Floor Statements

Madam President, as chair of the Health, Education, Labor, and Pensions Committee in the Senate--the committee that drafted large portions of the Affordable Care Act--in looking back at all of the hearings we had, the long markup sessions, working across the aisle with Republicans, working with the administration, finally getting it passed and signed into law, this is a great day.

There has been a cloud hanging over this because of those who didn't want to reform the health care system. They wanted to keep insurance companies in charge. Well, we said, no, we are going to change this; we are going to reform the system and make it work for people, not just for insurance companies.

There are those out there who didn't want to change, who didn't want to reform the system, and so they brought cases to court. And as we know, this issue has wound its way through the courts--some deciding yes and some deciding no--and then went to the Supreme Court.

I remember being in the Court this spring for the arguments on this law, and we have been waiting since for the Supreme Court to make its decision. Well, this morning, the Supreme Court gave a resounding confirmation that the Affordable Care Act is indeed constitutional.

Some have been saying President Obama wins this or the Democrats win or the Republicans lose--that kind of thing. I don't see it that way. What I see is that this is a great victory for the American people, for the businesses of America, and for our economy. That is what this is all about. It moves us forward so that every American--every single American--will have quality, affordable health care coverage--something we have never done in this country. That is why this is such a landmark bill and such a landmark decision by the Supreme Court.

The Supreme Court's decision allows us to move ahead and replaces what I have often called a sick-care system--a system that will maybe get to you, if you are lucky, in the emergency room if you are sick, but not one that gets to you before that to keep you healthy. That is what the Affordable Care Act is moving toward--a system of more preventive health care, more promoting of wellness and keeping people healthy in the first place by giving them the coverage they can use to access affordable wellness and preventive health care.

The Supreme Court has made it clear what we have known all along, that those who want to block this law and who are now clamoring to repeal it are on the wrong side of this issue. They are on the wrong side of history. We can go all the way back to those who didn't want to have a Social Security System. They were on the wrong side

of history. There were those who didn't want to have a Medicare system. They were on the wrong side of history. And those who want to repeal this law can stand with them. They can stand with them in history.

But I think history has shown that every time we expand the rights of people to certain basic needs in people's lives, we become a stronger country, a more unified country, a better country, with more opportunity for all.

For those of us who believe that quality, affordable health care is a right and not a privilege, this is a great victory.

I see that some in the House have scheduled a vote to repeal it after we get back from the Fourth of July break. They have already voted to repeal it; I guess they are going to vote to repeal it again. They are on the wrong side of history. I call upon my Republican friends in the House and the Senate: It is over. This is constitutional. Now let's work together to make it so that it is implemented and that it works for everyone.

I say to my Republican friends that I have never said the Affordable Care Act is like the Ten Commandments, chiseled in stone for all eternity. I have often likened it to a starter home to which we could make some additions and some improvements as we go along. But at least that starter home has put a roof over our heads--a roof that will give quality affordable health care insurance to every American. So I say to my Republican friends, bring your toolkits if you want to make it better and improve it. Bring your toolkits, don't bring a sledgehammer. Don't bring a sledgehammer to break it down and try to repeal it. So let's work together, put politics behind us, and make this bill work for everyone, make it work for every American. The Justices have spoken. Now it is time for us to get back to work to build a reformed health care system that works not just for the healthy and the wealthy but for all Americans.

This is a victory. It is not a victory for President Obama. It is not a victory for my committee or anyone else around here. This is a victory to make sure that no one--no one in the future is ever denied health care coverage because he or she got cancer, to make sure that no one in the future will be denied quality affordable health care coverage because they have diabetes.

It is a victory for families who have had a child who needed intensive, very expensive health care coverage to make sure that child would live and grow and be able to take full part in our society, although sometimes those costs are extremely high. In the past, there have been annual limits, and if you went above that, you had to pay out of pocket. There were lifetime caps. How many women have I met in the past who have had breast cancer and had to have intensive treatments for a period of time but they bumped up against a lifetime cap. They had to pay out of their pocket. So this is a victory for them. It is a victory for families so that they don't face lifetime caps and annual caps. It is a victory for every family in America to ensure that their child can stay on their family's policy until age 26. That is who wins here--ordinary hard-working families in America. It is a victory for hard-working families to make sure that insurance companies have to provide--have to provide--cost-effective, lifesaving preventive care at no cost to get to people early on to keep them healthy in the first place. It is a victory for working families so no longer do they have to choose between paying for health insurance or other critical family needs such as food, shelter, transportation, education. That is what this is about. That is what this victory is all about. It is a victory for American families.

I say to those who now want to repeal it, who are going to start to make a political issue out of this, you are on the wrong side of history. The American people will now begin to take a look at this bill in a new light: that it is constitutional, it will be implemented, and what is in it for us? And I just went through what is in it for every American family. The American people will not want to go back. They will not want to repeal this law. There may be improvements we can make as we go along. That is fine. But I say woe to those who vote to repeal this bill. The American people will hold you accountable for being on the wrong side of history, the wrong side of progress, the wrong side of ensuring that every American family has quality affordable health care in America.

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

Mr. President, I ask unanimous consent that Chris Ledoux, a detailee on Senator Johnson's Banking Committee staff, be granted floor privileges for the remainder of today's session.

Mr. President, again, we are on the Food and Drug Administration Safety and Innovation Act of 2012. As the chair just said, we have 6 hours 15 minutes of debate time. I am hopeful we don't utilize it all and that we can vote on this sometime later this afternoon.

We just considered this bill in the Senate a few weeks ago and passed it 96 to 1. Following the conference with the House, the House passed the bill unanimously last week. Today I trust that we will finish the job.

I am genuinely proud of this legislation. It will ensure that the FDA has the resources to speed market access to drugs and devices while continuing to ensure patient safety. For the first time, it will make new resources available to allow the FDA to clear its backlog of applications for generic drugs, which will help ensure that patients have access to less expensive medications. It will make sure the FDA has the funds to prevent there ever being a backlog in applications for biosimilars. These resources are vital to FDA's ability to do its job, to the medical products industry's ability to make these products and, most importantly, to patients who need both access to drugs and devices, and assurances that they are indeed safe.

This legislation has benefited from input from a diverse range of interested parties, Senators on both sides of the aisle, our colleagues in the House, industry stakeholders, consumer groups, and patient groups.

Over 1 year ago the parties started bringing policy ideas to the table. We worked together in bipartisan working groups to reach consensus on these policy measures. Where we could not achieve consensus, we didn't allow those differences to distract us from the critically important goal of producing a bill that could be broadly supported. As a result of this bipartisan process, we have a bill that advances our shared goals of patient safety, patient access, a well- functioning FDA, and strong and viable American businesses. We streamlined the device approval process while also enhancing patient protections. We modernized FDA's authority to ensure that drugs and drug ingredients coming to the United States from overseas are safe and to ensure that our domestic companies compete on a level field with foreign ones. We addressed the critical problem of drug shortages. We helped spur innovation and incentivized drug development for life- threatening conditions. We reauthorized and improved the incentives for studying drugs in children.

Finally, we increased accountability and transparency at FDA. So the bill strikes a balance. It will help keep our regulatory system in pace to adapt to technological and scientific advances. It will create the conditions to foster innovative advances in medical technologies. Again, it will do all of this without losing sight of the most important function of the FDA--ensuring patient safety.

So it has been a long road leading up to this moment. We have been working on this bill for well over 1 year and 3 or 4 months with the help of Senators on and off the committee.

Again, I thank my colleague, the ranking member of the Health Committee, Senator Enzi, for all of his diligent and hard work and that of his staff for helping to bring all the different parties together and making sure we had a consensus bill that responded to all of those inputs.

So we have had a great collaboration. I think we have an excellent bill. Again, I am hopeful we can have our comments and discussions this afternoon, but I urge all my colleagues to vote today to pass the FDA Safety and Innovation Act. It is critically important to the agency, the industry, and to the patients we get this done. This will be the final step.

As I said, the House passed it unanimously. If we pass it today, it can go to the President for his signature as soon as we pass it this afternoon.

Mr. President, I yield such time as he may consume to my good friend and colleague and ranking member, Senator Enzi.

Madam President, I ask unanimous consent that Senator Burr have the time until 4:40 p.m.; that I be recognized for up to 5 minutes, following the remarks of Senator Burr; further, that after my remarks, all remaining time be yielded back, the motion to concur with an amendment be withdrawn, and the Senate proceed to vote on adoption of the motion to concur in the House amendment to 3187.

I thank the Senator from North Carolina.

I thank my friend from New Jersey for the opportunity to clarify this point. The Senator is correct that this provision aims to provide incentives in the form of extended market exclusivity for certain antibacterial and antifungal drugs that treat serious or life- threatening infections. He is also correct that the list of qualified pathogens in the legislation is illustrative, and not exhaustive. Products intended to treat serious or life threatening infections caused by gram negative anaerobic bacteria would be qualified infectious disease products and would therefore be eligible for the 5 years of extended market exclusivity.

