Transcripts For CSPAN2 Key Capitol Hill Hearings 20140214

Thank you for joining us. I am honored to be here with my women colleagues who have taken the lead on when american succeeds women succeed. And we have the leader of the issue here. She is the booster of it all shall we say and sets the pace for all of us. Donna edwards the share of the Workman Group is here. We have the vice chair of the ste steering community. You will be hearing singing from Michele Grisham from new mexico and judy chew of california is here of the asianpacific organization. At lunch we presented what we will present to you to our members. It was not only advocacy, but a case study on how we are using Traditional Press on this issue and rosa will talk about our 16,000 person teleconference. As well as the social media. So with that, shall we play it again . [video playing] give sherrys berries. Lets pea treated equal this valentines day. What a girl wants, what a girl needs is equal way for equal work. For valentines day flowers, chocolate and a fine dinner are all great but they only last for a day. What women really need for the valentines day is equal pay for equal work. So on valentines day you can get chocolate and your contribution to the fact that women need quality. [music playing] i saw a tweet a with bunch of Women Holding chocolate hearts saying we dont want chocolate, we want equal pay. So bosses, dont give chocolates for valentines day. It is time to do away with work place policies that begin in a madman episode. Lets come together and businesses from wall street to main street to give every women for the opportunity she deserved because i believe when women succeed America Succeeds. All women need and want for valentines this year is to be paid equally to their male workers for the same job because we know when women succeed America Succeeds. I am joyce baity and i approve this message. Happy valentines day. As i mentioned, delor is our leader on this issue and we will be hearing from her. But first we will hear from Donna Edwards who is the head of the Valentines Day Campaign for women. Thank you, madam leader. And thank you all, too. What women really need for valentines day so we can afford to buy our own Valentines Gift is raise in the minimum wage and sick time and paid leave. We have launched this campaign and our is womensucce womensucceedraisetheway. Today men and women tweeted on the minimum wage. Today, february 13, marks the day when tipped worker havent had their raise in 23 years. Increase the tip minimum and we can go buy our own chaocolates. That hash tag is trending now. Look at all of members here. Our members have jumped on this men and women. We have held more than 60 events in congressional districts all across the country and there are more celebrating the idea that we can stand together for what women really need. You can say not just the members, but our allies, too. Women succeed when America Succeeds. Thank you very much, donna. Can you believe that minimum wage restaurant workers make 2. 13 an hour . Today, february 13, 2. 13 at 2 13 we had a tweet storm. You had a snow storm, we had a tweet storm and it is trending now so we are exciting about that. And all part of the three pillars of pay, of sick leave and of child care as i say inspired and led by the Congress Women. Thank you, madam leader. Great to see you all today. Hardy souls to be here with my colleagues. Over a number of months and a year, year and a half, both from Empirical Data and conversations with people all across the country, the issue of the economic challenges facing women is staggering. Women are in the workforce in great numbers. They are half the workforce and 2 3rds of the bread winner. They come in in jobs and occupations that pay less. There is the discrimination with regard to pay equity. 77 cents on the dollar. 23 women are minimum wage workers. They have less pension were protection retirement and more likely to be in bankruptcy. But they have the primary responsibility for all of the household duties including child care and also taking care of elderly parents. As a result of that data, and those conversations, what we put together was these economic agenda for women and family which is based on three pillars. Pay equity. Work life balance with paid and medical leave and child care. We have been talking about that for months. And grs one of the things we did on january 29th, which was the fifth anniversary of the signing of the lily led better fair pay act, we did a teleconference where we had 16,000 folks from across the country, the leader, congressman edwards and myself spoke. The stories were poinant from the women who were looking at leaving their children and going to work sick. Or taking their child to school sick. Or the inability to make medical leave. It was an incredible success listening to people relating their stories and then their questions to us about the agenda because this isnt based on something that is avemeral. This is agenda sponsored by a number of members. Paycheck fairness, 1213 years i have been working on it. Minimum wage, mr. Miller has been working on it a long time. These are real legislation that address the issue of economic insecurity for women and their families. This is another reincarnation of what women wont and that is pay quality, increased opportunity and educational opportunity. They want a better life for themselves and family because when women succeed america succeed. When women make less, over 60 of the people making minimum wage are women, and pay equity has its own toll. If women make 77 cents on the dollar, her male counter part who is equal means the first three month of the year the woman is working for three. It impacts her pension as well and the sick pay leave affects elder care. And we have worked on this issue in all phases of life but her focus was senior citizens. Thank you. Income discrimination follows women throughout their entire lives. If there were a private pension it is going to be reduced and when she gets her Social Security check it is going to be less. So equal pay, as we found with lily ledbetter, meant that right now. Lily is living on a shoestring because for 17 years she didnt know her male counter parts doing the same jobs were getting paid the same. It is equal pay for equal work duh. This is 2014 and it is time for us to finally get there. It is 50 years since the first passage of the equal pay act and yet we are still struggling. Women on average make 77 cents to the dollar but women of color do far worse. Diamonds may be a girls best friend and chocolates are fine, but we need an economic agenda that works for us. Thank you. My colleague from california is going to talk about what she is going to do next. We are proud of her work as chair of the Asian Pacific chair in the house. In los angeles everywhere i say the words women succeed America Succeeds i am met with wild applause. And i decided to have my own event and it is on march 10th and Speaker Pelosi is coming. We will hear from women. We will hear their stories. We will hear from women who are earning less than minimum wage and are working fulltime yet still cant make ends meet and still live under the poverty level, in fact. We will hear from women who are working at the same job and earn less than a man earns. And we have going to be focusing our attention especially on women of color who experience these inequalties at greater degrees. And we will have a jobs boot camp so we can offer real help so women can get the assistance they need. There is a huge anticipation on this event. We have had this whole flurry of events all across the nation. I happen there is going to be huge anticipation for what will come. And i am very much looking forward to spreding this word. We usually have folks going up to the microphone but we are excited about the roles that our colleagues have played in this. Joyce baity has energized the caucus. Thank you, leader. Being from ohio, the seventh larger state in the nation, i could not think of a better way to have a year of action. And thanks to the leader for the idea and the outreach. We, too, in ohio are going an event in early spring. We hope to bring thousands of women so they can witness what we see and say when women succeed, America Succeeds. When you talk about equal pay for equal work, it reminds me of my grandmother and my mother and how hard they worked. I am doing this for my granddaughter because it will make a difference in our lives and for the future. And you know why . When women succeed, America Succeeds. She started off with a song and i dont know if we can coax her into singing more, but she set the tone and pace for our wonderful film. I want to yield to the member from new mexico. Congresswoman grishem. I solved the old time saying should you sing or lip sing, and i think i should have lipped sing. I come from a state where we have been a minority majority. And women of color make less than 77 sents on the dollar. As a proud mother of two grown daughters i watch them struggle in this environment. It is unjust, immoral and with the number of women with und undergraduate degrees, think about the money