Medical Device Access and Innovation Protection Act

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.

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.

Mr. President, I ask unanimous consent to speak for 15 minutes in morning business and not to take time away from the debate on the bill.

Mr. President, I have had a conversation with them----

Mr. President, next week Americans are going to spend time honoring and commemorating the men and women who died fighting for our great country. Memorial Day is a day to reflect on and give thanks to the sacrifices made by those who made the ultimate sacrifice. It is also a day to look forward and to think about what we all can do to help our veterans who sacrificed so much and who deserve our support when they come home.

So I come to the floor today to discuss an issue that, quite frankly, defies common sense. The high rate of unemployment among recently separated veterans is an issue that continues to make the transition home for veterans harder than ever. Despite the fact that our veterans have the leadership ability and the discipline and technical skills to not only find work but to excel in the workforce of the 21st century, our veterans continue to struggle.

Despite the skill and talent and training of our veterans, statistics continue to paint a grim picture.

According to the Department of Labor, young veterans between the ages of 18 and 24 have an unemployment rate that is nearly 20 percent. One in five of our Nation's heroes can't find a job to support their family, doesn't have an income that provides stability, and doesn't have work that provides them with the self-esteem and pride that is so critical to their transition home.

We know this should not be the case. We shouldn't let the skills and training our Nation's veterans have attained go to waste. That is why all of us joined together to overwhelmingly pass my VOW to Hire Heroes Act here in the Senate late last year. Among many other things, that law would provide tax incentives to encourage businesses to hire veterans; it makes participation in the transition assistance program mandatory for most separating servicemembers, and expands the education and training we provide to transitioning servicemembers.

Thanks to that legislation, we have been able to take real concrete steps toward putting our veterans to work. The tax credit is working, and VA is set to begin accepting applications for a retraining program that will benefit unemployed veterans ages 35 to 60 and help them get back to work.

But that bill is only that, a first step. Today I am here to talk about the next step, and that step is to build partnerships with private businesses, large and small, all across our country, to hire our Nation's heroes. Recently I was up in New York where I participated in a lively roundtable discussion hosted by the Robin Hood Foundation. This discussion on veterans employment was moderated by Tom Brokaw on the USS Intrepid and brought together people of various backgrounds, including former Chairman of the Joint Chiefs ADM Mike Mullen, and Housing and Urban Development Secretary Shaun Donovan, to talk about this important issue.

What is very apparent is that there is momentum to build public- private partnerships. What is also apparent is there is a lot of room for improvement in this area.

I want to first make clear that a lot of companies across the country are far ahead of the curve. In fact, many private sector companies have already joined our efforts in addressing this critical issue. J.C. Penney, one of America's largest retailers, and Joseph Abboud, a men's clothing company, partnered with Iraq and Afghanistan Veterans of America to launch the Welcome Home Joe--Thanks A Million Program.

To prepare veterans for job interviews, this program has provided 5,000 veterans with certificates to purchase business attire. For the last decade, we have expected our brave men and women in uniform to prepare for the battlefield. In the process, they have become accustomed to wearing combat boots and battle dress uniforms. Now they are expected to wear a suit and tie for job interviews--something that sometimes seems pretty foreign to them. But thanks to this program, thousands of transitioning veterans can now hang up their battle dress uniforms and dress for their next challenge.

Other companies such as Schneider National, one of America's largest

trucking companies, are realizing the skills our veterans have gained over the last decade of work are directly applicable to their business. Schneider National recognizes that a veteran who has driven a 7-ton truck across Afghanistan's dangerous and rugged terrain is more than qualified to drive a freight truck across our Nation's roads. In addition to providing many veterans with new jobs, Schneider National also provides newly separated veterans with on-the-job training through their military apprenticeship program. As part of that program, veteran employees are eligible to earn a monthly educational benefit check from the VA in addition to a paycheck. Schneider National serves as a great example of how companies can hire veterans who have proven they can perform on the job but lack proper certifications for civilian employment.

