Interest Rate Reduction Act

Would the Senator yield for a unanimous consent request?

I do not want to change the Senator's line of thought. It was beautiful and I want to hear every word. Madam President, I ask unanimous consent that after the conclusion of the remarks of the Senator from Tennessee, that there will be 10 minutes given to the Senator from Wyoming, Mr. Barrasso, and that I have the remainder of the Republican time.

First of all, Madam President, let me say we are very fortunate to have the Senator from Wyoming, with his background, come and give us his second opinion. The ratings are very high on his second opinion, and I am very glad of that.

I am also very pleased we had the Senator from Tennessee talking about the big issue of today. There is no one--having been the Secretary of Education in a previous administration--who is more qualified to talk about student loans than the Senator from Tennessee. So I am very appreciative.

Ironically, we have talked about two subjects, and I am here to talk about one totally unrelated that I think is equally critical--and I have to be critical--of this administration. I am going to state something that hasn't been stated before. I am going to release something that hasn't been released before, and I think it is very significant that people really listen.

You know, this President has had a war on fossil fuels--and when we talk about fossil fuels, we are talking about oil, gas, and coal--ever since before he was in office. He is very clever because what he has attempted to do is to kill oil, gas, and coal when we had the huge supply of it here and yet do it in a way that the American people won't be aware over it. How many people in America, I ask the Chair, know what hydraulic fracturing is? I daresay more people know about it today than knew about it a short while ago.

So today I wish to address for the first time ever the questionable actions recently taken by the Obama administration's Environmental Protection Agency to stop domestic energy production, particularly doing so by using hydraulic fracturing.

Today I wish to draw attention to a little-known video from 2010 which shows a top EPA official, region 6 Administrator Al Armendairiz, using the vivid metaphor of crucifixion to explain EPA's enforcement tactics over oil and gas producers.

This is a long quote, and I am going to ask everyone to bear with me because it is all a quote by Armendairiz. He is, as I said, the Administrator of region 6, and he is instructing at this time people who are working for them in what their behavior should be. So this is an actual quote I am going to use. It is a long quote. Bear with me.

I was in a meeting once and I gave an analogy to my staff

about my philosophy of enforcement, and I think it was

probably a little crude and maybe not appropriate for the

meeting but I'll go ahead and tell you what I said. It was

kind of like how the Romans used to conquer little villages

in the Mediterranean. They would go into a little Turkish

town somewhere, they'd find the first five guys they saw and

they would crucify them. And then you know that town was

really easy to manage for the next few years. And so you make

examples out of people who are in this case not compliant

with the law. Find people who are not compliant with the law,

and you hit them as hard as you can and you make examples out

of them, and there is a great deterrent effect there. And,

companies that are smart see that, they don't want to play

that game, and they decide at that point that it's time to

clean up. And, that won't happen unless you have somebody out

there making examples of people. So you go out, you look at

the industry, you find the people violating the law, you go

aggressively after them. And we do have some pretty effective

enforcement tools. Compliance can get very high, very, very

quickly. That's what these companies respond to, is both

their public image but also financial pressure. So you put

some financial pressure on a company, you get other people in

that industry to clean up very quickly. So, that's our

general philosophy.

Again, that is a quote from the EPA Administrator of region 6. He actually said: You know, it is kind of like the Romans, when they used to conquer little villages in the Mediterranean. They would go into a little Turkish town and find the first five guys they saw and crucify them. That is how you get their attention.

I remember a few years ago a lumber company in my State of Oklahoma called me up and said: I am not sure what to do. The EPA is putting us out of business.

I said: What do you mean, putting you out of business?

This was a lumber company in Tulsa, OK--Mill Creek Lumber. The man who was calling me was the president.

He said: We have been disposing of our used crankcase oil in the same legal, licensed depository for 10 years now, and they have traced some of this oil to a Superfund site, and they say they are now going to fine me $5,000 a day for that violation. Now, that is what the letter said.

I said: Send the letter to me. That is a typical threat by the EPA to try to make you voluntarily go out of business.

So he sent it to me, and sure enough that is what it said. Any concerned reader would look at that and say: They are going to put us out of business. He said they could stay in business maybe another 30 days and that would be the end.

Well, that was a threat. That is what they do to intimidate people. It is not

quite to the level of a crucifixion, but nonetheless times have changed and things have gotten worse over the past few years. So, yes, they have the enforcement tools, and they are able to scare people, intimidate people. And these are the very people who are working and hiring people and doing what is necessary to run this machine we call America.

So according to Administrator Armendairiz, EPA's general philosophy is to crucify and make examples of domestic energy producers so that other companies will fall in line with EPA's regulatory whims. His comments give us a rare glimpse into the Obama administration's true agenda. No matter how much President Obama may pretend to be a friend of oil, gas, and coal, his green team constantly betrays the truth that the Obama administration is fully engaged in an all-out war on hydraulic fracturing, thinking people won't know that if you kill hydraulic fracturing, you kill oil and gas production in America.

Not long after Armendairiz made his stunning admission, the EPA, apparently, began to zero in on the first crucifixion victims. The Agency targeted U.S. natural gas producers in Pennsylvania, in Texas, and in Wyoming, and in all three of these cases, before these investigations were complete, EPA made headline-grabbing statements either insinuating or proclaiming that hydraulic fracturing was the cause of water contamination. But in each of these three cases, the EPA's comments were contrived, and despite their best efforts they have been unable to find any science to back up their accusations.

Of course, this administration has a propensity for making embarrassing announcements on days when they hope no one will notice. During the past 2-week recess, while Congress was out of town, the EPA released several late-Friday-night statements reversing their earlier assertions in these cases. Still, the problem is people are walking around believing these things are true.

The Agency hopes they can admit they were wrong quietly, but we are not going to let that happen. We are not going to let them get away with it. The American people deserve to know exactly why the EPA is pushing ahead with such intensity to capture alarmist headlines, and then, when no one is looking and when their investigation shows they were wrong, quietly backing away from it.

The EPA, in Texas, Wyoming, and Pennsylvania, not only reversed their assertions but did so with a stunning lack of transparency, strategically attempting to make these announcements as quietly as possible, at times they know Congress won't be looking. Let me quickly highlight a few of these examples. In Parker County, TX, the Agency's major announcement--the withdrawal of their administrative order--was announced at a time they knew Congress was adjourning for Easter recess. In Dimock, PA, the EPA made two announcements, and the same thing happened there. In Pavillion, WY, the EPA announced their reversal as Congress was wrapping up that week.

So the same thing was happening. The EPA's general philosophy is to crucify domestic energy producers. Let's look at the three of their crucifixions.

Parker County, TX. I think this could be the most outrageous of all the examples we will be talking about today. I will not have time to hit them all, but I will go back and make the complete statement I was going to make. Unfortunately, there isn't time to finish it now.

But what happened in Parker County, TX, took place in region 6, where my State of Oklahoma is located. Despite Texas State regulators actively investigating the issue, EPA region 6 issued a December 7, 2010, Emergency Administration Order, which determined--I use the word ``determined'' because that is the word they used--determined that State and local authorities had not taken sufficient action and ordered a company called Range Resources to provide clean drinking water to affected residents and begin taking steps to resolve the problem.

Along with this order, the EPA went on a publicity barrage in an attempt to publicize its premature and unjustified conclusions. The day of the order, EPA issued a press release in which it mentioned hydraulic fracturing--not once, not twice but four times--in trying to tie that to problems with groundwater contamination.

The Agency claimed they also had ``determined''--again, they used that word--that natural gas drilling near the homes by Range Resources in Parker County, TX, had caused the contamination of at least two residential drinking water wells.

Regional administrator Al Armendariz was quoted in a press story posted online, prior to him even notifying the State of Texas, that EPA was making their order--and the e-mails have been obtained from the day the order was released--showing him gleefully sharing information with rabid antifracking advocates--and this is a quote by this EPA regional administrator: ``We're about to make a lot of news . . . time to Tivo channel 8.'' He was rejoicing.

In subsequent interviews, Armendariz made comments specifically intending to incite fear and sway public opinion against hydraulic fracturing, citing multiple times a danger of fire or explosion. When State regulators were made aware of EPA's action, they made it clear they felt the Agency was proceeding prematurely, to which Armendariz forwarded their reply calling it ``stunning.''

What was ``stunning,'' to quote Armendariz, were revelations about the way in which the EPA acted in this particular case, which led me to send a letter, at that time, to the EPA inspector general requesting him to preserve all records of communication in connection with the emergency order issued by the EPA region 6 administrator.

Subsequent to the EPA's December 7, 2010, administrative order, on January 18, 2011, EPA followed through on Regional Administrator Armendariz's promise to ``make examples of people'' and filed a complaint in Federal district court, requesting penalties against Range Resources of $16,500 a day for each violation they alleged took place-- for each violation. I don't know how many violations there are. I think there are three or four.

Again, this goes back to the same thing that happened in my State of Oklahoma with the EPA trying to put a lumber company out of business by EPA, except this is a larger company so there are larger fines.

So $16,500 a day in order to align with Armendariz's pursuit of fines which ``can get very high very, very quickly.''

If these actions alone didn't create an appearance of impropriety and call into serious question the ability of Regional Administrator Armendariz to conduct unbiased investigations and fairly enforce the law, just 7 months prior to the region's actions in Parker County, Regional Administrator Armendariz laid the groundwork of how he planned to reign over his region.

In a townhall meeting in Dish, TX, he ``gave an analogy'' of his ``philosophy of enforcement.'' Again, we have already talked about that analogy.

This is a quote I highlighted at the beginning of my speech:

It was kind of like the Romans used to conquer little

villages in the Mediterranean. They'd go into a little

Turkish town somewhere, they'd find the first five guys they

saw and they would crucify them. And then you know that town

was really easy to manage.

Let me go back and be clear about this. This is President Obama's appointed regional administrator for the States of Arkansas, Louisiana, New Mexico, Texas, and Oklahoma comparing his philosophy of enforcement over the oil and gas industries to Roman crucifixions, where they would ``just grab the first five guys they saw'' in order to set the policy and to scare everybody else and crucify them.

