Senate Calendar

Thursday, May 24, 2012

May 24 2012

Senator Reid: (7:02 PM)
  • Unanimous Consent --
    • The Senate proceed to the consideration of H.R. 5652, that all after the enacting clause be stricken and the language of S. 1925, the Violence Against Women Act Reauthorization, as passed by the Senate on April 26 by a vote of 68-31, be inserted in lieu thereof, that the Senate insist on its amendment, request a Conference with the house on the disagreeing votes of the two houses, and the chair be authorized to all conferees on the part of the Senate and all the above occurring with no intervening action or debate (McConnell objected).

Senator McConnell: (7:05 PM)
  • Responded.
    • SUMMARY "This is a problem that has been created by the majority and I'm sorry they won't accept our offer to fix their problem so we can move forward on this legislation. We've all known for literally years when the Violence Against Women Act was going to expire. We've known that for years. During this time, Democrats controlled the Senate, yet our friends on the other side waited until February of this year - nearly six months after the current authorization expired - before they even reported a bill out of committee. They chose to wait almost three months more to bring a bill to the floor. Now, I don't know why that decision was made. Press reports indicate that members of the democratic leadership thought they could use VAWA as a campaign issue. When they finally chose to bring this bill to the Senate floor, Republicans consented to going to the bill, Republicans consented to bring the debate to a close, and Republicans consented to limit ourself to just two amendments. Just two. Our Democratic colleagues also had an amendment. It was a complete substitute. They offered it at the last minute. This substitute was a couple a hundred pages long and it added new sections to the bill. One of those sections would generate revenue by assessing new fees on immigration visas. I gather our Democratic colleagues did this because their bill, unlike the Hutchison-Grassley bill, would add over $100 million to the debt. Including this provision is obviously a problem in that adding a revenue provision in a senate bill violates the origination clause of the U.S. constitution. If we sent the Senate bill to the house in its current form, it would trigger a blue-slip point of order, as it always does."
  • Unanimous Consent --
    • The Senate proceed to the consideration of H.R. 4970, the House-passed Violence Against Women Reauthorization Act. Provided further, that all after the enacting clause be stricken, the text of the Senate-passed Violence Against Women bill, S. 1925, with a modification that strikes sections 805 and 810 related to the immigration provisions, that the bill be read three times and passed, the Senate insist on its amendment, request a Conference with the house and the chair be authorized to appoint conferees on the part of the Senate with a ratio agreed to by both leaders (Reid objected).

Senator Reid: (7:08 PM)
  • Responded.
    • SUMMARY "The Republican leader has now proposed an amendment to the Senate-passed bill. The Senate-passed bill - we're very proud of this. It's been engineered and advocated by all Democratic senators but mainly by the 12 women that are part of our caucus. This is an important piece of legislation. We all feel very strongly about this. I haven't looked at all the details of this amendment. And my first response is the amendment is something that the conferees should be working on. We can't do that here without proper input from all the interested parties, and we have 52 other than me on my side of the capitol here. That's why I've sought to go to Conference with the product that the Senate passed. It may be that at some time in the future that, after we evaluate all these pieces that has been suggested by my friend, the Republican leader, that we may be able to - proceed along that route if, in fact, we get to Conference. We've got to get to Conference. But we would have to have a wider discussions airing the proposed amendment and we've had just a little bit to look at it at this stage."
  • Performed Wrap Up --
    • The Senate will conduct Pro Forma sessions during the following days:
      • Friday, May 25th at 2:30 PM;
      • Tuesday, May 29th at 11:00 AM; and
      • Thursday, May 31st at 12:00 PM.
  • Monday, June 4th --
    • The Senate will convene at 2:00 PM and Majority Leader Reid will be recognized. It is anticipated that the Senate will resume consideration of the Motion to Proceed to S. 3220, the Paycheck Fairness bill.
    • At 5:00 PM, the Senate will proceed to Executive Session for 30 minutes of debate, equally divided, on Executive Calendar #613, Timothy S. Hillman, of Massachusetts, to be United States District Judge for the District of Massachusetts
    • At 5:30 PM, the Senate will conduct a ROLL CALL VOTE on the nomination.
  • Tuesday, June 5th --
    • At 2:15 PM, the Senate will conduct a ROLL CALL VOTE on the Motion to Invoke Cloture on the Motion to Proceed to S. 3220, the Paycheck Fairness bill.
The Senate stands adjourned until 2:00 PM Monday, June 4th.

Reid, Whitehouse, Harkin, Thune

Paycheck Fairness bill (S. 3220)

May 24 2012

Senator Reid: (4:00 PM)
  • Unanimous Consent --
    • The Senate proceed to Calendar #407, the 60-Day Flood Insurance Extension, that a Johnson substitute amendment which is at the desk be Agreed to, the bill as amended be read a third time, Passed, the Motions to Reconsider be laid on the table, there be no intervening action or debate (without objection).

Senator Reid: (4:26 PM)
  • Filed Cloture on the Motion to Proceed to S. 3220, the Paycheck Fairness bill.
  • At 2:15 PM Tuesday, June 5th, the Senate will conduct a ROLL CALL VOTE on:
    • Motion to Proceed to S. 3220, the Paycheck Fairness bill.

Senator Whitehouse: (4:28 PM)
  • Spoke on climate change.
    • SUMMARY "Too late will be the epitaph if we do not prepare now, and I very much regret that we are in a situation in which we don't seem able as a body to take this threat seriously. The House shows no indication whatsoever of taking this threat seriously. Even the White House has dialed back its expressions of interest and concern on this issue, probably for the practical reason that the Republican-controlled House doesn't want to deal with this issue at all, period, end of story. But it's happening out there. It's happening out there. People see the dying forests of the west, as the pine bark beetle works its way more and more north because winters are no longer cold enough to kill off the already ... People see the places where they used to be able to go fish with their grandchildren no longer available. Farmers see changes, gardeners see changes, plants that could no longer grow in certain zones now can. Tropical plants can grow in northern areas because of changes. These changes are really happening, and it is regrettable that we are unable to address them. The science has been discredited by propaganda campaigns that are deliberately and strategically designed to create doubt in the minds of the public where no doubt should exist. The fact of the matter is that this science is rock-solid."

Senator Harkin: (4:31 PM)
  • Spoke on climate change.
    • SUMMARY "What is so frustrating, and that is science knows what's happening. The scientists know what's happening. We have good data points about what's happening to our climate our atmosphere, our oceans. And yet we can't seem do anything about it."
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "Today with passage FDA Safety and Innovation Act and reauthorization of the user fee agreements we have helped both the FDA and the biomedical industry assure they cannot 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 a 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 it will also 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 are taking an important step to improving America's families' access to lifesaving drugs and medical devices."

Senator Thune: (4:52 PM)
  • Paid tribute to James Abdnor, former Senator of South Dakota, who passed away on May 16, 2012.

Vote Results (Passage)

Student Loan bill (S. 2343)

May 24 2012

Not Passed, 51-43-1:
S. 2343, the Student Loan bill (60 votes required).
The vote results will be posted here within one hour.

Vote Results (Alexander amendment #2153)

Student Loan bill (S. 2343)

May 24 2012

Not Agreed to, 34-62-1:
Alexander amendment #2153 (S. 2366) to S. 2343, the Student Loan bill (60 votes required).
The vote results will be posted here within one hour.

