good morning everybody and welcome to the subcommittee on oversight investigation on import safety and the status of f d a screening efforts at the border my colleagues today the subcommittee on oversight investigation examine the status of the food and drug administration's effort to ensure that americans have access to the safest and highest quality imported foods drugs and medical products this subcommittee has a bipartisan tradition of periodically meeting with and demanding accountability from the federal officials casks with screening food and medicines that the american people increasingly rely on for their health and quality of life as commissioner hamburg herself noted in their feb two thousand and ten f d a regulated products are currently imported from more than one hundred fifty countries with more than one hundred thirty thousand importers of record and more than three hundred thousand foreign facilities this hearing marks commissioner hamburg first appearance before a subcommittee since her confirmation since assuming her current position the commissioner has touted a vision for f d a to serve as a quote truly global public health agency in her own words the f d a quote the f d a faces a daunting set of tasks globalization has multiplied the scale of our responsibility and the challenges that we all face i applaud the commissioners expressed support for a number of important f d a an issue divs our concern this morning however is less with what has been promised and more about what has been achieved in the interest of public health for example in a february two thousand and ten speech the commissioner of ailed a new program developed over the previous decade enabling f d a for the first time to comprehensively and intelligently screen all food drugs and medical products that are entering the united states this system known as predict which is short for predictive risk based evaluation for dynamic import compliance targeting is a cutting edge risk based tool that could help vulnerability to poor quality imported food and counterfeit or otherwise prohibited pharmaceuticals however despite promises to begin deploying it nationwide by late two thousand and nine and have it fully up and running by the spring of two thousand and ten predict has only been deployed in three districts over the last fourteen months at this rate it would take f d a over five years to deploy predict in the remaining sixteen f d a districts f d a has informed committee staff that the technical glitches holding up predicts nationwide deployment have been resolved and that f d a anticipates deploying the systems of florida and puerto rico by the end of this month if the technical issues have been resolved why does f d a continue to deploy predict in such a piecemeal manner i don't see any reason not to push more aggressively for its immediate deployment nationwide i also expect to have the commissioner back here before the committee at a future time to comment on the progress of predicts deployment serious vulnerabilities in our import screening system do remain for example millions of parcels arrived by international mail and express couriers facilities at facilities every year predict is not deployed at any of these facilities presently nor am i aware of any plans for predict to be used in these settings f d a must treat each and every one of these parcels just as it does imported cargo shipments as potential carriers of dangerous tainted foods and adulterated or counterfeit drugs f d a cannot claim to be doing and all it can to protect the american people from these threats  so long as a major entry point for goods into this country remains largely unmonitored f d a is also should not overlook the threats posed by rogue internet pharmacies that falsely market their products as canadian in origin a recent sixty minutes c b s report on counterfeit drug imports featured a senior f d a official it miltie that his agency lacked the authority to destroy dangerous shipments and was forced to simply return them to the sender this report highlighted a serious and frustrating problem with our current screening process we need to better protect the health and safety of all americans in march  thousand and seven f d a learned that melamine contaminated vegetable proteins imported from china and found in certain pet foods were sickening and killing cats and dogs also the commissioner noted on sixty minutes that over eighty americans died in two thousand as a result of contaminated heparin a blood thinner which had also been imported from china the commissioner suggested earlier this year that quote regrettably another public health crisis like or melon mine seem inevitable and quote unless certain changes are made in our import screening process we cannot and must not accept this inevitable predicted the most promising to we have to enhance our defenses against such a threat let's deploy it nationwide and without further delay so i look forward to discussing with you the possibilities of legislation or perhaps a legislative report language to help provide more focus and support to the deployment of predict and other improvements to f d a import screening let me welcome our witness commissioner hamburg and i will now yield to the ranking member mr get from colorado for the purposes of opening statement thank you so much mr chairman i'm very pleased that we're having a hearing today about the safety of imports regulated by the f d a i think that the f d a plays a vital role in protecting the health and security of americans and i know we'll have probably many oversight hearings about this this roll over the next couple of years although i'm really happy to see commissioner hamburg here before us today though mr chairman i'm dismayed that for the for the third out of three of the last four hearings the majority has denied the minority a witness and this approach is inconsistent with the practice of all the other subcommittees on the committee and this congress and frankly i think consistent with the with the practices of this committee in previous congresses in today in the case of today's hearing we requested testimony from alan cockle director of the pew prescription project mr cockle as an expert on issues raised by the influx of imported drugs and other medical products and his testimony would have enhanced our understanding of this matter so i ask unanimous consent to put his testimony on the record mr chairman or thank you so much over the past decade imports of f d a regulated products have grown an astronomical pace in two thousand and four the f d a saw oversaw the entry of twelve million shipments of products like food a farmer so to sue tickles and medical devices in just six years the number of imports nearly doubled reaching twenty one million shipments by two thousand and ten and the number of imports is expected to grow unfortunately the f d a faces resource constraints that pose significant challenges to the agency's ability to keep the food and drug supply safe for example the f d a is able to physically inspect less than two percent of imported shipments in the face of such challenges the f d a has worked hard to become more efficient one example of this is the creation of the predict database system this system enables the f d a to target higher higher risk shipments for inspection in hansing f d a s ability to ensure the safety of imported food and drugs at ports of entry into the u s the system is currently in use in new york los angeles seattle and san francisco and soon it will be implemented nationwide so given the increasing number of imports and the resource constraints facing the f d a it's difficult to understand why we would be cutting f d a funding in h r one for example which was the majority's opening salvo in the budget debate the republicans proposed cutting f d a s budget by two hundred forty one million dollars the republicans fiscal year two thousand and twelve budget recently introduced by representative paul ryan culture massive reductions rolling back the agency funding to two thousand and eight levels in f d a scaife this would mean a budget cut of over six hundred million dollars a nearly twenty percent reduction in the agenc safe we're going to be voting on this budget this week and i'm hoping that we can reconsider these devastating f d a budget cuts even once per day is implemented nationwide it is not going to substitute for the budget that the f needs to have to to undertake its oversight responsibilities mr chairman as you so accurately noted in the last congress we took an important step forward regarding food safety passing the bipartisan food safety modernization act which gave the f d a new tools to protect the safety of the nation's food supply now we have an opportunity to provide the f d a with additional resources and i thort ease it so desperately needs for stock pharmaceuticals nearly forty percent of the pharmaceuticals in this country are imported and up to eighty percent of the active ingredients of drugs come from foreign sources the drug safety and half an act introduced yesterday by mr dingell will hold manufacturers responsible for the safety of the entire pharmaceutical supply change chain including components produced in foreign countries and it will give the f d a tools it needs to enforce these requests this is good legislation that deserves bipartisan support there's a lot of ground to cover today's hearing and again i appreciate commissioner hamburg for coming today i'm looking forward to hearing about the f d a efforts on imports about their predict database system about its work implementing the new food safety law and its views on the drug safety and have had an act and i hope that we can work together to explain why budget cuts to the f d a right now are not the way to go in order to