2:26 PM EDT

Tom Coburn M.D., R-OK 2nd

Mr. COBURN. Mr. Chairman, I ask unanimous consent to control one-half of the time, 1 hour, and allow the opposition to control one-half.

2:26 PM EDT

Tom Coburn M.D., R-OK 2nd

Mr. COBURN. Mr. Chairman, I yield myself such time as I may consume.

Mr. Chairman, we are going to hear a lot of debate this afternoon and statements about the intended purpose of this amendment. I want to say from the outset that this amendment is not intended to have an effect on any drug used for any purpose other than that which is specifically spelled out in this amendment.

The taxpayers of the United States spend a great deal of money each year in funding the Food and Drug Administration. There is something terribly wrong when we ask the taxpayers of this country to spend money in a way which is designed to give the Food and Drug Administration the ability to research and approve drugs that are designed to kill unborn children.

Now let me say that again. The purpose of this amendment is to limit the FDA's ability to approve any drug which has its sole purpose to eliminate and terminate an unborn child.

This should not be in a debate about abortion, and I do not intend it to be. It is about how we use taxpayers' money and for what purpose should that money be used.

Abortion is legal in this country. I recognize that. But allowing a Federal agency to spend taxpayers' dollars to perfect and approve a method under which we take life to me seems totally irreconcilable with the fact that our whole country is supposed to be about the pursuit of happiness, the pursuit of freedom and the pursuit of life.

So this amendment will not block Cytotech from being used in other medicines and in other ways, it will not block RU-486 if it has an intended purpose for giving life, saving life, prolonging life. It will not stop any utilization of FDA funds in terms of that effort. Its sole purpose is to say to the FDA none of their money should be used in a manner which will enhance the taking of unborn life.

It is a very simple proposition. Whether one believes in abortion or do not, both sides of this issue believe that we have way too many abortions. None of us think that abortion is a great thing. There are not many people who have been through an abortion who think an abortion is a great thing.

So I want to move our debate not to the issue of abortion, but whether or not we can in good conscience utilize taxpayer dollars to perfect drugs to kill unborn children. That is what the debate is about. It is not about whether or not somebody can have an abortion; we all know that that is possible.

[Time: 14:30]

Regrettably so, from my viewpoint. But, rather, the debate is about protecting unborn life from unwise use of Federal taxpayer dollars.

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

2:33 PM EDT

Tom Coburn M.D., R-OK 2nd

Mr. COBURN. Mr. Chairman, perhaps the gentlewoman did not hear my first statement. There is nothing in this amendment that will limit the research of any drug in any way, in any concept, whose purpose is something other than that. So if you were to take Cytotech or RU-486 and say you want to try to use it in a different way, this does not limit that at all. When you file an application with the FDA, you give what your intended purpose is.

What this amendment says is if you bring to the FDA a drug whose only intended purpose is to induce the separation of a blastocyst from the uterine wall, that is the technical term for what it does, that they should not spend money approving that.

If you bring the same drug to the FDA and say this is something that solves a problem with the liver, or this decreases portal hypertension, even though it might have that effect of causing an inducement of abortion, it is still approved.

Let me give you some examples. There is a new hair treatment to grow hair back on the head of the gentleman from California (Mr. WAXMAN), yet it cannot be used around anyone wanting to get pregnant. Why? Because it causes severe birth defects and can in fact induce abortions. That was approved. This would not eliminate that drug from ever coming to market or the FDA spending money on it.

2:34 PM EDT

Marcy Kaptur, D-OH 9th

Ms. KAPTUR. Mr. Chairman, reclaiming my time, I guess my point is to the gentleman that scientific inquiry and the work of the FDA by its very nature probes into the unknown, and even though the gentleman says that a given drug has to state a purpose, I am saying that we do not always know, once science begins to move, all of the various applications that science might ultimately have for that substance.

So I think that one of the reasons for my opposition to the amendment is I do not think we ought to prejudge science. We ought to let the Food and Drug Administration move forward, the scientists ought to move forward. Let them do what they do best.

I would guess that most drugs have more than one application, and the chemicals that go into them. Even today, many drugs are given, prescription drugs in fact, that may have side effects or other results that even the FDA scientists have not anticipated as they begin.