McConnell, Reid, Alexander, Harkin, Reed

Student Loan bill (S. 2343)

May 24 2012

Senator McConnell: (3:34 PM)
  • Spoke on the Student Loan bill.
    • SUMMARY "We're in a rather ridiculous process waiting for our friends to pass a process that will actually pass, when we've got one if front of us. We've wasted nearly two weeks on this student loan issue for no good reason. Neither I nor the ranking member have heard a word from the Democrats on how they propose to resolve the issue and actually prevent the interest rate from rising. As we learned earlier this week the president doesn't seem to even talk to his committee chairmen anymore. All of this suggests that the white house doesn't really want to solve this problem, that it would rather allow these rates to rise so we can run around all summer pointing our finger at those Republicans in the I'd like to believe that's not the case. We had chance to talk to the President about this and other issues last week at white house. I'm convinced that he'd like to get a solution. Yet the fact of the matter is, all he'd have to do is just simply pick up the phone and tell the democratic leadership here that he'd like to get this done, and I'm pretty confident that we could work it out. Unfortunately, we can't just wait around hoping the president is going to pick up the phone. College students can't wait either. They want us to resolve the issue now, and I know we can. So to move the ball forward, I would say to my colleague, the majority leader, if he agrees with me that Senator Harkin and Senator Enzi just did a good job of coming up with a bipartisan solution to this FDA bill, I'm confident that they could do the same thing on the student loan issue. They are the chairman and the ranking member of the committee that over sees student loan legislation. I have a lot of confidence in their ability to do it."
  • Unanimous Consent --
    • Following the completion of the two scheduled votes on the Student Loan bill, the next order of business be a Harkin-Enzi bill dealing with the issue of the current student loan rate, provided further that no Motions to Proceed to other items be in order, unless agreed to by both leaders (Reid objected).

Senator Reid: (3:37 PM)
  • Responded.
    • SUMMARY "We've all heard of a reverse engineering. What we've just heard is reverse reasoning. This is one of the most interesting things I have heard that makes no sense. We've been trying to get on this bill for weeks. The Republicans have refused to allow us to get on the bill. Student loan issue is important. We should already have completed this and had we been allowed to get on the bill. But we weren't allowed to get on the bill. We were faced with one of our many fables, scores of them - with one of our many filibusters, scores of them. Not one, two, three, or four - scores of them. This is another example of them stopping us from legislating on a bill. In our to come here and say, we could have been doing something ... You my friend knows the rules of this Senate as well as I do. And he knows this suggestion is absurd."

Senator Alexander: (3:38 PM)
  • Responded.
    • SUMMARY "On July 1 for 7 million students getting new loans to go to college, the rate for interest will go from 3.4% to 6.8%. This is an amendment to get a result. This is the House-passed bill. President Obama says he wants to freeze the rate for a year. Governor Romney says he wants to freeze the rate for a year. The House of Representatives has voted to freeze the rate for a year. A vote "yes" on the House-passed bill will permit us to send it to the President and he signs it and we solve the problem."

Senator Harkin: (3:39 PM)
  • Responded.
    • SUMMARY "While appreciate the compliments he and the Minority leader has in Senator Enzi's and my ability to get things done, what they are that we totally end, totally eliminate all the of the prevention and wellness money that we have out there in the wellness fund. What would this do? We got vaccinations for children, immunizations, smoking cessation programs, colorectal screening, diabetes prevention, breast cancer screening, all funded by this prevention and wellness fund. None one of them would be funded from that fund if that amendment passed. So the choice is very clear on the two amendments that 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 3.4%. Or, as the republicans want to do, totally eliminate the wellness and prevention fund, and he the money that we're putting into diabetes prevention, breast cancer, colorectal screening, all the things I mentioned. I don't 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."

Senator Alexander: (3:40 PM)
  • Responded.
    • SUMMARY "The other side have their usual solution to any problem - let's put some more taxes on the small business men and women. We have a better way to pay for this bill. We'll take some of the savings that the congressional budget office said that our friends found when they took over the student health program in the health care bill, instead of giving the students the benefit of those savings, they spent it on government. They spent $8.3 billion on the health care bill. So we'll give back to the students enough known pay for this freezing of the rate. We won't tax the small business people. We'll have a little left covered and reduce the debt. Then we can send our bill to the house, they'll pass it like that, send it to the president and the problem is solved."

Senator Reed: (3:41 PM)
  • Responded.
    • SUMMARY "The Republican's proposal goes right to the heart of health prevention. It will deny us the chance to ban the proverbial health care cost curve. If we do not control those costs, we will be in a fiscal disaster. That measure they're proposing does not make sense. We have proposed to close a tax loophole that has been described by the inspector general for the tax administration as a multibillion-dollar employment tax shelter. We have restricted it to the people who are receiving over $200,000 a year. This is not small business men and women. This is not the corner hardware store. These are lobbyists, these are lawyers who have craftily used subchapter S-corporations to avoid paying payroll taxes This is trying to find a loophole which has been criticized by the right as well as the left to pay for and ensure that we do not double the interest rates on students. I can't think of a clearer choice. Reject the Republican proposal, accept our proposal. Do not allow student interest rates to rise on July 1, as they're scheduled to do."

Vote Results (Passage)

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Passed, 96-1:
S. 3187, the FDA User Fee Reauthorization bill, as amended.
The vote results will be posted here within one hour.

Vote Results (Durbin amendment #2127)

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Agreed to, 77-20:
The Motion to Table Durbin amendment #2127 (dietary supplement registration) to S. 3187, the FDA User Fee Reauthorization bill.
The vote results will be posted here within one hour.

Vote Results (Sanders amendment #2109)

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Not Agreed to, 9-88:
Sanders amendment #2109 (drug exclusivity conditions) to S. 3187, the FDA User Fee Reauthorization bill (60 votes required).
The vote results will be posted here within one hour.

Vote Results (McCain amendment #2107)

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Not Agreed to, 43-54:
McCain amendment #2107 (prescription drug importation from Canada) to S. 3187, the FDA User Fee Reauthorization bill (60 votes required).
The vote results will be posted here within one hour.

Vote Results (Paul amendment #2143)

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Agreed to, 78-15:
The Motion to Table Paul amendment #2143 (dietary supplement claims; prohibition on FDA employees carrying firearms and making arrests without warrant) to S. 3187, the FDA User Fee Reauthorization bill.
The vote results will be posted here within one hour.

