Henry Waxman

Mr. WAXMAN

Mr. WAXMAN. Mr. Chairman, I yield for the purpose of making a unanimous consent request to the gentleman from Virginia (Mr. Moran). (Mr. MORAN of Virginia asked and was given permission to revise and extend his remarks.)

Mr. WAXMAN. Mr. Chairman, I yield myself the balance of my time. Mr. Chairman, I just want to point out to my colleagues, we are talking about something of the most significant importance to this Nation. We should not allow politics to be played with this matter. We have had a commission that was set up by a vote of the Congress. They came back with a unanimous recommendation. The other body adopted their recommendations unanimously, Democrats and Republicans. I strongly urge support for the Menendez substitute and a rejection of the Republican partisan bill. Mr. Chairman, I urge rejection of H.R. 10 and support for the substitute amendment so we can be in sync with the bipartisan vote in the Senate and the bipartisan recommendations before us. Mr. Chairman, I yield back the balance of my time.

Mr. WAXMAN. Mr. Chairman, I yield 2 minutes to the gentleman from Maryland (Mr. Van Hollen).

Mr. WAXMAN. Mr. Chairman, I yield 1 minute to the gentlewoman from Minnesota (Ms. McCollum).

Mr. WAXMAN. Mr. Chairman, I am pleased at this time to yield 3\1/2\ minutes to the gentlewoman from New York (Mrs. Maloney) who has taken such a strong leadership role in this legislation and is a cosponsor of the Shays-Maloney bill, which is part of the Menendez substitute.

Mr. WAXMAN. Mr. Chairman, the House is taking up legislation of enormous importance: how to make our Nation safe from future terrorist attacks. Outside of this body the effort to protect our Nation has been a united, bipartisan effort. Against the odds, the 9/11 Commission produced unanimous recommendations about how to protect our Nation. The Senate has carried their work forward. By an overwhelming 96 to 2 vote, the Senate has approved legislation embodying the commission's recommendations. Unfortunately, this bipartisan process has been hijacked in the House. There are just three numbers that you need to remember: 41 were the recommendations from the 9/11 Commission; 11 were the number of recommendations out of the 41 that they implemented; and 50 are the number of extraneous provisions inserted into the bill. The missing components are no minor oversights. H.R. 10 does not give the National Intelligence Director the full authority recommended by the 9/11 Commission. It falls short on border security, on aviation security, and on emergency response. During the first Presidential debate, both President Bush and Senator Kerry agreed that preventing nuclear proliferation was the single greatest threat facing our Nation, yet incredibly the Republican bill does not implement the recommendations for stopping nuclear proliferation. For the next 30 minutes we are going to talk about the areas of the bill in the jurisdiction of the Committee on Government Reform. Here the same pattern emerges. Key recommendations from the 9/11 Commission are ignored, while damaging extraneous provisions are inserted. One of the major recommendations of the 9/11 Commission was to improve information-sharing among intelligence agencies. In our committee we unanimously adopted an amendment to implement the information-sharing provisions recommended by the commission. These essential provisions, however, even though adopted unanimously by the committee, were dropped by the Republican leadership on the way to the House floor. At the same time, H.R. 10 includes extraneous provisions that are both dangerous and controversial. In one provision, and most people may not even be aware of it, the legislation establishes a fast track legislative procedure that allows the executive branch to undo all of the bill enacted in the legislation. The President can then send legislation to Congress that reverses the reforms we have just enacted, and Congress would be prohibited from amending the President's proposal. And here is another inexplicable extraneous provision. The bill actually repeals financial disclosure requirements for the intelligence agencies. Under this legislation, top intelligence officials no longer have to reveal if they own assets worth over $5 million, $25 million, or even $50 million. The substitute amendment that will be offered by the gentleman from New Jersey (Mr. Menendez) addresses all of the Commission's recommendations, it has the same structure and provisions as the Senate legislation that passed 96 to 2. It is that legislation that we should be enacting today. Mr. Chairman, I reserve the balance of my time.

Mr. WAXMAN. Mr. Chairman, I yield myself 3\1/2\ minutes. (Mr. WAXMAN asked and was given permission to revise and extend his remarks.)

Mr. WAXMAN. Mr. Chairman, how much time remains?

Mr. WAXMAN. Mr. Chairman, I yield 1 minute to the gentleman from Massachusetts (Mr. Lynch).

Mr. WAXMAN. Mr. Chairman, I yield 1 minute to the gentlewoman from the District of Columbia (Ms. Norton).