The second reason I oppose the gentleman's amendment is because I really do believe that this should be within the Food and Drug Administration. I do not think that we should be making this decision on the floor. We should leave it up to the people over at FDA to decide the procedures for drug approval and so forth, and Federal law currently provides that no Federal money can be spent for abortion. That has been on the books for many, many, many years. So I think that we should let the FDA do

its job.

Finally, I would say to the gentleman, with all due respect, this subcommittee of the Committee on Agriculture had absolutely no testimony on this issue. The gentleman is bringing a very important issue to the floor. I personally, as just one member of that subcommittee, would have appreciated to have the FDA testify before us, many scientists, to talk about the chemistry of what the gentleman is concerned about, to try to perfect the language of what the gentleman is trying to offer here.

We really have heard from no one in the public on this particular subcommittee. So I find it somewhat uncomfortable to try to accept the gentleman's amendment, when our subcommittee really had absolutely nothing, we did not spend one minute on this within the committee itself.

So for those three reasons, and I want to yield time to other Members to comment, on the basis of science, on the basis of the safety by having the FDA involved, and also committee procedure, I would respectfully oppose the gentleman's amendment.

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

2:38 PM EDT

Joe Pitts, R-PA 16th

Mr. PITTS. Mr. Chairman, I rise today in support of the Coburn amendment's efforts to protect the lives and health of our Nation's women and unborn children.

This amendment would bar FDA's approval and development of new drugs whose primary purpose is to induce abortion. Those are called abortifacients.

Some people believe it is in the best interests of women to make all forms of abortion available to women. However, even for those who support abortion on demand, approving RU-486 is shortsighted and it is a risky approach. Scientific studies have shown a link between abortion and breast cancer. Unfortunately, many who commit abortions do not want to let women know about that risk.

Breast cancer is the leading form of cancer among middle-age American women, but we do not even want to tell women who are considering abortion of this risk.

Ten out of 11 studies on American women report an increased risk of breast cancer after having an induced abortion.

A meta-analysis in which all worldwide data were combined reported that an induced abortion elevates a woman's risk of developing breast cancer by 30 percent. How can we in good conscience approve new forms of abortion before we study the breast cancer and abortion link further and let women know of the risk?

This is the kind of investigation that should be done. This kind of information should be held in hearings before the committee. So I urge the Members to support the Coburn amendment to protect women, both born and unborn.

2:46 PM EDT

Sue Myrick, R-NC 9th

Mrs. MYRICK. Mr. Chairman, I think most of us agree that we would like to be seeking alternatives to abortion, rather than making abortion more accessible.

But the one issue that I wanted to speak on today is what has been shown scientifically as an increased risk of breast cancer. Supposedly there is a link between breast cancer and abortion. This should be examined much more thoroughly before any new forms are approved.

Ten out of 11 studies on American women report an increased risk of breast cancer after having an induced abortion, particularly among women with a history of breast cancer in their families. We know this is already a major problem which we are trying to effectively deal with because currently cancer is the leading form, or breast cancer is the leading form of cancer among middle-aged American women.

In the few countries in which RU-486 is available, it is strictly regulated by the government's health care systems. However, in the U.S., control of abortion drugs is more lax, and sometimes they are often dispensed without a doctor's approval, which again potentially endangers women's health.

But because of the potentially dangerous side effects of abortion, and this is not just physical, this is emotional, as well, these drugs should not be administered without consultation and medical follow-up with a doctor. So I hope we give this serious thought.

2:47 PM EDT

Nita Lowey, D-NY 18th

Mrs. LOWEY. Mr. Chairman, I thank our ranking member for yielding time to me.

Before I address the overall issue, I would like to respond to my colleague, the gentlewoman from North Carolina (Mrs. MYRICK) by reading another quote.

``The Danish researchers concluded that induced abortion has no effect on the risk of breast cancer.'' When reporting on a particular study, the New York Times stated: ``This longstanding issue shall now be settled. No evidence exists to link induced abortion and breast cancer.''

Mr. Chairman, I rise in strong opposition to the Coburn amendment. The amendment would stop the drug approval process in its tracks by placing unprecedented roadblocks in front of the FDA. It puts ideology ahead of science and compromises women's health.

The Coburn amendment would block the final approval of a drug, RU-486, that the FDA has already declared to be safe and effective. I repeat, this amendment would block final approval of a drug that the FDA has already declared safe and effective.

