National Defense Authorization Act for Fiscal Year 2005

CONGRESSIONAL RECORD
SENATE
June 21, 2004
NATIONAL DEFENSE AUTHORIZATION ACT FOR FISCAL YEAR 2005

AMENDMENT NO. 3463 TO AMENDMENT NO. 3225
Mr. DURBIN. Mr. President, I send an amendment to the desk.
The PRESIDING OFFICER. The clerk will report.
The assistant legislative clerk read as follows:

The Senator from Illinois [Mr. DURBIN] proposes an amendment numbered 3463 to amendment No. 3225.
Mr. DURBIN. Mr. President, I ask unanimous consent that further reading of the amendment be dispensed with.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment is as follows:

(Purpose: To require certain dietary supplement manufacturers to report certain serious adverse events)

At the end of the amendment, insert the following:
(d) This section becomes effective upon enactment.
Mr. REID. Mr. President, I suggest the absence of a quorum.

The PRESIDING OFFICER. The clerk will call the roll.
The assistant legislative clerk proceeded to call the roll.
Mr. DURBIN. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. DURBIN. Mr. President, for the edification of my colleagues, we are working on a procedural agreement on how to address these amendments in a timely fashion. I hope we can reach that agreement, and I think we will soon. In the meantime, I will speak to the merits of the issue. Senators HARKIN and HATCH have offered an amendment relative to dietary supplements to the bill before us, the DOD authorization bill.

People are asking, Why would you have a debate over dietary supplements on this bill? Sadly, the fact is dietary supplements have been such a danger to our Armed Forces that between 1997 and 2001, 30 Active-Duty personnel in the U.S. military have died after taking ephedra, a dietary supplement marketed for weight loss and energy and was eventually banned by all branches of the armed services, and ultimately by the FDA.

In fact, the danger of ephedra-containing dietary supplements was first noted by our Armed Forces when they looked at the prevalence of their usage and the dangerous outcomes from these supplements. Before the FDA took this product off the market in America, the U.S. military took it off the market on all of our military bases and warned our soldiers. U.S. Armed Forces Commander, COL Jerald Cross said:

The bottom line is that dietary supplements are not a safe choice for soldiers or their families.

To argue that the issue of dietary supplements has no place in the Department of Defense authorization bill ignores the obvious. Soldiers serving America have died taking dietary supplements that were sold on military bases. As a result of those deaths and serious outcomes of more than 30 soldiers, the military banned dietary supplements, and particularly those containing ephedra. Now they are watchful of many others.

Recently published in one of the military publications was an article on performance-related supplements, it detailed the product, claim, and fact, so that members of the Armed Forces know the danger of dietary supplements. To suggest that this issue doesn't belong on this DOD bill is wrong. It is an issue which may not rise to the moment of fighting a war in Iraq or a war on terrorism, but it is a life-and-death issue which has claimed the lives of 30 unsuspecting, innocent, patriotic Americans serving in our Armed Forces.

Before us today is an alternative being offered by Senators HARKIN and HATCH. Both of them were involved in the early days in the creation of the bill that regulates dietary supplements in America. It is worth a minute or 2 to describe to those following the debate what this is about. The decision was made in 1994 to create a category of compounds being sold and call them dietary supplements. We originally had, of course, prescription drugs, over-the-counter drugs, and foods; and in 1994 the decision was made to create this new category of dietary supplements. Within that category falls a lot of benign and safe products that many of us take every day. I took my vitamin this morning. I asked Senator Harkin, and he took his, too. That is good. Maybe it is good for me, maybe it is not. I think it might be good for me to take it and so do millions of other Americans.

The obvious question is, when you go beyond the multivitamins, the vitamin C, fish oil, flax oil-when you go beyond these into new compounds called dietary supplements that are sold with the stated purpose of helping you to have more energy, to lose weight, then you have moved beyond the simple compounds in vitamins and minerals and into new combinations which, frankly, fall into the category of dietary supplements.

So how are these supplements tested? There is one thing Senators HATCH and HARKIN have not mentioned, which should be on the record. Dietary supplements, before they are sold to Americans, are not tested. There is no requirement in the law for dietary supplements to be tested. So when these products come to the shelves of our local vitamin and mineral nutrition store, or the local drugstore, and you walk in and read the label and think you would like to have more energy, so you will take this dietary supplement, understand this: You are a test case. You are testing this product. You are going to decide from your physical reaction whether this product is safe, whether, in fact, it should be sold in America.

