Frank Pallone

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I yield 2\1/2\ minutes to the gentleman from Massachusetts who, again, had quite a bit to do with this legislation, particularly on the safety provisions.

Mr. PALLONE. Thank you, Mr. Speaker, and I yield myself such time as I may consume. Mr. Speaker, this is an important day for American consumers. Thanks to the legislation the House is about to pass, the Food and Drug Administration will have the financial resources and authorities necessary to ensure patients have timely access to safe and effective therapies. First and foremost, this bill is about drug safety. In order to empower the FDA to protect the public from harmful drugs, we are giving the agency new authority to compel important labeling changes. This is a significant improvement over current policy, where FDA must haggle with drug companies and protracted negotiations that put patients and consumers at risk. Under this bill, FDA will also be better equipped to force drug manufacturers to fulfill their responsibility to the American public and complete postmarket study commitments which are critical to ensuring a drug is safe. In addition to these important new authorities, this bill authorizes the collection of $225 million in new user fees, a significant increase in the amount of funds dedicated for the use of drug safety activities. The FDA Revitalization Act also provides for commonsense improvements to our Nation's food safety system, such as more stringent ingredient and labeling standards, establishment of an adulterated food registry, and improvements in public notifications. Patients will be happy to know that the bill before us also requires greater transparency of drug makers by calling for clinical trials to be registered in a database monitored by the National Institutes of Health, along with basic results data. As we saw with the case of Avandia, making this information available to patients, providers and researchers is critical to uncovering potential harmful effects of a drug. And under this legislation, the public will also have greater access to internal documents that FDA used in its review of a drug application. We also secure FDA scientists' right to publish by requiring the Secretary to establish clear policies on the timely clearance of articles written by FDA employees. And finally, Mr. Speaker, this bill would make significant progress in reducing the number of conflicted experts who serve on advisory committees. Mr. Speaker, I'm proud to say that this bill reauthorizes two very important programs for our Nation's children, the Best Pharmaceuticals for Children Act and the Pediatric Research and Equity Act. These programs have been crucial in the successful cultivation of important research used by doctors and parents to better determine what kinds of drug therapy is safest and most appropriate for a child patient. In addition to the two existing programs, we're creating a new program that would help provide device manufacturers with greater incentives to conduct research and development of pediatric devices. Combined, these three bills will strengthen the research being done on pediatric uses of drugs and devices, and will make sure that our Nation's children have access to the medicines and therapies they need to grow up healthy and strong. And finally, this bill reauthorizes two critically important user fee agreements with respect to prescription drugs and medical devices. These programs provide FDA with the necessary resources to review applications in a timely manner so patients who rely on new and improved drugs and devices don't have to go without. In addition to reauthorizing these existing user fee programs, this bill would establish a new user fee for the specific purpose of reviewing direct- to-consumer advertising. I just want to commend Mr. Dingell, our ranking member Mr. Barton, Mr. Deal, and all of the members here, Mr. Waxman, Ms. Eshoo, Mr. Markey. Their leadership on these issues has been unwavering. It is to their credit that we have a bill on the floor today. This is a great victory for American consumers that will make tremendous strides in empowering the FDA and restoring public confidence in its ability to protect the public health, and I would urge my colleagues to vigorously support it. Mr. Speaker, I reserve the balance of my time.

Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from California who has been a leader on this issue for so many years.

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from Oregon (Ms. Hooley).

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from Illinois (Ms. Schakowsky).

Mr. PALLONE. Mr. Speaker, I would yield 3 minutes to the gentlewoman from California (Ms. Eshoo) and point out, again, her leadership on this issue, particularly with regard to children and the pediatric issues.

