Floor Updates

Wednesday, May 23, 2012

May 23 2012 9:30 AM

The Senate Convened.

Reid, McConnell

Opening Remarks

May 23 2012 9:55 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 Republicans controlling the first 30 minutes and the Majority 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.

Senator Reid: (9:40 AM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "Doctors never know which drugs will be accessible and which won't. Last year, FDA reported shortages of 231 drugs, including a number of chemotherapy medicines. In the last six years, drug shortages have quadrupled. Gone up 400%. Now, Congress can't solve every problem in this country, we know that but this is one problem we can solve with cooperation from the drug manufacturers and it will come about much more clearly if we pass the bill that's before the senate now. The Food and Drug Administration Safety Innovation Act, the one I've talked about several times already today, will help establish effective lines of communication between drug-makers, the food and drug administration, and doctors. When the FDA gets early warning from manufacturers, that shortages are coming, it can act quickly to find alternative sources of medication and ease supply problems by taking, for example, one place where they have a lot of medicine and move it someplace to where they don't. Drug-makers averted 200 shortages last year by voluntarily notifying the FDA of trouble on the horizon. But many shortages, perhaps all 231 last year could have been prevented if drug-makers had shared information with the FDA our bill will make that necessary and allow it - force it to take place. That's why Congress must act quickly to pass the legislation now before the Senate, which will ensure the FDA has the resources to approve new drugs and medical devices quickly and efficiently."

Senator McConnell: (9:46 AM)
  • Spoke on President Obama's PR campaign.
    • SUMMARY "While the President and his surrogates spend most of their time deflecting attention from his record he has Washington bureaucrats working overtime to actually try to put a good face on it. I mentioned yesterday the administration is spending yet another $20 million in taxpayer money to promote a health care bill that most Americans would like to see repealed. $20 million to promote a health care bill that most Americans would like to see repealed. But there's more. There's a pattern here that I, and I'm sure many other Americans, find pretty outrageous, at a time of trillion-dollar deficits and a nearly $16 trillion debt. The administration also spent more than $25 million in stimulus funds, stimulus funds, on grants to public relations firms, PR firms, ostensibly to do public relations relating to the stimulus. It spent $20 million on mailers to seniors about Obamacare, which overstated the law's benefits. Millions more in taxpayer funds were spent on postcards, postcards, that promoted Obamacare's small business tax credit. A credit that the GAO said was ineffective and infrequently used. These are just a few of the ways the administration is quietly promoting its own failed policies. How is it trying to change people's minds about the President's policies with their own money, using our tax money to try to promote the President's policies. You know, campaign is one thing, but using our tax money to promote the President's policies is really outrageous. But there's a larger issue here than the fact that the president is quietly marketing policies with taxpayer dollars that he's truly afraid to talk about in public. That's bad enough, but the larger point is the fact that we've got a nearly $16 trillion debt, the largest tax hike in history right around the corner, chronic unemployment, and sky-high gas prices, and the president thinks it's a good idea to spend $20 million to promote Obamacare. We don't have the money to begin with. And he's spending it to market his policies. The President needs to face the facts. Americans do not want him spending their hard-earned money trying to spin policies this they don't like. How about setting some priorities first? How about working with us to lower the deficit and the debt? How about working with us to fund things that we actually need? We're more than ready to work with the President as I've said time and time again over the past few years, but he needs to set some priorities, and he needs to lead."

Barrasso, Moran, Heller

FDA User Fee Reauthorization bill (S. 3187)

May 23 2012 10:20 AM

Senator Barrasso: (9:50 AM)
  • A Doctor's Second Opinion.
    • SUMMARY "For over two years the news about the law has not been good for those who support it, and the country has had opposition to the law continue to increase. Today 56% of Americans oppose the President's health care law. Say why is that, well, there are a number of reasons. One is the health care law is adding to the national debt. We just heard the Republican leader talk about the incredible national debt that the American people are facing. The health care law has increased premiums that people have to pay for their own insurance as a result, directly as a result of the health care law being passed. The President promised if you like what you have, you can keep it but actually the health care law has made it harder for workers to keep their employer-sponsored health care coverage. People want to have choices. They want to have patient-centered care yet this health care law established an unprecedented board, unelected bureaucrats, who will by their decisions have a direct impact on whether patients can get to see a doctor, whether they can receive care. When you look at the incentives that are part of this health care law, the incentives actually to me appear to encourage employers to either fire workers or stop providing health care coverage. To me this health care law is discouraging to students who otherwise might pursue a career in the medical field to provide care for Americans, and in my opinion this is a law that is actually weakened, not strengthened Medicare and it has done that by taking $500 billion away from our seniors on Medicare, not to help strengthen Medicare but to start a whole new government program for someone else. And the Medicare actuary came out with a report just last Friday to say when you actually get into a realistic assessment, a realistic assessment of the impact of this health care law, on Medicare, it weakens it, it shows that Medicare going broke sooner than initially thought, and this report on an actual realistic look, a realistic look of the impact of the health care law on Medicare is it's going to make it that much harder for our seniors on Medicare to get the treatment that they need, to actually even get to see a doctor, to find someone to care for them because of the implementation of this law which takes $500 billion away from Medicare, not to strength or save Medicare but to start a whole new government program for someone else."

Senator Moran: (10:00 AM)
  • Spoke on the Startup Act 2.0.
    • SUMMARY "The Startup Act makes permanent 100% exemption on capital gains taxes for investments held at least five years in a qualified small business so investors can provide financial stability at this critical point in their - in their growth. The legislation also includes a limited targeted research and development, R&D tax credit for start-ups less than five years old. So we alter R&D, we alter income taxes, we alter capital gains in a way that is designed to create better opportunities for access to credit. We attempt in this legislation to accelerate the commercialization of research. Billions of dollars are being spent, taxpayer dollars at universities, colleges across the nation, and we want to insure that research to be devoted toward things that can be commercialized, that bring new products, new businesses to market. And so we take existing resources and utilize those dollars to reward those universities that take their research dollars and use them in ways that are more likely to be commercialized. In other words, create products, pursue dreams and ultimately create jobs. In addition to that, we create competition, at least information, knowledge that allows somebody who is thinking about start ago business to decide which states are the most pro-growth oriented and make decisions about their location, where they should locate based upon information. That then would also encourage states to be very entrepreneurial and pro growth, pro-innovation in their state policies. And perhaps the most significant portion of this legislation creates two new visas. An entrepreneur's visa to help foreign-born entrepreneurs currently in the United States, currently legally in the United States to register their business and to employ Americans. In many instances, entrepreneurs, foreign born, here legally, have an idea and want to begin a company that will employ Americans but are told that their visa does not allow them to remain in the united states. The second visa that's created in this legislation is related to stem. That's a topic of conversation that I think is so important to keep important students who are studying the United States who have a PhD. Or master's degree in science, technology, engineering or mathematics. It's silly, it is wrong-headed for us to educate these individuals and tell them that we no longer want them in the United States once they receive their degree. And so the Startup Act 2.0 makes two important modifications to that current system of visas. And in addition to that, we adopted from the legislation introduced by Senators Rubio and Coons we eliminated the country numerical limit for employment-based immigration visas, another handicap in our system that prevents those who have the greatest skills and talents and intellect from being eligible for a legal visa to remain in the United States."

Senator Heller: (10:12 AM)
  • Spoke on the housing market.
    • SUMMARY "Nevada is the epicenter of our nation's housing crash. Home prices continue to decline in Nevada. In February of 2006, the average home value was $309,000. Today that has dropped to $120,000. Let me give you another fact. Five years. Five years. That's how long Nevada has led the country in foreclosures. The people of Nevada have suffered far too long because of the recklessness of wall street that caused this crash. A million Nevadans are struggling to pay their mortgage or have their homes in foreclosure as a result of poor job market and the economic downturn. Because of the high rates of foreclosure devastating Nevadans , many are being forced to move or to live in a new place. Washington must provide solutions that help those who have been hit the hardest by this tough economy. I have worked on several solutions that I believe that will provide some relief for many of those that are struggling. In February, I introduced the Keep Families in their Home Act, or just the Home Act. This legislation would allow banks, Fannie Mae, Freddie Mac to offer long-term leases for foreclosed homes. By doing so, it gives families the opportunity to stay in their homes while also easing the pressure that foreclosures put on home values. The next month, I joined Senator Stabenow to introduce the bipartisan mortgage Forgiveness Tax Relief Act which would ensure that homeowners who owe more on their mortgages than their homes are now worth would not be hit with an additional income tax if a part of their mortgage loan is forgiven. The current Mortgage Relief Act expires at the end of this year, and this bill extends this critical safety net for underwater homeowners through 2015. Today, I'm proud to announce the introduction of the Sold Act, homebuyers, sellers and real estate agents have long observed the banks have been slow to approve home short sales. Delays in approving short sales are a challenge to consumers and to realtors. These delays can cause canceled ... seen as far better outcome than foreclosure, finding a way to improve and make this process more efficient has been very, very difficult. My legislation, the Sold Act, would require that mortgage servicers respond to a short sale request within 30 days and make a final decision within 60 days of receiving the purchase offer. By placing a shot clock on these decisions it will reduce the amount of time it takes to sell property, improve the likelihood that the transaction will close, and reduce the number of foreclosures in Nevada and across this country. Stability in the housing market is critical for long-term economic growth."

Reid (UC Request)

FDA User Fee Reauthorization bill (S. 3187)

May 23 2012 11:23 AM

Senator Reid: (10:56 AM)
  • Unanimous Consent --
    • At 12:30 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).

