That the chinese have imposed on shellfish coming out of parts of alaska. Issue that might be very narrow in its scope but has great impact in a portion of my familyowneding businesses that are really taking a real hit right now. 6 tont a letter on march encourage that there be a delegation to go to china to discuss this issue with the chinese to see if we cannot get faster resolution of this. That thisnd from noah meeting is scheduled in china on march 21. The delegation is going to foreignnoah, the usdas service, but not the fda. The question to do you this morning is can you give us assurances that we are fast tracking a resolution of this issue, what the fdas role is, and if you will be sending someone as part of that delegation and if not, why not . This is an issue that has great importance. Noah andething where the department of commerce has the lead in terms of interactions with the chinese. Providingen information and support to them as well as information about Public Health assessments to be chinese, the chinese counterparts as well. We will not be formally part of the delegation but we will be in contact, working with them and supporting them and we have an office in china to provide additional support. We have input but we are not in the lead on this. Our focus is really on the Public Health assessment. I understand and appreciate that. My concern is that if there are issues that arrive a rise in the meeting that speak to the specific jurisdiction of the fda, i would hate we will be available to them and they know it, 24 hours a day to provide that support. I would like to turn to a subject that i have brought up before this committee, and no offense to the chairman, we often refer to this alien species of fish as a fra nkenfish. No offense to senator franken in any form. Offense taken, however. [laughter] i dont want to consume my time here so time here talking about how bad the name is. We will refer to it as genetically engineered fish, specifically salmon. I have very strong concerns and reservations. I dont need to show you pictures of beautiful wild alaskan salmon. I have them here. I will show you a picture of the where the dini has taken from. It is a bottom feeding fish that is injected into a salmon in an effort to cause these fish to grow quicker so they can get to a market more readily. Opposenue to strongly fda approval of geneticallyengineered salmon. I dont believe that the fda has adequately studied the environmental effects, the economic impact, not only on the wild salmon themselves but our Seafood Market and let alone the potential Health Impacts on humans. Given the concerns i have and many others have, can you assure me that fda is prepared to deny approval of the sale of ge salmon to consumers if youre agency determines it cannot guarantee that it is safe to eat . If we could guarantee that it was not safe to eat, then it would not pass our standards. What we are looking for is we want this assurance. We do not know if it is safe to eat. We do not believe that it has been determined that this genetically engineered salmon would be safe to eat. We also have not been able to determine whether or not it would impact negatively, jeopardize, the wild alaska salmon. I would ask again that you look very critically at this. The threat, i believe, not only to humans for consumption of threat tore fish, the our wild stock. If, in fact, the fda should advance to a level of approval for sale to consumers, i have been demanding that the agency very clear labeling to consumers. That that is what they would be purchasing for consumption. I want a level of assurance that if it is not safe to eat that it will not be out for sale, but if it is determined that it should be allowed, that there be clear labeling allowed. I know time is limited. A complicated issue. I can assure you a couple of things we have been taking a very systematic, sciencebased approach to the review of this application. It represents the first in its class. As a product in and of itself and although also the pathway for approval. We also undertook environmental assessments. To address your concerns, these of the wild salmon population, and we published in december 2012 our preliminary findings. 35,000 comments. This is a topic that people care a lot about. Were going to those comments, taking them very seriously, and we will be Going Forward in a way,erate, sciencedriven reflecting all the important what youcluding brought forth earlier. Hats time has expired, but dr. Hamburg, we could discuss this further, not only ge salmon but progress were making another areas. I will have other questions that i will submit for the record and i asked that you met paid attention to the level of inquiry about how were doing with als research and the joint meetings that we have been having with stakeholders and how we can advance a cure for als. Thank you. To any of the questions that you have for the record include nkenfish . To fra we will include them, then. [laughter] thank you, mr. Chairman. I will take a round of questioning. Welcome. I thinkingtart and rankingtman member alexander for calling this important hearing. It has been a pleasure working with both of them on a number of fda policies, most recently the pharmacy compounding legislation that passed into law on november. To thank you, dr. Hamburg, for