Fast forward to late Friday afternoon, March 30 of this year, just a few hours after Congress left town for the Easter recess. The Wall Street Journal reported that:

EPA told a federal judge it withdrew an administrative

order that alleged Range Resources had polluted water wells

in a rural Texas county west of Fort Worth. Under an

agreement filed by U.S. district court in Dallas, the EPA

will also drop the lawsuit it filed in January 2011 against

Range, and Range will end its appeal of the administrative

order.

Listen to this. A few weeks prior to EPA's withdrawal, a judge also concluded that one of the residents involved in the investigation worked

with environmental activists to create a ``deceptive video'' that was ``calculated to alarm the public into believing the water was burning''--water that was the result of the hydraulic fracturing--when it appears the resident attached a hose to the water well's gas vent, not the water, and of course lit it on fire.

I was on a TV show the other night by someone whom I will not mention their name--she happens to be one of my three favorite liberals--and she mentioned: ``This water is so bad it is burning.'' That judge showed what it was and of course made them cease from doing that.

Remember, this is only one of the three recent high-profile instances of backtracking on behalf of the Agency, after they have already scared everybody into thinking it is a serious problem.

Next we go into Wyoming--Pavillion, WY. Last December, EPA publicized and released nonpeer-reviewed draft findings which pointed to hydraulic fracturing as the cause of groundwater contamination. Again, the culprit is always hydraulic fracturing because we all know we can't get any large oil and gas out of tight formations without hydraulic fracturing.

Here again, the EPA stepped in over the actions of the State and made a press announcement designed to capture headlines where definitive evidence linking the act of hydraulic fracturing to water contamination simply didn't exist.

The announcement came in December, despite as late as November of 2011 EPA regional administrator James Martin saying the results of the last round of testing in Pavillion were not significantly different from the first two rounds of testing which showed no link between the hydraulic fracturing and contamination. That is three rounds of testing which showed no contamination from hydraulic fracturing. Yet only a few weeks later EPA announced the opposite.

In another reversal by the EPA in the past few weeks, the EPA stepped back and quietly agreed to take more water samples and postpone a peer review of the findings, something the State of Wyoming had been requesting for quite some time.

Again, the damage was done. They didn't do anything wrong. There was no water groundwater contamination at all. This is hydraulic fracturing.

As I have mentioned so many times before, I know a little bit about this because the first hydraulic fracturing took place in my State of Oklahoma in 1949. There has never been a documented case of groundwater contamination as a result of it. Yet this administration is doing everything they can to destroy hydraulic fracturing.

Dimock, PA, is the third site of the EPA's recent backtracking of its publicized attempts to link hydraulic fracturing to groundwater contamination. In this instance, the Pennsylvania Department of Environmental Protection had taken substantial action to and including working out an agreement with an oil and gas company ensuring residents clean drinking water.

In line with the State's Department of Environmental Protection, on December 2, 2011, the EPA declared that water in Dimock was safe to drink. Just over a month later, EPA reversed that position.

So they go back and forth. What do people remember? They remember this process of hydraulic fracturing is the culprit and is creating serious environmental problems.

What is maybe more egregious was--to quote Pennsylvania DEP secretary Michael Krancer--EPA's ``rudimentary'' understanding of the facts and history of the region's water: Independent geologists and water consultants such as Brian Oram have been puzzled by the Agency's rationale for their involvement in Dimock because the substances of greatest concern by EPA are naturally occurring and commonly found in this area of Pennsylvania. Yet EPA has chosen this area to attack because of the presence of hydraulic fracturing.

In other words, this has been going on for years, long before hydraulic fracturing.

By the way, I have to say they used to attack oil and gas, but it was always out West in the Western States. The chair knows something about that. This is different now because we have these huge reserves that are in places such as New York and Pennsylvania. All that time there has not been hydraulic fracturing, but as soon as hydraulic fracturing came in, they said this is the result of hydraulic fracturing when it has been there all the time.

Of course, this is part of the strategy to try to convince Americans we don't have the vast supply of natural resources we clearly have.

I was redeemed by this. I have seen saying all along that of all the untruths this President has been saying, the one he says more than any other is that we only have 2 percent of the reserves of gas and oil and we use 25 percent. It is not true. I don't want to use the ``L'' word. I don't want to get everybody mad, but it is just not true.

The U.S. Geological Survey revealed just a few days ago that President Obama's favorite talking point, that we only have 2 percent of the world's proven oil, is less than honest. The 2 percent the President quotes is proven reserves, but he ignores our recoverable reserves. This is coming from the USGS. Our recoverable reserves are some of the largest in the world.

According to information gleaned from the USGS report, America has 26 percent of the world's recoverable conventional oil reserves. That doesn't begin to include our enormous oil shale, tight oil and heavy oil deposits. That is just a fraction of it. But that is 26 percent of the world's recoverable oil.

Our problem is our politicians will not allow us--and particularly the Obama administration--to drill on public lands and to be able to capture that.

We also hold almost 30 percent of the world's technically recoverable conventional natural gas.

In other words, to put it in a way that I think is more understandable: Just from our own resources and at our own consumption level, we could run this country for 90 years on natural gas at our current level of consumption and for 60 years on oil. That is what we have. That is the answer to the problem. It is called supply and demand. There is not a person listening now who would not remember back in the elementary school days that the supply and demand is real.

But we all know he remains fully committed to his cap-and-trade, global warming, green energy agenda--a plan that is to severely restrict domestic development of natural gas, oil, and coal, to drive up the price of fossil fuels so their favorite forms of green energy can compete. It is, quite simply, a war on affordable energy--and, at that time, they weren't afraid to admit it.

Now they are backtracking a little bit--such as using hydraulic fracturing and not saying they are opposed to oil and gas.

Do you remember Steven Chu, the Secretary of Energy, President Obama's man? He told the Wall Street Journal that ``[s]omehow we have to figure out a way to boost the price of gasoline to levels in Europe.''

We all know the infamous quote from President Obama. He said that, under his cap-and-trade plan, ``electricity prices would necessarily skyrocket.''

The President himself has been on record supporting an increase in gas prices. Although, according to him, he would ``have preferred a gradual adjustment'' increasing the average family's pain at the pump. But this isn't a plan that gets you reelected. So the gas prices have skyrocketed, and with the utter failure of Solyndra, President Obama's dream of green energy economy is in shambles. We can be sure we won't be talking about this plan to raise energy costs until after the election.

I would have to say the President's own Deputy Energy Secretary Dan Poneman last month made a statement, and I appreciate it, because he said we have a very strong belief that the laws of supply and demand are real.

They have been saying that the laws of supply and demand are not real. Gary Becker--I quoted this the other day. He is a Nobel Prize- winning economist, professor at the University of Chicago. He has said ``supply and demand are the cause of the vast majority of large fluctuations in oil prices, and it is hard to believe that speculation has played a major role in causing a large swing in oil prices.''

The President tried to say it is not supply and demand. We do not need to

develop our own resources to bring down the price of gas at the pumps. It is speculation. Here is a Nobel Prize winner saying that just flat is not true.

The President's budget proposal this year alone--I want to get back to how he has made this attempt to tax oil and gas out of business. The President's budget proposal this year alone amounts to a $38.6 billion tax increase on oil and gas companies, which would hit my own State of Oklahoma where 70,000 people are employed in oil and gas development especially hard. His proposal specifically would either modify or outright cancel section 199--that is the manufacturers' tax deduction that is something all other manufacturers would be able to enjoy--for the intangible drilling costs, IDCs: percentage depreciation, tertiary injections. All of these were in his budget--not just this year, not just last year, but every year since his budget 4 years ago--to try to tax the oil and gas companies out of business.

His actions have not slowed his rhetoric. In fact, President Obama has become so desperate to run from his antifossil fuel record that he ran all the way to Cushing, OK. That is my State. We have a major intersection of the pipeline down there. This President, in his attack on fossil fuels, stopped the XL Pipeline that goes from Canada down through my State of Oklahoma. He came all the way to Oklahoma to say: I am in support of the pipeline that goes south out of Oklahoma into Texas.

Wait a minute, that is because he cannot stop it. He could only stop the other one because it crossed the line from Canada to the United States. So he came all the way to Oklahoma to say he was not going to stop something that he could not stop anyway.

President Obama is trying to take credit for the increase in oil and gas. I have to get this out because I think so many people do not understand this. The increase that is taking place in production is all on private lands. It is not increasing on public lands. It is decreasing on public lands, but on private lands he has no control. In the report by the nonpartisan Congressional Research Service, since 2007, quoting now from the CRS:

About 96 percent of the [oil production] increase took

place on non-federal lands.

According to the Obama Energy Information Administration, total fossil fuel sales of production from Federal lands are down since 2008--they are down, not up--and during a time of a natural gas boom throughout the country. In other words we have gone through the biggest boom on private land, but he will not allow us to do it on public land, and that is where these tremendous reserves are. Gas sales from production on Federal lands are down 17 percent since 2008.

Finally, according to PFC Energy, which is a global consulting firm specializing in the oil and gas industry, 93 percent of shale oil and gas wells in the United States are located on private and State lands, hardly the Federal Government triumph that the President falsely attempts to take credit for when you put all the pieces together.

President Obama's election strategy is clear: Say great things about oil and gas, say great things about coal and the virtues of domestic energy production, but under the surface try hard to manufacture something wrong with hydraulic fracturing. Remember, not 1 cubic foot of natural gas can be retrieved in tight shale formations without using hydraulic fracturing.

As I said before, that was started in my State of Oklahoma. We are going to make sure we are the truth squad that tells the truth about how we can bring down the price of gas at the pump. It gets right back to supply and demand.

I am going to come back at a later date and give the long version of what I have just given in the last 45 minutes, but I see my friend from Tennessee is here. So I yield the floor.

Mr. President, I thank the Senator from Utah for his concluding remarks regarding the amendment that I assume will be offered by the Senator from Illinois, as it is cleared to be offered.