Mr. WAXMAN

Mr. WAXMAN. Mr. Chairman, I rise in strong support of the substitute amendment offered by the gentleman from New Jersey (Mr. Menendez). The Republican bill is fundamentally flawed. There are 41 recommendations made by the 9/11 Commission, but the Republican bill implements only 11. Instead of implementing the 9/11 Commission recommendations, the Republican bill includes 50 extraneous provisions, many of them poison pills. There is a better way and it is this substitute. The substitute is bipartisan. It implements all of the recommendations made by the 9/11 Commission, not just 11 of the 41 recommendations, and it includes no poison pills. I want to point out to my colleagues, the substitute has the support of the 9/11 Commission and the family steering committee of the victims from 9/11. It has the support of Senate Republicans, Senate Democrats, House Democrats and President Bush. As we consider this legislation, let us remember the loss of the families of the 9/11 victims. These family members have found strength through their terrible losses. We have a moral obligation to pass legislation that honors the sacrifices that they have made. That is why we need to pass the substitute. But Members who are watching and the public who are paying attention to this issue may want to take note of the fact that when Congress voted to set up the September 11 Commission, so far all of the Republicans that have talked against the Menendez substitute, not a single one of them voted for the Commission in the first place. A number of them, the gentleman from Michigan (Mr. Hoekstra), the gentleman from California (Mr. Hunter), the gentleman from Illinois (Mr. Hyde) voted against setting up the Commission. Well, Congress voted to set up that Commission. They worked hard, and they unanimously recommended we adopt what is the Menendez substitute.

Mr. WAXMAN

Mr. WAXMAN. Mr. Speaker, I believe that H.R. 3015, legislation to support State controlled substance monitoring programs, is well intentioned. Non-medical use of controlled substances is a serious problem. Establishing State databases that contain information on prescriptions for such substances may help stem the practice of individuals seeking prescriptions from multiple providers for the purpose of non-medical use. However, as we forge policies to facilitate controlled substance prescription information sharing among providers, States, and others, we must carefully consider the privacy implications of such steps. The databases H.R. 3015 supports potentially will contain a vast amount of personal medical information--including individually identifiable data regarding many individuals who are given prescriptions for legitimate medical reasons such as recovery from surgery. The last thing we want to do is deter individuals from seeking medical care out of fear that the privacy of their health information will not be protected. I am pleased that, following up on concerns I expressed when the bill was under consideration in committee, sponsors of the measure agreed to add language that is a step forward from earlier versions of the bill with respect to privacy protection. This language includes (1) a requirement that the Secretary of Health and Human Services study and report to Congress on the privacy protections regarding each State database that receives funding under the bill; and (2) requirements that the State grant applications submitted to the Secretary of HHS propose standards regarding redisclosure of information, penalties for illegal redisclosure of information, and other privacy related standards. These provisions increase focus by States and HHS on the privacy issues raised by the State controlled substance monitoring programs. However, H.R. 3015's State-to-State disclosure and uniform electronic format provisions promote the development of, in essence, a national prescription database network. As such, it is particularly important that Congress work to ensure that appropriate privacy standards apply to databases in the network. The bill does not accomplish this task. It contains no minimum Federal standards or even a requirement that the HHS Secretary develop publicly reviewable criteria for assessing the sufficiency of the privacy standards that States must propose for their programs when applying for grants under the bill. I do want to recognize and acknowledge the efforts of the sponsors to respond to the privacy concerns that I raised, particularly the efforts of Mr. Pallone, Dr. Norwood, and Mr. Whitfield. And while I cannot support this bill at this point, I hope that with further consideration by the Senate and ultimately in conference, Members will carefully consider the privacy ramifications of controlled substance monitoring systems and make improvements in this area before the bill is enacted.

Mr. WAXMAN

Mr. WAXMAN. Mr. Speaker, I rise in strong opposition to House Joint Resolution 106, which would deny basic rights under the Constitution to gays and lesbians. This resolution is a cynical ploy to foster division and diversion for the election campaign. Even its strongest proponents know it has no chance of passing. Two short months ago, the House passed unprecedented legislation that would strip the federal courts of the ability to decide the constitutionality of The Defense of Marriage Act. And today the House will vote on whether to use the very document that guarantees our liberties and protections to restrict the rights of one group of Americans. Throughout U.S. history, the states have been responsible for marriage and family law. Thirty-eight states have already acted to define marriage as the union of a man and woman and no state has adopted legislation that would define marriage differently. This year alone, voters in eleven states will consider amendments to their state constitutions barring gay marriage. The charade on the House floor today is a strategy to change the subject, and I certainly can't blame the Republican Party for wanting to distract voters from their record. That is why the Republican leadership bypassed the committee of jurisdiction and brought H.J. Res. 106 directly to the floor in the middle of the campaign season.

