Post-Surgical Injections as an Opioid Alternative Act

Mr. Chairman, I yield myself such time as I may consume.

Mr. Chairman, I rise in support of H.R. 6, the SUPPORT for Patients and Communities Act. This bill makes incremental changes to support those affected by the opioid crisis, but it is far from perfect.

H.R. 6 does not adequately deal with the magnitude of the crisis that this country is facing, and there are provisions that I did not support at the subcommittee or full committee markup, including provisions that most Democrats voted against. Nonetheless, I am pleased that Democrats were able to secure positive provisions in the final package that we are considering today.

Most notably, H.R. 6 includes provisions from a bill introduced by Representative Tonko and Representative Lujan that would extend access to evidence-based, medication-assisted treatment. Specifically, this section of the bill will allow advanced practice registered nurses, including midwives, to treat patients with buprenorphine for opiate use disorder for 5 years. The bill will also allow nurse practitioners and physician assistants to treat patients with buprenorphine permanently, and allow qualified providers to treat up to 100 patients instead of 30 patients in their first year.

This is a critical step forward in the expansion of treatment, one of the major challenges that we continue to face in the fight against this epidemic.

Mr. Chair, I commend Representative Tonko and Representative Lujan for their ongoing leadership in this area.

This bill also expands coverage through Medicare by adding methadone clinics to the Medicare program. Right now, methadone clinics are not Medicare providers. Seniors who want to get treatment from methadone clinics have to pay out of pocket. Adding methadone clinics will address an important coverage gap in the Medicare program and meaningfully expand access to treatment for opiate use disorders.

The bill also improves coverage for vulnerable populations in Medicaid, ensures coverage for former foster youth up to the age of 26 nationwide, and supports State efforts to ensure continuity of coverage for people with substance use disorders as they leave incarceration.

The bill will also provide funding to Medicaid substance use disorder health homes, give States money to expand the treatment capacity of Medicaid providers, and raise reimbursement rates. It also mandates coverage of Medicaid for all forms of medication-assisted treatment for 5 years.

The legislation also mandates comprehensive substance use disorder benefits in the Children's Health Insurance Program, better known as CHIP. I am also pleased that H.R. 3528, the Every Prescription Conveyed Securely Act, authored by Representative Clark of Massachusetts, is included in the bill. E-prescribing is an important tool that will reduce opiate diversion and prescription fraud.

Further, the bill gives the Secretary of HHS the authority to expand the use of telehealth services in Medicare for substance use disorder treatment to help reach more people across the country.

These were all important Democratic provisions and priorities that we worked hard to have included in the final package. I think these will all make a real difference in our fight against the opioid epidemic.

Having said that, Mr. Chairman, I still have concerns with some of the provisions included in this final negotiated bill and the process by which we arrived here. For instance, there are two Medicare bills that I opposed through the committee process that I am concerned may not have a meaningful impact on the opioid crisis.

H.R. 5804 would increase reimbursement for certain interventional pain injections in the ambulatory surgery setting under Medicare. I have seen no evidence that increasing reimbursement for these injections would have a meaningful impact on opioid prescribing. While it is important that Congress finds ways to promote nonopioid therapies that will reduce opioid prescribing, this legislation endorses and incentivizes interventions that may not be effective for a majority of the patients receiving them.

I also have some concerns about H.R. 5809, which would extend a temporary pass-through payment for nonopioid analgesics for postsurgical pain management from 3 to 5 years in Medicare. I do question if this bill will have a meaningful impact on the opioid crisis.

I am also disappointed that partisan legislation that would direct the FDA to issue guidance on how the agency will apply the criteria for accelerated approval and breakthrough therapy designation to nonaddictive pain and addiction treatment was included in this package. This legislation would set the precedent of having the FDA opine on how expedited programs may apply differently for therapeutic areas.

It requires the agency to host a public meeting to discuss this and other topics, but provides no resources for the agency to complete these tasks. This is not legislation that FDA asked for or highlighted as a priority in fighting the opioid crisis.

While they may now be comfortable with the changes that have been made to the bill, I am not comfortable with the policy.

Finally, Mr. Chairman, I think it is essential that we keep this opioid package in the context of a larger healthcare debate in Congress. As I have stated before, my Republican colleagues are interested in taking credit today for some policies that helped those affected by the crisis while at the same time actively threatening and sabotaging the very healthcare coverage that many of the same people rely on in the first place. The ongoing efforts by House Republicans and the Trump administration to repeal or sabotage the Affordable Care Act have only harmed those affected by this crisis.

Earlier this month, Republicans directly threatened the healthcare of people with opioid use disorder when the Trump administration asked a Federal court to strike down key patient protections in the Affordable Care Act. If successful, the Trump administration's action would eliminate protections that ensure more than 130 million Americans with preexisting conditions cannot be denied coverage. And guess what is considered to be a preexisting condition? Opioid use disorders and people with it.

Republicans also continue with their attempts to gut the Medicaid program, which is our most important weapon in the fight against this epidemic. Both the consumer protections of the ACA and Medicaid have saved countless lives that would have otherwise been destroyed by the opioid crisis. So it is nice that we are passing this bipartisan package today, but we should not forget the tremendous harm Republican policies would inflict elsewhere on the same people we seek to help with this opioid package.

Mr. Chair, I reserve the balance of my time.

Mr. Chairman, I yield 2 minutes to the gentlewoman from California (Ms. Eshoo).

Mr. Chairman, I yield the gentlewoman from California an additional 30 seconds.

Mr. Chairman, I yield 2 minutes to the gentleman from California (Mr. Peters).

Mr. Chairman, I yield 2 minutes to the gentlewoman from Massachusetts (Ms. Clark).

Mr. Chairman, I yield 3 minutes to the gentleman from New York (Mr. Tonko).

Mr. Chairman, may I ask how much time I have remaining.

Mr. Chairman, I yield 2 minutes to the gentlewoman from California (Ms. Bass).

