission, individuals who 
     specialize in treating addiction, and patient and caregiver 
     groups.''.
       (b) Prohibited Acts.--Section 501 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351) is amended by 
     inserting after paragraph (j) the following:
       ``(k) If it is a drug approved under a covered application 
     (as defined in section 505-2(e)), the holder of which does 
     not meet the requirements of paragraphs (1) and (2) of 
     subsection (b) of such section.''.
       (c) Required Content of an Abbreviated New Drug 
     Application.--Section 505(j)(2)(A) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(j)(2)(A)) is amended--
       (1) in clause (vii)(IV), by striking ``and'' at the end;
       (2) in clause (viii), by striking the period at the end and 
     inserting ``; and''; and
       (3) by adding at the end the following:
       ``(ix) if the drug is or contains an opioid for which a 
     listing in schedule II or III (on a temporary or permanent 
     basis) is in effect under section 202 of the Controlled 
     Substances Act, information to show that the applicant has 
     proposed technologies, controls, or measures related to the 
     packaging or disposal of the drug that provide protections 
     comparable to those provided by the technologies, controls, 
     or measures required for the applicable listed drug under 
     section 505-2, if applicable.''.
       (d) Grounds for Refusing To Approve an Abbreviated New Drug 
     Application.--Section 505(j)(4) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(j)(4)), is amended--
       (1) in subparagraph (J), by striking ``or'' at the end;
       (2) in subparagraph (K), by striking the period at the end 
     and inserting ``; or''; and
       (3) by adding at the end the following:
       ``(L) if the drug is a drug described in paragraph 
     (2)(A)(ix) and the applicant has not proposed technologies, 
     controls, or measures related to the packaging or disposal of 
     such drug that the Secretary determines provide protections 
     comparable to those provided by the technologies, controls, 
     or measures required for the applicable listed drug under 
     section 505-2.''.
       (e) Rules of Construction.--
       (1) Any labeling describing technologies, controls, or 
     measures related to packaging or disposal intended to 
     mitigate the risk of abuse or misuse of a drug product that 
     is subject to an abbreviated new drug application, including 
     labeling describing differences from the reference listed 
     drug resulting from the application of section 505-2 of the 
     Federal Food, Drug, and Cosmetic Act, as added by subsection 
     (a), shall not be construed--
       (A) as changes to labeling not permissible under clause (v) 
     of section 505(j)(2)(A) of such Act (21 U.S.C. 355(j)(2)(A)), 
     or a change in the conditions of use prescribed, recommended, 
     or suggested in the labeling proposed for the new drug under 
     clause (i) of such section; or
       (B) to preclude approval of an abbreviated new drug 
     application under subparagraph (B) or (G) of section 
     505(j)(4) of such Act (21 U.S.C. 355(j)(4)).
       (2) For a covered application that is an application 
     submitted under subsection (j) of section 505 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355), subsection 
     (j)(2)(A) of such section 505 shall not be construed to limit 
     the type of data or information the Secretary of Health and 
     Human Services may request or consider in connection with 
     making any determination under section 505-2.
       (f) GAO Report.--Not later than 12 months after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall prepare and submit to the Congress a report 
     containing--
       (1) a description of available evidence, if any, on the 
     effectiveness of site-of-use, in-home controlled substance 
     disposal products and packaging technologies;
       (2) identification of ways in which such disposal products 
     intended for use by patients, consumers, and other end users 
     that are not registrants under the Controlled Substances Act, 
     are made available to the public and barriers to the use of 
     such disposal products;
       (3) identification of ways in which packaging technologies 
     are made available to the public and barriers to the use of 
     such technologies;
       (4) a description of Federal oversight, if any, of site-of-
     use, in-home controlled substance disposal products, 
     including--
       (A) identification of the Federal agencies that oversee 
     such products;
       (B) identification of the methods of disposal of controlled 
     substances recommended by these agencies for site-of-use, in-
     home disposal; and
       (C) a description of the effectiveness of such 
     recommendations at preventing the diversion of legally 
     prescribed controlled substances;
       (5) a description of Federal oversight, if any, of 
     controlled substance packaging technologies, including--
       (A) identification of the Federal agencies that oversee 
     such technologies;
       (B) identification of the technologies recommended by these 
     agencies, including unit dose packaging, packaging that 
     provides a set duration, or other packaging systems that may 
     mitigate abuse or misuse; and
       (C) a description of the effectiveness of such 
     recommendations at preventing the diversion of legally 
     prescribed controlled substances; and
       (6) recommendations on--
       (A) whether site-of-use, in-home controlled substance 
     disposal products and packaging technologies require Federal 
     oversight and, if so, which agencies should be responsible 
     for such oversight and, as applicable, approval of such 
     products or technologies; and
       (B) the potential role of the Federal Government in 
     evaluating such products to ensure product efficacy.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Oregon (Mr. Walden) and the gentleman from Massachusetts (Mr. Kennedy) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Oregon.