Lautenberg, Gillibrand, Durbin

FDA User Fee Reauthorization bill (S. 3187)

May 23 2012 12:07 PM

Senator Lautenberg: (11:27 AM)
  • Spoke on the Safe Chemicals Act.
    • SUMMARY "Studies by CDC scientists found 212 industrial chemicals, including six carcinogens coursing through American children's bodies. Toxic chemicals pose significant health risks. Chemical exposure accounts - and this chart tells a very bad, very sad story. 5% of pediatric cancers - 5% of children cancers, 10% of diabetes, 10% of Parkinson's disease, 30% of childhood asthma are significant health threats to children. And instead of protecting us from these harmful chemicals, our current law falls short. A law called TSCA, it was designed to eliminate these threats to children's health. It passed in the 1970's. It's so severely flawed that nonpartisan Government Accountability Office testified, and it's "a high-risk area of the law." Imagine the law so severely flawed that it's a high risk of the law. Nearly 35 years TSCA has allowed EPA to test only 200 chemicals of more than 80,000 chemicals. Thousands of chemicals, new chemicals are introduced every year in industrial and research facilities, but only 200 over that time. What does that say when you think about the number of children that we have trying to protect 80,000 chemicals and only 200 of them were tested, and four were banned? Sadly, however, it's hard to believe the chemical industry is fighting to keep the status quo alive at the expense of our lives, our children's lives, our children's health. Just recently the Chicago Tribune exposed how the industry uses dirty tricks and junk science to drive their public misinformation campaign. They want to mislead the public about what's going on. In their series, detailed how the industry repeatedly bullied and lied to state legislatures to prevent commonsense reforms. They bankrolled phony experts, a doctor in one instance, prominently stood up and protected chemical material, fire retardant. They're brought in there to convince stories that spout the company line all in the service of protecting not the health of children, but protecting their profits. It's a terrible exchange, all at the expense of safety and health. It's clear that chemical manufacturers purposefully hid the dangers of toxic flame retardants My bill, the Safe Chemicals Act, lays out a vision for strong, effective and pragmatic regulation of chemicals. The bill simply requires the chemical makers to prove that their products, their chemical is safe before they end up in children's bodies by being put into a product that children use. Most of the thousand chemicals that we use every day are safe, but this bill will separate the safe chemicals from the ones that are not, the ones that threaten our children and our families. It will ensure that chemicals are tested and that EPA can take unsafe uses of chemicals off the market."

Senator Gillibrand: (11:44 AM)
  • Spoke on the Safe Chemicals Act.
    • SUMMARY "Our nation's chemical regulations is an issue that matters to all of us, every single American and every single parent who has children. Our families are exposed to a variety of chemicals in every aspect of their daily lives, whether it's the soap we wash our hands with, whether it's the shampoo we wash our children's hair with, whether it's the detergent we put in our clothes washer when we're doing laundry at night, every day we are bombarded with chemicals in our lives. Understanding how these chemicals impact our health the health of our families is a growing concern not just for me but for constituents all across New York. But because of a very broken and ineffective system, our regulatory agencies aren't able to provide us with enough information. The challenge to our regulatory agencies are facing is a substantial one. Since the toxic control substances act that was enacted in 1976, the EPA has faced the daunting challenge to investigate more than 84,000 chemicals in commerce and their track record for success has been poor. Of the tens of thousands of chemicals on the market place, only 200 have been identified for further investigations and only five have been regulated. Weekly, there are news reports highlighting a new study of chemical concern found in everyday products in our homes, in our schools, in our places of work. These reports have caused growing concern amongst consumers because we've seen links, there's been studies that have linked these chemicals to rising causing of cancer, autism, learning disability, diabetes, asthma, obesity, disorders and others. These are disorders families are going to face, anyone of these. So this is what we need to know, are these affecting outcomes. Is there a relationship? Two amendments that I care a lot about, one is very simple, just making sure that parents have as much information as possible when there are disclosures that accompany medicines so you know what all of the impacts could be of that medication. I know that most of my colleagues and certainly most consumers didn't realize that the leaflets that come with our prescriptions isn't regulated by anyone and it's usually just written by a contractor. In 1995, the FDA recommended standards to improve the information provided to patients, but by 2008, only about 75% of information patients were receiving met the standards for usefulness and then last and quite simply, we use sunscreen everyday. My family, my kids, they have very fair skin. I want to know that the label on that sunscreen is accurate. I just want to know if it has the protection it says it does. And this is an area that desperately needs regulation. I support Senator Reed of Rhode Island's bill to finally give consumers the information they need with regard to sunscreen."

Senator Durbin: (11:51 AM)
  • Spoke on the Safe Chemicals Act.
    • SUMMARY "Senator Frank Lautenberg of New Jersey has created legislation that really calls on the chemical industry to take care with the chemicals that they put into everything we use every single day. To make sure that Americans and families have peace of mind when they buy products that the environmental protection agency is at least reviewing the chemicals that are being put in those products to decide if they're safe. If the Environmental Protection Agency doesn't do this, who will do it? Do we trust the chemical industry to do it? I don't think so. Can we trust the furniture industry? I'm not sure. But we know if the EPA does it, it can make a difference. 80,000 different chemicals out there now, many of them critically important for our safety and health. Safe chemicals that we can be exposed to every single day without concern. But there are others that aren't the flame retardant chemicals are a good example of that. And, as the presiding officer said when she was speaking on the floor, over the years, they have reviewed 200 of these chemicals out of 80,000. 200. And at the end of the day, they've banned five. Five. What about the rest of them? Have they taken a look? Where does the first level of responsibility start? Senator Lautenberg's bill says it starts with those who would put the chemicals in the marketplace, that there be a certain level of safety established before they can be sold across the board. I think that's essential."
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "The Food and Drug Administration , a small agency, has a big responsibility. Literally before any drug can be told as a prescription drug in America, the first sold as a prescription drug in America, the Food and Drug Administration has to establish, number one, that it's safe, and number two, that it's effective. If it says it's going to do certain things, it has to accomplish those things. So there's lengthy testing in terms of these drugs before they're actually licensed, allowed legal in America. The drugs that make it through all these tests can generate millions, even billions of dollars in profits for the pharmaceutical companies, but many don't make it through the testing process. But the FDA is there to establish that those drugs are safe and effective. And, of course, the consumers rely on it. When the doctor writers a prescription, you feel pretty certain that this is going to be something the doctor knows is good for you and it's already been tested through the FDA there's a whole other category of things, though, that we buy every single day that are treated differently. They are called dietary supplements. They include things like vitamin as that you take in the morning, minerals ... and dietary supplements also include things like energy drinks. Heard about any energy drinks lately? You can hardly escape them. The 5-hour energy drink, the monster drink, all these different drinks that you can buy turn out not to be the same as soda or soda pop but they are dietary supplements, in small print on the back of the label. Well, what's the difference? The difference is this. If you wanted to sell a bottle of cola a bottle of cola, there's a limitation by the FDA about how much caffeine can be put in each bottle but if you decide I'm not going to sell cola, which is classified as a beverage or food , Instead sell monster energy drink and I'm going to call it a dietary supplement, there is no regulation on the amount of caffeine that can be included ... I have an amendment that I am going to offer. This will come up I hope on the food and drug administration bill. Here's what it says: every dietary supplemental manufacturer who wanted to sell their product in America has to register with the FDA, tell the FDA the name of the product, the ingredients in the product and a copy of the label. That's it. No requirement for testing. Just so we know what's out there. And let me add, dietary supplements are coming in from all over the world into the United States. You walk into that vitamin store, nutrition store, you think everything in there has been tested? No. Virtually nothing has been tested. Do you still have a right to buy it? Yes, and I will fight to defend your right to buy but I also think we have a responsibility, too. If people get sick and die because of a dietary supplement, we ought to do something about it. It starts with registration, simple registration. So the food and drug administration knows what's out there."

Blunt, Grassley, Reid (UC Request)

FDA User Fee Reauthorization bill (S. 3187)

May 23 2012 12:40 PM

Senator Blunt: (12:04 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "I'm supportive of the bill that's come out of the help committee to reauthorize user fees for the Food and Drug Administration. We've tried these user fees in the past. They would be reauthorized for prescription drugs, for medical devices. This seems to be a way to help get these items to the consumer faster, to get them through the approval process more quickly, to allow the companies that develop new medical devices or new prescription drugs to recoup their investment in a quicker way, which also allows them to get to the generic market in a quicker way. I think it serves the purposes of health care well and the community that pays the user fees appears to be in support of their continued use, and I am, too. This adds generics for faster verification of generics and it adds a product called biosimilars to the process where fees would be paid and for all of the same reasons it seems that those fees would also make sense for health care and make sense for health care costs. It allows, again, recouping the investment that's made to develop a new drug quicker. That allows it to go to the generic market quicker. I hope this bill can be approved and be approved even before we leave here for the memorial day work period ... I know one of the areas where we're likely to have amendments would be the debate that we've had over and over again on whether or not prescription drugs can be imported into the country p. P and if that amendment is there, I'll have the same position that I've had in the past as long as someone from our government is willing to say that those prescription drugs are what they appear to be. They've been out of the chain of custody, out of the closed pharmaceutical chain supply system that we have believed is always essential to make sure that the drug you're getting is the drug you're getting. The vitamins that Mr. Durbin talked about earlier, I don't know what's in that capsule unless someone has verified what's purported to be in there is real in there. There are all kinds of examples of that all over the world. We want to be sure that American consumers, they're taking a health product, take that product for good cause. The senator from Illinois even mention that he had thought dietary supplements should be filed with the FDA. Well certainly anyone who would think that should think that prescription medicines, pharmaceutical medicines, that someone would need to verify that that medicine is the medicine you believe it to be because you're not taking it some additional dietary ran. You're taking it because your doctor has told you that's a medicine you need to take. That means there must be some health care reason you're taking it and you need to be certain, in my view, that that health care reason is being met."
  • Spoke on the $20 million Obamacare PR campaign.
    • SUMMARY "I read this week that at a time of trillion-dollar deficits, the Department of Health and Human Services announced that it would go forward with a provision in the Affordable Health Care Act that apparently allows the department to spend $20 million of taxpayer money to launch a PR campaign to convince Americans that they should like the Affordable Health Care Act better than they apparently do. $20 million at a time when we have these trillion-dollar deficits, at a time when in fact the health care law has even been challenged in court and we'll find out within the next month what the court thinks about the potential constitutionality of the health care law. Now, this is, I will say, the same Department of Health and Human Services that during the health care debate told insurance companies that they could not tell their customers they could not communicate with their customers in any way that suggested any possible negative impact that this law might create. I thought that was an incredible position for the government to take at the time, so maybe I shouldn't be surprised that now the government would spend $20 million on a health care on a PR contract to convince people that they should like this health care plan better than they do. In fact, poll after poll shows that the more that people know about the health care proposal, the less they like it. Two years after its passage, opposition to the health care larks I believe, is stronger than it's ever been. A recent Rasmussen poll said that 56% of voters favor a repeal of the Affordable Health Care Act believing that it is neither all that affordable or all that good for health care. According to a USA Today/Gallup poll, 72% think in this bill will make things worse or won't help their health care situation. It's clear in my view that this is a bad law that we can't afford, bad for families. It's bad for seniors, bad for job creators, and I guess maybe that's why we're going to spend $20 million to convince me and others that it's not nearly as bad as we think it is."