The U.S. Chamber of Commerce also should be commended for launching its Hiring Our Heroes initiative which has sponsored 150 hiring fairs in 48 of our States. At one of these recent hiring fairs, General Electric, the employer of 10,000 veterans, launched its veterans network transition assistance program. As part of that program, General Electric has vowed to hire 1,000 additional veterans every year for the next 5 years and provides job-seeking veterans with one-on-one mentoring sessions. Those sessions help transitioning veterans improve resume writing and interviewing techniques so they can capitalize on the skills they have developed during their military service.

That is just a fraction of the work being done by our Nation's employers. There are many success stories at big companies such as Home Depot and small companies such as General Plastics in my home State which has created a pipeline to hire veterans at its aerospace composite factory. All of these companies are not only examples of success stories but they have also created a roadmap about how best to find, hire, and train veterans. It is our job to make sure those lessons are being heard.

Today I am here on the floor to lay out a few things that all businesses, large and small, can do to bring our Nation's heroes into their companies. First, get the word out to companies to educate their human resources teams about the benefits of hiring veterans and how skills they learned in the military translate to the work a company does. I can't tell my colleagues how often I hear from veterans who tell me the terms they use in interviews and on resumes fail to get through to the interviewer.

Second, help our companies provide job training and resources for transitioning servicemembers. This is something I have seen done at large organizations such as Amazon and Microsoft, but also at smaller companies in conjunction with local colleges. In fact, the most successful of these programs capitalizes on skills developed during military service but also utilizes on-the-job training.

Third, let business leaders know how important it is to publicize job openings with our Veterans Service Organizations at local military bases so we can help connect veterans with jobs, and to work with local one-stop career centers.

Fourth, develop an internal veterans group within our companies to mentor recently discharged veterans.

Finally, if possible, please reach out to local community colleges and universities to help develop a pipeline of the many veterans who are using GI bill benefits to gain employment in a particular area.

If we can spread the message on just a few of these steps, I am confident we will be able to continue to build on the success we have had in hiring veterans.

There is one other even more important step we have to take to ensure that businesses are taking, and it has to do with the difficult issue that some potential employees face. I have heard repeatedly from veterans that they do not put their military service on their resume because they fear it stigmatizes them. They fear that those who have not served see them all as damaged or unstable. We have to understand what mental health challenges are and what they are not.

As we seek to employ more veterans, we need future bosses and coworkers to understand that issues such as posttraumatic stress or depression are natural responses to some of the most stressful events a person can experience. We need them to understand that these illnesses do not afflict every veteran and, most importantly, we need to understand that for those who are affected by these illnesses, they can get help, they can get better, and they can get back to their lives. We need to let businesses know if they have a veteran who is facing some challenges, we should do the right thing and encourage him or her to get help. They need to know it is OK to reach out. Help them take advantage of the excellent mental health care the VA is capable of providing. The veteran will be better and they will be an even stronger member of a company's team.

Those are some steps our employers can take, but we also need to make sure our veterans are taking steps to stand out as candidates. Unfortunately, too often our veterans don't see how the skills they learned in the military translate from the battlefield to the working world. One of the biggest reasons for that is often our veterans don't understand the vernacular of the working world.

A few weeks ago I was home in Washington State talking about this issue when I met a woman named Anne Spurte. Anne is a veteran. She helps other local veterans find work through an organization called The Unfinished Mission. Anne told me how often she has heard from veterans who told her they were not qualified for the jobs they had seen on line or in the paper. Repeatedly they told her they didn't see how their experiences mattered to employers in the area. So one day in front of a whole group of veterans, Anne pulled out this job advertisement from Boeing for a position as a fabrication specialist. Anne could once again sense that the veterans who sat there and read this ad thought they weren't qualified for this manufacturing job that is listed in Boeing's space exploration division. But then Anne concentrated all the attention of the veterans in the room on the competency and qualifications section that was listed on that job advertisement and she asked all of them: Did you spend time in the service working together to remove obstacles to help a team accomplish its goals? Did you work to fully involve others on the team in decisions and actions? Were you held responsible? Did you demonstrate your commitment to the team? Around the room, all of these veterans' heads were nodding as she read verbatim from the Boeing job announcement. Every veteran understood they had the core skills employers at Boeing were looking for, but they just didn't realize it.