Carper, Lautenberg, Manchin

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Senator Carper: (1:17 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "The FDA and how do we make sure the FDA has the resources they need to do their jobs. And like the other bills passed by the senate that I just talked about, this bill helps to create a more nurturing environment for businesses to thrive. Those businesses include pharmaceutical business, it includes businesses that make and sell medical devices. But just as important, this bill helps ensure that Americans get access to lifesaving medications and medical devices that are developed in this country as soon as and as safely as possible The legislation builds upon the successful current user fee programs that for a number of years that companies have paid a user fee if they want the FDA to approve a drug or medical device and we're making progress to have more resources to do this, but they need additional help. And this legislation would do that, paid for by the industries that are seeking the consideration of the new pharmaceuticals and the new medical devices. The legislation also adds important new user fees for generic and biological drugs. Those user fees are paid by bye the prescription drug and medical device industries to help cover the FDA's cost for reviewing new drugs and medical devices. What this means, safer drugs and a speedier process to bring new and less expensive drugs and medical devices to markets for consumers and I think it's a win-win for just about everybody. As a result of this legislation, the FDA legislation, affectionately known as PDUFA, the FDA's drug review times have already been cut in half, that's good. If these user fees, user programs are not reauthorized the FDA would have to lay off I'm told about 2,000 employees which would put them back in the soup, back had in the ditch if you will and begin delaying the approval of new drugs. We don't want to see that happen. That would threaten patent patient access to new therapies as well as pharmaceutical and medical devices for industry, for jobs and America's global leadership in biomedical innovation. The bill also makes medicines safer for millions of children, improves the FDA's tools to police the global drug supply chain and reduces the risk of drug shortages."
  • Spoke on McCain amendment #2107 (prescription drug importation from Canada).
    • SUMMARY "One of the amendments that we'll be voting on I believe a little bit later this afternoon is legislation that would in my view weaken or contaminate our country's supply of prescription drugs. Put our patients and our health care system at risk. Some of my colleagues have proposed to include a measure in this bill that ostensibly would lower prescription drug prices. This amendment in my view, however, is not without unintended consequences and we always have to be careful of those. It would increase the number of contaminated drugs 39 it would allow drugs to be imported wholesale, often from illegal internet pharmacy. And though the measure is supposed to be about importing drugs from Canada, in truth it would allow drugs to come from countries that don't have the policing of prescription drugs we have here in the United States. Instead of going down that road, we should work to increase the FDA's ability to protect and regulate our drug supply and while doing so, we should reject any proposal to import drugs, I think, from Canada that undermine our ability to ensure that prescription drugs are safe and effective."
  • Spoke on Bingaman amendment #2111 (generic drugs).
    • SUMMARY "It deals with generic drugs and concern about the ability for larger pharmaceutical companies to work with and really pay off, buy out the generic drug companies so they don't object to a - the end of - the generic drug company doesn't bring a generic version of a name brand drug to market. I just want to say, we need to be careful what we're doing here. I came out of the Navy, came to this Congress in 1983, a freshman congressman, in 1982, 20%, 20% of the prescriptions filled in this country were generic drugs. 20%. This year, 80% of the medicines that are being - prescriptions that are filled, 80% of generic. And one of the well-intentioned amendments offered today is one that says, well, we're not making enough progress toward allowing the generics to grow. Say that again. We've gone from 20% generic penetration in 1982 to today, 80%. 80%. And i would just suggest that we should declare victory and as time goes by that 80% will become 85% or 90%. We've gone a long ways and as a result of that people need to buy medicines, you can find a generic version of almost any medicine sold in this country. And I think the system is working just fine and we ought to allow it to continue to work."

Senator Lautenberg: (1:13 PM)
  • Spoke on McCain amendment #2107 (prescription drug importation from Canada).
    • SUMMARY "We know how important the prescription medicines are and improving health in this country and the need to make sure that those drugs are safe and affordable. Prescription drugs have brought great advances in health outcomes. Just look at how much longer people are living. Over the past century, life expectancy increased from 49 years to 77 years and that's over - since the past century, great improvements made. We know that beneficial drugs need to be more affordable, more readily available, but allowing drugs to enter into the United States from other countries is not the answer. The department of health and human services found that importing prescription drugs might save 1% to 2% on their prescription drugs, and I'm not describing that as insignificant. But these are modest savings compared to what the outcome might be. Importing risky prescription drugs from other countries could cause more health problems, more suffering and in the final analysis, more expensive treatments ... Imagine what would happen to a mother or a child if they were relying on imported drugs only to find out that the drugs were unsafe. We need to be absolutely certain that we are not putting Americans' lives at risk. And that's why I'm opposing amendment 2107, the McCain amendment, which would allow potentially unsafe prescription drugs to be shipped across our border and directly into the medicine cabinets of homes throughout America. Instead of safeguarding American patients, this amendment could bring potentially dangerous and ineffective drugs from Canada. And I say that, because though they may seem safe, Canadian drugs, but we already know that drugs that claim to be from Canada are not always reliable, that they're not worth a risk. An FDA investigation found that 85% of drugs imported from Canadian internet pharmacies were actually from 27 other countries, and many of these were pure counterfeit. The Senate already recognized the danger that imported drugs pose to Americans. On five previous occasions, this chamber has asked the department of health and human services to certify that importation will not put people at risk. And the secretary still has not been able to confirm that imported drugs would be safe."

Senator Manchin: (1:38 PM)
  • Paid tribute to WVU coach Bill Stewart, who passed away on May 21, 2012.
  • Spoke on Manchin amendment #2151 (hydrocodone schedule III drug).
    • SUMMARY "The prescription drug epidemic is destroying communities across this nation. It's wreaking havoc on our educational system. It's devastating our work force and our economy and tearing our families apart. Prescription drug abuse is the fastest-growing drug problem in the United States and it is claiming the lives of thousands of Americans every year. According to a report issued by the Center of Disease Control in November, the death toll from overdoses of prescription painkillers has more than tripled in the past decade. More than 40 people die every day - every single day - from overdoses involving narcotic pain relievers. These prescription painkillers kill more Americans than heroin and cocaine combined. It's especially tough in my home state of West Virginia which has the highest rate of drug overdose deaths in the country. Nearly 90% of those deaths are linked to prescription drugs abuse. For months now, I've been going out and listening to the stories of so many people in my state: law enforcement, business owners, schoolteachers, pastors, and especially the children, who ask for help to get their parents off this stuff. So I worked with all of them to offer an amendment to this bill that would make it harder for anyone to abuse prescription drugs. That bipartisan amendment was submitted on behalf of the countless West Virginians and Americans whose lives have been cut short by drug abuse and the families who are picking up the pieces. And it is on their behalf that I thank my colleagues in the Senate for passing it last night unanimously."

Corker, Portman, Hagan

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

  • Today --
    • At 2:00 PM, the Senate will conduct up to 6 ROLL CALL VOTES on:
      1. Paul amendment #2143 (dietary supplement claims; prohibition on FDA employees carrying firearms and making arrests without warrant);
      2. McCain amendment #2107 (prescription drug importation from Canada) (60 votes required);
      3. Sanders amendment #2109 (drug exclusivity conditions) (60 votes required);
      4. Durbin amendment #2127 (dietary supplement registration);
      5. Burr amendment #2130 (user fee agreement negotiation transparency);
      6. Passage of S. 3187, the FDA User Fee Reauthorization bill, as amended.
    • Upon disposition of S. 3187, the FDA User Fee Reauthorization bill, the Senate will begin consideration of the Alexander/McConnell Student Loan bill amendment (S. 2366) and S. 2343, the Student Loan bill, for up to 10 minutes of debate, equally divided.
    • Thereafter, the Senate will conduct 2 ROLL CALL VOTES on:
      1. Alexander/McConnell Student Loan bill amendment (S. 2366) (60 votes required); and
      2. S. 2343, the Student Loan bill, as amended, if amended (60 votes required).
    • Budget Act points of order are in order. If S. 2343, the Student Loan bill does not achieve the required 60 votes, it will return to the Senate calendar, and the Motion to Reconsider with respect to the cloture vote on the Motion to Proceed will be withdrawn.
    • Floor action in relation to the National Flood Insurance Reauthorization bill remains possible before the recess.