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume. Mr. Speaker, I just want to thank everyone, particularly the staff that were involved in putting this legislation together and all the negotiations. I want to thank our legislative counsel, Warren Burke, Energy and Commerce Republicans, Ryan Long and Nandan Kenkeremath; Mr. Deal's staff, John Little; our Energy and Commerce Democrats, John Ford, Pete Goodloe, Virgil Miller, Bobby Clark; and Mr. Waxman's staff, Karen Nelson, Rachel Sher, Stephen Cha, Anne Witt; and also Mr. Markey's staffperson, Kate Bazinsky. Needless to say, this bill is a product of a lot of hard work here in the House on both sides of the aisle, and, of course, we are also expecting, since this is going to be a consensus bill passed on the suspension list today, that it will pass easily in the Senate hopefully tonight or tomorrow. And it really addresses the problems and the safety issues that have come to light in the last few years. I think many of us know there has been a lot of media attention to the fact that oftentimes drugs in the postmarketing situation have been problems. People have died. People have gotten sick. This bill I think effectively addresses those issues. I hope and expect that it will be noticed, because it will make a difference in people's lives.

Mr. PALLONE. Mr. Speaker, I want to thank everyone again, and I yield back the balance of my time.

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

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, President Bush says progress is being made in Iraq, but many of the examples he pointed to in the nationally televised speech last week were overestimated or overly optimistic. Let me just cite a couple examples. First, President Bush said, ``Iraq's national leaders are getting some things done, such as sharing oil revenues with the provinces.'' But according to the Washington Post, the President's statement ignored the fact that U.S. officials have been frustrated that none of these actions have become law and that a possible compromise has collapsed. The President also thanked ``the 36 nations who have troops on the ground in Iraq.'' But if he had checked with his own State Department, he would have realized that only 25 countries are still involved in the war, supplying only 11,600 troops. Now, that is less than 7 percent of the size of the U.S. forces still on the ground. Mr. Speaker, this is nothing new. The President has been painting rosy scenarios for the situation in Iraq from the very beginning. Time and time again they have been proven wrong. The status quo simply can't continue. It is time to change course.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, for a decade now the Children's Health Insurance Program has provided 6 million children access to private health insurance. Thanks to CHIP, every year over the last decade, the number of uninsured children fell. That is until the last 2 years. Last week, the Census Bureau reported that the number of American children living without health insurance increased from 8 million in 2005 to 8.7 million in 2006. This is simply unacceptable. I would hope President Bush saw these troubling numbers and finally realized we cannot afford to ignore them any longer. Last month, this Democratic House acted by passing the CHAMP Act, legislation that will allow us to reach an additional 5 million children who are already eligible for the CHIP program. When CHIP was created back in 1997, it was supported by both Democrats and Republicans. But today, both the White House and the House Republican leadership oppose the CHAMP Act. Mr. Speaker, the Census Bureau report should serve as a wake-up call to the President to reconsider his veto threat of the CHAMP Act.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, President Bush has threatened to veto a bill that would provide health care insurance to 5 million children who are currently uninsured. The President's reason: The bill is simply too expensive. But what he ignores is the fact that the CHAMP Act is fully paid for. This Democratic House is concerned that too many children are growing up without health insurance, making it impossible for them to receive the regular checkups that they need to live long and healthy lives. The CHAMP Act would strengthen the CHIP program, a popular Federal-State health care partnership so we can reach nearly all of the children who are currently eligible for the program. The price tag is an additional $50 billion over 5 years. Again, the President says it is simply too much money. Yet, he has no problem asking this Congress to rubber-stamp a new Iraq war emergency funding bill that press reports say could be as high as $50 billion and that would only last about 5 months. Madam Speaker, it is time President Bush prioritize the health care needs of our Nation's children. He should simply support the CHAMP Act.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, I ask unanimous consent to control the time of the gentleman from Michigan.

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from Illinois (Mr. Rush).

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from Washington (Mr. Inslee). (Mr. INSLEE asked and was given permission to revise and extend his remarks.)

Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from Maryland (Mr. Wynn).

