>> i thank the representative of jordan for that statement. i shall make a statement, speaking as the representative of luxembourg. luxembourg deeply reset -- regrets of the resolution of prepared by the united states of the america was not adopted because of the member of the council russia. luxembourg voted in favor of the resolution. why? this draft resolution was anchored on principles of dialogue.

this draft resolution was intended to record the principles of the united nations, particularly in article two of the charger. it was intended to research the support for the sovereignty and territorial integrity of ukraine with in its internationally recognized borders. the security council should be unanimous and upholding these principles. the united nations charter stated that the security council shall act in accordance with the purposes and principles of the united nations. today they presented the security council from complying -- prevented the council from complying. now dialogue and implementation

of chapter six, the draft resolution before the council this morning was intended to urge all parties immediately to seek a peaceful settlement i direct this. and to engage fully in international mediation efforts. the referendum organized for tomorrow is intended to amend the statutes against the will of ukraine. this would be a unilateral act which would run risk of seriously destabilizing ukraine in the entire region.

the member states of the united nations have conferred on the council the chief responsibility for keeping this. we prevented the security council from carrying out this responsibility and interest in ukraine and europe. the referendum organized tomorrow runs contrary to the constitution of ukraine that says the territory is indivisible. the referendum is contrary to the constitution of the autonomous republic of crimea. the international community can in no way recognize its result. this is part of a vicious cycle. to authorize the use of russian armed forces on ukrainian territory and subsequent actions consequent the international law.

these actions violate the commitments russia entered into within the framework of the budapest manure and him. -- referendum. had it been adopted, the draft resolution would have been a contribution to halt this vicious cycle and it's accompanying nationalism. essentially for russia. would it be naive to hope despite this failure we can find a peaceful resolution? luxembourg is not wish to abandon this hope.

diplomatic efforts must continue to achieve a solution respecting the political independent territorial integrity with in ukraine within the interest of prosperity in europe. i shall resume my function as president of the council. i now give the floor to the representative of ukraine. >> thank you, madam president, distinguished members of the security council. i would like to express my sincere gratitude to the members of the security council for the overwhelming support of the resolution as well as for your support in trying to resolve the crisis by diplomatic and political means. i would like to thank all of the cosponsors of the resolution for your support.

we really need your support. i want to assure you that it is highly appreciated by the people of ukraine. i would like to particularly thank the member states under the budapest memorandum who supported ukraine. the united states, united kingdom, france, and china to several times a voice in favor -- who several times voice in favor of territorial integrity. the russian federation violated its own obligations. this appeals to the russian leadership. very successful. what we are discussing today, the crisis in ukraine in crimea. i got a call 40 minutes ago.

russian troops entered the mainland on the south from crimea. now we're facing new developments. we are to face further dangers. i ask you to find the means and measures as well as the bilateral level to do what is responsible to stop the aggressor. this is not a surprise this comes at custom for any measures to maintain international peace and security.

it is giving commissions in syria. it brought thousands. i'm confident we will speak about the reforms of the security council. two cases, syria and crimea will be considered of examples of how the council behaves when peace is needed. in that particular part of my intervention i would like to say some words in russian. >> the representative of the russian federation has a stated it's great to be to achieved

through the blood of the second world war. i would like to recall that this was collective bloodshed. and to manipulate this bloodshed is in the miscible. -- inadmissible. you're manipulating the veto right on new blood, the blood on your hands. georgian blood, now ukrainian. this should come to an end now. today i take an optimistic you of what is going on. i am sure that what the russian federation expressed was not the voice of the russian federation

but that of the soviet union. thousands and thousands of people have come to express their desire to protect ukraine and the territorial integrity. this the democratic future of russia them. it is on this basis we will build fraternal ties. there is the fall of the whole system of value established over the years. by the untiring work of members. a system of collective security. a process of nonproliferation. they demonstrated the unity, it ukrainian events.

it protects the system. to protect the global security there is a new approach. i am confident we are capable of this. thank you. >> i think the representative of ukraine for that statement. the represented -- the representative of the russian federation has asked for the floor. >> thank you. some colleagues today went to high levels. i have to note that the ukrainian colleague went far beyond anything permissible to forward to speak of blood. the blood is not on our hands

but on the hands of your friends. the blood of the ukrainians who were shot by snipers in february of this year and to actually upheld certain ideals reasonably and said that they have fought with the soviet union. i have to note that something jumps out at me. they have discussed not very developed argumentation on the whole but distorted elements of our position. i will not, and on everything which was heard today. i will make a few notes.

it didn't not notice the smallest hint of violence. two citizens were killed by fighters. the violence had to be noted. it happened over the month. violence. it threatens to spread to other regions. they blamed russia with the illegal pursuit of the ambitions. that does not go to us. this is from the political foreign-policy arsenal of the u.s.. they spoke of truth.

they would be very interested to know if washington would pay -- play the truth about this. they spoke about the terrines and aspirations while you negating the right of the people in crimea to express their will during the referendum. my colleagues that they were pushing for but had not excepted responsibility. the people of the region were the ones that should have been involved rather than intimidating people who spoke russian there. why was this not convened? it would be proven that there is not any ideology of national radicals. unfortunately, much time was

lost. we would repeal to all to stop this confrontation and to begin constructive confrontation. it includes the eastern and southeastern regions. >> i think the representative of the russian federation for that statement. there are no further speakers. this has concluded the examination. the meeting stands adjourned. [captioning performed by national captioning institute] [captions copyright national cable satellite corp. 2014] >> see you on monday. >> and "the guardian" has photos

from criteria. a voting box and booths and last-minute preparations under way to accommodate the boat that will be held in crimea. the united nations vote that we just saw would have invalidated the referendum, but it was vetoed by russia. the recommended is scheduled for tomorrow to decide whether the province will declare its independence from ukraine and become part of russia. the associated press reports the white house is getting regular updates on the situation. president obama's national security team is discussing the situation today. he and the leaders of other western nations have announced the vote as illegal and say they will not recognize the results. a congressional delegation was in tf earlier today. the chair of the house foreign affairs committee tweets that this is going to be a bogus referendum and the world knows it. senator durbin, who was on the

delegation, says -- senator mccain, also among the group in kiev, writes -- b senators held a press conference earlier today from kiev. they spoke about 30 minutes. >> good afternoon. i am senator john mccain of arizona and i am pleased to be joined today with a bipartisan group of my colleagues, senator the durbin of illinois, senator chris murphy of connecticut, senator ron johnson of wisconsin, senator john barrasso of wyoming, senator sheldon whitehouse of rhode island, senator john holden of north dakota, and my fellow senator from arizona, jeff flake.