Senator Corker: (12:58 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "Several months ago Senator Blumenthal and I introduced the Gain Acts, this bipartisan provision provides meaningful market incentives and reduces regulatory burdens to encourage the development of new antibiotics that will help save lives and reduce health care costs. Drug-resistant bacteria or super bugs as we call them, are becoming harder and harder to treat because we lack new antibiotics capable of combating these infections. Not only do these infections take a toll on patients and their families, but they also run up health care spending to the tune of $35 billion to $45 billion annually. It's crucial that these new antibiotics are discovered in order to stay ahead of this growing trend of drug resistance drug discoveries do not happen overnight as we all know so we must act to make sure we have lifesaving medications when we need them. The Gain Act is a commonsense bill that provides market incentives to encourage innovation without putting federal dollars at stake and is included in the FDA reauthorization. Antibiotic resistance is a growing issue that we must address now to properly prepare for the future."

Senator Portman: (1:01 PM)
  • Spoke on Portman amendment #2145, as modified (interstate drug monitoring efficiency).
    • SUMMARY "Preliminary research has shown that monitoring programs are highly effective in stemming the tide of abuse. That's why 41 states and one territory have them. Different states can't communicate with each other, though ... We want these states tock able to work together. That's why Senator Whitehouse and I have offered this amendment of it is a federal solution to offer sharing of information. The amendment also supports collaborating between in order to further research challenges that have an impact on state some have called for a national monitoring program, one federal program. I don't think that's necessary. I don't think it'll work as well. A lot of states have programs that are working extremely well. They have put a although of money into it and it is based on different health information standards state by state. Our amendment gets these disparate programs to work together securely, reliably and efficiently without undermining or jeopardizing the state you a tongue me. States should remain free to establish laws that determine user eligibility and reporting requirements you for instance. So this legislation, is smart legislation to help give communities the tools they need to fight this prescription drug abuse. Finally, I would say our amendment has no effect on direct spending or revenues."
  • Spoke on Portman amendment #2146, as modified (synthetic drugs).
    • SUMMARY "The other amendment I want to mention is about the dangers of what we unfortunately all here in this chamber heard about, which is synthetic drug abuse, including k-2 spice, bass bath salts, herbal. Let's prohibit these drugs from getting into the hands of our children, our servicemen and women, and others. This amendment addresses the growing use and misuse of synthetic drugs by placing 15 synthetic drugs, two stimulants, nine hallucinogens to expose those who distribute and export synthetic drugs. With full penalties and sanctions and regulatory controls ... The amendment would have no significant effects on direct spending and revenues over the ten-year period and again is a good commonsense approach to trying to get our hands around this issue, help the constituents we represent, help our communities to fight, to stem this substance abuse that's affect us all."

Senator Hagan: (1:08 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "There are so many rare diseases but fewer than 250 have FDA-approved therapies. The provisions of the treat act that have been included in this bill take great steps toward resolving the problem. There is currently a pathway at the FDA that expedites the review of drugs for illnesses that are serious or life-threatening and for which there is no adequate treatment. This is called the accelerated approval pathway. Since the early 1990's it has been successfully used to advance treatments for patients with HIV and cancer by leaps and bounds. However, it has not been applied regularly or consistently to the review of drugs to treat other diseases. And this is inconsistent and this inconsistency is why I introduced my bill will broadening the application of the accelerated approval pathway beyond HIV-AIDS and cancer to a wider range of diseases, with a particularly focus on rare diseases By providing for consistent application, we will help the FDA implement these provisions, assist drug makers navigate the approval process and hopefully bring safe and effective treatments more rapidly to the patients that need them. I'm also proud to have played a critical role that led to the negotiations of the first biosimilars user fees agreement which is also in the bill before us."

Vote Results (Murkowski amendment #2108)

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Not Agreed to, 46-50:
Murkowski amendment #2108 (genetically engineered fish) to S. 3187, the FDA User Fee Reauthorization bill (60 votes required).
The vote results will be posted here within one hour.

Vote Results (Bingaman amendment #2111)

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Not Agreed to, 28-67:
Bingaman amendment #2111 (generic drugs) to S. 3187, the FDA User Fee Reauthorization bill (60 votes required).
The vote results will be posted here within one hour.

Schumer, Harkin (UC Request), Durbin, Vitter

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Senator Schumer: (11:29 AM)
  • Spoke on Portman amendment #2146, as modified (synthetic drugs).
    • SUMMARY "It places synthetic drugs on schedule 1 as totally banned substances where they belong. These synthetic substances are also known as baths salts or in the case of marijuana spice or incomprehensive. Synthetic drugs aren't sold on street corners. Instead these drugs are legal, even though they're dangerous, and can be found in local corner stores across the country. They are as easy to buy as a logically pop or a - as a lollipop, but even more dangerous than the common illegal drug on which they are based. By - by passing this amendment today, we finally get these poisonous drugs off our shelves and keep our nation's youth out of emergency rooms."
  • Spoke on Eduardo Saverin.
    • SUMMARY "Last week, Senator Casey and I introduced the Expatriate bill. It is a bill that makes sure that people that renounce their citizenship for tax purposes don't escape what they owe and can come back without repaying all they avoided paying this great country. It's a modest proposal made in response to the regrettable effort by a person named Eduardo Saverin, who renounced his American citizenship to avoid paying even the historically low level of 15% on capital gains for the several billions in windfall profit he is set to receive from the Facebook IPO. Now, Mr. Saverin is no longer involved in the day-to-day running of the company and it bears mentioning that the current active leadership of Facebook is comprised of responsible corporate citizens who meet all their responsibilities and obligations and proudly maintain their American citizenship. Mr. Saverin, on the other hand, has chosen to disown the United States to save some money on his taxes. Senator Casey and I have proposed a response. Our bill would bar Saverin and others like him from reentering the country. It would also re-impose taxes on investment income earned in the United States even if an expatriate is living abroad. Now, I believe the vast majority of Americans of all parties and persuasions think that renouncing citizenship in America to avoid taxes is troubling, unwarranted, ungrateful. It is upsetting, to say the least, that when a person who has benefited so thoroughly from being an American, a person who accessed and enjoyed so many exceptional aspects of American society, just takes the money and runs rather than doing the right thing and repaying a debt to a nation that nurtured, facilitated and cheered his success. And I think the vast majority of Americans are receptive to suggestions for how we can address this kind of unacceptable behavior. Look, nobody enjoys paying taxes but Americans know that we wouldn't have a functioning society without them. We argue and debate about how the proper rates should be, what is fair, what level will sustain and grow our economy and our middle class. But I think that most Americans, agree that paying a mere 15% in capital gains taxes on a sum of $3 billion or $4 billion is not too much to ask a person."

Senator Harkin: (11:05 AM)
  • Unanimous Consent --
    • At 12:05 PM, the Senate will conduct 3 ROLL CALL VOTES on:
      1. Bingaman amendment #2111 (generic drugs) (60 votes required);
      2. Murkowski amendment #2108 (genetically engineered fish); and
      3. Paul amendment #2143 (dietary supplement claims; prohibition on FDA employees carrying firearms and making arrests without warrant).