Madam President, we are about to move to a vote on the FDA reauthorization bill, a bill which I have said earlier we spent more than 1 year working on in committee. It has had a lot of input from Senators on all sides, including industry stakeholders and consumer groups. This is the result of a wide collaboration on all these issues.

I wish to respond to a couple things my friend from North Carolina-- and he is my friend--said earlier about the amendment he was concerned about on the track-and-trace amendment. The Senator from North Carolina talked about speed. He said we were rushing this through. The vote in the Senate was 96 to 1. The House vote was unanimous. That doesn't happen if a bill is being rushed through. Anybody who tries to rush a bill is not going to get 96 votes in the Senate or a unanimous vote in the House.

Again, my friend questioned how hard we tried to get the track-and- trace provision included in the conference report. I might turn the question around and question how hard the Senator from North Carolina and the Senator from Colorado worked to get this included. We have been working on this bill for over 1 year. My friend, a good member of the committee, and his staff has been very much involved in many aspects of this bill. So I wonder why the amendment was dropped on our staff 1 day before filing the bill at the midnight hour. I might also point out that on September 14, 2011, our committee had a hearing on the supply chain issue. The record will show that I, the chairman, was the only one to raise the issue of track and trace at that hearing.

Two weeks before markup, Senator Burr and Senator Coburn introduced an FDA bill. Senator Enzi's staff and my staff worked for 2 weeks to incorporate elements of this bill into the reauthorization. These are elements of the bill that were introduced 2 weeks before by the Senator from North Carolina, Mr. Burr, and Senator Coburn. So our staff spent 2 weeks trying to incorporate elements into the bill, and they did. We did incorporate a lot of elements. I would point out there was nothing that mentioned track or trace that was in that bill that was introduced 2 weeks before.

Again, I just say, if this was so important, why wasn't it in their bill? If it was so important, why did they wait until Sunday evening at 6:20 p.m., the day before filing, to get the language? Again, who is trying to rush what? We did not try to rush anything, but when we get something dropped in our lap at

6:20 p.m. the night before the filing, it is hard to build a consensus, and that is what this bill is. We did go to conference on this, but this issue involves a lot of different players, and we could not get that consensus.

So I say to my friend from North Carolina, we are still working on this. We will work on it in good faith, but we have the State of California, we have the pharmaceutical manufacturers, we have drugstores, we have consumers, we have a lot of people out there who have something to say about this, and we have to build that coalition in order to get a good track-and-trace bill through.

We are now about to vote on the critical FDA bill reauthorizing user fees, modernizing FDA's authority in several meaningful and targeted ways, addressing the drug shortage problem, streamlining the device approval process, enhancing our global drug supply chain authority and all the while maintaining and improving patient safety. Because this bill will directly benefit patients and the U.S. biomedical industry, it is critically important to the agency, industry, and most important to patients that we get this done.

I urge my colleagues to vote for final passage and pass this bill. It is the same bill the House passed unanimously. Once it is done here, we can send it to the President and get it signed and move ahead with a good reauthorization of the Federal Food and Drug Administration.

I ask for the yeas and nays.

Mr. President, today, with final passage of the FDA Safety and Innovation Act and the reauthorization of the FDA user fee agreements, we have helped both the FDA and the biomedical industry ensure that they can get needed medical products to patients quickly. This legislation, now headed to the President for his signature, will ensure that the FDA can swiftly approve drugs and medical devices, save biomedical industry jobs, protect patient access to new therapies, and preserve America's global leadership in biomedical innovation. It will keep patients safer by modernizing the FDA's inspection process for foreign manufacturing facilities, while also improving access to new and innovative medicines and devices. It will reduce drug costs for consumers by speeding the approval of lower cost generic drugs and help prevent and mitigate drug shortages.

Finally, by improving the way FDA does business, increasing accountability and transparency, U.S. companies will be better able to innovate and compete in the global marketplace.

With the FDA Safety and Innovation Act ready to be signed into law, we have taken an important step to improve American families' access to lifesaving drugs and medical devices.

As I have said throughout this debate, the bipartisan process that produced this excellent bill has been a shining example of what can be achieved when we all work together in good faith. I worked very closely with my colleagues on both sides of the aisle, as well as industry stakeholders, patient groups, and consumer groups, to solicit ideas and improvements on the critical provisions in this bill. We have a better product thanks to everyone's input.

My colleague, Ranking Member Enzi, deserves special recognition, and I extend my sincerest gratitude to him. Without his strong leadership and cooperation in this open bipartisan process, we would not have the exceptional consensus measure we have today. So I thank Senator Enzi for his partnership and collaboration throughout the past almost year and a half.

I wish to specifically thank the staff of Ranking Member Enzi, as they have devoted countless hours to working with my staff and others throughout this process to build consensus for this legislation.

I thank Frank Macchiarola, Chuck Clapton, Keith Flanagan, Melissa Pfaff, Grace Stuntz, Katy Spangler, and Roley Swinehart. I sincerely thank them for their tireless efforts and loyal commitment to this cause.

I also thank all of the HELP Committee members as well as other Senate Members and their staffs who were thoroughly engaged with this process from the beginning as part of the bipartisan working groups. Each of you has contributed significantly to this legislation, and I am sincerely grateful for your contribution.

I also recognize Chairman Upton and Representative Waxman, as well as their staffs, who worked tirelessly to reconcile the differences between the Senate and House legislation.

Of course, I thank my own staff on the HELP Committee, who have spent many a night and weekend with Senator Enzi's staff, other Members' offices, and our colleagues in the House working to come to consensus on the critical policy issues in this legislation.

First of all, I thank our staff director Pam Smith, and I especially want to note the tremendous work done by Jenelle Krishnamoorthy through this last almost 15 months or more, for pulling people together and working on weekends. I don't know how she does it, and she still has time for the twins. It is remarkable, but she does it, and it is done remarkably well, and I thank Jenelle especially for her great leadership.

I also thank Elizabeth Jungman, Bill McConagha, Kathleen Laird, Dan Goldberg, Justine Sessions, Kate Frischmann, Elizabeth Donovan, Frank Zhang, and Evan Griffis.

I also thank our former staff director Dan Smith, who left the committee as staff director a couple of months ago, but he was very much involved in this until the time of his departure.

I also thank the Congressional Budget Office for their knowledgeable and capable team that was willing to work around the clock sometimes to estimate the budgetary effect of the legislation.

We also owe our gratitude to the staff members in the Legislative Counsel's Office--specifically Stacy Kern-Scheerer and Kim Tambor. This bill is a result of tremendous effort by their team to draft and redraft provisions in this measure, as well as address technical issues well into the nights and over weekends. I thank them profusely for their dedication.

This bill's final passage is a victory for millions of Americans who need medicines or medical devices, a victory that would not have been possible without the dedicated work of our Senate family.

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

The PRESIDING OFFICER (Mr. Tester.) Without objection, it is so ordered.

Food and Drug Administration Safety and Innovation Act

Mr. President, after many months of bipartisan negotiation, I have high hopes that the Senate will vote very shortly to invoke cloture on the House message to accompany the Food and Drug Administration Safety and Innovation Act of 2012.

I am pleased to report it is the product of excellent bipartisan collaboration on the Health, Education, Labor, and Pensions Committee, which I chair, and productive conversations with our colleagues in the House. The House passed the FDA Safety and Innovation Act unanimously last week. Now it is our turn to do our part. The backbone of this legislation is the user fee agreement that FDA has negotiated with industry.

I might just add this bill passed this Chamber about 3 weeks ago on a vote of 96 to 1. So it has strong bipartisan support. A sizeable part of FDA's budget comes from user fees that industry agrees to pay to allow FDA to more quickly weekly review product applications. We need to authorize FDA to implement those agreements if we want to keep FDA running at full steam, which is critical to preserving jobs at both the agency and in the industry and to ensuring that FDA has the resources to get safe medical products to patients quickly.

I want to be clear. These agreements affect all of us by helping to maintain and create jobs in our home States. For example, in my State of Iowa, these agreements will support our burgeoning bioscience sector which saw employment grow by 4.5 percent between 2007 and 2008. The implementation of these agreements will continue to foster biomedical innovation and job growth in all of our States.

The bill before us reauthorizes the prescription drug user fee agreement and the medical device user fee agreement, both commonly known as PDUFA and MDUFA, which will continue and improve the agency's ability to speed market access to prescription drugs and medical devices while ensuring patient safety.

I just might add that, again, uppermost, foremost, first is patient safety. That does not mean we cannot do things in a better manner, get products more readily available, speed up the process if we have the personnel and the equipment to do so. That is why this bill is so important. It provides that type of support so we can hire more people to make sure we get these products to patients quickly, but to make sure they are safe.

The bill also authorizes a new generic drug user fee agreement which is expected to slash review time to one-third of current levels, from 30 months to 10 months, drastically improving the speed with which generic products are made available to patients. The new generic user fee agreement will generate significant savings for patients and our health care system. In the last decade alone, from 2001 to 2010, the use of generic drugs saved the U.S. health care system more than $931 billion. This agreement will ensure that we continue to see those savings and that patients have access to cheaper drugs when they need them.