Secondly, what if it is not? What if the dietary supplement, created by some company here or overseas, is not safe? What if you take an ephedra product, as a 16-year-old high school student did a few miles from my home-he bought it at a gas station over the counter and washed it down with Mountain Dew because he wanted more energy for his high school football game. He took the product and started feeling poorly and died the next day of a heart attack-a healthy 16-year-old boy-from an ephedra product.

Ask yourself, if his family contacted the company that sold the product and said, what-he bought Yellow Jackets, which is the name of the ephedra product. If they notify the company, what does Senator Hatch's law require the company to do with that information? A 16-year-old boy died from that Yellow Jacket. The answer is, there is nothing, no requirement-none whatsoever-to report a death or heart attack or stroke from a dietary supplement. That is what DSHEA-the Dietary Supplement Health Education Act-is all about. There is no testing in advance to make sure the supplement is safe, no testing to make sure it actually gives you more energy, even if it claims it does on the label, and no requirement of the company making the supplement to notify the Government that people are getting sick and dying from taking the product.

How many Americans know that? How many Americans know that when you walk into that drugstore and grab that bottle of Metabolife, one of the biggest sellers of dietary supplements, that this product, a stimulant that could be dangerous for some people, has never ever been tested? No clinical testing whatsoever. How many people know that the claims that this product, Metabolife, gives you more energy have never been verified? They just state that on the label.

Consumer beware. How many people knew that Metabolife, which sold millions of dollars' worth to consumers all across America, caused significant adverse events when it was combined with ephedra? About 4 years ago, they went to Metabolife and asked: How many people have reported having taken your product and had bad results?

Metabolife said: None, zero.

Then do you know what happened? Lawsuits and investigations showed they lied, they deceived the Government. They had over 16,500 adverse events of Metabolife with ephedra reported. They never told the Government, but because of lawsuits, they were forced to disclose them. Some of them were extremely serious. More than 100 people had died from these ephedra-related products, and there was no requirement under DSHEA whatsoever for that company to report to the Government that, in fact, people had died as a result of taking it.

My amendment says, if you want to sell a dietary supplement containing a stimulant on a military base, you have to report to the Food and Drug Administration if there is a serious adverse health event from the product you are selling. If someone has a stroke, is hospitalized, faces some serious injury, or dies, you have to report it.
Now, is that too much to ask? Is that so radical that this industry is now flooding e-mails across America about this terrible Durbin amendment?

This is what they say about it: The Durbin amendment holds dietary supplements to a higher level of scrutiny than prescription drugs, over-the-counter drugs, and food additives. Partially true. Certainly a higher level than food additives. I do not think people who sell cinnamon, vanilla extract, or salt and pepper should be required to send in adverse event reports to the Food and Drug Administration, but I do believe if someone is selling Metabolife with ephedra or its latest replacement drug, this citrus aurantium, bitter orange, and people die as a result of it, yes, I think it ought to be reported. I would think if someone is buying dietary supplements, at the very minimum they would want that company to report to the Government that someone is dying from their products.

Now we have my colleagues from Iowa and Utah tell us this is an outrageous request, that it goes too far, that what we are asking for in this amendment is entirely unnecessary. At one point, they have called for a study that the Food and Drug Administration would engage in to determine whether these so-called adverse event reports should take place, not just for dietary supplements but for over-the-counter drugs.

There is nothing wrong with a study. In fact, a study is such a good idea that it has already been done, and it was released this year. Who asked for this study on dietary supplements? The Food and Drug Administration. Whom did they turn to ask for it? The Institute of Medicine.

I do not think this Institute has any ax to grind. These are professionals and they were asked to take a look at the dietary supplement regulatory structure.

Do my colleagues know what they found on page 13.5? Here is the recommendation from the Institute of Medicine: Congress should amend DSHEA to require that a manufacturer and distributor report to the FDA in a timely manner any serious adverse event associated with use of its marketed product of which the manufacturer or distributor is aware.

That is exactly what my amendment calls for when it comes to sales on military bases.

The Senator from Utah has said, Why are we not taking this up in a larger context? Why are we not discussing this for all dietary supplements for all Americans? I am for it. Let us hold the hearings.

I have already held three hearings in the Government Affairs Committee on dietary supplements. As a result of the first hearing, we started sending letters to Secretary Tommy Thompson of Health and Human Services, and after over a year of deliberation the Food and Drug Administration joined my State of Illinois and others, the nation of Canada, military bases, as well as major sports organizations, and called for the banning of ephedra. They said that dietary supplement was too dangerous.