What Anne made those veterans come to understand was that their skills were being lost in translation, and what many of them needed to do was simply articulate their experiences in a way that employers could understand.

So today I want to reiterate to all of our veterans that no matter what branch you served in or when you served or how long you served, the skills you learned are valuable and it is up to you to make sure employers see that.

Our veterans don't ask for a lot. Oftentimes they come home and don't even acknowledge their own sacrifice. My own father never talked about his time fighting in World War II. In fact, I never saw his Purple Heart or knew that he had a wallet with shrapnel in it from when he was hit or a diary that detailed his time in combat, until after he died and my family gathered to start sorting through his belongings. But our veterans shouldn't have to ask. We should know to provide for them.

When my father's generation came home from the war, they came home to opportunity. My father came home to a community that supported him. He came home to college and a job--a job that gave him pride and helped him start a family and one that ultimately led to me starting my own.

That is the legacy of opportunity we have to live up to for today's veterans. Together, working with the private sector, we can ensure that the brave men and women who have worn our uniform have that real opportunity. We can make sure they get a fair shot from America's employers, that they are not measured by fear or stigma but by what they can do, what they have done, and what they will do.

I thank those companies that are leading the way as our veterans transition from military service to the civilian workforce. The Veterans Affairs' Committee, which I chair, has a Web site with a list of some of those companies that are contributing to this effort. I would encourage all of our colleagues to visit that Web site and suggest companies that can be added to our list. I look forward to working with all of them, and many more of our Nation's businesses, on this important next step in bringing our veterans home to opportunity.

As we celebrate our fallen heroes on Memorial Day next week, let's all keep thinking about how we can make sure our veterans are getting everything they need after they have given so much.

Before I yield the floor, I wish to take a moment to acknowledge a young Marine reservist, an Afghanistan combat veteran, who has been working part time on my Veterans' Affairs Committee staff for the last year. Carlos Fuentes is a hard-working, well-liked young man who graduated from American University earlier this month. He has helped our committee get a better understanding of what our veterans are facing when they are looking for work, and I want to thank him for his continued service to our Nation. I need my colleagues to know that Carlos is going to be getting married this weekend and I wish him and his bride many happy years to come.

Thank you, Mr. President. I yield the floor and I suggest the absence of a quorum.

Mr. President, I call up amendment No. 2127.

Mr. President, this amendment is very straightforward. I will not ask for a show of hands among Senators, staff, or those who are following this debate, about how many of them got up this morning and took a vitamin pill. I did, and I didn't have a prescription. I bought it voluntarily. I don't know if it does any good, but it was my decision, right? I voluntarily made that decision. I think that is a good thing.

The FDA is an agency that looks at what we buy and consume. It has an important responsibility. When it comes to certain things, such as prescription drugs, they test them--maybe the pharmaceutical companies do the testing, but the FDA monitors it to make sure what is given to you by your doctor is safe, won't kill you, and is effective. The same thing is true for over-the-counter drugs. The FDA has that responsibility.

When it comes to the ingredients and the dosage, those things are established through the FDA based on disclosures by the companies, testing, experience--it is all there. But there is another world out there, a completely different world called dietary supplements, which includes the vitamin I took this morning. That is a much different world, a world with less disclosure, less transparency, and far less regulation. In fact, there is no requirement in the law today--none-- that the people who sell us dietary supplements have to register with the FDA the name of their product, the ingredients it contains, and a copy of the label.