Senator Grassley: (12:27 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "Today we will be considering, and are considering a vital piece of legislation that not only includes all four user fee agreements, but also includes policy proposals to improve food and drug administration review and approval of medical products, particularly in the pharmaceutical supply chain. In 2008, when Senator Kennedy was still in the Senate, he and I introduced the Drug and Device Accountability Act. This legislation was largely in response to the stiff oversight I conducted on the Food and Drug Administration. During these investigations, I identified serious problems including delays informing the public of emergency safety problems and lack of informed authority. Based on these findings, the Kennedy-Grassley legislation included provisions to ensure the safety of drugs, including foreign manufactured drugs. It would have expanded FDA's authority to inspect foreign manufacturers and importers on a risk-based schedule. It would have required all manufacturers to register with the agency so they can properly identify the number of manufacturers and where they're located. This would have also ensured that when a crisis occurred, we can quickly locate the questionable facilities. And it would have increased civil and criminal penalties with respect to the violations. Unfortunately, Senator Kennedy and I never had an opportunity to debate this legislation, let alone cast a vote on it. However, roughly a year ago Senator Harkin and Enzi forged a bipartisan working group to address these challenges. The group has worked tirelessly to produce a bipartisan bill that modernizes FDA's authority to ensure that drug products coming in to the United States are safe for American patients. This bill incorporates many provisions introduced in the Drug and Device Accountability Act Senator Kennedy and I introduced. It increases penalties for knowingly and intentionally counterfeiting drug products. It requires electronic submission of certain key information by a drug importer as a condition for grant entry. I would like to have seen additional enforcement tools included in the legislation. For example, granting FDA the authority to destroy unsafe products that are refused admission into our country. That would enhance FDA's ability to protect the public from tainted products. Likewise, I think FDA should have been granted subpoena authority and have it on a par with other federal law enforcement authorities because currently, FDA lacks subpoena authority and has to go through the department of justice, which is time-consuming and burdensome. Ultimately, this legislation is a needed step in the right direction towards securing our supply chain."

Senator Reid: (12:36)
  • Unanimous Consent --
    • 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 (without objection).
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "We're close to a way to move forward on the FDA bill. I do say this, however. We have on this side, we've cleared everything. So the disputes now are with the Republicans on a Republican amendment. We are willing to do whatever's necessary on that amendment. So I hope we can get this worked out. As we've heard all of the speeches about this important bill, it really is important. As I indicated today talking about some of the shortages we've had in Nevada where people die as a result of not having the medicine. And we're nearing a time where we can't prolong this anymore. This legislation is necessary because the bill, the information that we have in this bill, everything we need expires at the end of this month."

Klobuchar, Whitehouse, Udall-NM, Merkley, Shaheen, Sanders

FDA User Fee Reauthorization bill (S. 3187)

May 23 2012 2:04 PM

Senator Klobuchar: (12:38 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "I introduced a bipartisan bill with Republican Richard Burr of North Carolina and Democrat Michael Bennet of Colorado that would significantly improve the regulatory process. It would tackle three important things related to the approval process. First it would increase efficiency by strengthening the agency's lead burdensome principles which have been continuously overlooked by FDA's reviewers. The average time to approve a 510 application has increased 43% from 2003 to 2007 time period to 2010. This is simply unacceptable. Second it would improve conflict of interest provisions making it easier for the FDA to recruit top line experts to take part in the review process. This would allow the FDA to protect the integrity of the review from undue conflicts of interest but also take advantage of available expertise. Third, it would require the FDA to use an independent consulting organization to assess the management processes at the center on devices. This would encourage the agency to consider the impact of its decisions on innovation while also considering the balance between the risk and the benefits of the new devices. I'm thankful that in working with Senator Harkin and Senator Enzi we were able to include these improvements in this legislation. Equally as important as improving the regulatory process at the FDA, the legislation also includes my provision on drug shortages ... People have died because drugs were not available. The fact that physicians and nurses are spending hours and hours of time looking for pharmaceuticals is an outrage. We know there are many reasons for this. We are glad that the industry was willing to work with us to come up with at least a short-term patch here where the FDA will be alerted as a result of the provisions in this bill when the pharmaceutical companies believe that there's going to be a shortage. Right now they're only required to do it for orphan drugs. Now they're going to be required to do it for all drugs. And these can be shortages as a result of raw materials that aren't there, shortages as a result of mergers in the pharmaceutical industry, shortages as a result of decisions not to produce a drug because it may not be as profitable, shortages because of all kind of things that could happen in the course of commerce. The key point is here, when the FDA finds about things early, they have been able to avert drug crises. They find another drug abroad that's safe. They get the drugs in. They've done it over 200 times in two years. This will simply give them more tools to be able to avert what is in an escalating crisis in this country where we're seeing more and more short shortages of drugs on a weekly basis."

Senator Whitehouse: (12:58 PM)
  • Spoke on campaign finance reform.
    • SUMMARY "The Supreme Court's 2010 decision in Citizens United v. the Federal Elections Commission opened the floodgates to unlimited corporate and special interest money in our elections, bringing about an era in which corporations and other wealthy interests can drown out the voices of individual voters in our political system. Worse still, much of this spending is anonymous, so we don't even know who is spending millions to influence our elections ... Our campaign finance system is broken. Action is required to fix it. Americans of all political stripes are disgusted by the influence of unlimited anonymous corporate cash in our elections, and disgusted by campaigns that succeed or fail, depending on how many billionaires the candidates have in their pockets. More and more people feel that their government responds only to wealthy and corporate interests as they see their jobs disappear and their wages stagnate and bailouts and special deals for the big guys, they lose evermore faith that their elected officials are actually listening to them. And over the deafening roar of secret special interest spending, they get harder and harder to listen to. This growing consensus across the political spectrum was reflected in the brief that Senator John McCain and I filed last week in American Traditional Partnership versus Bullock. In that brief, we urged the court to reconsider the flawed central premise of its decision in Citizens United. The proposition that independent expenditures do not lead to corruption or the appearance of corruption. As the statistics about anonymous spending and public perception that I cited make clear, this premise is discredited. I'm proud to have worked on the brief with Senator McCain, who has long been a leader in Congress on campaign finance issues, and I hope that our partnership will mark the beginning of greater cooperation across party lines on this issue of vital importance to the integrity of our great American democracy. I also hope that the Supreme Court will take heed of the nearly universal opinion that the system that they've unleashed in Citizens United puts our very democracy in jeopardy. Until the court acts or until we enact a constitutional amendment to repair what they have done, we are constitutional amendment to repair what they have done, we are left with one weapon in the fight against the overwhelming tidal wave of money from special interests, and that is disclosure. At least make them fess up to who they are. That's why I stand here today in support of the Disclose Act of 2012 ... This legislation will shine a bright light on these powerful interests and their spending."

Senator Udall-NM: (1:15 PM)
  • Spoke on campaign finance reform.
    • SUMMARY "I join my colleagues today to highlight what I consider a significant problem in our country, the unprecedented flow of money into our democratic elections. Over the past several months, a group of us have been working together to address this problem. We have asked the FEC, the IRS and the FCC to take actions that would help curb the impact of money on our elections. Led by Senator Whitehouse, we have introduced the Disclose Act. This bill would shine a light into the dark corners of the campaign finance system. And Senator Bennet and I have introduced a constitutional amendment which currently has 22 cosponsors to overturn the disastrous judicial opinions that have led to the broken system we have today. In January, 2010, the Supreme Court issued its opinion in Citizens United versus FEC, two months later, the Speech Now versus FEC case was decided. These two cases gave rise to the SuperPACs. Millions of dollars now bore into negative and misleading campaign ads and often without disclosing the true source of the donations. But our campaign finance system was hardly a model of democracy before these disastrous opinions. The Citizens United and Speech Now decisions renewed our concerns about campaign finance, but the court laid the groundwork many years ago. We can go all the way back to 1976. That year the court held in Buckley versus Valeo that restricting independent campaign expenditures violates the first amendment right to free speech. In effect, that money and speech are the same thing. The damage is clear. Elections become more about the quantity of the cash and less about the quality of ideas. More about the special interests and less about public service. We cannot truly fix this broken system until we undo the flawed premise that spending money on elections is the same thing as exercising free speech. That only can be achieved in two ways. The court could overturn Buckley and subsequent decisions based on it, something the current court seems highly unlikely to do, or we amend the constitution to not only overturn the previous bad court decisions but also to prevent future ones. Until then, we will fall short of the real reform that is needed."

