Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2004 - Continued

AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2004-CONTINUED

Mr. DURBIN. I thank the Chair of the committee and the ranking member, Senator Kohl of Wisconsin, for agreeing to an amendment which will be offered here in a moment as part of a managers' amendment, to my understanding. This is an amendment with which I tried to construct a deal, facing what I consider to be an extremely serious situation.

We now have a body of law in America relative to products which are sold for human consumption, and there are different laws and standards for different products. The ordinary American walking into a pharmacy or drugstore or health food store or nutrition store may not know that, depending on which product you take off the shelf, there is a different standard of care, a different legal requirement.

I would like to spend a moment to discuss the differences.

If you were to go into your local pharmacy and have a prescription filled-which many of us have-this is what you know. This prescription drug has been tested for three things before it was sold to you. First, that it is safe, that you can consume it without injuring yourself; second, that it is efficacious, meaning it will do what it is supposed to do; and, third, it has been packaged and manufactured in a fashion so when they say it is 200 milligrams, it is in fact 200 milligrams. You know that. The Food and Drug Administration has required clinical tests to make sure it is safe-efficacious-and packaged in a fashion as it is represented. With that assurance, your doctor prescribes it and you take the medicine.

Now you walk down from the pharmacy counter in the drugstore and you decide to pick up some cough syrup such as this. You have bought this cough syrup. The question is: What standard of care, what body of law governed the manufacture of this over-the-counter drug, in this case, Robitussin DM, which was previously a prescription drug. It went through the same test for safety and efficacy to determine whether or not it met those tests and could be sold. Then it reached a point where a medical decision was made that you no longer needed a prescription and the component parts of this drug meet the same test of safety and efficacy and it is packaged in such a fashion that you know what you are buying.

I might also add for both the prescription drug and the over-the-counter drugs, which I have just described, if something happens-if you take this prescription, for example, and have a bad health result or this over-the-counter drug with a bad health report and you report it to the company or to your doctor, it is expected and required that adverse event, as it is known, will be reported to the Food and Drug Administration. They keep track of those. If they find out what they thought was a safe drug turns out to have a bad reaction, they will pull it from the market. The same is true with an over-the-counter drug. You know the standard of care for both prescription drugs and over-the-counter drugs.

We have other things which you will find in that same drugstore. One of them would be ordinary vitamin pills, the kind I took this morning. What are the standards for these vitamins-vitamin C or ordinary multivitamins? Unfortunately, the standards are much different. In this case, they are basically being manufactured and sold without the same clinical tests. No one has tested them for safety, for efficacy. Frankly, the standards for many are questionable as to even how they are packaged and sold to the public. But the belief is most of these naturally occurring minerals and vitamins and this type of supplement are generally good for your health. Those who believe in them take them for a variety of conditions. It is believed they cause no great harm; in fact, that they may have real health benefits.

We passed a law about 9 years ago which established a standard for something we call dietary supplements which are also for sale in the same drugstore with prescription drugs, over-the-counter drugs, and vitamins. These dietary supplements might be one such as this, natural herbal formula to promote energy and diet. What kind of standard of testing went into this product? The answer is none. There was no testing in advance required by law that what is included in this bottle is safe for human consumption or in fact even helps you when it comes to your energy or diet, and few, if any, standards about whether or not when they say this is 200 grams of one thing or another, in fact, are included. When you buy a dietary supplement, frankly, there are no standards of testing and care before the product is put on the shelf for the consumers.

I tell you this by way of background because that is why this amendment is important. When we passed the Dietary Supplement Health Education Act, we said we were dealing with natural supplements like vitamin C and garlic, multivitamins and the like. What has happened over the past 8 or 9 years is we have gone way beyond the basic vitamins. We now find a witches brew of a variety of different dietary supplements way beyond vitamins and minerals that are being sold under the same law with no testing standards, with no establishment of their safety or efficacy, no standards as to how they are packaged, and no requirement that they report adverse events to the FDA. As you walk into the drugstore and fill your prescription and walk past the counters, the American consumer has no idea that at end of the counter, the standard of protection and care changes depending on what you are buying.

That is why I am offering an amendment to this bill which earmarks $250,000 for the Food and Drug Administration to examine one particular compound being sold in dietary supplements. The compound is ephedrine. Ephedrine is a naturally occurring chemical that one finds similar to the synthetic chemical ephedra. Ephedrine is very closely monitored by FDA in both prescription drugs and over-the-counter drugs. But when it is sold in these types of dietary supplements, it isn't tested for safety, it isn't tested for efficacy, and it isn't tested in terms of how much is included in the bottle, and certainly no requirement for adverse events to be reported to the FDA.