This bill also authorizes a new biosimilars user fee agreement which will further spur innovation by the generic biologic industry. This chart shows again some of the savings we will get. The use of generic drugs has saved over $931 billion over the last decade, $158 billion just in 2010 alone. So we can see the better we are able to get generic drugs approved and in the pipeline--again, safely--the better off we are all going to be and more money that not only will we save as individuals but our entire health care system will save. That is almost $1 trillion over the last 10 years.

These agreements again, as I said, are vital to FDA's ability to do its job, vital to the stability of the medical products industry, and most importantly to the patients who are the primary beneficiaries of this longstanding and valuable collaboration between FDA and the industry.

After months of negotiation, FDA and the industry have crafted win- win agreements they stand behind. They are doing their job. Now it is time for us to do ours.

It is absolutely imperative that we authorize these user fee agreements before they expire. If we do not, FDA will lose 60 percent of its drug center budget and 20 percent of its device center budget. They will have to lay off nearly 2,000 employees. That is why it is so critical for us to do this at this time.

To be sure, the expiration does not happen until late this summer. But the FDA has told us if they do not get this reauthorization done, they will have to start sending out pink slips at the beginning of July. That is why it is so imperative for us to pass this legislation this week and send it to the President for his signature, so they will not have to go through that process of sending out pink slips.

But we can see how important this is. If this were to happen, it would have devastating consequences for patients whose health and lives depend on new medical treatments. We cannot let that happen. That is why for more than a year I worked closely with my colleague, the ranking member of the HELP Committee, Senator Enzi, and other members of the HELP Committee. Our aim has been to ensure that in addition to the user fee agreements, the other provisions in this legislation are also the product of consensus bipartisan policymaking.

We have used bipartisan working groups and an open, transparent process to ensure that we had input from our members and the stakeholder community at large throughout negotiations on the other titles of this bill. This is quite remarkable. We do not see much of it in this Congress these days. But we have had great cooperation from all members of our committee on both sides of the aisle.

This legislation has benefited greatly from all of the diverse input: from Senators, as I said, on both sides of the aisle, industry stakeholders, consumer groups, patient groups, and more recently from our colleagues in the House. The FDA Safety and Innovation Act is the result of concerted efforts to define our common interests, and these interests will directly benefit patients and the U.S. biomedical industry.

As you can see from this chart, the bill modernizes FDA's authority in several critical ways: It authorizes key user fee agreements to ensure timely approval of medical products. It streamlines the device approval process. It modernizes FDA's global drug supply chain authority, which is so important. It spurs innovation and incentivizes drug development for life-threatening conditions. It reauthorizes and improves incentives for pediatric trials. It helps prevent and mitigate drug shortages, and it increases FDA's accountability and transparency. So it addresses the broad array of critical issues that we face in today's global economy.

It is imperative that our regulatory system keep pace with and adapt to technological and scientific advances and that patient protection remains strong in this era of dynamic change. Keeping pace with the ever-changing biomedical landscape is precisely the aim of the FDA Safety and Innovation Act. This bill injects greater transparency into the device approval process. It bolsters FDA's ability to help U.S. manufacturers create innovative and safe devices, while also enhancing FDA's ability to determine how the devices perform in the real world and takes appropriate measures to protect patients.

The bill also reauthorizes and improves incentives for pediatric trials. It creates incentives for the development of new antibiotics and authorizes new drug and device provisions to help expedite the approval of important lifesaving drugs and devices without sacrificing safety.

In addition, the bill also helps address the national crisis prescription drug shortages. For the past several years, hospitals across the country and in my State of Iowa have experienced an increasing number of shortages of life-sustaining prescription drugs. These shortages directly threaten the public health by denying patients access to medications that are indispensable to their care. This bill requires all manufacturers of certain drugs to notify FDA if they expect a manufacturing disruption that could lead to a shortage because if FDA is aware of a potential shortage early, then the agency can work with manufacturers and providers to find other ways to get patients the drugs they need. This bill also addresses drug shortages by explicitly allowing FDA to expedite drug

establishment inspections and application reviews when needed to help prevent or mitigate a shortage. It establishes an FDA drug shortage task force to develop a strategic plan to address drug shortages and to improve communication and outreach to stakeholders preparing for drug shortages.

Another significant advance in the bill is the much needed modernization of the FDA's authority to ensure the safety of drug products coming into the United States from abroad. This bill, No. 1, allows FDA to prioritize inspections of both domestic and foreign firms based on the risk they present to patient safety. It requires importers to demonstrate that certain high-risk drugs are safe and compliant before they can be imported into the United States. It requires manufacturer accountability and oversight of the quality and compliance of their drug producers and suppliers. It enhances penalties for adulterating and counterfeiting drugs. It allows FDA to detain noncompliant drugs in U.S. commerce to prevent them from reaching patients. It permits FDA to destroy certain illegal drugs at the border instead of releasing them back into commerce. It clarifies FDA's authority to address criminal conduct that occurs abroad and threatens the safety of U.S. consumers.

An important point to remember about the importance of these safety provisions is that weaknesses in our pharmaceutical supply chain not only affect the health of American patients, they also affect the health of American businesses. U.S. companies that source and manufacture drugs in this country should not be placed at a competitive disadvantage by foreign firms that operate with less oversight and sell substandard ingredients into this country at reduced prices. This bill will help ensure that businesses operate on a level playing field by holding foreign actors to the same high standards as those in the United States.

The last policy provision I will highlight is a mix of device and drug authorities that together can fairly be described as the most significant advance for patients of orphan and rare diseases since the Orphan Drug Act was passed nearly 30 years ago.

In addition to the significant resources that will be devoted to rare diseases under the prescription drug user fee agreement itself, this bill, No. 1, expands the accelerated approval pathway to therapies for rare and very rare diseases, and it instructs FDA to weigh the rarity of a disease as a factor in its approval process.

Next, it directs resources to promising therapies for unmet medical needs, which will receive the new ``breakthrough'' designation.

Next, it requires FDA to consult with outside experts on rare diseases.

Next, it focuses on pediatric rare diseases by requiring a strategic plan regarding pediatric rare diseases and creating a pilot program to incentivize new therapies for pediatric rare diseases.

Next, it helps make devices for rare diseases more available by modernizing provisions relating to custom devices and making it easier for companies to make profits on devices for rare disease.

Lastly, it reforms the conflict of interest rules for advisory committees to make it easier for the FDA to fill panels, which will have particular impact regarding rare diseases because those panels are sometimes very hard to fill.

I am very proud of the advances this legislation represents for patients with orphan and rare diseases.

Not only does the bill support the biomedical industry and help patients get the medical products they need, it also reduces the deficit. According to the nonpartisan Congressional Budget Office, this legislation will reduce the budget deficit by more than $311 million in the next decade. So what we have is not only good policy, but it is fiscally responsible by contributing to deficit reduction.

As I have said, well over a year of diligent, bipartisan work has gone into the legislation before us today. Neither Democrats nor Republicans got everything they wanted in this bill. We sought out consensus measures. Where we could not achieve consensus, we did not allow our differences to distract us from the critically important goal of producing a bill everyone could support. As a result, this is a true bipartisan bill, and it is broadly supported by the patient groups and industry. In fact, it has wide support from medical associations and also from consumer groups and manufacturers throughout the entire country--a broad base of support. In fact, it is unique because it has the full support of manufacturers, the pharmaceutical industry, the device manufacturers, the FDA itself, and patients groups--people concerned about patient safety, cost, and availability of drugs and devices. So it has a broad base of support.

The FDA Safety and Innovation Act before us, which we will be voting on in a little while, authorizes the important FDA user fee agreements, and it modernizes our regulatory system to ensure safety and to foster innovation in the medical product industry. Our bipartisan work has produced an excellent bill. We cannot allow unrelated partisan disagreements or Presidential-election-year politics to interfere or keep us from completing our job.

I will say it again. We must pass this vital legislation now. It is critically important to the agency, to the industry and, most importantly, to patients that we get this done. Let's come together, Democrats and Republicans, to pass this legislation. Let's have a resounding vote on cloture. Hopefully we won't have to use the 30 hours and we can get to passage of the bill very rapidly so that we can get it down to the President for his signature.

With that, I yield the floor.

Mr. President, I ask unanimous consent that Bill McConogha, Lindsey Love, Bryan Rodriguez, and Tiffany Monreal of my staff be granted floor privileges for the duration of today's proceedings.

Madam President, this amendment is a solution in search of a problem. I don't know--have any of my colleagues here had unionized businesses come to them complaining that they can't give a raise? Have any of my colleagues ever heard of that--they have complained they can't give a raise?

