Frank Pallone

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. I rise in support of H.R. 1629, the Fairness in Orphan Drug Exclusivity Act. The legislation will close a loophole in the orphan drug program to ensure generic drugs can come to market and are not unfairly blocked by their brand competitors. This bill, which passed the House by a voice vote last Congress, takes steps to address two crises: one, the soaring cost of prescription drugs; and, two, the ongoing opioid crisis. It deserves our bipartisan support once again today. The Orphan Drug Act has been successful in driving research and discovery of new therapies to treat and even cure rare diseases. The law incentivizes the development of these therapies, including by awarding 7 years of market exclusivity and two pathways for manufacturers to receive these incentives. Under the first pathway, orphan drug status may be awarded when manufacturers develop drugs approved to treat diseases with patient populations of 200,000 or fewer. Under the second pathway, through the rarely used cost recovery pathway, they may receive orphan drug status if drug research and development costs are not expected to be recouped by sales of the underlying drug. Now, under certain circumstances, a manufacturer may also get additional rounds of exclusivity for additional drugs in their portfolio if they treat the same condition and have the same active ingredient, even if the second drug does not meet the orphan drug qualifications. This provision has allowed some manufacturers to circumvent the original intent of the Orphan Drug Act, which was to incentivize the creation of novel drugs for small populations. Because of this loophole, some manufacturers have been able to market widely used drugs to large populations, all while retaining exclusivity and blocking generic competition from coming to market. An example of this recently occurred when a formulation of bupe, a drug to treat opioid use disorder, was approved in 2017 and was allowed to carry the orphan drug designation granted to its manufacturer's original bupe drug more than 20 years earlier in 1994. When the original 1994 orphan drug designation was granted, it was expected that this drug would not be prescribed frequently. However, as the opioid crisis worsened, and our response to the crisis evolved, millions were eventually prescribed the treatment, generating billions in sales. Clearly, we knew in 2017 that bupe was not an orphan drug. Nevertheless, the drug was granted orphan drug status and exclusivity, and that delayed additional forms of generic competition. While the FDA eventually recognized this issue with this particular drug and revoked its orphan drug designation, its exclusivity delayed generic competition that otherwise would have been on the market. We need, Madam Speaker, every tool available to us to combat the opioid epidemic, including low-cost, affordable medication treatments, and loopholes like this one should not be allowed to limit access to low-cost drugs. H.R. 1629 would stop this from happening again in the future. It requires drug manufacturers to demonstrate in their application to the FDA that each drug application considered under the cost recovery pathway would fail to recoup development costs. The legislation would also ensure that these rules apply to drugs already on the market. This bill is a narrowly tailored fix for a narrow but very real loophole in the law. I thank Representative Dean from Pennsylvania for introducing this bill. It passed the House on a bipartisan basis, by voice vote, and without opposition last Congress. I look forward to it passing with bipartisan support again today and getting it through the Senate and to President Biden's desk so it can become law. I urge all of my colleagues to support the bill. Madam Speaker, I reserve the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise today in support of the Helping Emergency Responders Overcome Act, or the HERO Act. As we have learned over the past year, not all heroes wear capes. There are heroes in our communities working to save the lives of countless Americans, including our emergency responders, firefighters, healthcare workers, and hospital personnel, who, to this day, continue to battle COVID-19. Unfortunately, despite their heroic efforts, evidence suggests that suicide, depression, and substance abuse disorder are significant issues facing public safety personnel and medical providers. Those on the front lines of the COVID-19 pandemic have witnessed previously unimaginable conditions that are traumatizing for even the most resilient public safety and medical personnel. Madam Speaker, prior to COVID-19, it was estimated that 30 percent of first responders develop behavioral health conditions, including, but not limited to, depression and post-traumatic stress disorder, as compared with 20 percent of the general population. Tragically, a 2018 study found that public safety officers were more likely to die by suicide than professionals in other lines of duty. So this bill will help inform and support prevention and treatment strategies for addressing behavioral and mental health issues among public safety officers. The legislation would require the development of a data system to capture the incidence of suicides among this population, while also facilitating the study of successful interventions to reduce suicide among these frontline health workers. The bill also includes efforts to enhance behavioral health and wellness programs for healthcare providers, such as providing financial assistance to entities that establish behavioral health programs targeted to these populations. By utilizing the new data system, improved research, and programmatic findings, the Department of Health and Human Services will develop best practices and resources for addressing PTSD in these frontline workers. I want to commend Representative Bera, I know he spoke before during the 1 minute Special Orders on this bill, and also Congressman Fitzpatrick, for putting forward this bipartisan legislation. Madam Speaker, I urge my colleagues to help those heroes by supporting the HERO Act today, and I reserve the balance of my time. House of Representatives, Committee on Science, Space, and Technology, Washington, DC, May 4, 2021. Hon. Frank Pallone, Jr., Chairman, Committee on Energy and Commerce, Washington, DC. Dear Chairman Pallone: I am writing you concerning H.R. 1480, the ``Helping Emergency Responders Overcome Act of 2019,'' which was referred to the Committee on Energy and Commerce and then to the Committee on Science, Space, and Technology (``Science Committee'') on March 2, 2021. As a result of our consultation, I agree to work cooperatively on H.R. 1480 and in order to expedite consideration of the bill the Science Committee will waive formal consideration of this legislation. However, this is not a waiver of any future jurisdictional claims by the Science Committee over the subject matter contained in H.R. 1480 or similar legislation. I ask for your support of my request to name members of the Science Committee to any House-Senate conference that may consider this bill. Additionally, thank you for your assurances to include a copy of our exchange of letters on this matter in the Congressional Record during floor consideration thereof. Sincerely, Eddie Bernice Johnson, Chairwoman.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the bill (H.R. 433) to establish a grant program for family community organizations that provide support for individuals struggling with substance use disorder and their families.

Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material on H.R. 433.

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. I rise today in support of H.R. 433, the Family Support Services for Addiction Act of 2021. Addiction and substance use disorder are complex, yet diagnosable, treatable diseases. Families can play a significant role in helping an individual find treatment. Yet, there isn't a one-size-fits-all approach to making sure that loved ones receive the care they need and deserve. This, of course, can be a challenge to more than just the individual; it is a challenge to families as well. Madam Speaker, families across the United States are doing all they can to seek care for those they love. In fact, data from the Substance Abuse and Mental Health Services Administration reminds us that nearly 20 million Americans live with a substance use disorder. Unfortunately, only a fraction of those Americans receives treatment. H.R. 433, the Family Support Services for Addiction Act, builds upon congressional efforts, such as the Comprehensive Addiction and Recovery Act, the 21st Century Cures Act, and the SUPPORT for Patients and Communities Act, to help close the treatment gap and get Americans on the road to recovery. Part of paving a smooth road to recovery is providing evidence-based guidance for families and connecting them with other community support systems, which can dramatically influence an individual's trajectory. That is exactly what this bill sets out to do. The bill would authorize the Secretary of Health and Human Services to award grants to family community organizations that would work to develop, expand, and enhance evidence-based family support services. These family community organizations would be able to use these grants to reduce stigma around substance use disorder and build connections between families and providers, and foster care services and other peer support services. I commend the lead sponsors of this legislation, Representatives Trone and Meuser, and their staff, for advocating for additional support for families. I urge my colleagues to support this legislation. I hope the Senate will act on it swiftly. Madam Speaker, I reserve the balance of my time.

Mr. PALLONE. Madam Speaker, I yield such time as he may consume to the gentleman from Maryland (Mr. Trone), the author of this bill.

Mr. PALLONE. Madam Speaker, I have no further speakers, I am prepared to close, and I reserve the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise today in support of H.R. 1475, the Pursuing Equity in Mental Health Act. We have long known that people of color experience inequities in healthcare in the United States. While we have made progress to close these gaps in recent years, including with the passage of the Affordable Care Act, people of color in America continue to experience inequities in care and worse health outcomes compared to White Americans. These long-term trends are rooted in several social determinants that are often driven by structural discrimination and institutionalized racism, which has created systemic health inequity. The tragic result of these long-term trends is that people of color are more likely to suffer from underlying health conditions; have a much harder time getting access to care; and when they do, they are far more likely to experience bias, discrimination, and poor health outcomes. The Congressional Black Caucus' Emergency Task Force on Black Youth Suicide and Mental Health reiterated these points in a report last Congress that raised concern about the increasing rates of suicide and mental health trends among Black children. The bill before us today, H.R. 1475, is aimed specifically at addressing equity in mental health. It is a comprehensive approach to address increasing suicide rates and mental health disorders amongst Black youth. The bill would invest resources into better understanding racial and ethnic minority mental health disparities, improve outreach and support for racial and ethnic minorities, and expand provider support for students of color entering the mental health workforce. Madam Speaker, I am hopeful that this bill will help reduce the inequities in mental health. Before I conclude, I would like to thank my colleague, Representative Bonnie Watson Coleman, and her staff for leading this important legislation. She, of course, is in the district immediately next to me and a longtime supporter of these causes. So this is a bill that is significant, and I do want to thank the Congresswoman for being the sponsor. Madam Speaker, I urge my colleagues to support the bill, and I reserve the balance of my time.

