five minutes will begin today's hearing will once again explore the question of whether the food and drug administration f d a is adequately regulated overseas manufacture of pharmaceutical products as a subcommittee has report before a significant and so growing quantity of pharmaceutical products by americans are now manufactured with ingredients obtained overseas from countries and almost on almost every continent with the exact quantities and sources for these drugs difficult to determine the general consensus is that at least eighty percent of all active pharmaceutical and gradients as used by u s manufacturers are produced drugs are imported more importantly much of this production occurs in regions that lack robust regulatory systems such as china and india china alone has more firms registered to export drugs to the u s than any other country major challenges to the f d a as was noted by former f d a commissioner david kessler in a major news production and i quote china is as close to an unregulated environment as you can get in fact it is a lot like the us was in one thousand six he says that's why we developed an f d a quote the u s food and drug administration is the agency responsible for overseeing the safety and effectiveness of all human being of all human drugs marketed in the u s as part of this  effort to oversee the safety and quality of these products the f d a is policy is to physically inspect for an establishment that ship drugs to the american market last year the subcommittee asked the government accountability office g undertake a comprehensive audit of f d a s foreign drug regulatory system the preliminary findings of that audit were presented at a hearing before the before the subcommittee on november first of last year old reported that  substantial lack of human and economic resources weaknesses in databases and i t systems used by the f d a to track inspections and drug imports and the lack of permanent operational support in foreign locations were major challenges facing the program also found that many of the f d a databases used to track foreign firms that export to the united states contain substantial material inaccuracies that have yet to be reconciled by the by the agency more specifically a lack of resources was determined to be a major factor undermining drug inspection program for example while current law requires f d a to inspect domestic firms once every two years which f managing to do roughly every two point seven years old reported that f d a has only has enough resources to inspect foreign firms about once every thirteen years in china one of the largest producers of active pharmaceutical ingredients for the u s market f d a only inspects about ten to twenty firms each year against an inventory of more than seven hundred firms at this rate the f d a can only inspect each chinese firm once every thirty to forty years worldwide concluded that on an annual basis the agency only has enough resources to inspect about seven percent of existing foreign plants which amounts to inspecting one plant every thirteen years given that these inspections are the most important tool the f d a has to ensure firms are meeting u s drug safety regulations these rates are unacceptable f systems for managing inspections and prioritizing risk was another major concern highlighted at the november first hearing old testified that this system was antiquated not designed for this purpose and fraught with duplicate and inaccurate data such flaws made it difficult for the agency to assess risk and prioritize inspections f d a could not determine how many foreign firms were subject or subject inspections or where they were located one database suggested that there were three thousand foreign firms registered with f d a to market drugs in the u s and yet another database seemed to show that almost seven thousand firms actually shipped products to the united states how can there be any confidence that the f d a is adequately regulating foreign drug firms when the f d a has no idea who's making what where they are physically located and when they were last inspected these problems highlight it ten years ago still plague the agency today if the g a o and subcommittee findings were not enough to demonstrate that the f d a regulatory systems are broken allow me to provide more evidence in december of last year a specially formed committee for the f d a presented a comprehensive two year study in title f d a science and mission head risk report of the subcommittee on science and technology this science advisory board report assessed the agency's ability to support a variety of existing of existing and future regulatory operations the special subcommittee that concluded this review was comprised of nearly three dozen external experts who represent industry academia and other government agencies the subcommittee held a hearing on january twenty ninth two thousand and eight to explore both the general concerns raised by the science review board and their implications for food and drug importation the report advisors including chairperson dr cassell who will testify again today provided alarming testimony regarding f d a s deficiency in minutes regulatory responsibilities the panel was particularly troubled by the multitude of issues affecting the entire agency including those related to foreign drug inspection program with regard to the scarcity of resources for conducting foreign drug inspections at the agency the report states and i quote although approximately eighty percent of the active pharmaceutical and gradients used in our prescription drugs are imported from abroad and foreign drugs and foreign imports of drugs and app active pharmaceutical and gradients were valued at more than forty two billion dollars in two thousand and six f conducted only three hundred sixty one foreign croghan biological product establishments in two thousand and six only thirty two field inspections were made in india and fifteen in china the two largest sources of pharmaceutical exports to the united states millions of shipments of f d a regulated products are now imported into the country each year from foreign film facilities that have never been inspected by f d a and with current appropriations never will be end of quote the f commissioner was present at the january twenty ninth hearing during his testimony to come commissioner agreed to consult further with the subcommittee to explore ways to resolve the many problems identified in the science advisory report and address the multitude of concerns raised by the subcommittee and others related to food and drug imports almost immediately on the heels of the january syrian f d a was quickly overwhelmed by the very type of crisis these reports that potus audit predicted would occur pressure and as many as eighty one deaths we would learn that tainted heparin was imported from china and that the chinese facility chandu s p l which made the active ingredient had never been inspected by the f d a because of multiple internal continues this tragic episode underscores the vulnerabilities in the current system used to regulate foreign drugs we've spent almost a year investing the nature and extent of failures in the f d a as foreign drug inspection program at their several hearings the findings of the a own science board press articles in the subcommittees own work there are enough red flags to suggest to this chairman that it is time to act and fix this program jails set up perfectly in last year's testimony and i a response to systemic weaknesses in the management of this important program it cannot provide the needed assurance that the drug supply reaching our citizens is appropriately scrutinized and safe kind of quote to date a has been unable to ensure the public these products are safe because they do they have not addressed the numerous systemic weaknesses many of us have identified because others will report today that many of the same problems way down  year are still with us today i can only conclude that american lives are still unnecessarily being placed at risk i look forward to hearing from the commissioner today however given the current nature of his agency's foreign drug inspection program i think it is incumbent upon him to lay out a credible plan that demonstrates what steps the f d a has or will take to close these gaps and what resources are regulatory tools he needs to do the job last year this nation derogatory failure resulted in  dogs and cats this year it's tragically led to the deaths of people if we don't make some rapid progress on fixing the foreign drug inspection program the next melamine or heparin tragedy will soon be upon us with that i next recognize my ranking member of the committee mr shimkus from illinois for an opening statement please sir thank you chairman i'd like to my time to the ranking member of the full committee mr barton for his opening statement mr barton please for an opening statement thank you a for going out of order i've got another meeting up stairs that i'm going to go to after this date and then i'll come back down for the questions i want to commend chairman stu packin ranking membership for holding this hearing continues our bipartisan tradition of oversight work to ensure that the f d a is policing the safety of our drug supply i want to commend him for attending as he said he would when we had a hearing on this subject  drugs and we're even more concerned that many of those are coming from china which has a spotty record of regulating its its products which are sold for export and there's a long history of counterfeit products from china shoddy manufacturing sometimes shoddy manufactured products and counterfeit products cause real problems in our country the american people deserve it is something very very wrong with our system if we can't decide on a collective basis co operative basis with the administration of the congress what to do about this subcommittee is then outstanding work over the years in revealing the weaknesses in our current inspection program both domestically and foreign the risk from imported drugs have increased quite simply because the number of imported drugs has increased almost i was under the impression until preparing for this hearing that an active drug a new active drug ingredient if it's from an overseas plant had to be have pre approval and that required of on site inspection apparently that's not the case because we've got the evidence that the f d a has allowed foreign facilities to go on inspected are barely inspected it would seem that would be one change that we need to make and we need to make immedi in preparation not for this hearing but a previous hearing that we had the statutory authority to give to the f d a that if they felt like a facility or a particular drug or are basing gradient wasn't safe they could refuse it's and middens to the united states market apparently that's not the case it is an authority that the secretary of health and human services secretary leavitt is asked for it's an authority that i support giving the f and hopefully it's an authority that we can put into statutory law on a bipartisan basis later this year it's clear that the f d a needs to be needs a new thinking in how to deal with the twenty first century in the global commercial market that we have today we don't have the luxury that we had even fifty years ago of just staying here snug as a bug in a rug in our home country and locking out the rest of the world in terms of drug imports and things like that we have to come up with a system that makes sense both from an economic standpoint from a regulatory manpower standpoint but also from a safety  standpoint and that's the bottom line purpose of this hearing the agency congressional approval to clarify its jurisdiction to thwart criminal conduct outside the united states that threatens the health and safety of the united states population again that's something i hope we can give the f d a and statutory authority later this year the f d a needs a foreign inspection program with many many more full time inspectors overseas and with the with the availability to go into these foreign plants and conduct inspections in overseas plants like they're allowed to conduct inspections in domestic united states planes foreign inspections unfortunately are the neglected stepchild commission welcomed the panelists on the other panels this is an important hearing and hopefully while it's an oversight hearing will lead to some legislative action that this committee takes to help remedy this problem in this congress is adequately able to protect american services from or incompetent foreign manufacturers of pharmaceutical products or whether they have the will to get the money and the resources necessary to do so given the findings of the subcommittee as a recent disturbing event surrounded tainted heparin i believe that f d a is clearly not up to the test as it cannot or will not undertake the reforms needed to protect americans from this threat from abroad or get the resources that they need to carry out the business that they are charged with they don't even tell us what  are the challenges that are imposed upon them by their important responsibility of protecting the health and safety of american people now let's summarize some of the committee's key findings from its investigation so far and then let us ask the commissioner to defend the indefensible first significant and growing amount of pharmaceutical products are used because that are manufactured overseas at cent of existing firms shipping drug products to the united states annually now what does this mean more than seven hundred chinese firms are currently registered close chinese firm a single time assuming that no new firms are added to the list the information technology system or a system that f d a uses to track and manage data on foreign manufacturers and the drugs they expect export to the united states is archaic and fraught with inaccuracy as matter of fact pointed out to the committee or to the foreign firms are subject to inspection globally or where they are located g a o reports that f d a cannot determine how many forms firms are exporting drugs to the united