Floor Updates

Tuesday, May 22, 2012

May 22 2012 10:00 AM

The Senate Convened.

Reid, McConnell

Opening Remarks

May 22 2012 10:19 AM

  • Today --
    • The Senate will resume consideration of the Motion to Proceed to S. 3187, the FDA User Fee Reauthorization bill. The first hour will be equally divided, with the Majority controlling the first 30 minutes and the Republicans controlling the second 30 minutes.
    • At 12:30 PM, the Senate will recess until 2:15 for the weekly caucus lunches.
    • At 2:15 PM, the Motion to Proceed to S. 3187, the FDA User Fee Reauthorization bill, will be Agreed to, the Harkin-Enzi substitute amendment will be Agreed to, and Majority Leader Reid will be recognized.
  • As a reminder, on Tuesday, May 8th, a Motion to Reconsider the Motion to Invoke Cloture on the Motion to Proceed to S. 2343, the Student Loan bill, was entered.

Senator Reid: (10:02 AM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "There are 12 million people in the United States who face a cancer diagnosis today. Many have fought back against this terrible disease and won. Others are still fighting. Each one knows how difficult a cancer diagnosis can be. But imagine coming to terms with your diagnosis only to find out the life-saving drug you need to survive is in short supply or simply not available. I wish this were make believe but it's not. It's real America. That is the situation faced by many Americans battling cancer and other life-threatening illnesses As the number of shortages increase each year, more patients are forced to wait for treatment and worry. In the last six years, drug shortages have quadrupled. Last year, the FDA reported shortage of 231 drugs, including many chemotherapy medicines. That's 231 drugs. How many tens of thousands of people did that affect? Public pressure has prompted some drug makers to voluntarily notify the FDA of impending shortages, but congress must step in to improve communication between drug makers, the FDA and doctors who have to break the terrible news that life-saving medicines aren't available. There were a reported almost 200 drug shortages last year, but effective lines of communication could further reduce the number of shortages to save patients' lives. So I'm pleased the spirit of bipartisanship begun by my colleagues, Senators Harkin and Enzi, continued yesterday. I look forward to an orderly amendment process. I'm optimistic that the senate will move this legislation without unnecessary delays. I hope I'm not disappointed. Each year, more than 1.5 million Americans are diagnosed with some form of cancer. It's up to us to ensure not one of them waits and wonders if the medicine he or she needs to stay alive will be there when the need arises."

Senator McConnell: (10:07 AM)
  • Spoke on America's economic challenges.
    • SUMMARY "I want to call attention to a couple of stories from the last two days. I think they say a lot about the difficulties of addressing the economic challenges we face. The first is a story from POLITICO. It says the Budget Committee Chairman can't remember the last time he talked to the President. The Budget Committee Chairman can't remember the last time he talked to the President. Another Chairman dealing with student loans says he hasn't talked to the President in months, in months. The Democratic point man on energy doesn't seem to talk to the president much at all. If you want to know why we can't solve these economic problems, this is it. We've got a President who is more interested in running around to college campuses, spreading some poll-tested message than he is in actually accomplishing anything. That's the problem. Now, the second story, also interesting, is about HHS signing a $20 million contract to promote Obamacare. $20 million of taxpayer money to promote a bill most Americans want to see repealed. $20 million of our tax money spent on commercials to promote Obamacare. Let me suggest that the President spend a little more time trying to do something about spending and debt and gas prices and a little less time trying to spin the unpopular things he's already done. It might require a little more work, but it's what we need. It's time to lead."
  • Spoke on the Nuclear Regulatory Commission.
    • SUMMARY "Yesterday, we learned about the resignation of the Chairman of the Nuclear Regulatory Commission, Dr. Gregory Yazko. As I said yesterday, I'm not surprised by Yazko's resignation. Even Democrats on the NRC testified before Congress that his inappropriate conduct as chairman resulted in a hostile work environment for women and threatened to undermine the mission of the NRC itself. But what should surprise all of us is how this administration could remain silent for more than a year after the allegations of Yazko's offensive behavior first surfaced. Yazko's alleged behavior is unacceptable in any workplace. The fact that it was allowed to persist at a critical agency that oversees the safety of our nation's nuclear power plants is astonishing. The White House must now move swiftly with a replacement for Yazko, and I urge the Senate to move quickly to reconfirm the nomination of Christine Saviniky as NRC Commissioner before her term expires on June 30. Now, the only reason her nomination, Commissioner Saviniky's nomination was held up by the White House and the Democratic-led Senate in the first place was because she had the courage to stand up to a hostile work environment and to the bully who was responsible for it. Now that Yazko has submitted his resignation, it's time for the Senate to move forward on Christine Saviniky. Commissioner Saviniky's credentials are unmatched. She is one of the world's leading experts on nuclear safety. She was confirmed by the senate to her current term without a single dissenting vote. It's time we act. Saviniky has served as commissioner with distinction, is enormously qualified, has bipartisan support and deserves a speedy reconfirmation. The American people are best served by a commission that is fully functional."

Cardin, Kyl, Grassley

FDA User Fee Reauthorization bill (S. 3187)

May 22 2012 11:15 AM

Senator Cardin: (10:36 AM)
  • Spoke on the Small Business Goaling Act.
    • SUMMARY "If you're looking at job growth, which we all know we need in order to get our economy moving again, we know that there will be more jobs created from small companies than from large companies. About two out of every three jobs that are created in America will come from small companies. We also know that if you're looking at innovation, who follows the patents, who comes up with the creative new ideas for America to become as competitive as we need to, it will be more from the smaller companies. There is an incredibly larger number of patents from small companies than from large companies. So the growth engine for America's economy really rests with our small businesses. I'm proud to serve on the small business committee under the leadership of Chairman Landrieu. We have brought forward many initiatives that help small businesses, and I think it's made a huge difference as our economy is starting to recover, as we look at now 25 consecutive months of continuous private sector job growth where we have turned around the economy and we're now growing. In large measure, I think it's because of the attention that we have paid to the small business community. We are proud of what it's meant for our entire country. Let me just give you a little bit about my own state of Maryland. We have over 500,000 small businesses in Maryland that employ over one million people in my state in small businesses. So it is by far a huge part of the Maryland economy. Our strategy over the last several years during the Obama administration has been to concentrate on small businesses to help them recover, particularly from this economic recession. The first effort was to increase the capacity of the Small Business Administration. I was proud of the Obama budget that put more money back into the Small Business Administration. I was proud of the initiative that we had in the Senate to add funds to the small business administration so that they could indeed be the advocates for the small business community. They had someone in the government that was fighting for their issues and it's made a huge difference I come to the floor to announce a new initiative that I will be filing today, and that is the Small Business Goaling Act to deal with another problem we have with small businesses that I hope that we will be able to take up on the floor of the Senate in the very near future. It would increase the prime goals for small businesses in government procurement from 23% to 25% and increase the subcontracting goals to 40%, adding transparency to how government provides procurement opportunities of their government contracts to small businesses. We have taken some action in dealing with bundling and trying to prevent the bundling of small contracts into large contracts that makes it more difficult for small businesses to get prime contracts. This legislation will make it, I think, more transparent and visible so that we can, in fact, provide more opportunities so that the government leads by example by using small companies more to help them grow."