i won't forget when senator murphy and i were here months ago, we stood in the trade union building and watched as hundreds of thousands of ukrainian patriots stood in the freezing cold and demanded freedom, rule of law, and a european future. we are honored to be here to congratulate you on all that you have accomplished, and all of us joined the ukrainian people in mourning more than 100 brave souls who gave their lives for the ukraine's future. we met with the prime minister, government leaders, including the governor of dennis with leaders from across the political spectrum including the party's regions, and with representatives from ukraine's business communities, civil society, and the model movement. we are here to express a strong bipartisan support for ukraine that exists in the u.s. congress and among the american people. we are united in our full support for ukraine sovereignty, national unity, and territorial integrity.

then against russia's baseless violation of these principles and its efforts to divide this country. we are also deeply concerned about reports today of russian military movement into areas around eastern ukraine. these movements are deeply disturbing. ukrainian government is legitimate, constitutional, and have them portend popular mandate for change, but change will not be easy. it is essential now for the government here to reach out to all ukrainians and take steps to unify the country. among these are strengthening democracy, the rule of law, reforming the economy, and the military and moving ukraine toward europe. we are confident the government is committed to these principles. the government must also prepare the country for elections on may 25. during our visit, we have heard overwhelming supports for proceeding with elections on

schedule, and we believe it is critical. ukraine's journey will be difficult, but ukrainians will not make that journey alone. the united states and your other partners will be with you. many of us here serve on our foreign relations committee in the senate, and last week, we pass bipartisan legislation to support ukraine and support -- prepare for elections, enhance security cooperation it imposes severe sanctions on those responsible for violence and human rights abuses against peaceful ukrainian and those who threaten ukrainian stability, sovereignty, and territorial integrity, and on russian officials, responsible for corruption here. we want to assure you the united

states senate will pass this legislation imminently, and we are confident can soon become law. finally, let me say up word about military assistance, and this is my personal view. ukraine is going to need a long-term military assistance program from the united states, equipment both lethal and nonlethal. i see ukraine has been invaded. russia is blasting forces on the border, provoking unrest, threatening to annex part of the sovereign nation and possibly worse. victims of aggression wish to protect themselves and their homes from further aggression and when they ask for some modest means that can help them resist, i believe we should provide it. not to offer false hope -- not for ourselves, but simply because it is the right and decent thing to do. i also want to add there are now thousands of brave ukrainian

members of the military who are surrounding bases in crimea. we are deeply concerned about after this phony referendum that is going to take place that the lives and welfare of these individuals could be in danger. we urgently urge the russians to be restrained and to respect the lives and welfare of these brave ukrainian servicemen and women who are serving in that country. senator durbin. >> i want to thank my colleague, john mccain, and others who joined me. this is on extraordinary visit that we have made to ukraine. it is maybe the largest to senate delegation to visit ukraine in history. and the moment we came we thought was the right moment. we wanted to save the people of ukraine and million to support ukraine across the world that we stand shoulder to shoulder with ukrainian people who are seeking

a new future in a new opportunity. we know that they have a new government, with many challenges, including economic challenges. and we know that they are committed to the rule of law, to open and free elections, and we stand by them in this commitment. we have met with the president, prime minister, and leaders of this government. and the message we have given them is that we will be by your side on a bipartisan basis in the united states senate. the visit of the secretary of state john kerry, the meeting between the prime minister and the president just a few days ago are further indications of the strengthening alliance between the united states and ukraine. but we also, this moment because we know we are only hours away from the soviet style election in crimea. we know the outcome. we always knew the outcome of those elections long before they took place. keep in mind there was also a

vote today just hours ago in the un security council where the nations of the world serving a security council were asked to stand with ukrainian project this referendum. of course, the russians voted no. the chinese abstained. all other nation stood with the ukraine and the united states. it is an indication of the growing world support for the future of ukraine and resistance to what the russians are threatening now in crimea. we owe it to the people of ukraine and those in crimea to speak up or them at this moment and to tell russia we will not return to a history of invasion and aggression, which is too common in this part of the world. and we also need to make it clear that when countries like the united states, the united kingdom, russia, and ukraine enter into an agreement, the budapest memorandum, that it means something. when a country will step away from its nuclear arsenal, only asking for protection of its

territories and its future, we need to stand by them, and that is why we are here as well. we want a more peaceful world and we believe that standing with ukraine is the way to achieve that. i am proud of my colleagues are with me. i'll hope you understand the significance of our visit to the ukraine at this moment in history. >> good afternoon. my name is chris murphy, senator from connecticut and chairman of the foreign relations subcommittee on europe. senator mccain and i had the opportunity in december to stand on the maidan looking out over the almost one million protesters assembling peacefully, all united by the temperament that they wanted to bring dignity back to their country and to their existence. many were there because they wanted an orientation with your. others were there because they wanted to leaders in government, but they all held in common the basic simple belief that it

should be the people of this country, no outside entity, that dictates the future of this great nation. it is difficult in washington these days to get a group of senators as politically diverse as those that are standing here today to agree on much of anything. but we are standing here united, republicans and democrats, as we did in the foreign relations committee last week, making it clear that the united states is going to stand with a free and sovereign ukraine. that we are going to stand with this new government to help them do what it takes in order to prosper. we pass, as a senator mccain said, a strong bill for the foreign relations committee, with republicans and democrats supporting it, that will offer aid to keep ukraine's economy on its feet and deliver a strong message to russia that there will be consequences for the actions that have already been taken, and we are confident well that we will be able to join with our european allies in

delivering an economic blow to russia that will make it clear that there is a price to be paid for this type of aggression. the next several days will be critical. as we look at the broad scope of the history of this nation. we know that there are several thousand ukrainian troops whose lives are in jeopardy. we are here today to tell the russian forces that we hold them directly responsible for the safety of those brave young men and women who are now cornered in different parts of crimea. the world is watching, and the message that we bring today, both to ukraine and to russia, is that the united states senate is watching as well. senator johnson. >> thank you, mike. my name is ron johnson. i'm a senator from the state of wisconsin. i want to thank senator mccain for leading this delegation.

i want to thank my colleagues were standing together. the main reason we're here is to show that strong unified support for the courageous people of ukraine. unfortunately, i was not here for senator mccain and senator murphy when they stood with the ukrainians on the maidan, but we did walk down to the maidan. it was a moving experience. incredibly moving experience to understand what has happened, and i tell you what, my standpoint, there is one person i hold accountable for this aggression, and it is vladimir putin. and if there is further bloodshed, there is also one person i will hold responsible. there is one person that can stop it, that can prevent it, and that is vladimir putin. now, senator mccain and senator murphy mentions the brave members of the ukrainian military now garrisoned in crimea and those stationed along the border. i have seen moving pictures of journalists that have real

courage throughout this process. i want to thank all of you, and i want to ask you to maintain that courage, bring the pictures to the world of what is happening here, this aggression. it is probably the single most important thing that can be done to prevent further bloodshed. again, i want to thank our host, i want to thank my colleagues for showing the strong level of support, and i want to thank you for reporting and preview pictures to the world so that we can prevent further bloodshed. thank you. >> i am senator whitehouse from rhode island, and i thank senator the cane and senator durbin for leading this delegation. we have all been moved and inspired by our visit to ukraine and by ukraine's commitment to freedom, a simplified by the bloodstained maidan.