that is in the economy. So we are talking about an opportunity agenda for the entire country. In a state that is so poor and needs assistance, supporting women in a we should have been all long is something i am very proud to promote. And very excited about the message. Thank you, mitchell. As we talked to you yesterday, we talked about an economy that works for all americans and that is including all of us and that is one Important Pillar of the economic agenda going forward. We are very proud of it. It is something that is catching fire across the country. I presented it to the members, well they hear about it every week if not every day, but as a case study of how we will advance our agenda. We started with the paul tonko of new york about his event that had the headliner on the first page. It talked about how four stations played it. One as a preview and three covered it. And then it went on to the social media. So respectful of the role you play, we want you to be the one to see it first. And then we will, rosa, talks about how we talked about this and i thought it was like 17,000 people i could hear breathing but if you say 16,000 that would be standard fair for us. And donna is finding more innovative ways to reach out. She has probably had five sessions in her community. And then we go to the social media. This is our message today. At 2 13 we acknowledged and it was nice to see the look on the face to see the workers in the restaurant saying everybody be ready for the 2 13 protest. We have going to share chocolates with you. They have things on them that say pay leave. Equal pay. You get it. You get it. Child care. So happy valentines day. We will give you chocolate, you give us equal pay. Any questions . How will you advance the equal pay . That is what we have talking about. I keep coming back to lincoln. Public sentiment is everything and we will talk about that when we come in with the leadership. As you know, George Miller and tom harkin have legislation for this and 70 of the American People support raising minimum wage. On paycheck fairness, that has been passed twice in the house . You want to talk about other issues . How do we advance paycheck fa fairness . It has been an issue for a long time it passed under the leadership of Speaker Pelosi and the house of representatives and with 14 republican colleagues. On the first go around in the senate we lost by two votes. And i will not tell you who the two were. In any case, we lost a second time in the senate because of the fill buster. But it has been in the press that the colleagues on the senate side are raising the issue again. We are ready. We have 200 democrats and i am trying to get republicans on the legislation. But 200 democrats have signed on for paycheck fairness. This is long overdo. We can do it. I was going to say there has been pole polling of the womens economic agenda and among women and there is discussion among republicans and democrats and who is going to get the vote, among all of the lines and everything single age, these issues have great resonence across the board. We challenge our colleagues to say women across america want this and the people in america want this. The house of representatives have the capacity to do this. And we will mobilize so people hear what we are saying 54 of the republican women support this agenda. I want to say this taking each part, the minimum wage, we talked about that. And pay equity, we talked about that. And we advanced the first bill signed by president obama and more to come in terms of pay equity. Paid leave is one of the most poplar initiatives. Paid sick days. It is astunning across the board as the Congress Women said. In every category you can name support for paid sick leave. And i will close by saying this we had the privilege of hearing from marion wright. I was telling her about the speech that was on president nixons death and he vetoed the bill. We talked about having a bipartisan meeting of the people who were part of that legislation, many are not still in congress, but it happened them and it can happen again. George miller has the Bipartisan Legislation for early childcare learning. Rosa fought hard for a stronger, deeper head start funding and the rest. So people know that this has to happen because it is so important to americas families. And when women succeed America Succeeds. Picking up on what was said, 54 of republican women favoring this and higher numbers in the democrats, why isnt this level of public support translating into a democratic majority in the house with governors . Where is the disconnect between that level of support and the republicans appearing to be on the verge of keeping the house and taking the senate . I dont subscribe to that. This is about policy and people and we will leave politics for another day. This is for us. If we could win on these issues with legislative success that would be our victory. But i do think that people are watching to see where people come down on the simplicity of this. This isnt every issue you can name. This is prioritizing women into the work place and the balance between home and work. It is the most challenging issue that working families have to deal with. So we will see what it translates into. We would rather see it translate into the legislative success. That would improve policy and the lives of the American People. If not, i am sure people would watch to see who votes what way. But all we want is a vote. We think we have the votes in congress. All we want is a vote on these issues. We are not setting out to set up a political confrontation. We are setting out to have legislative successs. Thank you and enjoy the candy and what they stand for equal pay, child care, paid sick leave it is written on there. Thank you, my colleagues. We have the german caucus and the Leadership Team here. This is day two. Great sessions. Tonight we will hear from dr. Kim. The chairman of the world bank. And tomorrow we have the president of the United States. And we have to stay tuned because since the Vice President wasnt able to approve today for the lunch key note address, we are waiting to hear word if there might be opportunity for the Vice President , as well. Generally speaking, our members are not just thrilled that we have had this opportunity to really drill deep into the these issues that are so posimportant americans but we are going to the heart of issues Americans Care about. How do you build an economy that works for allamericans and build the ladders of opportunity . Guarantee Economic Security so everyone has a chance at the american dream. That is what we have been discussing and we have had wonderful people who help us hone own how we do that. And we have several dynamic speakers to go including the president of the United States. Were ready. I think we are fired up from everything we keep hearing from folks. And we know, as you just heard from colleagues who have been working so hard on this idea that if we help women succeed in america, that all of america will succeed. And we want to get to work on that. And we have agreed as democrats in the house of representatives that the house of representatives isnt done doing its work. That while some people considering this the donothing congress, we are ready to get to work. Since the president , a year and a half ago, just a bit more than a year in the state of the union in 2013 said we should increase the minimum wage and the house did nothing. He heard the president reiterate that again and we have yet to hear from the republican colleagues saying they want to do something. And given yesterday, the president took action to help the federal contractor employees get a raise so they can earn 10. 10, we believe we should join with the president and allamericans who say it is time for america to get a raise. We are going to go back in a week to congress, and we are prepared to submit a discharge position to begin the process of collecting the vote it will take to the house of representative to increase the minimum wage to 10. 10 for allamericans. We think that is the right thing to do and it is time to do it. We are prepared to take any questions as the democrats in the house of representatives are ready to lead and waiting for our republican colleagues to join us. I want to ask our assistant leader, mr. Clyburn to address the members first. To add to that, i would say that all of talk about building an economy that works for all, must be laid upon a Solid Foundation. And there is no more Solid Foundation than the minimum wage increased. All of us are aware of where we would be around 10. 70 if we had indexed the minimum wage the last time it was raised. And going to 10. 