Mr. PALLONE

Mr. PALLONE. Madam Speaker, at a time when there are serious problems in our health care system, the Children's Health Insurance Program, otherwise known as CHIP, has a proven track record. Over the last decade, as the number of uninsured Americans has increased, the number of children living without health insurance has actually decreased, and thanks to the CHIP program, we have experienced a 60-percent drop in the number of uninsured children. This week, the House plans to reauthorize the CHIP program. Congress must act on this legislation now. In the past, CHIP has received strong bipartisan support. However, in an about-face, the President and some Republicans have abandoned their support of CHIP on supposed philosophical grounds. If Congress refuses to act this week, the nonpartisan Congressional Budget Office estimates that nearly 1 million children will lose their health coverage. Democrats are simply not to get that to happen. We are going to pass the CHIP reauthorization today so that 11 million children have access to the health insurance they need to live healthy lives.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, there shouldn't be any doubt here today about what the Republicans are trying to do. They are trying to destroy the SCHIP program. We spent 18 hours in our committee where they wouldn't let the bill come up. The substitute that they had in the committee would put so many barriers in the program that, in effect, the program would die. Don't believe them. They don't want to provide the additional funds. They know that this expires on September 30, and it will if we don't do something today; that there will be a million kids that will automatically not have their health insurance. We're not changing any of the eligibility today. It's they that want to change the eligibility. The fact of the matter is CBO tells us, and I have it right here, that this bill would cover another 5 million children who are currently uninsured. Now, my colleagues on the other side know that the States have run out of money. Georgia ran out of money in March. They came to us and begged us for more money. States ran out each month of money. We had to put money in the supplemental appropriations bill because the States ran out of money. We need a lot more money to make sure that these 5 million kids are covered. They want to stop that. They're not proposing to cover any additional kids. They want to cut that. There's no illegal aliens covered in this bill. There never were. There's no language in here that says that. This is not an entitlement. It's a block grant set up by Newt Gingrich. Newt Gingrich was the guy who set it up as a block grant, giving the States flexibility. The States want flexibility. Some of them want to go a little higher. Well, it's George Bush, the President of the United States, that granted the waiver so they could have some adults or kids at higher incomes. Who are you kidding? This is a Republican program, but you are now walking away from it. You don't want to fund it. You want to deny eligibility. You want to kill the program. That's what you're all about here today. And don't let anybody kid you. Eighteen hours we had to listen while the bill was being read. Today, they want to delay. They're kidding no one saying that they want an SCHIP program. Don't believe what they say. It's simply not true. You vote for this bill today to expand this program to provide more kids, not more eligibility. And if you don't, this will die and those kids are not going to have health insurance. We have health insurance for our kids as Members of Congress. That's okay for our own kids but not for the rest of these poor kids. Announcement by the Speaker Pro Tempore

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, the American people are demanding that this Congress take action to responsibly end the war in Iraq and bring our troops home safely. If the results of last November's election were not clear enough, a poll released last week indicates that a majority of Americans look to Congress and not the President to extricate ourselves from this dangerous mess. Day after day we hear about Republicans ``questioning'' the President's stay-the-course strategy. But mere words that grab headlines will not guarantee the responsible disengagement of our troops. Congressional action can and will. Earlier this month, the House passed the Responsible Redeployment from Iraq Act, a plan that would bring our troops home by April of next year. Sadly, the measure received just four Republican votes. Rather than join our efforts, most Republicans continue to block meaningful attempts to end this war. Mr. Speaker, it is one thing to raise questions, but actions speak louder than words. This week Republicans get another chance. I urge my colleagues on the other side of the aisle to listen to the American people; take action now and bring our troops home.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, yesterday both the Energy and Commerce Committee and the Ways and Means Committee began marking up a comprehensive bill that ensures that millions of vulnerable children have access to health insurance through the Children's Health Insurance Program, otherwise known as CHIP. Democrats are proud of this legislation because it allows us to cover almost every child now eligible for the program. Since it was created a decade ago, CHIP has received strong bipartisan support here in Washington. But that all changed yesterday when Republicans in both committees used every tactic available to them to stall us from moving forward with this legislation. It's sad that Republicans refuse to engage in a substantive discussion on the future of CHIP. If Republicans were serious about strengthening this important children's health program, they would stop playing games and would allow a constructive debate to occur. These delaying tactics show that Republicans have no interest in ensuring our children have access to quality health care. The record is clear. Democrats wants to cover kids; Republicans don't.