Mr. Chairman, I yield 2 minutes to the gentleman from California (Mr. Cardenas).

Mr. Chairman, I want to enter into the Record my extended remarks regarding a provision included in H.R. 6 that does not enjoy bipartisan support.

Section 301 was passed out of the Energy and Commerce Committee on a party-line vote. Had a committee report been filed, I would have filed the dissenting views that I am now seeking to have added to the Record.

Mr. Chair, H.R. 5806, the 21st Century Tools for Pain and Addiction Treatment Act, would require the Food and Drug Administration (FDA) to hold a public meeting regarding the challenges and barriers of developing non-addictive pain and addiction treatments and to issue guidance regarding the eligibility of such treatments for either the Accelerated Approval Program or Breakthrough Therapy Designation. This legislation could undermine FDA's implementation of the Accelerated Approval and Breakthrough Therapy Designation programs and divert critical financial and personnel resources away from activities related to addressing the opioid crisis for purposes of incentivizing an industry that is already taking advantage of these programs. This legislation is a solution in search of a problem.

Opioid overdose death rates are now the leading cause of unintentional, non-traumatic deaths in the United States. According to the Centers for Disease Control and Prevention (CDC), overdose deaths from opioids have quadrupled in the last 20 years. Approximately 116 deaths per day occur from an opioid overdose resulting in over 42,000 deaths per year.

Of those deaths, 40 percent are due to a prescription opioid. Every day, over 1,000 individuals are treated in emergency departments for complications due to the misuse of opioids, and hospitalizations have increased by over 60 percent since 2005. It is within this context that there has been increasing interest in developing non-addictive treatments for pain and substance use disorders.

FDA, led by Commissioner Scott Gottlieb, has acknowledged that the agency has a role to play in addressing the opioid crisis, including ensuring that fewer individuals become addicted through medical use of these products. According to Commissioner Gottlieb, this includes ``helping support the development of new, safe and effective treatments for pain that don't carry all the same risks of addiction as opioid medicines.'' One of his first actions was the creation of the Opioid Policy Steering Committee (OPSC) that has been tasked with fostering the development of novel pain treatment therapies, and the advancement of non-addictive drugs and devices to treat pain was also included as one of the agency's priorities in FDA's 2018 Strategic Policy Roadmap.

Despite this, concerns have been raised from some pharmaceutical manufacturers that more could be done to help incentivize manufacturers to develop non-addictive treatments for pain and addiction. This included legislation that would direct FDA to issue guidance clarifying how and when the agency would provide accelerated approval and breakthrough therapy designation for medicines to treat pain or addiction. In addition, the proposal includes requiring a detailed annual report in which the agency would account for the number of requests received, granted, or denied for consideration under the expedited programs, the common reasons for granting or denying an application for expedited programs, timelines for drug development, timelines for product review, comparison of metrics among review divisions, common reasons for longer timelines for drug development and product review, as well as recommendations as to how the expedited programs could be better utilized. This legislation was subsequently released by Representative Burgess (R-TX) and was one of the bills noticed for a hearing on March 21, 2018. At this hearing, a representative from BIO testified that the legislation is needed to ``serve as a powerful signal to stakeholders and investors that treatment and therapies that improve and protect the lives of patients suffering from pain and addiction is a top public health priority.''

H.R. 5806, the 21st Century Tools for Pain and Addiction Treatment Act, was formally introduced on May 15, 2018, with Reps. Bucshon and Griffith joining as co-authors. As introduced, the legislation would direct FDA to hold at least one public meeting within one year of enactment to discuss the challenges and barriers of developing non- addictive medical products intended to treat pain or addiction, including the application of novel clinical trial designs and the use of real world evidence and patient experience, as well as the application of eligibility criteria for the Accelerated Approval program and the Breakthrough Therapy designation. In addition, the bill would also direct FDA to issue final guidance or update existing guidance regarding how the agency would apply eligibility criteria for the Accelerated Approval program and the Breakthrough Therapy designation to non-addictive medical products for pain or addiction, including considering the risk of addiction to controlled substances for pain when establishing unmet medical need, and considering whether pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening disease or condition. The guidance must also cover the methods by which sponsors may evaluate acute and chronic pain, endpoints for non-addictive medical products intended to treat pain and how the endpoints would be evaluated for efficacy.

FDA has repeatedly noted that it is actively working with industry and other government partners to encourage the development of non- opioid treatments for pain and addiction. Both former FDA Commissioner Robert Califf and current FDA Commissioner Scott Gottlieb have stated that FDA will use all of the tools at the agency's disposal to move alternatives to opioids as expeditiously as possible. This is a commitment that Commissioner Gottlieb has continued to echo in testimony before the Energy and Commerce Committee (the Committee), specifically noting that ``This includes programs such as Fast Track and Breakthrough Therapy Designations that are intended to facilitate development and to expedite review of products that, for example, are intended to treat a serious condition for which there is an unmet medical need. As a part of these efforts, FDA is meeting with innovators who are pursuing non-opioid alternatives for the treatment of pain to provide guidance on their individual products.''

However, FDA's commitment to this development has not been limited to testimony before Congress or through meetings with industry. In the last five years, FDA has taken a number of actions to help with development of alternative pain and addiction treatments, including convening the Science Board to discuss issues related to challenges facing FDA in supporting the development of pain medications; issuing final guidance and hosting two public meetings regarding the development of opioids with abuse deterrent properties; and as mentioned previously, the advancement of non-addictive drugs and devices to treat pain was also included in FDA's 2018 Strategic Policy Roadmap. Further, the agency also participated in a public-private- partnership under the Critical Path initiative, the Analgesic Clinical Trial Translation, Innovations, Opportunities, and Networks (ACTTION). ACTTION is a collaboration among a broad range of national and international groups working to advance the science in non-opioid and non-addictive pain medications, and includes participation from academia, government agencies, pharmaceutical and device companies, professional organizations, and patient advocacy groups. The agency has also approved non-opioid medications for treatment of chronic pain, including gabapentin, pregabalin, milnacipran, and duloxetine, among others.