states proper manufacturing practices no such imposition is going on with regard to foreign firms simply because f d a inspectors or tell us that these requirements are being put in place the last time the commissioner of food drugs was here he promised to return and give us the details of how he's going to fix the sorry mess i hope that his testimony today will not resemble what he told the senate appropriators last week which appeared to be extraordinary short on substance and heavy on bureaucratic buzzwords i'm hoping that the commission will finally tell us what additional resources the president's two thousand and nine budget does literally little if anything to close the gap in for an inspection to this point neither i nor the american people have any reason to believe that the administration is protecting us or shirish about protecting us from dangerous foreign made drugs or raw materials from which these drugs are made right great until the commissioner honestly tells the congress what new regulatory tools  needed and what it will take to fix the broken system and how many more personnel it will take to inspect foreign firms with meaningful frequency i fear that we're going to continue to see contaminated products entering both our food and our drug supply while f d a says helplessly by watching calamity and upon the safety and security of the united states this is an intolerable situation and this committee intends to address this with legislation this year we hope that the food and drug administration and this states part of the answer of course involves ensuring a sufficiently robust foreign drug inspection program this committee explored the foreign drug inspection program in some detail at a hearing this past november as with established at that hearing the present situation doesn't make sense we have an agency that is focused a majority of its facility inspections on domestic firms when most of the facilities involved in supplying drug product to the american public are now situated overseas a good portion of these facilities are in countries like india and china and we have an agency that has not implemented the systems and informational tools to identify fully and rapidly the risk confronting us from abroad let alone identify all the foreign facilities that should be subject to inspection we have already heard the numbers that show the imbalance in risk priorities with most a messed it firms inspected about every two years about literally hundreds of foreign firms that have not seen an inspection if at all in a decade clearly these priorities need to be brought closer into balance the subcommittee also established at frequent surveillance inspections are important for assuring good manufacturing practices and born facilities good manufacturing practices and related safeguards over the supply chain reduce the risk that dangerous impurities and substandard products will turn up in u s medicine cabinets we quality assurance safeguards have tragic effects as mr whitfield observed in november a bulk product that contains an empirically something that spot testing may not detect can cause injury or death to numerous people we saw this with chinese imports of genom i seen in the nineteen in  program he is here this morning to respond to findings by this subcommittee and the g o g a o as well as the f d a scientists vizor a board that panel a subcommittee report painted a picture of f d a struggling to fill its public health mission it describe reese resource shortfalls deficient information systems and structural problems at the agency that we should address i very much appreciate the commissioners willingness to step once more into the subcommittees fire but it is very important  here is plans to address the problems we see we will hear this morning some positive actions but are these actions anough is the agency using all the tools at its disposal to orient itself fully to the realities of foreign imports for example we know there are informational tools at the f d a as disposal such as pilot project system that promised large advances in real time risk assessment predict has been pilot tested but it we have yet to see this deployed widely why  holdup and why does this what does this say about the agency's commitment to modernize more disturbing is the agency's policy to waive inspections even in countries such as china for reasons that have nothing to do with the facility risk or location this  may be driven by resource constraints but it raises questions about the agency's policy priorities as well as we move through the hearing today i think it is important that first we develop good information about what the agency is doing now to improve it information systems and foreign posture we should learn how quickly it can bring some balance between its domestic and foreign inspection priorities we should discuss what authorities f d a needs regarding overseas criminal conduct this should help us improve our discussions about what congress can do legislatively and second as we discussed what more needs to be done and i'm hopeful we can also discuss where we want the agency to be ten years out do we want  see structured as it is today just with more people or can we find some agreement that we need a smarter more i more agile agency using all the best and integrated information technology that can tackle the challenges of global commerce more cost effectively than the current model mr chairman the subcommittee has done great work to identify the agency's weaknesses as they exist today gather some facts and perspective to develop a vision for this agency's future as well you the chairman and thank you for holding this hearing today i think it's timely in the heparin story unfolds we have no choice but to be more proactive in our safety measures abroad mr chairman i'm a physician before i came to congress and i know that i have to trust what i'm prescribing for my patients i have to trust that it is not adulterated that it has not been mislabeled i have to trust that someone with criminal intent has not adulterated the medication the reason i trust a medicine is because the food and drug administration approved it if it is if it is acceptable that we do not know exactly who manufactured the ingredients of a drug or if those ingredients are safe or not or if the factories have even been inspected then th whole system comes into question pure and simply doctors rely on the food and drug administration to approve drugs that keep the american public safe and they've done a great job over the years that safety is generally stipulated when a patient comes into a doctor's office and a prescription or treatment is recommended today we are very fortunate to have a physician at the helm of the food and drug administration and therefore you can relate to my concerns about the trust that physicians place in this federal agency that certainly would like to for once again appearing before us to continue this important dialogue on the food and drug administration's inspection program in addition to dr vanessa bach testimony we will also hear from the chair of the science board when we had our hearing earlier this year on the report i was very disturbed of some of the findings dr because cells testimony today will hopefully shed more light on how the report relates to the food and drug administration foreign drug inspection program with the significant increase in imports i think this program should one of the most crucial programs we have at the food and drug administration so dr saltz thank you for being with us today as well and i would be remiss if i did not welcome dr william hubbard dr hubbard you have provided this committee with great insight and i thank you for your commitment to making what i believe is arguably the most important federal agency in the united states better and stronger we heard the chairman of the ranking member of the subcommittee ranking member the full committee rather  talk about the ability to stop dangerous food imports from entering our country h r thirty nine sixty seven the imported food safety improvement act that was introduced earlier this year that bill came up largely as cooperation and instruction and advice from hubbard dr hubbard to to our office and we need the same authority now for the active pharmaceutical and gradients that are manufactured in other countries coming into our country mr chairman we are here today to better understand the food drug administration's foreign drug inspection program and unfortunately we all realize the food and drug administration has real problems in ensuring that our nation's food drug and devices are safe and effective what is not yet clear is how the agency has responded to these shortcomings and how effective these measures have been and how congress congress could actually be helpful in getting the the f d a to make the necessary changes according to the  report that we'll hear about today some changes are being made as to how the f d a handles drug importation but the changes will what will require wisely invested resources and firm leadership in order to have the complements that we all so much desire as a former speaker of this house of representatives newt gingrich's says time over time and time again real change requires real change new technology is desperately needed to help integrate the databases and modernize the record record keeping apparently there is talk of starting f d a field offices overseas a measure that i would likely support however the mission of these new offices is still not clear and establishing that clarity should be crucial for receiving the support of this subcommittee meanwhile we still consuming drugs from factories that have never been inspected or possibly completely unknown and we have people dying from these affected medicines they happen story is still evolving mr chairman to interesting that no test no test available would have detected the hyper self that hyper sulfated control it and present in the contaminated product that came into this country the very contaminant that is thought to have caused the adverse h reactions what additional resource with that the f d a is trying to improve and i believe is trying to improve and under the leadership of dr von essen bach change and progress is occurring but these improvements require resources that have been denied for many years now the chairman of the full committee asked a question the rhetorical question i assume what additional resources the f d a needs to protect the american  people he questions the administration's sincerity about protecting the american people and i think realistically anyone who's watched this full over the past several weeks would have to wonder book congressional intent and whether or not that's also suspect witness the ill advise bill we had a few weeks ago to have the f d a take on an entirely new venture to regulate tobacco in the lead editorial in today's wall street journal finishes with the observation congressional priorities are rarely so technology infrastructure prevents truly prevents the development of a twenty first century system that's needed to protect americans and after all the end of the day that's what we're all after providing americans for protection but they have grown to give  no other members we will call our first witness concludes the albany statements by members of the subcommittee on a core first panel witness to come forward our first panel we have the honorable dr andrew eschenbach commissioner of the food and drug administration it's the policy of this subcommittee take testimony under oath please be record commissioner your opening statement please thank you very much german's to pack ranking member shimkus members of the committee and chairman dingell over the past two and a half years every time i have appeared before this committee my message has been the same the f d a is immersed in a rapidly and radically changing world and we must make radical and rapid changes if we're going to continue our record of excellence as the world's gold standard regulatory agency for food and medical products for both people and animals i have consistently endorsed the fact that this would require additional resources and over three budget cycles have presented requests for those additional resources to the administration and to congress most importantly i've presented to this committee plans and proposals to use current and future resources wisely  to achieve our mission to protect and promote the health of every single person in this country and in fact around the world globalization increased product complexity and other market developments are placing tremendous strains on our import safety system these trends are not new or anticipated years ago and a report by the g a o agency's response has been delivered but nowhere adequate in proportion to the growth of the challenge first light i share with you just demonstrates the volume of f d a regulated products that are entering into this country data demonstrate that inspection at our borders for this volume of products could never be an adequate barrier that would assure protection to patients and consumers the next slide shows the number of establishment producing drugs outside the united states for import and is just looking at drugs there over third hundred sites and you can multiply this many fold if you consider active pharmaceutical and gradients biologics medical devices and generic drugs no matter how we arrived at this point if we were address the challenges of this reality the solution is not simply to just do more of what we have done in the past but we must do things differently the next slide indicates that f d a must not just be a gatekeeper but must be involved across the full lifecycle of the products that we regulate from their very production to consumption by imposing strategies that in compas prevention intervention and response across the entire supply chain both domestic and foreign as you mentioned this morning mr chairman at the core of this systems approach to this total engagement in product life cycle is the need to create a state of the art information technology infrastructure with data management systems