10 and index it so this is an issue we will not keep visiting is in fact the thing to do. As you just heard from the women in our caucus, 60 of the beneficiaries of a minimum wage increase would be women of which one of over four households will be women with children. We believe this is the way to go. I am looking forward to us coming back from this work period and starting to work on building a Foundation Upon which we can have an economy that works for all. With that, i yield back. There are a number of democratic priorities you could file a discharge commission on. The other is Immigration Reform. Why was minimum wage the one you started to move through with first . Or is this the start of many other issues . Our focus this weekend has been on the economy. Building the economy that works for allamericans. And we think this is as a fundamental pillar. We see immigration as an economic issue and reducing the deficit and growing the economy and that is not excluded to be a discharge. But right now we are starting with the minimum wage. It is part of the womens economic agenda of when women succeed, America Succeeds and we have the legislation of the Miller Harkin bill. You know if you were trying to collect signatures on monday, you would have all of them by tuesday. Immigration is going to be a harder fight. Some immigration people heard about this and they are saying just do it. You are going to open yourself up of being accused of playing politics without trying to move on it quickly would you like to rephrase that question . Tackle immigration first when you have 4050 republicans the moment you would issue it. On the house side, democrats made it clear where we stand on immigration. Hr15 doesnt leave you with a notion of principles. It isnt vague wording of what we might considering doing. It is legislative language, that we believe will save more money than the senate bill did when it passed with bipartisan majority. We are ready to go. As our leader said, the minimum wage isnt the only issue we wish to tackle, but we are hoping our republican colleagues, who are in the majority, will decide in midfebruary there is a lot to get things done. The minimum wage is making it clear we want to build allamericans. There are american other issues we will tackle, but we are prepared to submit the discharge position when we return for minimum wage. You are hypothesis is there are 4050 republicans who would sign that immediately they will get a chance in the relatively near future. We believe the minimum wage, we have been talking about the economy and the economy working for everyone, we believe the minimum wage and i want to make a comment, frankly if from 1968on it got a cola adjustment it would be far above 15. It was 10. 57 in 1968 and it is now 7. 25 in 2013. So it is very eroded from 1968. But they will get that chance. We believe the minimum wage is absolutely critical to lift people so they can be full p participants in the economy. We have heard economist after another tell us this is a demand drive n economy. Raising the minimum wage will increase demand and raise the growth level and create jobs and be good for everyone which is the central theme of this conference. But they will get their chance. Do you expect all 200 democrats to sign the discharge petition . Are you confidant you will get 18 republicans . How will republicans do you expect to get . I dont think we are every c confidant we will get 18 republicans to sign the discharge petition but we have some over here so perhaps thinks are changing. If they want to make sure people have an incentive to work they will pay them a wage to not leave them in poverty. I think the overwhelming majority of democrats will sign this. We presume it will be close to everybody. Well, we have been listening to some of the republican colleagues who have been asked this question, the same one you are proposing with respect to the minimum wage, some said no, and many have said they areo opn to it. So we will give them an opportunity to put their signature where their statements are. Or tell their followers if they are for or against it. 50 members on the republican side who have talked about supporting the Immigration Reform bill talk is one thing. Actually doing something is another. I am sure they will have a chance between now and november to let their followers know if they are serious about immigration. Many have said they are open to the minimum wage proposal so lets find out how open they are what issue do you see as the biggest brick wall taking back the house of representatives for democrats in 2014 . I dont accept there are brick walls. We punch through thoses. You should have the republican members who have decided to retire, who have now understood that if you are a moderate republican, there is no place for you in this majority. So there has been an exit of moderate republicans. Lets talk about pathways. Middle class Economic Security is a defining issue today. How you create broad and rising prosperity is a designing issue. People want solutions and priorities. If there is a republican who will not sign the discharge position because they argue the economy cant afford the increase in minimum wage. People will want to know why that person is voting for subsidies of Oil Companies of 40 million. And why they support subsidies to corporations to outsource jobs. Or a minimum tax credit for businesses to buy corporate jets. This is about contrast and priorities. The minimum wage is an illuminating contrast we have and wil be a defining issue over the next six months. There is no issue that causes you to lose sleep . He tells us the rest of us he loses sleep over the undisclosed special interest money that is poured into the system. And this isnt just about unease we have about winning the election. This is about undermining the democracy. And that is why we had a meeting with john bane who is taking the lead on the reform package. Amend the constitution to overturn citizens united. This big money does more to suppress the vote by suffocating the airwaves with endless special interest, undisclosed money that causes confusion and then people throw up their hands and say i dont get it, and that is a victory for the special interest in our country. And so we are very proud of the response we have gotten from the grassroot people and proud of the recruitment of the very good candidate under the leadership of steve israel. We feel we are into good place. Not just us, but our democracy, has a lot of sleep to lose over what the special interest money is doing to undermine what our founders fought for and sacrificed for their own words a government for the many, not for the money. I think the worry about brick walls is on the other side of the aisle. I say that because we talk about ladders of opportunity. That is a latter to the majority as well because 70 , 65 , and 60 of the American People agree with us on everyone of the issues we have been discussing. I was kidding to steve israel that two chairman decided to retire and i am guessing they dont think they will keep the majority. The administration announced another delay on the employer mandate on the Affordable Care act. Do you think that opens up wiggle room for democrats to delay the employee mandate that employees are required to buy . If not, why not . No. Because that is a completely different think. In other words, the president has, as we do with all legislation, the implimentation and how we can use this to improve the American Peoples lives. The mandate is central to what the law is. And the law is sound policy. To go back to the founders who sacrificed it all for life, liberty and the pursuit of ha happiness. This bill is central to that. I thought my shirt said it all here. It does. [laughter] hes getting ready for st. Patricks day. I was making a point going back to the question about the path as mr. Israel said. There has been more republicans retiring and we have a bigger chance of taking the seats from them. 133 in competitive districts. So in that oh, 113. Sorry. I think we stand well in terms of anticipation of the election. But that is months and months away and a lot can happen after we raise the minimum wage and Immigration Reform. I am going to make you a single weapon. Thank you very much. I have one more thing to say my colleagues set this up as we have the frame of building an economy that works for allamericans. The theme of the conference under the leadership has been strengthening ladders of opportunity. We see as a first long in the ladder, raising the minimum wane. And we see another wrong in the ladder of passing Immigration Reform. And we want to do so appropriately in the presence of so many stakeholders in that issue so that will be coming soon. But today we are announcing the first wrong minimum wage. Part of the full agenda and very central to who women succeed, America Succeeds. Happy valentines day. President obama will be in cambrid cambrid cambridge, maryland to speak to House Democrats about strategy. We will bring you the remarks live. Regular watchers of cspan 2 might have vonoticed something unusual about the vote on wednesday. We have more on what happened during the vote what happened wednesday during the vote was that the decision was made and we are learning from harry reid that the decision was made at the request of Senate Republicans to not have the clerk make the usual announcements of vote positions as the vote is ongoing. So the microphones were turned off. So if you were anywhere other than in the chamber itself, you were left to guess what was going on in terms of what the vote count was