working with us so closely on that. Thatur testimony you noted your quick interpretation of the law is allowing companies to register is outsourcing facilities already. This was a critical component of our bill. Can you tell the committee why this is so important . How does this new option improve Public Health and prevent a new outbreak . At highriskrgeted products. Injectables that we know can ontaminated and when they do they have serious consequences for health. Enable, for those companies that choose to register with us, a higher level of assurance in terms of good manufacturing practice and oference with the kinds manufacturing procedures that need to be undertaken to make these products safe. We think that this is hugely important. As a mentioned earlier, we that companies will choose to go this pathway and hopefully the marketplace will view this as appropriate standard of care for the health, safety, and protection of their patients in the health care system. Hopefully they will seek them out not just to registered, they will seek out not who just registered, but they will become outsourcing facilities with us in an ongoing process of oversight that includes regular inspections to ensure compliance with these important manufacturing procedures and safety protections. Thank you. As you know, i am proud to represent minnesota, where we have a true culture of innovation, particularly in my states medical Device Industry. I spent a lot of time with start up Device Companies which serve as a major source of innovation andin that Industry Innovation for the next lifesaving therapies for patients. These entrepreneurs and their investors are tenacious and they spend years doing r d before they see a dime of profit in hopes of creating a therapy that lives. S improves i have been doing my part to fight for our Device Industry in minnesota and around our country , the american Device Industry. That is why i have been fighting the device tax since it was first proposed and working now to find a bipartisan solution to all. L the tax once and for i want to do everything i can to sure our companies, which Face International competition, are able to succeed. Vein, another area i have done a lot of work on is making sure the process of review is streamlined as much as possible. I have seen this. The fda and the industry have different cultures and i have often seen the fda and the Device Industry sort of talk past each other. In minnesota, we did something tot i think is remarkable bridge the difference between the cultures. The fda and minnesotas own life science alley, which happens to be the largest statebased Life Science Trade Association in the country, formed a partnership that i have worked hard to support. It is called the medical device innovations consortium. This Publicprivate Partnership is the first of its kind. The goal is to create efficiency and iality of regulation guess it studies or talks about regulatory science. Can you tell me what progress has been made in advancing innovation and benefiting ancients patients because of the creation of this organization . Thank you for the question. I felt badly that i forgot to mention it when i was responding to senator baldwin. There is an element of what exciting things are happening in the area of medical device innovation. It is a Publicprivate Partnership as you mentioned and i think it has gotten off to a very good start. It was announced, we together launched it not too long ago and it has doubled in size. It spans Device Companies, consumer groups, patient groups, research organizations, and the fda is part of it. What is exciting about it is that it has created a Research Agenda to focus on how can we advance the underlying science so we can get the promise of science to people more quickly. It focuses on a number of critical areas. Trialitical clinical design so we can ask prickle questions more efficiently. Hopefully also encourage more Device Manufacturers to do their first in human studies in the United States rather than overseas. It is focused on patientreported outcomes and how they integrate that into device development, which is very important across all medical conditions and products. Devices in particular. One of the things that excites me is developing computer simulations and models so that you can study some of these devices in that context instead peoplenimal models or in in the early stages so that you manipulate things and play with it more but also reduce cost and potential risk to patients, but still get Important Information to move things that have promise into the marketplace and making a difference in peoples lives. I think it is a wonderful partnership. Thank you for your leadership in helping to make it possible. Are committed to working with it and we are seeing benefits already. We see the foundation for lots more progress. Thank you for your role in that and excitement about that. I am, too. Thank you, mr. Chairman. I would like to revisit the goals you immediately identified when you took the helm at the fda, modernizing how the agency considers new therapies and closing the regulatory science cap. Those goals are ones that we obviously all share. Ofre is a continued level frustration among patients and manufacturers that the fda lags inind other countries understanding clinical responsibilities, it