that are capable of acquiring the complex and diverse information from multiple sources with integration and analysis of that information that defines risks and targets appropriately f d a is regulatory resources and action at the last hearing i discussed with you our vision for our enhanced information technology infrastructure and the progress we are making a longer trajectory to a total rest renovation of this infrastructure by two thousand and ten but information management that provides comprehensive information about the regulated product is only one component of what is required we must assure that quality is built into these products at the very source of production and that all parties involved in the entire supply chain are held accountable for maintaining that quality f d a must be proactive in that regard today i described to you a major initiative of quality assurance f d a beyond our borders initiative this is dresses imported products with the systems based approach to th problem of the agency's regulation of food and cosmetics and medical products the initiative includes a number of broad activities including increased collaboration with foreign regulators use of third parties to provide information about regulated industry compliance with the f d a standards and also providing additional direction to the regulated industry for their global activities beyond our borders present and builds on the very extensive and successful collaboration we have already established with foreign counterparts including more than seventy cooperative agreements and thirty confidentiality agreements with trusted foreign regulators many of which provide the possibility of sharing inspection reports these relationships provide a strong foundation for more extensive collaboration is to prevent failure and quality to intervene earlier when standards are not being met and respond more rapidly in officially and efficiently to signals of adverse outcomes the increasing global nature product development production requires our continuous and intensive interaction beyond our border this plan includes the establishment of f d a offices in china india latin america europe and the middle east have been engaged with direct discussions in each of those areas to obtain support and a welcome for a u s f d a presence and that progress is well underway especially through establishing our first office in china f d a can rely in part on these efforts in making important risk based decisions regarding imports permanent overseas offices especially in china will allow greater access for f d a inspectors and very importantly greater interactions on an ongoing basis between f d a staff and chinese officials and manufacturers to help assure that products that are being shipped to the united states a standards for safety and manufacturing quality another component of beyond our borders leverage is private sector resources as recommended in the president's action plan for a is pursuing expanded use of third party certification by foreign producers to verify compliance with u s safety and security standards with f d a oversight and verification these third parties can include foreign government agencies as well as independent agencies accredited by f d a and they can provide helpful information about compliance with f d a requirements a certification would not supplant our inspection or responsibilities or our regulatory activities but would simply compliment them and expand our effect to help increase information about foreign facilities we will also engage external non governmental organization with foreign offices to conduct on site verification of registration data product listing information and the information so necessary in our ability to understand the source of these products we would also be visiting foreign firms and verifying and documenting that information on a continuous ongoing basis assisting foreign regulators to be able to understand implement and in body f d a standards is another essential component of this initiative to build capacity beyond the f d a to a global effort at product safety my written testimony about our prevention intervention response strategy provides more specific information about beyond our borders initiative and our efforts underway to enhance our oversight of imported products important of these is the request of new authorities that will help ensure that foreign manufacturers of drug products are in compliance with us law we have requested congress to provide statutory authority for f require certification by third parties and certain circumstances that incoming products must meet us importing standards that we can refuse admission of products for which f d a encounters und delay limits or denials of access for inspection of foreign manufacturing sites that we have the authority to expedite destruction of certain unsafe medical products and authority to seek asset forfeit remedies for criminal offenses involving fraud unit or counterfeit products i appreciate the opportunity to once again be with you today and i look forward to answering your question about the details of these proposals that  mr commissioner appreciate your in here today and thank you for taking time to come to our hearing invite you to stick around for our second panel of testimony what is this on our second panel represent more than one hundred years of working experience with the f d a in the pharmaceutical industry as well as significant over say experience at the jail so while we welcome your testimony we think their testimony would also be valuable in assisting you in making changes at the f d a and i think it be yes or no to these questions mr commissioner because every little time isn't it true that in two thousand and seven there were thirty two hundred foreign firms registered with ship drug products into the united states committee once every two point seven years foreign firms once every two or three years once every two or three years how can you justify not inspecting foreign firms at the same  now let's address your budget jail reports across forty one to forty four thousand for each for an inspection is that correct i cannot verify that number sir we have slightly different numbers but i'm hording to g a it would then cost f d a about sixteen million dollars if we use the estimates of g a o is that correct proximal yes do you differ with those well mr chairman i think it's important for me to point here under the budget of request of eleven million dollars thirteen million are not adequate is not right resources to do more but i'm trying to make the point that in addition to doing more we have to do it differently you know i've been in this business a long time and i've had food drug commissioners in the dialogue have on average wagon yesterday's or i've been talking food drug commissioners for forty years and you're not the first so that i've had to skin for not doing his job and coming up here and defending an indefensible inability to do your job because you don't have the resources chairman i agree with you that we need more resources i think the point of the story is the heparin situation indicated that even if we had done the inspection we would not have detected how much money do you really need to carry out your responsibilities in regard to foreigners foreigners are not compelled by absence of inspections by to carry out good manufacturing benefactors because you and us manufacturers on an adequate level and you do not inspect foreign manufacturers in the same way how much money do you need to do the job that you have to have give me an tired you are not doing your job how much money mr chairman that would require me to present a business plan you gave a figure forty five thousand dollars per inspection if we were to inspect everything of the food and drug administration you are presiding over an intolerable situation how much resources mr chairman i would like to have the resources that would enable us to do a systemic overhaul of the entire process not a figure have to do to see to it the good manufacturing practices are conducted in places like china so as to protect american consumers against commodity you have one fine scandal going on you have other manufacturers of pharmaceuticals that you have now going on with regard to american manufacturers so that you could there be good manufacturing practices carried forward in china citizens at risk so how much to do your responsibility of inspecting those foreign firms in china to say joy that they carry out their proper if there are three thousand facilities in china forty five thousand dollars per inspection that would be what you're saying if the estimate is that it costs forty five thousand dollars per inspection and there are three thousand facilities that would be figure but i'm trying to discuss with you the fact that i don't believe that is the solution to the problem i believe it is much more complex and the solution needs to be much more do this on an episodic basis of going and coming we have to have offices that are physically present in these countries where these products are being produced engaged in an ongoing continuous presence that involves inspections and enhancement of our inspections while at the same time building capacity within those confines simplify this and get rid of the total you've got forty five thousand per investigation three thousand firms that comes to solicit additional funds to address some of the funding constraints that the chairman tried to raise can you say that again yes sir i'm sorry thank  you one of the success of elected officials hopefully is to try to take the complex and make it simple for folks understand and i think that's where the frustration comes because we're not trying to manage and wield the bureaucracy we had a dime for every outsider who came in to reform the federal bureaucracy with all these great ideals and then and then left really being tamed by the bureaucracy not able to to really develop and there's some people and we're going to hear from other panelists later later on some of the questions i'll be poses how do we remake the agency in a new a new world in a new era was harder we you know some people say you know dismantle it if we were to start over from scratch what would we do i'm not i'm not convinced that you know more money is always solution i think there is an argument that more resources in this case but based on the whole budget and other priorities as i address to the other  members of the panel if you have a producer manufacturing facility in the united states that has operated ten years straight been investigated every two years five times was zero defects that may call for readjusting priorities and saying well you know you've clearly got this down we're  once every three years and then you can shift to areas that we know need to be inspected i like charts and slides and i can put this up like you did but the reality is you have a  factory and we've got raw materials coming in and we produce a product and it gets to the consumer and right here in the factories whatever everything happens and in good manufacturing practices under i s o standards or under any type of thing they test  materials coming in you test the product that's going out you should and you watch the chain inside the factory to make sure there's no contamination and and you have you have a process constitutionally i know the president proposes a budget we always get folks come up here that complain it doesn't matter which administration that they're cutting one side to give money to another and and we always respond i always find whether the president proposes and we dispose constitutionally all spending begins in the house so you know as much as we have identified a resource issue you have mentioned that you've asked for more resources it's up to the house of representatives in our preparation process if there is a shortfall for us to do that and there may be proposals that come through that that will end up doing that keep it simple so based upon the opening statements your testimony we've got a resource concern and we that we also know it's a manufacturing evaluation in these factories and we have technological hurdles many of us would have hoped we would have been before and seen a lot more progress then than what we think we're at inspections versus inspectors versus facilities and there we have foreign and there's a big gap the question is how do we fix that gap can you just and that's a whole that's a whole premise of this whole hearing yes how do we fix that gap so tell me what what you would how we do this as simply as possible because we're all basically simple people here this is the the answer to your very important point of looking at this and arriving at the conclusion is the fact that if we were just simply to increase the number of inspections which we need to but that in itself would not solve this problem no greater example of that than the heparin situation in which an inspection would have not detected that contaminate and so what i've been attempting to do what i tried to share with chairman dingell is that in addition to his addressing the need to increase our inspections we also need to overhaul the entire system everything from the creation of information technology infrastructure to working with our foreign components in other regulatory agencies and other governments to working with the private sector in terms of good manufacturing processes and hold them accountable for building quality inn at the outset let me because my time is short get through i think we'll build on these in the second panel geo testify on the next panel that although the agency has made positive progress in databases and and in steps to improve for inspections it is not enough as i said to close the gap and you've already started start talking about commenting we have established in good manufacturing that good manufacturing practice surveillance inspections are critical to assure quality of the drug supply and that more surveillance of foreign firms is needed and i think you would agree with that  how quickly do you believe it will take us to close this inspection gap the gap that i just raised