Mr. WAXMAN

Mr. WAXMAN. Mr. Speaker, I rise in opposition to this bill. The other side would have you believe that they want to repeal legislation in the District of Columbia to stop handguns. But that is not what this bill does. This bill repeals the District's laws on assault weapons. I want to show a chart, if I might, because one of the assault weapons that would be made legal if this bill passes is a semiautomatic 50-caliber sniper weapon. This is its actual size. It is capable of taking out an armored limousine from a mile away. Can you imagine that in the District of Columbia someone could have this assault weapon and stick it out of a window on Pennsylvania Avenue? We have people coming in and out of this city who are very important to the functioning of our government, international visitors. Yet they could own and possess this weapon if the legislation before us passes. We are spending millions of dollars to protect the Nation's capital from another terrorist attack, yet we are passing legislation today that would invite terrorists to bring assault weapons into the heart of the Nation's capital. There is a real irony. There are committees that are meeting today to pass different parts of legislation based on the recommendations of the 9/11 Commission. Those recommendations were to make our Nation safe from terrorist attacks. Yet in this bill we are telling terrorists that it is okay for them to have assault weapons when they visit the Nation's capital. We are under an orange alert because someone working with al Qaeda took photos of the World Bank, the IMF, and other buildings in D.C. Think of the damage that person could have done if he or she had a 50- caliber sniper weapon instead of a camera. Two years ago, this city, this whole region was gripped with fear when a sniper systematically stalked and killed 10 people. The gun he used was the Bushmaster XM-15 assault rifle. Along with AK-47s and Uzis, the Bushmaster assault rifle is one of the guns that this bill would legalize. The vast majority of the people in this Nation support the Federal ban on assault weapons. Even the President said he supported the continuation of the assault weapons ban, but we could not even bring it up for a vote in the House of Representatives. Instead, the Republican leadership in the House has brought up to the House floor legislation that makes assault weapons legal in the Nation's capital. I wonder if they are going to get around to mandating that each Member of Congress buy an assault weapon rather than ban it all around this Nation. This bill is being rushed to the floor to score political points with the NRA. The bill is an abomination. I urge my colleagues to defeat it.

Mr. WAXMAN

Mr. WAXMAN. Mr. Speaker, I rise to ask my colleagues to join me in honoring the life of a young man, Evan Asa Ashcraft, whose life was cut short serving our nation in Iraq. H.R. 5147, which has been cosponsored by the entire California delegation, would name the post office located at 23055 Sherman Way in West Hills, California the ``Evan Asa Ashcraft Post Office.'' Evan Ashcraft was smart, talented, and energetic. He represented the very best of American values. From an early age, he excelled in school, first at Welby Way Gifted Magnet School in West Hills, then at Nobel Middle School Magnet in Northridge and El Camino Real High School in Woodland Hills. Evan was devoted to his family--his wife, Ashley, his mother, Jane, his father, Asa, his younger brother, Drew, his stepmother, Beverly, and his two stepsisters, Felicia and Theresa. By all accounts, Evan was extremely dedicated. Anything he put his mind to, he accomplished in grand fashion, and his service in the military was no exception. He enlisted in the Army at the age of 20, and it did not take long for his superior officers to recognize that he was a gifted soldier. Midway through his basic training, Evan was made a team leader. Evan enjoyed his time with the 101st Airborne division. As was often the case in his life, however, he sought a greater challenge and volunteered for duty with the elite Army Rangers. Unfortunately, he was injured during training and returned to Company A, 1st Battalion, 327th Infantry of the 101st. On March 1, 2003, Evan was deployed to Iraq as part of Operation Iraqi Freedom. He saw action quickly, participating in the liberation of Baghdad International Airport and the mission that found two of Saddam Hussein's sons, Uday and Usay. A month later, the Humvee Evan was riding in hit a land mind and came under enemy fire. Both soldiers accompanying Evan were badly wounded and in desperate need of medical attention. Showing no regard for his own safety, Evan risked his life to pull the two men to safety. According to others on hand that day, were it not for Evan's quick and decisive action, both men would have died. One of the men Evan saved that day, Sergeant Arcebuce, said, ``Evan was always there for his men. He was a natural born leader.'' Like so many soldiers in Iraq, Evan had big dreams for his life after the war. He planned to move back to California with his wife, Ashley, start a family, and join the Los Angeles police force. His reason for doing so was simple according to Ashley: ``He was a person who really wanted to help other people, to protect them.'' Evan was not able to realize his dreams. He was killed with two other soldiers on July 24, 2003, when his Humvee was attacked during a reconnasissance mission near Mosul. To the people who knew him, Evan represented hope for America's future. After he died, his mother wrote, ``This loss is not just mine, it's the world's loss . . . Evan will always be with us in spirit. He still lives, and will continue to live, in all of us.'' Evan was awarded the Bronze Star for bravery, and was posthumously awarded the Purple Heart and the rank of Sergeant. By naming a post office in Evan's honor in his hometown of West Hills, his community and a grateful nation will always be reminded of the life, the contributions, and the ultimate sacrifice of this extraordinary young man. I urge unanimous support for H.R. 5147.