Mr. PALLONE. Madam Speaker, first, let me say that Congresswoman Bonnie Watson Coleman has, for years both here and in the State legislature and beyond, gone after issues that many of us have neglected or been unwilling to address. Maybe because they are controversial or whatever. She is always out there looking to help those people who are distressed or don't have someone to look out for them. Madam Speaker, I yield such time as she may consume to the gentlewoman from New Jersey (Mrs. Watson Coleman).

Mr. PALLONE. Madam Speaker, I, too, urge my colleagues to support this very important bill, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material on H.R. 586.

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. I rise in support of H.R. 586, the Suicide Training and Awareness Nationally Delivered for Universal Prevention Act of 2021, or the STANDUP Act. For the last decade, suicide has been the second leading cause of death in the United States for young Americans between the ages of 10 and 24. Since 2007, the number of suicides for this group has nearly tripled. We are witnessing notable disparities within this youth suicide crisis as well. Data tells us that young Black Americans, ages 5 to 12 years old, are twice as likely to die by suicide as compared to their White peers. Suicide rates for American Indian and Alaska Native teenagers between the ages of 15 and 19 are 60 percent higher than the national average for all teenagers. Additionally, among the more than 77,000 youth reporting suicidal ideations, over one-third of them are identified as LGBTQ. This data makes clear that more must be done to help those struggling. We can and must act now to help equip students and the community around them to identify risk factors, because oftentimes, it is the students who are the true eyes and ears of each campus. We can help provide them with effective tools so they can play an active role in preventing suicide or self-harm. H.R. 586 would encourage schools to expand evidence-based suicide awareness and prevention training to students. It would also require this training as a condition of receiving funds under the Substance Abuse and Mental Health Services Administration's Project AWARE grant program. The STANDUP Act, Madam Speaker, would also support technical assistance resources for schools and encourage the collection and reporting of data to track implementation of these policies and practices. Research shows that training students on suicide prevention makes an impact on student suicide rates and improves a student's willingness to seek help or help a peer. Much of this training is already taking place across thousands of schools nationwide, but STANDUP will help ensure that this good work is expanded to more schools across the country. For these reasons, I stand up in support of the STANDUP Act. I thank the lead sponsors, Representatives Peters and Bilirakis, and the many bipartisan supporters of this legislation for their work on this critical issue. Madam Speaker, I urge my colleagues to support this bill. I hope the Senate will act swiftly to pass it after we have taken action. I reserve the balance of my time.

Mr. PALLONE. Madam Speaker, I have no additional speakers at this time. I reserve the balance of my time.

Mr. PALLONE. Madam Speaker, I urge support on a bipartisan basis for this bill. I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. I rise today in support of H.R. 721, the Mental Health Services for Students Act of 2021. Mental illness, Madam Speaker, affects millions of Americans. With youth in particular, research shows that half of all lifetime mental illness begins by the age of 14. According to the Centers for Disease Control and Prevention, about three in four children between the ages of 3 and 17 suffer from depression and anxiety, and nearly half have behavioral problems. In fact, data from Mental Health America shows that youth between the ages of 11 and 17 are now at higher risk of moderate to severe anxiety and depression. For many students, schools are a critical place to get mental health or behavioral health support, and now with added public health concerns, economic pressures, online learning, and the social isolation that comes with these things, experts worry about the added repercussions we will see on the well-being of students across the country. This data, and the effect of the pandemic, make clear that we must do more to invest in preventative mental and behavioral health services and training in schools to give our kids and teens a brighter future. The American Academy of Pediatrics Committee on School Health recognized the increasing mental health needs of children and adolescents when it said, ``School-based mental health services offer the potential for prevention efforts as well as intervention strategies.'' Madam Speaker, H.R. 721 does just that. This bill would support comprehensive mental health programs at schools across the Nation by encouraging partnerships between State and local educational agencies and mental health providers. Funding would be made available through the Substance Abuse and Mental Health Services Administration. This funding would support prevention screening, treatment, and development of evidence-based programs for social, emotional, mental, and behavioral issues among students. H.R. 721 would also help us better understand the student, family, and educational outcomes of services provided to the students. I want to thank the lead sponsors of this bill, Representatives Napolitano and Katko, for their leadership and tireless work. Madam Speaker, it is critical that we support preventative mental and behavioral health services and training in schools for our kids and teens, particularly at a time when mental health risks are exacerbated by the COVID-19 pandemic. I urge my colleagues to support this bill. I reserve the balance of my time.