The fact is collective bargaining agreements already provide--many of them--for merit-based performance increases. That is part and parcel of a lot of the agreements today. So what this amendment basically does is it undercuts the National Labor Relations Act. That is exactly what it does. If you think we should do away with the National Labor Relations Act and all the benefits and all the protections it has both for businesses and for workers, this is your amendment right here. Quite frankly, I can't think of anything that would be more disruptive of a workplace than this amendment. When a business and workers have agreed on a collective bargaining agreement, this would destroy that kind of comity in the workplace.

Madam President, as is evident from the amount of debate and attention devoted to it, the Agriculture Reform, Food, and Jobs Act of 2012 is an enormously important piece of legislation for our Nation, as it certainly is for my State of Iowa. Although the measure is commonly referred to as the farm bill, that name captures just a fraction of what it contains to benefit all Americans and millions of others around the world.

Despite the severe economic challenges over the past half decade, agriculture and agriculture-related jobs and economic activity have been a real source of hope, opportunity, and recovery. That is especially so in my State, where agriculture generates about one of every five Iowa jobs and about a fourth of our State's economic output.

Iowa is well known, of course, for its distinctive farm state and smalltown character and for producing corn, soybeans, hogs, cattle, eggs, and other commodities. We have enjoyed tremendous benefits from greater diversification in agriculture and the rural economy. Take for example the boom in biofuels such as ethanol and biodiesel and in wind power.

It is critical for us to enact this bill in order to continue and enhance the contributions of agriculture and agriculture-related industries to our Nation's economy, to jobs, and to meeting ever- growing global demands for food, fiber, and energy.

I commend Chairwoman Stabenow and Senator Roberts, the ranking Republican member, for all of their hard, conscientious, and successful work on this bill. I also thank them for their efforts to take into account and reflect in this bill the circumstances, views, and needs of both rural and urban America as well as the various regions and types of agriculture across our Nation. I certainly appreciate their task. This is the eighth farm bill I have worked to enact, starting as a member of the House Agriculture Committee. Since 1985 I have served on the Senate Agriculture, Nutrition, and Forestry Committee and am proud to have been the chairman of that committee during the writing and enactment of the most recent two farm bills.

This legislation, approved by our committee in April, is a sound, balanced, and bipartisan bill crafted under budget conditions that have necessitated difficult decisions, judgments, and compromises. According to scoring by the Congressional Budget Office, this measure will reduce spending over the next 10 fiscal years by more than $23 billion from budget baseline levels.

The spending reductions in programs encompassed in this bill thus appear to be several billion dollars larger than the automatic spending cuts slated to begin in January of next year under the sequestration mechanism in the Budget Control Act of 2011. Hence, this farm bill is a serious, good-faith effort going significantly beyond the minimum to reduce our budget deficits and curtail our Nation's debt. Again, these spending reductions will have very real impacts, and frankly I regret them and their consequences. We are not as a Nation investing too much in the future of our Nation's agriculture and food system, in fighting hunger and malnutrition, in conserving our Nation's soil, water, and other resources for future generations, in securing our future with renewable energy and biobased materials, or in strengthening and growing jobs in our Nation's small towns and rural communities. Unquestionably, because of our Federal budget

situation and choices that have been made in dealing with it, there is less money to respond to national needs and priorities in the Federal policies and programs covered in this bill.

Given the budgetary hand dealt it, the Agriculture Committee, with the bipartisan leadership of our Chairwoman and Ranking Member, reported a bill combining budget savings with genuine reforms throughout its various titles. The most significant reform--in fact, pivotal reform--lies in the substantial changes in the commodity and farm income protection programs.

To help farm families and rural communities survive and manage the inevitable vagaries of weather and markets, the new farm bill continues a strong system ensuring a degree of stability and protecting against significant losses in farm income. The legislation contains major reform in terminating the existing direct and countercyclical Payments Program and replacing it with the Agriculture Risk Coverage, or ARC, program. ARC is designed to compensate for a portion of farm revenue losses and to supplement the revenue insurance policies that farmers typically rely upon to manage risk.

Because farm income protection based on revenue accounts for the fact that farm income is the product of crop yield times its price in the market, ARC is an improvement over the direct and countercyclical payments program in current law. Direct payments are made in fixed amounts according to each farm's base acreage and program payment yields, which in general were established decades ago. Consequently, the direct payments do not accurately reflect or respond to existing economic circumstances in agriculture because they are made without regard to a farm's current planted acres of crops or to whether crop prices and yields are high or low. The existing countercyclical payment program compensates for a portion of losses when the national average price of a covered commodity falls below a statutory target price. But the countercyclical program's target prices are well below current market prices and costs of production for commodities, and of course, a price-based system does not account for yield losses.

Agricultural producers have been divided over the direct payments since they were adopted in the Federal Agriculture Improvement and Reform Act of 1996 as a replacement for the then-existing target price income protection system. Supporters of direct payments note that they are considered not to be production or trade distorting and that they provide income assistance to farmers who may not benefit much from other commodity programs or crop insurance.

From their beginning, I believed that the direct payments were not sound policy. Within a few years, after they were enacted during a period of strong commodity prices, the direct payments proved inadequate to protect farm income in the face of a sharp falloff in commodity prices, and so we had to resort to enacting ad hoc emergency legislation to make up for the shortcomings of the direct payments.

To restore better protection against farm income losses, I introduced legislation in November 2001 to create a new countercyclical target revenue program. As chairman of the Senate Agriculture Committee, I was pleased that we then reinstated a countercyclical income protection program in the 2002 Farm Security and Rural Investment Act. In 2007 and 2008, with the leadership of Senator Dick Durbin and Senator Sherrod Brown, I was pleased that we included the Average Crop Revenue Election, or ACRE Program, in the Food, Conservation, and Energy Act of 2008. ACRE is, of course, the forerunner of the ARC program in the pending new farm bill.

The reform and evolution reflected in this new farm bill is very greatly facilitated by the significant improvement and strengthening of the Federal Crop Insurance Program. Crop insurance, particularly the revenue policies, are now vitally important to agricultural producers, their lenders and creditors, and to the rural economy. So it is an important feature of this bill that it further strengthens and improves the Crop Insurance Program, building upon the Agriculture Risk Protection Act of 2000 and additional improvements in the past two farm bills.

The pending bill also continues a strong conservation title with highly effective programs and funding for them, along with extensive reforms, streamlining, and updating of their structure and functioning. The Department of Agriculture's conservation programs have an outstanding record of success in helping America's farmers and ranchers produce an abundant supply of food, fiber, and fuel, while conserving and protecting our Nation's soil, water, wildlife, and other natural resources. Again, I very much regret that budget circumstances have imposed spending reductions in the conservation title of this bill. There is far more conservation work to be done and demand for USDA conservation assistance than can be met with existing levels of funding. But, as I have noted, these funding reductions are the reality for the crafting of this bill.

In the past two farm bills, as chairman of the Senate Agriculture Committee, I made a very strong push for strengthening the full range of USDA conservation programs and for increasing funding to respond to the need and demand for conservation assistance to farmers and ranchers across our Nation. In the 2002 and 2008 farm bills, we very substantially increased our Federal investment in agricultural conservation, building upon successes in preceding farm bills, especially owing to the leadership of the former chairmen of the Senate Agriculture Committee, Senator Leahy and Senator Lugar.

For many years, I have emphasized the necessity of promoting and assisting sound conservation practices on land in agricultural production, often referred to as ``working lands''. Agricultural producers are striving to produce much more food in the coming decades to nourish billions more inhabitants of the the Earth. If we hope to produce more and more food in the coming years, it is critical to conserve the underlying resources that support agricultural production.

My objective has been to enact and invest in programs that compensate and assist agricultural producers for their costs, foregone income, and environmental benefits associated with adopting and maintaining practices that protect and sustain soil, water, wildlife, and other resources. In the 1990 farm bill, the Food, Agriculture, Conservation, and Trade Act, we included the Agricultural Water Quality Incentives Program, which I had authored, to provide incentive and cost share payments for practices addressing water quality issues in agricultural production.

In the 1996, 2002, and 2008 farm bills, we substantially expanded and improved conservation programs covering land in agricultural production. I am especially proud of the Conservation Stewardship Program, CSP, which I authored and worked successfully to include in the 2002 farm bill, where it was then named the Conservation Security Program. CSP now has enrolled nearly 50 million acres of agricultural land across our Nation, including crop land, pasture land, range land, and forest land.

CSP and the Environmental Quality Incentives Program, EQIP, both focus on promoting and supporting conservation on land that is in agricultural production. They are not land-idling programs. Agricultural producers voluntarily enroll in CSP and EQIP because they are committed to good stewardship and these programs help them fulfill that commitment. CSP and EQIP also help farmers and ranchers to take voluntary action to solve environmental and conservation challenges and thereby avoid regulations. Participants in both programs contribute their own money, time, and effort, so the Federal funds leverage a significant amount of added private money. The level of interest in and demand for both EQIP and CSP greatly exceeds the funding now available and that which is provided in this bill.

To be clear, America's farmers and ranchers have done a tremendous amount of excellent conservation work. Even so, they know that a good deal more conservation work is needed, and they are dedicated to carrying it out. Providing them assistance through the several USDA conservation programs included in this farm bill is a tremendously important investment in conserving and protecting our Nation's vital natural resources for future generations.