Senator Whitehouse: (1:26 PM)
  • Spoke on campaign finance reform.
    • SUMMARY "The Supreme Court in the Citizens United decision was in a difficult situation. No member of the court had ever run for office, run in an election. It may be the first time in the history of the country that no member of the Supreme Court had ever run for office, so it's a Supreme Court that has as a corporate group was uniquely inexperienced in the actual ins and outs of elections and politics. Moreover, the way that the Citizens United case came up to the court, the question that they ended up deciding was one that they asked for additional briefing on. It's a question that in many respects the court raised itself. And the court did not have the benefit of the usual process of a case beginning in the trial court and amassing a record of evidence of testimony, of witnesses, of review of all of that at the appellate court level and then final review by the Supreme Court, so they did something very unusual. They actually made a finding of fact. Now, a finding of fact is not something that Supreme Court are supposed to do in the first instance. That's the job of the trial judge and the jury if it's a jury trial. Those are the fact finders in our system of law. And certainly, a Supreme Court that has an appellate tribunal between it and the trial branch as our federal system does, it's very unusual for them to be making findings of fact. They made findings of fact in this case, and unfortunately because they had no experience in elections, any of them, because they had no record, they made a finding of fact that was not in fact a fact. They made a finding of a false fact. And the mistake that they made was to determine that no amount of corporate spending in an election could create either the risk or the appearance of corruption. And I think the practical facts of that are pretty easy to rebut. They stood that finding of fact, that premise on two subordinate premises, and we rebut both of them in the brief."

Senator Shaheen: (1:30 PM)
  • Spoke on campaign finance reform.
    • SUMMARY "This excessive spending has really been a problem for the last two years since the Supreme Court's decision in Citizens United. Because their decision has allowed for the formation of what's been called SuperPACs which are really organizations that can spend unlimited amounts of money without ever having to disclose where that money came from so the public doesn't know who's spending the money. Doesn't know how that money - the decisions about spending are being made. And now we're actually in the middle of the first presidential election since that Supreme Court decision, and we can really see the dramatic impact of that spending. There are now more than 500 SuperPACs registered with the federal election commission. They're permitted to raise and spend unlimited amounts of secret money to fund political advertisements. And, again, I want to emphasize the fact that we don't know where this money's coming from. We don't know if it's coming from corporations, we've heard a lot of stories, seen a loft stories that there are very wealthy individuals who are putting up money for these SuperPACs. But the amount of money that has been spent by these SuperPACs so far this election cycle alone has just topped $100 million. And nearly $80 million of that came from just five groups. So I think as we're looking at this money being spent, it's important for all of to us reflect on our national priorities. What does it say about our country that we allow this kind of deluge of money to flood our electoral process? Who is really being represented? Are average voters in America being represented in this process? The Disclose Act will make sure that voters know who is really paying for all of these campaign ads, it doesn't eliminate SuperPACs but it's a very important step in the right direction."

Senator Merkley: (1:38 PM)
  • Spoke on campaign finance reform.
    • SUMMARY "If any three words were to summarize the heart of the Constitution, it would be those three words, "we the people" and we have a Supreme Court decision, Citizens United, that essentially unleashes a flood of special interest money. Is that fundamentally in conflict with the notion of we the people?"

Senator Whitehouse: (1:39 PM)
  • Responded.
    • SUMMARY "I believe it is. We operate in a modern world in which we are bombarded by media, and the average person, the average, ordinary member of the people does not have much access to that media, cannot get his or her voice much heard in that bombardment. But if you have enormous amounts of money, either because you're a corporation with a vast treasury or because you're a billionaire, you can take a big chunk of that media and you can use it to broadcast your view. And that will drown out other voices that don't have that power. So it really does attack the basic premise of we the people."

Senator Merkley: (1:38 PM)
  • Responded.
    • SUMMARY "So Citizens United goes right against the very heart of our constitution. How is it possible that the Supreme Court found in this 5-4 decision that this has no corrupting impact on our electoral process?"

Senator Whitehouse: (1:40 PM)
  • Responded.
    • SUMMARY "I think three things went wrong. First of all, this is a Supreme Court that unlike most if not all other Supreme Courts has no political experience, none has ever run for office so they don't have the practical sense of how politics engages in an election. Second, because they sort of invented this question, they didn't have a record where people who did know about politics and did know about elections and did know about corruption could assemble a record they could then learn from. So they were operating in a much greater vacuum than the Supreme Court usually does and finally, they made two presumptions that supported it. One was that the SuperPACs and all these big entities would be independent from the candidates. As we've seen, that was a false assumption. That was a wrong premise. Now the SuperPACs are connected to a candidate, they have one purpose, to get the candidate elected, they have funds raised by the candidate, they share staff with the candidate, they share consultants with the candidate, they use the same footage as the candidate. The idea that they are independent is really been made preposterous by the facts and the second was that there would be disclosure. So the public could at least evaluate, okay, this is the coal mining industry coming after somebody who is fighting for climate change, we get that, we can make an appropriate judgment about that use of corporate money to attack a candidate. They were wrong about that as well and that's why we're here on Disclose 2.0."

Senator Merkley: (1:44 PM)
  • Responded.
    • SUMMARY "It is my hope that the members of the Supreme Court will stand back and realize that they're finding of facts was wrong, their finding of fact that there was no corruption from this flood of money was wrong, their argument that it didn't attack the heart of the constitution was wrong, the fact that they didn't consider the . that this type of flood of money creates was an error and that they'll change their decision. But we can't be sure that this activist, right-wing court will consider the facts and reach a finding consistent with the Constitution, the very heart of our Constitution, we can't be sure of that so we have to do what we can in this chamber and that's the Disclose Act. The Disclose Act that says, at least at a minimum, this huge flood of money will be identified by the donor and it will be identified promptly so the citizens will be able to find out where it came from. And that the advertisements that are purchased by this money will have debt claimers, they will say who the major contributors are so that citizens can see it in real time. So when the group says that we are the group America for green forests and blue skies and it's really by a very powerful group that is against blue skies and against green forests, you can find out who it is. That's the heart of this. Citizens United is a dagger poised at the heart of the American Constitution. We must reverse it and we must use every tool at our disposal to make that happen."

Senator Sanders: (1:50 PM)
  • Spoke on campaign finance reform.
    • SUMMARY "I come to the floor this afternoon to express my profound disgust with the current state of our campaign finance Supreme Court and to call for more disclosure until we can finally overturn Citizens United. And I know the presiding officer from New Mexico has a very good constitutional amendment to do just that. I have one. There are other good amendments. Long term, no question in my mind we need to overturn Citizens United. In my view, it will go down in history as one of the worst decisions ever to come from the Supreme Court by a 5-4 decision. Five members of the court came to the bizarre conclusion that corporations should be treated as if they were people and that they have a first amendment right to spend as much money as they want in elections even though corporations can't vote. So the average American, with pride, on election day goes out and votes. Studies the issues, votes for the candidate of his or her choice. There are many people in this country who make campaign contributions. Maybe they'll contribute $25, maybe they'll contribute $50. Maybe if they have a lot of money, they may contribute $1,000 or $2,000. But what Citizens United is saying is that a small number of people who run large multinational corporations can spend as much as they want on campaigns. And if that is what American democracy is supposed to be about, you surely could have fooled me and I think many Americans who put their lives on the line to defend American democracy. What American democracy is one person, one vote. We're all in this together. You may be rich and you may be poor, but under our constitution you have one vote. And this country has had to go through a very rocky process to ensure one person, one vote."

Roberts, Schumer, Reid, Vitter

FDA User Fee Reauthorization bill

May 23 2012 2:44 PM

Senator Roberts: (2:01 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "The legislation also includes the Generating Antibiotic Incentives Act This title contains provisions that aim to boost development of products to treat serious and life-threatening infections, something that is a growing problem in all of our hospitals. It provides meaningful market incentives and reduces regulatory burdens. Glory be. Here's a bill that actually reduces regulations, to encourage development of new antibiotics. Why? Well, the antibiotic pipeline has slowed to an alarming rate. According to the FDA, the approval of such drugs has decreased by 70% since the mid-1980's. This is unacceptable. The development of just one new antibiotic can take upwards of ten years. We must act now to avoid a potential health care crisis When a problem exists in an urban set, simply multiply that ten times and that's what we have in our rural areas. This is a crisis. As difficult as it is to hear from my hospital administrators and pharmacists in Kansas about the difficulties they are having in getting drugs to fill prescriptions, nothing compares to the patients who can't get their drugs, who can't get their treatment, who are scared about their future and they can't get their lifesaving medication due to shortages. This is unacceptable. This is why I join the together with number of my colleagues to work together to see if we could come to a bipartisan consensus on a way to alleviate at least some of the burden that drug shortages do create. The legislation now requires reporting on drug shortages but it does provide some transparency and accountability in the hope that we can get to the root cause of this problem. Now, not everything in this legislation is what I would have done if I had my choice. That's obviously the case with every senator on every major bill that we must make decisions on. But I am certain that many of my colleagues on the HELP Committee are thinking the same thing, but I think we are pleased that we were able to come to a bipartisan consensus on this legislation, and in addressing many of the issues that are affecting Kansans and the rest of Americans."

Senator Schumer: (2:07 PM)
  • Spoke on campaign finance.
    • SUMMARY "It is no surprise, given mounting concern about the corrupting effect of unlimited and often anonymous campaign spending on our democracy, that so much individuals and groups have filed amicus briefs in this case, including Senators Whitehouse and McCain, several House Democrats, and dozens of others urging the court to uphold Montana's 100--year-old law. We cannot sit idly buy and watch our democracy go for sale to the highest bidders. Full disclosure, the kind that the Disclose Act of 2012 requires, is so necessary to shed light on which groups and individuals are funding or elections. To keep some modicum of faith that the voters at least know what's going on. In 2010, the original Disclose Act passed the House, had widespread support from the Senate and from the President but failed to gain cloture by one vote because not one Republican was willing to step across the aisle and do what clearly the American people regard is the right thing. Well, now there's no excuse. We've removed the original provisions that my republican colleagues most objected to. All that remains is disclosure. The time to act is now while America's richest billionaires to keep contributing millions of dollars to SuperPACs and 501-c's, America cannot afford to be kept in the dark any longer."