we hope our country can be helpful as ukraine rids itself of the shackles of corruption that have burdened its people and injures a new day. ukraine's new day is shadowed by menace, however. russia's conduct is already outside the conduct of the civilized nation. and russia has failed to provide the world adequate assurances that its conduct will not yet be even worse. we intend to take a unified message back to our president that he should support ukraine with strongest action he feels he can, to deter further aggression by russia, to protect ukraine's independence and territorial integrity, including imposing painful and damaging sanctions on russia and its industries and oligarchs. russia cannot expect to live in

a halfway world in which it enjoys the benefits of a community of civilized nations without conducting itself like one. and in the days ahead, let us all remember the ukrainian marines and other ukrainian forces garrisoned in the crimea. thank you very much. >> my name is john barrasso. i am a united states senator from the state of wyoming. a number of us on wednesday had a chance to meet with your prime minister, a man of great courage and determination, and to do so in washington, d.c., to see how the people in the united states could be helpful to the people of the ukraine. we told him that we did not think meeting with him about ukraine was enough just there. we wanted to come here to show our commitment. two people of ukraine, and that is why we are here in a unified

way, bipartisan, republicans and democrats from all different spectrum of politics in the united states. we walked the maidan. we saw the bullet holes in the trees and in the buildings. we saw the faces and the pictures of over 100 martyrs, those who gave their lives, and those faces are burned into our brains, and they will never be forgotten. we had a chance to meet and listen to members of the leadership of various parties in the government. we have had a chance to visit with people from different parts of the country, and what we heard from them and what we told them as well is a unified message of -- this will not stand. we cannot allow vladimir putin to do what he appears to be doing. we have great concerns for those who are surrounded right now in

the military barracks in the crimea, and we will hold vladimir putin personally responsible for anything, the damage that may occur to them. brave men and women risking their lives for freedom. thank you. >> i am john hoeven from the state of north dakota. i served as the governor of my state for 10 years. during that tenure timeline, i organized several trade organizations to come to the ukraine. last night, i had dinner with leaders from 10 different companies representing many other companies in many associations across the ukraine. that is from one state and our country, just one state. i make that point because we have so many relationships which we the united states and the

ukraine. we have much in common. we're here to show our solidarity. and as a way of showing that we truly are united. as senators, representatives of our congress and of our country, i want to read a short note that i took a few minutes ago when we were meeting with the ukrainian prime minister. the reason want to go through this for just a minute is because it was said by senator dick durbin, who is a democrat, and i am a republican, and i want to show that the support is truly bipartisan because i could not have agreed more with the point that he was making to reassure your prime minister that we stand with you. he said we need to take economic, diplomatic, and political sanctions against russia, that we need to use the magnitsky act to take strong action, and have it passed by

the full sun as soon as we get back. we need to undertake economic assistance to the ukraine, and we need to work with the imf to make sure that we provide that economic assistance as well as loans, not only from our country but also from the european union. we need to work with the european union so that when we say we stand with ukraine, we mean not only the united states but all of the european union and the world as well. jeff flake, arizona. >> thank you. my name is senator jeff flake from the state of arizona. my colleagues talk about walking the maidan, and to see the determination that is needed in the coming weeks and months,

just they were to russia -- this is not your grandfather's war. people are watching today like they never have watched before. there is no drama in tomorrow's referendum. but what is left unsaid, what is still left unknown, is how russia will treat soldiers garrisoned in crimea and what they do thereafter or don't do in eastern ukraine. people are watching like ever before. people can organize like never before. so we hope to have an outcome that is fitting and honors those who have fallen here. i am pleased to be here with my colleagues today. >> the time is running out for the referendum. we have talked about the

opinions of the congress of the united states that it is better for ukraine to keep up crime here and concentrate on the eastern part of the country. do you agree with that? >> we do not agree at all. we do not agree that vladimir putin has a license to invade a sovereign nation, as was mentioned by senator durbin. an agreement in 1994 that was made when ukraine gave up its nuclear inventory and return for guarantees of its territorial integrity, so we do not, and the last thing we want to do is send any message to people in crimea that we have abandoned them. yes, sir. >> cnbc. you wrote today, three u.s. presidents have sought to work with president putin when interests converge.

those interests do not converge much. he will always insist on being our rival. how far away is that rivalry between the u.s. and west and russia from becoming a new cold war? >> i do not believe there will be a reignition of the cold war. but i do believe it is long overdue that we understand vladimir putin for who he is and what he is and what his ambitions are. this is a person that stated that the greatest catastrophe of the 20th century was the breakup of the soviet union. this is a person who wants to restore it. this is a person that occupies parts of the sovereign nation of georgia, that occupies moldova, that has now acted in an act of naked aggression. and again, all of us are concerned about recent reports of additional military buildup in this area, and so we have to treat him for what he is, and

that does not reignite the cold war, but it means we enact steps that make it clear to vladimir putin that his images will not be -- his ambitions will not be realized by the great community of nations that would resist. i will give you a couple of things wrote quick. one, start the missile defense system again in poland and the czech republic that we abandoned once. look forward to perhaps moldova and georgia and ukraine, if they wish, to become partners in nato. have some military exercises with our baltic friends, latvia, estonia, lithuania, that are under severe pressure by by putin. we can ask to counter vladimir putin's ambitions without reigniting a cold war and without reigniting a conflict. margaret thatcher's famous words

about ronald reagan is that he won the cold war without firing a shot, and that can be accomplished. >> senator mccain, senator durbin mentioned that china today abstained from the bow. do you think there is a greater role that china can play in helping to defuse this crisis? >> why don't i let senator durbin -- >> i talked today to some powers, the member's -- the u.s. ambassador to the united nations, and she was trying mightily to bring in china to vote with us. the abstention is something, but we with that they had been with us -- we wish that they had been with us. we will continue to work with them. we need to increase that family of nations across the world that are willing to stand up, and i hope they will be part of it in the future.

>> mr. senators, [speaking foreign language] >> there is lots of information regarding the u.s. position on the crisis. particularly president obama that if russian forces crossed the border from the crimea into ukraine that this would mean a state of war exists, and the united states could potentially take part. is that a possibility?

