Frank Pallone

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I yield myself the balance of my time to close. Mr. Speaker, I just want to say in closing that I think you can feel the real enthusiasm and the hope that is involved with both the sponsors of this bill and those who spoke on both sides of the aisle. We consider ourselves, the Energy and Commerce Committee, the innovation committee, and I think this is a prime example of the type of innovation that we see for the future and the hope in ARPA-H. Mr. Speaker, I would ask for everyone on a bipartisan basis to vote for this, so we have a strong vote, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I ask unanimous consent that in the engrossment of H.R. 7666, the Clerk be authorized to correct section numbers, punctuation, spelling, and cross-references and to make such other technical and conforming changes as may be necessary to reflect the actions of the House.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker from New Jersey, I thank Chairman Scott for the time and all he has been doing with his committee to put this excellent bill together. Today, once again, in my opinion, the House is taking action to fight high gas prices and protect consumers by empowering farmers to provide homegrown fuel choices at the pump, an option that costs consumers 40 cents less per gallon. At a time when Americans are paying record-high prices for gas, Big Oil continues to exploit market instability caused by Russia's invasion of Ukraine to rake in record profits. Big Oil companies collectively made $41 billion in profits during the first quarter of this year. Some of these were record highs; others were the highest profits in over a decade. It is abundantly clear that Big Oil companies are more interested in funneling billions in profits to their shareholders and executives than in addressing record-high gas prices for American consumers. The House has to act, Mr. Speaker, to protect American families from this profiteering. That is why we are here today, to preserve and expand the availability of a cheaper and cleaner fuel option for the driving public. The Lower Food and Fuel Costs Act combats fuel prices by allowing for the voluntary, year-round sale of gasoline containing 15 percent ethanol, known as E15 or Unleaded 88. Blending more biofuels like ethanol into gasoline displaces demand for petroleum, helping to bring down gas prices for consumers. Today, drivers are paying, on average, about 40 cents less per gallon to fill up their tanks with E15. This fuel provides significant savings for families during the summer driving season. Let's ensure it continues to be available at gas stations across the country. Increasing the availability of E15 protects Americans from volatile global oil markets and eases the grip Big Oil has on American drivers. By relying more on homegrown biofuels and less on fossil fuels, this legislation insulates American drivers from dramatic global price fluctuations, enhances our national security, creates local jobs, and bolsters true energy independence. It is a win-win across the board. It is one of the most powerful tools in our fight against global price shocks and oil and gas profiteering. E15 is also a cleaner fuel option that emits less carbon pollution and burns cleaner than regular gasoline. Today's vote is also part of our broader effort to bring down prices while cutting climate pollution. I thank Representatives Craig and Axne for their leadership on preserving and expanding access to E15 across the country and Chairman Scott, once again, for including these critical E15 provisions in this package. Mr. Speaker, let's help bring down gas prices at the pump, strengthen our Nation's rural communities, and break the grip of Big Oil by passing the Lower Food and Fuel Costs Act today.

Mr. PALLONE

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

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 7667) to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes, as amended.

