Thomas Coburn

Mr. COBURN

Mr. COBURN. Mr. Chairman, will the gentleman yield?

Mr. COBURN. Mr. Chairman, I would just say that we would not want any drug, no matter what its ill-use might be, if it has a positive use to ever be denied by the FDA. We know lots of drugs today that are approved by the FDA that have tremendously, terrible side effects. Thalidomide has a terrible side effect profile, but yet it has some tremendous positive benefits.

Mr. COBURN. If the gentleman would yield further, the FDA makes a judgment on every drug application made to it.

Mr. COBURN. Very easily. RU-486 is used for other things besides that. So, if they did not specify it, then that RU-486 would be approved for whatever it is specified for. Very straightforward. Any drug that follows the guidelines of the FDA's NDA application process must state its intent. If RU-486 were applied for and it was not stated intent to accomplish what it in fact did, then it would be eligible for consideration under this rule.

Mr. COBURN. The question is that the RU-486 was not applied for under that rule initially and is now.

Mr. COBURN. Mr. Chairman, I offer an amendment.

Mr. COBURN. Mr. Chairman, this is a bill that is intended to do a very discrete function. Number one, we should look at what the definition of the charge to the Food and Drug Administration is. Let me quote from page 96 of this bill: ``The programs of the Food and Drug Administration are designed to achieve a single overall objective, consumer protection.'' Mr. Chairman, it is my contention that there is nothing associated with consumer protection in the development and securing of abortifacient drugs, that in fact this is an area far outside the charge of the Food and Drug Administration. What does this bill not do? This bill has no effect on the development of any drug which has a purpose other than abortifacient of an implanted blastocyst. This amendment will not prohibit the FDA from conducting its legitimate oversight function, and following its guidelines to in fact follow the charge of consumer protection. Part of the point of order that I am sure will be raised is that this is far reaching and goes outside the scope, which it does not, because it is not intended to completely block research on efficacious drugs. The other point that I would make, that the charge of the FDA is, is to maintain surveillance over food, drugs, medical devices and electronic products to ensure that they are safe, effective and honestly labeled. The use of abortifacients supported by our tax dollars, researched by our tax dollars, approved by our tax dollars, has nothing to do with the charge of the FDA. It would seem to me that if we wanted to be honest, that this is something that totally should be ignored, is not an area of safe and effective oversight of the FDA, and, in fact, raises several other troubling questions: Number one is we should be seeking, regardless of our position on pro-life or pro-choice, alternatives to abortion rather than making abortion easier. Number two, we markedly oversimplify the concept of abortifacient drugs by saying that we can have a pill that will solve this problem. Number 3, there is significant scientific evidence today that abortion is associated with a marked increase in the incidence of breast cancer. Number 4, abortion drugs are often dispensed without a doctor's approval and oftentimes endanger a woman's health rather than protect her health. Twelve States already give pharmacists the authority to dispense these drugs without the aid of a physician. Finally, if we talk about the research that has been done on the abortifacient drugs that are presently available or used in that manner, what we find is they are extremely ineffective. If my colleagues look at the studies that have been done in Brazil or in Europe on the multitude of drugs that are followed by this concept, what they will find is that 8 to 10 percent failure rate to accomplish what they were intended to do. What we find also is what has happened to the children that have been exposed to these drugs, and again let me bring this back. What is the charge of the FDA? The charge of the Food and Drug Administration is safety, is consumer protection. Having Federal dollars spent to perfect and introduce and license and hold up a drug that takes away life goes completely opposite of the charge of the Food and Drug Administration. Finally I would like to describe for my colleagues what happens to children who have been exposed to this. About 12 percent of the women who are exposed to the abortifacients that are out there now end up having to have an instrumented procedure. So, first of all, it fails for those 12 percent. Another 12 percent of the women do not abort. Of those 12 percent of women who do not abort, 9 percent, 8 to 9 percent, of the children are born.

Mr. COBURN. Mr. Chairman, of the 8 to 9 percent of the children that are born, 50 percent of those children, a large number, have microcephaly, which is a smaller-than-normal brain which leads to severe retardation, a large number have hydrocephaly, which means they have an inability to circulate the fluid around the brain. So if, in fact, we want the Food and Drug Administration to be about consumer protection, then we in fact ought to ask them not to have anything to do in their charge with abortifacient drugs.

Mr. COBURN. Mr. Chairman, I yield to the gentlewoman from New York.

Mr. COBURN. Mr. Chairman, I demand a recorded vote, and pending that, I make the point of order that a quorum is not present.

Mr. COBURN. To the gentlewoman from Ohio, I appreciate and I am sorry that she was not made aware of that. This was given to the committee, majority committee staff. Finally, I too believe that life begins at conception. But I know what the Supreme Court said, is they do not know when life begins. But we know life is present at 26 days. We know it. There is no doubt about it. Science has proven that by our very definition of death in this country. We say that you are dead when you do not have brain waves and you do not have a heartbeat. If you are dead, then if you have those two things, you have got to be alive. Otherwise, the definition of death is out the window in this country.