That is what my amendment says. We don't require any testing by a dietary supplement company. We don't require any assertions of safety. It would require simply that they register with the FDA that they are selling it in America. That, to me, seems pretty basic. It is not my original idea. It comes from a report of the General Accountability Office in 2009. They recommended this after they made a review of the safety issues with the FDA:

To improve the information available to FDA for identifying

safety concerns and better enable FDA to meet its

responsibility to protect the public health, we [the GAO]

recommend that the Secretary of the Department of Health and

Human Services direct the Commissioner of FDA to request

authority to require dietary supplement companies to identify

themselves as a dietary supplement company as part of the

existing registration requirements and update this

information annually; provide a list of all dietary

supplement products they sell and a copy of the labels and

update this information annually, and report all adverse

events related to dietary supplements.

In other words, did you take the pill and get sick? Does that seem like an onerous, heavyhanded, big government overregulation of an industry? Remember, the dietary supplement companies are not all based in the United States. Products are sitting on the shelf which you may not know come from other countries, including China. Do we want to know that? Would you want to know the company that is selling you whatever it is is at least registered in the United States? Is that too much to ask if you are going to sell the product in the United States, that they have to register with the FDA and tell us what the ingredients are? That seems pretty basic to me. I bet that 99 percent of the American people thought they already had to do that. No. Let me tell you that dietary supplements go beyond vitamin pills.

Yesterday I told the story on the floor about a 16-year-old girl in Hagerstown, MD, who drank two Monster Energy Drinks. When you go to the store, you see Coke and other things there. There are all kinds of them out there. She drank two of those Monster Energy Drinks and died of cardiac arrest. I met with her mom yesterday. She stopped breathing while watching TV. She was dead on the floor. They took her to the hospital and barely got her back to life for a little while, and then she died a few days later.

Is it too much to ask of a dietary supplement company that is making that to tell us what ingredients are in that drink? Is that the heavy hand of government? I don't think so.

Here is what we have found. Sometimes ingredients that may appear to be benign and OK today turn out to be dangerous when you look at them more closely, and maybe more dangerous for people who are younger, pregnant, or in a compromised immune situation.

This amendment basically says that American consumers have the right to know the dietary supplements sitting on the shelf have at least been registered with the FDA. I heard Senators Hatch and Harkin say this goes too far, it is too much to ask. I think they are wrong.

Manufacturers, some say, voluntarily provide product labels to the National Institutes of Health. That is true, and it is a voluntary system. Good actors share their labels with the FDA, but the bad actors don't do that. The NIH is in the process of developing a label database that currently has 7,500 dietary supplement labels. Do you know how many products are on the market? They have 7,500 labels, with 75,000 products--75,000. So 10 percent are volunteering this information. So to say the NIH already has the information is 90 percent wrong.

Requiring registration, they say, of these labels is just too much work for the FDA. No, as a matter of fact, the FDA responded to the GAO recommendation and said: We agree the agency's ability to ensure the safety of dietary supplements used by consumers would be improved if FDA had more information on the identity of firms marketing dietary supplements as well as the identity and compositions of the products they market. The FDA responded by saying: We want this information to keep Americans safe.

So to argue this is a burden we shouldn't put on the FDA, well, they asked for it. The other thing is about how many supplements are being sold in the United States. I said 75,000. That was the estimate in 2008. The number, I am afraid, is much larger. In terms of how many come on the market each year, it is just a wild guess because it is the Wild West. It is an open market. Any country that wants to export their dietary supplement to the United States--whether it is from China or India or Africa or Europe or Mexico--be my guest. They don't even have to show up and register with the FDA.

This is a simple amendment. It just says any company wishing to do business in the United States, to sell their dietary supplement, must tell us who they are and what they are selling and what their label looks like. That is not too much to ask to protect families from some harmful consequences.

I reserve the remainder of my time.

Mr. President, I ask unanimous consent that the time Senator Hatch used

be counted retroactively against the time in opposition to my amendment, No. 2127.

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

On my side?

Any time remaining on the opposite side?

Mr. President, I respect the Senator from Iowa and the Senator from Wyoming as well. They are two excellent colleagues, good people, and this is a tough bill. The underlying bill is a masterpiece of bipartisan accomplishment they can both be proud of.