>> senator durbin and i just got off the phone with secretary kerry. i can assure you that the congress and the president will be working with the president of the united states. this is too serious for any partisanship. i can't exactly say what the reaction would be because it would have to be the extent and size and other aspects of it, but i am confident that the united states of america with our european allies would have a very vigorous response. >> i would just say that when we met with the prime minister, arseniy yatsenyuk, in washington last week and again today, he made it clear that he is not anticipating be so-called military action of boots on the ground. that is not being discussed. we are talking about other ways that we can help ukraine, other

ways that we can put pressure on russia and other aggressors. >> i would just add that the line has already been crossed. there is no moving from crimea into ukraine. crimea as part of ukraine. so our message to russia and to vladimir putin is that he needs to take immediate steps to de-escalate a situation in crimea, and if he does not -- regardless of whether there is any additional incursion -- there is going to be an escalating series of steps from both the united states and europe to make it clear that the actions that have been undertaken already are completely unacceptable within the scope of the world community. china should be involved in this issue. every other nation should care about this because this essentially reorders the roles of the game when nations are allowed to unilaterally change borders. that is why this moment in our world's history is so important. >> what i would like to add is -- i do not think we should prescribe all the things we will or won't do right here, right

now. it is incumbent on russia and president putin to step back and defuse the situation. we will have to respond as that situation develops. the important point here is that we are together and we are solid with ukraine. >> can i just point out -- we have proven that economic sanctions can be very powerful weapons. we have seen the effect that it had on the iranians. most of us, all of us agree that it rot them to the bargaining table. the severe regimen of economic sanctions on individuals, corporations, and even governments, i think, can have a significant beneficial impact. >> i can volunteer one other thing that can help will stop we are producing a lot of energy and our country. my state is a great example. we are producing more natural gas every day. we are flaring it up. we need markets. what better way then to start bringing some of that liquefied natural gas over here and

putting some real pressure in an economic sense on russia and helping ukraine and the eu, which right now depend on russia for so much of their energy. there are many things we can do. that is just one example. and that is a solution that helps on a long-term basis. >> [microphone feedback] jimi hendrix. i'm from al jazeera america. there was a report of an -- an incursion into a ukrainian territory property. all of your ideas are very long-term, including economic and military aid. the russians are actually moving today on the ground. do you have any reaction or response to the immediate incursion by the russians rather than the long-term economic and military aid?

>> again, it is hard for any of us to respond to hypotheticals. but as i mentioned, we are deeply concerned about reports of russian military units moving closer and in a more tactical way around eastern ukraine. and i can't say exactly what our response will be, but i think it will be a breach of such enormous consequence that the united states of america and our european allies will be contemplating action that we have not ever in our relations with russia, to be honest with you. >> we talked but unity. we are united, democrat, republican. we are united from the senate to the house. we are united from congress to the present, we are united from you america to the european union.

the other thing we learned, and let's face it, the reason we came here was to show that unity, show that support for the ukrainian people. the one thing we learned, and one message that was given to us loud and clear is the ukrainians will defend themselves. they will defend themselves. even though the odds are against them, they will defend themselves, which is again why i will point out there is one person that can prevent further bloodshed. that person is vladimir putin. we will hold them accountable. >> thank you very much. thank you.

on "washington talksl," angela stent about meeting vladimir putin and his view on the u.s. we will have that at 9:00 a.m. eastern time. before that, a look at the transportation industry in light of disappearance malaysia airlines flight re-70. we will talk to former inspector general for the transportation department, mary schiavo. and the democrats campaign against the koch brothers and their influence with dave leventhal -- levinthal. all that plus your comments, tweets, and facebook, and slide again at 7:00 a.m. here on c-span. next, fda commissioner margaret hamburg testifying on her agency's new initiatives and priorities in the year ahead. she appeared before the senate

health, education, labor, and pension committee for just over a year and a half. hearingve convened this to examine fda positive limitation of key public health initiatives being undertaken by the agency including several significant reforms passed out of this committee over the last few years. our nation faces a variety of public health challenges in the 21st-century. there have been a rapid changes in where our products are made and how they are made and where our food comes from. there have been major innovations including treatments that save lives and better and more diversified food supply, but these new dynamics also present new risk and greater

challenges for regulatory oversight. the health committee has been able to address many of these challenges in recent years, proving that things can still get done in washington. i want to thank ranking member alexander for being a great partner and also for all the members on this committee and their staffs. we work together in a collaborative and bipartisan manner to address these public health issues head on. let me just him arise a few that we have. last fall, after -- the year after the meningitis outbreak and killed 64 people sickened 750 one patients across 20 states, we passed the drug quality and security act, which clarifies and strengthens oversight of compounded drugs. in 20 12, we passed the food and drug administration safety and innovation act, which, along with authorizing several fda user fee programs, set up patient access to generic drugs,

modernize fda's ability to regulate the global drug supply chain and established tools to prevent and mitigate shortages of prescription drugs and implement it reforms to help bring critical drugs and medical devices to market faster. in 2011, we enacted the food safety modernization act, a landmark law that brings america's youth safety system into the 21st century to better protect americans from contaminated food and foodborne illness. in 2009, the family smoking and -- prevention and tobacco control act for which this committee spearheaded, became law and gives the fda authority regulate the manufacture, distribution, and marketing of tobacco products. i believe this committee has been very active in addressing the health and safety needs of americans. i also want to take this opportunity to thank you, administrator hamburg, and to commend the fda for the proposal to update the nutrition facts panel we see on packaged foods.

the last update to this label prompted manufacturers to reduce trans fat in many of their products, and i'm hopeful this new proposal will further support americans in their efforts to make healthy decisions for themselves and their families. so this hearing will focus on fda's implementation of reforms as well as other key public health initiatives that are now confronting us and being undertaken by the agency and other concerns to members of this committee, so we are pleased to have commissioner hamburg of the fda here to talk about their efforts and answer our questions. alexandern to senator for his opening remarks. >> thanks, mr. chairman. thanks for having this very timely hearing. dr. hamburg, thank you for being here today. we look forward to visiting with you. i'm going to devote most of my attention to the drug quality and security act, which was signed into law last fall to clarify fda authority over compounding pharmacies. that's very important to many

states, but especially to tennessee. the fungal meningitis outbreak in 2012 was a nightmare for us. 130 seven tennesseans became sick. 16 others died from the outbreak. it's caused by contaminated steroid injections. while the final legislation, the law, was not a strong is the bill that passed this committee, it does make it clear that either the fda or the state is overseeing each compounding facility. compounding sterile drugs without prescriptions now have the ability to voluntarily register with the fda as outsourcing facilities. committing to higher standards for sterile compounded drugs to report adverse events put on certain labels and lift the product they make with the fda. the legislation, the new law cap state oversight of traditional drugstore, the corner

and fda oversight over drug manufacturers. the fda gets plenty of criticism from time to time, but i want to give credit where credit is due on this one. you responded to a crisis as if it were a crisis. you are off to a fast start in implementing this important legislation, and i appreciate that. after ther 4, 1 week legislation was signed into law, fda published three guidance documents. it has been a little over 100 days since the president signed a law, and in that time, 30 facilities have registered as outsourcing facilities nationwide. they have done this voluntarily. these facilities all have done this without receiving guidance on the requirements they will have to be for the sterile drugs they make. that's a good time. i believe that once we have more clarity, the number of gosourcing facilities will up significantly. now that the law is established, who is on the flagpole?