in the first question i believe that trajectory is going to be limited by resources and authority and capacity to absorb the change so tell us the authority and i wouldn't follow up with the chairman's question on what remarks nation that's what we all the information technology infrastructure could be in by two thousand and ten to two thousand and twelve at the very latest the expansion of the work force and enhancement of our capacity in our overseas presence could be done again within a matter of two to three years so i think the timelines for modernization of the a are relatively in a five year frame the we will examine happen next week more closely bug given the broader implications would good manufacturing practices surveillance inspection of the s p l plant which did not occur have provided information that would have helped in the current investigation now that's a different question than what you stated before  i cannot answer for that question as authoritatively today i don't believe it would have based on our current understanding of this investigation and our findings but it is only going as an ongoing investigation and i think the final answer is not yet determined yesterday f d a released a warning letter on the chinese based heparin firm that supplied the contaminated product which said violations cause to heparin to be considered adulterated if it wasn't for the happen recall how long do you think this plant would have shipped adulterated product before it was inspected i cannot give you a time when that it's u s client apparently didn't catch the violations wouldn't an earlier f d a have surveillance inspection have kept adulterated product off the market will end this contaminant was not detectable by the routine analytical method so the answer is no and that's going to be the debating point it's not detected but other aspects of a good manufacturing product evaluation might have highlighted flaws in the process where i concur i think that under current inspections we're tama two things i had to learn this one is getting the product after it's been produced and tested it to see if the efficacy and it's been adulterated all those other things but the whole process of the manufacturing process eases watching inspection that particular facility would have come under our regulatory intervention for other reasons and that in itself would have perhaps shut down that particular source there is my understanding that there are other factories other sources whose good manufacturing practices are quite appropriate in acceptable yet the contaminant was still yet it's the issue of that particular facility had problems we would have detected those but that doesn't mean we would have detected this contamination of the heparin supply because that's much more ubiquitous and would not have been establishments are essential component ensuring drug safety and of quote do you agree that yes sir i do get mr commissioner you keep saying that the inspection would not have detected the heparin contamination you don't know that you don't know that because you don't know what you have found if you would have inspected that lab or that plant because you didn't inspect intel after we had these deaths in fact mr commissioner the opposite can be true can it not that your lack of inspections thirty years in china actually encourages manufacturers to do substitutes like they did in this case here if i'm not going to be inspected for thirty years of use in the pig intestines that you're supposed to use why not use a self control no one's going to catch it so why not use it same thing with melamine we want to get a higher protein this industrial food why not put melamine in there you're not going to inspect the going take thirty years so you never catch one could easily argue that the lack of inspections actually encourage a less safe product in some of these plants is that not true well that's certainly one possibility so the only didn't answer we can give is look we didn't inspect it is wrong we're supposed to inspect and inspect in this country every two to three years we must inspect every two to three years for that  effect that inspections calls whether to the united states or in china or anywhere else in the world correct we need to inspect appropriately and what i've been trying to express is the fact that we need so inspections actually here and now you want to talk about other ways of doing inspections or last year and i mention the opening was january twenty ninth and you were at that hearing i know you sat through it and we appreciate the fact you did and you're talking about a as the final authority but actually you could turn the other way around and say the f d a is the foundation for all of that right when you're talking when mr king was asking questions other ways to do inspections you're talking about third parties that have third party sort of occasions right that's one of their addition yes or said expands our our effectiveness and our influence across allies or horizon in one euro or slide you show besides drugs we have medical devices animal food biologics all come in in this country from foreign countries right january twenty ninth when you're in a hearing we had a jail and they talked about your third party inspection programs and especially on medical device manufacturing your third party inspection program has been around since two thousand and four and is called the a credit persons inspection program pilot multi person purpose audit program and it shows that over a four year period only five inspections had been accredited by these organizations these third party organizations and the g a o concluded that the small number of inspections completed to date by credit third party organizations raises questions about the practicality anything of establish similar programs that rely on third parties to quickly help the f d a fulfill its responsibilities say in this proposal you're talking about even in your testimony so far at least the medical device it's not going to work it's not effective to few of them in five four years you had five inspections only from third parties so why is this going to be different well that's correct and i've spoken to the people in c d r h about what some of those barriers were for acceptance of that third party there are opportunities i think to improve upon that substantially the other thing is of course what we define by a third party that could also of course be other foreign regulatory agencies which have their own jurisdiction so it's a much broader scope sure but even the f d a says even looking at your beyond the borders program the one you talked about in your testimony were lacking specific implementation steps what are the associated times with this beyond our enhancing our current inspection ok enhanced in your current inspection what your what date are you going to have learned hands current inspections done by we did more for inspections this year than in the history of f d a you can do even more next year targeting be even with thirteen million dollars in each on cost forty five thousand dollars a year to do more we're targeting five hundred foreign inspections ice year in addition to creating the foreign presence five hundred level the five thousand dollars i was a math major that be about two hundred million dollars you're going to broken you don't prioritize it you can't even tell us what's being produced and sent to united states therefore it's hard to prioritize what is most significant to prioritize your inspections won't you start with your i t system so you know who's more years who are two more years before we have an id system that can tell us what's there what's who's producing what and then to be able to prioritize our inspection so we don't wait two more years before we can even prioritize incremental it's improving consistently and demanding that you proposed but not yet implemented a foreign vendor registration verification program what is that program going to start i understand it's supposed to help improve the accuracy of the information in your databases in the way i understand the program your foreign vendor registration verification program the f d a is going to contract with the next turn organization to physically conduct site verification on the registration data of the firms shipping drugs and other f d a regulate products united states is that going to start of you began the foreign vendor registration verification program it sounds to me you're saying we can't do it internally so let's get someone externally do it have you begun that prado it's a matter of leveraging where those verifications are occurring for multiple purposes we can benefit from that because as you pointed out in the data system there is a lot of redundancy there is in fact firms that registered and have are no longer shipping united states and that's what created that discrepancy right in the data you're going to have this will warn vendor registration verification program one is that if you contract with they want to do this that's why i'm asking that that's in process and i cannot tell you when that will be fully implemented but it's in prado nine i'd have to get back to you about this or do you have any money in the budget to implement a foreign vendor registration verification program these are parts of the unique identification number to every foreign establishment that makes a drug and that have all databases including those used by f d a customs tracked activities such as inspection products alert should we have  that you have that program right to be implemented where every establish that that's being done in collaboration with the other other agents that you talk to can't give them a foreign inspection number and tell you know what firms are out there right you've got to stablish the firms first before you give them a foreign inspection number right correct so it sounds like you are find out what's out there first correct combination of both their registration and our verification time is expired is revolves around the heparin story coming out of china but let's stay on that for just a minute what is the culprit there that's making people sick it was a compound that was added to the heparin that you looted to earl routine a little methods did not detect any abnormality it wasn't until we did very sophisticated testing with nuclear magnetic resonance and a variety of other very sophisticated strategies in highly specialize laboratories that we were able to detect the presence of something that shouldn't have been there and then that was subsequently identified as this particular compound good food and drug administration decided to start doing the  nuclear magnetic resonance test on the compound yes and we we launched that investigation we engaged both within the f d a as well as outside the f d a the appropriate scientists and then once we identified the compound we actually developed a nasa say that could be used for routine screening to be able to find that contaminants in in happen and that was distributed essentially worldwide so that many agencies around the world are now using our i say and evaluating their own heparin supplies but in december of two thousand and seven no one including the f d a already the beta factures or the importers rather or any other country would have been using that test no sir didn't exist didn't exist so it would have been impossible even had you you know we've heard all the stories about perhaps around manufacturing location was selected for inspection but even had all of the inspections even if we had an inspector in every plant in every foreign country likely as not this contaminant could have found its way through yes or fact it seems very likely that this contaminant was found its way through an irish stupor brings up a good point about we've got the melamine in the dog food and now we've got obviously i wouldn't ask you to speculate since i'm doing that for you but it does raise the those those very those very big questions so what ability do we have now we now realize the dog food wasn't wasn't your purview but what ability do we have to anticipate the next level of larceny or terrorism if i can use that word that might come our way in our food or the active pharmaceutical agreements that are coming from overseas well our ability to protect and promote the public health is going to be dependent upon the information that we have to act upon and what i am suggesting in the systems approach to our ability to now deal with products that are coming from all over the world have an extraordinarily diverse complexity that we have to be able to be much more present at the source of the production of those products yeah not only that you've got to think like a slug and have the and have the same type of simulations and i mean you could not have intuited it intuitively known that this product was going to enter the pipeline if i mean none of us know fat dumb and happy last christmas would have had any idea that this was about to happen to our pharmaceutical industry i guess right what i'm asking is is there a room of guys or men and women over the f d a one of whom thinks like criminals whom thinks like terrorists and they try to run these simulations where is our new solar ability and and in fact in fact that's been a model that we've benefited from as we looked at our food protection plan because we have been approaching food from the perspective of food defense as it related to intentional emanation as well as food safety as it related to the unintentional contamination that come from bacteria etc and chemicals and we appreciated the opportunity to integrate that into a cohesive system that is based on important intelligence as well as modern scientific analytical tools and that's a concept that we expect extended to all of the products that we regulate and it's inherent in this prevention intervention response strategy one of the things that really was striking when we had our food safety hearings earlier this year was the fact that there is no communication between the the various commercial interests that are overseas importing food back to our country there was no communication between them if they