What I am saying about dietary supplements is no reflection on Senators Harkin or Enzi. This is an industry I have been watching for a long time for a variety of reasons.

I would say the argument Senator Enzi made--that merely disclosing the label ingredients and name of the product to the FDA doesn't get to the consumer--argues for a bigger amendment than I am offering. It argues for a Web site and access and so forth. I understood that going in, and I agree with Senator Harkin that is an overreach in this time of budgetary problems. I wish we could do it. I think we should. I think we have an obligation to. But I didn't put it in here because I knew the first thing that would be said is we can't afford it.

So we went to the FDA and said: Do you want this information?

They said: Not only do we want it, we have already publicly stated we want it in reply to the GAO report.

We said: Can you handle it if we send you the basic information of the products presently being sold?

They said: Yes.

I could go further and say more can be done, but that calls for a bigger role of government than even this amendment suggests. But when the Institute of Medicine tells us that each year there are 1,000 new products--dietary supplements--being placed on shelves all across America in stores and drugstores, where families and children are walking in and buying them, how does anyone argue we shouldn't know they are here; that we don't want that Chinese product that just made it to the shelf in Springfield, IL, to register with the FDA before they do business here? How do you make that argument?

Shouldn't we assume, as a consumer, a family member, that when we walk in the store that somebody somewhere knows this company exists, that this product exists? Right now, they do not. The only disclosure to the government is voluntary. As I said, about 1 out of 10 companies volunteers the information. That, to me, is not the way to protect consumers.

Why do we need this information? Simply put, when an ingredient turns out to be dangerous, we want to know if that ingredient is in more than one product and then go after it to protect American consumers. If we don't know the product is in the United States, and we don't know what the ingredients are, how are we going to find that out? Wouldn't we want that basic information?

God forbid something happens with one of these products and someone loses their life, like this poor young girl in Hagerstown, MD, who drank that Monster Energy Drink. She had two of them, and it killed her, put her in cardiac arrest. God forbid that happens again and we say: You know, we didn't even know that product was in America because they don't have to tell anybody anything.

The argument made by Senator Harkin is they have to put a label on the product. That is a good thing. We also

found out that sometimes the ingredients listed aren't the actual ingredients. I will not get into that because that is another whole issue the FDA is working on. But that isn't enough. My colleagues should see some of the claims being made on the labels of these dietary supplements. They are preposterous. Not for all of them, some are basic and good, but some go way overboard.

Don't we owe it to consumers across America to give them the basic information, to at least let them know we know the name of the company and the ingredients in the product sold? Some people say they ought to be able to sell whatever they want in America and never tell a soul. I don't believe that. I think we have a responsibility in Congress to protect these families.

I reserve the remainder of my time.

Mr. President, how much time remains?

I will just close.

I thank the Senator from Iowa. He will acknowledge, I hope, that no one tests dietary supplements. No one tests them. Companies that make these products may test them if they wish, but there is no requirement under the law that they test them. There is certainly no agency of government that tests the dietary supplements. So to say they are perfectly safe as they instruct people to take them on the label, how would we know that? How could we possibly know that? There is no testing involved.

When it comes to prescription drugs and over-the-counter drugs, there is testing involved. At least we can point to the test to say whether it is safe and effective. Dietary supplements is a whole different world. I will just say that we are conscientious enough on behalf of consumers to limit the amount of caffeine that can be put in a cola, but then a company such as this Monster drink company decides to call theirs a dietary supplement rather than a beverage or a food, and it is no holds barred. They can put in as much as they want. That is why that poor girl died. Two Monster Energy Drinks--480 milligrams, I believe, of caffeine--and she died from cardiac arrest. Is it too much to ask that we know the ingredients and know the company?

The next time there is another tragedy, I would like to be sure we can say we at least took this modest, tiny, small step forward to say to the industry: If you are a good actor, don't be threatened. But when it comes to bad actors and things coming in from overseas, we are going to make you show up and identify who you are and what you are selling, period. That is it.

So at this point, I yield the floor and yield back the remainder of my time.

I suggest the absence of a quorum.