This amendment would make FDA drug approval contingent not on science but on politics. The FDA is charged with protecting the public's health, and should not be subject to congressional interference. Should we subject each FDA decision to a congressional vote? Mr. Chairman, let us allow the FDA to do its job free from right-wing intimidation. The American people do not want the Christian Coalition in charge of our Nation's drug approval process.

This amendment may also prohibit the development of new, more effective contraceptive methods, if Members believe, as some do, that any form of hormonal contraception, like in this bill, is tantamount to an abortion.

What about other drugs that as a side effect may induce abortion, like many chemotherapy drugs and anti-ulcer medication? Will research be halted on these lifesaving drugs as well? This amendment is too vague even to give us a clear answer to that question.

So, Mr. Chairman, this amendment is about much more than RU-486. It is about whether the FDA will be free to test, develop, and approve needed drugs without congressional interference. It is about whether politics or science will govern our Nation's drug approval process.

Since Roe v. Wade, the anti-choice minority has attempted to stymie contraceptive research and suppress advances in reproductive health. For example, there used to be 13 pharmaceutical companies engaged in contraceptive research. There are now four. Thankfully, despite pressure tactics, scientists have made some important progress. Among the most significant is the development of RU-486.

RU-486 would make a dramatic difference in the options available to women facing unintended pregnancies. It could make abortion, already one of the safest medical procedures, even safer. Women in France have been using RU-486 for a decade. It is also available in Sweden and Great Britain.

Over 400,000 women have had abortions using RU-486. The New England Journal of Medicine has published clinical trials confirming its acceptability and effectiveness. Also, RU-486 has another significant advantage over current abortion procedures, it can be given in the privacy of a physician's office.

What will the right do when it is approved? Will it picket every doctor's office in America? Will it harass every woman in the Nation? Thankfully, it cannot. That is why it is fighting to block the approval of this drug.

2:59 PM EDT

Nita Lowey, D-NY 18th

Mrs. LOWEY. Mr. Chairman, I would just like to refer my colleague again to statements from the National Cancer Institute, because we feel so strongly that we should not be mixing up politics and science, confusing our own personal views, and I respect the gentleman's, on whether or not women should have a choice. I would expect that the gentleman respects others'.

In 1996 the National Cancer Institute, concerned that some anti-abortion groups were misrepresenting the science on the subject, issued a statement, not my statement, their statement, and I quote, ``The available data on the relationship between induced abortions or spontaneous abortions, miscarriages, and breast cancer are inconsistent, inconclusive. There is no evident of a direct relationship between breast cancer and either induced or spontaneous abortion.''

3:00 PM EDT

Chris Smith, R-NJ 4th

Mr. SMITH of New Jersey. Reclaiming my time, Mr. Chairman, as I pointed out earlier in the debate 10 of the 11 studies on American women reported an increase on breast cancer when the women had an abortion. You may say there needs to be more studies. I say there needs to be more studies. Everybody says that.

But when we get a preponderance of studies pointing in the same direction, I think we should alert women that there is a negative devastating side effect sometimes manifesting itself 20 to 30 years down the line that cannot be ignored and trivialized.

When Janet Daling's study came out, which was National Cancer Institute-funded it received adequate coverage in [Page: H3802]

the Washington Post for one day. Then all trace of the story was killed with spin from the abortion rights side.

3:04 PM EDT

Marcy Kaptur, D-OH 9th

Ms. KAPTUR. Mr. Chairman, I yield myself such time as I may consume.

Mr. Chairman, I wish to state that, as I listened to the gentleman from Oklahoma (Mr. COBURN) and his desire to try to protect life, I think that his amendment and the words of his amendment, in fact, do not do that. So there is not a disagreement with the objective, but rather the means to get there.

Mr. Chairman, I yield 3 minutes to the distinguished gentleman from California (Mr. WAXMAN).

3:09 PM EDT

Tom Coburn M.D., R-OK 2nd

Mr. COBURN. Mr. Chairman, I yield myself such time as I may consume.

I would like to respond to the gentleman from California (Mr. WAXMAN). Number one, the definition of ``for'' under the dictionary that we have in the House is with the object or purpose of.

The gentleman refuses to address our issue. Our issue is that Federal dollars should not be used to enhance the taking of life. Now, his claim that he has no knowledge of the connection between breast cancer and abortion, I can take that. He probably had not read the studies. I have read every study. Having been trained in science and having read all studies associated with breast cancer and abortion, I think there is some legitimacy to it. I do not know how much there is, but I have read it

at least.

