Floor Statements

Mr. Chairman, today, as the House considers the Foreign Operations Appropriations Act of 2005, I respectfully submit the following statement into the record in order to raise awareness of an issue that I have found most distressing. For over three years, I have been working on behalf of a company in my district, Pennsylvania Ship Supply Inc. (PA Ship) to resolve a financial dispute with a Ukrainian entity, the Black Sea Shipping Company (BLASCO).

PA Ship is a company that provides ancillary services to ships at ports around the world. My office has been working on behalf of this company since June of 2001, although PA Ship's problems with BLASCO began much earlier. In 1996, PA Ship provided services to the BLASCO ship m/v Sosnogorsk in the amount of $17,242.44. Shortly thereafter, BLASCO filed for bankruptcy. To this date, PA Ship has yet to receive payment for the services it provided BLASCO.

This matter is made all the more alarming by the fact that BLASCO is a state owned company. My office has made numerous attempts, through the Department of State, to resolve this issue. Unfortunately, the government of the Ukraine has been either unwilling or unable to provide much more than contact information for the Director and Deputy Head of the Ukrainian State Department of Sea and River Transport. Further inquiries from the U.S. Embassy to these agencies in the Ukrainian government have been ignored.

I find this lack of concern on behalf of the Ukrainian government unacceptable. Ukrainian officials have indicated to my office that BLASCO's bankruptcy had been a major scandal in the Ukraine when it first surfaced in the mid-1990s. It is also my understanding that PA Ship was not the only company that has yet to receive payment for services rendered prior to BLASCO filing for bankruptcy.

The government of the Ukraine has a well-established history of ignoring the concerns of its international partners. Since 1993, Ukraine has been seeking to gain accession to the World Trade Organization (WTO). Negotiations between the government of the Ukraine and the WTO working party assigned to examine its application have yielded very little progress. Concerns about Ukraine's persistent failure to take effective action against significant levels of optical media piracy and to implement intellectual property laws that provide adequate and effective protection have prompted the United States Trade Representative to place Ukraine on its ``Priority Foreign Country'' list in its 2004 special 301 report, an action which could ultimately lead to an investigation. This dubious distinction is highlighted by the fact that the Ukraine is the only country to be placed on this list for this year.

I urge the office of the United States Trade Representative to advocate for the suspension of the WTO working party's negotiations with the Ukrainian government until these and other outstanding issues have been resolved.

Mr. Speaker, since its inception 150 years ago as a pioneering land grant college located in an area now known to millions as ``Happy Valley,'' the Pennsylvania State University has come to the forefront of American collegiate academic and athletic achievement by doing things honorably and exceptionally . . . by doing things ``The Penn State Way.''

Today, Penn State still maintains their commitment to providing premier agriculture science education while expanding their national prominence in the areas of engineering, business, architecture, meteorology, social sciences, arts, and communications. Penn State's 24 campus locations boasts an unprecedented 83,000 undergraduate, graduate, law and medical students that have the opportunity to take 11,300 courses in 180 degree majors! With so many scholastic avenues worth pursuing and exploring, Penn State provides every undergraduate student with a well-balanced education through their extensive general education requirements. However, Penn State's educational leadership far exceeds the boundaries of the classroom through their distance education and statewide agricultural extension programs.

If you have ever talked to a Penn State alumnus--and with 1 in 720 Americans holding a Penn State degree, it isn't hard to find one, it will take just a moment for them to envelop you with their enthusiastic love for the Nittany Lions. As Americans we have all benefited in one way or another from either a Penn State alumnus, or Penn State research guided achievement. Imagine what our lives today without the only FDA approved heart pump, the electron microscope, the screenplay to ``Casablanca'' or a Fischer Price toy. In addition to the hundreds of my constituents graduating from Penn State every year, I have been able to personally benefit from Penn State's outstanding academic programs through the knowledge that was imparted to my current staff, Judy Borger, Amanda Murphy, and Jeff Urbanchuk, and to former staff member Sara McGraw.

If you are lucky enough to visit, it can take as little as a walk through Old Main lawn while enjoying a scoop of Peachy Paterno ice cream from the Creamery, or sitting among 108,000 of your closest friends in Beaver Stadium watching the Marching Blue Band perform their signature ``Floating Lions'' drill to perfection, to understand why Penn State has the largest alumni association in the world . . . because once you've experienced Penn State, you will never want to let go.

For years, Penn State has built a reputation of integrity, respect, and competitiveness in their nationally-renowned programs in fencing, gymnastics, women's volleyball, women's basketball, soccer, and swimming--while more importantly serving as a shining example to other universities by putting the student before the athlete.

And then there's the football. One cannot talk about Penn State's history and achievements without acknowledging the 53 years of unmatched leadership from Joe Paterno--a truly great example of what it means to be Penn State proud. Under his watchful eyes, Penn State has become a national powerhouse in men's college football, accruing 2 national championships and 5 undefeated seasons. However, when asked about his most important successes, Mr. Paterno will not quote these figures for you, nor will he mention that he is one of the most winning coaches in NCAA history, because the most important figure to Mr. Paterno is his team's graduation rate--with over 80 percent of Penn State football players graduating within 6 years, well above the national average.

Even if a student hasn't experienced the pride of playing in the nameless blue and white uniforms, or enjoyed a Saturday afternoon at Beaver Stadium cheering on the team

with their friends--every Penn State student has benefited from Mr. Paterno's generosity and philanthropy as he contributed significant funds to an addition of the library that was completed in 2000, and was instrumental in raising more than a billion dollars for the university in only 5 years.

Happy 150th Birthday, Penn State . . . may we all be united in our own personal efforts to stand for your admirable principles and in that respect we will all be able to say, WE ARE . . . PENN STATE!