Mr. WAXMAN

Mr. WAXMAN. Mr. Speaker, I rise in strong support of H. Res. 772, a resolution supporting the goals and ideals of National Long-Term Care Residents' Rights Week and recognizing the importance of residents of long-term care facilities to our everyday lives. I want to thank Representative Tom Davis and Representative Danny Davis for working with me to bring this resolution to the floor in a timely manner. I also want to recognize Representative John McHugh for joining me in sponsoring this National Long-Term Care Residents' Rights Week resolution. Since coming to Congress 30 years ago, one of my top priorities has been improving the health care received by senior citizens and persons living with disabilities. It is these people whom we honor during National Long-Term Care Residents' Rights Week, which will begin this year on October 3. I am especially pleased to be following in the footsteps of the legendary Claude Pepper, who first introduced a resolution in 1980 to designate a Nursing Home Residents Day. As many of you may remember, Claude Pepper was a tireless advocate for the interests of senior citizens and the disabled during his five decades of public service. Since 1980, this commemoration has been broadened to include all 2.7 million persons who live in nursing homes, assisted living facilities, and board and care facilities in the U.S. A large number of these long-term care residents are members of America's ``Greatest Generation''--those men and women who protected our freedoms in World War II and helped rebuild the world in the post- war years. Our Nation should honor and celebrate these residents, recognize their rich individuality, and reaffirm their rights. These rights include the right to privacy, the right to be treated with dignity, the right to review one's care plan, the right to voice grievances without fear of reprisal, and the right to vote. Mr. Speaker, residents of long-term facilities are a vital part of our Nation and they deserve our honor today. I urge the passage of H. Res. 772.

Mr. WAXMAN

Mr. WAXMAN. Mr. Speaker, the tobacco industry distributes millions of coupons, surveys, and offers in the mail to its prospective customers. Sometimes, these customers or their loved ones write back. For years, these letters have been buried in secret industry files. As a result of tobacco litigation, they are now available to read on the internet. Here are a few examples: One New Jersey wife wrote, ``Please do not send anything about smoking. My husband . . . does not smoke any more. He has emphysema as a direct result of smoking. He is terminally ill. He will not get better and will eventually die from a lack of oxygen. . . . [he] is only 57 years old.'' An Arizona husband wrote, ``My wife of 28 years has been diagnosed with terminal lung cancer, caused by use of your product. . . . She is unable to go to the mailbox, much less read your self-serving propaganda.'' A son or daughter in New York wrote, ``This is to let you know that you can never get to know my father any better--he died from emphysema because of smoking most of his life. My mother, who passed away four months prior to my Dad, and never smoked, had the lungs of a smoker because of living with him all her life. Don't ever send literature like this to me again. . . . You have my permission to use this in your advertising program.'' A mother in Texas wrote, ``I will be delighted to tell you about my daughter. . . . She lost her life to lung cancer at the age of 40. Caused from smoking. . . . Hope you think again before you send out such a letter. You don't know how you hurt someone who has lost a loved one. A grieving mother.'' I urge all my colleagues to read these letters. You can find many of them on a new web site run by nurses called www.nightingalesnurses.org, and you can also search for more at http://legacy.library.ucsf.edu/ index.html.