protect our when you called the administration in to testify so i talked to our chairman emeritus mr dingell about this and i said you know when we were in the majority and and we called an administration witness and when the administration was of the other party did we allow the minority witness he said yeah if someone calls a witness it doesn't matter if they're a democrat or republican the fact is the minority retains the ability to call a hearing today witness we apparently everybody is on vacation so i want to give you credit you have our distinguished commissioner and i am absolutely certain that she's going to be able to handle any questions either group of us  posed to her we do welcome you madam commissioner you've got a very difficult job and we're always glad to hear your input this is an important issue it's not on the front pages right now which is a good thing in the last three to four years we've had several food poisoning situations that have made the front pages so it's good to hold a hearing in non crisis situation thanks chairman for the recognition and i will just mention to the gentle lady from colorado the ranking member of the committee that will support her efforts to have a full and open hearing on the heparin issue i tried to do that when i was ranking member of the minority and  truly at a crossroads of the issues that really impact our country today and will shape tomorrow from the food on our tables today to the cures drugs and devices that our nation's doctors will offer the patients of america the ability of tomorrow's doctors to alleviate human suffering is going to be something on a scale that none of us have ever seen before if they can get through the f d a and your agency commissioner is obviously at the forefront of those battles this committee with its oversight of food and drug is responsible for maintaining an active dialogue with you on the full breadth of your jurisdiction to ensure that you have the tools that you need but you are using them in a way that is beneficial for the country at large primarily this hearing today will focus on food safety and concerned about that for years in two thousand seven hundred use legislation that would give the secretary of health and human services the power to refuse admission to a food that was strongly associated with a suspected food borne illness we all remember the lou dobbs report from a couple of years ago when contaminated tomatoes were quarantined in texas and georgia and florida and it turned out these were peppers coming across the border it was found on a friday the afternoon and nothing could be done until monday because after all it was a weekend we've got to be able to stop that stuff when we find it when there's a known source of contaminated food you should be able to act without wasting time now we all know that we knew this year that coming into this year that another salmonella outbreak was going to happen we passed a food safety law last year we have increased the f d a budget so i am interested in do you have the tools you need with the new legislation that you have the budgetary allowance that you had no dr sharpstein came in and said you needed no more money for drugs and devices so i'm assuming you put a lot into food safety and we do want to know what is going to be different this april this may this june than previous about health without talking about holistic issues to and the in a relationship between components that nothing in health is isolated one of the things that is quite obvious that we are not going to specifically address the day but i think that we all have to be aware of that the reality of what is happening with our the development of drugs and the production of drugs in this country this issue of importation is going to grow dynamic literally right now you have companies that are leaving this country in droves and going overseas to not only produce the drugs but also the research and development and i just think this committee needs to just be aware that this issue may be reduced may be increasing substantially basically because we're seeing in the next generation of innovation and drug development literally leaving the country and sadly the fact is that  things like drug man a fact and research doesn't take a lot of time to leave the country and evaporate as much as let's say auto manufacturing we're seeing that go on so this problem this issue is going to grow but one place where it's going to probably be reduced by this crisis is the and that is something we need to talk very openly and frankly about the assumption that just that something claims to be being reimported so it's not reviewed not over there is no oversight as somebody was born and raised along the border and seen what happens across the largest port of entry land port of entry in the world if you want to san diego port of entry this is obviously something that's very near and dear not just to my constituents but to my family and i think that we need to address those issues and really talk about it extensively but i just think that as we look at th we've got to be aware of the crisis coming down the pike and address that with this thank you very much mr thank gentlemen and the gentleman from california mr waxman the ranking member is recognized for three minutes mr chairman this is the fourth oversight hearing and three out of the four we been denied minority witnesses i want to join this to get in complaining about it representatives ministration are not minority witnesses they represent the other branch of government and we're going to have to have a serious talk about this this isn't the way this committee is operated when the republicans controlled the committee or when the democrats controlled the committee in the past f d a is ability to protect the american public is an important topic for oversight and this would have added to that understanding of this hearing f d a is responsible for ensuring the safety of food drugs and medical devices and if the f d a does not do it lives are at stake in the official memo hearings hearing memo for today's meeting on the safety of imports the right questions were posed what are f d a solutions for the hansie the screening of imported food drugs and medical devices what is the f d a doing to improve its id infrastructure for risk based screening how can f d a better ensure the safety of imported products but there's an enormous disconnect between these questions and what is happening in congress this very week g a o reported told us that improving the safety of our food and drugs requires that we provide the f d a with more funding and resources yet we're doing the exact opposite just lacking last week representative paul ryan introduced the republican budget for fiscal year two thousand and twelve the house will soon be voting on this proposal there's not a lot of detail but there's enough to know what it would mean for f d a republicans proposed to roll back discretionary funding for all agencies of to fiscal year two thousand and eight levels in the case of the a f d a the agency budget would be reduced by six hundred billion dollars a budget cut of almost twenty percent this budget would require dramatic reduction in f d a funding to keep the food and drug supply safe the result would be the reverse of what the american people want fewer inspections and more adulterated and dangerous food and drugs mr chairman there's a word now i think part of the american merican language called hurts but it means you've got a lot of nerve and i think the republicans have a lot of nerve to hold the f d a commissioner up here and grill her about what f d a is not doing more why f d a is not doing more to keep the food and drug supply supply safe while simultaneously passing a budget that takes away the resources she needs to do our job hunts bodes well for the republicans on this subcommittee to complain that f d a is not doing enough about food safety when the majority of the members on this committee voted against the food safety modernization act which was the first expansion of f d a food safety authorities in seventy years commissioner hamburg i'm pleased you're here we appreciate your being here you were not here at the request of the minority it would be ridiculous to have this hearing without you mr chairman i want to yield the rest of my time two minutes to mr dingell who has been instrumental in the food safety food safety and drug and medical device safety questions  and it's important we hear from you know my directly you're allowing him to be two minutes given openness today if you i think my good friend from california for you leave me this time i commend you for having this hearing because it is a great opportunity for us i think for us to spend time caviling over whether a witness is a democratic or republican what this is a prodigious waste of time this committee has a fine history of heavy work together to put out good legislation that includes the the food safety legislation last congress also the wonderful legislation of that we put together over the question of consumer product safety commission and giving it the authority americans suffer from unsafe pharmaceuticals coming into this country they have neither the personnel nor the money to do the job that we need to do to catch these things coming in they function under inadequate law which does not enable  products coming into this country and to destroy them and rather they are turned around shut out come back in through another part americans are dying of this they're being denied proper prescription pharmaceuticals in order to address the problems that they confront in terms of dealing with major problems like cancer heart high to hypertension and other things that are killing americans yesterday i introduced was by colleagues ranking