during that extended viewing. Frequently what happens, as regular viewers knows, the clerk after going through the list of names and calling the role the first time, they will announce which senators voted in the afirmmitive and which in the negative. And then they will do a rolling announcement as others come and go and cast their vote. None of that happened yesterday. And this raises all sorts of questions. And as you reported, you and a number of other reporters, were questions this, and several other reporters, Andrew Taylor of the Associated Press is leading the chase for this. You are saying the republicans requested the microphones be turned off . That is correct. What i just received, and this is a quote from harry reids spokesperson the clerk didnt call the names at the senate request to make it easier for Republican Leaders to convince their members to switch their votes. End quote. That is what was suspected by people monitoring this. There were a number of senators who were republicans who after their vote it was clear they were 12 votes short of the 60 votes needed for a fill buster. So it was clear there was arm twisting going on to get over that hurdle. It wasnt clear that was going to happen until a republican from texas, john cormin, and Mitch Mcconnell voted in favor of the motion to cutoff debate. On that arm twisting, and you and others wrote about this, lets talk about the politics for those who didnt see the vote, what was at stake in bringing the debt ceiling for the senate . What was in stake for the republicans voting for it . The bill is a clean suspension of the debt ceiling for about 13 months. They are voting on, if you are a republican, or someone who is in a republican primary contest, there have been arguments that the republicans voted in favor of giving a blank check for more government borrowing for a little more than the next year. And that will not play in the republican primaries. And i think this is something that the republicans generally didnt want to have to vote for. They voted against it on the final passage vote. But as observers of the senate know very well, this isnt the kind of thing where the final vote is the one that is important. The vote that matters is the 60vote threshhold and this was demanded by ted cruz who wanted the threshold. Among the pieces you are writing on your blog, you said the republicans requested the microphone be turned off. Have the colleagues in the galley and yourself seen Something Like this before . We could not recollect. And i have been up there for several years on a daily bases and several people were there far longer than i could, and no one that i spoke with could recollect a similar situation where the microphones were turned off for the entire vote. And the other thing i know is i have checked in with a fellow who was a former senior floor aid and his recollection is it may have happened or hasnt happened frequently or recently. Although, people who sort of deal with the floor regularly are saying that vote announcement process, in their view, is more designed for the information of other senators and their staffs people who are on the floor. Although, it has become, in the televised world watching from another spot is paying attention to that. Cephal the viewers can continue to watch the senate when they return. Thanks for the update. An official tally sheet of the senate vote was reported to cq roll call and indicates the senators switched their vote from no to yes to end debate and bring there debt ceiling with too a final vote. It is possible that some of the markings on the page are due to a clerical error. You can read more at rollcall. Com. Next, here on cspan2. Drug shortages are examined. And then the Small Business committee looks at how elderly people are becoming Small Business owners. And then a look at how states handle emergency weather. Privacy laws are discussed later on. And then we look at Food Security issues and americans access to food. And your phone calls, Facebook Comments and tweets. Washington journal is live at 7 p. M. East. And friday, we will have a forum from the korean studies. You can see it live here on cspan. One of the things we worry about, obviously, cyber attacks, but physical dangers. And i think about what keeps me up at night when i think about what can happen next. I wonder what your greatest fear as to a physical attack here in our country is . I would say on the cyber side, i think an attack against our Critical Infrastructure and transportation, health care, financial and energy sector. On the kinetic side, there is a range of things that keep me up at night. When you see the mall attacks like in nairobi and during the Boston Marathon those are the things we Work Together to make sure we are sharing whatever we have on the defense side and also on the federal, state, local and tribal levels. I think that is an important aspect of what we are doing in the Intelligence Community the Senate Armed Services committee looks at worldwide terror threats, and terrorism. And as part of president s day weekend, on cspan 3, the american president s and the p portrpo portrpo portrait gallery. Now we have a hearing on the subcommittee and health about drug shortages. This is an hour and 15 minutes. The submcommittee will come o order. The chair recognizes them seset. In years, we have seen an increase in the number of drug shortages in the United States, particularly with generic sterile, injectible drugs. While the number of new shortages dipped, the total number of ongoing shortages have increased. This is unacceptable. What is the agency doing to help address these situations . News reports are highlighting coverage of items that are missing such as common saline solutions. Delays in treatment, rationing of care and higher cost are some of the problems this is causing. There are medical errors are providers are forced to seek alternative treatments. There is no simple solution to this challenge problem. To present and mitigate drug shortages and submit annual report to congress including relating actions taken by the agency. It also require gao to exam the cause of drug shortages and formulate recommendations how to prevent it. Last october fda issued the Strategic Plan for preventing and mitigating drug shortages. It only covers the first three quarters, 2013. They release the final report. While drug shortages continue to plague our health care system. They indicate some progress on some front. Im pleased to see the legislation has had a positive impact. I would like to welcome our witnesses. Marsha cross, health care cricketer at gao and douglas, Deputy Director of Regulatory Program at the fda. I would particularly like to thank gao for their comprehensive report. And the time they have spent with my staff on the issue. Ill yield the remain of my time to vice chair dr. Burg ease. Thank you, mr. Chairman. When doctors dont have the essential tool theyre restricted in what they can do for their patient. Members in this committee have taken the lead and made major strides by passing the food and Drug Administration safety and invasion act of 2012. In addition, i have worked closely with chairman upton and chairman pits on several of the provisions contained therefore in and things have gotten better. As recently as last week the food and Drug Administration listed sodium chloride as a drug shortage. Its not a particularly exotic molecule. For having that much trouble with salt, it only makes you wonder what other more difficult molecules may the shortages may encounter there. Food and Drug Administration has a role in addressing drug shortages. It is a complex issue. In 2010, over 240 drugs were in short supply or unavailable and more than 400 dper gear in rick were they operate on a margin so tight productions becomes corrupt companies cannot afford to continue the manufacturing. This leads to one of the more more than 3,000 backlog of applications. Physicians are faced with having to tell patients they cant receive the care they need not because there is no treatment because a product is simply not available. I thank the chairman for holding the hearing. So we can learn more on the drug shortage problem. Im pleased General Accountability Office report is being released and look forward to hearing from them on the findings. The law is aimed to ensure providers have the tool in this case need alleviate suffering of every patient and certainly anxious to hear testimony today yield back to the chairman. Thank you, chairman. Im glad were having the hearing today on the critical issue of drug shortages. Over the past several years, weve saw an alarming trend of increases in drug shortages. We know the devastating effect this can have on patients prolonging disease or closing permanent disability or death. This is an issue i and many of my colleagues on the committee long concerned about. Congress took action to provide the food and Drug Administration with tools to help address the problem through provisions in the food and Drug Administration safety and invasion act. Which passed on the strong bipartisan basis in 2012. We asked the government Accountability Office to