Senator Kyl: (10:46 AM)
  • Spoke on Keynesian and supply-side economics.
    • SUMMARY SUMMARY "I would like today to add a little context to the discussion of the fiscal cliff that our nation approaches, a reference to the combination of the largest tax increase in history, new taxes under Obamacare, sequestration, and the expiration of the payroll tax holiday, all of which take effect in January of 2013 unless the President and the Congress act. This is a key discussion to have because how we view the so-called fiscal cliff defines our perspective on how an economy grows and prospers. Edward Lazier wrote an op-ed. The Keynesian view and the view of supply-side economics. Keynesian views that spending is the key to growth. Keynesians believe that in recessionary times, government spending can take the place of private-sector activity and they present a false choice between government spending cuts, austerity, and growth. Their perspective holds that growth is contingent on government spending. This was the thinking behind the President's 2009 surplus spending package. The so-called cash for clunkers, and a litany of other recent government programs, transfer payments and temporary tax credits. The administration's insistence on enacting these temporary Keynesian spending policies to stimulate consumption I believe is misguided, and the evidence reveals has failed. Remember, the stimulus was sold as a measure to keep unemployment from topping 8% but, in fact, unemployment hasn't dipped below 8% for 39 months. And growth is very anemic. We're experiencing a recovery in name only. So there isn't much evidence that spending can revitalize a sagging economy. That is to say government spending. And even if government spending could be a boost as Lazier points out, he writes "even if a stimulus has some benefit, the cost is likely to be very large. In order to stimulate the economy, growth in, not just high levels of government spending, is required. To provide a stimulus comparable to the 2009 legislation, we would need to increase government spending by $250 billion. And he goes on the Keynesian view keeping spending constant at the higher level in 2014 would generate no growth for 2014 because there is no increase in spending over the 2013 level. If we want to delay our day of reckoning, he writes, we must keep spending at a higher level for each year that we want to postpone the negative consequences for growth." Supply-side economics, on the other hand, holds a different super expectative on growth, that government spending does not increase prosperity. That tax hikes hurt the committee economy and stifle growth. We believe that economic growth stems from combining three inputs - labor, capital, and technology. These three factors of production result in output that we can then consume. Without labor, capital, and technology, there can be no consumption. Focusing on policies that stimulate consumption targets the wrong side of the equation. In order to get the economy going, we need to focus on the inputs: labor, capital, and technology. We also believe that government spending cuts are beneficial because they free up private capital and help align revenues with government spending. Laziea argues that supply-sliders stand on firmest ground wit comes to economic growth. Here's what he writes. On the tax side there is strong evidence that supports the supplied-siders and he cites insight from Christina Romer. And her research shows that raising taxes by 1% of GDP raising taxes, which is what the administration proposes - lowers our gross domestic product by nearly 3%. So increased taxes by 1%, you lose 3% of gross domestic product."

Senator Grassley: (10:54 AM)
  • Spoke on the FEC-Lightsquared investigation.
    • SUMMARY "I'm pleased to see that Jessica Rosen Wiesel have been confirm. It's unfortunate that the FCC's stubborn response to, forced me to place a hold on their nominations for the past four months in order to get the FCC to move on giving mere the information that any member of congress ought to be entitled to. The FCC needs to learn a simple lesson from this episode. The public's business ought to be public. And transparency brings accountability. Eventually the truth will be known, so you might as well get it out there when the questions first come up. I initially placed my hold on the FCC commissioner nominees because the FCC had stonewalled a document request that I submitted on April 27 last year regarding their actions related to a company called Lightsquared, and the hedge fund harbinger capital that owns Lightsquared. Before I wrote my letter on Lightsquared, many concerns had already been raised regarding the company's plans for a terrestrial network and its potential to interfere with the global positioning system, or sometimes that's referred to as GPS in my first letter I raised those concerns as well. Unfortunately, the FCC doesn't appear to have taken those concerns seriously, but months later, independent testing verified the danger Lightsquared posed to industries from commercial aviation to even our own armed forces. It seems strange that a project that was so obviously flawed was allowed to go so far, but Lightsquared had help. In total, Lightsquared has paid 53 different lobbyists, some registered, some unregistered. They paid one former governor, three former senators, nine former members of Congress, including a former speaker and former minority leader, and a former White House counsel to advocate for them, that Lightsquared ought to go through. These lobbyists provided entry into the FCC and the white house, but they couldn't change the fact that Lightsquared's network simply couldn't coexist with GPS. Lightsquared has now declared bankruptcy, and it appears that its plan to build a terrestrial network are over, but many questions still remain. Some of those questions, why did the FCC give Lightsquared this unusual waiver in the first place? Why did Lightsquared's lawyers mention campaign contributions when they sought meetings at the White House? Why did a four-star general claim he had been pressured by the Obama administration not to criticize Lightsquared? When I first asked the FCC for documents, I was told they would take about two years to respond to my request through freedom of information. Then they told me that they do not voluntarily turn over documents to the 99.6% of the members of Congress and senators who do not chair a committee with direct jurisdiction over FCC after a lot of back-and-forth with the FCC 1993 they told me the reason they don't respond to 99.6% of Congress is because of just a one-line statement in the Congressional Research Service report. The line reads "oversight is most effective if it's conducted by congressional committees of jurisdiction." Now, the FCC somehow took this quote and conveniently came up with the idea that they don't have to give this senator any documents. And, of course, to anybody in the Congress, this makes no sense whatsoever, but that's what the FCC hid behind. And, of course, you know me, I didn't give up."

May 22 2012 12:33 PM

Senator Harkin: (11:25 AM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "Everyone has a common interest in ensuring that our products don't hurt patients. I have said in our hearings and I continue to believe that safety is the paramount consideration. We cannot sacrifice patient safety on the altar of other considerations. Patient safety still is the highest standard, the highest mark on which we aim our sights. But getting the products to patients quickly is also important. I have heard heart-wrenching stories of patients dress waiting for treatments, of inspiring accounts of small start-up companies seeking to entitle the needs of these patients with innovative medical products. Patient groups and industry alike have stressed the need for efficient processes to get products to patients quickly. Again, I will be pointing out later also that we do have - FDA does a very good job of getting products, both drugs and devices, to market quickly. In fact, of the 154 drugs approved in both the U.S. and Canada, this was a study done by "the New England Journal of ... dragging our heels and FDA hasn't been dragging its heels in terms of getting the job done. Now, some say that, well, sometimes products get approved more rapidly in Europe than they do here. Well, that's true, but it's important to note that the foreign approval standards are different so it's kind of an apples and oranges comparison. The FDA here approves drugs and devices based on their safety and effectiveness. Safety and effectiveness. Are they safe and do they actually do what they say they're supposed to do? Other countries basically in Europe only consider safety and not whether the device is effective. So as long as it's safe, they approve it. So, yes, they have a shorter approval time but they don't take into consideration effectiveness. I strongly believe the U.S. should keep this high standard, this high standard of both safety and effectiveness. It's important to know if a device is effective or not because that affects a patient's decision whether to accept the device's risks and whether to forego maybe alternative treatments. FDA officials testified before our committee this year, they submitted documentation showing that 95% of medical device applications were reviewed within the deadlines set in the past user fee agreement. Now, again, despite all this good work that FDA is doing, patients who are sick or dying, promising therapies can't be approved quickly enough. So the bill that we have before us will continue to support the agency and its good work but it will allow for some very big improvements. The medical device industry has agreed to double its user fees, to pay twice as much, and, in return, the FDA has agreed to speed review times, increase transparency, enhance communications, again, all of which will get devices to patients more quickly but still keeping in mind safety. So anything that we can do to both streamline the process, get drugs and devices to patients sooner, and making sure that we keep our high standard of safety and effectiveness is not only good for business but critical for the patients who need them."

Senator Blumenthal: (11:44 AM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "I'm pleased to say that it includes the Gain Act, which I helped to author and champion with my colleague, Senator Corker, and 20 other senators who have joined in this effort to incentivize the development of new antibiotics, to treat and stop and conquer the superbugs, as they are known, germs that are resistant to antibiotics as they exist now. To provide more drug security, the supply chain needs greater safeguards and I've worked with other senators on this measure. And I'm proud to say it's in the bill. The treatment and research on pediatric diseases and conditions And, of course, the work on medical device innovation and safeguards This measure in a way epitomizes the approach that we should take to FDA regulation, which is to enable devices to reach the market more quickly, to make sure that they are safe but available more promptly and to guarantee surveillance and oversight after they reach the market, and reporting by industry so that we enlist industry as a partner and make the FDA an ally, not an adversary. Nowhere is this approach more necessary than in addressing the drug shortage problem in this country, and it is a problem, it is a crisis, it is an outrage. The United States should be embarrassed and outraged that the greatest country in the history of the world, the strongest on the planet, having developed lifesaving medicines and devoted extraordinary research and development to make those medicines available to the people of this country still has shortages, crisis shortages, in those very pharmaceutical drugs. And that crisis is inexcusable and unacceptable. The bill takes a step in the direction of addressing and solving it. It is a first step I have refiled my amendment from the HELP Committee markup to impose penalties, tough penalties, for manufacturers who fail to notify. Notification is fine, but it will be less effective if there are no penalties for failure to notify. And we may try to walk a balance between enforcement and incentives, but enforcement in this area is critical, and this measure imposing penalties for failure to notify is critical as well. The amendment is a fair one. It provides for penalties of up to $10,000 per day, up to $1.8 million per violation for failure to notify the FDA within a reasonable time frame. I'm proposing an amendment as well that would require critical manufacturing reinvestment. I've worked with the manufacturing industry to create a public-private partnership to incentivize the development of additional manufacturing capacity. The root of the drug shortage problem is that these products are old and generic and difficult to make, so that we need more capacity, we need more plants making more of these drugs, and over the long term this kind of partnership will strengthen the markets and strengthen our capacity. It says that the Secretary of Health and Human Services has authority to implement an analysis of the root causes of the drug shortage and to proactively seek these kinds of partnerships with manufacturers to produce more of the drugs that may be in shortage right now, but to predict, to forecast what will be in short supply in the future. Market manipulation must be addressed more effectively. And I have proposed an amendment that will stop the gray market insofar as it is possible to do, to prohibit market manipulation of drugs that are in shortage, and prohibit the distribution of false information. It gives the FTC the authority to assess penalties for these actions."