Well, we held our hearings. I am certainly open to holding more, but we have a good starting point. It appears everybody agrees and understands the premise that if one is going to sell a product in America, that is supposedly designed to make people healthier, then, at the very minimum, when that product causes a bad health result, a serious adverse health result, it should be required to be reported so we can gather that information. If we find that 5, 10, 15, 20, 100, or 1,000 people are getting sick from this dietary supplement, for goodness' sake, would we not want to take it off the shelf? Do we not owe that to the American consumers?

Some argue, like the industry: Leave us alone. Let us sell whatever we want. Let us make whatever health claims we want. We should not have to test our products. We should not have to even have standards when it comes to what is included in those products.

I say to Senator Hatch, it has been 10 years since he enacted DSHEA and he knows, as I do, that the Food and Drug Administration has yet to promulgate good manufacturing practices for that industry. Do my colleagues know what that means? Ten years after Senator Hatch and Senator Harkin worked on this law, it means that even the things that are represented on the labels of these dietary supplements are not necessarily true. There is no requirement to list the purity of the ingredients. There is no requirement in terms of standards and contents of these ingredients. Here we are 10 years after this law was enacted and it is the Wild West. It is a product and an industry with, frankly, little or no regulation.

They put one provision in there which is supposed to give us some comfort, and cold comfort it is. The Food and Drug Administration, which, in the opinion of some has lots of resources and lots of time to spend on this thing, can decide that a product for sale in America is dangerous, investigate it, and remove it. The burden is not on the producer, the manufacturer; the burden is on the Government to prove it is dangerous.

So how often do my colleagues think the Food and Drug Administration can comb through the shelves of these nutrition and drug stores and come up with the new combinations and test them to find out that they are safe? That is an impossible responsibility to shift to the Food and Drug Administration. As a result of that-

Mr. HATCH. Will the Senator yield for a question?

Mr. DURBIN. I would be happy to yield for a question.

Mr. HATCH. I have been enjoying listening to the distinguished Senator. Let me ask this: Would the Senator be willing to resolve this problem by working with Senator Harkin and me to come up with a broad-based law that handles the adverse events reporting matter? Because my objection is that this is a helter-skelter approach to doing it, that will not solve the problems that the distinguished Senator thinks exist. I would be willing to work with the Senator rather than do this in this fashion on this particular bill, because I am not against adverse event reporting.

I am against premarket approval, which is what the Senator seems to be arguing for, which would price vitamins, minerals, and other products off the charts so that the average person, the 150 million people who use them for their health benefit, including, I am sure, the distinguished Senator and myself, would not be able to afford them.

I think it is going to take some very careful workmanship, working with the HELP Committee and with other Senators and Members of the House, to do an appropriate adverse events reporting enactment or statute that makes sense rather than do this on an ad hoc basis without defining how it is done, defining what adverse event reporting is, how they report, what they report on, and what is meaningful. I would be more than happy to work with my friend. I am sure I can speak for Senator Harkin as well. Our goal is not to allow companies that are not doing appropriate dietary supplements to be in business. If the Senator would withdraw his amendment, I am willing to work very carefully with him in good faith and work hard to try to resolve this problem, because I think the Senator also would-and I would ask him if he would know this as well-know that there are people in this world who do not like anybody and there could be a lot of phony adverse event reporting.

The Senator uses the term "serious." I am not against having serious adverse event reporting but what the Senator is asking for here is not definitive. It would not be accurate. It could be interpreted to place severe burdens on the whole dietary supplement industry, which has been a very health-promoting industry over the years and which is one of the great industries of our country.

Those who are the top people in the industry want the industry to be totally honest in its approach toward everything that is manufactured as a dietary supplement. Certainly I do and certainly Senator Harkin does, and I acknowledge that the distinguished Senator from Illinois does.

I would be happy to work with the Senator. I do not think this is the way to do it. In fact, I know it is not the way to do it. All we are going to do is get in big arguments without getting anything done.

Mr. DURBIN. I thank the Senator from Utah. In response to his inquiry, the answer is a very strong affirmative. The answer is, yes, I would like to work with the Senator from Utah and the Senator from Iowa.

Mr. HATCH. Then why do you not withdraw the amendment.

Mr. DURBIN. Let me make a suggestion to the Senator from Utah, if I may. First, a serious adverse health event is specifically defined in my amendment to include death, life-threatening conditions, inpatient hospitalizations, disability, and incapacity. So it is very serious.