had a bad supplier or they got  something that was contaminated with them there within their shop but they didn't communicate i guess largely because of competitive concerns with with their counterparts but really even more disturbing is they wouldn't communicate with food and drug administration that it just  and to that point dr burgess we have consistently enhanced our dialogue and collaboration with other federal agencies importantly our relationship with homeland security now earlier actually i guess was last year i introduced h r thirty nine sixty seven mr hubbard helped us a great deal with that and the whole idea there was to have the ability to stop something from coming into the country if we if we knew it was wrong if we knew it was bad right now it doesn't seem like we have the tools at our disposal and chairman bart ranking member barton mentioned that in his opening statement that we don't have the way to a way to stop this stuff from coming in and that is going forward that just seems to me to be something that is so critical that we need to incorporate that into whatever plan that you come up with where we come up with the whole concept of equivalence came up when we talked about food safety the equivalent standard that the united states department of agriculture has as for about the twenty percent of the jurisdiction that it has over imported food the food and drug administration has an eighty percent jurisdiction over imported food but doesn't have that same equivalency standard that even though the manufacturing is in a different country it's got to be equivalent to what the manufacturing process would be in this country as my understanding we don't even have that equivalency standing for the production of active pharmaceutical green ingredients we're one of the points of  borders is to work effectively with our foreign counterparts so that these products meet our standards before they are come into this country and there's a dialogue in that i think we need to find for harm convened the first meeting of all of the international regulators mature regulatory agencies around the world all twenty seven of them twenty four i believe they came to the meeting two years ago to begin this dialogue and we've had three meeting sense but it seems like the the standard are already set by the u s d a would be again that equivalency standard would would be one that would be pretty easy to talk about harmonization that's great but we have a standard out there that that works reasonably well for the twenty percent jurisdiction that's out there and at least for the active pharmaceutical in gradients it seems like that's something that we should be quick to to pick up there may be some issues with regard to the  individual products that may or may not create unique concerns about equivalence but that's an area where we're discussing do you have this discussion we're having about heparin right called generic biologics that biosimilars products that this committee the health subcommittee of this full committee is is investigating well again i think dr burgess it reflects the important testimony that you heard from our scientific advisory board at a previous hearing in that one month other component of this systematic modernization of the f d a is that we have a really robust and strong scientific infrastructure that will give us the modern tools of science and technology to make discriminating decisions about these complex and very difficult products to understand but to do that in a way that gives us greater  insight from a scientific perspective about those products and i think whether it's the dealing with the complexities of bio equivalence or understanding the components of a of a drug that's causing an adverse reaction  building the scientific infrastructure is one other pillar two to this new f d a let me just ask you one other question quickly because it's about money and chairman tingle went to some lengths to talk about money we've heard about the administration's budget of course congress has a pro fifteenth has come and gone and we have not passed a unified budget resolution clearly it is up to the house it's up the house leadership in fact it's up to the speaker of the house to war get initiate the work on those appropriations bill those critical appropriations bills that you're going to depend upon to get your funding the stories that i'm hearing are likely that we will not be able to do that work this year the environment is just too toxic and to contentious as a consequence there'll be a continuing resolution at the end of the fiscal year which essentially will leave you at level funding so although it's great to get to go into some sound a very about budget numbers the reality is the reality of where your agency is what is what is being handed to you by the speaker of the house is you're likely to have level funding this next year fiscal year and how is that going to impact your ability to do all of these things that we've talked about this morning i believe it's been my responsibilities and the two and a half years i've been at the f a the critically assess the status of the agency to bring multiple partners together to begin to define a strategic plan for what the agency needed to accomplish and how it needed to change and what those initiatives would be that would require support would require resources would require new authorities and we've done that across the wide spectrum of anything from our food protection plan to to  you not expect that maybe we'd be talking about heparin of some of the medication that's coming from china today but i believe what what's occurred is not necessarily things are getting worse i think what we've done is systematically  cover what has been a a significant set of issues and we're dressing them systematically and in an effort to resolve them i believe even if you'll give me a moment  when we first encountered the problem with melamine in pet food our ability to interact and work with our chinese counterparts at that time was nowhere near as effective as this most recent episode which happened where we had media and rapid access into the country worked directly with our counterparts at the s f v a sharing specimens engaging in analytical process is so i believe we're stand it's got contaminated or outside and there's some miranda of understanding or agreement that supposedly going on between the two countries ours is just point fingers at each other no there was  scientific dispute if you will about an analytical methodology and were engaged in the discussion of that we believe the analytical methodologies that we've applied and are being applied by others are the correct ones you know th there was a less point fingers between the germans and the chinese than between the united states and the chinese over the separate issue given china's fundamental difference in understanding the science used to assess what is causing the chain an eprom problem engaged i think in a very conscientious effort to improve their entire system within the country i've met with their minister of health to believe this is as important to the health and welfare of chinese people as it is to the rest of the world what is it that they've done that you can document well as part of the memorandum of understanding we've really engaged as i just pointed out with the heparin situation an opportunity for us to work directly with specimen work through the the process of how the science is going to be done on these products so that we will know yes sir and we convened an international meeting of which they were present and the scientist internationally have been engaged in this discussion and one that and we're continuing that shows that the the budgetary and the number of inspection inspections on inspections that were done overseas as opposed to inspections that are done here i'm trying trying to see if this was a trend or this just started at a certain period of time relatively flat while the number of products and firms that were producing things bring and coming into the united states was growing almost exponentially so the gap was was substantially widening and  we obviously need to keep pace so the i don't know that the inspections went down as much as stayed flat while the demand substantially increased so as we've exported all our manufacturing other countries we've not i've had some conversations with some some company representatives they seem to be opposed to any form of charge by the apartment to pay for the  inspections you know and i understand they don't want to have any cost additional cost incurred how do we pay for this since we don't have the money since we were left with a huge deficit and a huge problem appropriations are an important part of it user fees has also been a part of our budget when applied appropriately and segregated appropriately so they're not influencing our regulatory decisions and i think user fees  an alternative mechanism of support that it did someone in the department you or someone within the bonnet can make to say and surely saw this problem coming towards us did they not sorry about that the inspection problem the ability to not inspect to have the manpower and the money no one no one saw this coming do we just wake up last month and say oh no sir when when i arrived at f d a two and a half years ago i said five strategic priorities one of which was globalization and that was an effort to be to recognize what was occurring and what had been pointed out by others and to really begin a very aggressive systematic and systemic approach to being able to address the complexity and the magnitude of the problem and what we've been discussing other parts and pieces of that but the difficulty i have there with an aggressive approach is that you and i have three and a half years later we're here and we're getting dumped on with chemicals and bad bad drugs and such as that did you come to the congress did you go to the white house did you say somebody look we need to have the money even give it to us and user fees inspection seize or set up a mechanism where the companies can send people over there to inspect the products that are going to be part of their final products do we do any of that yes sir for the for the period of time i've been at the f d a i have consistently and continuously requested increases in the budget that trajectory is continuing we have consistently attempted to bring forward plans of initiatives that i believed would be demonstrated to have impact and for which we could be held accountable for outcomes we've talked on multiple occasions just even this morning about the transformation of our in i t infrastructure so you've requested show  your question the white house for the increase of the budget yes sir over the period of years and they've rejected that how much more did you ask for and for the specters from the white house well i've gone through a budget presentations and made my request to  department that subsequently went on but given how much patience and then recommended to the congress how much what what was the dollar amounts that you asked for to make sure that we were adequately supervising overseas manufacturing of our products i everybody's been talking about the last ten years surely people have to look to the future of where the jobs are going to go or maybe they didn't look to where the jobs are going to go and where the manufacturing was going to be done if we were friends with everybody in the world i probably wouldn't be sitting here having this conversation but as mr burgess contemplate it there are some people that don't really like us and this may be an avenue for them to terrorism to come after us and that's the last thing we need we need and so i would wish that that you would impose upon the administration the importance of food safety to this country's security i think my time is on the back but if i haven't thank the gentleman mr green for questions subcommittee over the last few years particularly after the two thousand and three medicare prescription act even before we've had a number of hearings barack committee concerned about my constituents going on the importing pharmaceuticals whether be from canada or europe or wherever because they don't really know where they come from and the argument we heard many times as we don't know where they come from we don't know if you're ordering it from a canadian pharmacy or you may be ordering it from a china pharmacy or somewhere else and yet now it seems like what we're hearing is drugs that are approved that eighty percent of the greedy and are imported and you know we've learned that there's no oversight over that or  t very little if any i guess my concern if i was in business producing a pharmaceutical just like of i was in the business of producing any other product the responsibility for that is the oversight w a but also with that person or that company who is importing that ingredient whether it's active or inactive is part of something we're putting in our body that's pharmaceutical has there been any discussion on what the pharmaceutical companies on our next panel here that is the f d a looked and said did you all go to this plant in china to look for the ingredients let me see your track record what you did because you are importing that product to put it in something that you're putting your name on you make a very very important point the corporate responsibility is an integral part of this whole effort and f d a holding them accountable for that has been a part this it is required that they carry out their own quality assurance and the vigilant in the screening of their materials and so i do concur with you that that's an important part of the of the effort and that holds them accountable secure our supply of drugs is there any information you can give the oversight committee on for example on health brown or whatever else that may come along when this developed the f d a go to that company and say ok let's see what you did on the quality of these this product that you're selling to our constituents when a company imports  an ingredient to an active pharmaceutical in greed to incorporate in the development of the finished product