Senator Durbin: (11:53 AM)
  • Spoke on Durbin amendment #2127 (dietary supplement registration).
    • SUMMARY "If you walk into your neighborhood drugstore and look at everything on the shelf, here's what I can tell you. All the prescription drugs, the pharmacy has access to have been reviewed by the Food and Drug Administration, that they're safe and effective. All of the over-counter drugs have been reviewed and registered with the Food and Drug Administration to make certain that they are safe and have been pre-cleared before they can be sold to you. Now when you move back to the vitamin counter, all bets are off. Those are called dietary supplements. They are not subject to the same level of scrutiny, inspection, testing or regulation. It is an entirely different world. Now, it's understandable. Those of us who want to be able to walk in and buy vitamins, for example, without a prescription, that's our right as Americans. But we also want to make sure that whatever is on the shelf at the pharmacy is not dangerous, or at least we know it's there. There are between 55,000 and 75,000 dietary supplements in America. We don't know the exact number. They include the obvious: vitamins, minerals. But they also go further. They include energy drinks. Ever heard of the 5-hour energy drink? Monster energy drink? Those aren't being sold as colas, sodas, or beverages. They are being sold as dietary supplements. Why? There is no regulation in terms of their content ... Here's what my amendment says. My amendment says that if you want to sell in the United States a dietary supplement, you have to do one basic thing. You have to go to the food and drug administration and say this is the name of my company. This is the name of my product. And the ingredients in it, and here's a copy of the label. That's it."

Senator Vitter: (11:58 AM)
  • Spoke on Bingaman amendment #2111 (generic drugs).
    • SUMMARY "I rise to strongly support the upcoming Bingaman-Vitter amendment which is basically an amendment form that Bingaman-Vitter Fair Generic Act that would stop an escalating trend in the drug industry which is pay-for-delay deals between a generic manufacturer and a big pharmaceutical manufacturer. Over the last several years we've seen a huge increase and we've seen this trend grow from modest to a raging trend. And it's anticompetitive. It's pay-for-delay deals in which the brand-name drug-maker pays off or settles with the first-to-file generic drug-maker, often restricting generic market entry for years into the future. As prescription drug prices have exploded and put real pressure and a real burden on many Americans' budgets, these deals are counterproductive because they're making medications that should be more affordable in terms of coming on to the market. They're postponing them, paying for delay, holding them off the market for longer and longer We would move the first filing exclusivity to a reward for filing and also successfully invalidating a patent. Realistic proposal. It would allow the first filer certainly to follow through on that filing. It would incent it, encourage it, but also if that's not going to happen, it would allow subsequent filers to litigate, invalidate the patent and thereby gain ability to enter the marketplace So to simplify it, if a first filer does not enter into a settlement with the restricted and delayed market entry date, and if it does diligently challenge and invalidate a patent, nothing changes under present law. The current six-month market exclusivity reward remains. So that incentive, that reward absolutely remains. However, if that doesn't happen and the first filer just wants to settle or park its filing and it's generic, a subsequent filer would have an ability to step up and challenge the patent. And if it won, it would have market access. This solution provides more litigation certainty. We propose basically a use it or lose it statute for the brand name to sue the generic within the 45-day window. Current law provides a brand manufacturer a 30-month stay if they sue the generic within the 45-month window but still allows a suit after."

Harkin (UC Request), Bingaman

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Senator Harkin: (11:15 AM)
  • Unanimous Consent --
    • The following amendments to S. 3187, the FDA User Fee Reauthorization bill were Agreed to:
      1. Leahy amendment #2142, as modified;
      2. Portman amendment #2145, as modified (interstate drug monitoring efficiency); and
      3. Coburn amendment #2131 (independent assessment of FDA drug application reviews).
    • The following amendment to S. 3187, the FDA User Fee Reauthorization bill was withdrawn:
      1. Coburn amendment #2132 (performance awards).
    • The following amendment to S. 3187, the FDA User Fee Reauthorization bill was Agreed to by Voice Vote:
      1. Portman amendment #2146, as modified (synthetic drugs).
    • The following amendments are pending to S. 3187, the FDA User Fee Reauthorization bill:
      1. Bingaman amendment #2111 (generic drugs) (60 votes required);
      2. McCain amendment #2107 (prescription drug importation from Canada) (60 votes required);
      3. Sanders amendment #2109 (drug exclusivity conditions) (60 votes required);
      4. Murkowski amendment #2108 (genetically engineered fish) (60 votes required);
      5. Durbin amendment #2127 (dietary supplement registration);
      6. Paul amendment #2143 (dietary supplement claims; prohibition on FDA employees carrying firearms and making arrests without warrant); and
      7. Burr amendment #2130 (user fee agreement negotiation transparency).

Senator Bingaman
: (11:17 AM)
  • Spoke on Bingaman amendment #2111 (generic drugs).
  • SUMMARY "This amendment addresses the very same issue that the senator from Maine was talking about, and that is how do we bring down the price of prescription drugs? How do we get competition into the market for prescription drugs? We have a circumstance today which, an anticompetitive, anticonsumer practice is engaged in, and our amendment will change the law so that that practice can no longer be engaged in. Now the practice I'm talking about is the entering into so-called pay for delay settlements between brand name drugs, brand-name pharmaceutical companies and generic manufacturers that have the effect, these pay-for-delay settlements have the effect of delaying timely access to generic drugs. These agreements between these companies shield billions of dollars in sales each year from effective competition. The pharmaceutical companies benefit from this lack of competition, and they do so at the expense of consumers. They do so at the expense of the federal government, since the federal government is a very large consumer and purchases a substantial amount of prescription drugs for the military and in other ways. A preliminary estimate from the CBO, Congressional Budget Office, indicates that this amendment will reduce direct spending by hundreds of millions of dollars at a minimum. Frankly, I believe that it will in fact save us billions of dollars annually at the federal government level. But the CBO also indicates that the amendment will reduce the average cost for prescription drugs and lower the cost of health insurance plans. Earlier access to generic drugs is a key to saving money in the health care system. The Kaiser Family Foundation has found this. They concluded that spending in the U.S. for prescription drugs reached $259.1 billion in 2010. That is nearly six times as much as we spent on prescription drugs in 1990. Since generic drugs are on average four times less expensive or - another way to put that is a quarter of the cost of the brand-name alternatives, they can be a very important source of, for reducing the cost in our health care system. To actually receive these savings, consumers have to have access to these generic drugs and have access to them in a timely manner."