Mr. WAXMAN

Mr. WAXMAN. Mr. Chairman, I would feel a lot better about this issue if the Republican leadership in the Congress decided to do something when they first heard that Tom Scully, who was the Administrator of the agency, Center for Medicare and Medicaid Services, threatened to fire the actuary if he gave Congress the accurate information about how much the Medicare bill would cost. We were told in the Congress that it was going to cost $400 billion. It turned out it was $600 billion. And the actuary knew about it, and Mr. Scully said to him if he told the Congress, he was going to fire him. I hear no sense of outrage from the Republican leadership of the Congress, of the House. I hear no sense of outrage from Republican Members who voted for this bill because they thought it would only be $400 billion and would have voted against it if they had known the true facts. The Government Accountability Office has issued its findings to the investigation in this matter, and they said what Mr. Scully did was improper, and he should not be paid. So under the amendment offered by the gentleman from California (Mr. Stark), we would take out $84,500 from the appropriations bill in order to make the point of protest as to what happened. That is not a lot of money given the scope of this appropriations bill, but I would feel more comfortable in deferring to the chairman of the subcommittee if he and other leaders on the Republican side of the aisle had at least expressed some outrage on behalf of this institution that we were treated the way we were. So I support the Stark amendment at least to do something about this issue.

Mr. WAXMAN

Mr. WAXMAN. Mr. Speaker, I deeply value the close relationship between the United States and Morocco and the effort to strengthen our economic ties. Morocco is one of our strongest partners in the war on terrorism. The Kingdom, under the leadership of King Hassan II and now his son King Mohammed VI, has long been a steadfast supporter and key player in the Middle East peace process. Its recent designation as a major non-NATO ally is an important step toward further enhancing coordination between our countries on security issues. In many ways, this free trade agreement, or FTA, is a tribute to the significant economic and political reforms that Morocco has recently undertaken to stimulate growth and development. I strongly support the FTA's robust anti-piracy standards to protect the transmission of digital, satellite, and other copyrighted material, as well as broad market access for a wide array of audio visual products and services. I regretfully rise in opposition to this agreement, however, because of a number of other troubling provisions that could have profound public health consequences for the Moroccan people. At the crossroads between Africa and Europe, Morocco is actively engaged in the battle against the spread of the HIV/AIDS epidemic. With 19 percent of its people living in poverty, the country's healthcare system is stretched thin and heavily reliant on the availability of generic drugs. It is shocking to me that despite this reality, the Bush administration's trade negotiators demanded intellectual property restrictions that will severely curtail Morocco's generic market. Most egregiously, the FTA requires Morocco to grant an automatic five-year monopoly to all new drugs introduced in the market, freeing them from competition with less expensive generic copies even if their patents have already expired. The Bush administration maintains that it negotiated the standard based on U.S. laws like Hatch-Waxman, which provides similar protections for new drugs introduced in the United States. But this is a distortion of the bill I co-authored. When Hatch- Waxman was devised in 1984, virtually no generic drugs were available in the United States. The law was passed to increase competition by easing the approval of low-cost generics while providing specified periods of exclusive marketing to help pharmaceutical companies recoup development costs. In sharp contrast, Morocco is a country with a robust generic market where the introduction of this measure will only reduce competition and cause drug prices to soar. As a co-author of Hatch-Waxman, I cannot emphasize enough that this carefully balanced legislation represented a tailored solution to a specific regulatory problem in the United States. It is irresponsible for U.S. trade negotiators to apply the same policy in a developing country like Morocco whose generic drug market, health-care regulatory system, and public health needs look nothing like those in the United States. Although the Bush administration has cited the inclusion of similar provisions in the Jordan FTA as a precedent, there is clear evidence that the restrictions on the availability of generics have already had a terrible impact there. First, as the Wall Street Journal recently reported from an interview with the Executive Director of the Global Fund to Fight AIDS, AIDS drugs purchased in Jordan with Global Fund money cost an average of $7,000 a year per patient, compared with the average $250 to $400 paid in other countries. Second, the U.S.-Jordan FTA was signed before the WTO's Doha Declaration on trade and health authorized developing countries like Jordan to resist such regulatory changes and preserve access to affordable drugs for life-threatening diseases. Under this agreement, the Moroccan government could not import generic copies of drugs if domestic prices became too expensive because the FTA codifies U.S. and Moroccan laws that allow patent holders to block the importation of their product. Here in the United States this provision undermines the ongoing debate in Congress over the legalization of re-importation of low-cost drugs. In Morocco, however, it is much more damaging because it makes it impossible for Morocco to change its laws, as permitted by the Doha Declaration, to import drugs if a public health crisis arises. In the event of a public health emergency, the only recourse Morocco would have is to strip a drug of its patent and issue a compulsory license for another company to produce a generic copy and distribute it at a lower cost. Even then, however, Morocco would be vulnerable to a trade challenge because the FTA's investment chapter allows companies to sue for the expropriation of intellectual property. Although the agreement specifies that a challenge could not be made over the use of the patent in order to produce the generic copy, it does permit challenges over the use of a company's undisclosed safety and efficacy testing data to approve its distribution. The pharmaceutical industry has spoken openly about its efforts to raise drug prices and profit margins around the world. I do not think we should let drug companies use trade agreements to undermine the Doha Declaration and get health policy changes they could not otherwise achieve. Unfortunately, these provisions have become part of a cookie- cutter mold that also appears in the recently negotiated U.S. FTAs with middle and high-income countries like Chile, Singapore, Australia, and Bahrain, as well as poverty-stricken developing countries like Thailand, Southern Africa, and the countries in the Andean and Central American regions. Another serious public health problem posed by the U.S.-Morocco FTA is its across the board cuts in agricultural tariffs that will eliminate Morocco's 25 percent tariffs on imported cigarettes. Although Morocco's 65 percent excise taxes on cigarettes will remain in place, I am disappointed that the FTA could increase cigarette consumption in a country where smoking is common among youth. In fact, in July 2002, I sent a letter asking the Centers for Disease Control a series of questions about the impact of tariff reductions in trade negotiations on cigarette consumption. After two years the letter has gone unanswered even as trade agreements with Morocco and Thailand have moved forward without regard to the crisis of tobacco addiction in these countries. I believe in the benefits of free trade, but not at the expense of public health. While I strongly support our alliance with Morocco and want to support this trade agreement, I cannot do so in good conscience. I hope that future trade negotiations will work for more progressive and forward-looking agreements that both expand markets and advance positions more respectful of our trade partners' public health needs.