reveal several factors related to drug shortages. I want to highlight the other aspects that addressed drug shortage problem. In the 2011 report the ago recommended and we heard from other stakeholders too and early information to requirement for potential shortages so fda can work with manufacturers sooner to take steps to prevent or mitigate shortages. We included sufficient a requirement in it and encouraging that the number of new drug shortages declined in 2012 compared to the previous two years. And that partial data from 2013 in the case of the trend is continuing. The fda has cited this and other drug shortage provisions as contributing to their ability to prevent by their calculation 140 drug shortages in the first three quarters of 2013. We also heard from stakeholders the need for fed to review time for gear in rick drug applications and reduce the significant backlog of pending application. As we heard a few months ago the agency has been a aggressively hiring for the generic drug program. Which is of course the complex problem. As im sure we will hear today from the witnesses drug shortages remain high and remain a problem. Many of the shortages are still a sterile injectable drug. Im aware the drugs face unique changes because they are technically difficult to manufacture. And each drug is also manufactured by one or a small number of Companies Making it difficult for other companies to be able to fill the need if any one company developed manufacturing problems. So it is clear while we have made progress in some areas, our work is not over, i thank our witnesses from fda and gao for being here to continue the topic on drug shortages. I look forward to learning with a we can do to prevent prevent them. I yield back. The time recognize the vice chair of the committee, gent the lay gentle lady from tennessee. I want to welcome our witnesses. Thank you for being here. I thank the chairman and the vice chairman of the committee for their attention to this issue. As you know, 2012, 2011 we healed hearings. We have looked a the the process and what the factors are. That are causing the drug shortages we know they increased recent a years. Lets get to the root cause and the problem. So we are solving this. I continue to talk with those Health Professionals in the community and tennessee and get their input on this. We take a bipartisan action. The chairman and the Ranking Member mentioned. And that was to address it the shortages and they did provide fda with the authority to say needed. It put new requirements on the manufacturers to help prevent and mitigate the shortages or supposedly on paper that is what theyre to do. So this is a wonderful opportunity for us to look at the gao report. To question do you hear from you and continue to try to look at the systemically holistically and get to the root cause of solving this problem. And mr. Chairman, i yield back to you for further yielding. Chair thank the gentle lady. It concludes the panels or members opening statement. On the panel today, we have two witnesses dr. Marsha crosse. Health care us Accountability Office and dr. Doug Deputy Director for Regulatory Programs. Senator for drug evaluation research. Thank you for coming. Your written testimony will be made part of the record. You have five minutes to summarize your opening statement. At this time the chair recognizes dr. Croses for five minutes for summary. Mr. Chairman, Ranking Member, members of the subcommittee, im pleased to be here today. To discuss our work on drug shortages. As you know, prescription drugs are a critical part of political care. Over the last decade theres an increase in the number of drugs that are in shortage. It included drugs that stablize dray tray ma victims, control pain during surgery, to treat heart disease, and cancer and provide nutritional support to premature infacts. A study you mandated. Im happy to discuss our key findings. We found the number of short shortages remains high and providers experience challenges responding to without affecting patient care. Beginning in 2007, the number of new drug shortages increased each year until 2012. When the number of new shortages declined. And that downward trend appears to have continued through 2013 based on the partial d. A. We analyzed. However, while the number of new drug shortages has begun to decline, the total number of shortages active during a given year including both new shortages and ongoing shortages that began in a prior year, has continued to increase because many shortages are prolonged with some spanning multiple years. The majority of shortages are Sterile Injectable Drugs particularly generics. Shortages of mltly necessary drugs can have a range of negative effects. A drug shortage may require providers to delay or ration care, create difficulties finding alternative drugs, increase the risk of medication errors, thread higher cost, reduce time for patient care, and result in the stockpiling or hording of drugs in shortage. For example, providers may have to ration care by prioritizing the patients who have a greater need for the drugs. The immediate cause of a drug shortage can generally be traced to a manufacturer halting or slowing production to address quality problems. Triggering a supply disruption. Other manufacturers have a limited ability to respond to supply disruptions due to con constrained manufacturing capacity. We also identified potential underlying causes specific to the economics of the generic sterile injectable drug market. Such as the low profit margin have limited Infrastructure Investments or lead some manufacturers to exit the market. Although there are few studies of underlying causes, among issues that have been examed are purchasers focus primarily on price rather than quality, reducing incentives for manufacturers to invest in maintenance or quality improvement. The group on the behalf of hospitals and other providers. Lowering Profit Margins for manufacturers that win contracts and leaving losing manufactures to exit the market. And 2005 change in Medicare Part b. Drug reimbursement policy for outpatient providers decreesed both demand and prices for generic drugs. The stakeholders we met with, which included manufacturers and Group Purchasing organizations has ,000,000ed view on the potential underlying causes with no general agreement on the role such factors may play. In examining fda activities, we found that the agency has prevented more potential Child Support age shortages and improved it. The new requirement that manufacturers must notify f f a in advance of a special short age allowed them to take steps to prevent and mitigate short ages sooner. For example, it has expedited application reviews and inspections. Exercise Enforcement Discretion, and helped manufacturers respond to quality problems. These steps are important to respond to some of the immediate causes of shortages. However, some of the underlying causes we identified are beyond the agencys authority. As fda does not have control over private Companies Business decision. For example, the agency is unable to require manufacturers to start producing or continued producing drug or build redundant manufacturing capacity regardless of the severity of a shortage. Of the information it has to address drug shortages. We identified shortcomings in the management and use of the agencys drug shortage data. And our report we made recommendations to fda to improve it data base and to conduct routine able cease of the agency agreed with the recommendations. In summary, all fda has made progress in preventing potential drug shortages, and responding to actual shortages, the number of shortages remains high and many persist for months and even years. The large number of potential shortages reported to the agency suggests a market is still at risk of supply disruptions. As a result, patients and providers will continue to struggle as a essential and life saving medications remain short supply. Mr. Chairman, this completes my prepared statement. I would be happy to respond to any questions you or other members of the subcommittee may have. Thank you. The chair recognizes five minutes to summarize his opening statement. Mr. Chairman, and member of the subcommittee. Im douglas Deputy Director of fda center for drug evaluation and research. Thank you for the opportunity to speak you about it about the work they are doing to address drug shortages. I would like to begin by discussing their causes. Drug shortages as others have said are usually proceeded bay disruption in manufacturing of a product. Some product disruptions are manufactured or controlled such as decisions to permanent discontinue reduction of a drug no longer profitable. Other factors are outside the manufacturers control such a natural disasters or the unavailability of materials needed for manufacturing. A particular problem the materials are only available from one supplier. Most often; however, shortages are the as a result of quality failures within manufacturing facilities. Preventing the supply disruptions acquires the manufacturer to commit to Quality Manufacturing. Turning to drug shortages in the u. S. Today work