Mr. PALLONE. Mr. 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. 7667.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise today in strong support of the Food and Drug Amendments of 2022, a bill that recently passed out of the Energy and Commerce Committee with unanimous support. This bill will provide the FDA the funding it needs to ensure drugs and devices are safe and effective. It also promotes development of new medical products to treat every American, reduces the cost of prescription drugs, and strengthens program integrity at the agency. Primarily, the user fee reauthorization's main purpose is to give the agency funding to conduct product reviews, facilitate the development of new products to treat rare diseases, inspect facilities to ensure they are compliant, and monitor medical products on the market for continued safety and effectiveness. It is essential that the House pass this legislation today because funding that comes from these user fees expires in September. At hearings earlier this year, senior FDA officials told us that failure to pass this legislation well before the September deadline could be catastrophic to the agency's operations and, more importantly, could limit our ability to get patients the medical products that they and their doctors rely on. Mr. Speaker, I am very pleased that in addition to coming together to reauthorize this funding, we have worked across the aisle to come to agreement on a wide-ranging package of programs to improve biomedical research and development, give FDA more tools to conduct quality inspections, improve the medical product supply chain, improve generic drug competition and access, and bring greater transparency and program integrity to FDA's operations. While I do not have time to discuss all the provisions in the Food and Drug Amendments of 2022, I want to highlight a few. First, the bill includes reforms to the accelerated approval program, which I first introduced in Congress earlier this year. Under the accelerated approval pathway, drugs may be approved based on a surrogate endpoint, such as an improved lab measurement or visualization on an MRI, even though additional evidence is still needed to show a clear clinical benefit for the patient. If a drug is approved under this pathway, the sponsor must conduct studies after the product is on the market to show that the drug actually provides a benefit to patients. This approval pathway has led to patients having access to groundbreaking treatments for cancer, HIV, and other illnesses faster than they otherwise would have. However, in recent years, it has become clear that some drug sponsors have failed to conduct their post-approval studies in a timely manner, while others have conducted studies that indicate that the drug is not effective but are able to keep the product on the market for years afterwards. Patients deserve to know the drugs they are taking are safe and effective. Food and Drug Amendments of 2022 ensures that the products patients are taking are providing a benefit by allowing FDA to require that sponsors begin adequate and well-controlled post-approval studies before the drug goes on the market. The legislation will provide greater transparency in drug labeling, and it streamlines the process for FDA to remove products from the market when the sponsors have failed to act with due diligence to conduct studies or where studies have failed to show a benefit to patients. The second thing is, this legislation ensures that clinical trials for drugs and medical devices are representative of the people who will use the products. The lack of diversity in clinical trials is an urgent problem. It compromises our ability to understand how drugs and diseases affect populations differently, compounds health disparities, and can hinder innovation and add cost burdens into the health system. Food and Drug Amendments of 2022 for the first time will require drug and device sponsors to develop a clinical trial diversity action plan early in the development process and submit the plan to FDA. This will help improve our understanding of these products and lead to better outcomes for all Americans. Food and Drug Amendments of 2022 will also help lower drug costs by making it easier for generic products to come to market. Under current law, generic drug sponsors sometimes need to play a guessing game of the ingredients in brand drugs, and this can add months on to the generic drug development process. Under Food and Drug Amendments of 2022, we are making it easier for FDA to communicate this information to drug sponsors, thereby speeding up development times for generics. The bill will also make it easier for generics to come to market when a brand drug changes its label at the last second in an attempt to limit competition. Together, these provisions will produce millions of dollars in savings for American families and the overall healthcare system. This legislation also takes concrete action to address the infant formula crisis American families are currently facing, and which we are so concerned about, and will prevent future problems related to food safety and supply, so it's not just about infant formula, but about food safety in general. Currently, FDA is operating its food safety and other divisions with one hand tied behind its back when it comes to hiring and retaining highly qualified scientific and regulatory staff. Today, FDA can hire technical staff in its drug and medical device centers under streamlined processes and compete with the private sector in terms of salary, but those same flexibilities do not extend to other centers, including those overseeing food at the FDA. Our bill would extend these to the oversight of food, tobacco, and other products regulated by the agency. While we must do more in this area, I am pleased that we are able to move forward on a bipartisan basis here today. I think it is going to make a difference, Mr. Speaker, not only with infant formula but with so many other food products. Lastly, Mr. Speaker, I thank my colleagues on the Energy and Commerce Committee for their cooperation and bipartisan work on this package. As I said, it passed unanimously out of the committee last month, thanks to the leadership of Health Subcommittee Chairwoman Eshoo, Ranking Member Guthrie, and the full committee Ranking Member Rodgers. When you bring a bill to the floor on suspension and it is bipartisan, and it was voted out of committee unanimously, it might kind of belie the amount of work that the staff who are here with me today and others put into this. This was a lot of work. It wasn't easy to get it done in a timely fashion, even though it has unanimous support. I hope today everyone will vote for it; I do not want anyone to get the impression that this was not an easy thing to accomplish because it certainly was. Mr. Speaker, I encourage all Members to support this bill, and I reserve the balance of my time.

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

Mr. PALLONE. Madam Speaker, I am prepared to close, and I reserve the balance of my time.