they are responsible and accountable for suring the quality of that ingredient and they have to assess it i think point we were making earlier with regard to the contaminants in heparin none of the conventional tests could detect that contaminants so that was something that was beyond our ability to using testing and i think what you're going to hear from most of us is that you know the f d a the traffic cop you need more resources to do that and i appreciate you asking ministration it's also our job as members of congress though and the chairman miscalculated two hundred million to twenty million that's why we were not the appropriations committee and but if we were we would probably be hit with what we've heard for a number of months we would probably be saying yes we need great and provide a lot more funding so you can do your job as a traffic cop but not take away the corporate responsibility because if i am speeding down the road and i have an accident sure if there'd been a policeman there stop me i would have that accident but it's still my responsibility for speeding down that road as chairman i think that's what we need to do and maybe the next panel will explain the corporate response below with our effort to try and make sure the f d a does your job as a graphic thank you preliminary results in they have been investigated and then it's my understanding that your agency has indicated that you have traced the contaminated material to to china is that right yes sir that's difference is that they believed that there was a product with which there were adverse events associated but they could not find the contaminant in that product and therefore they were refuting the causal link are as say our methodologies which are much more sensitive did in fact find the contaminant in that product so that's where there's a very specific difference to what i would do it what are the where do we go from here well i think what where we are at this point is we've assured that the so why if heparin in this country today is safe  we've prevented any further import of products coming from china from through an import of lurked from companies that are questioning and everything that is coming is being tested  before it's allowed into the united states to be sure it's free of the impurities so you under current law f d a has the authority in this case to prevent any product manufactured in china of that name from coming into the country so even if the chinese don't agree it really doesn't matter because the f d a can say you can bring it requested mr chairman if i can be explicit is we can deny product entry into this country if we deem it adulterated what we'd like to do is extend that to not allowing a product to come in if we haven't had the opportunity or been given the opportunity to inspect the facilities from which that's coming so the very fact we've been denied access to the to the facility and itself would allow that you've got the authority under existing law if we find  in here but when chairman doing was asking questions my understanding is that that he wanted you to give some assurances in terms of numbers of increased inspectors and in office that you want to locate f d a inspectors permanently overseas is that correct yes that's correct do you have an estimate yet as to how many inspectors and how much additional  resource in terms of dollars that you would need to do to implement this kind of general plan that you've talked to me about with specific reference to the first initiative in china we would anticipate placing thirteen  that that would also include our presence in beijing was euro where there's major food production and chiang kai where is the the largest exports are occurring and that approximate cost of that operation is about thirteen million dollars thirteen million now and then that specific case and have the chinese authorities been in consultation with you and your staff i apologize  staff consulted with the chinese authorities about this specific case yes sir so are they supportive neutral in opposition to they have been very supportive  across the number of their ministries but we are awaiting approval from their foreign office that is still outstanding but in our interactions with counterparts in their regulatory have the same authorities is inspect and united states in other words can they go into any facility at any time are they have to go through some procedure that would make it possible to let there be a cover up before they were able to actually undertake the inspection no we would anticipate they would have same authorities if they're coming from the united states on a slightly different topic it's been suggested that that  inspections overseas facilities overseas that the u s f d a does inspect that they be inspected on the same timetable as domestic facilities i e at least once every two years our g a o france are going to testify later today that if we implemented that system it would cost at least seventy million dollars a year just for china seventy million dollars a year in total and of that cost seventeen million would be in china by itself one do you agree with those numbers and if you do agree with those numbers is this funding level something that the f d a can digest without too much of a growing thing well to be clear i don't disagree with the numbers per se what i've tried to explain to chairman dingell was i really think the conversation has to be broadened beyond just number of inspections  their frequency i believe that it needs to be a tiered approach there are some facilities a quite candidly need to be inspected more frequently and more intensively than that and others by the very nature of their product and their history risk based approach may very well be able to be inspected less frequently than that with oversight by f d a by having the information in intelligence that comes from other regulatory agencies who are also doing inspections and by having also local and from ration from our local counterparts and the producers and suppliers so i was trying to explain to mr dingell that rather than simply responding to a formulaic number that what i really think we need to do is to create a much more strategic system of inspections that is tiered that is risk based and that is focused on on the particular issues of the product and its source well that that system that you just outlined do you do that in united states we're not to the degree  that we need to and this is all consistent with what is really an integrative program but this this idea is something that would be relatively novel if implemented well i think i think it it's the modern committee of oversight investigations going to take about five hundred f d a inspectors additionally do you agree or disagree with that number and if you agree with it how long  best guess it's not from think tank that tens of millions of dollars went into to come up with i can't refute the number but it would have to be a phased in approach to bring the number of people of that not three years i believe that could be accomplished as i indicated earlier an overall timeframe of five at the outset that particular process could be accomplished as early as perhaps three my final question are there any other countries that do foreign inspections like we're at contemplating asking directing the f d a to the europeans have more nerve actions in place in china other not necessarily that they have offices abroad  but they are engaged in foreign inspections ok thank you m in basically it didn't work and this is with europe the european union were supposed to mutual inspections in fact it says under this arrangement you member states will be taking the place of f d a when it comes to inspections for good manufacturing  because i believe fundamentally the world's a lot different in two thousand and eight than it was nine hundred ninety eight and people spanking is different i just recently even met a few days ago with growers when we want to try to get back with beyond our borders you're working with our european counterparts oh do you have an argument like that in your part of of this effort we haven't established in europe but it's part of the plan part of the plan which hasn't worked yet and i don't see how it's going to work let me ask you this and i don't mean to be argumentive draft legislation we've issued you're sent your office a draft of our committee our latest copy of our food drug inspection legislation have you seen this  is it true that foreign drug manufacturing firms can register with the f d a even if the firm does not intend on shipping products to the united states in order to do that you have to do an that foreign establishments who register with the f d a are serious about actually exporting drugs united states and others no other words a sizable registration fee would it we don't those firms just to register so they can market products elsewhere not to the united states i can comment that would be inadequate to turn or not and when coming up your databases aren't they these firms that applied to get the u s certification but that never shipped in your database  just coming up that i t system that we're having so much trouble with are they not well there may be important intelligence information about those firms that can be helpful to us i don't know that's coming up the system but they shouldn't be saying it would be i registered you would never know because you don't go back and check on because they're not the united states but by recognizing we might be able to cross reference them with other databases that exist in our other counterparts around many man hours and the amount of three we got letters how much time have you spent i can't give you exact hourly figure give me a guess the nation inspections could have done if we would have we had ninety thousand one hundred thousand more couldn't give you that estimates were because i don't think they're exactly equivalent well if you've gone over and done the inspection which was never done this plant before you already did one inspection there right on heparin that's approximately forty five thousand they have a couple of people  necessarily translate into those people doing inspections but to give you more money to do things let me just change gears here for a minute if the primary goal here is to protect the public health and let effects the national toxicity program at and i each as the chairman that b p a may cause neural and behavioral problems as well as effects in the prostate gland mammary gland in an early age where puberty and females the canadian government has and when you expect to have some decision on b p a a problem learning of the of the new data new information really convened an interagency task force to address that new data scientifically and that's in process and that will r our opportunity to make decision the canadians are continuing their process of assessment with the commentary period so we'll be working with them are their counterparts and our own internal scientific process which is underway but when you expect to have a decision so why is it taking us so much longer to get at this well i think it's again mr beck it's going to be based on what the science dictates and what the science tells us and until we have that analysis using the canadian government wasn't based on science  what i'm saying is that f d a is going to assess the science and make its own independent decision taking into account the information that's available from other sources like canada would like some be soon on  inspectors in every location and every port in the people's republic of china wouldn't found that goop that got into the heparin what it knows because we didn't know it was there we could we didn't test for it we didn't know to test for it correct now chairman also talks about he's concerned that all of these extra applications coming into the system are going to gum up the works are you at all concerned when you think about gumming up the works that might be a little concern but are you at all concerned about what we just did to the agency with dumping tobacco in your lap because this is huge new regulatory authority taken over by your agency that quite honestly we say that we're having trouble keeping up with what we're supposed to keep up with and now we've got a product that when used as directed kills forty thousand people a year and you're going to certify that it's safe and effective i mean to just beyond it's beyond goofy to think that that legislation is it makes sense with the crisis mode that the food and drug administration is in right now again it's our premier federal agency and we're treating it with extreme disrespect by adding that regulatory requirement to congress in october that the five billion dollars in user fees over the next decade was not enough to kick started tobacco division and that the food and drug administration may have to divert funds from its other programs is that assented the wall street journal get it right is that essentially correct i think the point of that was that the monies were not coming to the f d a they were going to general treasury with the idea that you've pointed out is that our resources and authorities have to be commensurate with our responsibilities and if we don't have capability of carrying out those responsibilities then we will have we will fail in our mission and we have been your mission is to things you've got to be safe and effective so can we ever do that with tobacco can we ever say it's safe well as a physician i know that there's no way that you can define tobacco product is being safe if used as directed it produces the result of disease and death well now there was a i thought a very insightful amendment offered during the markup process that would have allowed the food and drug administration the authority to either ban right or require that tobacco manufacturers produce a zero milligram nicotine cigarette if you're going to have to have this authority would you not think those two the most addictive substances that humans are exposed to especially during development as teenagers are that if you eliminated that completely you would eliminate the problem of addiction