remains progress has been made in the prevention and resolution of the drug shortages in the united. The agency is well positioned to work with manufacturers to find ways to prevent or reduce a shortage impact on patients provided we are aware there is the potential for a shortage. Early in timely information to by manufacturers has aided importingly by the executive order of the president as well as by passage of the it and enabled fda and manufacturers to prevent 170 shortages in 2013. We are also seeing fewer new shortages. Nut number of new drug shortages in the United States Rose Steadily from 60 in 2005 to alltime high in 2011 of 251 new shortages. After a seer of interventions the number of new drug shortages has fallen to a low of 44 in 2013. There continue to be shortages that persist for longer periods. Here while progress is being made expediting fda inspection and review the submissions for manufacturers currently producing as well as manufacturers who are interested in starting new production of a drug and shortage. And finally, exploring Risk Mitigation measures for products initially not meeting established stoonders allow them to remain available safe will safely. It do not change it balances our standards with the needs of patients for particular products. Considered before taking Enforcement Actions or are issuing warnings letters. Inappropriate cases temperature prayer exercise of regulatory flexibility is important tool in ensuring access to needed drugs. As a part of the work on drug shortages in 2013, the fda released the Strategic Plan as calmed for. The goal of the plan are to improve the agencys response to drug shortages anded a van locker term approaches for addressing the underlying causes of shortage. First, to improve how we address imminent or existing shortages ftd as potential shortages focusing in three areas. First, improving Communications Communications with within it the fda to ensure that our decisions are official and appropriate. Second, we are improving our data bases related to drug shortages creating a dedicated drug shortage data system to improve how we track drug shortages and allow us to better assess progress on prevention and mitigation of the shortages. Including the work we do to produce the annual report to congress required under it. Recognizing the commonly begin with the supply disruption related to product quality fda long range effort include a focus on preventing supply disruption and shortages by encouraging and sustaining improvement in manufacturing quality. For over a decade, fda has been working with academics and Industry Experts to stimulate the development of novel Manufacturing Technologies which can help prevent drug shortages linked to manufacturing quality. In conclusion, progress has been made in efforts to prevent and mitigate important drug shortages aided by Early Communications with sponsors about the potential. Shortages dont occur fda will continue to work to address them. Importantingly, fda dont work with others to support the pharmaceutical industry in the longterm effort to modernize drug manufacturing to prevent shortages. By working together, we can prevent drug shortages from occurring, address them when they occur, and provide patients with access to medicines when they are in critical need. Im happy to answer any questions so you. Thank you. It concludes the Opening Statements of the panel. Well now begin questioning, and i will recognize myself for that purpose for five minutes. Doctor, while it required that the report be submitted by no matter than december 31st, 2013, fdas first annual shortages report was submitted to the committee on february 5th. And with d. A. From only the first three quarters of 2013, you notice 170 shortages were prevented in 2013. This is up from 140 in the report fda submitted. I assume it means fda claims to prevent 30 shortages in the Fourth Quarter of the year, is that correct . We do have our full year Data Available now. We would be thiep that share with you, mr. Chairman. All right. Lets use that smaller sample size for sake of discussion. It would be help to feel have more detailed information about how fda prevented these shortages. What specific actions did the agency take . Which drug products would currently be in shortage if not for the agencys actions . I can get you some specific information. I can give you a general sense of some of the activities that we took in this last year. If that would be helpful. All right. One issue regards something called regulatory flexibility. These are places where we either expedited additional actions that otherwise would taken bit longer or taken a review and underhanded additional work on it. We had 76 instances of regulatory exercise effecting a total of 86 product. Theres another way of thinking about actions we have taken recently to speed the qoment of products or assure that product that go in to shortage remain available. Several of the offices receive applications from sponsors for new factories or new lines within a factory. Last year my office of generic drugs exexpedited 118 applications involving a total of 62 accelerated new drug applications. An important number of products where we worked hard to make certain they were more quickly reviewed than normal. Our office of new drug quality, which is another office looking at supplemental applications to approved drugs that improved innovator drugs. Looked at 52 supplemental applications and expedited form last year. And finally my office of bilogical products which look at new products very important issue in term of therapeutic qoment. They expedited seven reviews last year. I think in total those things reflect the commitment that my center has to looking at them. Expediting whenever were able to do it. You mentioned the office of generic drug expedited 118 applications included 62 abbreviated new drug applications. In order to prevent or mitigate a shortage how many of those application. Actually approved . I need get back with you about that information. Obviously were applying our usual standards but 118 applications speak to the level of effort we have undertook. On average how long did it take fda to approve the review status . Its a good question. Ly get back with you. With that information. Okay. I would like know more about expedited review means in this situation. Referencing a product in shortage go to the top of the cue is there a special team within the office of generic drugs responsible for moving them through the review process faster . This will be a longer conversation as im sure youre aware. We have number numerous forces under the act. As part of the resources we reorganized the Office Generic drugs. We are elevate it in term of the importance within the center for drugs. Its a part of that action were looking to be as efficient as we possibly can. To an your question, im going need to get back and look at the kinds of changes that office has made without the review staff. Did you have any discussions about what it mean farce shortage product to receive expedited review status within it . We did talk with fda about this. We are continuing or work where we plan on taking more indepth review of the number of drug shortages expedited and how that relates to the number of applications that are sitting in the cue for drugs that are . Shortage. One issue, of course, is that even when you expedite app an application if it is approved that doesnt mean that the manufacturer is ready to begin production that day and there is some concern that approving one may displays another drug within that manufacturers facility if youre trying to move very quickly to move something to the top of the line without the sort of normal planning time. So that is something we heard about. But we are looking further to try to get some statistics for you on how frequently fda is moving on the applications. And what proportion of the applications are getting moved on. Yeah. And i would also be interested in how fda works with the manufacturer to address their targets to assess Production Capacity and output addressed the shortage. My time is expired. The chair recognizes the Ranking Member for five minutes for question. Thank you, mr. Chairman. I want to start with the doctor doctor. I would like to know how helpful youre finding the drug shortage provision in it. I would like to hear more about the Strategic Plan for preventing and mitt gag drug shortages. I was pleased to see it released last october in one of the obligations. Essentially three questions. When you update how it stand today with with regard to the drug shortages in the agencys plan to address them. And now the fda has some experience with it, are there parts of the law dont work as intended or, you know, as well as as they should . And third are there other areas we should be thinking about to help address the shortages . Thank you. Let me say the provision of it that expanded the information to that manufacturers have been providing for us has been enormously helpful. Its hard for me to overstate that. We are learning about shortages earlier than we had previously. It is giving us the opportunity to