fda and states can take the action necessary to make sure compounded drugs are safer in the future. you continued inspections and enforcement actions. you have sent numerous warning letters, referrals to state boards and publishing inspection observations for many pharmacies. the question -- in the question time, i hope to learn what policies you are developing and when we will see the guidance on the quality standards outsourcing facilities most comply with. second, what are your enforcement priorities? how do you plan to follow up on the warning letters? the new england compounding pharmacy had received a warning letter, and i want to ensure there will be a appropriate follow-up from the agency this time. third, now that we have established who is on the flagpole, how are you coordinating with states on what they are doing? i thank you for your quick work in implementing this law, and i look forward to hearing about future plans on some other areas the fda pace seems to be moving rather slowly.

way you have worked on compounding pharmacies might set an example on how you might move ahead, for example, on the center for tobacco products. you gotten $1.7 billion in user fees to date for tobacco. over 4000 applications are filed. you acted on 34. congress also instructed fda to set up a regulatory pathway for bio similars. that was march 2010 and established by a similar user and almost four years later, we do not have an approved product in the united states, and many questions linger. my last example comes from the implementation of the food safety modernization act. my understanding is the fda is going to re-propose parts of the regulation due to widespread stakeholder concern about the complexity of these regulations after the law emphasized the need for science and risk-based flexible approach. i urge the fda to improve

responsiveness to congressional inquiries. there is one letter i sent last july to which i have not yet received a response. in that light, i will send in writing a question that senator fisher of nebraska has that she would like answered. i will not deal with that orally but provide that to you separately. all in all, i thank you for the fda's fast start on implementing the compounding pharmacy legislation, and we welcome you to the hearing. >> thank you very much, senator alexander. i would like to welcome after margaret hamburg, the 21st commissioner of u.s. fda since 2009. she is the top official of the fda, an agency with the fundamental mission of promoting health. she completed her residencies at new york presbyterian hospital while cornell medical center. the mission a hamburg has an impressive background as a

doctor, and nih scientists, and dr. hamburg, we thank you for sharing your expertise with the committee and being here today. your statement, which is an extensive statement, which i got through yesterday, last night, will be made part of the record in its entirety. i would like to give you up to 10 minutes to go through that if you would like. rather than five. however close you can keep it below 10 minutes. i will request that the record made open for 10 days -- record remain open for 10 days. leave.0, i have to both of us have to leave. >> [inaudible]

>> ok, good. i think senator franken said he would take over at that time if we continue on beyond that time, but we are managing a bill on the floor that we have to leave four at 10:30. again, welcome, and please proceed. >> thank you very much, and i know that you are pressed for time, so i wanted to keep my oral statement relatively short. really, thank you, mr. chairman, and members of the committee or the opportunity to be here to discuss with regard to the implementation of several new laws passed. the safety modernization act. job quality and security act. i really want to express my gratitude to you and the committee for championing the balls. they all represent remarkable accomplishments in a bipartisan

way. their importance to public health cannot be overstated. we welcome the opportunity to return to provide a more detailed review of the control act which lays a strong foundation for protecting public health. first, the safety. foodborne illness is one of the fda's most important responsibilities. the toll it takes is profound. and 3000 bonuses deaths every year from foodborne illness. overall negative impact may be as high as 77 billion per year. thanks to you and your

tools tos, fda now has significantly lessen these impacts. the central framework is aimed at building preventative measures from farm to table including roddick safety, modern preventive controls. new rules alone will not get us to our goal. they have the resources to tovide technical assistace capacity of our states and to begin the long-delayed process of better oversight of imported foods which are increasingly important in our food supply. without a significant increase

a modernot achieve food safety system in a safer food supply. model,g on a successful the safety and innovation act reauthorizes the program for drugs and medical devices and establishes two new important programs for bio similars and generic drugs. this is essential for safe and effective new products to patients and providing predictability and consistency for industry. the law gave been better authority to better address this by change in an increasingly global marketplace. provided themhey with new authorities to combat drug shortages and stimulate antibacterial drug development, enhance pediatric medicine and

encourage drug and product innovation. the to highlight a few of successes we have already seen. fda committed to meet much enhanced performance goal. wece fiscal year 2000 and have achieved a 27% decrease in the backlog of a lower device applications in a 10% decrease in the average total review time for high-risk devices. we have seen a 43% increase in the backlog and a 32% decrease in average total review time. recognizing the need to stimulate investments they created incentives for the development. 41 designations under this which is a promising new start. i am pleased that after a series number ofntions the

new drug shortages the client to vary significantly to 117 between 2011 and 2012 and then fell even further in 2013. there continue to be shortages that persist and we are working aggressively to prevent and mitigate them. with respect to the job quality last timety act, the i appeared before this committee we were in the middle of a related toth crisis the fungal meningitis outbreak. thanks truly to this committee's leadership and now have the drug quality and security act which contains important provisions relating to compounding also outlines steps to an interoperable system. week anoted, within one

passage, fda took several actions to begin implementation including issuance of draft guidance, notices listing and significant stakeholder outreach has been undertaken. as of this week, 35 firms have registered with the outsourcing facilities. andntend to continue this take enforcement actions as appropriate to protect patients. without a doubt, the responsibilities have undergone huge transformations under these new laws. our commitment to implementing the responsibilities entrusted i congress to improve the lives of the american public to protect their health, safety, and welfare is unwavering. we are committed to working closely with you on these important new laws as well as so many other issues.

we believe that our work is vital. difference ina the lives of americans. >> thank you. thank you. we will start a round of questions here. i have two tracks i want to go on. perhaps i will submit this on addressing sodium consumption. focus mywant to question on opioids. in 2002 doctors in america wrote 144 million prescriptions for opiates. when hundred 44 million. tenured leader a roach with 41 144 million.