I thank Senator Hatch for his great leadership on the issue of making sure the American people can have access to healthy, life-supporting vitamins, minerals and supplements, without having it go through untold processes and reviews and approvals by the FDA, and all that kind of regulation.

Senator Hatch was the leader on the DSHEA bill when we passed it in 1994. I was happy to work in tandem with him on that. It has proven, through the years, to be a great success for the American people. The American people all over this country take vitamins and other supplements, and they are living healthier because of this.

I say to my friend that I heard the Senator from Illinois on the floor yesterday give an impassioned speech about a very sad case about a young woman who evidently consumed some energy drinks with a lot of caffeine in them and had heart arrest and died. It is a very sad story. But as sad as that is, you can't keep people from abusing things. People also die every year from aspirin poisoning, where they took too many aspirin.

Reasonableness has to enter into this. We have worked together to make sure the labels are good on all of these things, so that people know what is in them. The FDA has the authority--as the Senator said, every Commissioner has said they have the authority to keep dangerous products off the shelf and to remove them from the shelf. They have all that authority. These cases, as I said, that Senator Durbin brought up are very sad, and you wish it were not so. I don't think it lends itself, though, to overturning what has been working now for 17, going on 18, years and working well for the American people.

I join the Senator from Utah, and I hope the amendment might not come up. But if it does, it does. I am sure there will be some debate on it. I join with the Senator from Utah in urging all Members of the Senate to vote that amendment down. If it comes up, I will move to table that amendment. Hopefully, we can approach this in a much more judicious, responsible, thinking manner.

I say to my friend from Utah--and I know he agrees--we are not taking the position that nothing has ever been changed. We have changed DSHEA in the past to make it work better. We did it after due deliberation, committee hearings, and going through the process to see what it means in terms of access to these products by the American people, to make sure we keep the intent of DSHEA there.

Again, I am more than willing, as chairman of the committee--and the Senator used to be chairman of the committee at one time, and then ranking member--we are always willing to look at these things and have a hearing on them and get more information. Again, I thank the Senator from Utah, who has been a great leader on this issue.

Mr. President, how much time does this side have on the bill?

I reserve the remainder of my time on the bill. If the Senator from Illinois wishes to bring up his amendment, we can bring it up.

Mr. President, again, I understand I have 24 minutes left.

I will make a short general statement about the bill. I talked about it in the past. I want every Senator to know that we are now on the FDA reauthorization bill. This is reauthorizing the prescription drug user fee, the medical device user fees, and then we are authorizing a new program, the generic drug user fee, biosimilar user fee, and so we are on the bill now. There is 30 minutes for debate on each amendment that has been listed. Senators know who they are and what the amendments are.

I want to make it clear that the unanimous consent we just adopted says that all debate time will expire at 2 p.m. tomorrow. So I say to Senators, if you want to take your 30 minutes and debate your amendment, now is the time to do it. If you wait too long, 2 o'clock will come tomorrow, you won't have the time, and you will be limited to 1 minute. There will be 2 minutes on each amendment after that. Those who have amendments and wish to discuss them, you are guaranteed at least 30 minutes, but all time runs out at 2 p.m. tomorrow. If you want to talk on your amendment and make your point, now is the time to do it this afternoon.

I yield the floor.

Mr. President, how much time remains on this amendment?

Mr. President, I just want to say, first of all, that I have the greatest respect, as he knows, for the Senator from Illinois. He is one of the true consumer champions in the entire Congress and has been for all of his time here. So it is kind of hard to argue against the Senator when he is such a champion of consumers. But on this issue I think we part a little company.

I want to make it very clear that under DSHEA, supplement labels must already disclose their ingredients--must disclose their ingredients. Even when a product is reformulated, if the supplement contains new ingredients, then the label must reflect that change. These were all added to the bill. We added that for consumer protection.

Now, again, it is not as though FDA doesn't know what is out there. Under current law, supplement manufacturers have to biannually register their products. There is a biannual registration requirement right now. So the concern is that FDA just doesn't have the resources to do anything. I have tried--and the Senator knows because he is on the Appropriations Committee--to get more funds for the FDA to do this, but we haven't been able to get the funds necessary for the FDA to even do what jobs they are supposed to do now.

I repeat for emphasis sake that every FDA Commissioner--those appointed both by Democratic or Republican Presidents--have said the DSHEA gives them adequate authority to keep dangerous products off the shelves. So the authority is already there. What the FDA needs is the resources. That is money. That means appropriations. Quite frankly, I don't see that happening this year--that we are going to give them any more. We are just going to give them more of a burden, and I think it will give a false sense of security to people because FDA simply won't be able to do that.

Lastly, as the Senator did say, we do have a voluntary program for ingredients and things with the dietary supplements with the National Institutes of Health that is already in place. That is coupled with the biannual reporting requirements plus the fact every dietary supplement has to have the ingredients listed on the label. So there is plenty of consumer protections out there. It is just that we can't protect a consumer who doesn't want to follow directions, who doesn't want to follow the guidelines listed on the labels themselves. I don't know how to protect people from that. Sometimes we just have to continually tell people to follow the directions. If they follow the directions, they will be fine.

That is why I think this amendment is ill-timed. I said to the Senator, and I mean this, that the Senator from Utah and our committee would be more than happy to have hearings again to flesh it out a little more and to see just what might be possible. But I come down to this as the bottom line: The FDA needs more money and they need more personnel to do this job.

I yield the floor.

Just one minor correction I would make, and that is under the DSHEA law, the FDA must approve any health claims made by any dietary supplement or vitamin. The only health claims they can make are structure function claims, but they have to be approved by the FDA. I just wanted to clear up that point.

I would also say further that I honestly don't know of any vitamin or supplement that is out there in the market that is dangerous if taken as directed--if taken as directed. As I said, anybody can abuse things. But if taken as directed, I, quite frankly, don't know of any supplement out there that is dangerous. Quite frankly, if taken as directed, they help maintain people's health and keep them healthy rather than being injurious to their health.

I yield the floor.

Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Again, Mr. President, I have to ask, how much time remains on the bill for both sides?

Mr. President, I object. How much time is left on the Sanders amendment?

Will the Senator from Oklahoma withhold? We have some people who want to speak. Once the time has run, then we automatically move on to another amendment and could bring up the Senator's amendment at that point.

There is 10 minutes in opposition to the amendment.

Senator Mikulski was here earlier. She wants to speak on this amendment. If we just wait 5 minutes?

I am sorry, I was wrong. I thought the Senator wanted to speak on the Sanders amendment. She wanted to speak on the underlying bill itself?

The Senator just seeks 5 minutes?

Since it is my time, I yield the Senator from Maryland 5 minutes on the underlying bill.

Mr. President, how much time is remaining on the Sanders amendment?

I will yield myself a couple of minutes.

I join with my colleague Senator Enzi in opposition to the Sanders amendment. We are all disturbed by a lot of what we are reading and these big settlements. I know the recent one a couple of weeks ago on Abbott Labs where part of the prosecution case was actually that this was part of their business model. Then they had to settle it. So this is all very disturbing.

However, that cries out more for, perhaps, looking at the criminal charges and perhaps strengthening some of those things but not taking away exclusivity. If you do that, a lot of times you could take away exclusivity from someone who just committed a misdemeanor. A lot of these settlements were misdemeanor charges where no intent was shown.

A lot of times, if you did this, you might penalize someone who maybe had done something wrong in the past, and now maybe they have new leadership, a new company, and reformed themselves, and now they have to lose their exclusivity? You would not want to do that.

Third, if you do this--I think Senator Enzi pointed this out correctly--if there is no reason to settle, then people are going to go to the wall in terms of defending themselves, and DOJ doesn't have all that kind of personnel and the time to do that. I think we would then have an even worse situation of people committing fraud because then they would know they would not have any reason to settle it whatsoever. Settlement is a good tool to be used by prosecutors to get cases to justice, to make sure consumers are made whole, and to let people know they are being watched. That is what they do.

I think the Sanders amendment, while maybe well-intentioned--I know it is well-intentioned. I know the Senator has all good intentions of what he wants to do. But I think it goes too far and is not the right solution to that problem. So I would oppose Senator Sanders amendment also.

I yield the floor.

Would the Senator yield for a question?

I think the Senator is making a lot of common sense. The only question I would ask is--and I don't know a lot about this. I haven't read the GAO report. But if, in fact, every employee says, I know they are going to get me on this timeliness. So it is the balance of safety and quickness, safety and expediency. In other words, we try to get a balance. We want devices and drugs approved as quickly as possible, but we don't want to jeopardize safety. Those are the two things we always try to balance here, safety being the foremost. We want things to be safe.

My question is, by enshrining this into law rather than in the administration, would this somehow put more undue pressure on reviewers and others to do something quickly and jeopardize the safety aspect?

Madam President, I join Senator Enzi in thanking Senator Burr for being not only a very valuable member of our committee but I would say the Senator's fingerprints are a lot on this bill we have before us. He has worked very hard on this bill and I think helped to improve it every step of the way over the last year.

I was looking through the list of different things here. Senator Burr was one of the leaders in our working group on the supply chain, which we have in this bill to make sure those things coming from other countries have good manufacturing practices on them and we can keep track of them.

The provision of clarifying the ``least burdensome'' standard on clinical data for device approval was also the result of the Senator's hard work. The Senator was also in the working group on the GAIN bill regarding antibiotic incentives for getting more incentives for new antibiotics. And there was a Burr-Coburn bill regarding enhanced reporting requirements for FDA, and that basically is also included in the bill we have in front of us.

So in every respect, the Senator from North Carolina is a great member of our committee, a very valuable member of our committee. As I said, we are looking at the amendment he has now brought up, and I am sure, as Senator Enzi said, we will be talking about this in the next few hours and going into tomorrow. But I again want to pay my respect to the Senator from North Carolina and thank him for all the hard work he has done on this bill.

I yield the floor.

Madam President, an inquiry: Is the Senator bringing up-- --no, the Senator does not have an amendment pending.