These actions are all in addition to the consultation and meetings offered by FDA to sponsors in this space in a one-on-one setting. FDA has committed, to discussion with individual sponsors related to questions about the development of non-opioid and non-addictive medical products for pain or addiction. No evidence has been provided by supporters of this legislation, or by the Majority, that has shown otherwise.

FDA has in place four pathways by which review and consideration of a drug can be expedited--Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track. These pathways provide the sponsor of certain drugs with access to assistance and streamlined review from the agency. At issue in H.R. 5806 is the application of Accelerated Approval and Breakthrough Therapy Designation.

Accelerated Approval, first established in 1992 and codified in 2012, allows drugs for serious conditions that meet an unmet medical need to be approved based on a surrogate endpoint. The use of a surrogate endpoint may predict the clinical benefit of a drug earlier, and FDA is able to require the manufacturers to conduct post-market confirmatory studies to verify the clinical benefit. The Breakthrough Therapy Designation, established in 2012, provides sponsors of drugs to treat a serious condition with preliminary evidence that they demonstrate substantial improvement over other available treatments with access to intensive guidance regarding their drug development program, more frequent meetings and communication with FDA, and rolling review. Both pathways are desirable from a manufacturer's perspective as it can allow products to come to market sooner. A recent study conducted by Friends of Cancer Research found that cancer drugs that received Breakthrough Therapy Designation received FDA approval nearly three months sooner than drugs that did not, and their development time was reduced by nearly two years.

The additional guidance, communication, and expedited review provided by these two programs does have an impact on both the financial and personnel resources of FDA. In fact, the Breakthrough Therapy Designation program received far more interest than originally projected, and given the access to FDA staff throughout the development and review process and has been described by the agency as posing a ``strain'' because the creation of the designation did not come with any additional resources. According to testimony from Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, over the first four years of the program the agency had received 492 requests for designation, and of those, granted 165 requests. As a result, industry and FDA negotiated to increase the number of staff dedicated to the Breakthrough Therapy Designation program by 36 full- time employees as part of the Prescription Drug User Fee Act reauthorization signed into law as a part of the Food and Drug Administration Reauthorization Act. While user fee resources may help to address the issues associated with the implementation of the Breakthrough Therapy Designation program, the Office of New Drugs within the Center for Drug Evaluation and Review (CDER) continues to be short-staffed with one estimate noting that the Office is 10 percent under the authorized staffing ceiling.

As previously mentioned, proponents of the legislation have argued it is necessary in order to help ``enable the utilization of Accelerated Approval and Breakthrough Therapy pathways'' for non-addictive pain and addiction treatments. ``Enactment and implementation of this legislation would provide FDA and the biopharmaceutical industry with a greater understanding of what is required to meet criteria for these expedited approval pathways and ensure processes intended to expedite development and approval meet the unique needs of

pain and addiction medicines,'' noted Ms. Cartier Esham, Executive Vice President, Emerging Companies Section and Senior Vice President, Science & Regulatory Affairs at BIO, in testimony before the Committee. Despite the claims of lack of clarity, there is evidence that industry has been taking advantage of both of these pathways currently.

Accordingly, in technical assistance provided by FDA the agency stated, ``We believe, however, that sponsors and potential sponsors of [non-opioid and non-addictive medical] products are already aware of these programs, and have been taking advantage of them. We also believe that to the extent there is a need for additional outreach on application of the expedited programs to these products, FDA has, and is committed to using, other means to accomplish this, such as public meetings . . . and discussion with individual sponsors.'' More than 60 percent of new molecular entities and biologics license applications approved in 2017 were eligible for one of the expedited programs--Fast Track, Breakthrough Therapy, Priority Review, or Accelerated Approval. This includes products in the pain and addiction space. On Breakthrough Therapy Designation, there have been 19 requests for designation from drugs with pain indications since the program was created, three of those were granted, 14 were denied, and two were withdrawn. According to FDA, ``In general, if a drug meets the statutory criteria it will get the designation.'' In regard to Accelerated Approval, there has been one drug with an indication for pain; another product has received Fast Track designation. All evidence indicates that sponsors of non- opioid and non-addictive medical products for pain and addiction are receiving access to FDA and have been able to take advantage of the expedited programs if they meet the statutory criteria.

The opioid crisis has made everyone rethink how we treat pain and addiction in this country and there is broad agreement that this conversation should include examining alternatives to opioids that are non-addictive. Patients and providers deserve to have options other than opioids for pain and addiction. It is clear that FDA has prioritized this effort and has been assisting sponsors in their development. No evidence has been provided that demonstrates otherwise. H.R. 5806 is legislation in search of a problem.

A key provision of H.R. 5806 is directing FDA to issue, or update, guidance regarding how the agency will apply the Accelerated Approval and Breakthrough Therapy Designation program to non-addictive medical products for pain or addiction. This would include the circumstances under which FDA may apply eligibility criteria to these products, how FDA will consider the risk of addiction of controlled substances approved to treat pain when establishing unmet medical need, and how FDA will consider pain, pain control, or pain management in assessing whether a disease or condition is a serious or life-threatening condition. Such an effort would be precedent-setting for the agency as it would be the first time the agency would do such a regulatory guidance for a product specific area.

In order to help drug sponsors make determinations about whether or not their products would be eligible for expedited programs pathways, as well as Fast Track and Priority Review, the agency issued comprehensive guidance outlining the requirements and features of each of the pathways in May 2014. As noted in the guidance, ``The purpose of this guidance for industry is to provide a single resource for information on FDA's policies and procedures for these four programs as well as threshold criteria generally applicable to concluding that a drug is a candidate for these expedited development and review programs.'' H.R. 5806 would move to change this by requiring the agency to issue new guidance for non-addictive pain or addiction treatments. According to technical assistance received from FDA:

Typically, FDA refrains from issuing product area-specific

guidance documents unless there is a need to address

scientific or clinical issues specific to those products. It

is not clear what scientific or clinical issues specific to

application of our expedited programs to non-opioid or non-

addictive medical products to treat pain or substance use

disorder would benefit from FDA guidance. To the extent

sponsors have questions about how FDA's expedited programs

apply to their specific products, such questions are better

addressed in our existing guidance on the use of expedited

programs in general and in meetings or other communications

between FDA and individual sponsors. These latter

interactions with FDA permit targeted, product-specific

discussion of a type that is typically not possible in

guidance--even product area-specific guidance.