This agriculture and food legislation also continues, with reforms and spending reductions, the Supplemental Nutrition Assistance Program, SNAP, and related programs that help low-income families put food on their tables. No title of this bill is more critical to those who rely upon its benefits, nor is any title more important to our Nation in meeting our responsibilities to our fellow citizens. We hear criticisms of Federal nutrition assistance, but let us not forget that the vast majority of Americans who receive this help are children, seniors, people with disabilities, or working families. Indeed, recent years have shown how vitally important SNAP and related nutrition assistance are to enabling working families and especially the children in these families avoid hunger and malnutrition.

The reforms in this bill reduce Federal spending by limiting eligibility and benefits. I regret that our budget circumstances have led to this outcome, but again I give credit to Senator Stabenow and Senator Roberts for holding these cuts to nutrition to much lower levels than other proposals that have been made, including the budget resolution adopted in the House of Representatives. It is also gratifying that this body has in recent days rejected several amendments that would have drastically reduced food assistance for the most vulnerable Americans.

Because the nutrition title in this bill is responsibly and carefully crafted, it continues important reforms and improvements that I am proud we were able to enact in the most recent two farm bills. In the 2002 legislation we restored certain benefits for legal immigrants, restored a portion of benefits that had been cut in previous legislation, increased incentives for work, simplified and increased integrity in nutrition assistance, increased emergency food assistance, dedicated mandatory funding to the Farmers Market Nutrition Program, and adopted a pilot program I authored to provide free fresh fruits and vegetables to children in schools. In the 2008 bill we likewise included key improvements to nutrition assistance, such as further restoring previously cut benefits, encouraging savings by recipients, adopting a pilot program of incentives for healthier eating through SNAP, improved benefits for families with high childcare costs, expanded the Fresh Fruit and Vegetable Program to a national program, dedicated mandatory funding for community food projects, increased mandatory funding for the Senior Farmers Market Nutrition Program, allowed a preference for purchasing locally produced food for child nutrition programs, and dedicated mandatory funds to the Farmers Market Promotion Program.

To promote energy efficiency on farms and in rural businesses and the production and use of renewable energy and biobased products, this legislation extends, improves, and strengthens programs in the energy title in the 2002 and 2008 farm bill. I am proud to have included the first farm bill energy title in the 2002 legislation, to strengthen and expand the energy title in the 2008 bill, and to continue the energy title as a prominent part of this bill. And thanks to the cooperation of Senators Stabenow, Roberts, Lugar, and Conrad, we were able to dedicate about $800 million in new funding to these critical energy initiatives in the bill reported from the Agriculture Committee.

In March of this year, I introduced S. 2270, the Rural Energy Investment Act of 2012, in order to extend the programs in the energy titles of the 2002 and 2008 farm bills and to provide mandatory funding for the energy title of this new farm bill. So I am very pleased that it includes a strong energy title and dedicates mandatory funding to it.

The bill continues the requirement I authored and we enacted in the 2002 farm bill for Federal departments and agencies to purchase biobased products and to create a ``BioPreferred'' labeling program to encourage private markets for biobased products. Also included in this bill are grants to assist pilot-scale biorefineries and loan guarantees for commercial biorefineries.

This bill appropriately continues the Biomass Research and Development Program, which is a joint initiative of USDA and the Department of Energy that awards grants for research on the full spectrum of bioenergy supply chains, from biomass feedstock development and production, to harvesting and handling, to biomass processing and fuels or products manufacturing.

The Rural Energy for America Program, REAP, the most popular program in the energy title because it provides direct financial support to many farmers, ranchers, and rural small businesses for rural energy systems or energy efficiency projects, is also continued. And this bill extends the Biomass Crop Assistance Program, BCAP, that supports establishment of biomass crops for bioenergy use and provides cost- share payments for harvest and delivery of biomass to user facilities in the initial years.

I am also very pleased that the bill continues, improves, and strengthens a number of initiatives that we included in previous farm bills to assist and promote opportunities for farmers and good nutrition for consumers through farmers markets and increased local production and marketing of food.

In this bill, the Farmers Market Promotion Program is renamed as the Farmers Market and Local Food Promotion Program, and it provides competitively awarded USDA grants to improve and expand farmers markets, roadside stands, community-supported agriculture marketing, and other direct producer-to-consumer marketing, including funding for mobile electronic benefits transfer technology. The grants may also be used to help develop local systems focused on serving low-income communities. This bill increases the mandatory funding dedicated to the program to a total of $100 million.

The bill also extends and increases funding for community food projects through grants to nonprofit organizations to be used in improving access to healthy, nutritious food in communities, which can include assistance to farmers markets and other local food marketing systems. We included $5 million a year in mandatory funding in the 2008 farm bill, and this bill doubles that to $10 million a year.

For the Hunger Free Communities Initiative, the bill dedicates $100 million in new mandatory funding for incentive grants to support increased purchase of fruits and vegetables by families participating in SNAP in underserved communities.

To help farmers cover the cost of obtaining certification as qualified organic producers, the bill includes an increased level of mandatory funding, and it continues and funds the organic research and extension initiative. Also continued are the program of block grants to the States to assist fruit, vegetable, and horticulture crop producers and a special program supporting research projects focused on helping these producers. The bill continues the initiative I was pleased to include in the 2008 farm bill to provide cost-share assistance through EQIP to farmers who are making the transition to organic food production.

Mr. President, these are only some of the important features in this new farm bill. It is a strong bill, with substantial reforms and continued progress toward improved food, agriculture, conservation, energy, and rural policies for our Nation.

Mr. President, Chris Bern retires on July 14 as president of the Iowa State Education Association after completing his second two-year term in that position. Chris is a longtime advocate for quality education within ISEA and is an important voice for teachers at the local, State, and national levels. I have valued Chris's views on a variety of education issues.

I am especially grateful to Chris for his leadership on anti- harassment and anti-bullying issues within the Iowa State Education Association and the National Education Association. Chris understood the importance of anti-bullying efforts before recent events drew national attention to the topic. Chris is a certified trainer for the NEA's program on school safety and anti-harassment issues. One of his leadership priorities at ISEA has been to promote anti-bullying awareness in our schools, traveling to locals around the State to talk about how to protect students from mistreatment by their peers.

After graduation from Buena Vista College, Chris started his teaching career as a junior high school math teacher in Woodbine, IA and then moved to Knoxville, IA, where he taught high school math. He soon became involved in the Iowa State Education Association, serving in a variety of local, State and national roles. Chris spent 11 years on various committees, including the ISEA Resolutions and

New Business Committee. He was elected vice president of the ISEA in 2006 and, on the national level, was a member of the NEA Resolutions Committee.

As Chris retires from his presidency of the Iowa State Education Association, I wish him the very best. Chris' service to education as a teacher and ISEA leader remind me of the quote by American essayist Christopher Morley who said, ``Things of the spirit differ from things material in that the more you give the more you have.''

Indeed, Chris Bern has much. I wish him the best in his future endeavors.

Mr. President, I wish to announce that the Committee on Health, Education, Labor, and Pensions will meet in open session on Tuesday, June 19, 2012, at 10 a.m. in SD 430 Dirksen Senate Office Building to conduct a hearing entitled ``Forty Years and Counting: The Triumphs of Title IX.''

For further information regarding this meeting, please contact Libby Masiuk of the committee staff on (202) 224 5501.

Committee on Health, Education, Labor, and Pensions

Mr. President, I wish to announce that the Committee on Health, Education, Labor, and Pensions will meet in open session on Thursday, June 21, 2012, at 10 a.m. in SD 430 Dirksen Senate Office Building to conduct a hearing entitled ``Olmstead Enforcement Update: Using the ADA to Promote Community Integration.''

For further information regarding this meeting, please contact Lee Perselay of the committee staff on (202) 228 3453.

Mr. President, there is a definition of ``United States Senator'' that I have always enjoyed: ``A United States Senator is a constitutional impediment to the smooth functioning of staff.'' We may laugh. But we all know that there is a lot of truth in that!

On the Committee on Health, Education, Labor, and Pensions, which I chair, I am blessed with one of the finest staff teams on Capitol Hill. And on that staff, Lory Yudin, our chief clerk, has set the highest standard for professionalism, expertise, and work ethic. So it is a sad day for the committee as Lory retires this week.

Actually, this is Lory's second retirement from the Senate. She originally came to work in the Senate in 1977, as a staffer for the Banking Committee, later moving to the Rules Committee, and retiring in 2001.

She was coaxed to come back to the Senate in 2009. It was a critical time for the HELP Committee, just days before the committee was scheduled to begin markup of the historic health reform bill. We were in sudden, urgent need of a new chief clerk. And not just any chief clerk. This was no time for on-the-job training. We needed a seasoned veteran who could step right in and take charge of a long and complex markup process. Long-time staffers put their heads together and came up with the answer: We need to persuade Lory Yudin to come back to the Senate.