thank you michel you're back the balance of my time that you know people want to sell goods and products to our citizens they need to be our standards and if you want to sell goods and services to our citizens you know i think we ought to be willing to pay for that opportunity since we are the market everybody wants to get to and you know shouldn't be the burden placed on taxpayers i also believe in trust but verify when you have international agreements and also that management by walking around or inspecting by walking around is still  you for your time sir thank you mr chairman just let me close by expressing i know what you share and others members of the committee share and that is although we are talking about the many important changes that have to occur at f d a some of the things that we must always preserve is the caliber and the quality of the incredible people the makeup that agency there are half of the agency involved in our field activities and they are doing her roic work as you just alluded to with regard to our ability to mediately mitigate the problems associated with contaminated happened and so i thank you for our opportunities to present to you a vision for the future and i appreciate your recognition of the incredible efforts that the people of f d a are making on behalf of the american people i agree with you know the best way we can honor their work is again the resources they need so they can fully do their job thank thank you like to call up our second set of witnesses and ask them to come forward here in a few moments  cassell vice president scientific affairs and distinguished lilly research scholar for infectious diseases at eli lilly and company dr marcia cross director of public health and military healthcare issues at the u s government accountability office previously held several senior level regulatory positions at the f d a and dr karl nielsen retired director of the division of import operations within the office of regulatory affairs at the f will give everybody a minute or two here to assemble before we do the looks like we have a body available policy of the subcommittee to take all testimony under oath please be advised that witnesses have the right under the rules of the house to be advised by counsel during your testimony do any of you wish to be represented by counsel and shaking their heads and they thank you mr chairman thank you mr chairman members of the subcommittee i'm pleased to be here today as you examine f d a foreign drug inspection program i testified before the subcommittee last november on the topic at that time i discussed how f d a programs were not keeping up with the globalization of drug manufacturing i testified about weaknesses in data systems difficulties in prioritizing for an establishment to inspect infrequent inspection and challenges unique to conducting foreign inspection slide this slide shows the large mismatch between the number of foreign drug and the number of inspections performed as you can see the largest mismatch is in china since the hearing in november f d a has announced a number of initiatives to a draw these concerns as we've heard today from the commissioner us that we examine these and the extent to which they will fill the gaps we identified f d a as initiatives have the potential to strengthen f d a s foreign drug inspection program but they did not fully address the weaknesses let me discuss in turn the four key areas of concern we previously raised i testified in november that f d a databases did not provide an accurate count of foreign establishment and provide widely divergent counts with the result that f d a does not know how many foreign establishments are subject to inspection one reason f d a and it should have is to require electronic registration to reduce inaccuracy in its registration database however this will not prevent erroneous registration by firms that do not manufacture for the u s market another initiative aimed at reducing duplications in its import database is a proposal that f d a has supported to change the dat receives from customs and border protection on products interim the united states however the implementation of this proposal is not certain and would require action from multiple federal agencies in addition to f a has also begun efforts to integrate its various databases this could provide f d a with a more accurate count of establishment subject to inspection but it's too early to tell how much it will help and this effort has not been fully funded in fact f d a officials told us that implementation has been slow because the agency has been forced to shift resources away from the improvements in order to maintain the current systems next i testified that gaps in information we can f d a processes for prioritizing the inspection of foreign establishment that pose the greatest risk to public health f d a lacks key information on many for an establishment this limits its ability to use its risk based approach to select establishments for inspection to address this f d a has discussed obtaining useful information such as inspection reports from foreign regulatory bodies however the agency already has a number of such agreements in place and it has faced challenges in using these arrangements in the past for example f d a had difficulties in determining whether the scope of other countries inspections met its needs and inspection reports were not always readily available in english f d a also told us that complete reliance on another country's inspection results is risky the result has been that f d a only used it existing arrangements six times in the past year this raises concerns about some of the proposals the commissioner has discussed to rely on inspections from others i also testified in november that a inspected relatively few for an establishment each year and at the current rate it would take f d a more than thirteen years to inspect all foreign establishment just once f d a slightly increased the number of foreign drug inspections  year two thousand and seven but the agency still inspect for an establishment of substantially lower rate than domestic establishments the foreign inspection shown in the figure are the largest number that f d a has ever conducted as budget calls for incremental increases in funding for foreign inspections f d a dedicated about ten million dollars to foreign drug inspections in fiscal year two thousand and seven and plans to dedicate about eleven million dollars to such inspections in fiscal year two thousand and eight however it would cost about seventy million dollars per year to perform biennial inspections of foreign establishment as is already required for domestic a stablish ment's the eleven million dollar a plans to spin this year for all foreign drug inspections fall short of the sixteen million dollars that would be needed each year just to conduct biennial inspections in china finally i testified that f faced certain logistical and staffing challenges unique to conducting foreign inspections including reliance on volunteer inspectors and a lack of translators f d a has proposed establishing a dedicated qadri of staff to conduct foreign inspections but the overall timeframe associated with this initiative is unclear f d a has also announced plans to establish offices overseas with an initial eight f d a staff to be based in china and five nationals to provide translation and logistical support however the impact that these offices will have on the foreign drug inspection program is unknown because these staff would be responsible for all f d a regulated products in china in addition to the estimated seven hundred fourteen drug a stablish ment's there are an estimated six hundred seventy five medical devices stablish ment's and many more firms manufacturing food and other f d a regulated products subject to inspection the agreement with china is not finalized and plans for other countries are still in development in conclusion americans depend on f d a to ensure the safety and effectiveness of the drugs they take the recent incident involving happen underscores the importance of f d a as initiatives f d a has actions if fully implemented could address some of the concerns we identified given the growth in foreign drug manufacturing for the u s market and the relatively few foreign inspections conducted by f d a the agency will need to devote considerable resources to this area if it is to increase the rate of inspections however f d a incremental increases will have little impact in the near future to reduce the interval between inspections for these establishment in addition many of f d a s initiatives will take several years to implement and require funding and certain interagency or intergovernmental agreements that are not yet in place taken together f d a plans represent a step forward in filling the large gaps in f d a s foreign drug inspection program but do little to accomplish or term change mr chairman this concludes my for scientific affairs and a distinguished research scholar for infectious diseases of eli lilly and company of relevance to my testimony today i previously been a member of the advisory committees of the directors of both the centers for disease control and the national i served as chair of the subcommittee on science and technology the science board which authored the report that you've heard referenced today by chairman is to pat the f d a science and mission at risk by way of background i just remind you to th december of two thousand and six the commissioner charged the science board with establishing a subcommittee to assess whether or not f d a is current science and technology can support the agency's statutory mandate to protect the nation's food and drug supply you've already also heard mr stupak allude to the composition of the committee i would just emphasize that this committee was made up of a very distinguished group of thirty experts including former our chief counsel to the f d a as well as not just knowledgeable experts some of whom had worked in the f d a over fourteen members of the thirty member committee thirty three member committee were members of the national academy of sciences and we have one laureate the record of the proceedings of the meeting in which we presented the results of this report will show that the report was accepted by the cool science board and in fact the full thirty three member committee adopted the recommendations of the report for over a group this year this group of experts worked intensively conducting our review it became rapidly apparent that the f d a suffers from seri scientific deficiencies and is not positioned to meet current are merging regulatory responsibilities is agency wide and not limited to a single program or center since every regulatory decision must be based upon the base available vailable scientific evidence in order to protect the public sell we concluded that american lives are at risk and that there's an urgent need to address these deficiencies of relevance to the topic that we have at hand today which is that of foreign inspections especially for drugs i might add that many aspects of food and drug manufacturing are also should be based upon the latest very latest science and technology including science and scientific methods and technologies that are the latest as far as specificity and sensitivity for detecting not only chemical contaminants but also microbial contaminants and that we should have investigators in the field performing those manufacturing saw inspections that in fact are qualified in terms of quality control and scientific expertise the level of concern by all of the members of our subcommittee of the science board why and remains high and that's the intensity of our commitment to the review and their insistence that the fine our findings be broadly communicated quite simply what we've found is that a resources have not increased while their responsibilities have increased extraordinarily and you've heard that from many different individuals today and you'll hear further from others we also found the agency has not adapted in order to maximize existing resources by capitalizing upon the scientific resources in the academic community and other government agencies i e leveraging their resources the specifics of  finding with the subject of a hearing as you have heard mr that refer to this morning on january the twenty ninth the sa will not discuss all the findings in detail but i would rather like to focus on those aspects of our review that are most relevant to the topic of today's hearing on foreign inspections growing to number one is the area of growing disparity between responsibilities and resources to gaps in scientific capacity and capability information technology and to a lesser extent organizational structure with regards to growing disparity between f d a responsibilities and resources there's no more quintessential a governmental responsibility than the protection of basic commodities of america li such as our food and drugs the science board emphasizes that the need for an effective f d a is greater today than ever before since the f d a regulates eighty percent a nation's food supply plays a critical role in ensuring the safety of therapeutic and vaccines and devices and regulates a vast number of other consumer products and historically has been the agency to which governments around the world look to for the throes of the safety of products more over something that hasn't been mentioned today i'd like to emphasize that f d a is increasingly important to the nation's e anomic well as it regulates a quarter of consumer expenditures and the industries that it regulates are innovative leaders in science and technology and among the few american industries where the foreign trade balance with other nations further f d a will be a critical component in combating terrorism that's been alluded to this morning but not to any great extent and something that certainly should be of great concern to all of us as we talk about intentional a potential for intentional contamination of the food and drug supply as it relates to bioterrorism the science board concluded that f d a is slowly being hollowed out