members polunin to get h r one forty three the drug safety and this legislation would require manufacturers to implement prove quality and safety standards including stronger supply chain management a matter often the concern of my republican colleagues it would require manufacturers to notify f d a of kind of fits or safety concerns of the list drugs and components by the country of origin to enable us to track the movement of these pharmaceuticals as they move through it would strengthen importers and customs brokers oversight it would arm f d a with administrative detention to structure a mandatory recall authority subpoena power and clear extra toward tauriel jurisdiction it would shrink criminal and civil penalties for crime deterrence and it would increase foreign manufacturing inspections to be on a par with those that are suffered by american manufacturers it would also create new funding mechanisms for  sexual activities so the globalization is not going to burden american taxpayers i have a excellent article about the safety problems that we could front together with an analysis of long serving as the former chairman of this committee and i would point and i asked based upon what mr get mr waxman indicated that last year under democrat majority they had a hearing with only the f d a commissioner on may six require that if that's where the chairman wishes to deal with we welcome our witness today the honorable margaret a hamburg medical doctor a commission of the for food and drug administration if you don't mind just turn your speaker on and move the speaker a little closer to y raise your right swear to tell the whole truth and nothing but the truth so we welcome your opening statement thank you very much and good morning chairman stearns ranking member to get members of the subcommittee i'm dr margaret hamburg commissioner of the food and drug administration joining me here is david elder acting deputy assistant commissioner for regulatory affairs for field operations he's been with the agency for twenty three years fifteen of which he spent in this field i appreciate the opportunity to be here with you to discuss our approach to import safety and the predictive risk based evaluation for a dynamic import compliance targeting application or predict and its role in our efforts to protect our nation's supply of food and medical products in an increasingly globalized market when president franklin delano roosevelt established the modern f d a back in one thousand nine hundred eighty eight the percentage of food and medical products imported into the united states was minimal today the landscape as you've already and estimated that between fifteen to twenty percent of all food now consumed in the united states originate outside our borders further up to forty percent of the drugs americans take and up to eighty percent of the active pharmaceutical greedy ansin those drugs come from foreign sources we face great challenges in ensuring that products are high quality and travel safely throughout their complex supply chain as members of this committee well know our concerns are not purely hypothetical the consequences of adulterated medical products throughout the world have already been noted and they have been tragic petfood adulterated with the industrial chemical melamine in two thousand and seven second several thousand pets here in the united states and that same contaminant was added to infant formula in china fatally poisoning about six babies and making three hundred thousand others gravely ill in that country and members of this committee are well aware of the two thousand and eight  contamination crisis in which adulterated heparin was associated with several deaths in cases of serious illness to address these threats and others we need a paradigm shift in our approach to import safety with the border is no longer our primary line of defense we must partner with industry and our global counterparts to push responsibility for safety and quality further up the supply chain and to monitor the integrity of that supply chain throughout that is why f d a is developing a global strategy an action plan more fully detailed in my written testimony which will allow us to more effectively oversee the safety of all products that we do with consumers in the future while we cannot simply be guardians at the gate border screening surveillance and intervention must remain an important part of our comprehensive import safety program the task is enormous in fiscal year two thousand and ten f received a total of twenty one point two million lines of f d a regulated commodities imported from over one hundred fifty countries f d a is currently managing two hundred sixty four active imported lurks which flag potentially high risk imports representing three thousand one hundred types of products from over eleven thousand manufacturers in a hundred fifty different countries or areas to help make our import screening more efficient f d a has developed the predict application a sophisticated information technology system which provides f d a staff on the front lines with more information regarding the many risks associated with products entering our borders and allows them to target for examination those shipments at greatest risk predict has been launched in los angeles new york seattle and san francisco covering about forty percent of all imports at the present time some technical difficulties as noted delayed our national rollout however i'm pleased to report that we've addressed those issues and are back on track this month predict will be implemented in our florida and san juan district expanding coverage to almost fifty percent of all imports if  successful it will then be rolled out across the country predict is an exciting and important innovation that harnesses advances in information science to enable us to do our job better and to improve our service to the nation but as i mentioned earlier it's just one step in our efforts to fully secure the supply chain congress has provided the agency with critical tools to assure the safety of imported food new regulatory authorities for drugs similarly may help ensure that we can hold industry accountable for the security and integrity of their supply chains and the quality control systems they used produce drugs for the american people those may include authorities in the areas of corporate responsibility enforcement and information sharing which are detailed more fully in my testimony thank you for the opportunity to testify this morning and i look forward to answering your question thank you commissioner hamburg we have a clip we're going to show on the screen here  which is from a speech you gave in january discussing the f t s new global challenges if we can play the clip maybe just drop the lights a little bit growing challenges regretably another public health crisis like hep or melamine seems inevitable unless we are able to truly for exchange of them how we ensure the safety and quality of food and medical products for our citizens and that that statement indicates that you believe the current threat is pretty serious and you have spoken repeatedly about the challenges shoring the safety and quality imported products in a global age you mentioned that in your opening statement and i think we can conclude obviously that imports safety is one of your top priorities and you have promoted predict as an important tool to leverage f d a resources in responding to this global challenge that's correct as you mentioned in your testimony you formally unveiled predict in february two thousand and ten speech and stated that you hope to have it up and running nationwide by the end of the spring of two thousand and ten as we recollect i guess the question is what did you do to try and greater efficiencies in how we target was sources and it is very exciting to see it now in action in four of our districts and covering about forty percent of all imports at the present time as we rolled it out from the very beginning it was determined that it should be done in a systematic stepwise way because very often with computer system implementations that involve extremely large databases there are issues that emerge in the process so we began in one location with a limited focus expanded the focus and then began to roll it out in the course of that unfortunately some issues did emerge and we actually at a certain point decided to stop with the actual use of predict in the field while we brought in experts and put together a team w than keeping a system let me get a little more specific for you after predict was deployed in the new york district in the spring of two thousand and ten there appeared to have been a five to six month delay while the government contractor wrote a white paper on a performance assessment project given the import safety is one of our top priorities i guess our question is why is this delay is to delay this deployment acceptable considering how important it is and you said earlier in your speech and everything that is has to be inforced mr chairman i understand your concern about an unfortunate delay that occurred in the process however this system is very very important it's critical that it work effective y and efficiently we had identified problems with its implementation we stopped the full rollout while we brought in outside experts in our own internal experts to identify the source of the problem the  effort that you mentioned was an effort to identify the can i say to morning that all the technical problems have been solved we build on a quizzically we have identified the underlying problem that ok i had to the the answer will be fully implemented by the end of the year at a safe that is our absolute goal but if there are problems in the implementation we will of course examine