Fortunately, Lory said yes. On her first day, she walked into a scene of disarray, with boxes, papers, and documents scattered across tables and lining hallways. Lory quickly took charge, imposing order and discipline--and, most importantly, projecting a sense of calm and competence. In short order, everything was sorted, organized, and under control. The committee was ready for one of the most

important markups in its history. As one senior staffer said about Lory's leadership at this time, ``She really rescued the committee.''

In the nearly 3 years since, Lory Yudin has become a beloved and respected chief clerk, looked up to by everyone as the quintessential Senate professional. And, of course, she has been a great friend to members and staffers alike. For younger staffers, she has been the perfect mix of mentor and mom, someone they turn to for wisdom and counsel.

Lory is very much a member of our Senate family. This is where she met her husband David, as well as so many of her lifelong friends. And while Lory has always been dedicated to her work here in the Senate, there is no question that her family has always come first, especially her son Eli. As we know, Lory is extraordinarily proud of Eli's graduation, just weeks ago, from the University of Michigan.

Today, as Lory begins the next chapter of her life, I join with the HELP Committee's Ranking Member, Senator Enzi, and all the committee's members and staffers in expressing our respect and love for Lory, and our gratitude for a job done with enormous skill and dedication. We wish Lory and her family the very best in the years to come.

Mr. President, I thank Senator Mikulski for her tremendous leadership on this issue--a lot of issues, quite frankly. But she has focused laser-like attention on this issue for so long, and I would hope, when we have this vote at 2:30, we can at least get to the bill and debate the bill and have amendments on the bill. But I am afraid our Republican colleagues are not going to let us do that.

Again, I applaud the senior Senator from Maryland, Ms. Mikulski, for introducing the Paycheck Fairness Act and fighting so hard for so long for it.

Again, to repeat what has been said before--but I think it needs to be repeated time and time again--in 1963, Congress responded to wage disparities between men and women by passing the Equal Pay Act of 1963. At that time, 25 million female workers earned just 60 percent of the average pay for men.

Now, nearly half a century after the passage of that landmark law, we have made some progress toward eliminating this gross inequality, but it is not enough. There should be no gap. But today, a wage gap continues to exist within every segment of our economy, at all education levels and in all occupations. So for every $1 a man earns now, a woman earns just 77 cents. That is better than 60 cents, as it was in 1963. But one would think a half a century later we would at least be equivalent. But now it is still just 77 cents.

Women's lower wages add up tremendously over a career. Over the course of a 40-year career, women, on average, earn nearly $400,000 less than men. Women with a college degree or more face a career wage gap of more than $700,000 over a lifetime of work when compared with men with the same education.

The consequences of the gender pay gap are enormous, impacting not just women but families as well. In today's economy, women represent half of all workers and earn an increasing share of family income. Two- thirds of mothers are major contributors to family income. In today's economy, when a mother earns less than her male colleagues, it is her family--her family--that often must sacrifice even the basic necessities, such as purchasing needed pharmaceuticals and putting healthy food on the table. In many cases, women have to work more hours to earn the same paycheck as men, reducing time spent with their family.

While many factors influence a worker's earnings--including occupation, education, and work experience--there is overwhelming evidence that actual gender discrimination accounts for much of the disparity between men's and women's pay. But, unfortunately, our laws have not done enough to prevent this discrimination.

While I am pleased that the first piece of legislation President Obama signed into law was the Lilly Ledbetter Fair Pay Act--again, that was only a first step; we need to do much more--too many women are still not getting paid equally for doing the exact same job as men. This is illegal, but it happens every day. There are just too many loopholes in our existing laws and too many barriers to effective enforcement.

That is why we need to pass the Paycheck Fairness Act. I thank Senator Mikulski for her leadership in advancing this bill. In 2010, we had a hearing on this in our committee, and I was hopeful it would pass in the last Congress. But as has happened too often in recent years, Senate Republicans filibustered the bill. So understand this: 58 U.S. Senators--58; that is more than just a small majority, that is a big majority--voted to support this legislation. But because of Republican obstructionism and filibusters, we could not even proceed to debate the bill because we had to have 60. We had 58 Senators supporting the bill. That was 2 years ago.

Two years later, Republican obstructionism continues. I want the American people to understand this. Republicans--the minority party-- are preventing this Senate from even considering the issue of unequal wages and gender discrimination. Let me repeat: Republicans are not just preventing this important legislation from receiving an up-or-down vote, they are preventing the Senate--supposedly the world's greatest deliberative body--from even debating and considering the bill. Millions of women and their families are concerned about the fact that they get paid less than their male colleagues. Nevertheless, Republicans will not even allow a debate on the issue in this body, debate and amendment on the bill.

As an aside, I might say another reason why we need filibuster reform. This country cannot go on like this. This country cannot go on with gridlock as

we have had it in the Senate. We need to reform and do away with the filibuster as it now is being used. We need to do away with it when the Senate reconvenes after the election next January.

Strengthening our existing laws by passing the Paycheck Fairness Act is the next step toward wage equality, but it cannot be the last one. We must also tackle the more subtle discrimination that occurs when we systematically undervalue the work traditionally done by women--I repeat, when we undervalue the work traditionally done by women.

The fact is, millions of female-dominated jobs--jobs that are equivalent in skills, effort, responsibility, and working conditions to similar jobs dominated by men--pay significantly less than the male- dominated jobs. This is hard to fathom and impossible to justify.

Let me point out a couple things. Why is a housekeeper worth less than a janitor? Mr. President, 89 percent of maids are female; 67 percent of janitors are male. While the jobs are equivalent, the median weekly earnings for a maid is $387; for a janitor, it is $463.

Truckdrivers--a job that is 95 percent male--have a median weekly earnings of $686. In contrast, a childcare worker--a job that is 95 percent female--OK, we got that: truckdrivers are 95 percent male, they get $686 a week, median; a childcare worker, 95 percent female, has median weekly earnings of $400.

Why do we value someone who moves products more than we value someone who looks after the safety and well-being of our children? I am not here to say the truckdriver is overpaid; it is to say that jobs we consider ``women's work'' are underpaid.

When we connect these things we say: You are right. Jobs we think of traditionally as being women's jobs are totally undervalued in our society. That is why in every session of Congress since 1996 I have introduced the Fair Pay Act along with Congresswoman Eleanor Holmes Norton, which would require employers to require equal pay for equivalent jobs--equalize pay for equal jobs. This bill would require employers to provide equal pay for jobs that are equivalent in skill, effort, responsibility, and working conditions.

Now, one might say: Well, that sounds way out. How can we do that? Well, in 1982, the State of Minnesota implemented a pay equity plan for its State employees. They found that women were segregated into historically female-dominated jobs, and these jobs paid 20 percent less than male-dominated jobs. So the State of Minnesota instituted this law. Pay equity wage adjustments were phased in over 4 years, leading to an average pay increase of $200 per month for women in female- dominated jobs. The wage gap closed by approximately 9 percent.

In 1984, the Republican Governor, Republican Legislature, passed similar legislation in the State of Iowa: pay equity for equivalent jobs--equivalent jobs. So this is not unheard of in this country. It is unheard of for us to do it at the Federal level covering everybody, but some States have already taken leave--as I said, Minnesota in 1982 and Iowa in 1984.

This bill would require employers to publicly disclose their job categories and pay scales--not individual employees' pay but their categories and pay scales. That way a woman would know whether she needed to negotiate a better deal. Right now women who believe they are the victim of pay discrimination must file a lawsuit and endure a drawn-out legal discovery process to find out whether they make less than the man working beside them. Well, with pay statistics readily available for categories and pay scales, this whole process could be avoided.

I asked Lilly Ledbetter at a hearing once: If the Fair Pay Act, the one I am talking about now, had been law, would it have obviated your wage discrimination case? She said with the information about pay scales this bill provides, she would have known she was a victim of discrimination and could have addressed the problem much sooner, before it caused a lifelong drop in her earnings and before she had to go all the way to the Supreme Court to try to make things right.

If Republicans allowed us to proceed to the bill, I would offer the Fair Pay Act as an amendment. Yet I emphasize again, because of the Republican obstructionism, we cannot even debate or amend the bill. We cannot even bring it up and amend the bill.

Finally, I want to comment on the RAISE Act. My Republican colleagues would have us believe that we can solve the pay gap by allowing employers to give merit-based pay increases above levels negotiated in a collective bargaining agreement. Well, this is nonsense. The RAISE Act has nothing do with women's pay. Rather than seriously discussing gender discrimination, the Republicans have tried to change the subject by resorting to yet another partisan attack on organized labor--on labor unions.

In fact, not only does the RAISE Act do nothing to address the discrimination faced by women in this country, the RAISE Act would both exacerbate the wage gap and lower pay for all workers. Collective bargaining agreements raise wages for all workers. The RAISE Act would undermine collective bargaining by requiring that all union contracts include provisions allowing employers to unilaterally grant wage increases to select employees.