Mr. HATCH. Those are broad categories.

Mr. DURBIN. I think death is a very narrow category. You stop breathing. If that occurs, I think perhaps your dietary supplement needs to be looked at.

Mr. HATCH. Is the Senator aware the pharmaceutical industry is willing to keep going because of the hoped-for benefits in the dietary supplement industry? There are 100,000 people a year who die from toxicity. Even in the cases the distinguished Senator has quoted, there is a real question whether the deaths occurred from dietary supplements or from other factors. I think it is very difficult. Naturally people want to blame it on dietary supplements, but we have had 100 years or more-actually centuries of dietary supplements without deaths. All of a sudden, every time somebody dies they blame it on a dietary supplement.

We are a far cry from defining what it means to report adverse events. I would be willing to work with the Senator. I believe we could come up with something that really would work, that would be accepted by the industry and accepted by the FDA, and would give the FDA even more teeth than it has perhaps now, although we gave them plenty in DSHEA. I went over that in my remarks on the Senate floor, but I would be happy to do that.

Mr. DURBIN. Let me say to the Senator from Utah, let me make a suggestion if I might. My bill to amend DSHEA has three component parts to it. One of them was to ban steroids sold as dietary supplements. I know the Senator agrees with that position.

Mr. HATCH. I do.

Mr. DURBIN. Because he and Senator Biden have introduced a bill to accomplish the same goal. I would like to suggest to the Senator from Utah that we work together to add the adverse reporting requirement into that bill.

Mr. HATCH. If the Senator will withdraw his amendment, I will commit to do exactly that. What I do not want is a Dietary Supplement Health and Education Act adulterated with helter-skelter amendments that do not apply across the board. Frankly, I think the amendment of the distinguished Senator is in that nature, even though I know it is well meaning and sincere. But I am saying if you work together, we will do that.

Mr. DURBIN. My good friend and colleague from Utah is an extraordinarily busy man with responsibility on the Senate Judiciary Committee and responsibility of chairing that important committee. It was important for me to get his attention and the attention of all those in this industry, and now we are in dialog and I would like to suggest to the Senator from Utah the following: If he will agree to work with me and others to amend the bill he has introduced with Senator Biden on the steroids used as a dietary supplement to include adverse event reporting, which at least meets the goals we have talked about here, I would be more than happy to work with him, and I will be prepared to withdraw my amendment.

Mr. HATCH. You will withdraw the amendment if I am willing to do that?

Mr. DURBIN. If I have your assurance that we can work on this.

Mr. HATCH. As long as the industry is being consulted and is not just being pushed around. If the industry is consulted.

Mr. DURBIN. Oh, absolutely.

Mr. HATCH. I believe responsible people in the industry-and most all of them are-if they are consulted, I believe they can help us in this area. I believe we can do the consuming public a great service in coming up with an efficient, workable, well-thought-out adverse event reporting system that FDA would appreciate as well. Yes, I am willing to work with the distinguished Senator, and I am willing to work-I can't speak for Senator Biden, but I believe he would be willing to work to add that to the ban on steroid use.

Mr. DURBIN. I say to the Senator, if I might through the Chair, I would like to set as a goal doing it this year.

Mr. HATCH. If we could get our leadership to do that on both sides, I would like nothing better than to pass that Hatch-Biden bill. I would like nothing better than for us to come up with an appropriate way of handling adverse event reporting that really makes sense, that helps the industry and yet makes sense for the consuming public as well, and to FDA. But it would have to have consultation with the industry as well.

Mr. DURBIN. I agree with the Senator. I would tell you endorsers of my amendment, the American Medical Association, American Dietetic Association, the American Osteopathic Association, the Center for Science and the Public Interest, the American Society for Clinical Pharmacology-I want them to be in on this conversation, too.

Mr. HATCH. No problem.

Mr. DURBIN. Let's bring them all together. With that understanding, I am prepared to withdraw our amendments which we have pending.

Mr. HATCH. We will withdraw ours if the Senator withdraws his.
AMENDMENTS NOS. 3463, 3462, AND 3225 WITHDRAWN

Mr. DURBIN. I ask unanimous consent to withdraw my perfecting amendment and, after the substitute is withdrawn, to withdraw my underlying amendment.

Mr. HATCH. Under these circumstances I ask unanimous consent to withdraw my substitute amendment as part of that unanimous consent agreement, and you will withdraw the underlying amendment?

Mr. DURBIN. That is correct.