Senator Vitter: (12:01 PM)
  • Spoke on the Child Tax Credit Integrity Preservation Act.
    • SUMMARY "I introduced last year to introduce a real problem with IRS enforcement, allowing illegal aliens to access the additional child tax credit. The reality is because of this enforcement problem, because of this loophole in terms of how the child tax credit is enforced, illegal aliens who pay no taxes, who are not entitled to this benefit, to this check from the government, receive $4.2 billion in 2010 alone, checks from the government through the child tax credit act. There have been several studies under this President Obama administration that say this is ridiculous, this is unintended, we need to stop this. So I'm proposing we do, we move forward in a simple bipartisan, commonsense way to stop it. Let me briefly note some of those studies. March 2009, the Treasury Department said "as it now stands, the payment of federal funds through this tax benefit appears to provide an additional incentive for aliens to enter, reside and work in the united states without authorization, which contradicts federal law and policy to remove such incentives." In July, 2011, again the Treasury Department, through its Inspector General, issued a report that was actually entitled "individuals who are not authorized to work in the United States were paid $4.2 billion in refundable credits." So again, under this administration, the treasury department, the IRS underscore that this is a huge problem to the tune of $4.2 billion every year. And so, I urge all of us to come together in a straightforward, commonsense, bipartisan way to fix this problem. The fix is simple and it's clear. The IRS, the Treasury Department has told us we simply need to mandate that folks applying for the credit use valid Social Security numbers. That will cut off the fraud. That will cut off $4.2 billion going improperly to illegal alien families. It will not cut off the benefit going to anyone who deserves it under the law."
  • Unanimous Consent --
    • SUMMARY The Committee on Finance be discharged from further consideration of S. 577, the Child Tax Credit Integrity Preservation Act, and the Senate proceed to its immediate consideration, that the bill be read a third time and passed, the motion to reconsider be laid on the table, and any statements relating to the measure appear at the appropriate place in the record as if read (Reid objected).

Senator Reid: (12:04 PM)
  • Responded.
    • SUMMARY "The Vitter-Sessions legislation literally takes a sledgehammer to a problem that deserves some very fine tuning scalpel. There are news reports that have suggested that some have claimed the child tax credit for children who actually live outside the United States. The tax code is very clear that a child tax credit is not available for children living outside the United States. Very clear. And if in fact someone is doing that and those filers and taxpayers are committing fraud on the people of this country. And that's something, if they are doing that and there's a loophole that's existing, we need to close that loophole. Chairman Baucus has already had his staff working with the IRS to determine if its procedures are strong enough to stop such fraud. We believe they are, but if they're not, it's up to us - Congress - to plug any loopholes that may exist. The Vitter-Sessions legislation, however, eliminates the child tax credit for filers who are fully complying with the law. That isn't a good result. In fact, this legislation that's proposed here fails to address the issue of the child tax credit being claimed for children not living in the United States. The problem is not solved by this legislation. And legislation goes well beyond what's necessary to stop fraud in the child tax credit program."

Senator Vitter: (12:07 PM)
  • Responded.
    • SUMMARY "Before the distinguished Majority Leader has to leave, I would just ask through the chair so that we can get some clarification and hopefully come to some consensus, is he suggesting that folks in the country illegally, illegal aliens in the country should continue to receive the credit and, is he suggesting that citizens who happen to live outside the country who qualify for the credit shouldn't get it? It seems to me the problem is illegal aliens receiving the credit, wherever they are physically. Not people outside the country receiving the credit, some of whom qualify for the credit."

Senator Reid: (12:07 PM)
  • Responded.
    • SUMMARY "Without fully debating this subject, and perhaps know more about it than I do, but what I do know is we want to make sure that any children who are here who are American citizens who are entitled to this, they get the benefits if they're American citizens."

Senator Sessions: (12:09 PM)
  • Responded.
    • SUMMARY "I would urge that we do not need to wait a great deal of time for this to be fixed. The Inspector General of the United States Treasury Department started raising this informally in 2005. The issue came up in 2007 from individuals in the Treasury Department who thought something wrong was occurring. So the inspector did a report, and he calls on us to fix it. In fact, he said in his report "we continue to believe the legislation is needed to ensure compliance with both laws." I would say that that is what we need to do. The House has acted, and we should act. $4 billion a year is a great deal of money. It's about $10 million a day that's going out of the country to individuals who should not be receiving it. According to the Inspector General report, the amount of the child tax credit - and as senator Vitter said, this isn't a tax deduction. This is a $1,000 per child tax credit that you have for people within the United States who work, would have worked lawfully, who have children. And they get a check. If they owe no income tax at all and a substantial percentage of the people who work in America don't end up paying income tax, but you still get a check from Uncle Sam for $1,000 per child. It was a policy I supported because over the years the families had not gained the kind of deductible advantage that had been done 30 years ago when people had children. And it sort of leveled the playing field in helping working families raise children in a decent environment. It is a policy I like but it is not for somebody illegally here who has children in some foreign country. That's not what it's about. And it's $4 billion, and it surged. In 2005 the Inspector General noted that the IRS pays out to these I-10 filers, $924 million in 2005. In 2006, it was $1.3 billion. In 2007, $1.7 billion. In 2008, $2.1 billion. 2009, $2.9 billion. And from 2009, Senator Vitter, when you first - 2009 to 2010, it went from $2.9 to $4.2. It's been surging every year. I would say as a matter of protecting the treasury of the United States from abuse, the IG says we need legislation, you've drafted, I think, legislation that will do the job precisely as it should."

Senator Vitter: (12:12 PM)
  • Responded.
    • SUMMARY "Too often folks in Washington want to make things overly complicated. Some things in this world, some things being debated in the Congress are complicated. Other things are not. They're just made a whole lot more complicated than they need to be made, and this is one of those. All we're saying is folks who qualify for this benefit under the law should get it. But folks who don't qualify including illegal alien families should not get it. The law is clear on that what we have is an enforcement problem. We have the Obama administration through the Treasury Department agreeing this is an enforcement problem and this bill is the legitimate and proper solution. Again, March 2009, the Treasury said "as it now stands the payment of federal funds through this tax benefit appears to provide an additional incentive for aliens to enter, reside and work in the U.S. without authorization. That means it's a magnet to draw more illegal crossings into the country. Again, July 27, the Treasury Inspector General had a whole report, and the title was "individuals who were not authorized to work in the United States were paid $4.2 billion in refundable credits." That Inspector General said that what we need is a fix legislation just like this. In fact, this is what we do with regard to the earned-income tax credit. We require for that separate tax credit a valid social security number. And we're simply applying that valid fix to this different tax credit. Again, let's not make a pretty straightforward situation difficult. Let's fix a glaring problem. And as the senator from Alabama has said, it's a $4.2 billion a year problem ... We have this glaring $4.2 billion savings that we're not taking advantage of. The House has acted. The House recently acted to pass exactly this provision. Let's act in a bipartisan, commonsense way in the Senate and tell the American people we're going to stop wasting $4.2 billion a year for this completely unauthorized purpose."