Mr. COBURN. I thank the gentleman from California for yielding. Mr. Chairman, I would like to make three points. Number one, we can deny medical scientific fact. We have heard that argument a lot. Scientific fact: Life is present at least at 26 days. We will recognize that in this country as a consequence of the logical recognition of when death is. Death is the absence of brain waves, death is the absence of a heartbeat, in all 50 States, also associated with the Federal code. We know at least life is present at 26 days. We are talking about using medicines to take life. We can deny it. But scientific fact has already proven that the heart is beating in a fetus at 26 days. Scientific fact, it has already been proven that the brain waves are functioning in a fetus at 41 days. Most women in this country have barely recognized conception by the time those two scientific facts have been made available. Number two. This was offered to the committee. The committee chose not to put it in its mark. So it is not that we did not approach the committee, we did in good faith, attempting to put this in the committee's mark. The gentlewoman makes a good point that there were not hearings on it. There do not need to be hearings on this issue in this country. We do not need to have a hearing, because the hearing is going to go back to the same issue, is it right to take an unborn life or not. Is it right? I mean, that is what it will all filter down to. My opinion, and that of a large number of this country and the majority of this body, is it is not right to take an unborn life. Scientific evidence now shows, without a doubt, that life is present at least at 41 days.

Mr. COBURN. I would just say, to do research to take life, to do research to take life somehow does not smell right in this body; to spend our dollars. I agree, nobody wins in abortion.

Mr. COBURN. Mr. Chairman, will the gentlewoman yield?

Mr. COBURN. Mr. Chairman, I would just again reemphasize, nothing in this amendment limits any drug whose primary purpose is not an abortifacient. There is no limitation on any research of any other drug if its primary purpose is not that of an abortifacient. I thank the gentlewoman for yielding to me.

Mr. COBURN. Mr. Chairman, I would like to respond to the gentlewoman's point of order.

Mr. COBURN. Mr. Chairman, this is an amendment based first on a limitation of funds. Number two, there is nothing in this amendment that requires anything additional by the FDA because every NDA that comes before the FDA today has to state the purpose for which the drug application is made. And then finally is that we would not agree to a stipulation, as the gentlewoman from New York pointed out, that would limit anybody's application for any drug and to apply this Rule of the House, we will happily concede, if we want to use the definition as she stated initially, in terms of abortifacient, if that is what she desires. But the point is the actual functioning of the FDA, having brought drugs to the FDA, having filed NDAs, her statement is inaccurate, it does not follow the rules of the FDA, it is not a true statement to say that this will require any additional burden on the FDA. Mr. Chairman, the FDA already requires every drug that has applied for it to state very specifically what its purpose is. If the purpose for the drug is not abortifacient, then there is no problem. If the purpose for the drug is it is, then the FDA would be limited. This is a medical term under which the FDA already knows the definition. There is no question about what the definition is. There is no question in Federal law about what the definition is. So to confuse the issue under this rule is wrong.

Mr. COBURN. Mr. Chairman, first of all let me say to the gentlewoman from Connecticut (Ms. DeLauro), I am very thankful that she is a cancer survivor. This amendment in no way whatsoever will limit any drug research. The other reason why I know that that is the case is because I too am a cancer survivor. I am 23 years out. I would never put forth an amendment on the floor of this House that would limit that. What this amendment does is have the FDA work on drugs that save life rather than take life.

Mr. COBURN. Mr. Chairman, if the gentleman will yield, every application made to the FDA has to have the primary intent of a drug, as the gentleman well knows. My objection to the point of order is we presented this just like every other limitation that has been placed in this Congress on the dispensing of funds, and we have followed that guidelines and made no new requirements on the part of the FDA.

Mr. COBURN. Mr. Chairman, will the gentlewoman yield?

Mr. COBURN. Yes.

Mr. COBURN. What the gentlewoman from New York will have to tell me first to answer that is how was the RU-486 applied for.

Mr. COBURN. That is true.

Mr. COBURN. The amendment would not apply to any drug that is applied to the FDA that the primary purpose is not intended to be an abortifacient. For example, there is a drug that is presently on the market called Cytotec. The gentlewoman is familiar with that drug. If that drug were being applied for now, its primary intended use is for ulcer prevention and treatment. This amendment would not preclude the application of that NDA for that drug.

Mr. COBURN. First of all, the department is much more knowledgeable than my colleague might give them credit for. They understand what drugs are used for, and they are scientists and very good at what they do. And if, in fact, some company is making application for a drug that the primary purpose is for something that fits the charge of the FDA, consumer safety, not death, not killing, but consumer safety, then I think they have very well the ability to figure out what the purpose of that application is. And they also have to very clearly state in their NDA what the purpose is for the drug.