two years later they wrote 241 million. heroin, opium, everything else combined. tin and all of those. 2013, the fda approved a new hydrocodone. toexperts urge the fda reconsider the approval. "in the midst of a severe epidemic, fueled by overprescribing of opioids, the lasting the country needs is a new, dangerous high-dose opioid." the president of the physicians for responsible open road use said it is a whopping dose of hydrocodone packed in an easy to crush caps off. it will kill people us to visit

his release. post ran getting some of this information is the riser panel voted 11-two against approving it. the fda went ahead and approved it. again. what i find startling is an united states we have 5% of the world's population but 99% of the world's consumption of hydrocodone. it is the most prescribed pharmacy drugs in the u.s.. million for opioids for hydrocodone. 2011. i didn't realize we were so painful in this country. what has happened?

go to a doctor in their describing descriptions. you can go back and get them refilled. what is happening to our doctors in this country. when we had a panel here last her, they said a lot of that. it is not physiologically caused. he may have a manifestation is not ideologically cause. now the fda comes along and approves what i understand to be something that is 10 or 20 times more powerful than oxycontin. could you address yourself to that? >> is a very complex problem. we are working very hard to withdraw us what the fda can do

to ensure that patient with legitimate pain needs to what they need it also to recognize the serious addiction potential of these drugs and that we need to do what we can internally and were more broadly with all the components. it is an important component of this. let me address this as best i can. importante is a very opiate for the treatment of legitimate pain. we do have many medical needs for both acute and chronic pain management. approvalne up into the is only available in a project that also included acetaminophen. patients respond to different drugs differently.

some can tolerate hydrocodone much better than they can tolerate other opiate drugs. at the lower doses, where it was available in the combination , serious risks of toxicity is city -- unique in its available as a single hydrocodone product with liver toxicity risk. the advisory committee met before we put in lace more stringent labeling requirements around the use of this class of drugs. important forare ensuring appropriate use for patients with legitimate pain. it is a schedule ii drug.

there are additional restrictions on prescribing a special license. there are limits on prescriptions. no regfills. there are special requirements that need to be undertaken and reporting requirements. it is a schedule ii drugs that have these additional requirements to limit the use and hopefully to make sure that it is prescribed and used appropriately. restrictions on the use and also requires the company to make available physician training for its appropriate use. that this is a

powerful drive. we also believe that appropriately used, it serves an withtant and unique niche respond to pain medication. it meets the standards for safety and efficacy. recognizing the addiction potential and understanding the broader context of the serious opiate medication abuse and misuse in this country. we weigh carefully risks and benefits. we hope that as a nation we can make progress in addressing all of the issues that contribute to this ongoing and very serious opiate misuse and abuse epidemic. will we will continue to push hard. we're trying to ensure the that respectgo forward with to the science and technology.

hopefully we can move in that direction going forward. >> thank you. i will submit those in writing. >> thank you. i have complimented you for your the start on implementing compounding pharmacy. i would like to discuss that with you a little bit. understand yourself on this. one of the reasons for the tragedy was some confusion about who was on the flight -- flagpole. whose job was it to regulate the massachusetts facility. the law clears that up. usespounding pharmacy that compound sterile drugs may orose to be regulated by you if not they are regulated by the state. is that right? youre thank you for leadership.

they heat for trying to clarify through legislation important aspects of the compounding pharmacy law and requirements for oversight. this is a very important step forward in terms of that effort into finding a new role for the f da. that thisu are aware was concerned about the fact this we know that it does apply nationwide. it is so possible this could be in compliance with some aspects of the compounding a specific project. in my be out of compliance with other components such as compounding and fda approved

drug. an opportunity for some confusion there. with respect to 503 b we are that some may not. in 503 a we may not even know it. i understand wanting to go further. the law did not go that far. you have 35y facilities that have already agreed to be regulated by you. ablee same time, you are issuing warning labels

to others. on your follow-up to the warning letters, i understand that some state are indicating that they an outsourcing facility chosen to be regulated by the fda also to be regulated by the state as a pharmacy. have you heard that? that was not the intent. a facility toit choose one or the other. that specificrd concern. considerably in terms of their laws and the reasons for the oversight of compounding pharmacies. what i have heard from states is that when there are these large facilities that are manufacturing high risk projects that they do not often feel equipped to provide the regulatory oversight. they hope that those facilities will register with that. >> manufacturers got it.

outsourcing facilities are all years. the rest are the states. issuing theu be draft standard? they know what will be expected of them if they choose to be in an outsourcing facility. >> we are working to develop the guidelines.turing we will get that out as quickly as we can. i think these understand the broad framework they can expect in terms of good sterility practices. this is very important. estimate onve any how many of these facilities

that compound sterile drugs exist that are eligible to be outsourcing? we really do not know what that number is. it'll begin this process that will begin to get a much better sense. we are also increasing the partnership with the state. we have a 50 state meeting next week to help strengthen the communication with the understanding and understanding the communication. we've also been doing a lot of out rich with providers. mechanism fore what is best with the oversight.

thank you. >> i have an order here. >> >> welcome. they estimate that more than 2 million people have the antibiotic resistant infections in the united states every year. there is increasing scientific evidence that the overuse of antibiotics is contributing to the rise in antibiotic resistance. the lesswe use it effective it becomes at fighting resistant infections. millionntinue to use 30 pounds of anna biotics and food

animals every year, which is about four times as much as we use in people, we are likely to have a lot more resistant infections and fewer antibiotics that work will need them. they concluded that this for production purposes to promote may contribute to antibiotic resistance. use for that antibiotic disease invention is all right. they asked them to voluntarily withdraw their approval once. --heard: mary reports preliminary reports that all 27 companies that manufacture animal antibiotics agreed to

this directive and will supplement new drug applications to revise that. guidance does not guarantee the prudent use of antibiotics. with every compliant guidance there could still be a lots of atibiotic use that is sensibly for disease prevention. it is still far more than necessary. it will continue increasing resistance. how does the review of labeling them ensure we are reducing the antibiotics used in iraq culture and decreasing the risks of perpetuating resistance.

i am encouraged with some of the steps we are taking now. there is the guidance acting -- asking for companies for manufacturers and generics. how they will products for growth promotion purposes. what we call non-judicious use of the antibiotics. there was a 90 day time frame for the companies to report to us how they would reply. that just closed. we have gotten limoneira

indications of participation. we will review what they have writing. with respect to your question, how do we insure these do not continue to be used inappropriately. we're also going to be moving the oversight of the use of thee projects to supervision of a veterinarian which is not the case now. it will be much like what you are familiar with, the prescription from a. there and the release of a drug -- a and the release of a drug which will be true with a veterinarian oversight with the use of these products. there'll always be a need for antibiotics to treat animals for

important bonuses they may have. there is a role for prevention. we want to make sure it is appropriate and adequately supervise. that is of importance when they have the importance for human medical needs as well. >> i appreciate that. i am running out of time. i was just making notes about moving this old veterinarian have to prescribe. i think it is a very good or step. richard marion's are permitted to describe this. permitted toey are use it effectively for preventive disease, that means there is the possibility of continuing to keep these drugs out of circulation, keeping them out there all the time. i will submit the rest of my questions so we can have some

detail. >> we're looking to the oversight. i appreciate this. i just want to encourage lee. thank you very much. >> thank you. thank you for being here. inc. you for your service. -- thank you for your service. skincare is reaching at dimmick portions. epidemicn -- proportions. it has been since 1998 was the last time the fda approved in for an enhanced ingredient for some screening capability -- sunscreening capability. senator reed and myself will be to makeing legislation

more transparent and more rapid determination in terms of ingredients and products. we do not want to legislate what they should approve it we want to get a more effective system of evaluating these important ingredients for this terrible cancer. would you commit to work with their officers to make sure we get a more rapid response to the determinations? absolutely. it has been taking too long. with you.eager tow ork work toare getting back sponsors on our assessments. we're also looking at whether we can modernize the overall framework for how some of these ducts submit projec applications to streamline it and make it more responsive.