Grassley, Enzi, Kyl, Snowe

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Senator Grassley: (10:34 AM)
  • Spoke on McCain amendment #2107 (prescription drug importation from Canada).
    • SUMMARY "During the health care reform debate in 2009, drug importation had a much better chance to pass than ever before. We in a Democratic supermajority in Congress, and we had a Democratic president who supported drug importation in the past. But in backroom deals between the Obama White House and the pharmaceutical industry, those deals prevented us from finally lowering the drug costs for all Americans. So, after all these decades and a half of effort, we're back here again trying to accomplish the same goal with Senator McCain's amendment. I have always considered drug importation a free trade issue. Imports create competition and keep domestic industry more responsive to consumers. Consumers in the United States pay far more for prescription drugs than those in other countries. For instance, U.S. prices are, on average, 52.5% higher than Canadian pharmacy prices. If Americans could legally and safely access prescription drugs outside the united states, then drug companies would be forced to reevaluate their pricing strategy. They'd no longer be able to gouge American consumers by making them pay more than their fair share for the high cost of research and development, because that's a fact. We pay for most of the research and development of new drugs because other countries are getting by dirt cheap, and there's not enough money coming in from those countries to pay for all the research that it takes. Because, you know, most of the cost of a drug is the research and development. It's not the manufacture of that little pill or a big pill, for that matter. In the United States, it's a fact. We import everything consumers want, so why not pharmaceuticals? The fact of the matter is that the unsafe situation is what we have today. Today patients who need a cheaper alternative are ordering drugs over the internet from who knows where and the FDA does not have the resources to do much of anything about it. The fact is that the McCain amendment would not only help to lower the cost of prescription drugs for all Americans, but will also establish a system where American patients can be certain that the drugs they are importing are safe. The amendment has requirements that a pharmacy must meet before the secretary may approve them for participation. This includes product testing in labs designated by the secretary. A list of approved pharmacies will be published on the FDA web site. Patients who are already forced to purchase their medications outside the United States would be able to access the list to choose a safe option. Additionally, the amendment lays out criteria that must be met before a patient may import drugs from an FDA-approved pharmacy. Patients must have a valid prescription from a physician licensed to practice in our country, the purchase must be for personal use and the drug must have the same active ingredient, route of administration, dosage form, and strength as prescription drugs approved by the Secretary of HHS the McCain amendment would improve drug safety. It would not threaten drug safety. And it would open up trade to lower-cost drugs, and it would make other consumers around the world to start paying for some of the research and development that the American consumer is paying such a high price to provide for. We should do all we can to get miracle drugs originated and developed, but the American consumer shouldn't be paying the entire bill. We need to make sure that Americans have even greater, more affordable access to lifesaving drugs by opening the doors to competition in the global pharmaceutical industry."

Senator Enzi: (10:42 AM)
  • Spoke on McCain amendment #2107 (prescription drug importation from Canada).
    • SUMMARY "This amendment would require the Food and Drug Administration to allow individuals to import prescription drugs into the United States from Canada, notwithstanding any other provision of the federal, food, drug, and cosmetic drugs that supposedly come from Canada can originate in any country in the world and merely be shipped to the United States from Canada. Canadian law does not prohibit shipment of drugs from any country into Canada and then into the United States. They don't care. In 2005, FDA conducted an investigation of drugs that American patients thought they were ordering from Canada. 85% of the drugs represented as coming from Canada actually came from 27 other countries. A number of drugs were found to be counterfeit. A letter from Canada to the U.S. Surgeon General said that you Canada does not assure that product being sold to U.S. are safe, effective and of high quality and does not intend to do so in the future. The pending amendment would allow importation from Canadian internet pharmacies, Canadian internet pharmacies openly acknowledge that they obtain most of their drugs from other countries. The specific language of the pending amendment gives rise to the additional safety concerns. For example, it will not prevent the importation of drugs that need special handling, such as refrigerated or photo-sensitive drugs. It would not prevent the importation of special drugs, such as those inhaled during surgery or administered intravenous lymph the pending amendment would not allow - there would be a list. But not a licensing or registration. Do we really want anyone, even someone under investigation or with the suspended or revoked license, to be in the business of importing given the well-known risks? The FDA advises consumers that some including those who that bear the name of U.S. products may be counterfeit versions that are unsafe or ineffective. It can have all the ingredients, if it's not put together it doesn't dissolve and there would be no benefit even though it looked like the real thing, tasted like the real thing, went down just like the real thing but if it's not the real thing, it can cause real trouble with people's health."

Senator Kyl: (10:48 AM)
  • Spoke on Bingaman amendment #2111(generic drugs).
    • SUMMARY "It ignores fundamental economic realities of pharmaceutical patent litigation. And it would ultimately result in fewer generic drugs being brought to the market and delays in the launch of many of the generic drugs that do go to the market. Under current law, a generic drug company that is the first to file an abbreviated new drug application, that's the application they file for an existing patented drug, is entitled to 180 days of market exclusivity once the generic drug is approved. In other words, they have the exclusive market on it for half of a year. This creates a powerful incentive for drug companies to bring generic drugs to the market. The present amendment would dilute this right of 120 days of exclusivity and would potentially require the exclusivity period to be shared with another drug company's product. Under the amendment, the only way a generic drug company that files the first could be assured of getting its 180 days of exclusivity is by litigating a challenge to the validity of the branded drug's patent all the way to final judgment. This is not a sound approach. First of all, patent litigation is very expensive. Full litigation of a drug patent suit typically costs between $3 million and $5 million. And second, most drug patents are ultimately found by the courts to be not invalid. That is, most validity challenges to these patents fail. Generic drug companies like everyone else have limited litigation budgets. As a practical matter, if we force them to litigate every patent case to a final judgment in order to preserve their exclusivity rights, they will pursue fewer abbreviated new drug and fewer . generic drugs and higher costs for consumers."
  • Spoke on Sanders amendment #2109 (drug exclusivity conditions).
    • SUMMARY "This amendment would undermine the government's ability to fight fraud and harm patients and U.S. competitiveness by eviscerating existing incentives to invest in medical innovation. The Sanders amendment would result in the automatic revocation of any remaining regulatory exclusivity on a product when a company is convicted of or even enters into a settlement agreement for certain violations of the Food, Drug and Cosmetic Act or any violations of the false claim act or several other listed statutes. There are several reasons why I think this is the wrong approach. First, the amendment will result in less lifesaving drugs ever getting to patients. Obviously we should be fighting for lifesaving drugs getting to patients even faster. We provide these periods for exclusivity as I mentioned earlier, for a reason, to enable companies to recoup the significant investments that they make. As high as over a billion dollars, $1.2 billion per drug to develop new medicines. Some of the exclusivities that the amendment would revoke are those reenacted to encourage companies to ensure the safe use of pharmaceuticals in children or to find cure for rare diseases that affect a very small number of people ... Second, reduced investment in U.S. drug development is not only bad news for patients, it's bad news for the economy because the amendment, the Sanders amendment, would create a disincentive to invest in drug development. The National Venture Capital Association has stated the amendment has the potential to inadvertently undermine innovation and undermine decades of policies enacted by congress with the goal of fostering medical innovation, end of quotation. Defined periods of exclusivity provide some small measure of predictability in what is otherwise a risky and unpredictable process and venture capitalists rely on these periods of exclusivity to make development decisions. By threatening the termination of exclusivity for products that are many years removed from the development process, the sanders amendment would introduce greater uncertainty into the R&D process. We need to reconsider the environment for innovation in the United States yet here we are considering an amendment that if enacted would make the U.S. climate far less attractive for these companies even as other companies are actively courting the biopharmaceutical industry. Third, while the amendment purports to fight fraud, in reality it would undermine the ability of the government to fight fraud by undermining its ability to settle cases. The Sanders amendment would revoke exclusivity not only upon conviction, even if it's later overturned on appeal, but also on settlement, and this is a huge problem. Because it creates a disincentive for companies to ever settle. As it would make more sense to drag out the district court litigation while any relevant exclusivity period is still running for the company. Fourth and finally, the amendment is not actually even necessary because the outcome called for by the sanders amendment can be achieved under current law. In appropriate cases because the government can and does have the power to negotiate the relinquishment of exclusivity as a condition to settlement. It can already do this."