Sadly, this product I have in my hand, known as Yellow Jackets, is sold as an extreme energizer, an herbal dietary supplement containing ephedrine. The reason I have kept this bottle is because 30 miles from my hometown in Springfield, IL, just last year a young man who was a high school senior and a football player in preparation for a football game decided he needed a shot of energy, a boost of strength to go out and play for his team. He went into a local gas station and bought these Yellow Jacket energizers and washed them down with Mountain Dew, which is heavy in caffeine, had a heart attack, and died. Ephedra products, as a consequence, have been under suspicion for a long time.

The sad reality is the United States is almost last in the world when it comes to dealing with ephedra products. You may not know it, but almost 2 years ago Canada banned ephedra products for sale in their country. They said it is too dangerous. Over a year ago, the American Medical Association said to the Food and Drug Administration, take these ephedra products off the shelf; they are dangerous. After 30 service men and women had serious adverse health effects, we have removed all ephedra products from military commissaries across the United States. The National Football League, the NCAA, the National Basketball Association, and major league baseball have banned the use of these products. You can't use them if you want to compete in Olympic competition. Yet kids in junior high and high school can walk into a gas station and still buy this in most States, with the exception of Illinois, and I believe New York and California have joined suit in banning ephedra products.

Over a year ago, I wrote to Secretary Tommy Thompson of Health and Human Services and said you have to do something. If Canada believes they are dangerous, if we think they are dangerous for service men and women, if the American Medical Association says they are dangerous, and if major sports have banned them, why in the world do we allow them to be sold in America?

What happened in the meantime is the Government did absolutely nothing-issued a press release and did nothing to take these products off the shelf.

What happened was a lot of the victims and their families went into courtrooms. A lot of people are critical of people filing lawsuits. This is a clear example where that was the only place to turn to protect innocent families and victims across America. Because of the class action lawsuits that were filed, we have now determined there were over 16,500 adverse events reports related to ephedra products that had been accumulated by all the companies that were selling them. Now they had to turn them over and disclose them.

Within those 16,500 adverse events there were events including seizures, strokes, and 155 deaths. I think, frankly, we all know what is at stake here. We realize major drugstores see liability if they continue to sell products like these Yellow Jackets and they will take them off the shelf. Walgreen's, CVS, Eckerd, Rite Aid, and Wal-Mart, representing 17,300 stores nationwide, have pulled these ephedra-containing dietary supplements from shelves. GNC, the largest specialty retailer of nutritional supplements in the country, with 5,300 stores nationwide, stopped selling ephedra products in June.

One of the largest sellers of ephedra products, Metabolite-I am sure you have heard that name-sold ephedra compounds and was sued right and left because of these compounds. They said at one point they didn't have any adverse event reports. After they were pressed in a lawsuit they turned over thousands of examples of people who had bad health events because they took Metabolite's ephedra products.

Metabalife is now advertising what they are selling is "Ephedra free." Despite all this having taken place, our Government has done nothing, absolutely nothing. I have written over and over again to Secretary Thompson. I have met with Dr. McClellan, the doctor in charge of the Food and Drug Administration, and asked: When are you going to start protecting Americans? We have a clinical trial in America today. We are selling Ephedra to innocent people and seeing if they have a seizure or heart attack.

Secretary Thompson, in April, said he was concerned about Ephedra and had taken more and stronger actions to address public health issues raised by Ephedra alkaloid than in the previous decade.

That was his letter to me in April. Since Secretary Thompson wrote that letter to me, another 38 reports of death related to Ephedra have been accumulated, bringing the total to 155.

A representative of the FDA spoke in front of the Senate Commerce Committee last week and said the Agency is in the process of analyzing 30,000 comments they have received in response to the reopening of the 1997 proposed rule on Ephedra and they are reviewing scientific evidence. Of course, delay means death, delay means injury, and delay is evidence that the Food and Drug Administration is not meeting its obligation under the law to protect American families from dangerous products.

We had a hearing in the Senate Commerce Committee before Senator McCain last week. A case was made very clearly that it is time to change the law. But first, get Ephedra off the shelves. That is why I introduced this amendment, put $250,000 in the FDA, earmarked to deal with Ephedra, to get an answer, get a conclusion and get it off the shelf as quickly as possible.

When that is done, we will have made progress. But we need to do more. The makers of dietary supplements such as this one must be required by law to report to the Food and Drug Administration if people are dying from their products. That is not too much to ask in this society. Those who say that, because I am going after a deadly product like yellow jackets, that my real war is against vitamin C just do not understand the reality. The reality is vitamin C can help. Vitamin C is not going to kill you.

This product killed a 16-year-old high school football player in Lincoln, IL. It has been attributed to the death of a Major League baseball player of the Baltimore Orioles.

I asked the committee to earmark this money. I am glad the chairman has accepted. I hope that finally this will push Health and Human Services into doing the right thing and banning this dangerous substance.

I yield the floor.