Mr. Speaker, I thank the chairman for yielding to me, and I thank him for hosting this special order. I worked with the chairman and other members of the Republican conference for years to try to bring this prescription drug benefit into law. And while I did, there were two images that I kept in my mind that drove me as many long hard nights as it took to get this legislation passed.

One of them was a letter I received from an 86-year-old woman that was handwritten several years ago. I do not know if she is still alive, but she described in detail how she has to take six medications. She had no prescription drug benefit whatsoever. She had to pay for those medications out of the little meager Social Security check that she received. And she said to me in this letter that she can barely afford, but she could manage to buy her heart medicine, because that she needed or she would not stay alive. She would die. She could scrape enough money to pay for the medicine that kept the diabetes she was suffering from from killing her.

She was able to get blood pressure medicine that she needed to stay alive, and even pay for the cholesterol-lowering drugs. But she had no money left for the medication that she needed to end her pain from arthritis, and she had no money left to end the emotional pain she suffered from her depression.

So there she was, in a dilemma: Able to pay for the drugs necessary to keep her alive, but not able to pay for important drugs that would make her life worth living.

The other image that I recall vividly is that in one of my offices in the district there is a watchman, a security guard. An elderly gentleman. A wonderful fellow. And every time I walk through the doors, I would go past his desk. And particularly years ago when my daughters were younger, he would always give me two lollipops for my daughters. And he would say, How are you guys in Washington doing on that prescription drug benefit? Because my wife is very ill and she needs so much medication, and we have no benefit. And the reason I have to work at my age is just to make enough money to try to pay for her drugs. And every day I would say, we are working on it, we are working on it, we are going to get it done. And I would almost be afraid to go in a week later and say we had not succeeded.

In fact, we passed a prescription drug benefit in this House in the year 2000. We did it again; it died in the Senate. We did it again in 2002; died in the Senate. Finally, in 2003, we got the bill passed in the House, as we all know by one vote. The Senate passed it with bipartisan support and the President signed it. And finally, finally, after all of these years, after seniors waiting for nearly 40 years for a prescription benefit, we have created it.

Now, what happens? We are subject to criticism night after night. As I am working in my office, I am looking on the monitor watching C-SPAN and I see some of the Democrats on the other side railing and railing against the prescription drug benefit, which, as the chairman just pointed out, amazingly, amazingly, the most liberal Members of the Democratic party had, not too long ago, introduced a bill that did precisely the same thing; used precisely the same mechanisms.

The problem is, they have a political problem. The political problem they have is that the Democratic party has always said, oh, we are the party that loves the senior citizens. We are the party that will deliver them the benefits under Medicare. But they failed. And they failed for all of the time in which they had control of the Congress. And it kills them that it was a Republican House and a Republican Senate and a Republican President that actually got it enacted in law. It is driving them crazy.

So what do they do? They have no choice but to come and trash the very bill that parallels the bill they introduced and try to scare senior citizens into not taking advantage of it. In my district, we hold meetings to explain the new Medicare drug card so seniors understand it. But in the districts of those who come to the floor and oppose it, there is no one there to even help them. Their Congressperson and staff does not help the seniors to understand and navigate the system.

Fortunately, the Medicare program over at CMS has a wonderfully helpful Web site that seniors can go to. They just go to the Web site, and if they do not have access to a computer, they can go to a library or a senior center and get help there. They put in the drugs they take, and they look at the variety of discount cards and pick the one that is best for them.

But it is when you do something, it is when you actually accomplish something and get it done that you are subject to criticism. It is hard to criticize someone in detail about something they never accomplished. We got the job done, so we suffer the criticism. That is fine. The bottom line is that the seniors and those who are physically disabled in America now have the benefit.

The full benefit could not come overnight. You cannot go from zero to 100 miles an hour overnight. You have to set up a system. So we have this interim period with the drug cards. If you are poor, $600 of free drugs and a discount.

If you are not poor, you get the discount; and you get a discount tailored to your needs.

In January of 2006, the full benefit becomes available to every Medicare recipient, every elderly person, every disabled person in the country, a historic occasion, a historic occasion for this country. Finally, everyone in America in those categories will have access to a first-rate pharmaceutical program.

I am proud to say that in Pennsylvania my constituents in my State will have the best program in the country, because what we did in Pennsylvania is we made sure that the Pennsylvania Pace Program, which is now spending $400 million a year, dollars derived from our lottery, that $400 million a year is no longer going to be needed to pay for drugs for the poor people in Pennsylvania, because our Medicare program will do that.

So now with that extra money, we are going in Pennsylvania to be able to fill in some of the shortages in coverage, the so-called doughnut hole, and be able to pay some of the shared cost for our recipients. The people in Pennsylvania will have an exquisitely generous program, and people across the country will have a very good program beginning in January 2006.

I am proud to have worked so hard to gain the success. I am proud of the chairman, the gentleman from Florida (Mr. Bilirakis), for his work; proud of the President for supporting this bill and signing it; and I think it is high time that instead of fear-mongering for political purposes, every Member of Congress ought to get on with the business of encouraging their seniors back home to take advantage of this program. It is in their interest to do so and explain to them how it is to their benefit to do so. That is public service. Public service is helping the elderly and the disabled in their district get access to a very helpful program. It is not public service to simply malign the program for political purposes.

Mr. Speaker, I thank the gentleman from Florida (Chairman Bilirakis) for yielding.

Let me say to the chairman, he has had a long and distinguished career in the United States Congress, and I am sure that at the end of that career, the gentleman will look back with pride and say, if he is proud of anything he was able to accomplish in all of the countless 2 o'clock in the morning, 3 o'clock in the morning, 6 o'clock in the morning sessions we have spent here, I would think it would be that you were at the helm when this Congress passed prescription drug benefit for seniors. It is an historic accomplishment, and the gentleman should be proud of it. I know he is.