Mr. PALLONE

Mr. PALLONE. Mr. Speaker, yesterday, we introduced the CHAMP Act, an essential package that addresses the health care needs of our children and seniors while also meeting the needs of our doctors. I am particularly proud of our efforts to ensure that 11 million children receive the health care coverage they need to lead healthier lives. Today, we are at a crossroads on children's health. Studies show that if we ensure that children receive preventative health care in their formative years, they will lead healthier lives. But over the last year, the number of uninsured children has increased for the first time in a decade. That is why it is so important to strengthen SCHIP. This is not an expansion of the program. Today we are reaching 6 million children. Under the CHAMP Act, we will reach an additional 5 million children who are already eligible. Over the past 10 years, SCHIP has received strong bipartisan support because it serves as a lifeline to those most vulnerable among us, our children. It has always received strong bipartisan support. At a time when the number of uninsured is increasing, I would hope Republicans would join us in passing this legislation.

Mr. PALLONE

Mr. PALLONE. Mr. Chairman, I want to thank the gentleman from Massachusetts, the chairman of the subcommittee, for this colloquy. Mr. Chairman, in New Jersey, and all over the country, certain waste handlers and railroad companies have tried to exploit a supposed loophole in Federal law in order to set up unregulated waste transfer facilities. Under the Interstate Commerce Commission Termination Act of 1995, the Surface Transportation Board, or STB, has exclusive jurisdiction over transportation by rail carriers and the ability to grant Federal preemption over other laws at any level, local, State or Federal, that might impede such transportation. But Congress intended such authority to extend only to transportation by rail, not to the operation of facilities that are merely sited next to rail operations or have a business connection to a rail company. Unfortunately, certain companies have exploited this loophole to build or plan waste transfer stations next to rail lines and avoid any regulation from State or local authorities. Mr. Chairman, I appreciate the Senate's efforts to close this loophole. They have passed an amendment in their version of the fiscal year 2008 Transportation, Housing and Urban Development appropriations bill, and I wanted to thank your subcommittee for recognizing this important issue in this bill's report language. I had intended to offer an amendment, which I will not offer at this time, that would take the STB out of the waste management business by ensuring that funding for any decisions relating to waste transfer stations be eliminated. Again, you have dealt with this in the bill's report language, so it is not necessary to move this amendment at this time. But it is important that States and local municipalities have some say in this process.

Mr. PALLONE

Mr. PALLONE. Madam Speaker, the denial of the Armenian genocide is an absurdity. Looking at the history of this catastrophic event from 1915 to 1918, it is impossible to deny that this was indeed genocide on all accounts. One way to bear witness to the truth is to make reference to the war trials that took place immediately following the end of World War I. Looking at the substantial evidence and testimony gathered during these war trials proves that this was an indisputable genocide aimed at destroying a race of people. Following the Ottoman Empire's defeat in World War I, a new government formed and accused its predecessor, Young Turk regime, of serious crimes. These accusations led to the court-martialing of the leadership of the Committee on Union and Progress, the party that had seized and held power since 1908. Nearly 400 of the key government officials implicated in the atrocities committed against the Armenians were arrested. They were deported to Malta, where they were held while searches were made of archives in Istanbul, London, Paris, and Washington to investigate their actions. The charges included the unconstitutional seizure of power, wartime profiteering, and the massacre of Armenians. At least six regional courts convened in provincial cities where massacres had occurred. The first recorded trial took place in Yozgat, charging three officials, including the governor, of mass murder of the Armenians of Ankara. Testimony revealed Major Tevfik Bey, commander of the Yozgat military police, had almost completely wiped out the Armenian population of Yozgat. It confirmed that the deportation of the Armenians was ``a policy of extermination,'' and that the people were marched off with ``arms and hands tied up'' and later killed with ``axes, spades, swords, knives and hatchets.'' Meanwhile, Governor Kemal told the captain that he had ``made a vow on the honor of the prophet: I shall not leave a single Armenian alive in the sanjak of Yozgat.'' The most famous trial took place in Istanbul in April 1919. There, 12 defendants, all members of the Committee on Union and Progress leadership and former ministers, were tried. Seven key figures, including Talat Pasha, Minister of Interior; Enver Pasha, Minister of War; and Cemal Pasha, Governor of Aleppo, had fled and they were tried in absentia. One authenticated secret telegram from July 17, 1915, quoted orders from Pasha that quoted: ``The salvation of the country requires the elimination of the Armenians.'' Even more evidence against these top officials was delivered in the key indictment which included 42 incriminating documents that had been gathered by the Mazhar Commission. These documents, such as telegrams, memos, statements, and depositions all confirmed that the campaign to exterminate the Armenians was premeditated and deliberate. Some of the accused were found guilty of the charges. There were three hangings and numerous convictions. Most significantly, the ruling triumvirate of Young Turks consisting of Mehmed Talaat, Ismail Enver, and Ahmed Djemal, were condemned to death. They, however, eluded justice by fleeing abroad. Many more of the convicted did not serve out their prison sentences, and a majority of the perpetrators escaped punishment after a prisoner exchange deal. To this day, there is still no justice for the victims of the Armenian genocide. Madam Speaker, I wish to express my support for swift passage of House Resolution 106, which reaffirms the Armenian genocide. It now has 224 cosponsors, a majority of the House. As the first genocide of the 20th century, it is morally imperative that we remember this atrocity and collectively demand reaffirmation of this crime against humanity. We must stand up and recognize the tragic events that began in 1915 for what they were, the systematic elimination of the people. By recognizing these actions as genocide, we can renew our commitment to prevent such atrocities from ever occurring again.

