Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act

Floor Speech

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Mr. PALLONE. 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.

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

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

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

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

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

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

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

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

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Mr. PALLONE. 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.

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

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

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Mr. PALLONE. 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.

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