The Senator wishes to speak on which amendment?

Madam President, how much time is remaining on the Grassley amendments, the amendments offered by the Senator from Iowa?

How much time does the Senator wish to take?

I would ask that 10 minutes of the time in opposition to the Grassley amendment be allocated to the Senator from Minnesota.

I ask unanimous consent that the order for the quorum call be rescinded.

Mr. President, how much time remains on the two amendments offered by the Senator from Maryland?

Mr. President, I will speak on the time available for the amendments.

Amendment No. 2125

First of all, amendment No. 2125 will help ensure that health care providers, patients, and payers better understand the benefits and risks associated with drugs, especially with respect to those drugs by underrepresented subpopulations.

I believe this is an important and noncontroversial amendment. I hope we can support this amendment.

Amendment No. 2141

On the other amendment, No. 2141, which is the small business report, I think it is important FDA give small businesses a helping hand. I understand each FDA center has a small business office and that each of FDA's five regional offices has a small business representative. This report the FDA would have to submit on the basis of the amendment offered by Senator Cardin would provide Congress with more information about how FDA uses its resources for small businesses to help encourage small companies.

Again, I think this is another valuable addition to our bill and, hopefully, we can support that amendment also. So I thank the Senator from Maryland for his offering these two amendments and for what I consider to be improvements to the underlying bill.

I thank him very much for that.

Mr. President, again, I would say to the Members who may be in their offices that we still have some extra time before we will be adjourning this evening. Again, I would advise Senators that by at least 2 p.m. tomorrow, when the bell rings, we will be moving to voting, if not before then. So any Senator who has an amendment to bring up and who wishes to talk about it, I wish they would come to the floor and do that now.

Mr. President, I yield the floor.

Mr. President, I ask unanimous consent that the time during the quorum call be divided equally.

Mr. President, I rise in opposition to the amendment offered by the Senator from Kentucky, and I oppose it for several reasons.

I believe I am in the court of equity now: I come with clean hands because I am one of the authors of the Dietary Supplement and Health Education Act, along with Senator Hatch, in 1994. We worked in tandem over a period of a couple of years to get the legislation through. A lot of compromises were made at that time, not only here in the Senate but also with the House when we went to conference. I believe the right balance was struck, and I think it has proven its worth over the years.

We have done some minor modifications to it over the years. As I have often said, when we write laws around here they are not chiseled in stone for all eternity. These aren't the Ten Commandments, they are laws, and sometimes they need to be modified and changed a little bit, usually tweaking. But this amendment basically turns the whole law that we had since 1994 on its head.

We have a process now where the FDA regulates the supplements as foods. These are foods, not drugs. So as

we hammered out this agreement, supplements can make nutrient, structure, function claims without any FDA preapproval. If they want to make a health claim, then it has to be approved by FDA, and FDA has to find that it is supported by appropriate scientific evidence. Under this amendment, substances that today are considered drugs and used to treat diseases as serious as cancer or HIV could be marketed without any rigorous FDA review that we have heard from many speakers here today is the gold standard of drug regulation throughout the world. It would turn our current system of drug regulation on its head. It would be a huge setback for health. It would foster a system rife with potential for health fraud. The big losers would be patients.

Frankly, as someone who is a strong supporter of the Dietary Supplement Health and Education Act, and I would say along with Senator Hatch one of its protectors for all these years, I daresay the amendment offered by the Senator from Kentucky would destroy DSHEA. It would destroy it and I don't want to see it destroyed because I think it is doing a lot of good for a lot of people in this country. It is working well. Consumers have access to a wide range of safe products. There is no reason to upset its success, because this amendment would do that.

To think that somehow you could go out and make any health claim you want? Back to the days of snake oil salesmen: ``This elixir will do everything, it will cure every ailment you have and turn the clock back 20 years on your age.'' People would buy it, and what was it? It was 80-percent alcohol and 20-percent water or something like that. They made all these crazy claims. We are going to move to that kind of system now? And the only recourse would be to take them to Federal court and then have a trial and go through all that and then, OK, then they appeal it and finally you find out, OK, the court says no, there is not enough scientific evidence to warrant it so you have to take that product off the market.

We are going to do that for every one of the thousands and thousands of different products that are out there? What a mess this would be. First of all, the Federal courts would not have the wherewithal to do every one of those. Second, who has the money to take all that to court? And it would literally destroy--bring down an industry that has done well in this country. The dietary supplement industry, the vitamins and minerals industry in this country, has done a great job and I do not want to see it ruined. This would ruin it.

Last, the Senator from Kentucky talked about increasing the mens rea, the mind; you know, in law school, what your mental condition, what your thought processes were--what was your intent. It would increase it. It would need to be shown to enjoin or prosecute serious violations of the Food, Drug, and Cosmetic Act. I find this amazing. This idea that we need to make it harder to enforce a public health protection statute, not easier, is deeply troubling. I see no legitimate reason to do this.

The goal of this amendment is clearly to render the FDA virtually incapable of addressing industry abuses. I think this amendment would have deleterious effects on the Dietary and Supplement Education Act, and the industry, and also on the FDA's ability to regulate prescription drugs. You can say just about anything about what your health claims would be on any kind of product and the only recourse, as I said, would be to go to Federal court.

Again, this is a consensus measure. We have built a very broad bipartisan support for this FDA user fee bill. It is must-pass legislation. We cannot jeopardize that consensus.

For those reasons, I oppose the amendment offered by the Senator from Kentucky.

Mr. President, I suggest the absence of a quorum.

Mr. President, I ask unanimous consent the order for the quorum call be rescinded.

Mr. President, how much time remains on the amendments offered by the Senator from Maryland, Senator Cardin?

Mr. President, I ask the Senator from Colorado, how much time does the Senator seek?

I ask 10 minutes of the time from amendment No. 2141 be yielded to the Senator from Colorado.

Mr. President, I join Senator Enzi in thanking Senator Bennet for being a very valuable member of our committee and for all of the great work the Senator did on this bill. His fingerprints are all over this bill, and, as he pointed out, it is a great bill. There was great bipartisan support.

I thank the Senator for all of his work in our working groups, especially the drug supply chain. This is a key part of this bill. The FDA will have the authority and the wherewithal to go back up the chain to where these drugs come from. The Senator was the first one to point out to me at the committee hearing that I think about 80 percent of all of the ingredients that go into our drugs in this country come from outside this country, but we had no real idea on where and how, and now we can insist on good manufacturing practices. So I would say this singular addition to this bill can be traced right back to the Senator from Colorado, and I thank him very much for his leadership on this issue and in helping us to get this bill to where we are today. I thank the Senator.

I would like to yield 10 minutes off of the opposition of the Grassley amendment 2121 to the Senator from Minnesota.

Mr. President, as the Senator said, his amendment would amend the Controlled Substances Act to make any substance containing hydrocodone--Vicodin--a schedule II drug. As he said, this is presently a schedule III drug. The most significant difference is, for patients, schedule II drugs are not allowed to be refilled. That is the key to the amendment.

I applaud the Senator. I have great concerns regarding the increased abuse of prescription drugs. According to the Centers for Disease Control and Prevention:

Overdoses involving prescription painkillers are at

epidemic levels--

Epidemic levels--

and now kill more Americans than heroin and cocaine combined.

That is a quote from the Centers for Disease Control and Prevention.

According to CDC, more than 40 people die in America every day from overdoses involving narcotic pain relievers such as hydrocodone.

For this reason, I applaud Senator Manchin for his amendment and the efforts he has undertaken to reschedule this drug. It is the most frequently abused narcotic and that is a strong reason to reschedule it into section II.

Again, I thank the Senator for this amendment. At the appropriate time I will ask for its adoption. Again, I thank the Senator from West Virginia. This is a great amendment. It improves the bill. It is widely accepted, and the Senator has been on the right track on this issue for a long time. I applaud him for doing this and, believe me, a lot of people in America are going to thank the Senator for getting this drug rescheduled to cut down on the terrible overuse of this drug in America. I thank the Senator very much.

If the Senator would withhold the unanimous consent request.

We have a number of amendments we are putting together, and at the appropriate time I will make sure that happens.

Mr. President, I ask unanimous consent to set aside all pending amendments in order to call up Reed amendment No. 2126, and I ask that the clerk report the amendment by number.

Mr. President, I further ask unanimous consent that the following amendments be agreed to en bloc: Cardin No. 2125; Cardin No. 2141; Grassley No. 2121; Grassley No. 2129; Manchin No. 2151, as modified; and Reed No. 2126.

Mr. President, we are finished with business for today. We do have some more amendments to be called up and voted on tomorrow. I understand we are coming in--I do not know exactly what time has been set for the morning, but after the leaders' time has been used, we will be back on this bill.

Again, I remind Senators and their staffs that we have until 2 p.m. for their amendments to be brought up and to be debated. The sooner we get to those in the morning, the better off we will be.

So as soon as the leader time is exhausted tomorrow morning, we will be back on our bill.

So, Mr. President, I suggest the absence of a quorum and ask unanimous consent that the time in the quorum call not be taken off our bill.

Madam President, I ask unanimous consent that the pending amended be set aside so that I may call up amendment No. 2125.

Madam President, I ask unanimous consent that that amendment be set aside so I may call up my amendment No. 2141.

Madam President, I rise to discuss the FDA Safety and Innovation Act, the bill now under consideration here in the Senate.

I applaud Chairman Harkin and Ranking Member Enzi for their leadership in moving this critical legislation through the HELP committee, and now to the Senate floor.

As an agency of the Department of Health and Human Services, the FDA has as part of its broad mission to protect Americans' health by assuring the safety of drugs, biologics, medical devices, our Nation's food supply, vaccines, tobacco, cosmetics, and animal food and drugs. Every single day, every single American depends on the vital work of FDA's employees.

There is a second key element to the FDA's work--helping to speed innovations to the marketplace through the drug, biologic, and medical device approval process. It's that component of the FDA's mission that we are addressing this week--reauthorizing the user fees that help fund the approval process.