By requiring the agency to issue such guidance, despite FDA's concerns, H.R. 5806 is now raising questions regarding whether or not the criteria for the expedited programs applies differently for each product area, and could expose the agency to a multitude of additional requests from other therapeutic areas for product area-specific guidance about the eligibility for these pathways.

In addition, H.R. 5806 would also require the agency to host at least one public meeting to examine challenges and barriers facing non- addictive medical products for pain and addiction, including application of novel clinical trial designs, use of real world evidence and patient experience data, as well as the eligibility criteria for Accelerated Approval and Breakthrough Therapy Designation. Public meetings and guidance require considerable staff time and financial resources, diverting time away from other activities such as meeting one-on-one with sponsors or responding to questions regarding submissions. This legislation does not provide any new resources for these activities, and would have been more appropriately discussed during consideration of the user fee reauthorization that could have accounted for the need for additional resources to implement these activities.

As FDA has noted, the agency grants access to the expedited programs if products meet the statutory requirements of such programs. Proponents have argued that legislation is necessary to incentivize industry to develop non-addictive pain and addiction treatments as well as to make sure that the expedited programs and processes ``meet the unique needs of pain and addiction medicines.'' This makes clear the legislation is not about greater clarity as supporters have argued, but is instead about re-interpreting the requirements of the expedited programs to ensure that non-addictive pain or addiction treatments will be eligible. H.R. 5806 as such could be used in the future for stakeholder to request the eligibility for the expedited programs be changed to guarantee that their products can receive Accelerated Approval and Breakthrough Therapy Designation should the guidance provided under this legislation not be suffice. This could have the effect of unintentionally weakening the benefits of Accelerated Approval and Breakthrough Therapy Designation pathway by expanding it to even more products, and put strain on FDA's resources by expanding such programs to products that were not planned for under the user fee reauthorizations. While we all want to bring alternatives to opioids to market sooner, we must seriously consider the implications of expanding FDA's expedited programs.

Finally, this is not legislation that FDA has asked for or highlighted as a priority in fighting the opioid crisis. While the agency has indicated that they are not opposing the legislation and believe the changes that have been made are helpful, this legislation can have real and serious implications for the drug approval process.

It is for all these reasons that Democrats unanimously opposed H.R. 5806.

Mr. Chair, I reserve the balance of my time.

Mr. Chair, I have no additional speakers, and I reserve the balance of my time.

Mr. Chair, I continue to reserve the balance of my time.

Mr. Chairman, I want to thank the staff who worked so hard on H.R. 6 and the opioid bills, in general. Democrats worked to make H.R. 6 a better bill, even though we have concerns about the overall impact of the opioid package.

Mr. Chair, I ask my colleagues to support the legislation, and I yield back the balance of my time.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days to revise and extend their remarks and include extraneous materials on H.R. 6.

Mr. Chairman, I yield myself such time as I may consume.

Mr. Chairman, I rise today in support of H.R. 6. This is the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT for Patients and Communities Act.

I was proud to introduce this bill with my bipartisan colleagues: Energy and Commerce Committee ranking member, my friend from New Jersey, Mr. Pallone; Ways and Means Committee Chairman Kevin Brady; and Ways and Means Ranking Member Richard Neal.

These past 2 weeks, this House, the people's House, has dedicated tremendous amounts of time and energy to send a simple message to millions of Americans impacted by the opioid crisis. And that message is: Help is on the way.

Not only are we passing legislation, dozens and dozens of bills that will save lives, but also we want to leave no doubt in the minds of those suffering from addiction that the United States House of Representatives, Republicans and Democrats alike, stand with them together.

For too long, embarrassment and stigma surrounded the disease of addiction. It is time for that to change. If you are struggling with addiction, if you are fighting that invisible battle, please know that it is okay to seek help.

Opioid overdoses take the lives of more than 100 Americans each and every day. In fact, Mr. Chairman, a thousand people in our country will go to an emergency room in the next 24 hours, suffering an overdose from opioids. We don't want those people to become part of that deadly statistic.

You matter. You are worthwhile. And I pray that the various legislation we vote on here today, and that we voted on throughout the last 2 weeks, can help you begin your journey of recovery.

H.R. 6 includes several bills that went through regular order at the Energy and Commerce and Ways and Means Committees, but the bill we will vote on today also includes dozens of other pieces of legislation that have recently passed the House, most unanimously or with very strong bipartisan majorities.

You see, at a time when it seems we couldn't be more divided, it is clear that striking back against addiction is something that transcends politics and brings us together as a community, as a country, and as a Congress.

Remember, this legislation is not the first action that this Congress has taken to combat the opioid crisis, and I am sure it will not be the last. I guarantee you that.

The Comprehensive Addiction Recovery Act and the 21st Century Cures Act, both of which were signed into law nearly 2 years ago, and an additional $4 billion in resources for States and communities that was provided in the omnibus appropriations bill just a few

months ago, indicate we have been at this for awhile, and we will be at this for a while longer.

Taken together, this is one of the most significant congressional efforts against a drug crisis in our Nation's history. But we must continue to legislate, evaluate, conduct oversight, and work together to provide new solutions, so that we can rise to this ever-challenging situation.

Today, we have an opportunity to continue our work to combat this crisis, an opportunity to save lives, and we cannot let it pass. The legislation before us will help advance treatment and recovery initiatives, improve prevention and educational efforts, protect our communities, and bolster our efforts to fight deadly synthetic drugs like fentanyl.