Senator Reid: (2:20 PM)
  • Spoke on the National Flood Insurance Program.
    • SUMMARY "I've had conversations over the last few days, in fact a longer period of time than that, with Senators Vitter and Senator Coburn, Senator Johnson, Senator Shelby and others on flood insurance. Like a lot of things that happen, this has become critical that we do something on flood insurance. It affects almost six million people, and we need to get something done on a more permanent basis. There's been a general agreement - we don't have it in writing yet but I want to make sure the record is clear here on the floor what my intention is. Is that we would have a 60-day short-term extension, and that extension there would be language for the duration of 60 days that would include in that the second-home subject that's part of the underlying bill that Senator Coburn has focused on. That would be for 60 days. Then I would be happy to make a statement here on the floor today during the next work period that we will move to that bill, the Flood Insurance bill, so that we would have the opportunity to make it permanent. It's very important we do that, with the economy being such as it is, we can't in this area, and probably others, but this one, we can't have short-term extensions that doesn't allow people to do what they need to do. 40,000 homes a day go through a process where they have to have flood insurance. If there is no flood insurance, that's 40,000 loans every day that will not be approved. So, Senators Johnson and Shelby have done good work to narrow down the list of amendments that we would have to consider when the senate takes up this long-term Flood Insurance bill. It's my understanding there are a dozen or so amendments, six, eight on each side. I hope we can do that. If we can't do that, we're going to have to go to the bill anyway."

Senator Vitter: (2:23 PM)
  • Responded.
    • SUMMARY "That there's been great work and great progress in narrowing the field of relevant amendments. I certainly hope that leads to a limited and reasonable number of amendment votes, as he does, on the floor. I understand what he said about if that becomes unwieldy, we'll just proceed with the bill as is. But certainly it's my expectation - I'll continue to work on that amendment list so that we have a reasonable opportunity for relevant amendments."

Reid (UC Request)

FDA User Fee Reauthorization bill (S. 3187)

May 23 2012 3:00 PM

Senator Reid: (2:24 PM)
  • Unanimous Consent --
    • The Motion to Proceed to S. 3187, the FDA User Fee Reauthorization bill, is Agreed to.
    • The Harkin-Enzi substitute amendment #2122 is Agreed to.
    • The following amendments are in order to S. 3187, the FDA User Fee Reauthorization bill:
      1. Bingaman amendment #2111 (60 votes required);
      2. McCain amendment #2107 (60 votes required);
      3. Sanders amendment #2109 (60 votes required);
      4. Murkowski amendment #2108 (60 votes required);
      5. Cardin amendment #2125;
      6. Cardin amendment #2141;
      7. Grassley amendment #2121;
      8. Grassley amendment #2129;
      9. Manchin amendment #2151, as modified;
      10. Portman amendment #2146, as modified;
      11. Portman amendment #2145, as modified;
      12. Reed amendment #2126;
      13. Coburn amendment #2132;
      14. Coburn amendment #2131;
      15. Durbin amendment #2127;
      16. Paul amendment #2143; and
      17. Burr amendment #2130.
    • At 2:00 PM tomorrow, the Senate will conduct a series of ROLL CALL VOTES on the amendments listed above (all votes after the first vote will be 10 minute votes). There will be no second-degree amendments in order prior to the votes or relation there to. There will be no points of order other than budget points of order and applicable motions to waive or motions to table. There will be up to 30 minutes of debate on each of the amendments, with the exception of McCain amendment #2107, which will have 2 hours of debate, and there will be 1 hour of debate on the bill, with all time equally divided. Upon disposition of the amendments, the Senate will conduct a ROLL CALL VOTE on 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 proceed to the consideration of S. 2343, the Student Loan bill and conduct 2 ROLL CALL VOTES on:
      1. McConnell Student Loan bill amendment (S. 2366) (60 votes required); and
      2. S. 2343, the Student Loan bill (60 votes required).
    • 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.

Hatch, Harkin, Durbin, Enzi, Sanders, Enzi

FDA User Fee Reauthorization bill (S. 3187)

May 23 2012 3:42 PM

Senator Hatch: (2:30 PM)
  • Spoke on Durbin amendment #2127.
    • SUMMARY "Senator Durbin, has filed an amendment to the current bill that would undo that well-balanced approach .. I strongly oppose his amendment. It would require facilities engaged in the manufacturing, processing, packaging and holding of dietary supplements to register with the FDA provided with a list of all ingredients as well as a copy of the labeling for each dietary supplement product. Additionally, the facilities must also register with respect to new, reformulated and discontinued dietary supplement products. While I appreciate my colleague's commitment, his amendment is based on the misguided presumption that the current regulatory framework for dietary supplements is flawed and that the FDA lacks authority to regulate these products. This is simply not the case. Previous FDA commissioners, . have all agreed that DSHEA provides a sufficient level of oversight for this industry. Under DSHEA, Congress set out a legal definition of what could be marketed as a dietary supplement and safety standards that products have to meet. It allowed the FDA to develop good manufacturing practice standards and clarified what types of claims could be made. And it provided the Secretary of Health and Human Services with the authority to impose an immediate ban on any dietary settlement that poses an imminent risk to public health. DSHEA already provides the secretary with enforcement tools of seizure, injunction or criminal prosecution for ingredients that pose an unreasonable risk of illness or injury, are poisonous or deleterious, contain unapproved drugs or food additives or fail to meet good manufacturing practice standards. Furthermore, under the dietary supplement and nonprescription drug consumer protection act, a manufacturer, packer or distributor whose name appears on the label is required to report a serious adverse event related to the use of a supplement within 15 business days to HHS, submit any related medical information received within one year of the initial report within 15 business days, maintain records related to each report for six years and permit inspection of such records. To me, that sounds like a whole lot of regulation."

Senator Harkin: (2:46 PM)
  • Responded.
    • SUMMARY "We've worked together to make sure that the labels are good on all of these things, that people know what's in them, that FDA has the authority as the senator said. The FDA every commissioner said they have the authority to keep dangerous products off the shelves and removal themselves - remove them from the shelves. They have all that authority. So, you know, these cases like Senator Durbin brought up, they're sad, very sad and you wish it weren't so. But I don't think that that lends itself then to overturning what has been working now for 18 years - no, 17 going on 18 years. Working well for the American people. So I just join with the senator from Utah. I would hope that the amendment might not come up. But if it does, it does. And I'm sure there will be some debate on it. But I would join with the senator from Utah in urging all members of the Senate to vote that amendment down if the amendment does come up, I would move to table that amendment, by say to my friend from Utah, and hopefully that we can approach this in a much more judicious, responsible, thinking manner."

Senator Durbin: (2:55 PM)
  • Called up Durbin amendment #2127.
  • Spoke on Durbin amendment #2127.
    • SUMMARY "The Food and Drug Administration is an agency which takes a look at what we buy and what we consume. And it has an important responsibility. When it comes to certain things like prescription drugs, they test them. Maybe the pharmaceutical company actually does the testing but the FDA monitors to make sure that what is given to you by your doctor is safe, won't kill you, and effective, does what it says it's going to do. Same thing true for over-the-counter drugs. The Food and Drug Administration has that responsibility. And when it comes to the ingredients, the dosage, those sorts of things are established through the food and drug administration based on disclosures by the companies, testing, experience, it's all there. But there's another world out there, completely different world called dietary supplements which includes the vitamin pill I took this morning as did the Chairman. That is a much different world. It is a world with less disclosure, less transparency, and far less regulation. In fact, in fact, there is no requirement in the law today, none, that the people who sell us dietary supplements have to register with the food and drug administration the name of their product, the ingredients it contains, and a copy of the label. That's what my amendment says. We don't require any testing by dietary supplement companies. We don't require any assertions of safety. Just simply that they register with the FDA that they're selling in America."

Senator Enzi: (3:03 PM)
  • Responded.
    • SUMMARY "I appreciate the concern and the interest and the effort that the senator from Illinois has gone to on this bill, but in looking at it, there's still a couple of steps that are missing if this were to become law. Yes, it would provide a lot of information at the FDA it would, in fact, flood them with information. And I think it would food them with more information than they could possibly process. But that part doesn't even bother me. What bothers me is, how do you get that information to the consumer? It's the consumer that needs to know what they're drinking, eating, everything else and that's why we provided labeling on a lot of things. But even the things that we already provide labeling on, the consumer doesn't necessarily pay a attention to it. And probably the people that need to pay the most attention to it don't pay any attention to it. And so just making this information available to the FDA doesn't get it to the point where the consumer can know. And, of course, any time we start talking in this area, people get really worried about the amount of regulation that we put on things that they consider to be very important to them and do no harm. So I think the right way to address this issue would for the help committee to hold hearings and to work together, weaves done on this bill, to find common ground - as we've done on this bill, to find common ground on the policy. And when we have common ground, like we have on this FDA bill, then we can get something done. I think this is a bit premature so i would hope people would not support this amendment at this time."

Senator Harkin: (3:04 PM)
  • Responded.
    • SUMMARY "I want to make it very clear supplement labels must disclose their ingredients. Must disclose their ingredients. Even when a product is reformulated, if the supplement contains new ingredients, then the label must reflect that change. These were all added, that we added for consumer protection. Now, again, it's not as though FDA doesn't know what's out there. Under current law, supplement manufacturers have to biannually register their stuff. There's a biannual registration requirement right now so that - really, the concern is that the agency just - FDA just doesn't have the resources to do anything. I've tried - the senator knows, he's on the appropriations committee - to get more funds for the FDA to do this but we haven't been able to do it, to get the funds necessary for the FDA to even do what jobs they're supposed to do now. And I repeat, for emphasis sake, every FDA commissioner, that was reported by democratic presidents or republican presidents, as said that gives them adequate authority to keep dangerous products off the shelves. So the authority is already there. What FDA needs is the resources. That's money and that's appropriations. And, quite frankly, I don't see that happening this year, that we're going to get anything more. We're just going to give them more of a burden to do and I think it's going to give a false sense of security to people because FDA simply won't be able to do this. Lastly, as the senator did say, we do have a voluntary registration program of ingredients and stuff with the office of dietary supplements at the national institute of health so that's already there. That coupled with the biannual reporting requirements plus the fact that every dietary supplement has to have the ingredients listed on the label. So there's plenty of consumer protections out there."