including assessing the values of new therapies and how the risk of violation and mitigation strategies are tools to both protect patients and allow access to higher risk products where patients are desperate for treatment. And senator hartmans opening statement, he mentioned a case with the committee voted against a product and was overridden by the fda. I will talk about a different situation and that is dealing with multiple sclerosis. The fda made a decision to break with an overwhelming Advisory Committee vote to support the safety and effectiveness of a novel therapy for multiple sclerosis. The agency chose not to approve the drug despite it being approved and 30 other jurisdictions face on the same data set. Can you explain the logic behind that . Fda seehe ftc that the advisory could not . That may address your broader question about we are at the cutting edge in terms of review and approval of new products if you look at drugs approved in recent years. About 3 4 of them are approved in the United States first. Apart from the highest risk devices, i think we are at par with comparable other countries in terms of review times, etc. We do ask for more Clinical Data on the higher risk devices. There is some urban mythology about where we stand in comparison to review times and leadership. I think the User Fee Programs for devices and drugs have made a real difference in our ability to be as competitive as possible. With respect to the role of Advisory Committees and the decisionmaking within the fda, the committees are a very Important Committee component of the review process but they are not determinative. Expert advice in many ways, including Advisory Committees. They are not used with every product that is reviewed, of course. It is sometimes frustrating for me. Abouteople ask questions specific product and why we did not approve it, that information confidential and information that we are not allowed to share without permission from the company. I can assure you that the fda review teams take their job very, very seriously, going through in a systematic way the dam data that is available to them and looking the overall riskbenefit and the benefit to patients. Things that are not obvious that make a real difference in terms of a decision that is made. The Advisory Committee is not the Advisory Committee is a very important part of our input on a decision. I would say that the majority of times, our decisional lines, but not always. Youre saying they are lacking information that the fda would have . They are not getting the full story . I think that there are many components to the review and the Advisory Committee is an important piece of it. NotAdvisory Committee is spending time at the patient level data that the review teams are and there are aspects of the review that the Advisory Committee is not always engaged their input. Lue we take it very seriously and we try to engage subject Matter Experts to the greatest arena we can. Degree that we can. I noticed that this one had been approved in 30 other jurisdictions. Those of the sturgis those other jurisdictions are considered wrong, too. I guess that is a decision the fda can make. We do want you to keep it safe. My time has run out. Would you care to ask another question . Please. It would be your term. I know, but go ahead. [laughter] i know that the fda is under way a simple mentation of the generic drug user fee add. It is my understanding that not all the first generic applications have been approved as the day as the patent expiration. Is there a reason . That weis a program have had backlogs, serious backlogs in. Part of why the User Fee Program was begun with the passage of it. We are moving forward in implementing that, hiring up, addressing the backlog in critical ways, also addressing the issues of expanding our inspectional capacity so that we can do those critical expections inspections which are increasingly over seeds. We are not where we need to be at increasingly overseas. We are not where we need to be at yet. We are moving forward and we have made progress but there is a lot more work to do. I will submit more information that i would like. How money applications the agency has received for these first generic products and how many have missed the approval of the earliest possible date and what youre doing to ensure that the future generic applications are reviewed. Id like more detail on that. Again, i thank you for being here today to answer our questions. We do not get the opportunity very often and you have done an outstanding job. Thank you. [captions Copyright National cable satellite corp. 2014] [captioning performed by national captioning institute] ringingn, 35 years of Public Affairs from washington to you, putting you in the room at white house events, briefings, and conferences and offering complete coverage of the u. S. House all as a Public Service of private industry. We are cspan, created by the cable tv industry 35 years ago and brought to you as a Public Service by your local cable or satellite provider. Follow us on twitter. Address, weekly president obama talked about strengthening overtime pay protections. Congressman bill johnson of ohio has the republican address. Impact of thehe Affordable Care act on Senior Citizens in his district. Hi, everybody. In this year of action, im doing everything i can, with or without congress, to expand opportunity for more americans. This week, i ordered a review of our nations overtime rules, to give more americans the chance to earn the overtime pay theyve worked for. Heres why this matters. Our businesses have created 8. 