We owe it to the families we have heard from. We owe it to our friends. Our communities need this and our country needs this to lift our people out of addiction and, together, win this fight.

Mr. Chair, I urge my colleagues to support H.R. 6, the SUPPORT for Patients and Communities Act, and I reserve the balance of my time.

Mr. Chairman, I yield 1 minute to the gentleman from Kentucky (Mr. Guthrie), the vice chairman of the Subcommittee on Health, a great leader on these issues and more.

Mr. Chairman, I yield 1 minute to the gentleman from West Virginia (Mr. McKinley), who has been a fierce fighter to resolve this issue in his State and our country.

Mr. Chairman, we were glad to work with Mr. Peters on his legislation to make it bipartisan and get it across the line.

Mr. Chairman, I yield 1 minute to the gentleman from Florida (Mr. Bilirakis).

Mr. Chairman, I want to thank Ms. Clark and Mr. Mullin for bringing that issue to our attention. We were proud to work with them to get it in the bill.

Mr. Chairman, I yield 1 minute to the gentleman from Indiana (Mr. Bucshon), who is one of our doctors on the committee.

It is now my great honor, Mr. Chairman, to yield 1 minute to the gentleman from California (Mr. McCarthy), who is the majority leader of the United States House of Representatives. He has been extraordinarily helpful in our efforts to move this entire bipartisan package forward to save lives and help people in addiction.

Mr. Chair, I thank my colleague from California for bringing this issue to our attention and helping us help these kids who need this assistance.

Mr. Chair, I yield 1 minute to the gentleman from Wisconsin (Mr. Ryan), the Speaker of the United States House of Representatives.

Mr. Chairman, I want to thank my colleague from California for working with us. We were happy to include his bill in this compilation of legislation.

Mr. Chair, I yield 1 minute to the gentleman from Georgia (Mr. Carter), our resident pharmacist in the United States Congress and on the Energy and Commerce Committee.

Mr. Chair, I yield 1 minute to the gentleman from New Jersey (Mr. Lance), who has been very, very involved in this effort.

Mr. Chairman, I yield 1 minute to the gentleman from Michigan (Mr. Walberg), who has been very involved in this effort as well.

Mr. Chairman, I yield 1 minute to the gentleman from Georgia (Mr. Allen).

Mr. Chair, I yield myself the balance of my time.

Mr. Chair, I want to thank my colleagues on both sides of the aisle. We have had individual Members come to the floor today from both parties. Together, we have broken through what others might see as dysfunction in Washington to achieve a comprehensive legislative package that will provide treatment; save lives; stop illegal fentanyl from coming into this country; and, in no small measure, move America forward in a much better direction.

I want to share with you, Mr. Chair, a letter to the Speaker and to Ms. Pelosi, urging us to support H.R. 6. It comes from not 1 or 2 but, literally, 161 different groups that are very involved in the recovery effort.

I want to share a couple of comments, Mr. Chairman: ``Substance use disorder not only impacts the individual, but the family and community as well. According to the Substance Abuse and Mental Health Services Administration, approximately 9 million children across our Nation live in a home with at least one parent who uses an illicit drug.

``Tragically,'' they write, ``children in these homes are at an increased risk for depression, suicide, poverty, delinquency, anxiety, homelessness, and substance use disorder. In addition, while our Nation has made significant strides in both our understanding and response to the drug crisis, it is clear that too many communities across our Nation still have fragmented prevention, treatment, and recovery infrastructures.''

Introduced by myself, Mr. Pallone, Mr. Neal, and Mr. Brady, they write: ``The SUPPORT for Patients and Communities Act,'' this bill, ``would strengthen key Federal low-income assistance and senior health insurance programs to better respond to our Nation's drug crisis. In addition to serving as the vehicle that will advance many other significant proposals already considered in the House, this legislation will give critical Federal safety net programs more tools to prevent and help treat substance use disorder.''

They write: ``We applaud the champions of H.R. 6 for treating addiction like the disease that it is and for their bold leadership, in their respective committees and on the House floor, to advance so many innovative, bipartisan proposals that will have an immediate and positive impact to address addiction. We respectfully urge the full House to immediately consider and pass H.R. 6, which represents a significant step toward building the comprehensive response needed in our Nation so that fewer lives are lost to substance use disorder.''

Mr. Chair, this comes from the people who live this every day, who help our neighbors, our friends, our families, and our American citizens get the help they need to beat the disease of addiction and to reclaim their lives, their families, and their future.

Mr. Chairman, I urge my colleagues to support passage of H.R. 6, and I yield back the balance of my time.

Mr. Chairman, I have an amendment at the desk.

Mr. Chairman, I appreciate all the work that has been done on this bill up to this point, the great bipartisan work, the biggest effort, I think, Congress has ever undertaken to address this terrible, terrible addiction problem of opioids and everything related to it.

This amendment before us is a bipartisan manager's amendment. It is filed by chairmen and ranking members of the Committees on Energy and Commerce and Ways and Means. This amendment makes simple technical corrections and conforming changes to the underlying H.R. 6 bill that the leaders of our two committees introduced last week.

As has been noted, the policies in H.R. 6 were moved through regular order in our two committees. I appreciate the bipartisan cooperation and teamwork of my colleagues and our terrific staffs who have joined me in introducing H.R. 6.

Mr. Chair, I encourage support of the amendment, and I urge adoption of the amendment.

Mr. Chairman, I yield back the balance of my time.

Mr. Chairman, I thank Mr. Neal for yielding.

Mr. Chairman, I support H.R. 6 as a step to the puzzle to address substance abuse. However, I think we need to expand this bill in an important way as it moves forward.

To prevent opioid addiction, we must address the social and emotional harm caused by trauma that often underlies opiate use.