Senator Sessions: (12:15 PM)
  • Responded.
    • SUMMARY "I would point out to my colleagues how much $4 billion is. It's a matter that we deal with in a regular basis around here. It's a number that's come up several times recently. For example, we had a shortfall in our plans to fund the federal highway program, a deeply disappointing event that we couldn't get that bill passed. It started out as a $4 billion shortfall. They worked that number down but they're still not fully paid for. We lack just a few billion dollars to pay for the bill. It hasn't been passed. The student loan fix, where the interest rates would be dropped. If I'm not mistaken, that was $4 billion needed to reduce interest rates on students. $4 billion going to the IG is going out of our country illegally every year that we could save. The President spent a lot of time traveling around the country saying we should raise taxes on the rich and we should pass the Buffett tax. And he had a proposal for the Buffett tax. How much would the Buffett tax raise? $4 billion. That's how much this illegal event occurs. Frankly, I'm a little disappointed that the Treasury Department officials and the administration itself hasn't seized immediately upon this loophole that's costing the taxpayers large amounts of money and responded themselves, sent legislation over and ask us to pass it. Why aren't they asking us to pass it, to begin with? Well, the Inspector General, who's independent gets some little independence from the Department of Treasury but, in fact, he's an employee of the Department of the Treasury. He says we need this. Quote the report "clarification in the law is needed to address whether or not refundable tax credit such as ACTC may be paid to those who are not authorized to work in the United States." Well, of course they ought not to be getting a check from the United States taxpayer if they're not authorized to be working here. So as the ranking member on the budget, knowing how tight our budget is, I salute Senator Vitter not just for doing it this year but he saw this problem last year and attempted to get it passed. And I'm pleased that the House has passed it."

Senator Vitter: (12:18 PM)
  • Responded.
    • SUMMARY "I want to encourage the distinguished Majority Leader to look at the actual details of the problem and this legislation. When he does, he'll see that this legislation is very finely tuned to the actual problem, and it is an outrageous problem. There was quite a bit of media attention on this abuse in the last several months. A lot of it came out of Indiana and a tax preparer there brought cases in Indiana, said he got no response from the IRS when he tried to report completely fraudulent returns using fake income and documents. He pointed to a number of actual tax forms in which illegal aliens were exploiting this. And he said "I can bring out stacks and stacks. It's just so easy, it's ridiculous" and an illegal alien who was actually interviewed admitted in another case that his address was used by four other illegal aliens who didn't even live there. All told, they claimed 20 children were living in one trailer and they received checks from the government through this program totaling over $29,000. Only one child was ever observed at that mobile. 20 other children live in Mexico , have never even visited the U.S. again, Let's not make a simple fix overly complicated, because it's not. This is an outrageous abuse. The Obama administration Treasury Department has said so. They have endorsed this fix, the house has passed this fix. Let's us in the Senate pass this fix on a bipartisan basis and save the American taxpayer $4.2 billion each and every year."

Senator Sessions: (12:21 PM)
  • Responded.
    • SUMMARY "I think the American people are unhappy with their leaders. They feel like that the money that they've sent here is not being well spent, not being watched closely enough. We have a big judicial conference for the second year 2010, the second time, to spend a million dollars on a resort conference in Maui. We have the Solyndra loans going out to cronies that are not being paid back in any way. We have the General Service Administration having a big party out at Las Vegas with hot tubs and magicians and so forth. We've got no budget for three consecutive years in the United States Senate. And what are we hearing from many of our leaders here in Washington? Well, we've got a problem, American people, we've got too big a debt; send us more money. Send more money. We're not - we don't have enough. We're borrowing 40 cents of every dollar we spend. Send more money. I think the American people are tired of hearing that. I think they have a right to be tired of hearing that. Until this country is willing to face up to save $10 million a day on this kind of manipulation that's been going on since 2007 at least and been raised by the Inspector General since 2009, until those kind of things are stopped, I don't think they should send any more money to Washington. We need to honor the money they're spending."

Senator Brown-MA: (12:22 PM)
  • Honored Tom Hunder, retired U.S. Navy Captain.
The Senate stands in recess until 2:15 PM for the weekly caucus lunches.

Reid, Alexander, Murray

FDA User Fee Reauthorization bill (S. 3187)

May 22 2012 2:39 PM

Senator Reid: (2:15 PM)
  • Unanimous Consent--
    • The Senate will resume consideration of the Motion to Proceed to S. 3187, the FDA User Fee Reauthorization bill.
    • At 4:00 PM, the Motion to Proceed to S. 3187, the FDA User Fee Reauthorization bill, will be Agreed to, the Harkin-Enzi substitute amendment will be Agreed to, and Majority Leader Reid will be recognized (without objection).

Senator Alexander: (2:16 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "It will make medical devices and biosimilar products get to market. And, more important, get them to the market quickly so people who need help can use the medicines. We're reauthorizing two user fees. These things have absurd names like the prescription drug user fee act is called PDUFA and the medical device user fee modernization act is called MDUFA. And there are two new ones which are GDUFA and PSUFA. These are absurd and I promise never again to use those phrases for these user fee programs, but they're critically important programs that give the food and drug administration needed resources to review new medically necessary products. For example, there's the Better Pharmaceutical for Children's Act. It's a part of what we're doing this week This makes permanent the best pharmaceuticals for children act and the pediatric research equity act is reauthorized. One is an incentive and one requires pharmaceuticals to when they develop new drugs for adults, they figure out the effect that those drugs will have on children. Too often we don't know the answer to that and the drugs are either ineffective or can have bad results sometime. This is a very important part of the bill. Another important part of the bill has to do with medical devices. The United States is a world leader in medical devices. In Tennessee, we have lots of them, especially in Memphis. We need to improve the regulatory process. There are many who believe the FDA is over-regulating medical devices. That has a negative effect on the industry's ability to raise capital, create jobs, doesn't make those devices available, most importantly, in the U.S. and in Europe. This will help address those problems. For example, it will allow customization of medical device for small populations. That means five people or less without going through a very burdensome approval process. And it changes the humanitarian device exemption to encourage and incent the development of devices to treat patients with rare diseases. That would be groups of patients of less than 4,000 people. There's another problem that's addressed in this legislation. It's the generation of antibiotic - dealing with antibiotic resistance. We know there's a growing problem with resistance by - as bacteria continuously mutate and involve in their resistance to the drugs and the medicines that we - we develop. And while efforts have been made to preserve existing antibiotics, drug development hasn't kept up with the pace. These changes will provide meaningful market incentives and reduce regulatory burdens. In addition, I'm very pleased with the results of our work on drug shortages on dealing with drug shortages that. Is a part of this bill. It will give the FDA additional tools to help prevent drug shortages and require FDA to look internally at regulations to see if the FDA is making the problem worse. "

Senator Murray: (2:27 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "If we do not make this legislation a priority, by the end of September, over 2,000 employees at Food and Drug Administration are going to be sent packing with pink slips. But what's just as important, if want more important, is failure to pass this legislation will put drug and medical device approval at a standstill. That will not only halt innovation but it will put the lives of many Americans at risk while they wait for potentially lifesaving medicines ... Passage of this bill helps to provide both the resources and incentives for FDA to rapidly review and approve important therapeutic breakthroughs for patients in need. That highlights the importance of this legislation. But I also want to highlight another part of this bill that I've been very focused on, that the senator of Tennessee just talked about, and that is the need make sure that drugs and medical devices are specifically tested and labeled and proven to be safe and effective for our children. This is so important for families and doctors across America, so I really want to thank Chairman Harkin as well as Ranking Member Enzi for including my bill, the Better Pharmaceuticals and Devices for Children Act in the legislation that we are considering today This bipartisan language will make sure our children are prioritized in the drug development process and that drug labels provide clear, detailed information about the proper use and dosage of medications for children. It will give parents and doctors more information and make sure the key programs we count on to protect our children do not expire. And it'll push to make sure children are never just an after-thought when this comes to the safety and effectiveness of our nation's drugs and medical devices. So, as you have heard here today, this is a bill that has received bipartisan support. I want to commend all the senators who have worked on this in a bipartisan way. We don't get credit enough for that here in this country. But this is certainly one where everyone came together worked together in our committee, and this bill really holds the livelihood of so many Americans in its balance. I urge the Senate to move forward quickly and support the legislation and get it passed."