those and correct them but we are moving forward we see no barriers predict benefit from a program focused oversight structure with executive level involved involvement would it benefit from any other site and more focused approach with a more executive level involvement instead of you having these technical white papers can't you just have your staff focus down on this and bring in sort of the executives to make decisions you know i feel that we have been implementing this in a very was sponsible way with a clear program plan with internal and external experts overseeing the project when problems emerge we've taken the appropriate actions to remediate them we now have the system up and running in the desired way providing benefits well right now in these products right now in congress i guess the question is do you think you need congressional support should we pass legislation that specifically authorizing this program and working with the appropriations committee to include report targeted legislation or activities for the predict program as i said i believe that it is moving forward in a appropriate and valuable way and that it was our responsibility as problems emerged to identify the source of those underlying problems fix them and make sure that the program in place in fact was fully functional and able to do the tasks that we're asking it to do and it is proving to be of great value as we screen product my time is expired the generally from colorado is recognized for five minutes thank you mr chairman so dr hamburg let me get this straight it was about fourteen months ago february of last year that the f d a announced this predict program right when i in the speech that you saw the segment of formally announced that is predict about four months with correct going to start to unfold and then you started implementing it and you found some problems and so you had to correct those problems as the implementation went forward correct that is correct and if you had just tried to implement the whole thing within two months it's your view that that that it may not have worked because it had some problems right it would not have well as of today fourteen months later it's about forty percent implemented correct and you need to use words efforts over the last fourteen months it is our belief that through this systematic scale up and examination of problems as they emerge that we've been able to correct the underlying problem in  code which actually wasn't didn't predict it was an interface when i say ok and that now the system is working in the sites that it's in place and we see no barriers at the present time to the full implementation and  a believes in this program and wants to implement it as quickly as possible as well as the absolutely so i you know i join with mr services in saying you know whatever we can do to help implement this we think that it's important and it should be done as soon as possible but it should also be done right but but here's my next question is yes it as you said in your testimony predict isn't the only thing we need to do why is that because the volume of imports coming in at the borders and the the number of sides of importation are so huge that the ability to really do the hands on inspection  even with a screening tool like predict limits in our reach we want to reach back further closer to where the products are actually produced and manufactured and try to build in assurances of safety and quality from the very beginning and throughout the supply chain so ok working more closely with industry in terms of the standards that are expected working with with sister regulatory authorities and countries around the world so we have this harmonization of standards share ok nation with others and so let me ask you because we passed the food safety modernization act last year do you think that the a needs new supply new authorities to begin to do what you're talking about and to protect the safety of the drug supply i think the food safety modernization act has clearly given us additional authorities a new framework for addressing food safety in this context i think we do need to very carefully examine the opportunities on the drug side as well we know that there are huge challenges and it was noted they are growing we do need  additional authorities to be able to do our job and of course resources as well yeah what one thing that i worked a lot on in the food safety bill that is also in the drug safety enhancement act is mandatory recall authority for the f d a for drugs do you believe this author already is necessary i do believe that authority and why is that so that we can move swiftly when there is an imminent threat to the health of the public to take action to make sure that a proper product with risks does not get out to consumers is pulled back from shelves when it is out there is very violent important in our current authorities require us to either act through the authorities of state to in bargo or pull back these products or to seek the support of the court in taking these action you know you know this is one thing when i worked on mandatory recall for the food safety my constituents were shocked because they thought the f d a already had that authority and i bet that's true with drugs too i bet people just think the f d a has that authority with drugs one last question one of the one of the controversial areas in this new bill that we introduced calls for new registration these and i wondering if you can talk about what the f d a opinion is on this registration well i think it's very very important that we recognize that the magnitude of the problem is huge and growing and outstrip available resources clearly we need to bring appropriate resources to bear clearly this is a responsibility that the american people care about as well as industry and i think it's appropriate that these programs be supported  with industry contributions as well and the ability to work with industry to achieve common goals in reducing these threats to health and safety will be i think enhanced course brings me back to the eprom question if you were kind enough to come in briefly last year in the last congress if i could let me just recapitulate a couple of the things we talked about that i would like to have the part of the of the the record i mean i can't produce that correct and i understand that so i was asking if you could produce it for us and did the subject of the adulterated help come up when you when you met with the chinese officials it did the cover what happened what was indicated to me was that they felt that there was not anything to be gained at this point by trying to continue the investigations of the similar problems will not occur going forward and we do have a memorandum of understanding with the chinese government's respect to some of the critical public health measures that that need to be in place and are in place to help that protect  problematic because now we have with all good intentions food drug safety legislation being introduced but we don't really understand what happened and how we're going to control it and that  for for legislative difficulties but the heparin question is so fundamentally different from the melamine when i mean it could be argued was the equivalent of of a dishonest grocer putting his thumb on the scale when he weighed your produce but about the heparin this was a molecule that was developed specifically to defeat the mass spec test that was used by the manufacturer to document that in fact what they had extracted from the live specimen was of the desired active pharmaceutical grade so hyper sulfated controlling the sulfate would exactly reside within the peak that normal heparin would provide all the only when it was done with an ultra sensitive machine could you separate out and say oh there's actually two competing pounds here instead of one and that compound was was patented in under the chinese system so why was it created and what possible use could it have a lead in a commercial application and how in the world did it find itself find its way into contaminate the pharmaceutical supply chain i mean these are some pretty critical questions that need to be answered and should just say well we're just going to going forward work we're going to be sure things are done right i'm sorry maybe they will be done right but what was the intent here was it wasn't simply a dishonest retailer or was there was was there support and we just simply don't know so now you have the chairman emeritus and the ranking member writing legislation which in all likelihood i could support in principle but we don't know what we're trying to fix we don't know what happened in the first place that's why we need your help you were in china you met with these officials we need your help to understand how we how we do in fact prevent this from happening in the future what would not agree with  agree that this is a very serious concern and i agree that the hepburn contamination was a very sophisticated example of a broader phenomenon in fact which you note the economic adulteration of products and i think it speaks to the urgency of our really strengthening the activities to ensure import safety the importance of additional resources and authorities the importance of didn't we why didn't we see it coming i don't i just ask you a question though because this is so important i get this into we're getting a lot we had a hearing from device manufacturers we hear from drug manufacturers there's a lot of complaints that the process that people have to go through with a to get drugs and devices approved is is in fact at this unknowable and it makes the investment community nervous and in fact it makes the investment dollars dry up or worse yet go overseas so these drugs and devices are  developed