Mr. WAXMAN

Mr. WAXMAN. Mr. Speaker, I staunchly oppose H.R. 3313, the so-called ``Marriage Protection Act.'' This bill is an attack on our Constitution, an insult to the fundamental freedoms of our society, and a shameful election year stunt by the Republican party. Sadly, although its hard to imagine, this bill is even worse than the proposed Federal Marriage Amendment. While I also oppose that legislation, and any effort to write discrimination based on sexual orientation into our laws, this measure presents an even deeper constitutional crisis. What this bill attempts to do is strip the federal court system and the Supreme Court of the ability to decide the constitutionality of a law. Regardless of the issue in question, this bill is a flagrant attack on the basic separation of powers enumerated in the constitution and the inherent right of each branch of government to have full power over its sphere of jurisdiction. Equally troubling is the purpose of the bill--to single out one minority group and argue that they do not have the right to be heard in court on an issue important to them. The idea that the gay and lesbian community somehow doesn't deserve equal protection under the law is an affront to the Bill of Rights and its guarantee that all Americans have a right to due process. It is no secret that the Bush Administration will stop at nothing to appeal to its conservative base by discriminating against same-sex couples. But it is an embarrassment to our democracy that the Republican party would promote these initiatives as a ploy to distract from the Administration's far-reaching policy failures. One recent e- mail newsletter sent on June 7, 2004 by veteran right-wing conservative Paul Weyrich openly suggested: ``The president has bet the farm on Iraq . . . Given what the continued killing has done to the president's standing in the polls this far, it is a lead-pipe cinch that as we lead up to the first days of November 2004, violence is going to be horrific. . . The only one alternative to this situation: change the subject. . . Ninety-nine percent of the president's base will unite behind him if he pushed the [Federal Marriage] Amendment.'' I opposed the Defense of Marriage Act when it was considered in the House in 1994. Ten years later, I continue to believe that these initiatives against gay marriage do nothing to preserve the institution of marriage, but serve only to fan the flames of intolerance and prejudice. I urge my colleagues to reject this woefully misguided bill and its crude objectives.