I'm proud of the FDA's workers--the majority of the agency's more than 11,000 employees are based at its headquarters in Silver Spring, MD. It's

there that the process of medical innovation, which begins at NIH with basic research, is completed as lifesaving drugs and medical devices are approved for use.

A recent report from the IMS Institute for Healthcare Informatics found that in 2011 ``medicines with new mechanisms of action were launched in greater numbers than in prior years, with many representing significant breakthroughs and first-time therapies became available to treat several types of cancer, multiple sclerosis, hepatitis C, and cardiovascular conditions.''

At the same time, we know that greater resources are needed for the agency to be able to fulfill its mission in a timely and effective manner. For all of our Nation's investment in health care research, additional new medicines will not reach patients promptly unless the FDA has the necessary funds to perform its regulatory duties.

That's why the user fee amendments are so important. This 5-year reauthorization bill is Congress' opportunity to improve and update the regulatory process, and augment appropriations so that the agency can achieve its goals.

The purpose of the user fee program is to reduce the time in which FDA can review and make decisions on marketing applications. Lengthy review times affect drug and medical device manufacturers, who face delays in bringing their products to market, and more importantly they affect patients, who face delays in receiving needed treatments and cures.

The bill reported out of committee will move us forward. It will reauthorize the prescription drug user fee program, PDUFA, through October 1, 2017.

This is necessary so that the Federal Goverment can continue to collect application, establishment, and product fees from drug companies to support the review process for the next five years.

It will also reauthorize the medical device user fee program, MDUFA, through 2017 as well, and in an effort to ensure that the FDA's personnel needs are met, it would authorize a streamlined hiring of employees. Additionally, the Critical Path Public-Private partnerships, which are so important in encouraging medical product innovation, are reauthorized through 2017.

Two new user fee programs are established in the bill for generics and one for biosimilars. It's estimated that the monies generated from the generic user fee program will enable the FDA approval time for generics to be shortened from the current time frame of 30 months to 10, speeding savings to patients and to all taxpayers, as Medicare, Medicaid, and CHIP programs will reap considerable cost savings.

The base bill takes key first steps toward resolving the vexing issue of drug shortages. I want to acknowledge Senator Klobuchar's work in this area.

All of us have heard from our community hospitals and physicians about the anguish they feel when they cannot secure medicines necessary to treat the patients in their care. I certainly have, and I have also heard from patients themselves who cannot fathom how such shortages could occur.

Carey Fitzmaurice of Bethesda, who is undergoing treatment for ovarian cancer, wrote to me:

My doctor put me on Doxil and carboplatin to try to get rid

of some tumors. Doxil was chosen because of recent research

showing that it works especially well in those patients with

the BRCA gene, like me.

I had four treatments with both drugs and was responding

very, very well. I have now missed three doses of Doxil due

to the shortage. I am ``treading water'' with the Carbo but

am frustrated that I am no longer making progress towards

remission. Then there is all of the stress involved with the

shortage--not knowing if there is anything I can do, or what

will happen next or how long I will be in treatment.

I am trying to continue to be a wife and mother and to hold

down a job. This shortage is adding insult to injury. I

wonder why we are being asked to raise money to find cures

when we can't even get access to the cures that exist now.

Carey is one reason why I am a cosponsor of Senator Klobuchar's bipartisan bill, the Preserving Access to Life Saving Medications Act, and I am pleased that the bill's early notification requirement provisions are included in the PDUFA bill we are considering today. It also requires the Secretary to establish a task force and create a strategic plan to address shortages.

This is also an urgent matter because shortages affect the ability to conduct clinical trials. Senator Rockefeller and I worked together some years ago to get Medicare beneficiaries coverage for the routine costs associated with clinical trials.

As a result of Senator Brown's work on the Affordable Care Act, insurance companies now must also cover the routine costs of trials. Access to trials often means the difference between life and death for cancer patients, and the availability of trials has enormous implications for the effectiveness of treatments for all patients going forward. There are more than 150 cancer clinical trials being conducted now at the NIH Clinical Center in Bethesda.

But the impact of shortages on clinical trials has not received a great deal of attention outside the research world. It is an extremely important issue for Medicare beneficiaries, who have the highest rates of cancer incidence. Cancer trials do not usually use placebos.

Rather, they compare standard of care drugs, versus, or in combination with, the experimental drug.

Doctors face difficult choices when the standard of care drug is in short supply. They must decide whether to use the limited supply of an existing drug to treat new patients, or use it in clinical trials to help find a cure for those who are seeking new therapies. Cancer trials have been delayed, limited the number of patients enrolled in the trial or stopped the trial entirely because there is simply not enough of the standard of care drug.

So I am pleased that the bill contains language requiring the Secretary's strategic plan to considering the impact of drug shortages on research and clinical trials.

The Finance Committee held hearings on drug shortages earlier this year as well, and we learned that the majority of shortages are found in the generic drug market. Some are due to a lack of raw materials, while others occur because the drugs yield lower profits than newer generics, and the interest in continuing to market those drugs is no longer there.

The notification language in this bill is a good start, but I believe it should be strengthened to better ensure compliance, and so I have cosponsored Senator Blumenthal's amendment establishing civil monetary penalties for manufacturers who knowingly fail to notify the FDA of shortages for essential medicines.

I express my appreciation to Senator Pryor for his leadership on nanotechnology. I am pleased to join him in this effort and am hopeful that the language we have sponsored can be included in this bill.

Nanotechnology has become increasingly indispensible in our daily lives--everything from cellphones and MP3 players, to packaging of our snack foods, to cancer treatments in development employ the use of nanotechnology.

As this burgeoning technology continues to power more of our consumer products and drive job creation in America, it is essential that we fully assess, understand, and address any risks that it may pose to safety, public health and our environment.

By soundly assessing the safety of nanotechnology and developing best practices, the Nanotechnology Regulatory Science Act of 2011 will further job creation, public safety and growth in the industry.

Our bill would establish a program within the FDA to assess the health and safety implications of using nanotechnology in everyday products, and develop best practices for companies using nanotechnology. This new program would bring more highly-skilled research jobs to Maryland.

FDA's laboratories and research facilities at its consolidated headquarters are ideally suited to conduct the scientific studies required under the bill.

The USDA's Beltsville Agricultural Research Center, BARC, is similarly equipped to provide innovative scientific technology, training, methods development, and technical expertise to improve public health.

Lastly, I urge my colleagues to support language addressing the lack of available information on the benefits and adverse effects of drugs and medical devices for minority populations.

Today, warnings and safety precautions are included as part of the initial approval by the FDA. The Agency

may also require them post approval--after the drug has been approved and sold for months or years. We know that additional side effects or risks may become known once a product is in the market and a much larger, diverse patient population is using it.

Ideally, a detailed conversation between physician and patient about the risks versus the potential benefit of taking a drug would always take place in a timely and informed manner. However, this is not always the case and is especially true if the warning is added after drug is initially prescribed and been on the market for an appreciable time period.

The randomized controlled trials used by the FDA when reviewing new drug applications, while the gold standard for examining efficacy, do not necessarily reflect the overall population for a variety of reasons.

For example, members of minority groups are generally underrepresented in clinical drug trials even though they are disproportionately affected by diseases such as diabetes, hypertension, colorectal, prostate and cervical cancer, stroke, congestive heart failure, acute coronary disease, and asthma.

We know that there are racial and ethnic differences in responses to pharmaceuticals, and they may not become known until the drug is in wide use, certainly beyond the constraints of a controlled clinical trial.

In today's world, post-approval surveys and studies are becoming more prevalent, and our ability to discern the effect of a drug over time on a variety of patient types is significantly improving. This information should be made available in a variety of ways to ensure that it reaches physicians, payors and patients, and I have filed an amendment that would greatly improve access to this information.

It would build on the current HHS ``Strategic Action Plan to Reduce Racial and Ethnic Health Disparities'' by directing the Secretary to develop a communications plan to ``address the best strategy for communicating safety alerts, changes to the label or labeling of drugs, including black box warnings, biological products or devices, health advisories, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including varied means of electronic communication.''

This amendment has the support of the chairman and the ranking member, as well as the FDA and BIO, and I urge the Senate to adopt it.

Mr. President, PDUFA reauthorization is essential to furthering the Nation's health, bringing the medical innovations conceived by researchers and entrepreneurs into practice, and creating jobs. I look forward to working through the process to improve this bipartisan legislation.

Again, I thank and congratulate Senator Harkin and Senator Enzi for their incredible work in bringing forward this bill that is so important to the public health of our Nation. We are dealing with the safety of drugs, biologics, medical devices, our Nation's food supply, vaccines, cosmetics, and the list goes on and on. It is critically important that we have the proper authorization so that the FDA has the resources it needs to advance innovation into the marketplace, products that fall within the jurisdiction of the FDA.

We know that the basic research has gone on at NIH. To get products to market, it is important that the FDA have the resources in order to move the process forward. I am proud of the 11,000-member workforce headquartered in Silver Spring, MD, for the FDA. They work very hard. This reauthorization legislation of the user fees will give them the tools in order to get the job done. I am particularly impressed that this is a 5-year reauthorization bill that will give them predictability, which is needed in order to get the job done.

I applaud Senator Harkin and Senator Enzi. We don't see enough of these bills moving forward with the type of process our leaders have brought forward. They have resolved a lot of the issues, and we thank them for that. They have brought us a bill that enjoys broad bipartisan support and is in the best interest of our Nation. I am proud to support this legislation, and I thank them for the manner in which they have proceeded in committee and now on the floor.

Also, I point out that this bill deals with the drug shortage issues. I applaud the occupant of the chair, Senator Klobuchar, and her efforts in dealing with those issues. We need more effective notification of potential shortages so that we can take appropriate action to make sure the people of this Nation have an adequate supply of medicines.

Let me share with my colleagues a letter I received from Carey Fitzmaurice of Bethesda, MD, who is undergoing treatment for ovarian cancer. She wrote:

My doctor put me on Doxil and carboplatin to try to get rid

of some tumors. Doxil was chosen because of recent research

showing that it works especially well in those patients with

the BRCA gene, like me.