The primary effect would be to weaken the union's ability to bargain for higher wages for all workers. It would also give employers unfettered discretion to dole out pay increases to preferred employees. That is a recipe for more discrimination, not less.

I urge my colleagues to stand with Senator Mikulski in support of the Paycheck Fairness Act today. It is a simple, commonsense piece of legislation. There is no reason we should not take it up and pass it right away. Once we have closed the loopholes and ensured effective enforcement of the Equal Pay Act, we must turn our attention to the millions of women, especially low-wage workers, whose work is undervalued. Think of childcare workers. Think of the women who are now taking care of our elderly who are living longer but need supportive care in their later years, mostly women. Why is that work being undervalued? We must ensure they receive the recognition and fair treatment and fair pay they deserve by passing the Fair Pay Act.

In closing, the fight for economic equality is far from over. It should not be over until every working woman in America receives a fair day's pay for a fair day's work.

As the chair of the HELP Committee, I plan to keep advocating for fair pay and focusing on equal wages until we have achieved real equality for women across the country. But first things first. It is time for our Republican colleagues to end the filibuster and allow the Pay Check Fairness Act to come to the floor this afternoon for debate, amendments, and a final vote.

I yield the floor.

Mr. President, I wish to announce that the Committee on Health, Education, Labor, and Pensions will meet in open session on Tuesday, June 12, 2012 at 10 a.m. in SD 106 Dirksen Senate Office Building to conduct a hearing entitled ``Equality At Work: The Employment Non-Discrimination Act.''

For further information regarding this meeting, please contact Dan Goldberg of the committee staff on (202) 224 5441.

Mr. President, I wish to announce that the Committee on Health, Education, Labor, and Pensions will meet in executive session on Wednesday, June 13, 2012 at 10 a.m. in SD 430 Dirksen Senate Office Building to consider pending nominations cleared for action.

For further information regarding this meeting, please contact the committee on (202) 224 5375.

Mr. President, I ask unanimous consent that Shaun Robinson and Shannon Smith of my staff be granted floor privileges for the duration of today's session.

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

Mr. President, I understand the Republican leader is about to come to the floor to give his leader remarks.

I just wish to let Senators know we are moving ahead on the bill. Senator McCain just brought up his amendment and spoke about it. I know there are some who want to speak in opposition to the McCain amendment. We still have amendment No. 2111 by Senator Bingaman to be called up. We have two amendments, No. 2146 and No. 2145, by Senator Portman that need to be called up. I ask Senators to please come over and call up their amendments so we can debate them and move ahead to expeditiously voting on those amendments and final passage of the bill.

I see the Republican leader is on the floor, and I yield the floor.

Recognition of the Minority Leader

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

Mr. President, I ask unanimous consent that the time in quorum calls be evenly divided on the McCain amendment.

Mr. President, I again say we are rapidly coming to a close. Again, the sooner we can get to voting, the sooner we will close out the business for the day and probably for the week.

I again would point out that we have Senator Bingaman's amendment No. 2111 yet to be called up. Senator Portman has two amendments--Nos. 2146 and 2145. Those basically are the only ones left to be brought up. So I would urge them to come and others who have indicated they want to come and speak on the amendments that are pending. The McCain amendment, the Sanders amendment, the Murkowski amendment, the Durbin amendment, and the Paul amendment are still pending. People have indicated they want to come over and speak on these various amendments. I would hope they would do so, so we can perhaps get to voting on the amendments and final passage of the bill sooner rather than later.

With that, I suggest the absence of a quorum.

Mr. President, prior to Senator Bingaman bringing up his amendment, I ask unanimous consent that the following amendments be in order and made pending: Leahy No. 2142, as modified, with the changes that are at the desk; Portman No. 2145, as modified, with the changes that are at the desk; and Portman No. 2146, as modified, with the changes that are at the desk.

Amendment 2146, as modified, filed by Senator Portman, places a number of synthetic drugs within schedule I under the Controlled Substances Act.

I am glad that those bills and, therefore, the substance of this amendment have already been given careful consideration by the Senate Judiciary Committee. That gives me comfort in including this amendment among those to which the managers of the bill consent.

Absolutely.

It is too bad that so much progress has been blocked by so few in this Congress. I am glad that the Food and Drug Administration Safety and Innovation Act may provide an opportunity to make progress on this important issue.

Mr. President, I ask unanimous consent that the following pending amendments be agreed to: Leahy No. 2142, as modified; Portman No. 2145, as modified; and Coburn No. 2131; and that the Coburn amendment No. 2132 be withdrawn.

Mr. President, it is my understanding that we are ready to act on the Portman amendment No. 2146, as modified.

Mr. President, I yield the floor.

Mr. President, I concur with Senator Enzi on that, to stick to the bill.

I ask unanimous consent, notwithstanding the previous order, the Senate proceed to votes in relation to the following amendments at 12 noon with all other provisions of the previous order remaining in effect: Bingaman amendment No. 2111, Murkowski amendment No. 2108, and Paul amendment No. 2143.

Mr. President, I would modify my unanimous consent request to have the vote start at 12:05.

Madam President, first I ask for the yeas and nays.

Madam President, I inquire what the next vote would be on?

Madam President, I ask that that vote be a 10-minute vote.

Regular order, please.

Madam President, parliamentary inquiry.

There is a lot of commotion going on. I want to know where the time is coming from for the Senator from Tennessee.

Madam President, how much time is left on the bill?

How much time does the Senator from Tennessee need?

OK, that is fine.

I will, too, if he needs it.

Madam President, if I may inquire of the Senator how much time she wishes.

I yield 6 minutes off the bill.

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 suggest the absence of a quorum, and I ask unanimous consent that the time during the quorum call be taken off of the Burr amendment and be equally divided on both sides.

Madam President, I appreciate the remarks made by my good friend from Delaware. I thank him and his staff for their input on this bill. Again, this bill is the work of a lot of different people, and I want to thank the Senator from Delaware for helping us get to the point where we have a good consensus bill.

Madam President, is there any time remaining on the Burr amendment?

Madam President, I yield 6 minutes off of the McCain amendment, on our side, to the Senator from New Jersey.

Madam President, I yield 6 minutes to the Senator from West Virginia, again off the opposition to the McCain amendment time.

Madam President, how much time remains on the McCain opposition?

Madam President, I yield myself that time and a couple of minutes off the bill.

Madam President, I wish Senators to know that we will start voting here in 9 or 10 minutes, and these will be 10-minute votes.

The first vote will be on the amendment offered by the Senator from Kentucky, Mr. Paul, followed by Senator McCain's amendment, Senator Sanders' amendment, Senator Durbin's amendment, and then final passage.

By an earlier consent, all of those votes will be 10-minute votes. I wanted to make sure that people knew what the lay of the land was here.

We are rapidly approaching the final passage of this bill. We have had great cooperation from all Senators on both sides in moving this legislation forward here on the floor. We have had good debates. They have not been drawn out endlessly, but we have had good debates and a good airing of the amendments on the bill. I thank all Senators for that, and hopefully we can move rapidly to wrap up this bill and move on.

This bill is the product of 18 months of very hard work by Senator Enzi and all of the Senators on our committee on both sides of the aisle. It is a true compromise and bipartisan bill. As I mentioned earlier, it has the support of a broad spectrum of stakeholders, from the pharmaceutical companies to pharmacists to consumer organizations, across the broad spectrum who support this bill, and it is necessary that we get it done. That is why we have urged everyone to expeditiously get this done before the break period coming up for Memorial Day so the Food and Drug Administration won't have to start sending pink slips out to people this summer, and so there will not be any disruptions. It will allow them to get on with the business of making sure we get drugs and devices to patients expeditiously but safely, making sure our drugs and our devices are safe.

It is a good bill, and it is the result of a lot of hard work by a lot of people, so I hope we can move these amendments rapidly and move to final passage this afternoon.

I yield the floor.

Madam President, I yield myself as much time as I may consume off the bill.

Madam President, we are rapidly approaching a vote on the Paul amendment, and I know the Senator wants to have a couple of minutes to speak on that.

I rise in opposition to the Paul amendment. I oppose it for several reasons. Perhaps the most important reason is that this is a drug bill. This bill deals with drugs and devices. It does not deal with food. We dealt with dietary supplements and vitamins and things such as that in the food safety bill that we passed 2 years ago and that bill, again, was a consensus bill that has been through the committee structure. We brought it to the floor and had a lot of debate on it. We made modifications at that time to the whole area of vitamins, minerals, and supplements, and that is the proper place to address it, not on a bill such as this. This bill is a bill on drugs, not on supplements and food, so that is the most important reason.

I will make that same argument on the Durbin amendment. That should not be here because this is a drug bill.

On substance, I would say this bill kind of turns food law on its head. It would allow supplements to be sold with claims to cure any disease, such as AIDS or cancer, without any kind of FDA review whatsoever. I take a backseat to no one in terms of my support for the vitamin, mineral, and supplement industry and their products. Senator Hatch and I were the two people who put through the DSHEA bill, the Dietary Supplementary Health and Education Act in 1994. If I might say, we have sort of been protectors of it in working to make sure it has been implemented correctly since that time.