The other people who are proud of it, interestingly enough, are, as the chairman just said, the AARP, the American Association for Retired Persons, and all of the groups that care and are devoted to the care of patients. So if you are an organization like the AARP, there is no organization more respected by seniors than they, if you are one of the thousands of organizations that are devoted to making sure that people with illnesses get medicine, you are for the bill.

So, how could we imagine that, after 35 years of struggling, nearly 40 years of struggling without success to get a prescription drug benefit, finally the Members of this Congress, the House and the Senate in a bipartisan fashion, with the President of the United States signing the bill, we get it done, we devote half a trillion dollars to these prescription drug benefits, and who in the world would imagine that the reaction would be, from some quarters, let us criticize it. Let us attack it. Let us destroy it.

Let me let you in on a little secret: A Democratic pollster provided some strategic information to the Democratic Party about how to respond to the fact that we had accomplished this great thing as Republicans and they needed a political strategy.

What the pollster said, this is Greenberg Quinlan Rosner Research, Inc., in a Lake, Snell, Perry & Associates memo to the Democratic Party, they said, ``A message of fixing the bill reinforces the AARP message that we have made a good start and might continue to improve it. But that would give the message that the law is not all bad,'' so what she suggested was that we have to ``shift the debate in our favor as the straight negative portrayal of the law.''

So any sort of sensible approach that says, hey, after all these years, we made a great start, let us keep making it better, let us enrich the benefit over time, you do not win the political debate if you do that. So you have to say the whole darn thing is no good, it was done for the worst of reasons, and let us condemn those who tried to make it happen.

It is pretty astonishing hard to believe, hard to imagine that you would come along and spend half a trillion dollars to take care of the prescription drug benefits and needs of the seniors and the disabled, and the response is so negative.

One of the chief critics of the program is the gentleman from Ohio (Mr. Brown), the ranking member on the committee of the gentleman from Florida (Mr. Bilirakis). The gentleman from Ohio (Mr. Brown) is a friend of mine and a colleague, but he has a penchant for never being able to have a debate. He says you think this way and I think that way, and that is a philosophical debate. He always has to assume the worst of motives.

One of his criticisms is the way this benefit is delivered it through private pharmaceutical benefit managers. We set up a system so various companies can compete in the marketplace to deliver low cost drugs to seniors. What we know is that they are going to want to be able to make some profit on this, so they will go to the drug manufacturers and negotiate hard. ``You want me to cover your arthritis drug, you better give me a darn low price.''

That is the way it works in the marketplace, and they get competition going between the various drug manufacturers to see who is going to give the lowest price. That is why we developed the system that way.

Interestingly enough, every Member of Congress who chooses to receive his or her prescription drug benefit through the Federal Government receives their benefits exactly the same way, private companies. We do not have a special agency full of Federal employees that dispense drugs to Members of Congress, or to the 8 million other Federal employees. Eight million Federal employees, it is shocking that there are so many, but 8 million Federal employees who are eligible to purchase a prescription drug benefit through the government program, they buy it using the exact same model that we have provided for the senior citizens, the exact same model.

Every man and woman in the United States military who participates in the military health programs gets their drugs the same way that we set up for the Medicare program.

Now, the gentleman from Ohio (Mr. Brown) says no, that is not why you did it. You did not do it because it is efficient. You did not do it because you get the best prices. You did not do it because the private sector can instantaneously put a new drug into the plan, while the bureaucratic process would take months and months to add a new product. He says we did it because of contributions from the drug companies.

I am here to say, as one who has never received a contribution from a drug company, I did it because I believe it is the right philosophical thing to do, it is the right way to benefit the seniors of our country.

Again, Mr. Chairman, I am proud of you for your work on this, and thank you for giving me the opportunity to speak this evening.

Mr. Speaker, I yield 1 minute to the gentleman from California (Mr. Cox), the coauthor of this bill.

Mr. Speaker, I yield myself 2 minutes.

This bill is on the floor for one reason and one reason alone. That reason is that across this country there is a crisis. The crisis is that the cost of medical malpractice insurance is so expensive that trauma centers have to close, that obstetricians cannot deliver babies anymore, that neurosurgeons cannot preserve lives, that orthopedic surgeons cannot do what they are supposed to do. It is a crisis. It also so happens that if this bill is passed, it will, according to the CBO, reduce the cost of medical malpractice insurance by 25 percent which will go a long way to solving that crisis.

It also has some side benefits. By making the cost of medical malpractice insurance less expensive, it makes the cost of health care less expensive which means that more employers can offer more of their employees insurance.

In fact, according to the CBO, 3.9 million Americans who do not have health care today would get health care just because we passed this bill. We ought to do it. Another side benefit, according to the CBO, is that because these costs are built into the costs of Medicaid and Medicare, we would save $15 million in those programs over the next 10 years, which we could apply to real important health care needs.

The gentleman from Michigan (Mr. Conyers) has said we are passing this bill on the floor, it is never going to pass in the Senate. This bill went to the Senate and Majority Leader Frist made a motion to consider the bill, and the Democrats objected to the consideration of the bill, to even having the debate. And then when it came time to vote on whether to have that debate, the Democrats voted no, we do not want to even debate this bill. So one can debate the fine points. One can say I have a better way to solve this problem or another Senator can say I do not like the cap here or I do not like this aspect of it. The most deliberative body on the face of the Earth is supposed to come to the floor of the Senate with their ideas, with their amendments, and engage in a debate. Instead, all that they have done is obstruct.

Announcement by the Speaker Pro Tempore

I yield to the gentleman from Arizona.

Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, I would like to read from two letters. The first is from Engel, Smith & Associates, an obstetrics and gynecology practice, a letter written to their patients.

``It is with great sadness that we are writing to inform you of the plan to close in its present configuration the Engle, Smith & Associates obstetrics and gynecology practice. We have diligently tried over the past several months to find an alternative solution as we struggle with this decision. Unfortunately, the practice environment for physicians in our specialty has become so difficult that we have no choice but to dramatically change the way in which we provide care.

``We, like many of our colleagues in high-risk specialties such as obstetrics, have a crisis situation because our malpractice insurance premiums have more than doubled in the past 2 years. These increases are being driven primarily by skyrocketing jury awards in Pennsylvania, which have been forcing both insurance companies and physicians out of business.''

Here is the impact on patients, a letter to me.

``I am a Pennsylvania native. I was born and raised in the Philadelphia area, an area that used to be known for excellent medical care. Eight months ago, I again found a wonderful OB-GYN office. The doctors are wonderful, respectful and well-educated and overall just great. They delivered my beautiful baby girl for me, and I could not have been happier with their care. I referred my sister, who is currently pregnant and due in a few short weeks. She too, is satisfied with them.

``Two weeks ago we were outraged to discover that they were closing the doors at the end of May 2002. My sister, who has been going to their office for all her prenatal care visits, cannot even have her after-delivery exam by the doctor who delivers her first child. I will not be able to return to them for subsequent health care or even normal GYN care.

``This is an outrage. It is also the second physician's office I have been to in the last couple of years that has been forced to close due to medical liability costs. Another office that I was aware of closed as well for the same reason. I cannot even switch to see them, because they no longer exist within our State. I do not know who I can go to even now. No other OB-GYN physicians practice in my area anymore.''

Mr. Speaker, this is the face of the medical malpractice crisis. This is the bill that will resolve that crisis. We believe that this legislation will solve the crisis in the near term for malpractice insurers, for doctors and for patients, and, in the long run, for 3.9 million Americans, give them health care that they do not have today.

Mr. Speaker, I demand a recorded vote.

Mr. Speaker, on the occasion of the 25th anniversary of the enactment of the Taiwan Relations Act (April 10), I wish to congratulate the people of Taiwan. For the last quarter century, the Taiwan Relations Act has been the cornerstone of the U.S. relationship with Taiwan. It has enabled Taiwan to move from an authoritarian state to a full democracy and has provided the people of Taiwan with the tools necessary to achieve the highest standards of living.

Taiwan has now completed its third ever direct presidential election. Even though incumbent President Chen Shui-bian won a razor thin victory over his opponent, Taiwan's latest presidential election has demonstrated to the world that the people of Taiwan have exercised their democratic right through a remarkable 80 percent voter turnout.

Let us hope that in the days and months ahead Taiwan President Chen will use the power of his office to lead Taiwan's 23 million people, and that peace and stability will continue to prevail in the Taiwan Strait for the next 25 years and beyond.

In the meantime I wish to salute Taiwan Ambassador C.J. Chen, who will be returning to Taipei next month. He has served Taiwan well as his country's top diplomat in Washington during the last 4 years. He and his wife Yolanda will be missed by their friends in Washington.

Mr. Speaker, I move to suspend the rules and pass the Senate bill (S. 1881) to amend the Federal Food, Drug, and Cosmetic Act to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernization Act of 2002, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on S. 1881.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise today in support of S. 1881, the Medical Devices Technical Corrections Act. S. 1881 is the companion to H.R. 3493, a bill I introduced with the gentlewoman from California (Ms. Eshoo), which makes technical and clarifying amendments to the Medical Device User Fee and Modernization Act of 2002. That bill was signed into law by President Bush on October 26, 2002, and made sweeping changes to the laws that govern device approvals to establish new programs and streamline processes to accelerate the availability of medical devices to patients.

H.R. 3493 passed the House on January 27 by a vote of 333 to zero and S. 1881 had passed by unanimous consent in the Senate on November 25, 2003. S. 1881 amends the Medical Device User Fee and Modernization Act to ensure that it is being implemented properly.

These two bills differ slightly, and the amended bill we are considering today is the conferenced version of this legislation. Staff have resolved the fairly minor differences between the Senate and House versions of the legislation, and this legislation should ultimately become law.

Some of the changes are truly technical, while others clarify the intentions of Congress in the Medical Device User Fee Act. For example, this legislation ensures that the user fee reductions that apply to small businesses apply for 2004 and years in the future. In addition, S. 1881, as amended, clarifies that as part of the third-party inspection program, companies must submit reports of inspectional findings consistent with current FDA practices. And S. 1881 clarifies which data need to be submitted for a firm to be eligible for third- party consideration.

Medical devices are some of our health care system's most remarkable innovations. The provisions in this technical and clarifying amendments bill will allow the FDA to continue to reduce review times, increase the efficiency of its operations, and allow these wonderful technologies to be delivered to patients more quickly.

I want to thank the gentleman from Texas (Chairman Barton), the gentleman from Florida (Mr. Bilirakis), and the ranking members, the gentleman from Michigan (Mr. Dingell) and the gentleman from Ohio (Mr. Brown), as well as the gentleman from California (Mr. Waxman) and each of their staff for this legislation. This has been another outstanding example of teamwork and bipartisanship on the Committee on Energy and Commerce. I urge Members to support this legislation.

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

Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.

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

Mr. Speaker, I would like to take this opportunity to commend the Lower Bucks County Disabled American Veterans Chapter #117- PA, an organization that will be celebrating its 50th anniversary on February 15, 2004.