I had four treatments with both drugs and was responding

very, very well. I have now missed three doses of Doxil due

to the shortage. I am ``treading water'' with the Carbo but

am frustrated that I am no longer making progress towards

remission. Then there is all of the stress involved with the

shortage--not knowing if there is anything I can do, or what

will happen next, or how long I will be in treatment.

I am trying to continue to be a wife and mother and to hold

down a job. This shortage is adding insult to injury. I

wonder why we are being asked to raise money to find cures

when we can't even get access to the cures that exist now.

That is a frustration that is out there on drug shortages. I am very pleased that this legislation will move us in the right direction in answering that question.

It doesn't only affect those under active treatment, it also affects a number of clinical trials. There are currently about 150 clinical trials at NIH involving cancer and trying to find answers and cures for cancer. The problem is that on these clinical trials they don't use placebos, they use the current drug therapy that is known for the treatment against an experimental process. If there are not enough drugs available to treat people for the current protocols, how can those drugs be used in a clinical trial. As a result, we are finding it very challenging to move forward with the clinical trials that are needed. This legislation recognizes that concern and specifically deals with it. I congratulate the committee leadership for addressing that issue.

I also will mention one other issue: nanotechnology. I congratulate Senator Pryor for his leadership in this area. Programs at FDA to access health safety facts and using nanotechnology in everyday products is something we need to do. This legislation advances that. I point out that I am proud that the lab facilities at the FDA are fully capable of dealing with the challenges presented by nanotechnology. This legislation acknowledges that.

We also, in Maryland, are proud of the Beltsville Agricultural Research Center, which will advance nanotechnology and the impact it has on everyday products and safety. Those issues will be addressed also by the underlying bill. We very much appreciate the leadership of the committee.

Let me talk for a moment about the two amendments I have brought forward. Amendment No. 2125 deals with safety warnings, particularly as they affect the minority community. Clinical trials don't always represent the diversity of our community. We know there is underrepresentation of minorities within clinical trials. Quite frankly, when the FDA gives approval, they give approval to the known risks, as I am sure you are all aware, but it doesn't always represent the impact on all communities. We also know there are racial and ethnic differences in response to pharmaceuticals, and they may not become known until the drug is in wide use, certainly beyond the constraints of a controlled clinical trial. So we do have the initial approval of FDA that includes the known risks, but we also have the capacity under FDA to do postapproval warnings. My amendment deals with that aspect.

Health and Human Services has a strategy to deal with minority health and health disparities. It is called the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities. We also now have an institute at the National Institutes of Health that deals solely with minority health and health disparities. We have a commitment to do a better job as a nation in dealing with minority health disparities. This amendment would help us move forward in that regard.

One particular drug that is used to treat an inflammatory disorder has been determined by several studies to have a mortality risk that is three times higher for African-Americans than the general public. However, it is still widely prescribed, and ads for the product on the Internet and on television prominently feature African-American actors.

This is an area in which the National Medical Association and many other groups concerned about the quality of minority health have focused on for years. Beyond the black box warning, which is the most serious warning that can be issued about the side effects of approved drugs, there are other concerns about products that are marketed for the overall population that may have side effects, but the specific data has not been developed yet to warrant a black box warning.

The amendment I have offered directs the FDA to develop communication plans to address the best strategy for communicating benefits and risks, safety alerts, changes to the label or labeling of drugs, including black box warnings, biological products or devices, health advisories, any information identifying particular subpopulations, and any other relevant information as determined appropriate to enhance communication, including a variety of means of electronic communication.

I might point out this amendment has the support of the FDA and BIO, and it is budget neutral. So I would urge my colleagues to support this amendment to advance the commitment we all have made to deal with reducing and hopefully one day eliminating minority health disparities in our health care system. It is totally consistent with the Strategic Action Plan to Reduce Racial and Ethnic Health Disparities at the Department of Health and Human Services.

The second amendment I have brought forward, amendment No. 2141, deals with small businesses. This is a very appropriate amendment, as it is being considered during Small Business Week. We all acknowledge the importance of small business in the growth of our economy. Two out of every three new jobs are created through small business. We get more innovation through our small businesses on a per-employee basis than we do through larger companies. It is critically important small businesses be energized if our economy is going to rebound, as we know it needs to.

This is particularly true as we deal with innovation in drug development or medical devices. My amendment deals with the issues of coordinating the work between the FDA and small business. It provides a listing of the staffing levels at the small business offices of the FDA so that we know the capacity we have and we can evaluate that. It is our responsibility to do that. It provides an overview of the status of partnership efforts between the FDA and the SBA. We want the two agencies, the Food and Drug Administration and the Small Business Administration, to be working in concert to advance the cause for small businesses as well as the mission of the FDA.

My amendment provides a summary of all outreach efforts to small businesses and small business associations. It details the number of small businesses receiving protocol assistance. It shows the number of unsolicited and solicited grant applications to small businesses, again, so we can evaluate that. Most importantly, it calls for the examination of existing barriers, particularly as it relates to the generic drug shortages.

It is interesting that with regard to the fee schedule, the FDA has the authority to do waivers as it relates to brand names. We know a lot of the generics are where we have our shortages because of the economics of the circumstances. But the SBA has limited ability to waive the fee structure as it relates to the general development of generic drugs. My amendment would ask the SBA to report back to Congress on what impact that has on small businesses being innovative in developing generic drugs to help us generally with less costly drugs that are available for treatment, but also to make sure we deal with the drug shortage issue, which I alluded to earlier.

This amendment is also supported by Senator Landrieu, the chairman of the Small Business Committee, on which I have the pleasure of serving. I urge my colleagues to support both amendments I have brought forward. I believe they only enhance the strength of the bill before us and are totally consistent with the work of the chairman and the ranking member of the committee.

With that, Madam President, I would again urge my colleagues to support both amendments and to support the underlying bill.

I yield the floor, and I suggest the absence of a quorum.

Madam President, I ask unanimous consent that the order for the quorum call be rescinded.

Madam President, I ask unanimous consent to speak as in morning business.

Madam President, next month students all over the United States will begin graduating from college. There is a lot of pride in that experience. Family and friends will gather and celebrate. These young graduates are going to be filled with hope and expectation, and gratitude to those who helped them reach this milestone in their lives. But they are also going to be graduating with debt--in some cases massive amounts of debt.

Ninety-six percent of for-profit college students will graduate with a debt of $33,000. Fifteen percent of them--one out of six--will default on their loans within 2 years. There is now more than $1 trillion in outstanding student loan debt. As I have mentioned on the Senate floor several times, a little over a year ago, for the first time in history, student loan debt in America surpassed credit card debt.

One of the reasons there has been such a huge influx is that college costs continue to rise at unsustainable rates. Tuition fees at 4-year schools have rocketed up 300 percent from 1990 through 2011. Over the same period, broad inflation was just 75 percent. Even health care costs rose at half the rate of the cost of higher education.

The average for-profit college costs $30,900 a year in tuition and fees. Private nonprofit institutions are not too far behind. The average tuition and fees run about $26,600. Schools with larger endowments charge even more--upwards of $50,000 to $57,000 in total fees. They use their endowment to give students large financial aid packages, which is admirable, but it has consequences. The elevated sticker price for these schools provides for-profit colleges the cover to raise their prices to similar levels.

Let me remind you, for-profit schools, for-profit colleges in America get up to and more than 90 percent of their revenue directly from the Federal Government. They are 10 percent away from being Federal agencies.

Students graduating this year have one advantage: If they took out Federal subsidized loans, their interest rate is low. In 2007, Congress set interest rates on subsidized Federal student loans for the last several years. Current graduates have low, affordable interest rates on their Federal loans, ranging from 6.8 percent to 3.4 percent, depending on the year they took out the loan.

Graduates next year may not be so lucky. The interest rate goes up to 6.8 percent for all unless Congress acts. That is because these interest rates are set to double for 740 million students across the country on July 1 and will only be changed if Congress acts. That is going to affect 365,000-plus borrowers in my State of Illinois. Each borrower in Illinois will save $1,000-plus over the lifetime of their loan if current interest rates of 3.4 percent continue. Across the State, borrowers will save a total of $387,000.

Every week in my office we hear from students who would be directly affected by interest rate increases. One of them is George Jacobs, a constituent of mine and a graduate of the International Academy of Design and Technology in Chicago, a for-profit college owned by the Career Education Corporation.

Every day of his life, George Jacobs regrets that he ever attended this school. He is 29 years old. His current private student loan balance has ballooned to $107,000. The original loan was $60,000. But with a variable interest rate, George has been paying anywhere from 7 percent to 13.9 percent. Combine that with his Federal loan balance, and his total outstanding student loan debt is $142,000. George is not even 30 years old, and he already has the debt the size of some people's mortgages on their homes. Unlike a lot of his peers who attend for-profit colleges, George has a job in his field of study. His annual salary is $45,000, but since his lender will not let him consolidate his loans, his monthly payment is $1,364. Half of his income goes to pay his loan.

Unfortunately, because of high interest rates, very little of his payment reduces the principal. He does not know when he will possibly pay off this loan. When asked if he has tried to work out a plan with his lender, he says: They won't talk to me. They just don't care.

George was the first in his immediate family to attend college. He did not ask people for advice on financial matters. He trusted the school. George was subjected to high-pressure sales that some for- profit colleges use.

Reflecting on that experience now, George believes the school took advantage of him. He believes the school's primary focus is to identify people they can make money off of. George owes about $29,000 in Federal loans. With low interest rates, his monthly payment is $230 a month on the Federal loans--an amount he says is not a real problem.

He is married, and although he and his wife own a car, he does not think they will ever qualify for a mortgage. He is 29 years old.

George is not the only one affected by the private student loans. His parents are in their fifties. To help George, they cosigned his private student loans. They cannot refinance the mortgage on their home because of George's outstanding debt.