Senator Durbin: (3:08 PM)
  • Responded.
    • SUMMARY "This is an industry which I've been watching for a long, long time for a variety of reasons, and I would say the argument that Senator Enzi made that merely disclosing the label ingredients and name of the product to the FDA doesn't get the information to the consumer really argues for a much bigger amendment than I'm offering. It argues for a web site and access and so forth, and I understand that going in. I agree with is that right Harkin. It's an overreach in this time of budgetary problems. I wish we could do it. I think we should. I think we have an obligation to. But I didn't put it in here because I knew the first thing they'd say was, we can't afford it. We went to the FDA and said do you want this information? They said, not only do we want it, we've already publicly stated we want it in reply to the GAO report. And we said, can you handle it if we send you the basic information of the products presently being sold. They said, yes. Now, you can go further and say more can be done. That calls for a bigger role of government than even this amendment suggests, but how do you argue when the institute of medicine tells us there are a thousand new products a year coming in called dietary supplements on the shelves all across America, in stores and drugstores, where families and children are walking in buying them, how do you argue that we don't want to know you're here, we don't want your Chinese product that just made it to the shelf in Springfield, Illinois, to register with the FDA before you do business here? How do you make that argument? Wouldn't you assume as a consumer, a family member, when you walk in the store that somebody, somewhere knows this company exists, that this product exists? Right now they don't. The only disclosure to the government is voluntary. And as I said, about one out of ten products, companies, volunteer the information. That, to me, is not the way to protect consumers."

Senator Sanders: (3:16 PM)
  • Called up Sanders amendment #2109.
  • Spoke on Sanders amendment #2109.
    • SUMMARY "When we talk about prescription drugs, it's important to understand that in our country we pay, by far, the highest prices in the world for prescription drugs. That's simple - that's simply the reality. And that causes enormous problems because millions of our people go to the doctor, the doctor writes a prescription, and then the person can't afford to fill that prescription. So that's pretty crazy because doctors are doing their diagnosis, telling the patients what they need, the patients can't afford to pay for the drugs because they have the highest prices in the world in this country. So, this is an issue that we have got to deal with. Now, there are a number of reasons why prices in this country are higher than in Canada, Europe, Scandinavia, and certainly one of them is that we are the only major country on earth that doesn't have a national health care program so that the government can negotiate prices with the drug companies. So what happens in this country is the drug companies simply charge us what the market will bear, any price they can come up with by which they can make money, and the end result is that we pay - in 2009, prices in this country were 85% higher than Canada, 150% higher than France, Italy, Sweden, and Switzerland and so forth and so on. But the reason the drug prices are high in this country is not just that we don't have a national health care program, it's because of the enormous amount of fraud that takes place within the pharmaceutical industry. In fact, every single year the major drug companies are ripping off the American people to the tune of billions of dollars a year because of fraudulent practices The amendment that I am offering would send a strong and clear message to the drug industry. Illegal behavior will not be rewarded with continued government-granted monopolies. There are some things - patient safety, the devotion of scarce public resources to provide health care to needy patients - that are more important than drug company profits. This amendment is designed to effectively deter pharmaceutical fraud by making government-granted monopolies contingent on good corporate behavior. And I think that is the least that we can do. Our amendment, this amendment would penalize any instance of pharmaceutical fraud resulting in a civil or criminal judgment or a settlement with an acknowledgement of fault by revoking any applicable data or marketing exclusivity for the particular drug or product involved in the fraud, giving pharmaceutical companies another factor to consider when weighing whether or not to violate the law in their sales or billing practices. So, if a company violated federal or state law by inflating the price of a drug in Medicare or Medicaid billing or illegally marketing a medication, under my amendment that company would lose the remainder of any exclusivity period for that medication. Companies would be required to self-report, qualifying violations to the FDA within 30 days."

Senator Enzi: (3:32 PM)
  • Responded.
    • SUMMARY "I have to oppose the amendment number 2109 because of some of the unintended consequences it will have. This amendment would require drug companies to forfeit exclusivity for certain violations of the federal drug and cosmetic act and other laws. Exclusivity means exclusive market rights granted by the food and drug administration upon approval of a drug to encourage people to develop drugs. It may or may not run concurrently with the patent. Exclusivity is a very important type of intellectual property protection. Without it innovators can't predictably obtain returns on their drug development investments. The stated purpose of the amendment is to combat health-related fraud. The premise is that companies know their profits are at risk they'll be discouraged from engaging in fraudulent activity. But this amendment is counter productive. It will make it more costly law enforcement to fight fraud."

Mikulski, Harkin, Coburn, Grassley, Burr

FDA User Fee Reauthorization bill (S. 3179)

May 23 2012 4:27 PM

Senator Mikulski: (3:39 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "The worst thing you want to hear is that there is a shortage of that drug to take care of that child not because it hasn't been developed, not because there hasn't been a scientific breakthrough. But because there's been a manufacturing problem or because the company stopped making the drug when it was no longer profitable. That is inexcusable, and the bill before us does something about it I want to make a few points, that in 2007 we had more than in 2011 we had more than 250 drug shortages, incidents. That's 250 drugs that were on shortage. And half of the drugs experience a shortage that goes in to multiple times. This drug shortage threatens public health by preventing patients and physicians from accesses needed medications. It forces doctors to often delay medical he procedures, use alternative products that carry on one its side effects to rely on foreign versions of drugs that might not have been reviewed by FDA or it sends their very able pharmacist in their institutions to spend endless hours and hour on the phone to be able to come up with the needed drug. As I said, this was brought to my attention by letters, some famous constituents, meaning well-known, in our community with great health insurance, who had a child, who had leukemia and then found the drug was in short supply. We heard from doctors who were forced to delay. Hospitals scrambling to manage these shortages. Pharmacists trying to track down needed treatments. Even then we heard about gouging and we heard about a gray market. The gouging was for pumping up the price where there is a shortage and then for gray market where you can buy these drugs but might not be the drug you wanted or might have been on somebody's shelf a long time and were flawed and even dangerous, or they hadn't been refrigerated. I could go through one horror story after another. But, I wanted to bring this to the attention of the full Senate because as we work on this excellent bipartisan bill on user fees, what we also have is a way for dealing in a very commonsense way with the drug shortage issue."

Senator Harkin: (3:44 PM)
  • Spoke on Sanders amendment #2109.
    • SUMMARY "I just want to join with my colleague, Senator Enzi, in opposition to the sanders amendment. Look, we're all disturbed by a lot of what we're reading in these big settlements. I know the one of Abbott labs where part of the prosecution case was actually that this was part of their business model. And then they had to settle it. So this is all very disturbing. However, that cries out more for perhaps looking at the criminal charges and perhaps strengthening some of those things but not taking away exclusivity. If you do that, a lot of times you could take away exclusivity from somebody that just committed a misdemeanor. A lot of these settlements are misdemeanors where no intent has to be shown. A lot of times if you did this, might penalize someone who had maybe done something wrong in the past, maybe they have new leadership, new company and reformed themselves, but then they still have to lose their exclusivity. You wouldn't want to do that. And third, if you do this, I think Senator Enzi pointed this out very correctly, if there is no reason to settle, then people are going to go to the wall on terms of defending themselves and DOJ doesn't have all that kind of personnel and that time to do that. I think we would then have even a worse situation of people committing fraud because then they would know they would not have any reason to settle whatsoever. Settlement is a good tool to be used by prosecutors to get cases to justice, to make sure that consumers were made whole and to let people know that they are being watched in what they do."

Senator Coburn: (3:46 PM)
  • Spoke on Coburn amendment #2131.
    • SUMMARY "This amendment simply says that what we're going to do for the device in the bill already, we're also going to do for the drug side of the FDA it's about gathering knowledge, both for the FDA and for us, as we help this agency perform very needed things. I read a lot about new science on new drugs as a physician. I want to tell you, the things that are coming into this country are going to be phenomenal in terms of new treatments and new drugs and new capabilities. We need in terms of our competitiveness worldwide but also in terms of how we address these diseases to have the most efficient regulatory agency we can. So all I'm asking is that we treat all of FDA the same in terms of taking a look, how well are they doing, what could they do better, how could they do it better? That report comes to us and the FDA we haven't been through every area of the FDA as members of the Senate, and to have an independent assessment of the drug side as well as the device side will pay huge benefits to the FDA, but mostly it will pay huge benefits to the people of this country in terms of timeliness of drug presentation."
  • Spoke on Coburn amendment #2132.
    • SUMMARY "This is an amendment that comes out of a study of GAO's findings, and GAO did a wonderful job looking at the FDA what we found out, part of it will be covered if, in fact, we do this other study on the management, but what GAO is telling us is there is an irregular pattern of performance review at the FDA about 40% of the people who are involved in the drug and device approval process, part of their evaluation in terms of their performance review has to do with the timeliness of their work product. And it's only a small component but it's yet still a component of it, and what this amendment does is just said FDA, make this a part of your component on the people that are actually reviewed in the review process. Not to try to push them to do it better but to have a management tool with which to evaluate individual employees doing this. The fact that they are already doing this on some and what GAO really said is just a lack of management effectiveness that they haven't installed it everywhere else, all this amendment says is this should be a component, as they evaluate their employees that are associated, as one component of their performance review, how did you do on timeliness? Was your work product timely? The idea behind this is not to push drugs out that shouldn't be approved. It's not to push out devices that shouldn't be approved, but remember the purpose for PDUFA in the first place and MDUFA. The purpose was to find FDA with more money so they would be more timely. The opposition that I hear to this amendment is that we're afraid if this is a component of review that they might review a product and let it go when they shouldn't doesn't make sense since already 40% of the employees that are doing this are being evaluated on this performance standard anyway. So I would raise the question if we're in opposition to this amendment, why in the world haven't we eliminated this as a part of all the review process already if, in fact, it's a concern. And there isn't a concern with it."