Mr. WAXMAN

Mr. WAXMAN. Mr. Speaker, domestic healthcare policy should not be decided in trade agreements. That is why I rise in opposition to the U.S.-Australia Free Trade Agreement. I strongly support the opportunity for increased trade with Australia, our closest ally and strongest economic partner in the Pacific rim. I support the agreement's strong protections for digital copyright, the elimination of tariffs on entertainment and media products, and improved market access for U.S. films and television via cable, satellite, and the Internet. I am deeply concerned, however, that this agreement also involves a deliberate effort to drive up drug prices in Australia and set precedents that could be used to undermine efforts to lower drugs prices here in the United States. It is wrong for us to interfere with another country's domestic health policy, particularly when it comes to the affordability of medicine which is an equally sensitive issue here in the United States. I staunchly oppose provisions in this agreement that make it easier for pharmaceutical companies to challenge decisions made by the Australian Pharmaceutical Benefits Scheme, or PBS, a formulary system used by the Australian government to negotiate prices on behalf of its citizens and keep down drug costs. I am also concerned that the Bush Administration has set an irresponsible precedent that could bring scrutiny upon our own federally sponsored health programs like Medicare and the VA formulary system, which we rely upon to reduce drug prices for seniors, veterans, and the military. This is special interest policymaking at its worst. The Bush Administration is letting the pharmaceutical industry use trade agreements to manipulate the drug laws of the United States and other countries in ways that the industry could not otherwise achieve. For example, the Australia agreement codifies provisions of U.S. law that prohibit reimportation of medicines that are produced in the United States and sold at a discount in other countries. I strongly oppose the inclusion of this controversial issue in a trade agreement when it is the subject of ongoing Congressional debate. Bills currently under consideration in the Senate and already passed by the House of Representatives will now be in technical violation of our trade obligations. Since the provision will have no actual impact because Australian law already prohibits wholesalers and pharmacists from exporting low-cost drugs procured through the PBS system, it appears that its sole purpose is to serve as a basis for the inclusion of similar provisions in future agreements. Unfortunately, it is not just the Australia free trade agreement where these back door assaults on domestic healthcare programs are taking place. The U.S. has also negotiated trade agreements with Central America, Morocco, and Thailand that would significantly impede and delay access to cheaper generic drugs in these developing countries where the availability of quality healthcare is already limited and few can afford medicine. All of these efforts fit into the pharmaceutical industry's agenda to raise drug prices and profits around the world, even at the expense of saving lives. Because of unique dynamics between the United States and Australia the net effects of this agreement on health programs may be negligible. But that doesn't mean they aren't bad policy and bad precedents. I am voting no on this agreement, which I would have liked to support, in order to register my strong protest against the Bush Administration's work with the pharmaceutical industry on provisions that sour an otherwise promising trade opportunity. International trade has the potential to raise the standard of living and quality of life for millions of people around the world. To uphold that vision, we must work for future trade negotiations that ensure that our citizens and our trading partners have the opportunity to experience the full benefits of free and fair trade.

Mr. WAXMAN

Mr. WAXMAN. Mr. Speaker, we have before us today S. 15, the Project BioShield Act. This bill is substantially the same as H.R. 2122, which passed the House on July 16, of last year by a vote of 421 to 2. This bill is in essence the conference report on the bill, and includes some minor improvements made by the Senate. I urge members to support this measure as well. Given the serious threat of bioterrorism, the development of effective countermeasures to biological agents is vital to our national security. The goal of Project BioShield is to encourage the development of these products. I fully support the intent of this legislation. I also agree with its premise-- that when the market cannot foster the development of critical products by itself, the government must rise to the challenge. The bill before us today includes several significant improvements from earlier proposals. For example, it includes important protections against waste and abuse that are standard for government contracts, such as preserving the government's rights to review contractor's books and records. The bill also permits the use of certain streamlined procurement procedures, but only if the Secretary of Health and Human Services determines that there is a pressing need to do so. The Senate bill appropriately strengthens some of these provisions and also allows for recovery by the government in the event of grossly negligent or reckless conduct on the part a contractor. In emergency situations we should not impede the development of necessary products. However, any exceptions from standard procurement procedures should be made only when necessary and should be subject to review. This proposal preserves that standard. The provisions of Bioshield authorizing the emergency distribution of unapproved drugs and devices, whose risks and benefits are not fully tested, impose an unprecedented responsibility on the government. FDA must be vigilant in protecting the public against unnecessary risks from these products. In part because of these concerns, the bill requires that health care providers and patients be informed that the products have not been approved and of their risks. The bill also requires that manufacturers monitor and report adverse reactions to the products and keep other appropriate records about the use of the products. These conditions are essential for the safe use of unapproved products, and they should be imposed in all cases, except in truly extraordinary circumstances. In addition, the HHS Secretary is authorized to limit the distribution of the products, to limit who may administer the products, to waive good manufacturing practice requirements only when absolutely necessary, and to require record keeping by others in the chain of distribution. We expect the Secretary to consider the need for these additional conditions in each case and to impose them to the full extent necessary to protect the public from the risks of these products. The bill before us today is an improvement over the original proposal, and represents a bipartisan consensus of the House, the Senate, and the White House. It deserves our support.