Mr. PALLONE

Mr. PALLONE. Madam Chairman, I move to strike the last word.

Mr. PALLONE. Madam Chairman, I rise in support of the Whitfield amendment to fund NASPER, the National All Schedules Prescription Electronic Reporting Act, which the gentleman from Kentucky and I sponsored in the last Congress. As was mentioned already, this is the authorized program that would deal with this issue. And I don't want to get into necessarily contrasting this with the other program that the gentleman from New York mentioned, but I do think it's necessary to understand that this program is authorized and it's not funded. I mean, obviously we should be funding programs that are authorized, not those that are not. But beyond that, the bottom line is that the NASPER program mandates that States participate in the program. We only have about 22 States now that are participating, so I would certainly argue that the status quo with this alternative Justice Department program simply is not working. If we want more States to get involved, we need to fund the authorized program. During the time since August of 2005 when this became law and has not been funded, during this time since then prescription drug abuse has reached an all-time high, with an estimated 9 million Americans using prescription drugs for nonmedical purposes. Most disturbing is the fact that there is an epidemic of prescription drug abuse among teenagers. So if the argument is that the existing Justice Department program is working and we don't need to fund this authorized program, I think the facts show very much the opposite. NASPER will ensure that prescription drugs are only being used for medical purposes. With better monitoring and tracking systems, people will not be able to seek multiple prescriptions or cross State lines to get prescriptions filled without their provider knowing. NASPER reaches across State lines, with timetables and benchmarks aimed at eliminating the problem of prescription drug abuse. It's a public health program in the Department of Health and Human Services, where it belongs, not in the Justice Department. And most important, it is the only statutorily authorized program to assist States in combating prescription drug use. Right now, a lot of the program is with doctors. The Justice Department program doesn't really help doctors prevent this epidemic. Also, the Justice Department program is totally focused on enforcement, not on trying to get people more involved in the States at a preventive level dealing with the doctors. We have enforcement as well, but it's not the only thing. I would simply say that we've made this pledge a couple of times. My understanding is that this amendment is going to be withdrawn. But I just need to ask the appropriators, please consider the fact that in the future we need to address this. This needs to be affected. The other program that's in effect now is not doing the job. We simply ask that you collectively take a look at this and figure out how to do it so we can get funding for the NASPER program, which is the one that the Congress authorized and which will address this epidemic effectively. We're not having an effective response right now. With that, Madam Chairman, I would yield back the balance of my time.