talk with manufacturers in ways we hadnt had an opportunity to before. And we have been able to prevent short ables as a result. So unquestionably that aspect of it has been useful from the fdas perspective. We continue to make use of it. As you know, are continuing to write rule making and things related to it. But it is fundamentally a valuable aspect of the work were doing that is useful. The other aspect i think have been useful for us as well. The requirement to produce an annual report i think is valuable because it does give us an opportunity on annual basis to look back and assess whether there are things we need to continue to work on where progress has been made. Thats a piece we were able to provide to you recently for three quarters of the years data. We obviously need to update you with the full year data. We think that gives a fuller picture of the activities that the fda has conducted. And so fundamentally it has been valuable to us from a shortage prevention strategy. You asked whether addition signal things were identified in the Strategic Plan that needed to be done and the short answer is yes. There are many things we can do internally. There are things we need to do from a process sphoaft make sure that the fda continues to improve our responses to the drug shortages issue. Those relate many of them to process. I share the task force that has been steering our response to drug shortages since the passage. That task force is made up of individuals from across the agency so not just simply my center but also the center for buy logics, the Inspection Branch of the fda all of us are coming together to talk about the things we need to do. The things we need to communicate about better. To be able to basically do the job more feshtly and more appropriately. We also recognize we need to improve our communications to communications we place on the website are looked at hundred of thousand of times by individuals looking for information about shortages. We heard loud and clear when we talked to the stakeholders that needed to be improved so the information was easier to find so that topical information was easier to identify the normal shortage, for instance, was at the top of the cue. You opened up the web page you get the information quickly. We have heard the kinds of comment. Were doing what we can to improve the communications. Separately; however, there are things that as doctor said outside of our scope and outside the thing the fda is able to undertake. There are things that the manufacturers, we believe, have a role to explore. There are other thicks that other stakeholders could explore that have great potential, i believe, in addressing underlying causes of shortage im happy to talk with you about those if youre interested. Let me get to one more question. One of the gaos investigation they conduct routine able sis to identify trends. That seems like a reasonable suggestion. Request you tell us a little bit more what you shop the improvement will accomplish and fda believe that performing analysis such as gao recommendation help it come up with the recommendations for avoiding shortages. 15 seconds. Thank you, mr. Chairman. And again, i thank each of you for being here with us. I want to ive got just a couple of questions. I know, that the fda report said, you know, the number of reporting shortages has declined in 2012. And for the first three quarters of 2013. But then gao says the total number of active shortages continues to be high. So do you each agree with that . Dr. Croses . Yes, we agree. The number of new shortage has decreesed. And we think that the early information to has been very help informal that regard. But a number of shortages have persisted across time okay. I think we present that information in your report. Yes, you do. Do you continue do you agree with that the shortages continue to be too high . Absolutely. Okay. Just want to be sure. Everybody is in complete agreement on that. Because what i am hearing from the providers in tennessee they agree with the gao report. And they look at yours. Its kind of a head scratcher. Because theyre not seeing the amount of the improvement your report would lead people to believe is there. Injectable drug. The ive fluid. The medications for anesthesia, some of the cancer therapy. These are problems. You might be making some progress. It is not coming fast enough. Let talk about fda implementing the system preventing getting to the point if they can prevent new shortages in decrease the bag lock of the current shortages. Give me a couple of things we need to be holding them responsible for doing. I think we need to look a little more closely at the generic drug applications. The tex tend they have been able to expedite the applications, which could be something that would help. Okay. There are stale number. If i engage you. You said you expedited 118 this year. Generic applications. Okay. With a would be a better number . If you were setting a goal for him. How many should they be expedited this year . I dont know. I dont know. I think there is a concern if you expedite too many then youre creating a clog at the top. And even within the priority. And approved but then they cant put straight in to manufacturing. Right. There needs to be conversations within the manufacturers about how quickly they come online. They need to be engaging them on the front end rather than the back end. At this point, approval. Would predictability in the process with the review system. As i talked to some that are working generic space biotherapyic space, the un pre predictnt seem to be a problem. Its not something they pointed to here because the unpredibilitiability when a shortage might occur. Okay. I want to draw a distinction between the number of ongoing short acts that those that last extend period of time which are important. Its one group of shortages. I think we need know less about than we need to. Having said that; however. Ic we have to acknowledge there has been work that has been important that has been able to prevent new shortages from adding on to that pile, if you were. We were able to prevent shortages that matter. Our new important task. A task we need undertake is understand those longer. My time is expired. I thank you for that additional explanation. Mr. Chairman, as i yield back, i want to take a moment and wish happy birthday to congressman gut i. I yield back. Happy birthday. The chair recognizes the Ranking Member of the full committee. Five minutes for questions. Mr. Chairman, i thank for your courtesy and holding this important hearing. Properly address the business of the properly address the business of the entity. While we made some progress in this area the last time the Committee Held a hearing on drug shortages the situation was dire. Is it correct that the number of new drug shortages quadrupled from 2005 to 2011 . Yes or no . Yes. Yes. From, is it correct that fda successfully prevented 170 through shortages in 2013 . Working with manufacturers, yes. Doctor, at that time used slightly different metric. Did the agency also find a decrease in new drug shortages in 2012 . Yes. Did the new authority provide to the agency in fda sia help fda to reduce the number of drug shortages. Yes or no . Yes. Would you submit to the record additional changes that need to be made to further reduce the delays and the shortages when they occur. Yes. I also would like to know would piers them and more money assist fda in terms of addressing these questions . Would you commit a monoimraf. Do they need additional authorities to help combat both existing and future drug ages. Yes or no . Existing authority are providing important tools. Would you please detail response to the record including the resources needed by the agency . Yes. Doctor cross, gaos report on drug shortages face two rights to fda specifically you recommended the agency uses drug shortage data base in more proactive manner to identify friends and veterans to help prevent shortages before they occur. Is that correct . Yes. Doctor, does fda agree with this recommendation . Yes. Would you please both submit a detailed response for the record regarding how fda could use this data base more proactively and whether you need more resources to implement the recommendations . Yes. Now i am pleased with the progress made. And preventing drug shortages since the passage of fire fdas sia. We need to take step back and look at the big picture. Drugs are in shortage because we simply arent making enough of them. As you know, many current short js are generic Sterile Injectable Drugs. Does fda believe there is sufficient this market today . Or more needed . Important question i cant answer it without fuller discussion with more stake yes. Now, i think it is time to start thinking outside the box about how question continue to make progress on preventing these drugs. And combating existing shortages. When you do a new innovative idea to help solve the problem as well as cooperation for all stakeholders. I look forward to working with my colleagues on the committee, the fda, and all stakeholders on this critical issue of moving forward. Mr. Chairman, i thank