Mr. PALLONE. Madam Speaker, I have no additional speakers at this time. I reserve the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. I rise today in support of H.R. 2877, the Behavioral Intervention Guidelines Act. Madam Speaker, behavioral intervention teams are multidisciplinary teams that support students' mental health and emotional well-being by detecting patterns, trends, and disturbances in behavior, and by conducting outreach to students who are unable to manage distress in healthy and constructive ways. These teams are already active in some educational settings, such as Wichita State University, Southern Connecticut State University, and Rochester Institute of Technology. This bill requires the Substance Abuse and Mental Health Administration to develop best practices for schools that have or want to have behavioral intervention teams. These best practices would cover the proper use of these teams and how to intervene and avoid inappropriate use of mental health assessments and law enforcement. These best practices would then be required to be posted publicly on the Department of Health and Human Services website. HHS would also help to provide technical assistance to entities implementing these best practices. We know that three in four children between the ages of 3 and 17 with depression also have anxiety. Anxiety and depression are the top two mental health concerns among college students as well. Unfortunately, recent data found that over 80 percent of young people with mental health needs did not receive the care that they needed. Young people in crisis should be able to access the care they need or be able to find support from peers who can direct them toward appropriate services. This bill helps bridge that gap. The champions of this legislation, Representatives Ferguson, Peters, Burgess, and Panetta, worked together to help provide these behavioral health prevention tools to schools and colleges around the country, and I applaud them for their bipartisan effort. Madam Speaker, I urge my colleagues to support this bill, and I reserve the balance of my time.

Mr. PALLONE. Madam Speaker, I urge support for this bill. This is just another tool to help provide behavioral services--in this case, to schools and colleges around the country. I think it deserves our support. Madam Speaker, I yield back the balance of my time.

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

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the bill (H.R. 1260) to amend the Public Health Service Act to establish a grant program supporting trauma center violence intervention and violence prevention programs, and for other purposes, as amended.

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. Trauma is a pressing public health epidemic. In 2016 alone, trauma accounted for more than 29 million emergency department visits and 39 million physician office visits in the United States. Tragically, homicide is the leading cause of death for Black males between the ages of 1 and 24 and the second leading cause of death in Hispanic males in the same age group. Regardless of race, of the people who survive a single violent trauma, it is estimated that up to 45 percent will experience a second violent trauma. This is where H.R. 1260 steps in to provide critical data-driven interventions. The Bipartisan Solution of Cyclical Violence Act directs the Department of Health and Human Services to establish a grant program for specified trauma centers and nonprofits to establish or expand intervention or prevention programs related to intentional violent trauma. These programs, Madam Speaker, help identify patients at risk of repeat violent injury and connects them with hospital and community- based resources. The bill bridges tragedy with hospital-based violence intervention programs by providing intensive case management to people who have experienced at least one violent trauma. These programs have been shown to successfully reduce injury recidivism and help those at risk for violence live safer lives. I commend my colleagues, Representatives Ruppersberger and Kinzinger, for spearheading this initiative. Again, I urge my colleagues to support this important bipartisan bill, and I reserve the balance of my time.

Mr. PALLONE. Madam Speaker, I also urge my colleagues to support this bill. Again, this one, dealing with intervention for violent traumas, is part of this package today. Madam Speaker, I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise today in support of H.R. 1205, the Improving Mental Health Access from the Emergency Department Act. I would like to begin by recognizing a member of our committee, Representative Ruiz, and his staff for their work on this important legislation. As an emergency room physician himself, Dr. Ruiz knows firsthand the needs of both the medical professional and patients in the ER. Among those increasing needs is support for mental health services. Research has shown that one in every eight emergency department visits in the U.S. is related to a mental health issue. And since 2009, mental health emergency room visits have substantially increased, most of which is driven by adolescents and young adults. This is especially concerning given the recent report from the Government Accountability Office that found emergency department visits for suicide attempts from mid-March to mid-October 2020 were up 26 percent from 2019. Now, this bill would help to provide increased access to care for people who report to an emergency department for acute mental health episodes. Under the bill, the Secretary of Health and Human Services is authorized to award grants to support innovative approaches for providing follow-on care for individuals treated in the emergency department for acute mental health issues. This includes increasing the number of inpatient psychiatric beds and alternative care settings, supporting a patient's transition to appropriate mental health services, or the use of tele-psychiatric support or other remote psychiatric consultation methods. Madam Speaker, emergency departments can sometimes feel like a stressful place, especially for people in crisis. However, they are often the last remaining safety net in many communities. We know that follow-up care for people with mental illnesses is linked to fewer repeat emergency room visits and improved mental and physical health. So let's do our part to support the emergency room staff and patients in need by passing this bill today. Madam Speaker, again, I urge my colleagues to support H.R. 1205, and I reserve the balance of my time.

Mr. PALLONE. Madam Speaker, again, we are trying with these series of bills today to address mental and behavioral health problems, and this one deals with the emergency room. So that is very important, and I would urge my colleagues to support it on a bipartisan basis. Madam Speaker, I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I reserve the balance of my time.