7 million new jobs over the past four years. But in many ways, the trends that have battered the middle class for decades have grown even starker. While those at the top are doing better than ever, average wages have barely budged. Too Many Americans are working harder than ever just to keep up. Weve got to build an economy that works for everybody, not just a fortunate few. We know from our history that our economy grows best from the middle out, when growth is more widely shared. So weve got to restore opportunity for all the idea that with hard work and responsibility, you can get ahead. Now, for more than 75 years, the 40hour workweek and the overtime protections that come with it have helped countless workers climb the ladder of success. But today, an overtime exception originally meant for highlypaid employees now applies to workers who earn as little as 23,660 a year. It doesnt matter if you do mostly physical labor, or if you work 50, 60, even 70 hours a week. Your employer may not have to pay you a single extra dime. In some cases, this rule makes it possible for workers earning a salary to actually be paid less than the minimum wage. And it means that Business Owners who treat their employees fairly can be undercut by competitors who dont. Thats not right. So were going to update those overtime rules to restore that basic principle that if you have to work more, you should be able to earn more. And well do it by consulting workers and businesses, and simplifying the system so its easier for everyone. Americans have spent too long working more and getting less in return. So wherever and whenever i can make sure that our economy rewards hard work and responsibility, thats what im going to do. Because what every american wants is a paycheck that lets them support their families, know a little economic security, and pass down some hope and optimism to their kids. Thats something worth fighting for. And ill keep fighting for it as long as im president. Thanks, and have a great weekend. Good morning. My name is bill johnson, and im proud to represent eastern and Southeastern Ohio in the house of representatives. Four years ago today, president obama came to our state and promised our seniors that his Health Care Law would protect their benefits. He said this if you like your plan, you can keep your plan. If you like your doctor, you can keep your doctor. I dont want to interfere with peoples relationships between them and their doctors. Now, the reality is, that not only is the president s Health Care Law interfering with these relationships, its ending them altogether. Because of obamacare, many seniors enrolled in the popular Medicare Advantage program are paying higher premiums and outofpocket costs. Many are losing access to their physicians. And many more will, unless the president takes action. Last month, Republican Leaders wrote a letter to the president asking him to develop a plan to deal with these problems. Nothing was done. In our weekly address, we urged him to listen to stories of seniors in florida paying more money for fewer choices, less access, and far less peace of mind. Still nothing. Just this week, a Bipartisan Coalition of more than 200 members of the house and senate came together to press the Obama Administration on this issue. Because this transcends politics. This is about keeping the promises we make to the american people. In january, i sat down with a group of local doctors to talk about all this. One told me that many seniors in our area who need to see a specialist will now have to drive up to cleveland or pittsburgh to receive care. Another cited hundreds of cases in which patients were blindsided by these changes. And last month, i received a note from a cancer survivor in poland, ohio who said that, because of the Health Care Law, she and her husband are losing the eye doctor theyve been going to for nearly 30 years. Heres what she had to say. We have always taken care of ourselves. We had four children, took care of their education, and never asked for handouts. Now, we are older, and we have to be concerned about not having the doctors and services we like and will need. Remember how the president said he didnt want to interfere in these relationships . More than 794,000 seniors in ohio rely on Medicare Advantage. Thats hundreds of thousands of broken promises in waiting in just one state. Older americans deserve better. They deserve the benefits they were promised. If the president wont help us repeal this law in its entirety, he ought to step up here, do the right thing, and protect our seniors. And he ought to do this soon. Cspan created by americas Cable Companies 35 years to go and brought to you today as a Public Service by your television provider. Joining us on the communicators is Jonathan Edelstein who served on the federal communications a federalian communications administration. This is the association that represents companies that build jonathan build wireless networks. Thateople that send all information to your cell phone, countries like sprint