[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.
____________________