Frank Pallone

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise to speak in support of H.R. 3723, the Consumer Safety Technology Act, and I want to begin by thanking Representatives McNerney and Burgess for their leadership on this bill, which they reintroduced this Congress. This legislation will help modernize our consumer protection agencies and encourage the use of advanced technologies, like artificial intelligence and blockchain in support of product safety and consumer protection. These technologies can help the Consumer Product Safety Commission and the Federal Trade Commission improve their operations and more effectively carry out their mission. Technological advances and globalization have greatly expanded the range of consumer products on the market. And as consumers shop online, more and more of these products are being shipped directly to homes. Artificial intelligence could help the CPSC oversee the increasingly complex range of products under its jurisdiction by helping to identify new injury trends and emerging hazards. AI can also help the CPSC monitor online marketplaces for the illegal sale of recalled products. The persistence of recalled products on online third-party marketplaces is a particularly pernicious problem that puts Americans needlessly at risk. For example, months after the dangerous Fisher-Price Rock `n Play and other infant inclined sleepers were recalled, a Consumer Reports investigation found that these products were still being sold on sites like Facebook Marketplace and Craigslist, even though they had been linked to dozens of infant fatalities. I am hopeful that artificial intelligence can be harnessed here to help eradicate the illegal sale of recalled products on online marketplaces. The CPSC could also use AI to assess the risks of the growing number of imported consumer products entering our country and being sent directly to consumers. This bill incorporates a bill originally introduced by Representative Soto and Guthrie, the Blockchain Innovation Act, and a bill originally introduced by Representatives Davidson and Soto, the Digital Taxonomy Act. As incorporated in this legislation, these bills will help identify ways blockchain technology can be used to further support consumer protection. It will also make sure that scammers and fraudsters don't get ahead of consumers and law enforcement in the realm of blockchain and digital tokens. Mr. Speaker, finally, I thank Ranking Member Rodgers and Consumer Protection and Commerce Subcommittee Ranking Member Bilirakis for working with us to move this bill; and as always, to the chairwoman of the subcommittee, the gentlewoman from Illinois (Ms. Schakowsky). Mr. Speaker, I call on my colleagues to support this measure, and I reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I yield 4 minutes to the gentleman from California (Mr. McNerney), who is the prime sponsor of this bill.

Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from Florida (Mr. Soto), another sponsor of the bill from the Energy and Commerce Committee.

Mr. PALLONE. Mr. Speaker, I yield 3 minutes to gentlewoman from Illinois (Ms. Schakowsky), the chairwoman of the subcommittee.

Mr. PALLONE. Mr. Speaker, I also urge support for this bill, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 3182) to provide that inclined sleepers for infants and crib bumpers shall be considered banned hazardous products under section 8 of the Consumer Product Safety Act, and for other purposes.

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. 3182.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise to speak in support of H.R. 3182, the Safe Sleep for Babies Act. This important piece of legislation was reintroduced this Congress by Vice Chair Cardenas and Chair Schakowsky of our Consumer Protection and Commerce Subcommittee. Parents and caregivers deserve the peace of mind that any infant sleep product they buy is consistent with longstanding safe sleep recommendations that babies should only sleep on their backs on a firm, flat surface free of extra bedding. This legislation would ban two very dangerous products for babies that defy safe sleep best practices and have tragically taken far too many infant lives: inclined sleepers and crib bumpers. To date, inclined sleepers have been linked to at least 94 infant fatalities, and crib bumpers have contributed to at least 107 deaths. Inclined sleepers position babies on a dangerous incline that can lead to the baby's airway becoming obstructed, among other hazard patterns. Crib bumpers create unnecessary suffocation, entrapment, and strangulation risks for babies. There is simply no reason either of these products should still be on the market. Yet, incline sleepers and crib bumpers are heavily marketed and remain widely available online and on store shelves. Many parents, grandparents, and caregivers continue to purchase these products, wholly unaware of the grave risks they pose to babies. Since April 2019, when Consumer Reports first reported on the deadly toll of infant inclined products, an independent expert hired by the CPSC has confirmed that all sleep products with inclines greater than 10 degrees pose serious dangers to infants. Earlier this month, CPSC approved a strong, new Federal safety standard on infant sleep products that will effectively prohibit infant inclined sleepers. However, the new safety standard will not take effect for some time, and there is still no Federal standard to eliminate the hazard posed by crib bumpers. That is why this bill is necessary. H.R. 3182 bans crib bumpers along with inclined sleepers, and it will take effect 6 months after the date of enactment, making sure strong protections for babies are not needlessly delayed. We must take action on this bill today, Mr. Speaker, to protect babies across the Nation. I call on my colleagues to support this measure, and I reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I yield such time as she may consume to the gentlewoman from Illinois (Ms. Schakowsky), who is the chair of the subcommittee and one of the major sponsors of the bill.