Senator Grassley: (3:59 PM)
  • Called up Grassley amendment #2129.
  • Spoke on Grassley amendment #2129.
    • SUMMARY "This amendment before the Senate will impose a deadline by which the NIH will finalize both the proposed and final regulations. Further, two years after the regulation has been in place, the Government Accountability Office will conduct a study on compliance with the regulations and will look at, among other things, whether the applicable clinical trial is conducted domestically, in foreign sites, or in a combination of sites. The rapid increase in trials being run overseas makes it imperative that the government accountability office investigate this matter. Currently, 80% of approved marketing applications for drugs and biological contained data from foreign clinical trials. And the FDA inspected 1.9% of domestic clinical trial sites and .7% of foreign clinical trial sites. We need stronger reporting requirements to make sure we understand what the implications are of this move to having so many trials conducted overseas."
  • Spoke on a Portman amendment.
    • SUMMARY "The amendment offered by Senator Portman that will make dangerous synthetic drugs like K-2 and bath salts schedule one narcotics. I've worked for over a year now to get this legislation passed through the Senate the use of synthetic drugs has grown very rapidly with the number of calls into poison control centers going from as few as 19 in the year 2009 to over 6,000 in the year 2011. The House passed their version of this bill last December on a strong bipartisan vote, but one senator has blocked consideration of this legislation in this chamber up to now. And so I am grateful that we're finally able to have a vote on this issue."
  • Called up Grassley amendment #2121.
  • Spoke on Grassley amendment #2121.
    • SUMMARY "Whistle-blowers point out fraud, waste, and abuse when no one else will, and they do so while risking their professional careers. Whistle-blowers have played a critical role in exposing government failures and retaliation against whistle-blowers should never be tolerated. For this reason, I offered an amendment that expands whistle-blower protection for uniform employees of the public health service. It corrects the anomaly pointed out by the court of federal claims and ensures that officers in the public health service have some baseline whistle-blower protection. It expressly includes the commission corps of the public health service within the protections of the military whistle-blower protection act. This is consistent with the structure of the commissioned corps' functioning like a military organization and matches that - the fact that these officers receive military like benefits and retirement. Unfortunately, this amendment, which I was able to get into this legislation, only covers employees of the public health service. It does not address the commission corps of NOAA because of other senators' concern that is not related to the underlying bill, so I hope to be able to address that remaining gap in whistle-blower protections in the near future so that all employees of the federal government are so covered. All federal employees should feel comfortable expressing their opinions both inside the agency they work on as well as to congress. The inclusion of this language will ensure those opinions receive appropriate protections."

Senator Burr: (4:12 PM)
  • Called up Burr amendment #2130.
  • Spoke on Burr amendment #2130.
    • SUMMARY "The amendment merely states that if a member of congress wants to attend or if they want to have their designated staff attend in their place, that they may. This amendment does not call for members of Congress to participate in the negotiation or certainly staff. The negotiations would still be between the FDA and the industry. But it does not ensure that members of Congress or their staff may be in the room and be informed of the negotiations in real time. Congressional staff may be required to comply with all the applicable confidentiality agreements. The FDA's negotiations with the industry would not be jeopardized. Let me say that again to my colleagues, would not be jeopardized, because the members of congress or the staff would be there just for observation purposes. Let me suggest that if us being in the room jeopardizes the outcome, then we wouldn't be allowed to attend the Supreme Court when some of the most important cases are tried across the street. But members of Congress and their staff regularly sit in and listen to the arguments that are made. The fact is, Congress should not have to wait to be informed of how FDA's public health mission could be strengthened and improved on behalf of patients. By having the option to attend the negotiations, Congress and their staff would gain invaluable insight into how Congress can work with the FDA to ensure that the agency is fulfilling its public health mission on behalf of patients."

Franken, Murkowski, Cardin, Harkin

FDA User Fee Reauthorization bill (S. 3187)

May 23 2012 5:14 PM

Senator Franken: (4:29 PM)
  • Spoke on the Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "Three provisions that I championed are included in this legislation in addition to the base bill, which we negotiated as a committee. The first provision will strengthen the Food and Drug Administration's workforce by removing overly restrictive requirements that keep the FDA from consulting with outside is experts. Again, something that the presiding officer has been a leader on as well. This provision will change the rules that keep the FDA from talking with many outside experts. It will make these rules consistent with those of all other agencies, including the national institutes of health, so as the FDA's experienced workforce retires, the FDA will be able to consult with leading experts when they are reviewing a new technology or a new treatment for a rare disease. This provision will give the FDA the flexibility it needs to consult with experts and keep patients safe and at the end of the day that means more patients will get the healthcare that they need. The second provision will require the FDA to remove new and burdensome guidance on the industry that could triple the number of required new submissions for existing devices. This provision which Senator Burr also championed, from North Carolina, will prevent this guidance from overburdening both the industry and the FDA, which could have caused innovation to come to a screeching halt. And my third provision will help companies develop innovative new products for patients across the country with rare conditions. According to the National Institutes of Health, 25 million Americans struggle with a rare disease, and these patients have to jump hurdle after hurdle to get the care that they need. Many of them will go from doctor to doctor for years before they find a specialist who understands their condition. Now, if you live in rural Minnesota, you may have to drive hundreds of miles to find a doctor who can help you. Even for patients who find the right doctor, too often treatment for their condition doesn't exist or hasn't been approved. So my provision will reward companies that choose to develop treatments for patients with rare diseases. We did this in 2007 to help companies develop devices for children with rare conditions, and we saw the number of devices that companies develop quadruple in a few years. This provision will help get treatments to adult patients with rare conditions in Minnesota and around the country, and really around the world."

Senator Murkowski: (4:39 PM)
  • Spoke on Murkowski amendment #2108.
    • SUMMARY "I want to discuss the amendment that I have filed which would require NOAA to conduct a full environmental assessment and analysis of economic impacts to affected fisheries before the FDA approves any of these genetically engineered fish I am not looking to pull the plug on the FDA I am not looking to insert Congress's judgment into the FDA process. I am asking that when we are talking about basically a new fishery for a modified salmon, I'm asking that the agency that is tasked with our fisheries have some role in what is moving forward."

Senator Cardin: (4:54 PM)
  • Called up Cardin amendment #2125.
  • Called up Cardin amendment #2141.
  • Spoke on Cardin amendment #2125.
    • SUMMARY "Amendment #2125, which deals with safety warnings, particularly as it affects the minority community. Clinical trials don't always represent the diversity of our community. We know there is underrepresentation of minorities within clinical trials, and quite frankly, when the FDA gives approval, they give approval to the known risks, as I'm sure you all are aware, but it doesn't always represent the impact on all communities. We also know that there are racial and ethnic differences in response to pharmaceuticals and that they may not become known until the drug is in wide use, certainly beyond the constraints of a controlled clinical trial. So we do have the initial approval of FDA that includes the known risks, but we also have the capacity under FDA to do post-approval warnings. My amendment deals with that aspect of it. Health and Human Services has a strategy to deal with minority health and health disparities. It's called the strategic action plan to reduce racial and ethnic health disparities. We also now have an institute at the National Institutes of Health that deals solely with minority health and health disparity. We have a commitment to do a better job as a nation with dealing with minority health disparities."
  • Spoke on Cardin amendment #2141.
    • SUMMARY "My amendment deals with the issues of coordinating the work between the FDA and small business. It provides a listing of the staffing levels at the small business offices of the FDA so that we know the capacity we have and we can evaluate that. That's our responsibility to do that. It provides an overview of the status of partnership efforts between the FDA and the SBA we want the two agencies, the Food and Drug Administration, Small Business Administration, to be working in concert to advance the cause for small businesses at the same time the mission of the FDA my amendment provides a summary of all outreach efforts to small businesses and small business association details the number of small businesses receiving protocol assistance. It shows the number of unsolicited and solicited grant applications, again, to small businesses so we can evaluate it. And most importantly, it calls for the examination of existing barriers, particularly as it relates to the generic drug shortages. It's interesting the fee schedule, the FDA has the authority to do waivers as it relates to brand names. We know a lot of the generics are where we have our shortages because of the economics of the circumstances. But the SBA has limited ability to waive the fee structure as it relates to the generic - the development of generic drugs. My amendment would ask the SBA to report back to congress what impact that has on small businesses being innovative in developing generic drugs to help us generally with less costly drugs are available for treatment but also to make sure we deal with the drug shortage issue."

Senator Harkin: (5:08 PM)
  • Spoke on Cardin amendment #2125 and Cardin amendment #2141.
    • SUMMARY "First of all, the amendment #2125 will help ensure that health care providers, patients and payers better understand the benefits and risks associated with drugs, especially with respect to those drugs by underrepresented sub populations. I believe this is an important and noncontroversial amendment. I hope that we can support this amendment. On the other one, the #2141, which is the small business report, I think it's important that FDA give small businesses a helping hand. I understand that each FDA center has a small business office and that each of FDA's five regional offices has a small business representative, that this report that FDA would have to submit on the basis of the amendment offered by Senator Cardin would provide congress with more information about how FDA uses its resources for small businesses to help encourage small companies, and again I think it's another valuable addition to our bill and hopefully we can support that legislation, that amendment also. So I thank the senator from Maryland for his offering these two amendments and for what I consider to be improvements in the underlying bill."