But the Paul amendment would go way too far. It is not consensus policy. In fact, it is strongly opposed by even the dietary supplement industry. I would note that the Natural Products Association, United Natural Products Alliance, and the Council on Responsible Nutrition, all three are big umbrella groups that oppose the Paul amendment. This would open this industry to snake oil salesmen.

Again, those of us who want to make sure people have unfettered access to safe products and to good, nutritious vitamins, minerals, and supplements, the last thing we want to see is people in their garages mixing it up and selling it as snake oil. This is not good for America, it is not good for people who want to take vitamins and supplements and minerals for their own health. It would throw this thing open and turn the clock back 50 years or more where anybody could make any claim they want and the FDA would have no way of reviewing it whatsoever.

I will move to table the amendment at the appropriate time, but I urge all Senators to oppose the Paul amendment.

I yield the floor.

Madam President, I move to table the amendment by the Senator from Kentucky and ask for the yeas and nays.

I ask for the yeas and nays.

Mr. President, first of all, this is a drug and device bill, not a food bill. We addressed food issues in the food safety bill 2 years ago. That doesn't solve the problem Senator Durbin talked about. This bill is a very delicate balance. We have worked on this for 18 months. Stakeholders all over the country, consumers, the pharmaceutical industry, and pharmacists all support this bill. This would upset that delicate balance.

I say to the Senator that every supplement has a label, the ingredients, and the potency, by law, on every single item sold as a supplement. This is a drug bill, not a food bill.

Madam President, I move to table the Durbin amendment, and I ask for the yeas and nays.

Madam President, I move to reconsider the vote and to lay that motion on the table.

The motion to lay on the table was agreed to.

Prescription Drug Information

I applaud the work of the Senator from New York on this legislation and share her commitment to ensuring patients receive standardized and accurate information about their prescription drugs. While verbal counseling by a pharmacist is still critical, the patient medication information is also an important resource to help patients use medications safely.

I agree we need to take steps to improve the information patients receive and look forward to working with the Senator on this issue.

The managers' amendment to 3187 revises section 506(b), removing the explicit language in current law requiring postapproval validation of surrogate endpoints. However, this is not intended to restrict the Secretary's current ability to require such validation postapproval, if appropriate. Equally important, the change likewise is not intended to suggest that any such validation should now occur prior to approval under section 506(b). Rather, in keeping with current practice, the bill's new language continues to permit the Secretary to require postapproval studies to verify the effect on the surrogate endpoint or predicted clinical outcome, i.e., verification of the predicted clinical benefit. In addition, it continues to allow the Secretary to withdraw an accelerated approval if the required studies fail to verify and describe the predicted effect.

Madam President, we have all put in a lot of work and benefited greatly by the constructive ideas and efforts of all the Members of this body. I sincerely thank all my colleagues, especially Senator Enzi, for their hard work on this must-pass legislation.

This excellent bill is a shining example of what we can achieve when we all work together. Now we must keep our promise to patients and the biomedical industry and pass this critical bill.

Today, with one vote, we can reauthorize the essential FDA's user fee agreements, systematically modernize FDA's medical product authority, and help to boost American innovation and ensure that patients have access to the therapies they need.

So I urge my colleagues to join in this bipartisan spirit of cooperation and pass this important legislation, the FDA Safety and Innovation Act.

Madam President, I ask for the yeas and nays.

Madam President, today, with passage of the FDA Safety and Innovation Act and the reauthorization of the FDA user fee agreements, we have helped both the FDA and the biomedical industry ensure that they can get needed medical products to patients quickly and safely.

This legislation will ensure that the FDA can swiftly approve drugs and medical devices, save biomedical industry jobs, protect patient access to new therapies, and preserve America's global leadership in biomedical innovation. It will keep patients safer by modernizing FDA's inspection process for foreign manufacturing facilities, while also improving access to new and innovative medicines and devices. It will reduce drug costs for consumers by speeding the approval of lower cost generic drugs and help prevent and address drug shortages. Finally, by improving the way FDA does business, increasing accountability and transparency, U.S. companies will be better able to innovate and compete in the global marketplace.

By passing the FDA Safety and Innovation Act, we have taken an important step to improve American families' access to lifesaving drugs and medical devices.

As I have said throughout this debate, the bipartisan process that produced this excellent bill has been quite remarkable. I have worked closely with my colleagues on both sides of the aisle, as well as industry stakeholders, patient groups, and consumer groups to solicit ideas and improvements on the critical provisions in this bill. We have a better product thanks to everyone's input.

I extend a special thank-you to my colleague, Ranking Member Enzi. I have been working with Senator Enzi for over a year on this bill. It has been a wonderful and cooperative partnership and a trusting friendship. I can honestly say we would not have gotten this done without his excellent leadership and wise counsel. I thank him for that.

I also thank all of the HELP Committee members, as well as members off the committee, who were thoroughly engaged with this process from the beginning as part of the bipartisan working groups we established. Each of them has contributed significantly to this legislation, and I am sincerely grateful for all their contributions.

Madam President, I will submit for the Record a list of all staff members who were part of our bipartisan working groups throughout the past year. We all know we could not have achieved this without the tireless and diligent work of our loyal staffs. I extend my deep appreciation for their hard work and extraordinary efforts.

I ask unanimous consent that the list of staff members be printed in the Record.

On that note, I specifically thank the staff of Ranking Member Enzi's office. I thank Frank Macchiarola, Chuck Clapton, Keith Flanagan, Melissa Pfaff, Grace Stuntz, Katy Spangler, and Riley Swinehart. I

know they have developed a close working relationship with my staff throughout the year, and I am sincerely grateful for their dedicated efforts.

I thank my own staff on the HELP Committee, who have spent many a night, long days, and weekends with Senator Enzi's staff and other Members' offices working to come to consensus on the critical policy issues in this legislation.

I thank our staff director, Dan Smith; his assistant, Pam Smith, who, by the way, will be very shortly taking over as our new staff director. Dan Smith is leaving our staff and going into the private sector. Pam Smith will be taking over as our new staff director. I also thank Jenelle Krishnamoorthy, who heads our health division, for all of the tireless work she has put in. I can't thank her enough for all her hard work. I also thank Elizabeth Jungman, Bill McConagha, Kathleen Laird, Kathleen Wise, Dan Goldberg, Justine Sessions, Kate Frischmann, Elizabeth Donovan, Lory Yudin, Frank Zhang, and Evan Griffis. Each of them has done a remarkable job. I thank them from the bottom of my heart for getting this legislation through.

We would be remiss if we didn't also thank the Congressional Budget Office for their knowledgeable and capable team that was willing to work around the clock to estimate the budgetary effects of this legislation.

Finally, we owe an enormous debt of gratitude to the staff members in the Legislative Counsel's Office. They too worked long hours, nights and weekends, to assist my staff in drafting this critical legislation and working out technical issues.

This bill's passage is a victory for the millions of Americans who need medicines or medical devices--a victory that would not have been possible without the dedicated work of our Senate family. I thank all of you for your extraordinary public service.

Mr. President, while I appreciate the confidence the Republican leader has in the ability of Mr. Enzi and me to get things done, frankly, we are confronted now with two votes. Which way do we want to go? What they are proposing is that we totally end, totally eliminate all of the prevention and wellness money that we have out there in the wellness fund.

What would this do? We have vaccinations for children, immunizations, smoking cessation programs, colorectal screenings, diabetes prevention, breast cancer screening, obesity prevention--all funded by this Prevention and Wellness Fund. Not one of those would be funded from that fund if that amendment passes.

The choice is very clear on the two amendments we have coming up. We can either vote to close a tax loophole that allows wealthy tax dodgers not to pay their fair share of taxes--we can close that loophole and keep the interest rates at 3.4 percent--or, as the Republicans want to do, totally eliminate the Wellness and Prevention Fund and end the money that we are putting into diabetes prevention and breast cancer and colorectal screening and all the things I mentioned.

I do not think the choice could be more clear to the American people about the direction we ought to go. Close the tax loophole. Keep the prevention fund in there. Keep our people healthy.

The President has already said if the Republican measure were to pass and sent to him, he would veto it. That is a nonstarter. Surely my friend from Tennessee does not want to cut out all of this funding that we do for hepatitis screening and colorectal screening, diabetes prevention, vaccination for our kids, all of which are funded. All of that would be ended by their amendment.

I do not know what my friend is talking about in terms of student money and this and that. Their provision takes all of this money out of the Prevention and Wellness Fund. That is not what we want. We do not want to keep our kids from getting vaccinations or hepatitis screening or diabetes prevention in order to keep the interest rates low. Let's close the tax loophole that has been talked about, that both Senator Reid from Nevada and Senator Reed from Rhode Island talked about. Close that tax loophole and send it to the President. He will sign it. That way we will keep the interest rates down at 3.4 percent and not allow them to double on July 1.