SOUND Disposal and Packaging Act

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. Speaker, I urge all my colleagues to please support this legislation.

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. 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.

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.

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

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. 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.

Mr. Speaker, on that I demand the yeas and nays.

Mr. Speaker, had I been present for the vote on H.R. 5687--the SOUND Disposal and Packaging Act (Roll Call No. 269), I would have voted ``aye.'' This bill would require the Federal Food, Drug, and Cosmetic Act to improve packaging and disposal methods for certain drugs.

Additionally, had I been present for the vote on H.R. 5676--the SENIOR Communities Protection Act of 2018 (Roll Call No. 270), I would have voted ``aye.'' This bill would authorize Medicare prescription drug plans and MA-PD plans to suspend payments to pharmacies pending investigations of credible allegations of fraud.

Mr. Speaker, due to adverse weather and numerous flight delays and cancellations in North Carolina, I was unable to vote yesterday during Roll Call 269, the motion to suspend the rules and pass as amended H.R. 5687, the Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act of 2018, as well as Roll Call 270, the motion to suspend the rules and pass as amended H.R. 5676, the Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018.

Had I been present, I would have voted Yea on Roll Call 269 and Yea on Roll Call 270.