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I couldn't agree more with what Ranking Member Guthrie said, and also our full committee ranking member, Mrs. Rodgers. This is a product of a lot of hard work on behalf of members, as well as the staff that are here, and others. It is really great that we are able to do it in a timely fashion because we want the FDA to be able to operate, not to have to put out pink slips because the authorization expires in September. This is really a reauthorization that does a lot more than just reauthorize the current programs. It really is going to make a difference in terms of our ability to innovate and also affect access to generic drugs. Madam Speaker, I encourage all Members to support the bill. We are going to work hard to get this passed in the Senate in a timely fashion. Madam Speaker, I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I rise today in strong support of the Infant Formula Supplemental Appropriations Act. I particularly thank Appropriations Committee Chairwoman Rosa DeLauro for all she has done to shed light on the contamination of infant formula and the problems with FDA enforcement. She talks about me, but I will talk about her, because she has really taken this issue to heart for such a long period of time. I have to say that I am extremely upset listening to the Members on the other side, the Republicans, talk about this crisis and how it could have been avoided. I have been on the Energy and Commerce Committee for over 30 years. FDA's policies of food safety, unlike that for drugs and medical devices, are not based on fees paid by the manufacturers. This is because Republicans in the past have not been willing to impose those fees on the manufacturers. I can tell you from personal experience, when I tried to include a fee structure in food safety initiatives in the past before my committee, the Energy and Commerce Committee, every time, it was opposed by the Republicans because they were listening to the manufacturers who didn't want that fee schedule imposed on them. We have it for drugs. We have it for medical devices. We don't have it for food safety, and that is right in the hands of the Republican leadership. I am not particularly blaming the appropriators today, because this was not an appropriations issue. This was an Energy and Commerce issue. But to suggest in some way that this is the Democrats, I will tell you, it is the Republicans. If that money had been in place, we would have had the inspectors, and we would have had the ability, in my opinion, to do a lot more on the issue of food safety. So this crisis, to some extent, is based on the Republicans' unwillingness to adopt a fee schedule and provide that regular source of funding for the FDA. Now, let me also say that in addition to the emergency funding, the House is also voting tonight to grant flexibility to the WIC program. I thank the Committee on Education and Labor for that. The Biden administration has taken a number of important actions to respond to this shortage, including working with manufacturers to increase production and encouraging importation of safe infant formula. Today, as the chairwoman of Appropriations said, the operation the White House has announced, including the use of the Defense Production Act, shows that this administration has continued to commit to end this crisis. The Energy and Commerce Committee also today unanimously passed a measure to allow the FDA to streamline processes for hiring highly skilled professionals and retain them with competitive salaries. This will help to ensure our infant formula supply is safe and inspectors are on the job. Now, I just want to say, Madam Speaker, manufacturers have to do a better job in the future to alert the FDA of potential shortages so we can shift production quickly. The FDA must be empowered to move more quickly to set limits on contamination, which is currently bogged down in long and cumbersome regulatory processes. We understand that more needs to be done, but this bill needs to be passed today.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I rise today to recognize the Associate Alumnae of Douglass College as its members commemorate its 100th anniversary this year. The Associate Alumnae of Douglass College was founded by members of the Class of 1922, the first graduating class of the New Jersey College for Women (present day Douglass Residential College). Since that time, the organization has continued to advance its mission to develop, promote and support Douglass alumnae. The Associate Alumnae of Douglass College is led by a volunteer Board of Directors, all of whom are Douglass alumnae. Throughout its first century, the organization has been led by many distinguished alumnae, including Inez Phillips Durham, Victoria Dabrowski Schmidt, Evelyn Sermons Field, and its current President, Jeanne Fox. Today, the Associate Alumnae of Douglass College consists of a network of over 39,000 women across the globe with a shared pursuit of lifelong learning. Through its programs, services and networks, the Associate Alumnae of Douglass College advances the personal and professional growth of its members. The organization provides opportunities to engage in both social and educational forums, fostering connections and empowering women. In addition to its programs, the Associate Alumnae of Douglass College oversees endowment funds, including the Douglass Fund, and ensures proper management and distribution. Madam Speaker, I sincerely hope that my colleagues will join me in congratulating the Associate Alumnae of Douglass College on its 100th anniversary. The organization has paved a successful path for generations of women and its efforts are truly deserving of this recognition.