>> we will certainly work with you and your office to be a positive influence. get the decisions to be made. we know that is your responsibility. the second question has arisen in my district from a couple of companies that have asked me questions. i will not get into a specific question but i want to ask you and how belongs to appeal to the decision. with a particular case where a decision was made by fda. they still have not gotten an answer when they call for an update. this is been eight or nine months. what can people expect on an appeal in terms of a reasonable time within which to get an answer? i cannot give you a

one-size-fits-all answer. i will say that i recognize how important it is to make sure these processes work well. it is no doubt an area where we can often be more efficient and responsive than we have been. we really are committed to trying to do the best job possible and not knowing the specifics. i will get back to you on your query.c clare

we have been working hard to streamline and modernize our system to address the business process issues that slow things down into recognize the importance of good, clear communication with companies around these kinds of activities. >> i understand with recruiters some -- with breakthroughs, sometimes they use them with pharmaceuticals themselves. it is very complicated. arena, authorities a very different today. modernizey we have to their updating the pharmacy loss, etc. -- laws, etc.

we are always looking to see whether our systems much the real world needs. andy time is almost up here i will submit another very important question with concern to the regulation of medical i.t. >> there's a great deal of interest. >> we need to look at the congress responsibility in that as well. i look forward to that. thank you for your service. >> thank you. i would like to thank you and the ranking member for holding this hearing. welcome back. i want to take a minute to thank you for the work over the last years. it has not been easy to implement a comprehensive fda aform bill while having compounding bill. you can not to my home state of colorado in 2011 and listen to many people in our bioscience

community who are having backculty communicating and forth with the fda. you made a commitment that things are going to get better. i for this for many will back home. they have seen a positive change. a lot of that is due to your leadership. nothing is perfect. i hear consistently how much things approve at the fda. i want to thank you for that. i was pleased to see the implementation of a bill i worked with senators burr and hatch that created a break through therapy designation with dramatict have shown german changes. would be sitting here with 40 drugs and i would have said you were delusional. that is what has happened. drugs that are trying to cure and many other

life-threatening conditions. i visited a number of colorado patients that are receiving rate through therapies and i can tell you firsthand that it has truly made a life-saving dip in its for many tell me their dream is only to live a normal life or that is all they wanted to do. as a result of this effort to efficiently, we see a number of people writing to our office asking for more direct dialogue. no one wants to a duly influenced the science and data they look at. i think there should be an avenue for patients to report their opinions about what might be considered for a breakthrough. i wonder whether you could talk a little bit about the new designation this has had about the agency.

and whether you might be willing to have more open dialogue with patience to consider information they would supply with respect to the designation. i'm excited to see something in our government working well. >> i could give you an answer that would be very long, too. it has been such an important and exciting new opportunity for us. it has been much more popular and successful that we had anticipated. the other side is that we did not get new resources to implement this program. we have been able to identify a number of exciting drugs that the oftense to treat life-threatening illnesses. we have been able to approve underdifferent products this breakthrough therapy

pathway. i think that we will continue to it. it underscores another set of important points that have broader ramifications. one of the aspects that have been so successful is the early reviewent with the fda teams and senior-level scientists to really help shape what is the best development strategy so we can ask and answer all the critical questions to address the safety questions but actually move it through the system as quickly as possible. the engagement of patients is critical. in another aspect of our work, we have also been establishing a series of meetings with patience

around some critical disease areas to get their input in terms of how the disease manifests itself in their lives, how we should be thinking about patient reported outcomes as an integral part of our study and design and how to really make sure that we are helping to address critical unmet medical needs while trying to help speed innovation and product development. >> i want to thank you. has really made a material difference. as we see the at ea exercising its muscles -- the fda exercising its muscles around this one part of the pipeline, my hope is that we're going to be able to see it across this.

>> thank you. my thanks to you. i'm very grateful for you taking that over. both bid and then -- both bennett and roberts were on that issue. >> enqueue. the ease that 10 seconds of my time. -- thank you. that used up 10 seconds of my time. i will follow up on what senator warner was warning about. director proposed the from a heavily populated state. this is understood.

we have some different problems of that. i am going to submit this one in writing. on thebeen working amendment which is the food modernization act that provide specific, nations for preventative controls for small farmers and producers. what is the status of the implementation? one of the things as we have been doing out of reach in rulense to the proposed taking co we are the impact on small farmers and the fact that we have a system where there are very different types of food producers.

>> there is the overly prescriptive framework. this is not appear as though the sba has. to the procedures act and how it went about publicizing the proposed rule. can you provide the committee leave commitment you will here to act on further rulemaking? >> i've not heard that concern. we have done a remarkable job in terms of outreach and engagement. i will go back and asked some questions about that. >> we will provide more detail on that. foreman we are concerned about

the deterrent formulations. makes it a little harder to inject it. if they establish a clear pathway for determining claims, they continue to invest in this kind of research. i'm thankful for the manufacturers would like to this.the view the do you plan to finalize guidance? you expected to also include generic urchiversions? it is also there to use all the available tools. this is slowing down the particular tool. it is unacceptable. can you commit to me to finalize? the guidance is here.

we really need to incentivize companies to work hard on this. we want to provide them with as much clarity as possible. approachesdevelop for these powerful drugs. >> there is no timetable? >> i am not sure what the time frame is. maybe a few months or a year ago. i would like a fairly extensive answer on it. i appreciate the efforts on that. tore's also a new pathway approve bio similars. and that helped lead discussions to ratify the user fee to support that.

i am looking for a commitment that the fda will be transparent. it will issue guidance as needed. stakeholdersve the the opportunity around the key policy questions before the final decisions were made. >> we are standing up. we have had many discussions that are either developing or interested in developing them as part of the new pathway. >> thank you. where are we now? >> thank you very much.