Number two is, for the gentleman to object that this is not a place for this debate, again it is not inappropriate, for we have an opportunity as Members of this House to put limitation amendments on appropriations bills. We may not like it, and I understand that, but it does not mean that it is inappropriate or wrong for us to do it.

I also have the legislative history where my dear friend, the gentleman from California (Mr. WAXMAN), has been very effective in doing some of these same things in the past himself. So the use of a limitation amendment on an appropriation bill is both appropriate and within the rules of the House.

So again I want to say this amendment will not, and I will take my colleagues to the application of the Food [Page: H3803]

and Drug Administration, one has to list a purpose or indication for a drug when one applies. If that is something other than the inducement of abortion, then they can approve anything. The gentleman from California (Mr. WAXMAN) knows that. He knows what the forms say. He knows more about the Food and Drug Administration than anybody in

this Congress. I understand that. But he also knows full well that this amendment will have its intended purpose, and that no drug whatsoever which has a purpose other than that will be limited in any way.

3:10 PM EDT

Henry Waxman, D-CA 29th

Mr. WAXMAN. Mr. Chairman, I will insert for the RECORD a statement from the Food and Drug Administration where they say very clearly they do not read the gentleman's amendment as he does. Their lawyers have said this will prevent them from dealing with any drug that is brought to them for approval that may have the consequence of terminating a pregnancy.

But my view is, even if its original intended purpose is to terminate a pregnancy, if it is a safer way to do that, we may be saving lives as a result. We may be saving the life of the mother.

3:11 PM EDT

Tom Coburn M.D., R-OK 2nd

Mr. COBURN. Reclaiming my time, let me give the gentleman from California some reasons why we have breast cancer associated with abnormal pregnancies. When a woman is pregnant, there is a large increase of both estrogen and progesterone. The abrupt termination of those, one has turn-on factors in the breast tissue which are not modulated in a normal cycle that the body knows how to do it. That is why we also see an increased risk of breast cancer in women who have late onset pregnancies.

This is not something that is new to the medical community. This is something that we suspect, and now we are starting to see data for. I understand the gentleman's opposition. I would say I would be happy to take an amendment from the gentleman from California (Mr. WAXMAN) that puts the word ``solely'' in there. I would happily agree to that. But I think his real objection is that we should not be doing this. But the point is I am happy to accept an amendment that will say solely for

that, because, as a practicing physician, I know we sometimes get consequences that are ill-effective, and I have no intention of stopping it.

The final point that I would make is the lawyers for the FDA ought to read the legislative history. This passed the House last year, and the history on it shows very much, we actually even had a ruling from the Chair which the gentleman from California (Mr. WAXMAN) had the point of order on, which said this would do that, and the Chair ruled it would not.

Mr. Chairman, I yield 5 minutes to the gentleman from Indiana (Mr. HOSTETTLER).

(Mr. HOSTETTLER asked and was given permission to revise and extend his remarks.)

3:12 PM EDT

John N. Hostettler, R-IN 8th

Mr. HOSTETTLER. Mr. Chairman, I rise in strong support of this amendment from the gentleman from Oklahoma (Mr. COBURN). The Supreme Court has told us that we have to allow the killing of unborn children on demand. It has not, however, told us the government has an obligation to facilitate this service.

This amendment would help ensure that American taxpayers do not end up funding the approval of drugs that are designed to kill our unborn children. FDA's mission, as it was created by this very Congress, should be to approve drugs that save lives, not end lives.

I would just hasten to add that Congress does have oversight responsibility with regard to all agencies of the Federal Government. It has been stated that Congress is sticking its nose into places it should not be. Well, if Congress should not be here now, then it is assumed that the proponents of that philosophy say that the Federal Government should not have been involved in the Food and Drug Administration's creation.

Secondly, there has been the point made with regard to the Supreme Court and the Supreme Court decision that has been made. Earlier today we heard an oath from a new Member that said he swore to support and defend the Constitution of the United States. He did not say anything about according to what the Supreme Court says that the Constitution says.

Separation of powers says that the House of Representatives, the Congress, has the constitutional obligation to determine constitutional intent; and that is what the amendment of the gentleman from Oklahoma (Mr. COBURN) is doing right here, saying that it is Congress' obligation to determine how the taxpayers' money is spent.

The point has also been made that Congress are not scientists. Well, there are several of us that happen to be scientists. We are not in the area with regard to medical science, but we have been told about other doctrines of science, other theories of science; and that is one of those old theories that we are asked to subscribe to today.