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from Texas (Ms. Jackson Lee).

Mr. PALLONE. Mr. Speaker, I also ask for support of the bill, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 1314) to require the Consumer Product Safety Commission to promulgate a consumer product safety rule for free-standing clothing storage units to protect children from tip-over related death or injury, and for other purposes.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I rise to speak in support of H.R. 1314, the STURDY Act. I want to begin by thanking Consumer Protection and Commerce Subcommittee Chair Schakowsky for championing and reintroducing this critical piece of legislation, which will help protect children from deadly furniture tip-overs. Tip-overs remain one of the top five hidden hazards in the home. According to new data from the Consumer Product Safety Commission, between 2000 and 2019, tip-over incidents have been linked to more than 450 child fatalities and tens of thousands more injuries. Every 46 minutes a child is injured in a tip-over incident. The victims tend to be young children who are curious and creative, eager to climb and play make-believe with the world around them. But dressers pose a deadly danger, and their crushing weight can lead to tragedy in just minutes. These incidents often happen silently, too. Parents who have lost children from furniture tip-overs report never hearing the dresser falling because the child's body had absorbed the brunt of the impact or a child was pinned in such a way that he or she couldn't even scream or cry out. The current voluntary furniture stability standards are woefully inadequate and have not stopped children from dying from unstable dressers. In March, Consumer Reports reported on two tip-over incidents, including one death that happened within 1 week of each other, highlighting the ongoing and urgent need for this lifesaving legislation. Our children deserve a strong, mandatory standard that keeps them safe from such a common household danger. Right now, the current voluntary standard only applies to dressers 30 inches or taller, despite multiple fatalities and injuries involving shorter dressers. Also, the voluntary testing doesn't incorporate the upper weight range for children affected by tip-overs. It also ignores real-world dynamics, such as the movement of drawers and different flooring surfaces that a dresser might be resting on. The STURDY Act would finally establish a strong mandatory furniture stability safety standard and protect children from being crushed under the weight of their bedroom furniture. This legislation will save lives, and that is why I call on my colleagues to support this measure. Mr. Speaker, I reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I yield such time as she may consume to the gentlewoman from Illinois (Ms. Schakowsky), the chairwoman of the subcommittee and sponsor of this bill. I am sure many have noticed today that many of these bills that protect consumers, particularly children, have been championed by Ms. Schakowsky.