Senator Snowe: (10:56 AM)
  • Spoke on McCain amendment #2107 (prescription drug importation from Canada).
    • SUMMARY "Americans are facing tremendous increases in prescription drug prices. For far too long, and I think it's at a point in which Congress should address this issue and precisely on this particular piece of legislation that is before us today, it couldn't be more appropriate to have this amendment offered to this legislation. In 2010, AARP found that retail prices for the most popular brand name drugs increased 41.5% while the consumer price index rose just 13%. In other words, the cost of prescription drugs rose more than three times as much as the inflation rate. That's completely unacceptable If the Senate and the overall congress were to adopt the McCain amendment, it would allow Americans to purchase safe medications at a lower price than they're available for us here in this country. We could begin to turn this disturbing trend around Millions of Americans and certainly millions have already purchased drugs from Canada safely at a significant savings over the years. They've had to go to great lengths in order to purchase those lower priced medications. They've taken bus trips to Canada to purchase that medication because that was the only way they could have access to the prescriptions that they so desperately need. The McCain amendment builds on that foundation ... It would allow Americans to import medications from accredited Canadian pharmacies, from a list approved by the Secretary of Health and Human Services. These accredited pharmacies must commit to ongoing quality assurance programs and product testing to determine the safety and efficacy of these products. And this amendment is more narrowly focused provides a pathway to a more limited approach for Americans to access affordable medications. In fact, there's been a very recent study, that was conducted by Roger Bate of the American Enterprise Institute what he discovered is "that if some foreign web sites sell safe prescription drugs with substantial price discounts but American consumers are guided to buy from U.S. web sites only, the FDA could potentially discourage price competition between the U.S. and foreign pharmacies and thereby reducing drug affordability within the United States. The danger of reducing price competition depends on whether consumers can distinguish trust worthy web sites from the vast pool of foreign web sites." So here we have the documentation by a very significant study that talks about how Americans can access these affordable medications. We shouldn't be discouraging price competition, as this study illustrates, and that's one of the points that I've been arguing over the years, that the real problem in this country with respect to prices for prescriptions is that we don't have competition within the industry and competition for those medications."

McCain, McConnell, Menendez

FDA User Fee Reauthorization bill (S. 3187)

May 24 2012

Senator McCain: (9:43 AM)
  • Called up McCain amendment #2107 (prescription drug importation from Canada).
  • Spoke on McCain amendment #2107 (prescription drug importation from Canada).
    • SUMMARY "All this amendment does, it allows U.S. consumers who need more affordable prescription drug options either to go without their medications or pay higher prices than they could get from ledge it Canadian pharmacies. But that's not a reason for us to stop fighting for those in the United States who need more affordable prescription medications. There are Americans in this country today who cannot afford their medications. They have a choice between taking their prescription drugs. Meanwhile, there is a way for them to get much cheaper drugs and this amendment does that. And you'll see and you'll hear from the pharmaceutical company supporters here in the senate who will talk about safety and we don't have the - the Canadians don't have the same standards that we do. Really? Do we really believe that the Canadian regulations and oversight are any better or worse than the United States? To ensure U.S. patients have at least one option, this amendment takes a very narrow approach to safe importation by focusing on legitimate Canadian pharmacies. Under this amendment, the Secretary of Health and Human Services will certify "approved Canadian pharmacies based on certain safety and quality criteria to ensure patients are not exposed to unsafe medications, approve Canadian pharmacies can only sell to U.S. customers that are the same as U.S.-approved drugs. To protect U.S. patients against drug distributors, rogue distributors, a list must be published by the secretary so Americans know which pharmacies are legitimate. The cost of health care including prescription drugs continues to increase. However, there is nothing in the underlying FDA bill that will bring down the cost of prescription drugs. I wonder if a bill should be enacted when it doesn't address costs. The quality of pharmaceuticals in this country is outstanding. And I recognize that. But don't we all know how expensive it is, don't we know that."

Senator McConnell: (10:03 AM)
  • Spoke on the Student Loan bill.
    • SUMMARY "Today we will once again attempt to prevent student loan interest rates from going up. This problem could have been solved literally weeks ago, but our friends on the other side were not interested in solving the problem. They wanted a scapegoat more than a solution. So this afternoon we'll vote on two different waifs addressing the issue. The Democratic plan designed to fail. In order to cover the costs of the temporary rate freeze that both parties actually want, they propose to divert $6 billion from Medicare and to raise taxes on small businesses. Hurting the very companies we're counting on to hire today's college graduates. They've known for months that we won't support this tax hike and that it couldn't pass this chamber or the House of Representatives. It has already failed, but they're proposing it anyway a second time. If our Democratic friends would allow it, the chairman and ranking member could write a bill that could actually pass, but since the passage isn't their goal, our friends on the other side huddle behind closed doors out of sight of the public and the press and produce the tax hike instead of letting the committee actually do its work. We already know how this story is going to end. We know exactly already how the story will end. So why are the democrats forcing us to vote on their failed proposal yet again? Because, as i said, they're more interested in drawing our opposition of trying to create a bad guy here than in actually solving the problem. When it comes to college graduates today, the bigger issue is the President's economic agenda, which has created an environment in which most of them can't find a decent job. So I can understand why our Democratic friends want to change the subject, but if we're actually going to do something to solve the problem, we're going to need to get past the political theatrics. If Senate Democrats reject the bipartisan fix that the house already passed, one that doesn't raise taxes or divert a single dollar away from Medicare and is an offset that they have used themselves before, then I hope they will turn around and work with us on a bipartisan fix that doesn't tax small businesses, a proposal that is actually designed to pass and become law. But let's be clear about something: like the real issue the real issue here isn't the fact that certain students are going to see an interest rate hike, because we will address that concern, it's that so many young people today can't find a job that will enable them to pay off their loans in the first place. That's the much larger problem. And the solution is a pro-growth agenda that would make it easier for U.S. businesses to hire, not a tax hike that will make it actually harder for them to hire. In the short term, Republicans are ready to work to offer this temporary relief, but we're still waiting on the Democratic leadership to propose a solution of their own that can actually pass either one or two chambers of Congress. And I would once again urge the President to get involved. If the President has got time to run around to late-night comedy shows and college campuses talking about this issue, then he can pick up the phone and work out a solution with democrats here in the Senate. Last week at the White House, I pressed the President to get involved in order to prevent the student interest rates from going up, a goal we all share."
  • Paid tribute to U.S. Army Specialists David W. Taylor, who died on March 29, 2012.