you. I yield back the balance of my time. The chair thank the gentleman. Yield five minutes to dr. Burr guess for questions. Thank you, mr. Chairman. Doctor, we have the executive order from october of 2011 and then food and drug reauthorization in july of 2012. But for the casual observer to this problem of drug shortages, can you kind of give us a thumbnail what is being done to deal with the existing drug shortages . We have a number of things. First off, existing drug shortages especially those that lasted for a prolonged period of time are hard to resolve. Hold on for a second. Let me ask you the manufacturers have been responsive . They understand the issue. We have been in close discussion with many of the manufacturing organizations Police Department a and other groups. They identified this group. These groups of longer term shortages as things we need to continue to talk about absolutely. Is dr. Cross talked about Enforcement Discretion and you talk abouted exercise of regulatory flexibility propofol is there anywhere where regulatory for examplability may help in the particular sort age . They were in limited ability because they are having a hard time producing enough sufficient materials. Fda expedited any and every review. Expedited all of our activities to make certain whatever the manufacturers was able to provide we were able to make certain available to serve the infant the newborn as quickly as possible. We had other camps where they have been found. Camps of drugs and shortage. Articulates have on surface required sensation manufacturing. Have it has been scoafm. Well talk about propofol. I get a lot of questions. Lack of anesthetic drug is a big deal. Absolutely. And propofol is a slightly different situation because theyre the issue is a large fraction of the prop follow comes from there are concerns about importation because of use of propofol in unapproved uses. The fdas interest focus weve had is make it available for patients who are using it on label. As indicated. As you said in outspaisht settings for an though an though is a. Received when it was indicated for them. Abbreviated to the other compound peevely available. Absolutely we know in the past there was a propofol shortage move from propofol to other products they were less familiar with, you know, mistakes occurred. They were not as familiar with the dosage and how to monitor patients and things like that. Making certain the product is available is important for the u. S. Just very briefly. And the cost for tam flu expore initially increased. Did you speak to that. I havent heard that the cost of tam flu has spiked. There are other increases in pricing that we have been hearing about. Its not something that the fda normally has the Statutory Authority over. And while there were some spots shortages with tam flu we think were able to produce the needed necessary amount of it necessary. Thank you. I have some additional questions ill submit in writing. I thank you for the courtesy. Recognize the lady from virgin islands. Thank you, mr. Chairman i want to thank you and the Ranking Member for the hearing today. While im happy to hear that the drug shortages are reducing as everyone has said they remain too high. And we know that rural areas communities of color, territories like my district will be some of those where we will feel it. The most where there is a drug shortage. I will a i have a question that digs a little deeper in to my colleague from tennessee. The vice chairs question. They were forcing manufacturers to come up with a stateoftheart manufacturing practices even though the old tried and true were completely adequate to ensure safety and effectiveness. The argument is meet the new status some companies had to shut down. The facilities resulting in shortages. And eventually those warnings unfortunately came through. Can you comment on these two different perspectives . You mentioned in your testimony that fda is trying to encourage industry to duck new technology for at the same time that fda is not raising the bar. Not raising the bar in standards for existing appropriate technologies. It seems very nuanced point. Can you e lash rate for me . Absolutely. There are a set of standards that are in place right for manufacturing for certain Quality Manufacturing that we would expect the firm making propofol, the firm making a tablet form whatever. The set of standards they have in place that would guide, you know, the manufacturer of product so the sufficiently safe and 66 indication and Quality Manufacturing. Those things are working. And were not changing those standards to help guide drug manufacturing. And then make recommendations in the form of guidance and ways that manufacturers can look at to do better than the current. Were not looking to change the current assessable processes. Were looking to increant vise a move toward a more efficient and continuous kinds of manufacturing we think offers a lot of potential for preventing shortages by improving the overall quality of manufacturing. Thank you. Dr. Doctor would you like to add anything it. Well, too, heard from industry. The same concern and fda. The same response. Fda has moved increasingly and now under it explicitly is moving to a riskbased nmtion Decision Making process about which manufacturers they should be inspecting which frequency. The drugs that are in shortage of the sterile injectables are inherently risky in the manufacturer. And so you would expect there to be a higher level of inspection of those facilities. Just because of the risk of the product. We as part of the ongoing work i mentioned before. We are looking at the pattern of inspections that have fda has had across number of of years of the facilities to see if were seeing any change because it was a concern raised to us by manufacturers. It doesnt focus on shortages of millionly important jokes. Can you tell us how trends provided in the report are likely to track with the millionly important drugs. Is that something you can focus on in the future . Theyve had a data base for longer. We were able to look at trends across time. Fda didnt develop it until 2011. We wanted data going back to 2007. The majority of the data that utah millionly necessary drug. Theres a close alikement. Theres a difference in the way fda and utah count the drugs. So the numbers may look different even though you are talking about the same drug shortage. This really important for me to always remember the whole project pie. The military and the like. In the budget debate as people say we hear the discretionary part of the budget, we are illed a violated not to always talk about the problems of mandatory spending. I would say fda is one of the few agencies that got a few through the budgetary fights than a lot of other agencies. Which iman in prior years. Now i guess the first question i have is on so in the 2000 you have 40. Thats true. Not cumulative of all. Some are resolved and so they drop out. We have some extended for five years. A small number. Most are resolved within one year or two years. But there are a few small number of shortages that have continued across multiple years. Thank you. The lighter plu portion is success has been made in the new shortages. What most people talked about. I guess a couple of years ago when weve been having this debate, i always wondered why the market itself doesnt respond to alleviate the shortages based upon a price. Dr. Burgess mentioned mentioned which you may have dismissed there was a tam flu signal sent. I dont know that you said you didnt know that. Why i have a minute left. Is there something structurally about how we either the government in its coding or its spend through medicare and medicaid or the assurance applications of purchasing drugs. Is there something that distorts the market signals for shortages . Im not sure, you know, we didnt really look at that. Maybe thats something mr. Chairman followup with. On another question in the future. What do you think. I think others commented economics have to be playing a role in the decisions that the manufacturers are making here. I think we know less about that speaking for myself. Those are important. A lot of these shortages are low margin generic drugs too. If theyre low margin they make penny on whatever the application is. Others remember better. Someone said the profit on a dose in the tens of cents. Great. Excellent. Thank you very much, mr. Chairman i yield back. Gent nice the gentleman from kentucky. I appreciate what the gentleman from jill is asking. I had a High School Reunion with friends. A friend of mine is an physician. He was telling me about the shortage of drugs. It wasnt the expensive stuff. He couldnt do the service. There are price control but not ability to move the price for some reason. To investigate then you would say it is going to be shortage in quality. Its two things you mentioned shortage of the ability and quality and seems theres not a price signal that gentleman from illinois allow other people to enter. Were not talking about hundreds of dollars or thousand of dollars. Were talking about cents and dollars. And people are getting over that. In the