Mr. PALLONE. Mr. Speaker, I also urge my colleagues to support this legislation, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members have 5 legislative days in which to revise and extend their remarks and to include any extraneous material on H.R. 3841.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, American Indian and Alaska Native communities experience disproportionately worse health outcomes than other groups in the United States. The root causes of these poor health outcomes are complex, but, unfortunately, not surprising. For centuries, American Indian and Alaska Native communities have been displaced and damaged by violence, poverty, disease, and adverse social conditions. As a result, Tribal members live shorter lives than any other demographic group. Unfortunately, the COVID-19 pandemic has also devastated Tribal communities. According to data from the Centers for Disease Control and Prevention, American Indians and Alaska Natives are at greater risk of COVID-19 infection and more than three times more likely to be hospitalized. Moreover, there are significant gaps in data collection and the full picture of the disease burden is really unknown. So it is important for us to improve Tribal health data collection efforts so that we can improve health outcomes. Tribal Epidemiology Centers manage regional public health information systems and disease prevention and control services. These centers also collaborate with other public health authorities to study, collect, and analyze epidemiological data. Clear communication and coordination by Federal, State, and local public health departments is necessary to the success and security of these efforts. So the bill before us, H.R. 3841, the Tribal Health Data Improvement Act, equips Tribal communities with enhanced resources to collect public health data and adapt public health programs to improve health outcomes. The bill clarifies the Federal Government's role in the collection and distribution of public health and disease surveillance data. It does this by creating a strategy to share information with the Indian Health Service, Indian Tribes and organizations, and Tribal Epidemiology Centers. The legislation requires the Secretary of Health and Human Services to release all applicable public health data to Tribal entities within 180 days of enactment. It also requires the CDC to encourage and enhance collaborative efforts between States and Tribal organizations to synergize data collection. Finally, the bill reauthorizes the National Center for Health Statistics with an additional $185 million in funding to implement the programs established by the legislation. I thank Representatives Mullin and O'Halleran for their bipartisan efforts to bringing this bill forward. They are always champions for the Tribes. Mr. Speaker, I urge my colleagues to support the bill, and I reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 3841) to amend the Public Health Service Act with respect to the collection and availability of health data with respect to Indian Tribes, and for other purposes.

Mr. PALLONE. Mr. Speaker, I also urge support for the bill, and I yield back the balance of my time.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I thank the chairman of the Veterans' Affairs Committee, my friend from California, for moving this bill through the committee as quickly as he did. I rise today in support of the bill, H.R. 1257, the Homeless Veterans Credit Repair, Enhancement, and Debt Improvement for Tomorrow Act. We know that veterans' homelessness continues to be a blight on our Nation. Congress and advocates from across the country have worked hard to nearly halve the homeless veteran population in the past decade. Unfortunately, the coronavirus pandemic jeopardized this progress by negatively impacting the credit and financial stability of our Nation's veterans. Now is the time to redouble our efforts and do everything we can to ensure stable housing for veterans. We must start by examining the underlying causes of veteran homelessness in our Nation. The VA has declared credit and financial counseling services a top 10 unmet need for our homeless veterans. My bill directs the Secretary of the VA to conduct a study of the credit and financial counseling services available to homeless veterans and veterans facing housing instability. The study will assess current services available to veterans and the barriers they face in utilizing them, including the COVID-19 pandemic and other health challenges. During a time of such economic uncertainty, we must look out for our most vulnerable communities, including homeless veterans and veterans experiencing housing instability. We have a responsibility to help those who served in uniform and stood ready to make the ultimate sacrifice for our country. The CREDIT Act will identify the credit and financial counseling services needed to help our veterans avoid financial pitfalls and make informed decisions about their future. Madam Speaker, again, I thank Chairman Takano for his partnership on this issue, and I urge my colleagues to support this commonsense, bipartisan legislation. Together, we can improve veterans' financial literacy to build a better life for themselves after they complete their service to our country. Madam Speaker, I also thank my staff member, Jake Freed, who basically came up with this idea, after talking to various veterans groups, and put this together.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and add extraneous material on H.R. 1629, the Fairness in Orphan Drug Exclusivity Act.