Research demonstrates that exposure to four or more adverse childhood experiences, such as neglect, experiencing a parent battling addiction, witnessing violence, or observing domestic violence, makes an individual 10 times more likely to misuse illicit narcotics. These drugs serve as a coping response to traumatic life experiences.

The Senate's bipartisan Opioid Crisis Response Act included provisions from my Trauma-Informed Care Act with Senator Durbin to help improve the Federal response to trauma to help prevent opioid abuse. These provisions would expand the workforce capacity to help children exposed to trauma, they would improve our understanding of trauma by improving Federal data and best practices, and they would increase services for children exposed to trauma to help these young people heal.

Our efforts to prevent the opioid crisis will be insufficient unless we address the role of trauma in it, which is why 28 organizations supported my effort to amend H.R. 6 to focus on trauma--organizations like the Child Welfare League of America, the Jewish Child and Family Services, the National Association of Social Workers, Partners for Our Children with the University of Washington, and the YMCA USA--but my amendment was not made in order.

The science is clear that trauma has devastating effects on a child's healthy development well into adulthood. When children experience traumatic events, stress alters the developing brain, which harms them physically and mentally.

Mr. Chairman, I include in the Record this outline of the research by

the Society for Research in Child Development documenting the harm caused by trauma and parental separation.

[From the Society for Research in Child Development, June 20, 2018]

Statement of the Evidence--The Science Is Clear: Separating Families

Has Long-Term Damaging Psychological and Health Consequences for

Children, Families, and Communities

After the United States Department of Justice announced the

``Zero olerance Policy for Criminal Illegal Entry,''

Immigration and Custom Enforcement (ICE--an arm of the

Department of Homeland Security) separated approximately

2,000 children from their parents in April and May 2018 as

they approached the U.S. border. Children and parents were

placed in separate facilities as they were being processed

and were not told when or how they would be reunited. This

policy and its consequences have raised significant concerns

among researchers, child welfare advocates, policy makers,

and the public, given the overwhelming scientific evidence

that separation between children and parents, except in cases

where there is evidence of maltreatment, is harmful to the

development of children, families, and communities. Family

separations occurring in the presence of other stressors,

such as detention or natural disaster, only adds to their

negative effects.

Evidence on Harmful Effects of Parent-Child Separation

The evidence that family separation is harmful dates back

to studies on the effects of parent-child separations on

children's well-being during World War II. This research

documented far reaching effects of these separations into

adulthood, including increased risk for mental health

problems, poor social functioning, insecure attachment,

disrupted stress reactivity, and mortality (Pesonen &

Raikkonen, 2012; Rusby & Tasker, 2009; Mitrani, Santiste-ban,

& Muir, 2004). Other research similarly documents the harmful

effects of parental separation on child wellbeing in a

variety of other child populations including children in

Romanian orphanages (Zeanah, Nelson, Fox, et al., 2003),

children in foster care (Flannery, Beauchamp, & Fisher, 2017)

and children of incarcerated parents (Geller, Garfinkel,

Cooper & Mincy, 2009; Miller, 2006). More recent work has

documented the increased mental health risk faced by both

parents and children when they are separated in the

immigration process (Suarez-Orozco, Bang, & Kim., 2011; Rusch

& Reyes, 2013). Parent-child separation has long-term effects

on child well-being, even if there is subsequent

reunification. After being separated, reunited children can

experience difficulty with emotional attachment to their

parents, self-esteem, and physical and psychological health

(Smith, Lalonde, & Johnson, 2004; Gubernskaya & Debry, 2017).

For some children, time does not appear to fully heal these

psychological wounds (Shonkoff et al., 2012).

Parents Buffer Children from Adverse Effects of Toxic Stress

Parental separation is considered a toxic stressor, an

experience that engages strong and prolonged activation of

the body's stress-management system (Bridgman, 2014) The

physiological and psychological toll of early life stress,

including parental separation, changes how the body responds

to stress in the long term, disrupting higher-order cognitive

and affective processes as well as negatively altering brain

structures and functioning (Lupien, McEwen, Gunnar, & Heim,

2009; Pechtel & Pizzagalli, 2011; Kumar et al., 2014). Such

stressors put children at greater risk for a multitude of

health and psychological impairments, including anxiety,

depression, post-traumatic stress disorder, lower IQ,

obesity, immune system functioning, physical growth, cancer,

heart and lung disease, stroke, and morbidity (Granqvist,

Sroufe, Dozier, Hesse, & Steele, 2017, Heim & Nemeroff, 2001;

Mamam, Antornadis, & Morris, 2014; Pechtel & Pizza-galli,

2011; Shirtdiff, Coe, & Pollak, 2009; Taylor, 2010).

Children depend on their primary caretakers to successfully

navigate stressful and traumatic events. Children's

physiological responses to stress can be significantly

reduced by access to their primary caretaker (Hostinar,

Sullivan, & Gunnar, 2013). The separation of the family unit

under extreme conditions of stress worsens the psychological

and physiological ramifications of that stressor on children,

especially younger children (Masten & Narayan, 2012).

Conversely, ongoing contact with primary caregivers under

conditions of stress can protect against risk (Rodriguez &

Margolin, 2015).

Child-Separation from Parents Impacts Children at All Ages

Much of the research on family separation has focused on

the impacts on children early in development. However,

puberty is also an especially vulnerable time of rapid change

(Doom & Gunnar, 2013). Stressors during adolescence can have

lasting impacts--the effects of which may not become evident

until adulthood--(Humphreys, Gleason, Drury, et al., 2015;

Lupien, McEwen, Gunnar, & Heim, 2009). Further, the effects

of traumatic experiences are cumulative; children and

adolescents who have already faced previous adversity are

particularly susceptible to long term further negative

consequences (Brown, Anda, & Tiemeier, et al, 2009,

MacKenzie, Bosk, & Zeanah, 2017) Thus, the research shows

that across infancy, childhood, and adolescence, child-family

separations can be related to negative outcomes across the

lifespan.