Lower Bucks County DAV Chapter #117 shares a proud history with one of the Nation's oldest and most important housing developments. In 1951, developer William Levitt first unveiled the three styles of homes that would eventually populate what would later be known as Levittown, a planned housing development constructed to meet the needs of the employees of the Rohm and Haas Chemical plant in Bristol, 3M in Bristol Township, and the new steel-making facility for U.S. Steel-Fairless Works in Falls Township. Many veterans of World War II and the Korean War purchased homes in this community under the GI Bill's mortgage package. As a result, numerous Veterans of Foreign Wars and American Legion posts were established in the area to meet the needs of the local veteran population.

Although differing in their individual mission statements, all these groups had one common denominator: war-inflicted injuries. As a means of combating some of the myths associated with conflict-related disabilities, a small group of World War II and Korean War veterans petitioned the National Disabled Americans for a charter. On October 21, 1953, Lower Bucks County DAV Chapter #117-PA was established; and over the years, its members have shown that those injured in battle can become indispensable members of society through their activities within the community.

Throughout the past 50 years, Lower Bucks County DAV Chapter #117's leadership and its members have never failed to remember their primary objective: to come to the aid of veterans and to be an active service organization within the community it serves. I commend DAV Chapter #117 for its continued leadership, and I wish it all the best as it enters its next 50 years of service.

Mr. Speaker, the global community, particularly the poorest countries of the world, face significant problems in the area of reproductive health and family planning. A critical shortage of international funding for family planning exacerbates severe threats to maternal and child health. To examine current population developments, the European Population Forum 2004 was held January 12-14, under the auspices of the United Nations Economic Commission for Europe and the United Nations Population Fund. I encourage members of this body to take note of the following statement written by Werner Fornos, president of the Population Institute and recipient of the 2003 United Nations Population Award. The following article, which appeared in the International Herald Tribune on January 14, 2004, sheds light on the dangerous and false belief that population growth is no longer the global concern it was a decade ago.

[From the International Herald Tribune, Jan. 14, 2004]

A Global Concern

A Population Crisis Still Looms

(By Werner Fornos)

As the European Population Forum in Geneva draws to a

close, coming to grips with high fertility rates remains a

daunting international challenge, particularly in the poorest

countries of the world where population growth continues to

outstrip resources, place pressure on the environment, and

exacerbate social disintegration. Despite encouraging recent

reports from the United Nations, human growth remains an

issue that requires priority attention around the globe if

there is to be realistic hope for achieving sustainable

development.

Only 3 years ago, the United Nations estimated that by mid-

century the planet's human population would have risen from

about 6.2 billion to 9.3 billion. More recent figures project

the 2050 population to be 400 million less than the previous

estimate. When the numbers are examined more closely,

however, we find that the population of the industrialized

countries is estimated to remain constant through 2050 at

about 1.2 billion. Virtually all human growth will occur in

the developing world, where the population is expected to

increase from the current 5.1 billion people to 7.7 billion.

Considering that developing countries bear the brunt of the

earth's grinding poverty, desperate hunger, disease,

illiteracy and unemployment, the recent downward revision of

demographic figures does not warrant celebration. In fact,

some developing countries, including Burkina Faso, Mali,

Niger, Somalia, and Yemen, are likely to quadruple their

population by mid-century.

Over the past 40 to 45 years, the world's population has

doubled. But annual population growth has been decreasing

since the 1990's, from a high approaching 90 million to less

than 80 million. These declines have spawned a pervasive myth

that population growth is no longer a matter of global

magnitude--a myth that is spread, unsurprisingly, by the same

crowd that 10, 15, and 20 years earlier insisted that

population growth was never a problem in the first place:

religious extremists and reactionary political ideologues.

The irony of the myth is that this year marks the 10th

anniversary of the International Conference on Population and

Development. That meeting, in Cairo, established important

quantitative goals for the next 20 years, including efforts

to ensure that every pregnancy is intended; to protect women

from unsafe abortion; to promote education for all and to

close the gender gap in education; to combat AIDS; and to

bring women into the mainstream of development.

A key concern, however, is that expenditures for

implementing family planning and reproductive health programs

have fallen well short of the $17 billion that the Cairo

meeting estimated would be required by 2000.

Industrialized countries were expected to come up with one-

third of that total, or $5.7 billion, but by 2001 had

contributed only $2.5 billion. Developing countries and

private sources, expected to spend $11.3 billion on

population activities by 2000 had contributed only $7 billion

by 2001.

Global goals for drastically reducing poverty, maternal and

child mortality, illiteracy and hunger will be mere wishful

thinking unless and until population growth is substantially

lowered. For this to happen, the international community must

clearly understand that to achieve an improved quality of

life for all, now is the time to accelerate population

stabilization efforts, rather than retreat from them.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 3493) to amend the Federal Food, Drug and Cosmetic Act to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernization Act of 2002, and for other purposes, as amended.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and insert extraneous material on H.R. 3493.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, H.R. 3493 is a bill that I introduced with the gentlewoman from California (Ms. Eshoo), which seeks to make technical and clarifying amendments to the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). That bill, which was signed into law by President Bush on October 26, 2002, made sweeping changes to the laws that govern medical device approvals to establish new programs and streamline processes to accelerate the availability of medical devices to patients. For example, MDUFMA established a user fee program that will provide substantial new resources to speed up the approval of the medical devices. It streamlined the approval of combination products such as drug-coated stents which are one of the most exciting new areas of technology. It expanded the role of third parties and outside experts to augment the FDA resources to help FDA meet its beneficial manufacturing inspection requirements; and MDUFMA also extended the use of third-party review programs for 1 year so that it expires in conjunction with other device provisions.

The legislation before us today amends the Medical Device User Fee Modernization Act to ensure that it is being implemented properly. While some of the amendments are truly technical, others clarify the intentions of Congress. For example, this legislation ensures that the user fee reductions that apply to small businesses apply for 2004 and years in the future. In addition, the legislation clarifies that as part of the third-party inspection program, companies must submit reports of inspectional findings consistent with current FDA practices.