                             General Leave

  Mr. WALDEN. Mr. Speaker, I ask unanimous consent that Members may 
have 5 legislative days 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 in strong support of this bipartisan legislation, 
and I want to thank Representatives Hudson and Butterfield, both of 
North Carolina, for their hard work on it.
  Opioids are often prescribed in higher volumes than necessary and not 
properly disposed of after patients no

[[Page H5236]]

longer need them. That leads to an oversupply of unneeded drugs that 
can be subject to abuse by family members and others.
  In order to reduce the volume of unused opioids in the market, this 
bill will direct the Food and Drug Administration to work with 
manufacturers to establish programs for the efficient return or 
destruction of unused schedule II or III opioid analgesics.
  In addition, this bill will facilitate utilization of packaging that 
may reduce overprescribing, diversion, or abuse of opioids.
  Finally, the bill will require the GAO to study new and innovative 
technologies that claim to be able to dispose of opioids and other 
unused medications safely.
  This bill takes several targeted steps to minimize the amount of 
unused opioids on the market, and I encourage my colleagues to support 
its passage.
  Mr. Speaker, I yield such time as he may consume to gentleman from 
North Carolina (Mr. Hudson), one of the authors of this important 
legislation.
  Mr. HUDSON. Mr. Speaker, in 2018, more than 2 million Americans will 
suffer from addiction to prescription opioids.
  As I have traveled across my district, I have seen firsthand the 
devastating effects these drugs can have on families, friends, and 
loved ones. There is no barrier for these drugs. They strike at every 
level of society and across every geographic region. It touches all of 
us.
  In North Carolina, we have 4 of the top 25 worst cities for opioid 
abuse in the country. This truly is the crisis next door, and I am 
proud of the collective effort the House of Representatives has 
undertaken in a bipartisan way to address this epidemic.
  One important piece of this effort is a bipartisan bill I worked on 
with my colleague G.K. Butterfield, the SOUND Disposal and Packaging 
Act, which will direct the FDA to work with manufacturers to help 
reduce diversion, overprescribing, and abuse of schedule II or III 
opioids.
  I focused on packaging and disposal because it seemed everyone I 
talked to had sort of a lightbulb go off. So many of us have unused 
opioids in our medicine cabinets from surgeries, accidents, or hospital 
visits.
  With 70 percent of heroin addictions beginning in the medicine 
cabinet, attacking this oversupply with packaging on the front end and 
disposal on the back end was a logical place to start. We need to 
reduce the supply of opioids that find their way out of the medicine 
cabinet, and this legislation is the first step.
  I appreciate the leadership of my friend, G.K. Butterfield, for 
working with me in a bipartisan manner in authoring this bill. I want 
to thank the leadership of the Energy and Commerce Committee and Health 
Subcommittee, Chairman Walden and Chairman Burgess, and Ranking Members 
Pallone and Green for their partnership and help to ensure this could 
be a reality today.
  Mr. Speaker, I include in the Record a letter from DisposeRx in 
support of H.R. 5687, the SOUND Disposal and Packaging Act.