There was a story in the Washington Post about 2 weeks ago of a woman--a grandmother--who now has her Social Security check garnished because she was kind enough to cosign her granddaughter's college loan. Her granddaughter has defaulted. Her grandmother is watching her Social Security check reduced.

Making college affordable should not be partisan. It affects everybody. Just this week, during a news conference in Pennsylvania, Gov. Mitt Romney acknowledged the tough job market new graduates face and expressed support for keeping interest rates low. He said:

I fully support the effort to extend the low interest rate

on student loans . . . . temporary relief on interest rates

for students . . . in part because of the extraordinarily

poor conditions in the job market.

Higher education is not a luxury anymore. It is part of the American dream that many of us bought into and invested in. An educated workforce will make us a stronger nation. By 2018, 63 percent of jobs will require postsecondary education. Keeping debt levels low and manageable for college graduates is essential.

George Jacobs, like so many other students I have spoken about on this floor, is going to spend the rest of his young adult life paying for student loans. There has always been a lot of talk around here about mortgage crises--and rightly so--but think about the 17- and 18- and 19-year-old students signing away their income for the next 30 years before they can even dream of owning a home.

When we get back from the break in about 10 days, we are going to consider legislation on making sure student loan interest rates are manageable. There is more to this issue. We have to deal with the reality the President raised in his State of the Union Address. This spiraling cost of higher education is unsustainable and unfair-- fundamentally unfair.

We say to the young people: Get educated for your future.

They follow our advice and walk into the student loan trap. Unfortunately, many for-profit schools are the worst offenders. These schools have enrollment that has grown 225 percent over the past 10 years. According to the Chronicle of Higher Education, the enrollment of for-profit colleges in my State has grown 556 percent over the last 10 years. They enrolled 1.2 million students in 2009. In the 2008 2009 academic year, the GAO found for-profit colleges took in $24 billion in title IV aid; 4-year for-profit schools an average of $27,900 a year before aid, as compared to $16,900 for public 4-year universities.

The chief executives at most of the for-profit schools--parent companies--make many times more than their counterparts in nonprofit schools. Remember, 90 percent-plus of their revenue comes directly from the Federal Government. These are not great entrepreneurs; these are folks who have

managed to tap into one of the most generous Federal subsidies in the law.

Five years ago, we gave them a break. In the bankruptcy bill, we said private for-profit schools will be the only private loans in America that are not dischargeable in bankruptcy, which means you carry them to the grave. So the for-profit schools give these private loans to students, and their parents sign up for them. When it is all said and done, they end up saddled with this impossible debt for a lifetime. That is not even to go to the question about whether they are receiving any kind of valuable education in the process.

For-profits, incidentally, spent 21 percent-plus of their expenses on instruction--21 percent on instruction. It was 29.5 percent at public institutions, 32.7 percent at private nonprofit institutions.

USA Today reported that for-profits educate fewer than 10 percent of students, take in 25 percent of all Federal aid to education, and account for 44 percent of defaults among borrowers. Remember those numbers: 10, 25, and 44. They are taking in 10 percent of the students, taking in 25 percent of all the Federal aid to education, and 44 percent of the defaults on student loans are attributable to these for- profit schools.

According to the Project on Student Debt, 96 percent of for-profit college students graduate with some debt, compared to 72 percent of private nonprofit grads, 62 percent of public school grads. The Project on Student Debt also reported that borrowers who graduated from for- profit 4-year programs have an average debt of $33,000, compared to $27,600 at private nonprofits, $20,000 at public schools.

Last year, the Department of Education released a report showing that for-profit schools have a student loan default rate overall of 15 percent, compared with 7.2 percent at public schools, 4.6 percent at private nonprofit schools. If I were to stand before you and talk about any other business in America, heavily subsidized by the Federal Government--beyond 90 percent of all the revenues they take in--that is luring students and their families into unmanageable debt, I would hope both sides of the aisle would stand and say that is unacceptable. How can we subsidize an operation that is causing such hardship on students and their families--a hardship they are going to carry for a lifetime.

George Jacobs, at age 29, is writing off the possibility of ever owning a home because he signed up at one of those for-profit schools in my State.

The Senate HELP Committee also discovered that out of $640 million in post-9/11 GI benefits, a bill we were all proud to vote for, out of the $640 million that flowed to for-profit schools in the last academic year, $439 million went to the largest 15 publicly traded companies. For-profit colleges are receiving $1 out of every $2 in military tuition assistance, according to the Department of Defense, and more than 60 percent of education benefits available to military spouses go to for-profit schools.

This is significant. We capped Federal aid to for-profit schools at 90 percent of their revenue, but we created an exception for the GI bill. So some of them are up to 95 percent Federal subsidy and still we have these terrible results and terrible indebtedness.

Students at for-profit colleges have lower success rates than similar students in public and nonprofit colleges, including graduation rates, employment outcomes, debt levels, and loan default rates. Yet the Department of Defense is paying more to for-profit schools for the GI bill than public and nonprofit institutions.

I wish to have printed in the Record, along with my remarks, an article that appeared in the Wall Street Journal on Wednesday, April 18. It tells the story of Jodi Romine, who between the ages of 18 and 22 took out $74,000 in students loans. She attended Kent State University, a public university in Ohio. It seemed like a good investment at the time. But now it is going to delay her career, her marriage, and her decision to have children.

Ms. Romine's $900-a-month loan payments eats up 60 percent of the paycheck she earns as a bank teller in South Carolina, the best job she could get after graduating from college.

Her fiance spends 40 percent of his paycheck on student loans. They each work more than 60 hours a week and volunteer where they can to help the local high school's football and basketball teams. Ms. Romine works a second job as a waitress, making all her loan payments on time. She cannot buy a house. They cannot visit their families in Ohio as often as they would like or spend money to even go out.

Plans to marry or have children are on hold, says Ms. Romine, ``I am just looking for some way to manage my finances.'' This is an indication of a debt crisis that is coming. It is different, I would agree, than the mortgage debt crisis we faced. Smaller in magnitude, perhaps, but no less insidious and no less of a problem for us when it comes to the growth of our economy.

I have a couple bills pending. One of them goes to a very basic question: Should any college, public, private, profit, nonprofit, be allowed to lure a student into a private student loan when they are still eligible for government loans? In other words, should that not be one of the causes for a discharge in bankruptcy? It is fraud. It is fraud to say to that student: You have to take out this private student loan, even though the school knows that student is still eligible for low-interest rate accommodating Federal loans. They are luring them into a debt that is unnecessary and a debt which is crushing, in some circumstances.

At the very minimum, that should be considered fraud in a bankruptcy court, and that debt should be dischargeable in bankruptcy because of the failure of the school to disclose that the student still has eligibility for a Federal loan.

Secondly, I know I am probably crying in the wilderness, but I still find it inconceivable that the only private sector business loan in America that is not dischargeable in bankruptcy goes to these heavily subsidized for-profit schools. First, we lured them with Federal money--90 percent-plus--and then we turn around and say: And we will protect you. When the student who is likely to default ends up defaulting, we will make sure they still have the debt, carrying it to the grave. What were we thinking to give this one business this kind of fantastic Federal subsidy and this kind of amazing support in the Bankruptcy Code?

I ask unanimous consent to have printed in the Record, along with that article from the Wall Street Journal, a recent article from Barron's of April 16.

They identified those who were offering these private student loans. The major players in the private nongovernment-backed student loan market: SLM let me translate--formerly known as Sallie Mae, Discover Financial Services, Wells Fargo, and PNC Financial Services. Even with the defaults, if there are defaults on these loans, these loans are protected because they continue forever.

I do not know if my colleagues will join me in this, but all I ask them to do is go home and please talk to some of

the families in their States, and they will find this student loan crisis is not just something manufactured by politicians; it is real, and we are complicit in it. When we allow low-performing and worthless schools to receive Federal aid to education, students and their families are lured into believing these are real schools.

Go to the Internet and put in the words ``college'' or ``university,'' click the mouse and watch what happens. You will be inundated with ads from for-profit schools. Some of them will tell you: Go to school online. One of them ran a television ad here in Washington--I think they have taken it off the air now--that showed this lovely young girl who was in her bedroom in her pajamas with her laptop computer on the bed. The purpose of the ad was: You can graduate from college at home in your pajamas. It is a ruse. It is a farce. It is a fraud.

Many times these schools offer nothing but debt for these students. The students who drop out get the worst of the circumstances. They do not even get the worthless diploma from the for-profit schools; all they get is the debt. That is not fair. If we have a responsibility-- and I think we do--to families across America, for goodness' sake, on a bipartisan basis, we should step up and deal with the student debt crisis and the for-profit schools that are exploiting it.

I yield the floor.

Mr. President, I rise to discuss my amendment that would repeal the costly and counterproductive medical device tax in President Obama's health care law. In the mad scramble to find money to pay for his $2.6 trillion health spending law, the President and his Democratic allies created a number of new taxes that serve no purpose other than to fuel this new spending. Economically, these taxes are a disaster. They will undercut job creation, and they will increase costs for patients.

The new 2.3-percent tax on medical device manufacturers, which kicks in at the beginning of next year, is particularly onerous. For that reason, last year I introduced legislation to repeal it. That bill, the Medical Device Access and Innovation Protection Act, S. 17, has been cosponsored by 25 of my colleagues.

They understand that all of ObamaCare needs to go. The President's health care law is now over 2 years old. It is not aging well. Even before ObamaCare became law, the American people made themselves absolutely clear they wanted nothing to do with this Washington takeover of the Nation's health care system. The President and his advisers refused to face reality, telling reluctant Democrats all

was well in spite of the tea party townhalls.

According to the President and his congressional Democratic leadership, as soon as the legislation became law, Americans would come to embrace the wonderful benefits bestowed on them by the Department of Health and Human Services. It has not quite turned out that way.

Poll after poll shows that substantial majorities of Americans continue to oppose the law and favor its full repeal. A majority of Democrats think the law is unconstitutional. In a matter of weeks, the Supreme Court might issue a coup de grace to President Obama's misguided adventure in big government.