H.R. 3493 clarifies which data need to be submitted for a firm to be eligible for third-party inspection.

Medical devices are some of our health care system's most remarkable innovations. The provisions in this technical and clarifying amendments bill will allow the FDA to continue to reduce review times, increase the efficiency of its operations and allow these wonderful technologies to be delivered to patients more quickly.

I want to thank the gentleman from Louisiana (Mr. Tauzin), the gentleman from Florida (Mr. Bilirakis), the gentleman from Michigan (Mr. Dingell) and the gentleman from Ohio (Mr. Brown) as well as the gentleman from California (Mr. Waxman) and each of their staffs for this legislation. This has been another outstanding example of teamwork and bipartisanship on the part of the Committee on Energy and Commerce.

Mr. Speaker, I urge a ``yes'' vote on this bill.

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

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

Mr. Speaker, I yield myself the balance of my time.

I also would like to thank my very able staff member, Mr. Alan Eisenberg, for his tireless work on this and so many other issues.

Ms. JACKSON-LEE of Texas, Mr. Speaker, I rise today as a supporter of H.R. 3493 which amends Federal Food, Drug, and Cosmetic Act. This legislation is necessary to clarify certain provisions relating to the Medical Device User Fee and Modernization Act of 2002. I am pleased to see that this bill enjoys broad bipartisan support in this body after it was passed by unanimous consent in the Senate. It is imperative that we continually update and rework the regulations that govern the use of our Nation's medical devices.

I would also like to recognize my distinguished colleague Representative Sherrod Brown and affirm his view on the necessity of providing additional appropriations funding for the Medical Device User Program. In the last series of appropriations this vital program was under funded and was left with a potentially dangerous mandate. While H.R. 3493 is a timely bill, we must make sure to provide the necessary resources for all medical device programs in order to make this legislation truly effective.

Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.

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

Mr. Speaker, I ask unanimous consent that it may be in order at any time on Wednesday, February 4, 2004, for the Speaker to declare a recess, subject to the call of the Chair, for the purpose of receiving in joint meeting His Excellency Jose Maria Aznar, President of the Government of Spain.

Mr. Speaker, I thank the gentlewoman for yielding me this time.

About 5 hours ago, I had what I consider to be one of the greatest moments of my 11-year congressional career as I got to watch the President of the United States sign into law a Medicare reform bill that will finally provide a prescription drug benefit to our seniors and our disabled.

For 38 years, every Congress, Republican, Democrat, every administration, Republican, Democrat, had failed to accomplish this. It was not because most Members of Congress did not want to do it. I dare say every single Democrat sitting in this House and serving in this House wanted to make sure that we got a prescription drug benefit delivered to our elderly and our disabled, and most Republicans wanted to do it for many years. And why did Congress fail year after year? Not because of lack of desire to get the job done, but because the job is extraordinarily difficult.

It is extraordinarily difficult to craft a bill that is conservative enough to get most Republicans and liberal enough to attract some Democrats. It is very, very hard to do. We had to thread a needle, we had to say to the liberal-most Members of Congress, we cannot make you happy, we cannot spend that much money. And we had to say to the most conservative Members of our party, we cannot make you happy. We had to say we are going to do this entitlement, we are going to expand this entitlement, and it is not going to make you happy. We had to thread the needle, and the eye of the needle in this case was so narrow and the size of what we were trying to accomplish so large that yes, it took us an extraordinary amount of time to get this vote done.

The Speaker did not violate a rule of the House. The Speaker is entitled to take as much time as he wishes for a vote. And in this case, in this case, the stakes were high, the cause was great. The gentlewoman from California (Ms. Pelosi) said she will take this message to the election. This is an election-year issue. I say to the gentlewoman, take that message; we will take the message that we provided seniors a benefit.

I thank the gentleman for yielding me this time.

Mr. Speaker, I rise in strong support of S. 650, the Pediatric Research Equity Act. This legislation was passed by the Senate by unanimous consent on July 23. Earlier this year, along with the gentlewoman from California (Ms. Eshoo) and the gentlewoman from Ohio (Ms. Pryce), I introduced this legislation in the House. Both of these Members have been leaders on trying to get this legislation enacted into law.

Children, their physicians, and their parents need to know that the drugs they use are safe and effective. Just over a year ago, a Federal court struck down the 1998 Pediatric Rule on the grounds that Congress had not explicitly given the authority to require that these much- needed pediatric studies be done. The Pediatric Research Equity Act creates a critical safety net for children by restoring this authority. Before it was struck down, the Pediatric Rule led to invaluable pediatric safety and dosing information. The rule places children on equal therapeutic footing with adults by ensuring that medicines coming into the marketplace will be labeled for pediatric use and be available in formulations such as liquids or chewable tablets that children can take.

This legislation will also ensure that there will be no delay in the approval of drugs for adult use by allowing pediatric testing to be deferred until after approval if these studies would delay the availability of the product for adults.

Mr. Speaker, this legislation complements the Best Pharmaceuticals for Children Act which Congress passed 2 years ago. That law recognizes the importance of pediatric drug testing by offering an incentive to companies who conduct tests of drugs on children. However, certain medicines are not captured by the Best Pharmaceuticals for Children Act and, therefore, will be left unstudied for pediatric use without the rule. Both the BPCA and the rule are needed as a strong, two-prong approach to ensure that drugs are appropriately studied and labeled for infants, children and adolescents.