Senator Menendez: (10:16 AM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "This bill is about more than drug safety. It is about more than protecting patients. It's about improving the approval process to speed access to new lifesaving, life-enhancing drugs and devices and making sure that the FDA is a partner in the production of safe and effective products. This bill does and accomplishes several key goals that are critically important to our nation's health care system. Not only does it reauthorize the key user fee agreements for prescription drugs and medical devices, but it establishes agreements for generic drugs and generic biologic drugs called biosimilars. Together they will provide the FDA with the resources necessary to improve the drug and device approval process to move more quickly and more efficiently bringing new products to market. It will enhance communication between manufacturers and the agent to foster a more cooperative environment and will allow for better and more thorough post-market reviews to ensure continued patient safety and product efficacy. Mr. President, there's more to this bill than the FDA user fees. It permanently reauthorizes two programs that are a vital life line to our nation's country. The Best Pharmaceutical for Children Act and the Pediatric Research Equity Act which are incredibly important to our children, helps reduce and mitigate the ongoing problem of drug shortages we have heard throughout the country. It provides for enhancement to the prescription drug supply chain, and increases the accountability and transparency of the Food and Drug Administration. It's good for children, it's good for business, it's good for patients, it makes the FDA a more effective partner in the process, and it demonstrates that we can reach across the aisle and work together to tackle tough issues and find solutions that benefit the people we collectively represent."
  • Spoke on McCain amendment #2107 (prescription drug importation from Canada).
    • SUMMARY "It seems that once again despite the countless times, the countless times the Senate has rejected the policy that my friend from Arizona pursues, he has brought us an amendment that I believe puts Americans at risk, undermines FDA's authority, and would have a devastating ripple effect throughout our country's drug supply by allowing untraceable foreign pharmaceuticals into our country. Now, this amendment would ostensibly only allow drugs from Canada into the United States. However, nothing in the amendment comes close to ensuring that's the case. In fact, this amendment would easily allow web-based pharmacies within Canada to provide untraceable, unaccountable drugs from all over the globe into the United States market without any FDA oversight whatsoever. This amendment does not provide the FDA with any additional resources to monitor the drugs coming in from Canada, and even the Canadian authorities have said they cannot be expected to monitor all the drugs coming through their country and into ours and once one of those drugs hits and causes consequences, we will all be running and saying how did we allow that to happen. The Senate has soundly and repeatedly voted against this type of drug importation because we understand the implications it has in bringing counterfeit and dangerous products into the nation. As we work to strengthen the FDA, I ask my colleagues to join me in opposing this amendment which would significantly weaken the agency and put Americans at risk."
  • Spoke on Sanders amendment #2109 (drug exclusivity conditions).
    • SUMMARY "This amendment will lead to uncertainty among investors, it will dry up capital, it will further delay access to new medical products, it will pull us back from the cutting-edge research and development that has always made this nation great."

Reid

Opening Remarks

May 24 2012

  • Today --
    • The Senate will resume consideration of S. 3187, the FDA User Fee Reauthorization bill. There will be up to 30 minutes of debate, equally divided, on each amendment, with the exception of McCain amendment #2107, which will receive up to 1 hour of debate, equally divided. In addition, there will be up to 2 hours of debate, equally divided, on the bill.
    • At 2:00 PM, the Senate will conduct up to 12 ROLL CALL VOTES on:
      1. Bingaman amendment #2111(generic drugs) (60 votes required);
      2. McCain amendment #2107 (prescription drug importation from Canada) (60 votes required);
      3. Sanders amendment #2109 (drug exclusivity conditions) (60 votes required);
      4. Murkowski amendment #2108 (genetically engineered fish) (60 votes required);
      5. Portman amendment #2146, as modified (synthetic drugs);
      6. Portman amendment #2145, as modified (interstate drug monitoring efficiency);
      7. Coburn amendment #2132 (performance awards);
      8. Coburn amendment #2131 (independent assessment of FDA drug application reviews);
      9. Durbin amendment #2127 (dietary supplement registration);
      10. Paul amendment #2143 (dietary supplement claims; prohibition on FDA employees carrying firearms and making arrests without warrant);
      11. Burr amendment #2130 (user fee agreement negotiation transparency); and
      12. Passage of S. 3187, the FDA User Fee Reauthorization bill, as amended.
    • Majority Leader Reid has indicated that some ROLL CALL VOTES could occur earlier, possibly before 12:00 PM. There will be NO ROLL CALL VOTES between 1:00-2:00 PM. All votes after the first vote will be 10 minute votes and Budget Act points of order are in order.
    • Upon disposition of S. 3187, the FDA User Fee Reauthorization bill, the Senate will begin consideration of the Alexander/McConnell Student Loan bill amendment (S. 2366) and S. 2343, the Student Loan bill, for up to 10 minutes of debate, equally divided. Thereafter, the Senate will conduct 2 ROLL CALL VOTES on:
      1. Alexander/McConnell Student Loan bill amendment (S. 2366) (60 votes required); and
      2. S. 2343, the Student Loan bill, as amended, if amended (60 votes required).
    • Budget Act points of order are in order.
    • If S. 2343, the Student Loan bill does not achieve the required 60 votes, it will return to the Senate calendar, and the Motion to Reconsider with respect to the cloture vote on the Motion to Proceed will be withdrawn.
    • Floor action in relation to the National Flood Insurance Reauthorization bill remains possible before the recess.
  • On Wednesday, the following 7 amendments to S. 3187, the FDA User Fee Reauthorization bill were Agreed to:
    1. Harkin/Enzi substitute amendment #2122;
    2. Cardin amendment #2125;
    3. Cardin amendment #2141;
    4. Grassley amendment #2121;
    5. Grassley amendment #2129;
    6. Manchin amendment #2151, as modified; and
    7. Reed amendment #2126.

Senator Reid: (9:32 AM)
  • Spoke on the Senate's Agenda.
    • SUMMARY "I was pleased yesterday to reach an agreement with the Republican leader on how to move forward with this FDA bill. This legislation would establish a protocol and ensure FDA resources are there to approve new drugs and medical devices quickly and efficiently. We're going to consider a number of amendments and I'm optimistic that we'll pass this on a strong bipartisan vote. The week has been productive. And, we have not had to break or try to break a single Republican filibuster. That is a good day in Washington. Doesn't happen very often. Hope it happens more often. If this trend continues, we could return to the way we used to be; that is, do things that were good for the country and not be trying to stop everything from moving along. I'm also hopeful this week that the Senate will be able to find a path to renew the flood insurance program. We need a long-term solution to this problem. We have about 40,000 loans every day that are approved. They are approved because you can make that check that you do have flood insurance. If there's no way to buy flood insurance, you can't make that check in that box, and you can't get a loan. This would be devastating to our fragile economy. We've got to get this done and get it done before the end of this month. The cooperative work on that measure and the FDA bill renew my hope that congress will reach an agreement to prevent student loan interest rates from doubling for 7 million young men and women. We have two proposals to freeze interest rates at their current levels. The Republican proposal is paid for by stripping Americans of lifesaving preventive health care. Can't say anymore clearly than that. It would be a shame to use that pay-for. That program has already been stripped bare. Taking more from it would really hurt the health of America. Our proposal is paid for by closing a loophole that allows wealthy Americans to dodge their taxes. I'm certainly aware how things work around here. Neither one of these things are going to pass. I'm sorry to say. These two proposals were not created equal. But I hope a few reasonable Republicans will join with us to not put Americans' health at risk. We need to come to an agreement on the student loan issue. We only have until the end of June to do this. Also, I hope to resolve an issue dealing with paycheck fairness over the next work period. In addition to that, we're going to deal with the Farm bill, flood insurance, as I've talked about, a small business tax relief program. Last Congress we passed the Lilly Ledbetter Act ... The legislation, led by Senator Barbara Mikulski, the Paycheck Fairness Act is a logical extension of protections under the equal pay act. It will create strong incentives for employers to obey the laws already in place. Republicans deny they're wage ago war on women, yet they've launch add series of attacks on women on wages and contraception this year. We're going to give them the opportunity to back up their speech with action. To send a clear message that America appreciates the contributions that women make every day."

May 24 2012

The Senate Convened.

May 24 2012

The Senate is considering S. 3187, the FDA user fee bill.  The Senate will also consider S. 2343, the Reid student loan bill, and a Republican substitute amendment.  Republican senators continue to focus on creating jobs, lowering the deficit, reducing gas prices, and replacing the Democrats' health care bill with reforms that will actually lower costs.