Whatever the Supreme Court does, I want to be clear about something. All of ObamaCare needs to go. It needs to be pulled out root and branch. The entire thing needs to be repealed. That said, some part of the law stand out for their wrongheadedness. The individual mandate and Medicaid expansions are flat out unconstitutional.

The IPAB, the CLASS Act, the Medicare cuts, and the employer mandate all deserve honorable mention for being bad public policy. Among the most counterproductive parts of the law are its over $500 billion in new taxes and penalties.

The medical device tax sits at the top of the list of foolish new ObamaCare taxes, and my colleagues who have supported S. 17 and this amendment understand the critical importance of eliminating it. I thank in particular my colleagues, Senator Brown from Massachusetts, and Senator Toomey from Pennsylvania, who have spoken on this issue and understand completely the devastation this tax will create for patients and for employers who provide good jobs for communities in their States.

Thanks to ObamaCare, medical devices will get hit with a $28 billion tax. So we are clear about what these medical devices are, they include surgical tools, bed pans, wheelchairs, stethoscopes, and countless other products that patients and doctors rely on every day. Surgical masks, gloves, blood pressure monitors, scissors, needles, cribs, trays, lights, stents, pacemakers, scales, scalpels, inhalers, and ankle, knee, and hip braces, and a lot more.

The cost of all of those products is going up thanks to this tax. Somebody is going to have to pay for it, and that someone is the already overburdened American taxpayer and middle-class breadwinner.

The President and his supporters seem to think we can simply tax corporations and individuals with impunity and face no adverse economic consequences. Yet economists understand when we tax these companies, employees will pay for it in lower wages, the unemployed will pay for it with a job that was never created, and patients will pay for it with higher health care costs.

Whatever our economic circumstances, this tax is bad news. But it is particularly foolish given the precarious state of our economic recovery. The President once liked to tout all of the jobs created or saved by his over $800 billion stimulus bill. Yet by supporting the medical device tax, the President and his allies have shown a real disregard for good high-paying American jobs.

Medical device companies employ nearly half a million people. They pay a salary that is nearly 40 percent higher than the national average. These manufacturers are small businesses we must be cultivating if our economy is going to recover and we are going to be successful in bringing down unemployment.

Roughly 80 percent of medical device companies have fewer than 50 employees; 98 percent have fewer than 500 employees. ObamaCare's $28 billion tax hike on these manufacturers will do nothing to improve health care, but it will do plenty to undercut the viability of these companies that provide good wages and good opportunities for American families.

According to one recent analysis, the medical device industry provided jobs to 409,000 employees in 2009. Yet this tax could result in job losses in excess of 43,000. It will hit certain States harder than others: California, Florida, Illinois, Massachusetts, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Wisconsin, and my State of Utah. The presence of medical device manufacturers is significant in all of these States.

This new tax will roughly double the device industry's total tax bill and raise the average effective corporate income tax to one of the highest effective tax rates faced by any industry in the world. The President and his allies frequently attack industries that choose to move their operations overseas. But they do not seem to grasp that their policies are driving these industries to do just that. With the onset of this new tax, U.S. device manufacturers are increasingly likely to close plants in the United States and replace them with plants in foreign countries.

According to another report by the Lewin Group, the medical technology industry contributes nearly $382 billion in economic output to the U.S. economy every year. President Obama, in the middle of a weak economy, facing high rates of joblessness, has decided to attack that industry. It is bewildering to me. An industry that pays workers on average $84,156 has become a victim of the President's desire to pay for his new health spending law or, better put, those workers and the families they support become the victims of the President's health spending law.

In my own State of Utah, the device tax is an issue of great importance. There are over 120 medical device companies in Utah. As the Utah Technology Council wrote in a letter to me, these companies ``are a vibrant part of the Utah economy providing high-paying, high-tech jobs for citizens of our great state.''

They certainly are all of that, and they are under assault as a result of this tax, targeted for nothing other than their success and the fact that they were a so-called stakeholder that could pay a so- called fair share to subsidize the President's health spending bonanza.

I ask unanimous consent that letter be printed in the Record.

Just yesterday, the Governor of Utah, the Honorable Gary Herbert, sent a letter to Congress addressing the negative impact this tax will have on our State. He wrote:

As a Governor of a state with a significant concentration

of medical technology manufacturers, I believe this tax could

harm U.S. global competitiveness, stunt medical innovation

and result in the loss of tens of thousands of good paying

jobs.

Now, there is little doubt the President's medical device tax, one that unfortunately received the vote of every Democrat in the Senate, will do just that--kill jobs and undercut our economy.

I ask unanimous consent that Governor Herbert's letter be printed in the Record.

The President's health care law is a travesty. The American people know it. They think it is fundamentally illegitimate, unconstitutional to its core, and enacted over the deep and loud objections of citizens and taxpayers.

All 2,700 pages of that law must be stricken from the U.S. Code one way or another. Eliminating its medical device tax is absolutely essential. It is critical for our States, for our economy, and for America's families and workers. I ask my colleagues join the repeal effort, and I thank my colleagues who have already joined as cosponsors.

I would like to briefly touch on one other issue that is of great importance to me and to the people of Utah and others all over the country. Over 150 million Americans regularly consume dietary supplements as a means of improving and maintaining their health.

The passage of the Dietary Supplement Health and Education Act, or DSHEA, in 1994 brought clarity, predictability, and a better understanding of what the FDA expected from industry and vice-versa. DSHEA provides an appropriate structure that balances the risks and benefits to consumers, with continued access and affordability.

Unfortunately, my colleague from Illinois, Senator Durbin, has filed an amendment to the current bill that would undo that well-balanced approach. As the author of DSHEA, along with my dear friend and colleague, Senator Harkin in the Senate, I strongly oppose his amendment. It would require facilities engaged in the manufacturing, processing, packing, or holding of dietary supplements to register with the FDA, provide a description with a list of all ingredients, as well as a copy of the labeling for each dietary supplement product. Additionally, the facilities must also register with respect to new, reformulated, and discontinued dietary supplement products.

While I appreciate my colleague's commitment, his amendment is based on the misguided presumption that the current regulatory framework for dietary supplements is flawed and that the FDA lacks authority to regulate these products. This is simply not the case. Previously FDA Commissioners, including Drs. Jane Henney, Mark McClellan, Les Crawford, and Andy von Eschenbach, as well as the former Deputy Commissioner, Dr. Josh Sharfstein, have all agreed DSHEA provides an appropriate and sufficient level of oversight of this industry.

Under DSHEA, Congress set out a legal definition of what could be marketed as a dietary supplement and safety standards that products have to meet. It allowed the FDA to develop good manufacturing practice standards and clarified what types of claims could be made. It provided the Secretary of Health and Human Services with the authority to impose an immediate ban on any dietary supplement that poses an imminent risk to public health.

DSHEA already provides the Secretary with enforcement tools of seizure, injunction, or criminal prosecution for ingredients that pose an unreasonable risk of illness or injury, are poisonous or deleterious, contain unapproved drugs or food additives, or fail to meet good manufacturing practice standards.

Furthermore, under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a manufacturer, packer, or distributor whose name appears on the label is required to report a serious adverse event related to the use of a supplement within 15 business days to HHS; submit any related medical information received within 1 year of the initial report within 15 business days; maintain records related to each report for 6 years; and permit inspection of such records.

To me, that sounds like a whole lot of regulation. The FDA already has a tremendous amount of regulatory oversight and enforcement tools when it comes to dietary supplements. Yet instead of urging FDA to use its current enforcement authority to find and punish those companies that are not following the law, Senator Durbin's amendment serves to punish all responsible companies with its overreaching mandates.

Finally, I would be remiss if I did not mention another obvious point. Senator Durbin's amendment would have the devastating effect of piling on more work for an underfunded agency already struggling to keep above water with its current core responsibilities.

Now, let me just say this: Before we passed DSHEA, there basically was no regulation over this industry. We brought together, Senator Harkin and I, the whole dietary supplement industry to get behind DSHEA. They are behind it. It took over 10 years to get the good manufacturing practices completed by FDA--more than 10 years, as a matter of fact. But we provided for them in that agreement. We provided all the tools that are necessary to supervise and regulate dietary supplements. To now add other obligations

onto this industry is just plain not right, and I hope my colleagues in the Senate and the House of Representatives will recognize this is an overreach and not put up with it. We are not going to put up with it. I will be voting against Senator Durbin's amendment, and I urge all of our colleagues to do the same.

At this point, I pay tribute to my colleague, Senator Harkin from Iowa. Senator Harkin worked tirelessly on this bill along with me. We worked all the way through the Senate on a number of occasions on various things. We have improved the bill from time to time. We have gone along with the improvements. We have done everything we can to protect the American citizens with everything that should be done. Nothing further needs to be done.

This is an industry that deserves support, not condemnation. Senator Harkin has been there every step of the way. He is a champion for the dietary supplement industry, as am I, and a lot of others in this body. I think it is time to quit trying to overregulate everything to death and cause costs to go up by leaps and bounds. Dietary supplements are not inexpensive today, although they are a lot less expensive than they would be if we keep piling on these regulations.

Frankly, we believe we have all of the necessary language in the law today to protect the American public regarding dietary supplements. We have given the Food and Drug Administration all the authority they need, and every FDA Commissioner has met with me, as I recall, since DSHEA was passed in 1994, and has said they have enough tools to be able to supervise this industry properly and they don't need anything more.

To make a long story short, again, this is an overreach by a colleague, sincere though he may be, and as important as he believes it to be. I hope he will withdraw his amendment so we don't have to go through this again. If he won't, I hope our colleagues on both sides of the aisle--and this is a bipartisan effort--will rise and say we have had enough of this and let's vote these kinds of amendments down.

I yield the floor.

I thank the Senator from Iowa. I know Senator Durbin is sincere, but, my gosh, there is enough regulation and regulatory authority in this bill, including the amendments we have added voluntarily, to resolve any problem that exists. Frankly, I hope everybody will vote against the Durbin amendment.