Impact of Border Family Separations on U.S. Citizens

There is also evidence that family separations harm U S.

citizens whose family members experience border detention or

deportation. Parental separation increases the risk for these

U.S. children's mental health problems such as anxiety,

depression, behavior problems, and symptoms of post-traumatic

stress disorder (Allen, Cisneros, & Tellez, 2015; Rojas-

Flores, Clements, Hwang Koo, & London, 2017; Zayas, Aguilar-

Gaxiola, Yoon, & Rey, 2015). U.S. citizens of Latino descent

also report heightened worries and concerns for their

families and their communities as a result of changes in

implementation of immigration policies such as the Deferred

Action for Childhood Arrivals (DACA) policy (Roche, Vaquera,

White, & Rivera, 2018). Moreover, countries with supportive

integration policies are more likely to have child

populations with better overall health and mental health

indicators than those with less supportive approaches (Marks,

McKenna, & Garcia Coll, 2018). Thus, there is evidence that

policies about parental separations can negatively affect

American citizens.

The Policy Implications are Clear

The scientific evidence is conclusive. Parent-child

separations lead to a host of long-term psychological,

social, and health problems that are not necessarily resolved

upon reunification. In particular, the disruption of

biological stress regulation mechanisms in the body induced

by the need to seek refugee or asylum status are further

taxed by the absence of parental support. The science is

clear: policies that separate immigrant families upon entry

to the U.S. have devastating and long-term developmental

consequences for children and their families.

That is why the administration's intentional infliction of trauma on children by separating children from their parents is so cruel and inhumane. Causing intentional harm to children is a human rights violation and is un-American. We must stop this appalling policy immediately, reunite parents and children without delay, and provide intensive services to help these families heal.

Mr. Chairman, I yield myself 4 minutes.

Mr. Chairman, I rise in support of H.R. 6.

It has become all too clear that the ongoing opioid epidemic has gripped our Nation's families and communities. It crosses social spectrums and is a public health, safety, and economic crisis as well.

In Massachusetts in 2016 there were 2,083 confirmed cases of opioid- related overdose deaths. This is a 26 percent increase from 2015 and a 54 percent increase from 2014. In 2017 there was a small decrease, but clearly there was still a strong need to address this devastating trend.

This week, the House has considered opioid bills in committee and on the floor, and some of these, in fact, will expand treatment options for the care that is necessary.

However, a number of the Democratic priorities here, I think, really provide real investment and opportunity. For example, it incorporates a bill I introduced that would expand Medicare coverage for opioid treatment programs. Currently, Medicare does not cover this sort of treatment. This would give Medicare beneficiaries access to a broad range of treatment options, leading to opportunities for lasting recovery.

Although many think of opioid use disorders as a problem faced by young people, many may be surprised to learn that it is rapidly growing among our Medicare beneficiaries. Medicare part D spending on opioids for treatment outpaces enrollment, growing 165 percent from 2006 to 2015. In 13 States, the over-65 population has the highest rate of opioid-related inpatient stays.

H.R. 6 also expands coverage of medication-assisted treatments and allows nurse practitioners and physician assistants to prescribe or dispense certain opioid treatment drugs. The measure also provides consistent Medicaid coverage for at-risk youth and expands Medicaid coverage for foster youth until the age of 26.

These bills are pieces of a large, complex puzzle. We need to find realistic solutions with long-term outcomes. Part of this approach is to protect and strengthen Medicaid and the Affordable Care Act.

The ACA guarantees parity and nondiscrimination for people who need substance use disorder treatment and mental health treatment. Thanks to the ACA, millions of previously uninsured adults now have access to health insurance and, I might add, the expansion of Medicaid.

There are many efforts here, I think, time and time again, to dismantle the Medicare proposal, as well as cutting back on many of the initiatives that we have proposed in the past. Instead of strengthening and ensuring a sustainable future for the ACA and for Medicaid, some of our colleagues want to cut them to pay for a $2.3 trillion tax plan. Efforts to sabotage the ACA, coupled with premium hikes, slashing preexisting condition protections, and increasing drug prices will lead to more uncertainty.

Dismantling current health benefits would damage any progress that we are making today with the opioid crisis. It would also increase healthcare costs and lower coverage and quality of life for Americans and their families.

I urge my colleagues to recognize that many families, who are devastated by addiction, are going to need the opportunities that we are embracing today.

The impact of the opioid crisis on the labor participation rates in America should concern all of us. According to a recent report, the economic burden from opioids was estimated at $95 billion.

The American people are facing two-pronged obstacle health challenges. Uncertainty remains one of them. We want to make sure that we don't sabotage the ACA. And part of the path forward today is highlighted by the achievement we are all about to recognize.

Mr. Chairman, I reserve the balance of my time.

Mr. Chairman, I yield 4 minutes to the gentleman from Illinois (Mr. Danny K. Davis).

Mr. Chair, I reserve the balance of my time.

Mr. Chairman, I yield myself the balance of my time.

Mr. Chairman, I want to close by thanking Chairman Kevin Brady and acknowledging Chairman Walden and Ranking Member Pallone for their hard work on what is really a good step forward.

As I said earlier in my remarks, this bill is not going to solve the opioid crisis tomorrow, but it does include a number of important provisions that will expand access to treatment and recovery options for all Americans. This was a bipartisan piece of work in our committee. I think we can be proud of it. We know many who need treatment now cannot access it, and this bill will take significant steps to change that.

I want to thank Jessica Shapiro and Karl Hagnauer from the House Legislative Counsel for their hours of work in helping us to put together H.R. 6; the staff of the Centers for Medicare and Medicaid Office of Legislation, in particular Ira Burney and Jennifer Druckman; and the staff of the Congressional Budget Office, including Rebecca Yip and Lara Robillard.

Finally, I want to thank the Ways and Means Republican staffers led by Emily Murry, the Energy and Commerce Democratic staff led by Tiffany Guarascio, the Energy and Commerce Republican staff led by Josh Trent, and my own Democratic staff at Ways and Means, which is always superb, led by Amy Hall, Melanie Egorin, and Rachel Dolin.