Paul, Harkin, Bennet, Klobuchar, Murray

FDA User Fee Reauthorization bill (S. 3187

May 23 2012 6:16 PM

Senator Paul: (5:22 PM)
  • Called up Paul amendment #2143.
  • Spoke on Paul amendment #2143.
    • SUMMARY "It attempts to stop the FDA's overzealous regulations of vitamins, food and supplements by codifying the first amendment prohibition on prior restraint. What do I mean by that? The first amendment says you can't prevent speech, even commercial speech, in advance of the speech. You can't tell Cheerios that they can't say there's a health benefit to their cheerios. Under our current FDA laws, the FDA says if you want to market prune juice, you can't say that it cures constipation. You can't make a health claim about a food supplement or about a vitamin, you can do it about a pharmaceutical but you're not allowed to do it about a health supplement. I think this should change. There have been several court cases that shows this goes against not only the spirit but the letter of the law of the first amendment. So this amendment would change that. This amendment would stop the FDA from sense you're claims about curative, mitigate effects of dietary supplements and stop the FDA from prohibiting distribution of scientific articles and publications regarding the role of nutrients in protecting against disease. Despite four court orders condemning the practice as a violation of the first amendment, the FDA continues to suppress consumers' right to be informed and to make informed choices by denying them this particular information. It's time for congress to put an end to FDA censorship. Second, my amendment would disarm the FDA some of you might be surprised the FDA is armed. You shouldn't be. We have nearly 40 federal agencies that are armed. I'm not against having police, I'm not against the army, the military, the FBI, but I think bureaucrats don't need to be carrying weapons and I think if there is an armed policeman to be there, the FBI who are trained to do this should do it My amendment will require adequate mens rea protection. In other words, if you have a crime you're supposed to prove the intent. People have to have intended to harm on someone, can't be a situation where you didn't intend to harm someone. If you want to put someone in jail, it should be a mens rea requirement. It comes out of our common law tradition. This amendment would fix this problem by strengthening the mens rea component by including the words "knowing" and "willful" before we address and accuse someone of a crime. This I think would give protection to folks who are guilty of inadvertently guilty of breaking a regulation and would keep from overflowing our jails."

Senator Harkin: (5:29 PM)
  • Responded.
    • SUMMARY "This amendment basically turns the whole law that we had since 1994 on its head. We have a process now where the FDA regulates the supplements as foods. These are foods, not drugs. So as we hammered this agreement out, supplements can make nutrient, structure, function claims without any FDA preapproval. Now, if they want to make a health claim, then it has to be approved by FDA, and FDA has to find that it is supported by appropriate scientific evidence. So under this amendment, substances that today are considered drugs and used to treat diseases as serious as cancer or HIV could be marketed without any rigorous FDA review, that we have heard from many speakers here today that's the gold standard of drug regulations throughout the world. It would turn our current system of drug regulation on its head. It would be a huge setback for health, it would foster a system rife with potential for health fraud. The big losers would be patients. And quite frankly, as someone who is a strong supporter of the Dietary Supplement Health and Education Act, and one of I would say along with Senator Hatch, has been one of its protectors for all of these years, I dare say the amendment offered by the senator from Kentucky would destroy it the senator from Kentucky talked about increasing the men srea what's your mental condition, what your thought process were, what was your intent? It would increase it. That would be need to be join to enjoin the food, drug and cosmetic act. I just think that somehow we would make it harder to enforce a public health statute harder to enforce, not easier, sink troubling. I see no legitimate reason to do this. The goal of this amendment is clearly to render the FDA virtually incapable of addressing industry abuses."

Senator Bennet: (5:42 PM)
  • Spoke on the FDA User Fee Reauthorization bill.
    • SUMMARY "Colorado is the sixth largest medical device sector in the country with over 600 bioscience companies overall. We obviously need to strike a balance as we think about this legislation, because as we speed the FDA to increase approvals, we've got to ensure devices are safe. This year has represented a good-faith bipartisan effort among members on and off the help committee to find policies that will empower the FDA to ensure safer devices and also ensure our companies on the ground have more regulatory certainty and predictability. About the challenges the device sector faces: reviewer turnover, young, less experienced reviewers and management challenges. At the same time, we've heard from venture capital investors that regulatory uncertainty at the FDA is the reason they've been hesitant about continued investments in the United States and have thought about future investment in Asia and Europe. The new medical device user fee will go a long way toward ensuring the FDA has the resources to provide effective medical devices in less time and with more predictability. We were also able to craft policies on innovation and safety. This includes Republican forcing regulations in place since 1997 that require the FDA to take the least burdensome approach by not asking companies for unnecessary or unrelated information. It also includes provisions to provide tracking so if there is a problem, doctors can quickly know if their product is one that works. Now, I'd like to say a word about drug shortage, discussion issue that every member is hearing about in their states and the FDA in just the last year was notified of about 220 drug shortages. We know that the amount of patients this affects is monumental. For cancer alone, over 550,000 patients have been currently affected by our national drug shortage crisis the Senate bill would give the Food and Drug Administration the much-needed authority to require drug manufacturers report any discontinuance, interpretation, or other adjustment that would likely result in a shortage, especially those drugs needed to provide emergency care. I'd also immediately create a task force that would develop a strategic plan to address drug shortages and submit recommendations to Congress as well as study the effect that drug pricing relates to shortages."

Senator Klobuchar: (5:52 PM)
  • Spoke on a Portman amendment.
    • SUMMARY "In 2011, Poison Control Centers received nearly 13,000 calls about synthetic calls. How many did they get in 2010? Only 3,200. Look at that. 3,200 to 13,000 in just one year. In Minnesota there were a total of 392 calls to Poison Control relating to synthetic drugs. In 2011 compared to 107 in 2010. A tripling of calls about this problem in just one year ... I introduced bill which would add 2ce and similar drugs to the banned substances list so they will be treated in the same manner as other banned drugs. That they claim to represent. I'm also a cosponsor of the two bills authored by Senators Grassley and Schumer. All three of these bills are contained in the amendment that we're offering with Senator Portman. These drugs can kill and if we don't take, a, action, they will become more and more prevalence. They are available on the the federal government has to make sure that they are illegal buy these drugs that have numbers like 2ce. They don't really know what they are. They get them and they turn out to be deadly I hope we ban these drugs as part of our debate on the bill. We know that the DEA has been take action on its own and they've temporarily banned some of these drugs. But most of the substances covered in our three bills have not been banned including all the in my bill. That is why in fact we are offering this amendment of on the state level, roughly 40 states have banned some synthetic drugs including my state where a major law regarding synthetic drugs took effect in July. We need a federal law. This crosses the state line. A lot is done on the internet. We can't have this state by state and passing a federal law will help create the partnership we need to send a strong message that we need to eradicate these substances. I'm very pleased that this amendment is being offered. We need to get it done now, ban these drugs, and make a clear, clear statement that these drugs are illegal."

Senator Murray: (6:00 PM)
  • Spoke on the Hire Heroes Act.
    • SUMMARY "According to the Department of Labor, young veterans between the ages of 18 and 24 is an unemployment rate that is nearly 20%. One in five of our nation's heroes can't find a job to support their family, don't have an income that provides stability, and don't have work that provides them with the self-esteem and pride that's so critical to their transition home. We know this should not be the case. We shouldn't let the skills and training our nation's veterans have go to waste. And that's why all of us join together to overwhelmingly pass my vow to hire heroes act here in the Senate late last year. Among many things, that law will provide tax incentives to encourage businesses to hire veterans, makes participation in the transition assistance program mandatory for most separating service members and expands the education and training we provide transitioning service members. Thanks to that legislation, we have been able to take real concrete steps towards putting our veterans to work. The tax credit is working, and VA is set to begin accepting applications for a retraining program that will benefit unemployed veterans ages 35 to 60 and help them get back to work. But that bill is only that: a first step .. the next step, and that step is to build partnerships with private businesses large and small all across our country to hire our nation's heroes."

Manchin, Harkin

FDA User Fee Reauthorization bill (S. 3187)

May 23 2012 6:32 PM

Senator Manchin: (6:18 PM)
  • Called up Manchin amendment #2151.
  • Spoke on Manchin amendment #2151.
    • SUMMARY "Basically, what we're doing is we're changing the hydrocodone combination drugs to a schedule two from a schedule three. That makes it much harder for people to have access of this drug that has been wreaking havoc throughout the country and throughout our states. I would appreciate the adoption of the amendment."

Senator Harkin: (6:18 PM)
  • Responded.
    • SUMMARY "This amendment would amend the controlled substances act to make any substance containing hydrocodone , vicodin, a schedule three drug. The most significant difference is that for patients, schedule two drugs are not allowed to be refilled, and that's the key to the amendment. I applaud the senator. I have great concerns regarding the increased abuse of prescription drugs. According to the Centers for Disease Control and Prevention "overdoses involving prescription painkillers are at epidemic levels, epidemic levels, and now kill more Americans than heroin and cocaine combined." .. According to the CDC more than 40 people die in America every day from overdoses involving narcotic pain relievers such as hydrocodone."
  • Unanimous Consent --
    • The following 6 amendments to S. 3187, the FDA User Fee Reauthorization bill, have been Agreed to (without objection):
      1. Cardin amendment #2125;
      2. Cardin amendment #2141;
      3. Grassley amendment #2121;
      4. Grassley amendment #2129;
      5. Manchin amendment #2151, as modified; and
      6. Reed amendment #2126.

May 23 2012 6:53 PM

Senator Reid: (6:35 PM)
  • Performed Wrap Up --
  • Tomorrow --
    • The Senate will convene at 9:30 AM and 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 listed below, 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 (60 votes required);
      2. McCain amendment #2107 (60 votes required);
      3. Sanders amendment #2109 (60 votes required);
      4. Murkowski amendment #2108 (60 votes required);
      5. Portman amendment #2146, as modified;
      6. Portman amendment #2145, as modified;
      7. Coburn amendment #2132;
      8. Coburn amendment #2131;
      9. Durbin amendment #2127;
      10. Paul amendment #2143;
      11. Burr amendment #2130; 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.
    • 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 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. 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.
  • On Wednesday, the following 6 amendments to S. 3187, the FDA User Fee Reauthorization bill were Agreed to:
    1. Cardin amendment #2125;
    2. Cardin amendment #2141;
    3. Grassley amendment #2121;
    4. Grassley amendment #2129;
    5. Manchin amendment #2151, as modified; and
    6. Reed amendment #2126
The Senate stands adjourned until 9:30 AM Thursday, May 24th.