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I rise today to congratulate Senator Cory Booker, Veronica Buffaloe-Stubbs, Peggy Cadigan, Sergeant Kimberly Leavy and Monmouth Medical Center as they were recognized as Library Champions by the Long Branch Free Public Library on April 29, 2022. Each year, the Long Branch Free Public Library recognizes those who are committed to the success of the library, and libraries in general, with its Library Champions Dinner and Awards. These individuals and entities promote library programs and resources and support its objectives. Senator Booker, Veronica Buffaloe-Stubbs, Peggy Cadigan, Sergeant Kimberly Leavy and Monmouth Medical Center are truly deserving of the Library's Champion distinction. As a United States Senator from New Jersey, Senator Cory Booker continues to advance legislation that directly impacts our state and residents. In addition to introducing and supporting legislation benefitting children, immigrants and veterans, Senator Booker co- sponsored the Build America's Libraries Act. His efforts to advance underserved populations, improve library access and internet connectivity for all individuals, and support community improvements embody the mission of the Long Branch Free Public Library. He has also recognized the value of libraries, and the Long Branch Free Public Library in particular, supporting the New Jersey State Library's IMLS Leadership Grant and nominating the Long Branch Free Public Library twice for the National Medal for Museum and Library Service. A Long Branch native currently residing in Neptune, New Jersey, Veronica Buffaloe-Stubbs is an active member of both communities and recognizes the importance of civic engagement. Ms. Buffaloe-Stubbs is the founder and CEO of A.S.T.E.P. (After School Tutorial Educational Program), a tutoring, enrichment and mentoring program for local students and volunteers her time with the Second Baptist Church of Long Branch, the Long Branch Chamber of Commerce, the Girl Scouts of New Jersey, and the Long Branch Elks Lodge No. 742, among others. She is also a 30-year employee of the U.S. Army Communications-Electronics Command and has previously worked as a youth counselor for the Monmouth County Juvenile Detention Center, substitute teacher and a certified nurse's assistant/home health aide. Throughout her library career, Peggy Cadigan demonstrated a remarkable commitment to her profession and the community. Recently retired from the New Jersey State Library after nearly 20 years as Deputy State Librarian for Innovation, Ms. Cadigan previously served as a Reference Librarian and a Junior Library Assistant at the Ocean County Library. Her knowledge and experience were well-regarded in the field. She gave valuable presentations throughout the United States and to remote audiences abroad and served as a consultant for the libraries of Dubai. Her vision, encouragement and support has helped other libraries improve their programs and adapt to societal changes and advancing technologies. Additionally, Ms. Cadigan expanded the Fresh Start re-entry program launched by the Long Branch Free Public Library. In her positions with the Long Branch Police Department, Sergeant Kimberly Leavy has been engaged in community programs. During her time as a Detective, she was focused on matters involving juveniles and currently serves in the Urban Enterprise Unit as a Community Police Officer in the Patrol Division. Through her role as a Community Police Officer and her work with National Night Out and the Citizens' Police Academy, Sgt. Leavy continues to enhance the relationship between the community and the police force. She has served as a Liaison Officer for many community organizations and has collaborated with the Long Branch School District and the Long Branch Free Public Library, promoting mutual programs and participating in educational presentations. Monmouth Medical Center continues to provide outstanding health care services to the greater Long Branch community and has been a valuable partner of the Long Branch Free Public Library. Working with Monmouth Medical Center, in particular Eric Carney, CEO and President, Jean McKinney, Regional Director of Community Health, Social Impact and Community Investment, and Sylvia Jacobs, Director of Diversity and Inclusion, the Long Branch Free Public Library has expanded their programs and improved their community outreach. Public libraries are an integral part of our communities, and it is my honor to join with the Long Branch Free Public Library in recognizing the contributions of Senator Cory Booker, Veronica Buffaloe-Stubbs, Peggy Cadigan, Sergeant Kimberly Leavy and Monmouth Medical Center.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I include in the Record an exchange of correspondence between myself and Chairman Jerry Nadler acknowledging the Committee on Judiciary's agreement to waive consideration of H.R. 5657 and the Committee on Energy and Commerce's acknowledgement that such waiver does not in any way diminish or alter the Committee's jurisdiction on this or similar legislation in the future. House of Representatives, Committee on the Judiciary, Washington, DC, March 31, 2022. Hon. Frank Pallone, Jr., Chairman, Committee on Energy and Commerce, House of Representatives, Washington, DC. Dear Chairman Pallone: This letter is to advise you that the Committee on the Judiciary has now had an opportunity to review the provisions in H.R. 5657, the ``Medical Marijuana Research Act,'' that fall within our Rule X jurisdiction. I appreciate your consulting with us on those provisions. The Judiciary Committee has no objection to your including them in the bill for consideration on the House floor, and to expedite that consideration is willing to forgo action on H.R. 5657, with the understanding that we do not thereby waive any future jurisdictional claim over those provisions or their subject matters. In the event a House-Senate conference on this or similar legislation is convened, the Judiciary Committee reserves the right to request an appropriate number of conferees to address any concerns with these or similar provisions that may arise in conference. Please place this letter into the Congressional Record during consideration of the measure on the House floor. Thank you for the cooperative spirit in which you have worked regarding this matter and others between our committees. Sincerely, Jerrold Nadler, Chairman.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the bill (H.R. 1218) to require the Federal Communications Commission to incorporate data on maternal health outcomes into its broadband health maps, as amended.