A lot of hard work goes into this sort of legislation and a lot of complexities have to be addressed during the process, and oftentimes that is not the sort of information that finds its way to the public light. But acknowledging here those people who helped to put this together as well as the men and women of the committee, I think, frequently is missed, and we want to do that so that they receive the, I think, due praise that they are entitled to.

I hope that this, when matched with Senate provisions, will quickly become law.

One of the things that unites every one of us in this Chamber is that we all know somebody--a family member, somebody who lives down the street, or a coworker--who has an opiate addiction. I think that Congress taking this step today in this direction will provide some sense of hope for those families and friends who find themselves, for a variety of reasons, suffering from the pain economically and physically that comes from opiate addictions.

I think, as we close here, this is a good day for the Ways and Means Committee, Energy and Commerce Committee, and, I think, for the members and the staffers whose work is reflected in this product.

Mr. Chair, I yield back the balance of my time.

Mr. Chairman, I thank the gentleman for yielding, and I want to congratulate the gentleman for his work, his tireless effort, and his passion for those who have been afflicted with the addiction and have lost the battle.

Mr. Chairman, I rise today to urge the passage of H.R. 6 which contains more than 50 opioid-related bills which we have considered in the past 2 weeks.

We have in this body the opportunity nearly every day to approve legislation of great consequence to millions of people. But rarely do the consequences feel so immediate and so vital as they do for the opioids package we are considering. That is because this legislation has to do with the deadliest drug crisis in our Nation's history.

The grim truth is this: More Americans have died from drug overdoses since the turn of the century than died in the Civil War. Yes, you heard that right. In less than two decades, more than 630,000 people have died because of drugs. Half of those deaths had to do with opioids. This death toll is the ``American carnage'' that President Trump referred to in his inaugural address.

My hometown of Bakersfield has been devastated by illegal drugs, mostly heroin and meth. In 2016 alone, 54 people in my county died of an opioid overdose. This is a statistic made up of 54 stories of unimaginable sadness. They are stories of happy families torn apart by deceit, abuse, and death; stories of parents robbed of children, children robbed of parents, and friends robbed of friends. My local news talked

to one man in Bakersfield who has lost four friends to overdoses in the past few years alone.

Of course, these tragic events are not confined to just my district; they are happening everywhere across the country, coast to coast.

So I would like to tell you another story, this time from the other side of the country. It is the story of Eamon Eric Callanan, age 28. He did not live to see age 29.

Eamon came from a family with deep roots in Rochester, New York. One of his great-grandfathers was a chief of police in Rochester. His grandfather was a judge, and his parents are attorneys. They were the very definition, in other words, of a law-abiding family. But in early 2012, a series of events took place that sent Eamon down a different path and stole him from his family forever.

At age 25, Eamon hurt his back--a story that many in America have seen--while he was on his job. He began taking opioid painkillers in response to his pain. When the pills became too expensive, Eamon, like many Americans, switched to heroin. Before long, the loyal, goofy kid his family once knew was gone. Drugs had dampened the beautiful music of his life and turned it into a sorrowful echo.

Eamon Eric Callanan died of a drug overdose on June 8, 2016. Last Wednesday marked the 2-year anniversary of his funeral.

In many respects, Eamon's story is not unique. He was one of 169 people in his county--42,000 people in our country--to die of an opioid overdose that year. Eamon was just one body in a grim tide of overdose deaths.

So why am I telling you this story? I am telling it to remind you that each one of those victims had a name and a life and friends and family whom they loved and left behind.

One of those people Eamon loved and who loves him deeply in return is actually sitting in this Chamber right now. Her name is Erin. She is Eamon's sister and my press secretary. Erin was 24 days from her wedding when she learned that she would never see her brother again and that he would not be there to celebrate with her on one of the happiest days of her life.

Let that be a lesson to all of us. There is no event so joyful, no place so safe that it is untouched by the drug crisis--even a wedding chapel, even here in the Halls of power, even in my office.

Mr. Chair, if we hope to defeat the deadliest drug crisis in history, we will need the biggest response in history. Rest assured that the response is already underway, led by this administration and this Congress. We are wrapping up voting on more than 50 bills to help millions of Americans affected by the opioid crisis. We are about to vote on a package that contains almost all of those bills, H.R. 6.

Among others, it contains a bill by Congressman Mike Bishop that will reduce the flow of Chinese fentanyl into our country by giving law enforcement new tools to detect suspicious packages in the mail. It includes a reform to the so-called IMD exclusion, an outdated regulation that restricts Medicaid funding for large inpatient treatment programs, programs with the potential to heal substance abuse patients like Eamon.

Those are just two of the important bills that are part of this package. It is no exaggeration to say that they can save lives and save families from the immeasurable grief of losing a loved one to an overdose.

Yes, I am confident these bills will help stem the tide of drug abuse, but I will end on a note of caution.

If defeating the opioid crisis is left to government alone, then we will surely fail. Healing the wounds of drug abuse will take more than just this body can provide; it will take the commitment by every citizen to fulfill our duties to one another.

We have all been touched by this tragedy, so we all have a part to play in its resolution. That means supporting people near us who are struggling with drug addiction. It means rebuilding families and towns torn apart by isolation, addiction, distrust, and death. It means supporting the many charities, ministries, and nonprofits that are already healing the sick in our communities.

In Bakersfield, that means groups like The Mission, the Christian charity where I volunteer. The Mission operates a faith-based addiction recovery program that is changing lives, even knitting together families that have come apart at the seams.

Because of The Mission, a husband and wife with five children overcame their past of drug addiction and drug dealing, and they did it together. Then they convinced their niece to get clean, too.

We need more stories like that. In the days ahead, this House has a chance to do its part to ensure that more stories of abuse and despair have their own happy ending. We will do this work for the healers and protectors, for the suffering, and for all those like Eamon who are now at rest.