[Time: 15:15]

And that is that we are led to believe that if a child, if an individual is conceived, that 9 months later it turns into something that it was not. During the Dark Ages and shortly thereafter, that was a scientific theory that was subscribed to, called spontaneous generation, which said basically if rancid meat sat in the corner for 24 days, there will be flies there. So that meant that rancid meat ultimately turned into flies.

Well, that is not the point here. The point is that a child at conception is a child at conception, it is a child 2 months after conception, it is a child 9 months after conception, and it is a child 2 years after it is born.

We should not, as Members of this House, be asked to subscribe to a theory in science that was done away with hundreds of years ago by scientific knowledge at that time. Therefore, we are being asked to facilitate the FDA doing something safe and effective. If that child is a child at conception, and it does not automatically spontaneously generate into a child sometime later, then we are to make sure that drugs are safe and effective for children that are inside the womb as well and not be facilitating

the destruction of that human life.

Finally, I will say that there has been much said here about cancer survivorship, and I would be one that would say that I am pleased at the rate of survivorship of Members of this House, Members of this Chamber. My mother is a cancer survivor. However, my father had cancer and he is not a survivor of cancer. This weekend I am going to take part in a relay for life where those survivors of cancer are going to come and celebrate life. My father will not get to take part in that process this year

because he is not a survivor of cancer, but I can tell my colleague this: that the way my father raised me is such that he would not take one innocent child's life in order for him to survive cancer.

And that is not what this amendment does. It says and I quote, ``None of the funds made available in this act may be used by the Food and Drug Administration for the testing, development, or approval, including approval of production, manufacture or distribution, of any drug for the chemical inducement of abortion.''

This amendment by the gentleman from Oklahoma simply deals with a phenomenon of the day, and that is RU486, an abortifacient, that is not being used to treat people and cure people of cancer as it could have my father. Let us remove all the veneer, let us remove all of the camouflage over this and tell the story as it is. The gentleman's amendment will not stop one drop of research into saving people's lives that have cancer. I wish that research would have happened a few years earlier, so that

my father could have taken part in that relay for life this weekend.

Let us do say a word for life today. Let us say that innocent preborn life is worth securing, is worth protecting and is at least worth not spending taxpayer dollars on to find a more efficient way to exterminate it.

3:18 PM EDT

Diana L. DeGette, D-CO 1st

Ms. DEGETTE. Mr. Chairman, I am frankly disturbed by the claims that are being made by the proponents of this amendment. The proponents of the amendment say that the drug cannot be used for the sole purpose of abortion or the primary purpose of abortion, but [Page: H3804]

that is not what the text of the amendment says. What the text of the amendment says is none of the funds appropriated shall be used for the testing, development or approval of any drug for

the chemical inducement of abortion. Those words are not in there.

But there are more problems than that. The other problems are that there is no recognized definition by the FDA of the words ``chemical,'' ``inducement,'' or ``abortion.'' So nobody is filing applications with the FDA saying we want to use this research solely for the purpose of the chemical inducement of abortion.

The truth is the way this amendment is written it would prevent research on many, many drugs which may have a side effect of causing abortion. And if my colleagues believe the last speaker, many people believe that that is appropriate. Many people believe that it is a worthwhile societal goal to have millions of cancer victims die in order to stop what may be abortions. That is unacceptable both from a human and a scientific standpoint.

The truth is under this amendment we would be banning research of drugs which would cause miscarriages by treating cancer, hypertension, cirrhosis, rheumatoid arthritis, and even some vaccines. We cannot sacrifice scientific research into abortion, which is legal, or equally importantly into cancer and all these other things simply because of a political agenda. And that is what we are talking about here. We are talking about a political agenda.

And the reason this amendment is written so broadly is because there are people who would ban drugs whose primary purpose is for other purposes, like cancer research, in order to stop abortion. And that is wrong. Defeat the amendment.

3:22 PM EDT

Tom Coburn M.D., R-OK 2nd

Mr. COBURN. Mr. Chairman, I would say to the gentlewoman that there is nothing in the legislative history or the ruling of the Chair from last year or the legal parameters that we have had that makes the gentlewoman's statement a true statement.

The fact is that all drugs whose sole purpose is something other than the chemical inducement of abortion have free reign at the FDA, and I thank the gentlewoman