Mr. WAXMAN

Mr. WAXMAN. Mr. Chairman, I support this amendment and urge my colleagues to do the same thing. It is appropriate because, under the act, all the gentlewoman from Ohio is asking is that we comply with existing law. It would be a lot easier if we had an administration that would be more forthcoming about the way this all is being handled. The gentlewoman from Ohio (Ms. Kaptur) has requested information, as have others, and this administration has refused to comply with the congressional request for information regarding Iraq. During their hearings, the gentlewoman from Ohio (Ms. Kaptur) requested basic information about credit guarantees approved for Iraq; and despite USDA's promise a year ago to coordinate with the Treasury Department to provide these records, no information has been forthcoming. Unfortunately, this is not an isolated incident. I have faced similar difficulties in getting information from the administration about Iraq contracts. It is not just the White House. Yesterday we received some documents from the Defense Department we requested 6 months ago, but DOD still has not sent other documents requested last December. The gentlewoman from Ohio (Ms. Kaptur) should get the documents she has requested. She should get those documents if Congress can make informed decisions about extending agricultural credit guarantees to Iraq. In the meantime, it is essential that the administration comply with existing law as this amendment would have them do.

Mr. WAXMAN. Mr. Chairman, I am pleased to join in a bipartisan group in support of this amendment. The bill that passed through the House called for $9.6 billion of taxpayer dollars to be used to pay those who own these quotas for tobacco, and no strings were attached to that dishing out, that handout, of $9.6 billion. They can just keep on growing tobacco. What is more, the bill favored just a few select growers. According to an analysis by the Environmental Working Group, more than two-thirds of the money would go to just 10 percent of the recipients. The bill would pay more than $1 million to only 462 individuals, corporations and estates. This amendment provides that no taxpayers' money can be used for this purpose. If our colleagues who want support for the tobacco growers want to pay for it, that is something different. But all this bill that passed the House would do is to increase the deficit. So the Flake-Van Hollen proposal before us would be to put in this appropriations bill a restriction not to enforce that bailout, buyout, handout, should it pass. Now, even the Louisville Courier-Journal said, rather than a buyout, the bill should be called an ``entitlement'' because ``farmers, quota holders, warehouse holders and others would end up getting taxpayer money pretty much just because they are who they are.'' Well, I do not think that is the American way, to take the tax dollars of hard-working Americans and just give it to people, billions of dollars to them, just because they are who they are. So I think it is important to adopt this amendment, to let people who want to do something along these lines come back with a better proposal. And if they stick with the proposal that we were not even allowed to have a vote on in the FSC bill, then they will find that this restriction, should it become law, will not allow the Department of Agriculture to disburse the funds. Mr. Chairman, I urge support for the Flake-Van Hollen amendment.

Mr. WAXMAN. Mr. Chairman, I rise in support of the amendment. The issue before us is the process by which the FDA decides whether to make Plan B, a form of emergency contraception, available over the counter. Plan B has long been considered a safe and effective prescription method of emergency contraception. Earlier this year the FDA's expert advisory committee and its scientific staff both concluded that it was safe and effective for use over the counter, as have several other countries. It was therefore with grave concern that I learned that the FDA decided to reject the scientific recommendations of its staff and expert committee and refused to grant over-the-counter status for Plan B. Instead of science, the over-riding basis for the FDA's decision appeared to be the Bush administration's desire to cater to its right- wing base in an election year. The FDA has a long and respected tradition of making decisions on the basis of science. FDA's drug approval process is admired and emulated around the world for this very reason: its decisions have always been based on the best available evidence. America's health and the industries the FDA regulates have thrived under this system. I am concerned not only because improperly withholding emergency contraception will result in countless unnecessary abortions and unwanted pregnancies. I am concerned because public health agencies like the FDA run tremendous risks when they allow an ideological agenda to subvert science. They run those risks with their own credibility, with the credibility of the products they regulate, and ultimately with the lives of the American people. An FDA motivated by politics instead of science is bad for America's health. The Bush administration has repeatedly shown its willingness to distort science to suit political ends, from suppressing the science on global warming, to censoring websites about sex education, to appointing unqualified individuals with lead industry ties to expert advisory committees on lead poisoning of children. Let's send them a strong message today: decisions as important to the public health as the availability of emergency contraception must be based on science, not ideology. Anything less is unacceptable.