Durbin, Sessions, Pryor

FDA User Fee Reauthorization bill (S. 3187)

May 22 2012 3:40 PM

Senator Durbin: (2:42 PM)
  • Spoke on the DREAM Act.
    • SUMMARY "11 years ago I introduced the DREAM Act, legislation that would allow a select group of immigrant students with great potential to contribute more fully to America. The DREAM Act is not an amnesty bill. It would give students a chance to earn legal status in America. And there are standards that they have to live up to. One, they came to the United States as children. Number two, they've been long-term united states residents. Number three, good moral characteristic. Number four, graduate from high school. And, number five, either serve in America's military or complete two years of college. The DREAM Act also includes important restrictions to prevent abuse. Under the DREAM Act, no one would be eligible for Pell grants or any other federal grants when they went to the school, and individuals who commit fraud under the DREAM Act - who lie, misrepresent their status - would be subject to tough fines and criminal penalties including a prison sentence of up to two years. It is serious. No one would be eligible for the DREAM Act unless they arrived in the United States at least five years before the bill becomes law. There is no exception and no waiver. My colleague from Florida, Senator Marco Rubio, said in a recent speech that the dream act is not an immigration issue; it's a humanitarian issue. I might add that I think it is an issue of justice. Thousands of immigrant students in the United States were brought here as children. They didn't make a decision at the age of two to come to America. It was not their decision come to here, but they grew up here. They went to school here. They stood up in classrooms across America, pledging allegiance to the only flag they ever knew, singings the Star Spangled Banner believing they were part of America. The fundamental premise of the DREAM Act is that we shouldn't punish children for their parents' actions. It is not the American way. The DREAM Act says to these students, we're going to give you a chance. Now, these dreamers - and I have come to know them - don't want a free pass. All they want is a chance to earn their place in America. That's what the DREAM Act would give them. The dream act just isn't the right thing to do. That would make America a stronger country by giving these talented young people a chance to serve in our military and to contribute to our future. Tens of thousands of highly qualified, well-educated young people would enlist in the armed forces. That's why we end up with the support of people like General Colin Powell. Here is a man who has given his life to America and the security of America. He says the DREAM Act is the studies found deem act participants would contribute literally trillions of dollars to the U.S. economy during their working lives."
  • Spoke on debit card swipe fees.
    • SUMMARY "Many other countries, Canada, European countries, have vibrant debit card systems with swipe fees strictly regulated or prohibited altogether, and in the United States, debit swipe fees used to be tiny until Visa took over the debit card market in the mid 1990's and used tactics that I think boarded on violations of antitrust. By 2010, the U.S. swipe fee system was growing out of control with no end in sight. There were no market forces serving to keep fees at a reasonable level. Merchants and their customers were being forced to subsidize billions in windfalls to the big banks. That's when I introduced an amendment, the Wall Street Reform bill, that for the first time placed reasonable regulation on swipe fees on debit cards ... My amendment said that if the nation's biggest banks are going to let visa and MasterCard fix swipe fees for them, the rates must be reasonable and proportional to the cost of processing a transaction. There would be no more unreasonably high debit swipe fees for big banks. My amendment also included a non-exclusivity provision which aimed to stop visa from taking over the debit card market entirely. This provision says there needs to be a real choice of card networks, real competition. The regulatory steps my amendment proposed were modest. Most other countries have gone a lot further in regulating their credit and debit systems. But if you listened to the banking industry and card companies, you would have thought my amendment would be the end of the world as we know it. They made outrageous claims, the regulation of swipe fees would kill the debit card system, devastate small and community banks and particularly be an end to credit unions and cause banks to raise their fees on consumers. My amendment passed the Senate with 64 votes signed into law and it's been eight months since the swipe fee reform took effect. Well, it turns out all the scary scenarios threatened by the banks have not come to pass. First, the banks claimed it was impossible for Visa and MasterCard to establish a new tier of regulated swipe fee rates. As it turned out, creating this two-tiered system was easy. There were already hundreds of rate tiers so adding another one wasn't difficult. The banks then claimed that small banks and credit unions would be hurt by reform even though all institutions with a value of less than $10 billion were exempt. As it turned out, small banks, community banks and credit unions actually thrived since this reform took effect. Why? Because under my amendment, small banks and credit unions can receive the higher interchange fees from Visa and MasterCard, higher than the big banks, although they control about 60% of the market. And those big banks have been so heavy-handed in their response to swipe reform, they have driven their consumers, many of them, straight into the arms of the community banks and credit unions. Credit unions in particular are flourishing after the passage of the law that had swipe fee reform, a law which they actively opposed. Last year, 1.3 million Americans opened new credit union accounts that was up from 600,000 the year before. More than twice as many people switched from banks to credit unions. Credit unions now have a record number of members across the nation. Almost 92 million overall. So much for the prophecy by the credit unions that this change in the law would be the end of them. It's turned out to be the best thing that's ever happened to them."

Senator Sessions: (3:11 PM)
  • Spoke on the Budget Control Act.
    • SUMMARY "I'm on the floor this afternoon to discuss a discovery, really a stunning discovery for me that's important for all of us. As many people know, congress and the President struck a deal last summer to raise the debt ceiling. That deal set in place discretionary spending caps, not nearly enough to balance our budget over ten years but a step in the right direction. That legislation said that we will raise the debt ceiling $2.1 trillion but we will cut spending $2.1 trillion over ten years, a promise to cut spending over ten years. That legislation also required the Senate Budget Committee, of which I am the Ranking Member, it required that the Chairman of the Committee by April 15 of this year to file aggregate spending levels, spending limits based on the Congressional Budget Office's March, 2012, financial baseline, and to allocate the funds that could be spent under that Budget Control Act legislation to each of the Senate Committees, Appropriations Committees. In other words, these levels as submitted tell the appropriators how much they can spend, and the Budget Chairman has that responsibility and duty to do that. He takes a level agreement that was agreed to and he sends that over. These are real dollars that each appropriating committee is therefore allowed to spend, yet we have learned something that's disappointing, really astounding to me. The numbers filed by Chairman Conrad, my good friend who is a fair and able Chairman, are not, in fact, the spending levels of the CBO baseline, as the statute sets forth. Instead, the discretionary outlay total submitted by the Chairman to the Committees for fiscal year 2013 is derived from the President's budget. Not from the CBO baseline. The discretionary spending allocation for the Senate is therefore inflated by about $14 billion more than what was agreed to just last August. We told the American people we would raise the debt ceiling, continue to borrow money but we were going to reduce spending. So let me repeat that. These allocation levels have been inflated by $14 billion to match the President's budget, not the CBO baseline that the BCA Committee was working from. It raises outlay levels over that august agreement, and that I submit was a solemn agreement between the members of Congress, both the Senate and the House, the American people and the President himself who signed that agreement."

Senator Pryor: (3:20 PM)
  • Spoke on the National Flood Insurance Program.
    • SUMMARY "The primary objection that I have is in section 107 of the legislation. It's called mandatory coverage areas. Basically what it does is it redefines special flood hazard areas, and this may not sound very exciting or very fun to people, but this is critically important. I'm showing a map here on the floor today. All of these counties in the dark green, there's 881 counties total that have levees in their counties. It's my understanding, about well over 50% of the U.S. population lives somewhere near a levee. They may not realize it because the levees work and they don't have floods but if you see this map, you can see the levees all over the country and if you're a senator representing one of those states, by strongly encourage you and your staff to look at section 107 of the legislation. This is 107-b and it says residual risk areas. The regulations required by sub section a shall require the expansion of areas of special flood hazards to include areas of residential risk located behind levees, near dams or other flood control structures as determined by the administrator. Subsection c says mandatory participation in National Flood Insurance program. C-1, in general, any area described in subsection b, the one I just read, shall be subject to the mandatory purchase requirements. Okay. Then if I go down to c-3, it says in carrying out the mandatory purchase requirement under paragraph one, the administrator shall ensure that the price of flood insurance policies in areas of residual risk accurately reflect the level of flood protection provided by any levee, dam, or other flood control structure in such area regardless, regardless of the certification status of the flood control structure. So regardless of whether these levees and dams are certified, in many cases by the corps of engineers, in other cases by private engineering firms, regardless of whether they are certified, the people behind those levees are going to be required to purchase flood insurance. It says he regulations required by subsection shall require - no wiggle room there - shall require the expansion of areas of special flood hazards to include these areas. This is a great expansion of this program. I want to talk about the expansion here in just a moment. But let me say that the folks in these areas they currently pay for flood protection. In most cases what they do is through some sort of local levy or local tax, it's different in different places, but somehow, some way they pay to build and maintain these levees. They are paying out of their pocket right now to make sure that they don't get flooded. Now what this bill does and what FEMA would do under this bill, would be required, no wiggle room, what they would be required to do under this bill is make them pay again. Not only pay for their own levee, play flood insurance for floods that will never happen in their areas because these levees are certified. Again, this is 881 counties, 50% of the U.S. population. Over half the counties in Arkansas have levees, and there's over 1,200 dams in our state. I don't have the number of dams for everybody all over the country but it's over 1,200 in my state, so you can multiply that out by how many dams you think there are in the U.S. it's a huge number and it's going to affect well over half the people in the United States. So I mention that these folks are already paying for their own flood protection through local levies. They also are going to now according to this law have to pay for insurance but in addition to that to rub salt in the wounds, what they're going to have to do is - their local counties are going to have to pass an ordinance that FEMA has written, and it's going to restrict the land use. And in many cases, that ordinance will diminish the property values, diminish the ability for them to do development, economic development in their communities."