in other markets red in the united states so it's a it's an outsourcing it's an offshoring problem as well what are you doing within the agency to ensure that those pathways can in fact be known before someone starts so that you can actually tell people what they will need to provide and then not change the rules of the game as they go through it you raise a really important issue for our nation in terms of supporting innovation critical industries  economic and global competitiveness and f d a clearly has an important role to play we are looking very carefully at our regulatory pathways and how we can be more transparent and predictable also looking at how we can bring the best possible science to bear so that we have better knowledge and tools and approaches to make the regulatory pathways more effective and efficient we're working in partnership with academics scientists in industry science and government scientists to really try to strengthen the underlying science because some of the problem with the regulatory pathway is in fact scientific uncertainty about how do you take a good idea and make it into a real world product and of course a bit outside of the f d a bailey which is the important question of what are the after nomic incentives to help our investments in important candidate products that hold real promise i think we both have to agree that the timeline is a strong economic disincentive i heard from us from a physician who developed the product as he watched his son being circumcised and decided there had to be a better way to to do some of these things and going to college and it's still tied up in the f d a thank you legal back gentlemen time has expired the gentleman from needs to be done to monitor imported drugs and pharmaceuticals now having said that recent reports by c b s news more than thirty six million americans have knowingly purchased drugs on kind of fed drug web sites often these purchases are being dropped in the mail where they may not be tested either by customs or border patrol by understanding that under current law if f d a recognizes counterfeiter dauterive drugs f d a can not detain or destroy products on site without going through a lengthy process providing notice and an opportunity for hearings so the f d a would set off a ship drugs back to back to the sender is that correct that is correct so order current law it's to keep trying to fit drugs from riyadh or your country through alternative mail facilities or other facilities yesterday that is correct section two or one of the drug safety and has yesterday with my colleagues m alone to get would give f d a officers or employees the authority to order destruction section two o two of the bill would authorize the destruction of any drug valued at two thousand dollars or less or that secretary davis to be a significant adverse health risk anything valued at more than two thousand dollars could not be destroyed don't notice an opportunity for hearing occurred if you believe having this authority would discourage counterfeit drug operations from their products into the u yes yes now we know that these cuts are fitna adulterated drug operations are a lucrative business these operations make money out of the pockets of consumers who may not know that their prescriptions are either unsafe or ineffective i believe that we must impose severe penalties at least equivalent to similar violations relating to different kinds of products so as to discourage their continued operation the legislation introduced yesterday proposes strengthening civil and criminal penalties for any person who knowingly distributes unsafe pharmaceuticals you believe that criminal and civil penalties discourage the counterfeit and adulterated drug operations yesterday yes i believe they would  drug safety and has nec would also require f d a to inspect every establishment foreign and domestic at least once every two years following registration you at f d a have been continuously and chronically underfunded personnel new safety authorities for food safety that you are required to implement would you agree that a fee system could help provide a stable funding source for drug safety yes or no i believe we need have in charge of dealing with imports of pharmaceuticals you don't have to tell us this morning but that for the record would you also submit to us how much that cost memory serves me correctly the food safety bill is not working well we're still very early in the implementation but it is it is a huge contribution a historic shift really in how we are able to address  hamburg thank you for being here today and for your leadership at the helm of the f d a i greatly appreciate your efforts and focus on efforts to encourage the f d a to adapt and improve its functions including the use of of the predict software on our borders and ports of entry and we appreciate that going to the predictive model one that is flexible and able to meet new and emerging threats to our borders and ports in many respects i see the f reform in much the same light now i think from your previous statement statements here i know you do as well federal initiatives to develop new drugs and diagnostics whether in the antibiotic space or elsewhere can be greatly supported by the f d a that flexible adaptable to new technologies an understanding of the human body in genome is critical how important a role do you think that the regulatory science you reference at earlier  how important a role do you think regulatory science can be to support the f d a and its work in the coming years and decades i think it's enormously important night truly appreciate your question it's an area of science it's the knowledge in the tools that are needed to really affective lee and efficiently evaluate a product for safety efficacy quality and performance and there's been huge advances in science and technology that can be brought to bear on the regulatory process as well as on the drug development and medical product development process to make it more streamlined and more modern and will give us tools so that we can really shorten the timeframe for the regulatory process in key ways using innovative clinical trial models using biomarkers  to help us identify early concerns like toxicity not to have thanks thank you and i think you know i'm currently working on some proposals in support of science and hoping that i can get your authentication system to help combat the counterfeit drugs can you update us on f d a efforts in this area and give me your thoughts on the scope of drug counterfeiting and diversion in the united states what else can we as a congress do well with respect to the big picture we know that counterfeit drugs represent a very large and growing problem it's most of the burden is most pronounced in the developing world where in some countries thirty to fifty percent of drugs for serious diseases being used in fact are not what they purport to be it is a smaller problem in this country in large part because we have a very strong regulatory framework and we work very closely with counterpart agencies to minimize the problem but with the growing complexity of supply chains and globalization and the fact that we know that especially in the absence of strong civil and criminal penalties that counterfeiting is an increasingly attractive area for some bad guys i'm sad to  say we cannot be complacent and we need to make sure that we have the programs that will be before the hearing started i had but with you briefly about the sixty minutes clip that i'm sure a lot of a lot of folks on the both sides of the alce all recently and  magnitude of the problem is down scary and certainly this is a timely hearing real quickly in the last minute that i have there been some controversy related to the approval and subsequent price increase of a drug manufactured by the pharmaceuticals for the prevention of prima to a birthday present to a labor and possibly pupil premature birth while not directly tied to import screening it does involve f d a submission to ensure the safety of efficacy of our nation's drug supply and it was initially thought that pharmacies would be precluded from compound being versions of this product which they had been doing for some time and selling but much less than the product marketed back and because of the controversy that ensued k b ultimately significantly lowered the price and f d a analysis that it would not initiate enforcement actions against the compound in pharmacies have a couple questions in regard to that issue are you aware of any safety concerns with patients taking are you aware of any safety concerns with patients taking a compound adversion this drug versus a mckenna product as far as i know we have not had reports of adverse events associated with the compound of this particular product and then the last thing and i realize and a little bit over time are any ingredients for the compound version imported as far as you know you know i i would have to get back that pretty much over and done with in terms of the investigation of who actually instigated this economic adulteration of the heparin product the investigations have come up dry and there are not acted new leads i think the other side of it that's important for you all to understand in the american people to understand is that we do have a very large number of steps in place in safeguards to protect against the importation of contaminated heparin and if there were those who chose to try to  thank you dr hamburg the job that you have taken is so expansive from baby food to medical devices and everything in between and i know that imports  a regulated products have dramatically increased over the last seven years in two thousand and four f d a oversaw eleven point eight million shipments of products like food and pharmaceuticals