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 Drugs Exclusivity Act, a bill that will help make some prescription drugs more affordable for the American people. This Democratic Congress is committed to lowering the costs of prescription drugs so that families are no longer forced to choose between paying for a lifesaving drug or food and rent. This legislation today, H.R. 1629, closes the loophole that has blocked patients from accessing cheaper generic drugs. Last Congress, this legislation passed the Energy and Commerce Committee and the House by voice vote. Last week, it garnered support from a large majority in the House but not the two-thirds necessary to pass under suspension of the rules. And so, we are here again today to debate and pass H.R. 1629 that will help us address two national crises: first, the soaring costs of prescription drugs; and second, the ongoing opioid epidemic. Madam Speaker, this legislation does that by closing a very narrow but real loophole in a program known as the orphan drug program. This program was created through the Orphan Drug Act, which has been successful in basically doing more research and discovery of new therapies to treat and even cure rare diseases. The law incentivizes the development of these lifesaving therapies by awarding 7 years of market exclusivity to manufacturers who receive orphan drug status. There are two ways that manufacturers can receive these incentives. The first is when manufacturers develop drugs approved to treat diseases with patient populations of 200,000 or fewer. And the second way is if the manufacturer believes that the research and development costs are not expected to be recouped by sales of the underlying drug. This is known as the cost recovery pathway. It is rarely used, but unfortunately, it has led to manufacturers sometimes inappropriately receiving additional exclusivity and, therefore, delaying lower cost generics from coming to the market. For example, under certain circumstances, if a manufacturer receives orphan drug status for one drug, that status and its incentives can be passed on to future drugs if those drugs treat the same condition and have the same active ingredient. The status and incentives would be available even if those future drugs do not meet the orphan drug qualifications. What this means, Madam Speaker, is that future drugs can benefit from the 7 years of market monopoly without having to demonstrate that the drug will treat a population of 200,000 or fewer or that they may not be able to recoup the costs of producing the drug. As a result of this loophole, some manufacturers are marketing widely used drugs to large populations while also blocking generic competition from coming to market. Now, if I can give an egregious example of this, it comes from one of our most effective drugs to combat opioid use disorder. In 1994, an oral formulation of buprenorphine was granted orphan drug status. At the time, it was not expected that the drug would be prescribed frequently, and as a result, it was unlikely the manufacturer would recoup its development costs. More than 20 years later, however, in 2017, the same manufacturer developed a new injectable formulation of the same drug with the same active ingredient to treat the same condition. As a result, the manufacturer was able to prevent cheaper generics from coming to market. But by 2017, the opioid epidemic worsened. Our response to the crisis evolved, and millions were eventually prescribed buprenorphine for treatment, generating billions of dollars in sales. We know that buprenorphine was not an orphan drug as the law envisions. Nevertheless, the new injectable drug was automatically granted orphan drug status and exclusivity based on the original oral drug's orphan drug designation. This delayed the cheaper generic treatments for opioid use disorder from coming to market, and it kept the price of the drug high and limited access for those in need of treatment. 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 be on the market today. The bottom line is, Madam Speaker, we need every tool available to combat the opioid epidemic, including low-cost, affordable medication treatments, and loopholes like this have to be closed. 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 Orphan Drug Act cost recovery pathway would be unable to recoup development costs at the time of approval. This would include all drugs that seek the orphan drug designation under the cost recovery pathway, including the injectable buprenorphine example I just described. The bill would also ensure that these rules apply to drugs already on the market, so no drug manufacturers can claim orphan drug status without first meeting this requirement. Now, I want to explain, because I know this is complicated, this bill is narrowly tailored to fix a narrow but very real loophole in the law. We cannot allow these manufacturers to game the system any longer, and that is why we have to close this loophole today. I thank Congresswoman Dean, who is the sponsor of the bill. The merits of this bill are obvious, and I know she is going to talk about it more, but that is why it has received strong bipartisan support. I am confident that it will once again get bipartisan support today, make its way through the Senate, and the President will sign it. I regret that we were not able to pass this legislation last week under suspension, but I believe that we will come together today to close this loophole. I thank our ranking member of the full committee, Mrs. Rodgers, for all of her help with this. Madam Speaker, I reserve the balance of my time.

Mr. PALLONE. Madam Speaker, I would ask for support for this bill from both sides of the aisle. As I have mentioned in the past, it has passed the House previously. Madam Speaker, I yield back the balance of my time.

Mr. PALLONE. Madam Speaker, pursuant to House Resolution 403, I call up the bill (H.R. 1629) to amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes, and ask for its immediate consideration in the House.

Mr. PALLONE. Madam Speaker, I yield such time as she may consume to the gentlewoman from Pennsylvania (Ms. Dean), the sponsor of this bill. I commend her for all the work she has done on this bill. This has been several Congresses now, and we are hoping this will be the final one where we get this bill passed.