Hatch, Reed, Reid

FDA User Fee Reauthorization bill (S. 3187)

May 22 2012 4:16 PM

Senator Hatch: (3:39 PM)
  • Spoke on the U.S. fiscal crisis.
    • SUMMARY "We find ourselves in the midst of a presidential election. In years past, its might have been expected that during a presidential election, politics would take precedent over fallacy. That was not right then but it is certainly not right now. Our nation faces serious problems, immediate problems, and we cannot wait to tackle them until after the election. We are over $15.7 trillion in debt and before the end of this year will be over, $16 trillion. We have a tax code that is unmanageable and a burden on conscientious taxpayers. And if the President and Congress fail to act, we have a tax increase coming next year that will dwarf any in our nation's history. We cannot afford to wait another seven months to get our fiscal house in order and we need to act now. President Obama at least claims to understand that we cannot wait to address this fiscal crisis. He remarked recently that the fact that this is an election year is not an excuse for inaction. Now, unfortunately, other than talk, the President and his liberal allies have done nothing to address either our rising debt or the fiscal cliff that we are quickly approaching, both of which are significantly hindering our economic recovery and job growth. Last week, President Obama's budget received zero votes in the United States Senate. For the second year in a row, every Republican and every Democrat who voted on the President's budget voted against it. And remarkably, not one Democrat voted for the serious Republican budgets offered by my friend, Chairman Paul Ryan, and my friends and colleagues, Senator Toomey, Paul, and Lee. While he talks a big game, President Obama has shown little interest in lighting a meaningful path towards balancing the budget. Reforming the tax code, and reducing the tax burden on working families and small businesses. Instead, President Obama seems to have a single-minded focus on his reelection. But while he attempts to scare up votes in swing states, Americans across the country are suffering due to President Obama's failed economic policies. The people of Utah and the people across the country are naturally growing restless. They look to Europe and see the consequences of out-of-control spending and taxes, yet even with the example of Europe, the President and his friends resist meaningful spending cuts at every turn and his liberal allies have done everything they can to mislead the public about the responsible intentions of Republicans to reduce wasteful government spending. Just as critical for our economy is the President's failure to do anything to address the tax relief that will expire at the end of this year. If the President allows current tax relief to expire, the result will be at least a $4 trillion increase, tax increase, on the American people. You can call this a fiscal cliff you can call it tax-mageddon, as others have done. Whatever you call it, it will be a disaster for the middle class and it will be a disaster for small businesses that will be the engine of our economic recovery."

Senator Reed: (3:53 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "This legislation would give the FDA the resources to approve additional drugs and devices every year for their safe and effective years. Without this agreement, the FDA starting in October would lack these resources which are necessary to approve new drugs and devices. And they would also lack resources to monitor the drugs and devices on the market. This would our drug and device approval. I am pleased that for the first time the generic pharmaceutical industry will provide the agency with $1.5 billion over five years for faster product reviews. The essence legislation is that the industry providing resources for the monitoring and approval of the drugs. Getting generic drugs onto the market sooner will help lower costs for individuals and families as well as for the federal and state governments. This measure would also significantly improve FDA's regulatory authority including its ability to help prevent drug shortages and to help develop new medications to treat life-threatening diseases that are becoming resistant to antibiotics. This is very important ... With the passage of the best pharmaceuticals for children act in 1997, and the pediatric research equity act of 2003, 427 drugs have been relabeled with important pediatric information. Now, just 46% rather than 80% of drugs are being used off-label in children. But that number is still too high. The legislation before the senate makes critical improvements to these laws so we can further lower this percentage. It would make these two acts permanent, just like the laws that govern the approval of drugs for our use. It would also provide the certainty that pharmaceutical companies believe is necessary to wisely invest in the appropriate use of drugs and children. The legislation will also help ensure pediatric studies are planned earlier in the development process and completed sooner The legislation that is before us would require pharmaceutical companies to work with the FDA early in the process of developing these drugs to create a reasonable and essential plan for studying the product. It would also for the first time vide FDA with an enforcement tool that will deter companies from neglecting their obligation to complete these studies on time. Our bill responds to the needs of the development of pediatric medical devices. Not just pharmaceuticals but devices in children, which can lag five to ten years behind those manufacturers for adults Three new devices have been approved for use in children in the last three years. This is an incredible increase as a result of this incentive. This policy has shown much promise, and I'm pleased continuing this bill along with the pediatric device consortia grant program which assisted in the development of 155 proposed pediatric medical devices in the last two years. The Food and Drug Administration Safety Innovation Act would also extend this humanitarian use device incentive to manufacture device and use for adults with rare conditions. While it is my hope this policy is equally effective in spurring devices for use in adults as it is for children, I'm concerned it could impact the development and marketing of devices for use in children. I plan to monitor this policy closely should it become law, but I have full expectation that both noble objectives can be achieved. There are some children, however, who do not receive the full benefits of the BPCA and the PRIA Act. I'm pleased the senate bill addresses this problem for pediatric cancer patients and children with other rare diseases. It calls on the FDA to hold a public meeting to discuss ways to encourage the development of new treatments for this population. Indeed for some pediatric cancers, the treatment hasn't changed in many decades. For other rare diseases, an effective treatment has yet to be found. I look forward to receiving the recommendations that might stem from this important meeting as well as working with my colleagues to respond to their needs with reasonable and sensible policies."
  • Spoke on the Student Loan bill.
    • SUMMARY "Let me raise another pending issue, which is of critical importance. In 40 days, as I think many of us recognize, student borrowing rates for college will double unless we act. And we have seen both sides of the aisle, colleagues from both sides come down and say we cannot let this happen. We can't let it happen. That means we have to take action to prevent the doubling of interest rates on Stafford loans. Unfortunately last week we had a see budget votes which most of my republican colleagues supported which, if they passed, mandated the doubling of the student loan interest rates. So I think we have to move away from the, this debate in terms of doubling and actually pass legislation which will prevent the doubling of student loans by July 1. I hope we can do it promptly, certainly before July 1. And also I hope that we can find an effective offset. What the republicans have suggested is using the prevention fund. The President made it clear he would veto the legislation if it included that offset. And also what should be clear is that using resources to prevent disease not only helpful for the American public but also probably one of the practical ways we're going to be able to begin to bend that very important cost curve going forward. This prevention fund is going to help everyone but it is going to particularly help middle-income families who are struggling with medical bills, struggling to find insurance. The same families are struggling to pay the cost of college for their children. It makes no sense to me to take from one program that will benefit, working families to pay for another program that will benefit working families. We have an offset which is an egregious tax loophole which allows lobbyists and financiers to create subchapter S-corporations. That I think is an appropriate way to pay for this support for students and education. If there are other ways beyond the prevention fund, I'd be certainly happy to listen to them. If there were other principal ways to avoid doubling the interest rate for student loans."

Senator Reid: (4:06 PM)
  • Unanimous Consent --
    • The Senate will resume consideration of the Motion to Proceed to S. 3187, the FDA User Fee Reauthorization bill.
    • At 11:00 AM tomorrow, the Motion to Proceed to S. 3187, the FDA User Fee Reauthorization bill, will be Agreed to, the Harkin-Enzi substitute amendment will be Agreed to, and Majority Leader Reid will be recognized (without objection).
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "As I said here this morning, I hope that I'm not disappointed and I hope the Senate's not disappointed in not being able to finish this FDA. bill. We're on the bill. I hope we can work out some finite list of amendments. That would be the best thing to do for this bill. I say to everyone, I hope we can do that. I don't want to have to come here tomorrow and file cloture on the bill, but that's a choice I'll have. Or I can do this, and maybe what I might do is move to reconsider the student loan. I have the ability to do that at any time. We need to get this done. Today is Tuesday. I just think it's unfortunate. There's an event tomorrow night that we can't get out of. It's been long-standing for the Senate and their spouses. So we don't have a lot of time. So tomorrow morning, if we don't have something worked out, I think we're going to have to do some other things and recognize that all the happy talk on this bill may not come to be."