and medical devices but by two and and so i wanted to ask you about the resources that you really have to to deal with that the president budget for two thousand and twelve ask for a significant increase in the f d a is budget proximately thirty three percent which actually includes the new user fees that mr dingell had had mentioned bring it to a total of four point three billion dollars but the republican budget as presented by paul ryan we understand would likely roll back f d a funding to the f y two thousand and eight funding levels which means the agency would be cut by about six hundred million dollars  so what i'm concerned about in my first question is what effect would a funding cut have on the ability as specifically as possible to be able to do its its job what would you how would that affect ordinary consumers and what would you have to do with the magnitude of the cut you describe you know would be enormously difficult for our agency to absorb without taking  serious cuts in critical programs for the health and safety of the american people with respect to our ability to inspect and and support the safety of the food supply our ability to  re the safety of the drug supply our ability to approve new and promising medical products for the american people are ability  protect the safety of the the blood supply and other critical f d a regulated products that people depend on every day and it would certainly make it very very hard for us to move forward to more fully and effectively address the challenges of the import safety that are being discussed and what then would be your priorities were the increases to to go through if if the congress were in fact to give you more money for example would we be able to dr burgess mentioned would there be any possibility of speeding up the permits for new pharmaceuticals or new products we are trying to target additional resources and additional energy in the area of supporting innovation and really modernizing our regulatory pathways dr mentioned the importance of regulatory science and investments there are making a difference in really moving our systems forward but a lot of what matters and moving a product swiftly and surely through the regulatory pathway involves having the staff were sources to work with the sponsor companies to lay out the expectations for what kinds of data and evidence they need to put forward to support the approval of their product and to to work with them as they are collecting that data analyzing that data and presenting it to us so if we if we have deep cuts we will not be able to achieve some of what we know makes a difference in terms of the review teams and what needs to be done we won't be able to apply vance's and science and technology to modernize our regulatory pathway and we won't be able to do the important work every day both to ensure the safety and quality of the manufacturing and production of drugs and the important work to make sure that once those drugs are approved and they're being used by people in the real world we continue to monitor for the safety and the the efficacy of those drugs so that the american people can actually recognize for five minutes thank you mr chairman and thank you both for being here and we do appreciate the work i know you've got a very difficult job as was previously mentioned hamburg mr elder were interviewed on that sixty minutes special regarding the start of counterfeit imported drugs from the to the u s pharmaceutical supply would you mind if we just play the clip so everybody could see products coming into the country with the increase in volume the food and drug administration's david elder told us when they do find a fake drug they're often forced to ship it back to the sender on this day they found pills in vials from india posing as legitimate by royal fertility in hypertension medications they had to send it all back that sounds crazy why not go after this person we don't have the authority to actually destroy this on site this product could very well come back into the country through a different mail facilit maybe it gets through maybe it gets stopped her bank and i want the signs are going to know that they are thank you it is really frightening i think to all of us because we share your concern and i know you've already answered the questions that you don't have the authority etc but in two thousand and nine in two thousand and ten the u s customs and border protection seized approximately two thousand parcels of pharmaceuticals coming through the mail do you have any way of knowing how many of those were screened by the f d a or that were destroyed to return to the sender do you have any way to track any of that the way the system works is that the products come in to the mail felicity customs and border patrol screens those that that look like they contain drugs or medical products get then targeted to the f d a we work closely with c p of course and then we undertake the examination of a subset of those products that have been targeted to us through customs and border patrol and you know unfortunately we cannot screen all right those products because of limited resources and we do lack the authority when we find violative products to actually detain and destroy them and when we returned to the sender i mean that's kind of the majority of the work that you're doing over it you can't destroy them so you have to return them to the sender is that correct we have a couple of options  we can hold the product and seek support from the courts to to destroy them whether it would be helpful to you if you had some authority from us to be able to absolutely it would it would make much more sense in terms of of addressing important public health problems and efficient use of resources i hear less is a separate question i hear a lot from patients and doctors in my ear they have really big concerns about the f risk benefit analysis f d a threatens to remove certain drugs and devices and market that have relatively low risk compared to a patient's risk of death without access to the drugs or devices and in some cases we're talking about terminal illnesses and patients are often willing in that case to take a little extra risk because it means they can live longer so how does the f d a take these patients into account when it comes to approval and sometimes withdrawing the approval and can the approach that you use being approved and improved in any way in your opinion well it's it's you know such an important part of how we think about and use drugs in this country we obviously do look at the rates and benefits in the context of a given disease and what other right ants are available and people are willing to accept many more risks criteria for weighing risks and benefits in different contexts both in terms of the understanding that our own staff have about how to think about it in the training but also so that medical products sponsors and the public including importantly patients can can understand this as well and we're doing this in an open way getting input as we try to shape this model i really appreciate it because it's heartbreaking when you sit with somebody who is using a drug and it has successfully prolong their life and they're living a normal life and then the drug is called there so that can't be used for that particular disease so it presents a big challenges breaks your heart so i appreciate your looking at thank you m entry and igniting of course that f d a can to inspect every import shipment the system enables the agency to target shipments of the more likely to violate f d a regulations so as i understand  the predict is fully operational for all f d a regulated products in los angeles new york seattle and san francisco did you say some long as well not yet in san juan it is being implemented in the staged way and and so components of it even those four sites aren't as fully fleshed out as they will be over time but but the major components are fully operational and covering forty percent of imports out of those four districts and thank you and i know that the chairman and asked several questions about the delay and you said that there were problems and if you've already specifically stated what those problems are apologize but why specifically what were the problems that caused the delay in the full deployment of the bill as we started to to implement the system it was operating much more slowly than people expected it was much more cumbersome  and questions were asked about why that would be was initially thought that it was an infrastructure problem that we were overlaying a very large data management set of tasks onto our existing infrastructure that was systematically at it actually turned out that that the problem was really most focused in a piece of software that interface with the predict system that was slowing it down because it was doing a series of initializations underlying the the entry process and that was corrected and it's now working in a very efficient way and we are seeing measurable improvements in our ability to quick we move low risk products through and target high risk products and and then you convene the high level group of f d a officials to identify and fix the problem the just to clarify that the problems that you identified with predict cause any risk to the public health or food or drug safety at any time well i really appreciate that question because i should emphasize that even when we were having problems with predict we still had underlying systems that were supporting our screening and while not as robust and rich as predict day we're still able to provide the core set of public health responsibilities that go with our import screening actually thinks that you know i think it's important not to make a mountain out of a molehill here the