i wanted to try to get to at least two areas. one is on this issue of a locks oxin that allows them to be able to administer a judge in the case of an overdose to reverse it. i am particular want to highlight an element of legislation. senator udall has a senate bill 1657 which is increasing the safety of prescriptive drug use. one of the provisions would ask to reconsider the status. i want to have you speak to that. i know you cannot make a determination here today. i want to have you speak to that value interms of its

the context of law enforcement and as a way to deal with a crisis situation. very important medicine in terms of being able to reverse opiate overdose. frequentnly is a very basis in the health care setting. concerned that many opportunities have been limited because they occur in the community, not the health care setting. toencouraged and reached out manufacturers of the product to with ar coming into us formulation that could be provided by an auto inject your or a nasal inhaler that could be more available in community settings.

they could take advantage of this formulation. it could save lives. we are encouraged by the response we have had by the manufacturer. we will continue to work on this important issue. >> i appreciate the issue. raise the issue. a lot of people are working on this. it is stunning. , theumbers we have seen one number i keep coming back to is people heal abuse prescription drugs are 19 times more likely to abuse her when. -- heroine. disobeying is not third -- pennsylvania is now third in terms of heroin abuse. we are not saying this in places where you might, or the popular image is in big cities.

we are seeing in rural areas and small towns. very substantial. let me move to one more issue. one issue under the chairman raise a question of the advisory committee recommending against the approval of the product but the abuse determined. a related question is the concern of thinking number of us have. the implications of allowing this new product on the market without beethese. can you speak to that? >> i would love if we had to turn formulations that were

actually meaning all and activen and effective at deterring it in all instances. they put it out as guidance for how we would be thinking about approvingand deterrent formulations, what they would need to be able to demonstrate. it does not do any good to label something as abuse deterrence that is not abuse deterrence. right now, unfortunately, the technology is poor. there is one formulation that is in the market place, recently approved. it is abuse deterrent in terms of immediate crushing for injection or sniffing. it does not prevent the abuse or misuse when taken orally. it is not where we need to be.

it demonstrates utility and opportunity. we need to continue to work with companies and the broader scientific and engineering community to come up with better formulations. we also are committed to working non-opioid pain medicines. pain needs tonic be treated. opiates are very effective for acute pain. we do not have a lot of it alternatives. they have made this to work with companies to try to develop thatpioid pain medicines really will make a difference. let's i will send some more for the record. we will go next.

>> thank you so much for coming. i know your time is very valuable. this is the same question he asked. it gets pretty specific. "yes." your answer was that is the answer i was looking for. will give that a try. there is concern from our leaders about the implementation of the food safety modernization act. specifically concerns related to the preventative controls for human food proposed rules which i believe is still open for comments. they are interested in the proposed rule mentioning testing and supplier education environments but does not provide a specific requirement in the rule. this can get pretty expensive.

there's a whole host of organizations which i will not go into. can you assure me that you will not finalize the rule with these more prescriptive supplier verification requirements? must they go through a full notice and comment regulatory process with advised analysis. can you also assure me this will not be rural as an interim final rule? from the very beginning, we reach out to all of the different stakeholders, hear their concerns. we have done lots of public meetings. visits. meetings with specific groups and individuals. it has been a complex set of rules to perform word.

many different competing interests and concerns. we have gotten a lot of response back. we're going to be carefully going through all of the comments when the different peri ods end. issueld re- -- well may res codified language on certain key provisions because of some of the concerns you have raised. i have had concerns about the impacts as well. we will work in a very deliberate, transparent way and continue to try to drill down on these critical questions so that we end up with something that really works. i appreciate that. i think that is a long yes. i thank you for going into that. drug safety act would ask the gao to look into

how policies and practices could be modified, streamlined or discontinued in order to prevent .uch drug shortages this was also discussed at length with the fda staff during the drafting of the legislation. is you tell me where the fda in regards to their internal review of the regulations and what has been done to address instances in which the policies are or were leaving to drug shortages. progress hasunt of been made in the drug shortage area. working longbeen hours and very diligently to address those existing shortages and imminent potential shortages in this country. industry plays a critical role. the shortages that occur oferally occur because

issues with either their supply or qualityroducts concerns in the manufacturing. real improvements in the number of shortages in .ecent years the passage of it has strengthened progress that was tong made and enabled us institutionalize important ways of interacting with industry. we're moving forward. we have made real progress. i think we have systems that are working in need to continue to be strengthened. >> i understand you're making progress. we have about 11 seconds. where is your internal review? where would you say that stands now? are you halfway through question mark where are we? --are we halfway through?

where are we? sure what you say in respect to regulations. we had some delays in getting the reports up to you. >> it is an ongoing process but you are getting there. >> we are getting there. i really do think it is a system that is working. >> ok. i appreciate that. thank you. >> before we go to senator baldwin, i want to thank him for your work on the compounding bill. now we will go to you. >> thank you. i appreciate that. i'll happy to compound with you anytime. [laughter] [applause] we will go to senator baldwin. thank you.

fornt to thank them convening this hearing and giving us the opportunity to ask questions of you. welcome. a community home to of medical device companies. there are always interesting things going on. wisconsin innovators are making significant contributions to medical treatment with rick through technologies such as a state-of-the-art colon screening test and a sepsis device. in the last several years, the fda has taken on some encouraging steps to enhance patient access to devices in spur product innovation. somee very excited about of those, in particular the pilot program a parallel review cmf allows both the fda and

to simultaneously review innovative vices for market approval and coverage determinations. this will help streamline the process for companies andth the patients fewer search by the innovations. recently indicated that the agency plans on establishing lerate theway to acce approval of certain devices for patients with serious unmet medical needs. approach, some of the data that typically is collect kb submitted to the fda.

it allows them to target their resources most efficiently and effectively throughout the approval process. i am hoping we can elaborate on the development of this new pathway and specifically if he could tell me how the fda will assure predictability throughout the process for the device howl the agency make sure that the needed evidence is collected in a post-market setting to guarantee patient safety. >> so much exciting innovation. hardenter has been working in a number of arenas.

how we can work from the same to try toys their build in some new mechanisms, benefitsng some safety duct hasnts of a pro to be a lifecycle approach. as we look at the preapproval, we also have opportunities to deepen our understanding in real world the use with post marketing surveillance and collection of data and additional studies that are continued. that has been a theme on the job site for quite a number of years and continuing now.

there is a look into the overall assessment and ongoing understanding of a device. it is very key. it is being shaped. we are going to be eager to work with industry >> thank you. we will follow this and look for more details with great interest. of as chairman, i'm going to submit additional questions but thank you for the opportunity. >> we will do that. >> welcome. we appreciate all that you do. there have been good questions asked about fda approval of a certain drug, drug shortages. these are issues i have concern with. time, i wanto your to shift to a subject that have not been brought up. one of them