Bingaman-NM, Brown-MA, Durbin, Isakson

FDA User Fee Reauthorization bill (S. 3187)

May 22 2012 4:56 PM

Senator Bingaman-NM: (4:06 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "Whereas the original intent of Hatch-Waxman in court was to reward companies that were the first to swallow and bring their drugs to market, currently the reward goes to the first company to submit the necessary paperwork, and bringing the generic drug to market immediately has become an option which can be negotiated away. To fix the pay-for delay problem, the law needs to be changed so that the first filers who enter into pay for delay settlements can no longer block generic subsequent filers who successfully challenge patents from entering the market and bringing affordable drugs to consumers. The amendment that we are offering provides this solution or this fix in the following three ways. First of all, the amendment grants the right to share exclusivity to any generic filer who wins a patent challenge in the district court. This means that if a subsequent filer successfully challenges a patent, even after a first filer has entered into a pay-for delay settlement with a brand him company, that subsequent filer has a right to share exclusivity with the first filer. This provision provides an incentive for subsequent filers to challenge patents and to stimulate competition. Second, the amendment we're offering maximizes the incentive for all generic challengers to bring products to market at the earliest possible time by holding generic settlers to the deferred entry date agreed to in the settlements that they have signed. Third, our amendment creates more clarity regarding litigation risks by requiring brand name companies to make a decision to litigate a patent challenge within the 45-day window provided for in the Hatch-Waxman Act. This use it or lose it provision enhances market certainty by eliminating the option for brand names to litigate patent challenges well after a generic has come to market. And finally, I think it's important to point out, that the amendment that we're offering does not interfere with the rights of the parties to settle their patent litigation if they choose to do so. There have been numerous antitrust experts and consumer groups that have identified the Hatch-Waxman Act's structural flaw, the one that I have been describing here, as the source of this pay for delay problem and have called for a legislative solution. In addition, in 2003, Senator Hatch himself expressed concern that the flaw remained despite an attempt to fix it by including "use it or lose it provision in the Medicaid Modernization Act of 2003. Senator Hatch emphasized that the law should be changed to reward and not penalize generic companies that successfully invalidate a patent and are ready to come to market."

Senator Brown-MA: (4:26 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "A very important piece of legislation that will help ensure Americans have access to safe, innovative medical treatments by giving the FDA the resources it needs to review new products as safely and as quickly as possible, while also giving the industry the certainty it needs to continue investing in new research as I travel around Massachusetts, the number-one issue I find is that lack of regulatory certainty and sometimes tax certainty, so this is certainly a step in the right direction. I'm pleased that this legislation takes many steps to strengthen the medical innovation industry in the United States. I have championed one such provision with Senators McCain and Casey that will smooth the regulatory path that I referenced earlier for new moderate risk medical devices. The underlying bill before us needs to be passed as quickly as possible to guarantee that regulatory certainty at the FDA for the industry and its stakeholders. However, I'm disappointed that the Senate has not yet taken the time to address the key area of concern relating to this bill, and that's the new medical device excise tax. The new 2.3% tax on medical device sales that was imposed in the federal health care law will cost our economy thousands of jobs and limit Americans' access to the most ground-breaking state-of-the-art medical devices which many people need. For the past 18 months, I have been pushing for the Senate to consider a medical device tax repeal bill that I introduced back in February of 2011, one of the first bills that I introduced, and today I along with others will be introducing an amendment to repeal this job-killing tax, a tax which will in fact drive up the cost of health care and care for patients and make our workers and our companies less competitive. I can tell you in Massachusetts, we have over 400 medical device companies. We're an innovative state. We have the ability to have companies like this in Massachusetts employing nearly 25,000 workers and contributing over $4 billion to our economy, and that is obviously a substantial industry in Massachusetts, and it affects each and every person throughout this country indirectly. If it goes into effect next year, this harmful tax will put American workers at a competitive disadvantage and chase jobs overseas. There is already companies that have been over the last year and a half looking overseas, already shifting their strategy. Where is that money coming from? Where that 2.3% tax that in some instances represents the entire net profit for some of these young companies in Massachusetts and throughout the country. It will potentially cost 43,000 jobs across the country, with a loss of $3.5 billion in wages. I'm not quite sure how that makes sense in anybody's book. Massachusetts alone is expected to lose over 2,600 jobs as a direct result of this tax and up to 10% of our entire medical device manufacturing work force ... We can't have this type of job loss in our economy when we're still struggling."

Senator Durbin: (4:32 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "Dietary supplements have become a common health aid in medicine cabinets across America. More than half of us in America use dietary supplements including this senator, who for a variety of reasons takes a multivitamin tablet every morning. In spite of their popularity, many people would be surprised to learn that the Food and Drug Administration doesn't know how many dietary supplements are being sold in the United States. Most people don't know that if a date taxpayer supplement ingredient presented serious health concerns the food and drug administration doesn't have the information to track down products containing the harmful ingredient. We assume if it's for sale in America, some government agency is taking a close look to make sure that that product is safe and that we know what's inside of it and that it wouldn't harm a customer, an innocent customer. Turns out that may be true when it comes to prescription drugs and over-the- counter drugs by the dietary supplement drug world is a much different world with minimal regulations. I have an amendment to ensure the Food and Drug Administration has the information it needs to respond quickly and efficiently when safety concerns arise concerning dietary supplements. This would require date taxpayer supplement manufacturers give the Food and Drug Administration the name of each supplement they produce, along with a description, a list of ingredients, and a copy of the label. It's not an onerous requirement but for the first time the Food and Drug Administration would literally have a catalogue of all the date taxpayer supplements being sold to Americans all across the nation. Now, with this information the FDA is better equipped to protect consumers' health and to work with manufacturers to address any problems if they arise. The 2009 report by the Government Accountability Office found that the Food and Drug Administration is limited in its ability to respond to safety concerns because dietary supplement manufacturers don't always provide basic information, like product names or lists of ingredients. This commonsense amendment that I'm offering is supported by the Consumers Union, and it would give the Food and Drug Administration basic information it needs to protect the public."

Senator Isakson: (4:43 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "There are component parts of this legislation I want to illuminate for just a second because I had a lot to do with them because they're very important. One deals with third party logistics providers. As the Chair is aware and the Senate is aware we have a placeholder in the manager's amendment for third party providers with track . It's the mechanism of tracking the drug from its origin to the individual using the drug to make sure we have safety and security. But there are third-party logistics carriers to deliver an awful lot of content like fed ex and u.p.s. who operate in all 50 states and we ought to have a too-state seamless delivery rather than 50 states all having regulatory authority. So my first message today to send to the conferees when the committee is ultimately reported is to take these placeholders on these third party providers and in the track and trace regulations we provide a us who consume those pharmaceuticals. Secondly, there is another provision called the Medical Gas Act, Gas Safety Act, which was included in this legislation and I am very grateful that the managers of the legislation agreed to put it in the bill because it's equally important for our people in this country. But I want to make sure one thing is underlined. Medical gases are critically important to sustain life, gases like oxygen, like night truss oxide, called by laughing gas. But I want to make sure as we go through this process we have a system where medical gases that have stood the test of time remain available through medical use and brand-new medical products that have never been through the testing time go through an appropriate FDA review which is what the original act, the Medical Gas Safety Act included, and wanted to be included in this legislation."

Harkin, Grassley, Burr, Bennet, Shaheen

FDA User Fee Reauthorization bill (S. 3187)

May 22 2012 6:06 PM

Senator Harkin: (5:19 PM)
  • Paid tribute to Katie Beckett, who passed away on Friday, May 18th.