                                                    DisposeRx,

                                                    June 18, 2018.
     Hon. Richard Hudson,
     House of Representatives,
     Washington, DC.
       Dear Representative Hudson: As our country continues to 
     combat the opioid epidemic, we commend the United States 
     House of Representative for voting on your legislation, H.R. 
     5687, the ``the ``SOUND'` Disposal and Packaging Act.'' 
     Opioid overdoses kill tens of thousands of people each year, 
     and this landmark legislation is pivotal to saving lives and 
     overcoming the opioid crisis.
       Our mission at DisposeRx is to empower the consumer to 
     safely and permanently dispose of unused medications, 
     including opioids and drugs with abuse liabilities, with at-
     home solutions that render drugs non-retrievable. Research 
     has shown that take-back and kiosk strategies are 
     inconvenient and encourage diversion, whereas at-home 
     solutions that empower consumers to destroy their drugs in an 
     environmentally friendly manner are a better solution to 
     preventing opioid abuse, overdoses and deaths that begin in 
     the medicine cabinet.
       For years, the federal government has recommended 
     substandard methods of disposal for controlled substances, 
     such as placing them in coffee grounds or kitty litter, and 
     even flushing them down the toilet for eventual transport to 
     our nation's waterways. With the passage of H.R. 5687, 
     Congress will be taking a crucial leap to change how we deal 
     with drug disposal. In particular, section 2(f) of H.R. 5687 
     will require the General Accounting Office (GAO) to provide 
     an independent report to Congress on the benefits of in-home 
     disposal of controlled substances. We believe that the bill 
     represents a clear recognition that immediate disposal of 
     prescription medications within the home will reduce the 
     number of new addictions and deaths.
       We are grateful for your leadership, and that of your 
     cosponsors, including Representative G.K. Butterfield, in 
     this critical area and we congratulate you on this pioneering 
     legislation. We thank your staff and that of the House Energy 
     and Commerce Committee, especially Preston Bell, who has 
     tirelessly championed deterrent solutions to prevent abuse 
     before it begins.
       We are passionate about providing a solution to our 
     country's epidemic of overdose and death brought about by the 
     misuse and abuse of opioids. Thank you for your 
     consideration, and we look forward to working with you and 
     your colleagues to confront and reverse this crisis.
           Sincerely,
                                                      Wm. Simpson,
                                                        President.

  Mr. HUDSON. Mr. Speaker, I urge all my colleagues to please support 
this legislation.
  Mr. KENNEDY. Mr. Speaker, I yield myself such time as I may consume.
  I rise to voice my support for H.R. 5687, legislation authored by my 
colleagues, Mr. Hudson and Mr. Butterfield, to provide the FDA with 
authority to employ the use of packaging and disposal technologies to 
help mitigate the risk of abuse and misuse of opioids.
  As a part of FDA's efforts to help prevent misuse of opioids, 
Commissioner Gottlieb has been actively exploring how packaging and 
disposal innovations can deter abuse and reduce the supply of opioids 
in the market.
  This included hosting a public workshop in December to explore how we 
can harness these technologies in the fight against opioid addiction 
and how to improve the safety of these products for those patients who 
rely on them to manage chronic pain every day.
  Commissioner Gottlieb also noted, Mr. Speaker, that the use of these 
technologies, such as packaging, merits consideration through a 
careful, science-based process, one that I hope will continue.
  The legislation we are considering today builds on this work and 
grants FDA authority to require packaging and disposal technologies for 
schedule II and schedule III controlled substances that reflect a level 
of risk associated with that substance.
  FDA is provided with the flexibility to permit a range of options for 
packaging or disposal technologies, as long as such technologies 
demonstrate comparable effectiveness. This flexibility will be crucial 
to reduce barriers to generic entry, one of the concerns that was 
raised during our committee consideration, and to maintain appropriate 
patient access to these substances.
  H.R. 5687 also clarifies that labeling related to the inclusion of 
packaging or disposal technologies cannot be used as a blocking 
strategy by brand manufacturers.
  If enacted, it is my hope that the FDA will continue to work with 
stakeholders, including manufacturers, to ensure that generic entry is 
not impeded by the requirement of packaging or disposal technologies. 
Both brand and generic manufacturers should be held to the same 
performance outcome of mitigating risk and abuse; however, at a time of 
rising drug costs, I believe manufacturers should be afforded enough 
flexibility to pursue cost-effective technologies that will also meet 
the shared goals of the FDA and patient community.
  I also hope that any costs associated with the adoption of packaging 
or disposal technologies will not be borne by the patients who rely on 
these medications to manage their diseases or conditions.
  Mr. Speaker, I want to thank Mr. Hudson and Mr. Butterfield for their 
work on this issue as well as the FDA for their guidance through the 
process.
  Mr. Speaker, I urge my colleagues to support H.R. 5687, and I yield 
back the balance of my time.
  Mr. WALDEN. Mr. Speaker, I have no other speakers on this 
legislation. I encourage my colleagues to support the bill, and I yield 
back the balance of my time.
  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. 5687, as amended.

[[Page H5237]]

  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. WALDEN. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this motion will be postponed.

                          ____________________