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. 1218.

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise in strong support of H.R. 1218, the Data Mapping to Save Moms' Lives Act. Tragically, the United States has the highest rate of maternal mortality across developed nations. While maternal mortality and morbidity are problems that affect women across the country, these concerns are especially pronounced in Black and Native American communities. Maternal mortality rates for Black women are three times higher than those of White women, and the rate of death for American Indian and Alaska Native women is two times higher. This legislation seeks to provide a visualization for the public on how connectivity and these health data intersect. It will help guide policymakers on how to target telehealth services to vulnerable populations and communities at risk in an effort to reduce maternal mortality and morbidity in this country. For pregnant women, access to telehealth services like routine checkups, health monitoring, and updated prescriptions can go a long way in ensuring the health and safety of both the mother and child. Specifically, under this legislation, the FCC is required to integrate publicly available data related to maternal health, including mortality and severe morbidity, into its Mapping Broadband Health in America platform. The FCC will be required to consult with the Centers for Disease Control and Prevention to determine the right data to include for this effort. I commend Representatives Butterfield, Bilirakis, and Blunt Rochester for their bipartisan efforts on this legislation. I also thank Subcommittee Chairman Doyle for working to get this legislation through the Communications and Technology Subcommittee. I also commend you, Madam Speaker, as the vice chair of the Energy and Commerce Committee, because you have spent quite a bit of time dealing with these maternal mortality issues. This initiative, combined with other good work we and the executive branch have done, will help us better understand the communications barriers some pregnant women face so that we can then explore connectivity policies that help keep these women safe and healthy. I know the Senate has passed a companion bill recently, led by Senators Rosen and Fischer. Although there are some technical differences between the two bills, my hope is that we can get those worked out as quickly as possible and get this legislation to the President's desk. Madam Speaker, I urge my colleagues to support the Data Mapping to Save Moms' Lives Act in a bipartisan manner, and I reserve the balance of my time.

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

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

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

Mr. PALLONE. Madam Speaker, I urge bipartisan support for this bill as part of our continued effort to address maternal mortality, 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. 2501.

Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the bill (H.R. 2501) to require the National Telecommunications and Information Administration and the Federal Communications Commission to update the memorandum of understanding on spectrum coordination, as amended.

Mr. PALLONE. Madam Speaker, I yield myself such time as I may consume. Madam Speaker, I rise in strong support of H.R. 2501, the Spectrum Coordination Act. Our country's airways are foundational to next-generation wireless networks. These networks offer so much promise to better our lives, as they can promote enhanced telehealth services and educational opportunities and offer new ways of engaging in entertainment and e- commerce. These networks can also help propel advancements in manufacturing and enhance critical public safety communications to save lives. But to achieve these important objectives, our airwaves must be managed competently and correctly. Unfortunately, in recent years, our country has not hit this mark. Instead, the two agencies charged by Congress to manage the public's airwaves, the FCC and the National Telecommunications and Information Administration, or NTIA, have often bickered and refused to coordinate their efforts. I am pleased to see that with new leadership over the last year, the FCC and NTIA have begun to make some headway towards ensuring the Federal Government once again speaks with one voice in overseeing our airwaves. H.R. 2501 helps advance the ball even further. This legislation requires the FCC and NTIA to update their memorandum of understanding on spectrum coordination by the end of this year. The last time this MOU was updated was in 2003, and much has changed since then. An updated MOU will reaffirm the commitment of these two agencies to provide and allocate our airwaves in a way that best serves consumers, commercial carriers, and Federal agencies in the days and months to come. Over the past several years, the Energy and Commerce Committee has worked on a bipartisan basis on several important telecommunications matters. I want to commend Subcommittee Chairman Doyle and Representative Bilirakis for continuing this tradition through their leadership and bipartisan work in advancing this bill out of the committee. I hope the Senate can follow suit soon. Madam Speaker, I urge my colleagues to likewise support the Spectrum Coordination Act in a bipartisan manner, and I reserve the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I move to suspend the rules and pass the bill (H.R. 5657) to amend the Controlled Substances Act to make marijuana accessible for use by qualified marijuana researchers for medical purposes, and for other purposes, as amended.