Senator Grassley: (5:27 PM)
  • Paid tribute to Katie Beckett, who passed away on Friday, May 18th

Senator Burr: (5:33 PM)
  • Spoke on the Veterans Integrated Service Network Reorganization Act.
    • SUMMARY "This legislation would significantly reorganize the structure of the Departments of Veterans Affairs or V.A. in their veterans integrated service networks or VISNSS. To make these networks more efficient and to allow resources to be moved to direct patient care. The veteran's health care system in our country was originally established through combat-related injuries and to assist in the recovery of veterans with service-connected disabilities. Since its start, the scope of veterans' health administration or VHA has expanded and now treats all veterans enrolled in the health care system through hundreds of medical facilities located around the country. Prior to 1995, VHA was organized into four regional offices. These regional offices simply channeled information between the medical centers and the V.A.'s Washington, DC headquarters office. Since the regional office's duties were to pass on information to the facilities, they had little ability to exercise independence in implementing policies based on the need of the veterans in their regions. So in March, 1995, based upon the recommendation of former under Secretary of Health, Dr. Kenneth Kaiser, V.A. underwent a significant reorganization of its Washington, DC, and regional offices. Basically, the VHA health care system was divided up into 22 geographic areas, now 21, with each region having its own headquarters with a limited management structure to support the medical facilities in that region. The goal of the reorganization was to improve access to, quality of and the efficiency of care to veterans through, and I quote, "patient firstâ€? focus. This structure would improve care by empowering VISNSS with the independence of how to best provide for the veterans in their region. This change also would have made the most of spending for patient care by suggesting that VISNS management be located on a V.A. medical center campus. The aim was to provide better organized system that would have oversight management responsibilities of the medical facilities through a new structure called the veterans integrated service network. This bill, my bill, would bring about a much-needed change to the VISNS structure. It would, one, consolidate the boundaries into nine VISNSs. Two, move some jobs back into the V.A. central office. Three, reduce the number of employees to 65 per VISNS. And, four, require VHA to review the VISNS staff and structure every three years. What a novel suggestion that we would actually review the progress that we make. My colleagues may find it a bit odd that we could reduce the staff of VISNS headquarters while also increasing the size of the Veterans' population and facilities from some VISNS headquarters, but because we're reducing what the task that the VISNS headquarters perform transferring several jobs to new regional support centers or RSC's, VISNS headquarters staffs would be more productive in carrying out the simple budget, management and planning duties that they were originally tasked with in 1995 in the reorganization. While the consolidation of VISNS would result in the closure of nine VISNS headquarters, no staff would lose their job as a result of this legislation. Staff whose jobs would be eliminated because of the consolidation would have a chance to be transferred to other positions within the V.A. staff who performed the oversight functions that would be moved to the newly created RSC would be given the opportunity to continue to work at the RSC this legislation also returns the idea that VISNS headquarters should be located on V.A. campuses by directing that VISNS headquarters, if possible, be located on a V.A. medical center campus. Relocating to vacant space on a V.A. medical center campus hopefully would reduce the cost to V.A. in the long run but more importantly it would bring the headquarters staff closer to the facilities they oversee. I realize this would be an enormous change in the way VHS does business, yet I believe that this can be accomplished without any changes to how V.A. provides treatment and care to our nation's veterans. In fact, I believe it will improve how V.A. cares for veterans by increasing the resources directly available for patient care."

Senator Bennet: (5:47 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "In 2010 I introduced a bill called the Drug Safety and Accountability Act. Chairman Harkin and Ranking Member Enzi took notice and we were able to form a working group to address serious problems in the FDA statutory authority. FDA laws that are supposed to protect our domestic drug supply were created in 1938 and desperately needed to be updated for the 21st century. Back then, the lines of commerce were based on 48 states. Now we live in an era where over 80% of the active ingredients of our - in our pharmaceuticals in our drug supply are being manufactured abroad with the FDA laws that force them into expect American facilities every two years but have no mandate on how often they inspect facilities overseas, the GAO, the Government Accounting Office, has found FDA could only keep pace with inspecting the most high-risk overseas facilities, the places where our moms and dads are getting pharmaceuticals for our children, once every nine years. Once every nine years. So patients taking their pills have no idea whether the ingredients in their drugs were made in China or in India or if they were ever inspected. Our American manufacturers are operated on an uneven playing field. They have to expect a surprise FDA inspection every two years on average here to make sure they're following all their good manufacturing practices when their foreign counterparts don't have to worry about FDA visiting them for a decade, if ever. Because they can delay or refuse FDA inspections because they're overseas. Patients groups and the industry came together to try to change that, and this bill does change all of that. It would implement a risk-based inspection schedule for both foreign and domestic manufacturing sites, it would make sure that drug manufacturers know who is in their supply chain every step of the way, and for the first time, if you're abroad and you refuse or delay inspection without a fair reason, the FDA can refuse to let your product in this country. These are all the steps American families already think we have in place to protect them. I can't tell you how many town halls I've had where people have been shocked to learn that the products that they have in their medicine cabinets have never been inspected by anybody. This will change that . I also want to talk about something called track and trace. American families also want to know what happens to their pills, pills that can mean the difference between life and death, once they leave the manufacturer, enter the country, and change hands several times. Right now we can know a lot more from a bar code on a gallon of milk than there a bar code on medications. And that seems be absurd to people at home. And I want to take a moment again here to thank the Chair and Ranking Member for their commitment to working together to meet the challenge of developing a uniform traceability system. This is something that has been worked on for over a decade in this town, and we are finally this close to making it the law of the land."

Senator Shaheen: (5:55 PM)
  • Spoke on Small Business Export Growth Act.
    • SUMMARY "For so many small businesses, those foreign markets have remained an untapped resource for most of them. Over 95% of the world's customers live outside of the United States, but only 1% of our small businesses export. That's a particularly shocking number when you compare it to large businesses, because over 40% of large businesses sell their products overseas. So we've got to do more to help our small businesses get into those international markets. At our field hearing, we heard about some of the barriers that our small businesses face when they try to go global. And our legislation is an attempt to remove some of those barriers so that small businesses can access new sources of revenue and are create jobs. One of the problems we heard about is that navigating the federal bureaucracy can be a special challenge for small businesses that wish to export In New Hampshire, we're very fortunate because our state and federal export services work seamlessly and that's been really important in helping our businesses grow their exports. In 2010, New Hampshire's exports grew about 40%. That was almost twice the national average and the most of any state in the country, so it's been very critical to our small businesses. But we also heard that state and federal agencies don't always have that same collaborative relationship in other places across the country. According to our former New Hampshire Trade Director, Don Wibble, these services sometimes in some places can overlap or, even worse, sometimes there are agencies who refuse to work together. Our bill attempts to require better coordination to make more successes like secure care a reality across the country. Our bill also encourages the federal government to do more to promote the opportunity of exporting and to get the word out about federal export programs. Foreign markets can be daunting for small businesses but that shouldn't stop our innovators from trying to compete. Our small businesses must be assured that the federal government will help them when considering exporting, that part of our responsibility is to try and do everything we can to put in place policies that help small businesses."

Brown-OH (The Senate Stands Adjourned)

FDA User Fee Reauthorization bill (S. 3187)

May 22 2012 6:40 PM

Senator Brown-OH: (6:15 PM)
  • Spoke on the manufacturing industry.
    • SUMMARY "We stepped in with the auto rescue not just for Chrysler and GM not just for Honda and Ford in my state where 800,000 jobs - it is officially estimated - are affiliated with the auto industry. But it also meant these jobs in tier-one suppliers. Some of them were about to collapse. The rescue of the auto industry also directly helped to rescue some of those tier-one suppliers ... We also knew that the tier-two, three, four suppliers making components you might not recognize if you held them in your hands what they exactly were but that go into the cars in those tier-two, three, four supply chain were not able to get financing all the time. We helped in the auto rescue to be able to do that. What Vice President Biden saw in Youngstown, in Lordstown, Ohio, what he hear in Dayton and Columbus and Mansfield, and in Toledo and Rossfor when I hear these workers say they understand that this auto rescue, where the government invested - these companies are paying these investments back, but the government invested because nobody else would have - it saved all these jobs. It's why manufacturing is beginning to turn around. There are other factors, of course. One of them is because the President of the United States is enforcing new trade laws. The stood up to the Chinese when the Chinese were gaming the system on tubular steel used for drilling natural gas. All of that has mattered to this manufacturing job growth. We're not there yet. We need the administration to step up on a real policy for manufacturing, a real strategy. I think they're starting to do that on better tax law, better trade larks better enforcement of trade laws, on sages manufacturing when we can partner with them, not picking winners and losers but understanding that manufacturing to create you either grow it, mine it or make it. My state does all three, does all three very well. Will continue do with this kind of partnership as we move forward."
  • Performed Wrap Up --
  • Tomorrow --
    • The Senate will convene at 9:30 AM and Majority Leader Reid be recognized. It is anticipated the Senate will resume consideration of the Motion to Proceed to S. 3187, the FDA User Fee Reauthorization bill. The first hour will be equally divided, with the Majority controlling the first 30 minutes and the Republicans controlling the second 30 minutes.
    • At 11:00 AM, the Motion to Proceed to S. 3187, the FDA User Fee Reauthorization bill, will be Agreed to, the Harkin-Enzi substitute amendment will be Agreed to, and Majority Leader Reid will be recognized.
    • The time from 1:00-2:00 PM will be under Majority control.
  • As a reminder, on Tuesday, May 8th, a Motion to Reconsider the Motion to Invoke Cloture on the Motion to Proceed to S. 2343, the Student Loan bill, was entered.
The Senate stands adjourned until 9:30 AM Wednesday, May 23rd.