Mr. Speaker, this legislation was discharged from the Committee on Energy and Commerce. Many of us on both sides of the aisle had hoped that the committee would consider this through normal order as there were issues that both sides wanted to make about the legislation. But due to the Medicare and the energy conferences and the limitations those bills have created in the committees, it was necessary for this legislation to be discharged. While this was not the perfect process, I urge my colleagues to join our colleagues in the Senate and the 25 children's health groups, including the American Academy of Pediatrics and the Elizabeth Glaser Pediatric AIDS Foundation, who support this legislation. In their own words, quote, we cannot overstate the extraordinary contribution this legislation will make to children's health.

I would also like to thank my staff member Alan Eisenberg who has worked very hard for a long period on this issue. I urge passage of the legislation.

Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 421) to reauthorize the United States Institute for Environmental Conflict Resolution, and for other purposes.

Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days within which to revise and extend their remarks and include extraneous material on H.R. 421.

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I am pleased that we are here today to consider H.R. 421, the Environmental Policy and Conflict Resolution Advancement Act of 2003. H.R. 421 amends the Morris K. Udall Scholarship and Excellence in National Environmental and Native American Policy Act of 1992 to reauthorize the Environmental Dispute Resolution Fund.

Specifically, the bill authorizes the fund at $4 million and extends it through fiscal year 2008. The bill also stipulates how the funding is to be distributed: $3 million to pay for the operating costs of the Institute for Environmental Conflict Resolution, and $1 million for grants to encourage participation of non-Federal entities in Federal environmental disputes.

In 1998 the Institute for Environmental Conflict Resolution was established as part of the National Environmental Foundation. The Foundation administers the Environmental Dispute Resolution Fund. The institute was created to assist in the resolution of Federal environmental, natural resources, and public lands conflicts and controversies through facilitated negotiation, mediation, and collaborative problem-solving. The Environmental Dispute Resolution Fund is maintained separately from the Udall Trust Fund and provides the financial support for the operation of the institute.

I want to thank my distinguished colleague, the gentleman from Arizona (Mr. Kolbe), for introducing this legislation and for ensuring that it was brought before us today. I want also to urge my colleagues to join me in support of H.R. 421, the Environmental Policy and Conflict Resolution Advancement Act of 2003.

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

Mr. Speaker, I yield 3 minutes to the gentleman from Arizona (Mr. Kolbe), the author of the legislation.

Mr. Speaker, I have no further requests for time, and I yield back the balance of my time.

Mr. Speaker, I yield 1\1/2\ minutes to the distinguished gentleman from Colorado (Mr. McInnis), a member of the Committee on Ways and Means.

Mr. Speaker, I yield myself 4 minutes.

Mr. Speaker, first off, let me suggest to the gentleman, my friend the gentleman from Wisconsin (Mr. Kind), that we take his motion seriously. Having said that, we all know that motions to instruct conferees are only that. They have no ultimate effect.

The fact of the matter is the negotiations have been ongoing in the conference committee, and whether this motion passes or does not pass, the conferees on the part of the House and the part of the Senate, the Republicans and the Democrats, are and have been and will be continuing to negotiate all of these issues, and they will all be negotiated in the context of all of the other issues that they are negotiating.

But having said that, I also want to, at least in this point in the argument, assume that the gentleman's arguments are sincere, and I would like to address them.

First off, with regard to the argument that we need a fallback, a government-run fallback, for the prescription drug program, the gentleman's point is well taken. We do, and we should have, and we should guarantee that, in every region of the United States of America, every senior will have access to a good and affordable prescription drug plan.

We believe that the bill as adopted by the House already does that, that the incentives that we give the Secretary to offer to the plans, in fact, does guarantee that there will be at least two programs, two plans, in every district, in every region, and, in fact, the CBO expects within the first year it will be available, the plan will be available, to 95 percent of seniors; in the second year, 99 percent.

On the second issue, the gentleman from Wisconsin argues that we need to pay hospitals a fair amount, and, indeed, we should. We relied upon the Medicare Payment Advisory Commission, MedPAC, who said what would be fair based on all of the data available is to include a 3 percent market basket update as opposed to a 3.4 percent, as the gentleman from Wisconsin argues.

Having said that, what the gentleman does not take into consideration is that is not the only increase in payments to hospitals available under our legislation. Looking at Iowa, for instance, a very rural State, they get a 1.6 percent increase under the standard amount, an additional 0.8 percent for the labor share, and 0.1 percent for medical DSH increases, which gives the hospitals in Iowa actually a 5.5 percent increase as opposed to a 3 percent increase. In Oklahoma, that number comes to 5.7 percent; the same in Montana, 5.7 percent; South Dakota, a very rural State, as rural as you can get, 5.4 percent.

So we think that the gentleman's objective in making sure that hospitals get healthy increases and reimbursements is, in fact, met by the legislation that this House passed and is continuing to be negotiated in the conference committee.

On the third major point of the gentleman's motion, he suggests that each and every rural provider increase in either the Senate bill or the House bill will be incorporated into the conference committee. The gentleman's objective is to make sure that the benefits are available in the rural areas. We all share that objective. But I would note that the House-passed bill itself included nearly $25 billion increases in payments to rural providers, which will help rural hospitals and physicians, among others, continue to provide care to rural Americans.

So on the substance, I believe that the bill, as adopted by the House, meets the gentleman's objectives already. Secondly, again, a motion to instruct, while fun to debate, actually will have no impact on the negotiations themselves. I think we ought to let those negotiations continue and allow the conferees to come to an agreement, and I believe that they will, that this House can adopt and send to the President.

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

Mr. Speaker, I yield myself 30 seconds to say that I am sure my friend from Ohio did not mean to misspeak with regard to my previous comments. What I said is that both the gentleman from Wisconsin (Mr. Kind) and Members of this side of the aisle want to make sure that there is a guarantee that our seniors in all regions have access to a plan. We think we do that adequately by the requirement that the Secretary provide incentives. The gentleman from Wisconsin (Mr. Kind) offers another way to do it, but we have the same goal.