f d a is implementing a brand new i system to help keep the food and drug supply safe and it seems to me the agency is doing exactly the right thing in the right way no i think system is implemented without problems with the key is that what you've found the problems you acted rapidly to identify and fix them and to make sure that the public health was not harmed so we're looking forward to the full implementation and i couldn't see if i can get another question and i'd like to ask you about korea fees because millions of shipments of f s to express scorrier facilities like fed ex and u p s every year and the president in his budget for twenty twelve proposes a new international courier fee that would be assessed so the president's budget requests the new international career field not to exceed five point three million dollars what activities with that fee support well it would enable us to do the kind of review and when necessary examination of products coming in that mechanism it's a growing component of imported products it's one that operates on a twenty four seven time frame because of our limited resources we haven't been able to target the courier services in the way that would most benefit them and so actually this is something that i think they're very eager to work with us  are committed to very rapid transit of the materials that they're importing and this will enable f d a to be able to support their business model in terms of transit of products that are how was your budget been impacted by the new ministration proportionally from the previous administration which your resources has the budget been severely reduced or has it been enhanced to some degree or what's the well actually beginning in the last administration we began to see significant increases in our budget so over the last few years we have had increases in our budget that have been very very welcome we do have any idea what kind of percentages you've seen in the last twenty four months in the last twenty four months since you've been there well we had in the this issue that we've got china demanding that research be done in china for drug development if anything so there are so going to see a shift there we can see a major shift in the emphasis why manufacturing should go to china with this basically extortion games on there you've got europe that is really reducing their their review of drug and devices to a point way below basically looks like much more efficient they're getting more efficient going out so we've got this potential of this big increase of imports coming in as we're watching our manufacturing capabilities be exported are you reflecting that are you planning on that increase in your inspection at the borders that looks which everybody in the industry is saying is basically an indication we're seeing across the board let me first address some misperceptions there there is a sense that we are much slower than europe our counterparts there in  revealing drugs and devices in the drug area in fact we went back and looked over the last couple of years and the majority of new molecular entities new drugs  that both of us approved were approved first in the united states and in fact he looked at priority drugs the number is actually high i would i would like to see that because the applications were made here first and many a times and they were basically moved on others because they were perception but the fact is that the data we have and the data i've received basically reflects the fact that even though you had major increases and i think this is an issue about what do we do with the money that you have you know we're looking at a twenty eight percent slowdown of the review review of drug processing by f d a to time your budget was expanding so there's a lot of these institutional changes that we've got to address and just sending money  cross over doesn't necessarily guarantee the jobs going to be done efficiently and or not officially but basically the mindset of the bureaucracy does affect timeline and performance does it not let me just assure you we take very seriously the timeliness of our reviews and through the use of the program we actually negotiate with industry about timelines for production dr let me let me just say we've got industry people that we're going to have to have t estify about your operation behind closed greens because they're that scared of the process but in all fairness at a time that you had major expansion of resources to get the job done the numbers that we've got before our committee is a twenty eight percent  longer period for drugs a forty three percent expansion on the extension of time for devices that means that just by giving you more money doesn't mean the system's going to run the run more efficiently i don't know those numbers and we'd be delighted to sit down with you and go over an hour but i think you know the bottom line is that we need to do better we can do better and we are working with industry related to this issue related to this issue that means we have a vested interest in safety to try to make the system more efficient here as a real life not just not just safety and efficiency but also the timeline because that timeline affects the decision of do you produce it in the united states or do you go overseas and then we buy our own inefficiency here or lack of reform here in processing we create a crisis for ourselves to have to review that much more coming and address this issue and i hope we have that kind of commitment by your agency that showing that slowing down the process is not just an issue that makes it safer the bureaucracy it's something that makes it more risky for everybody because it may have unintended consequences such as cause you know  have to import more drugs that have to be reviewing well i understand your concerns and we're very committed you know we do take the performance timelines very seriously and we are meeting the majority of our goals  i'm also systematically reaching out listening to industry and their concerns i just met yesterday most of the day with a group representing both device and pharmaceutical industry represent or former representative to hear more about some of these specific concerns and how we can identify areas to work on together to streamline the process to help support the need to devices into this country i was not ok do you do you have a position on that device tax and its impact you know it's a complex issue it's not within our jurisdiction and that are just mr chairman i think before we do things like device tax and protection we should be asking regulators about how it's going to impact their job these things are all related like i said it's holistic you can't do one without impacting the other and you're back in time is expired i think will go a second round here bilbray point about the devices i can hardly go anywhere and speak to any group some of them pulling me aside so i'm heartened by the fact that you're having you're hearing some of the same things but also his point that people are afraid to come forward when i have someone to come and tell me their particular tale of woe about what they've developed and where they are and in the process and i and that's a that's a the unfortunate place for us to be and mr bilbray is also correct the device tax essentially zapped the research and development budget for many of these small startup companies we also in addition to your agency's regulation we also have the comparative effectiveness because the patient centered outcomes a research institute that was funded in the page protection affordable care act all of these things now interplay with the bringing of new drugs and devices to market witness the controversy that has existed over provenge in a vast and the past so it's first of the year we've certainly heard a lot about prostate cancer and the period of time that it provides for survival is not it's not cost effective to provide it to prostate cancer patients but i think there was recently a relaxation of that ruling breast cancer with a vastin some of the same considerations i also hear people ask me why can we not talk about surrogate endpoints that was very effective in developing the drugs that are now useful for trying to get hiv aids if surviv ability is the only endpoint that can be used and we're not certain how reduction of viral load will affect that survivability in the early days of that having a surrogate end point actually allowed those products to move forward much with a great deal more facility and provide relief to a segment of the population that previously had had been denied relief so these are not just abstract issues that we're talking about they're very real issues and again i know that because i can't go anywhere in the country without someone telling me that you know i was delayed for years with this anti cancer drug i'm saving twenty five hundred people a year now so i have to assume ten thousand died while i was put on hold a regulatory agency i mean that that's pretty severe where we put it in those types of numbers so i am encouraged that you're you're considering this but please also understand that we don't even have the freedom to bring these folks to committee and ask them questions because they're fearful of retaliation from the f d a surely you've heard that before you know i can assure you that we make our decisions based on the best available data not on you know other information they do not need to worry about retaliation i think what we need to focus on together though is to make sure that our regulatory pathways are as well defined and is as predictable as possible for sponsors who are bringing new candidates products before us we need to make sure that we are able to work with them closely so that it's clear understanding of what's expected