Mr. Speaker, I yield 3 minutes to the gentleman from Texas (Mr. Burgess).

Mr. Speaker, I yield 4 minutes to the gentleman from New Jersey (Mr. Ferguson).

Mr. Speaker, I yield myself such time as I may consume.

I would compliment the speaker on his argument and suggest, though, that his constituents must be able to make choices, and thoughtful choices, because they chose him. And I suspect that if they are sophisticated enough to choose the previous speaker, they can probably choose themselves a good Medicare plan as well.

Mr. Speaker, I yield 5 minutes to the gentleman from Oregon (Mr. Walden).

Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I want to thank the gentleman from Wisconsin (Mr. Kind) for offering the motion to instruct and for the temperate way in which he conducted his debate on the substance, as is his style. And the debate went pretty well like that until the previous speaker kind of laid down some political gauntlets. And I cannot resist the opportunity to respond.

The gentleman from Texas (Mr. Sandlin) asked the question repeatedly, who will stand up for seniors, and who will not stand up for seniors. The historical record shows that Medicare was created in 1965, and in the 30 years that followed, the United States Congress failed consistently to get anywhere on the provision of a prescription drug benefit for Medicare beneficiaries.

As the previous speaker and earlier speaker said, there was an attempt 15 years ago when the Democrats controlled the House under Chairman Rostenkowski. It was immediately repealed. It was a dismal, dismal failure, a great disappointment to the seniors who had hoped for something that would be useful for them.

This Congress, where we happen to have a Republican majority in the House and a Republican majority in the Senate and a Republican in the White House, we have for the first time in the history of the United States brought ourselves to the point where we are poised to provide the senior citizens of this country a prescription drug benefit, and they need it.

We have all received letters over and over again from seniors who are forlorn and despairing over the fact that they are suffering from a variety of illnesses. They go to the doctor, they get a prescription, and they cannot fill that prescription. I remember a poignant letter from one of my constituents, an elderly woman from Bensalem, who said, I have eight prescriptions. I can afford to buy the ones that will keep me alive. I just cannot afford to buy the ones that will make my life worth living, and that letter has remained in my mind ever since, and it had driven me to work as hard as I can with colleagues interested in accomplishing this goal on both sides of the aisle to get a prescription drug benefit done.

It is hard. The reason it had not been done for 30 years is because it is so difficult, because it is so complex, to figure out how to do this in a way that is affordable, that maximizes a benefit for the very poor, that provides something worth happening for the middle class, asks a reasonable contribution from them, still does not create a disincentive for employers to continue to provide a prescription benefit for their retirees.

To deal with all of the rural issues, all of the provider issues is extraordinarily complicated and very difficult to do. If this body were 100 percent Republicans, it would be hard to do. If it were 100 percent Democrats, it would be hard to do because it is tough policy.

I think we are on the verge of being there. Our negotiators in the conference are working with the staff day and night to get us there. I believe that they will succeed. I again respect the gentleman from Wisconsin because he is bipartisan by nature. We ought to keep this debate bipartisan, consistently. That is the only way we will succeed in doing this. There are not enough Democrats to pass a Democratic plan. There are not enough Republicans to give the seniors this benefit with Republican votes only. We need to have a bipartisan bill. We will have a bipartisan bill.

On the subject of medical malpractice, the Democrats sat down year after year while the physicians of this country are going out of the profession, and we passed a bill in this House. It was a good passed bill. We did it in a bipartisan fashion, and if the Senate would come up with anything at all, we could go to conference on that bill, and it would also bring down the costs of medicine in health care in the United States.

Mr. Speaker, I yield back the balance of my time.

Mr. Speaker, I thank the gentlewoman for yielding me this time. I had not come to the floor expecting to speak; but when I heard the gentleman from Ohio speak, I really felt compelled to.

I think it is sad and it is distasteful when we hear this kind of rhetoric that questions the motives of Members of the House, that makes such ridiculous statements as Republicans want to end Medicare. What a stupid thing to say. Republicans on this side of the aisle have worked so hard for so many years to improve Medicare; and the record is replete with the work that the gentlewoman from Connecticut (Mrs. Johnson) has done, that I have done, that many Members on this side of the aisle have done with Members on the other side of the aisle.

It is an insult to the intelligence of this body and it is an insult to the intelligence of the senior citizens of this country for any Member of Congress to stand before this body and make a statement that would suggest that any one of us, who work so hard on these issues, would want to do anything except make the program as good as possible for our parents and for our constituents. It is just absurd.

Now, the fact of the matter is that we do have political and philosophical differences about whether or not what we think the role of the private sector should be in the delivery of the Medicare system. Seniors got choice, the opportunity to have prescription drugs under Medicare for the first time when we had Medicare+Choice, and it was allowing the private sector to go in and offer plans that were more efficient than the Medicare fee-for-service program. And with that efficiency, they provided the prescription drug benefit for the first time. Now, this Congress failed to fund those plans, and so they went away.

Now, nearly everyone in this country who has a prescription drug benefit receives that benefit from some kind of private sector pharmaceutical benefit manager. That is the way we all get our drugs. And that is the reason that the newest drugs get quickly available to us because the private sector can compete against itself, negotiate price, and get the best newest medicines available to all Americans. And all we are suggesting is that that is the most efficient, the most cost-efficient and the most compassionate way to bring prescription drugs to the seniors.

Now, if the other side of the aisle disagrees with that, fine, it is a good argument to have. But it really is stupid to stand here and pretend that there are some people in this House who actually care about the program and there are others who do not. We need to elevate this argument way above that.