of them and why we need to make sure that we're bringing the best possible science to bear in terms of making sure  that the data that's being collected in support of a product is the right data and that you know things you just mentioned about surrogate endpoints we do you get end point but we need to be undertaking a massive for working with scientists in industry and government to really develop much more innovative clinical trial models that will enable us to get the robust scientific answers we need but with shorter times lower cost and fewer patients in other areas where we can apply better science to both the and i corrected that was actually patented under a chinese patent i don't know the answer to that what was what is the purpose of developing a molecule like that does it have a use in industry i don't know the answer to that i'd be happy to get our experts at the agency to provide you with additional information well it might be something that's useful to know again we're talking about the committee developing legislation to prevent these products from coming into the country we need to know what what was involved and  easy information for us to actually get and you're well the reason i'm asking the question is because i know that the f d a is working on trying to streamline the approval process but at the same time making sure that the process for each each hinder our ability and you know we are talking very large numbers especially if you look at the drug in the device side and you know as we've been talking about already the ability to really support sponsors in their efforts to bring products before us does require is a resource intensive staff intensive activity to be able to provide the best possible and the most timely review and you know you can streamline processes and i assume you're doing that but at some point it does take the resources to pay for the staff to review the applications and and to do what needs to be done is that right that's correct a second question i have is is this this discussion that a lot of folks have been having in this hearing about the approval process resulting in a slow and more cumbersome process than in the e u and i hear i hear this a lot and i've read it a lot in the media i'm wondering i don't think you got to fully explain what the what the f d a found when when they looked at this claim that the e u is much more fast and efficient and and does a better job i'm wondering if you can just just finish your answer to that question ok you know we did take a very serious look at at the exact numbers because we were hearing more and more questions raised in this area and what we found you know was was very striking i may get the number slightly wrong because i didn't review them before coming to this hearing i was more focused on the import safety issues but i believe that between two thousand and six and two thousand and ten if you look at there were about fifty three or fifty four new millennium molecular entities that were approved by both the e u and the u s and that we we re in fact significantly more rapid in approving those drugs in you know well over fifty percent i think was forty three or so of those those products if you actually look at at cancer drugs and the time frame that we looked at for that was a little different i think it was two thousand and three to two thousand and ten but there were twenty three new cancer drugs that were approved by both entities and that we were first in approving those so you know there clearly is a misperception that we are slower than our counterparts in the european union and for the priority drugs were very significant were almost twice as fast in approving these and was this a study that you did it was it was a systematic review if you had we had a feeling that what i viewed as better than i mean i fear i probably should not have even tried to give numbers  would be under this drug safety in halfman act with which mr dingell and and some of us introduced yesterday what would that give the f d a new authorities to address issues like intentional economic adulteration like in the heparin situation i think it could very well give us important authorities that would make a difference additional authorities to you know really pursue investigations in places outside of our our borders when there are public health concerns our ability to share information with counterpart  of curious about these two hundred fifty countries that import food and drugs to us if you don't mind you could send us a list of those countries be helpful and just going your web site and pulling up the website i noticed that just for this year  countries that there have been alerts on for example bangladesh had ten alerts cambodia had one indonesia twenty seven alerts the ivory coast considering what's going on there at three nicaragua had nine thailand had forty seven  countries considering the danger coming well are are important lurch are based on public health risks but certainly they are targeted to can you say you have the authority to stop for example from thailand where there's unrest and they had forty seven alerts should not enough to say you're going to stop altogether well i think you know important in timely example is you have the authority and do you have the authority to do that we do product or set of products but if you had an alert in ivory coast three and indonesia twenty seven isn't that enough to suddenly specially if there is i don't know what particular product where there are so you don't have the authority with you've got identify the risk in detail before you do that otherwise you don't have the authority right we don't do blanket restrictions based on circumstances within a country ok mr talked about a little bit about the budget and i mentioned earlier that the budget your budget went up by a hundred seven million dollars did you know that we have as i said had a very significant increases in our budget in the last couple of years it's made a difference i think it's important to recognise that that you know we have been under was sourced for literally decades but you understand the budget has gone up for the fiscal year and i think in very appreciative but as i understand when you're talking to  weren't you weren't sure clearly what the percent by just going up and you weren't really clear what your budget numbers is that correct that you weren't quite clear on the you know this is been of unusual budget period he was asking me what the increase in the  last twenty four months but i think what but you know we certainly do have that information so you don't really know your budget numbers at this point you don't know what they've gone up as correct well we're still we're still looking forward to learning are our budget numbers this year ok we have a chart here that is come from you folks f y two thousand and ten zero zero our field work place i just want to show you this and staff is given if you go down to the fifth line i know president obama has talked about food safety being one of the top priorities and he has indicated that it's very important for the administration yet when you look at import foods in general on this line in the work land for f t s which i understand f t s are basically the federal quibble it federal time equivalent so what you're not people but are just lock outs it and forced on import foods is that correct that it's a little surprising considering the priorities of particulate you've talked about to think that the man hours are actually in this area has gone down and i just want to explain why has it gone down i'm going to let you know the imports have increased so the figure is not not to say that but it the point is with the increase of the imports and yet your manpower has gone down this is just a little puzzling what we call program assignment code zero three eight one nine a and b its import foods in general it does reflect a point of zero point seven f t e decrease from the previous year it is not the only program however biggest program you have when you look at all the other figures it's multiples of all the other programs so i think you're sort of discounting a program in which it is the top program and to see the top program actually in man hours go down in terms of how the f d a is work plan is a little quite startling i think that mr elder was indicating though that this is just one component of our overall import safety program for foods and that that program has actually priorities no but i think we need to also look at the overall program and how individuals are being deployed and this does not mean that the overall food import program has decreased in fact it has increased in terms well i would say that your workplace changes that you show does not show that increase decrease my time has expired the gentleman from michigan is recognized for five minutes you know first of all it's not a competition and we obviously have different regulatory framework but when you look at the numbers in both drugs and devices the lag time are not what has been put forward in fact in the drug as i said they've been in areas we clearly have approved critical products more swiftly the device system in europe is quite different than that here we are early in the implementation of this historic piece of legislation but we are making good progress and we can see that it will very significantly strengthen our ability to protect the safety of the  supply to be able to really shift to a preventive approach and to work in greater partnership with our state and local partners with foreign governments and with industry clearly in terms of being able to implement all of the requirements and there are many in that food safety modernization act you know we again face the resource limitation issue and we're hoping to be work with