by a progression of budget cuts and in the to agencies need that deterioration in turn means that not only can the agency not fulfill its public health mission but the safety of the citizens of the well being of our country are undermined furthermore as the agency falls further and further behind the publically public is increasingly losing confidence in the government's ability to protect them the demands upon the f d a have soared as we've already said the metrics alone are dawning one hundred twenty five new statutes added to the f d a as workload by congress in the past two decades most without resources and reference to the number of established months we were told during our review that there were a total of three hundred seventy five thousand stablish months outside the united states making products coming into the united states and in fact that these were  extraordinarily new health threats that threaten contamination of products including mad cow disease one five seven six that are a but perhaps most emblematic of the trend of the ten fall increase in the past decade of imports from other countries today as you know fifteen percent of our food supply is imported from more than one hundred nations along with over half the drugs yet f d a has been given virtually no new authorities nor resources to address a dramatic change in the sourcing from products made overseas often in developing countries with little or no tradition of scientific rigor what about gaps in capacity and expertise f d a has resources have not only kept pace with its responsibilities many critical agency programs have sustained actual cuts i won't go into the cuts as it relates to but certainly that was one of our areas of biggest concern although one f d a new function new drug and device review has received additional funding from industry paid user fees it is important for you to realize that the agency as a whole has lost a thousand people over the past decade that perform critical functions some of them relate to of course the foreign inspections that we're talking about today this loss in scientific capacity has resulted in a loss of personnel to perform not only the inspection with associated with marketing products but is equally important in that it is a and i would contend that this applies both with regards to manufacturing of those new products as much as it does to pre approval of those new products we're on the cusp of another revolution in therapeutics breakthroughs in human yet f d a is not and does not have the capacity to prepare for these breakthroughs whether it be again in the pre approval process or the post marketing surveillance or manufacturing inspection tens of billions of dollars are being spent by both the public and private sector a lot of elements such products yet f d a has been denied their relatively minor funding necessary to ensure their rapid and safe entry into the market at a time in which u s competitiveness in science medicine and food production are under increasing strain from overseas a weak and underfunded f d a will be a brake on the very technologies that the united states is relying on for its medical and technological future it's absolutely critical that individuals involved in inspection of these products coming in for us from overseas in terms of manufacturing inspections have the adequate science and technology to allow them to do a better job and they're currently being able to do today they should have the methods to perform increased sensitivity testing looking for contaminants both chemical and m drugs and in vaccines biologic and also the perhaps even including something as we heard this morning maybe others would not call it quite a sophisticated it's much more practical than most w admit but perhaps an m r technology as well i would also be remiss if i did not remind you however that again the f d a food safety program is one that needs the greatest support with regards to these new technologies because they are simply at rock bottom both in terms of numbers of scientists but also there's scientific capabilities as far as rate monitoring the food supply the science board subcommittee viewed the current scientific needs of f d a to be extensive and diverse and critical terms i mean in terms of critical expertise infrastructure and knowledge perhaps as i've said of cross the agency and we do believe that this we heard during our review of the center for biologics for example that that center mandates that some of their scientists be present in manufacturing inspections to play a role in quality control so that they can be assured that the right technologies are being plied to a value way the quality of the drugs being manufactured and i would submit to you that this should be something that shouldn't be an exception with regards to biological products  vaccines but it also should be true or drugs yes i think commendable that f d a was able to develop a new test very quickly that has picked up the contaminant and heparin but a also certainly has shared it around the world but in fact perhaps it could have been done more quickly had more sensitive test been in operation and used all along dr would you summarize yes thank you in situation is developed over years the question is not why or how we got here but how we're going to go forward the report actually could serve as a blue print with regards to that and we recognize that the financial additions to the budget are not the only answer as we've already heard this morning while our report focused upon the f d a organizational structure related most of the scientific infrastructure it might well be a light of continuing issues related to globalization that we should be asking what f d a organizational structure is needed to protect the public south in the twenty first century setting globalization with rapidly expanding i of foreign drugs vaccines and biologic and again while our focus on organizational structures that related to the scientific infrastructure congress may like to consider requesting for example the institute of medicine to form a more in depth study to evaluate the overall structure as it relates to food safety and also drug safety and with that because out of time i will but thank you very much for your patient deaths began to come in and reports and so i appreciate the fact that you've stayed with this issue because i do think it needs to be stay with us until we find a solution and while i can with absolute  think that is a very appropriate analogy for us to consider when congress created the f d a no six you had a marketplace overrun with problems of unsafe foods and drugs and with three characteristics you had widespread substation of cheap but unsafe food these factors are very clearly the case now with our import system f d a has found substitutions of cheaper but dangerous ingredients and it's often from less developed nations if you mention melamine antibiotics and seafood sac masking petri dish water down apple juice the list list is a fairly long one and for the foreign producers that you referred earlier mr chairman can rely on the fact that f d a is not on the case and that a firm is unlikely to be caught and then if they are caught they are unlikely to be punished and so the incentive for all of the wrong place and in and then lastly you've got equally evident that these governments of these nations are incapable in my view of assuring the safety of the products they send to us and in fact they often did not a very existence of the problem so we really only have three alternatives we do nothing that that's been the default for many years and just for the best we can rely on the assurances of these foreign governments but as i said i just don't think that's meaningful in this environment or we can accept the fact that we have not taken care of the f d a and given it the means so know that we have built a terrific regulatory authority in this country over almost a century with we've built up the f d a it's got wonderful scientists dedicated personnel but we don't use it in protecting us from these foreign drugs and which i just think is a tremendous lapse and we're not given in the tools and resources they need you know as consumers we spend a penny a half a day on the f d a and i believe we just spent two or three program and i hope my participation will help the subcommittee develop effective remedies for a public health and safety system a serious attention the press has been very active the last couple months following the contaminated happened story f d a had a press call yesterday and reported there are now eighty one deaths associated with the use of contaminated have grown from china truly the heparin story is a tragedy that seems to keep growing in magnitude because the f d a investigation has not isolated the likely not in the supply chain where the contamination occurred f d a is encouraging all batches of heparin to be tested is that sufficient f d a wants to be able to say it would not have made a difference whether the plant was inspected earlier that the contamination would not have been discovered f d a is responding in its usual reactive mode to a serious and jarius event after the damage is done not a prevention mode granted the mandatory identity test in each batch of a p i received by the drug manufacturer would not have identified the contamination but facility inspections do help leverage safety i say at the chinese foreign manufacture and its suppliers had it here did good manufacturing practices and control of raw material and if f d a had inspected the plant to verify good manufacturing practices were in place then perhaps eighty one lives could have been say of compliance with the current g m p regulations could not have reasonably prevented or deterred the contamination of the happier and that it may be time to finally update and rewrite the drug g m p regulations rather than trying to convince industry through non binding guidance documents to enhance scrutiny of active ingredients and other components the vulnerability of the u s drug supply to imported substandard or counterfeit active pharmaceutical and gradients or a p i is not a new issue before the agency beginning in one thousand nine hundred one my colleague benjamin ellington who is also appearing on his behalf another f d a investigator and i an issue aided numerous international investigations with u s customs related to a p i is from several foreign countries including china in my previous testimony before this subcommittee on november first two thousand and seven i stated those counterfeit investigations found evidence that there were deaths associated with the use of hundred ninety six while i was a senior special agent and f d a as office of criminal investigations i wrote an internal memorandum to upper management of the o c i describing the potential threats of harmful impurities being introduced memorandum was produced to this subcommittee by f d a during a hearing in june two thousand on the subject of counterfeit drugs all the macleay months after i submitted my memorandum a meeting was held in the commissioner's office in february one thousand nine hundred seven and the imported counterfeit drug problem was verbal a declared top priority unfortunately there was a leadership change at the agency within a month and the counterfeit issue largely left the agency radar scope it seems it takes numerous deaths now to generate a call to evaluate and modify f d a requirements and operations it has been eight years since the two thousand hearing on imported counterfeits and seventeen years since it first imported counterfeit a investigation the same regulatory requirements for receiving and accepting components by finnish drug manufacture remain the same identity tests and certificates of analyses provided by the suppliers sadly when looking at the history of the problem it should not be a surprise that it is possible for the recent helper and student to occur it is time for a radical change and improvement an adjustment of agency operations that fits the international trade paradigm and facilitates the trade of safe products f d a must have a credible presence and foreign markets to better and sure compliance with good manufacturing practices and other requirements that ensure a supply of safe and effective drugs they have for an incident demonstrates just how internationally linked we are relative to drug safety prescription drugs and over the counter medicines may represent less than ten percent of all imported regulated commodities but the heparin scenario shows the serious cascading adverse health effects of the contamination of just one common and old drug f d a can be rebuilt but it will be expensive the public health cost is higher though if no significant investment is made as demonstrated by the heparin incident effective post market surveillance activities are essential a s public health and safety mission there are many great ideas for syrian f d a affectively into the twenty first century but what's out investment in the integrated i t execution of the great ideas are not very likely if the development is functionally absent from corrective measures then we should just plan a ten year reunion to revisit what should have been known or down debris vent more deaths from contaminated drugs the foreign firms may not be immediate reach for inspection but the products are imported drugs are not going into a black hole i thank you for your time and look practicing attorney and i represent foreign and domestic food drug medical device and cosmetic companies and matters and involve the f d a a seventeen year veteran of the f d a my written testimony which supplied for the record discusses my background in greater detail i'm not go belabor it here i'm pleased that the subcommittee is taking up the initiative to press for solutions for managing the safety risks associated with imported products again and the focus today specifically upon f d a as foreign drug inspection program i am troubled that we are again meeting in the shadow of adverse events that have claimed the lives of american consumers and we're still hearing about all f d a is doing after the fact the last time i appeared before you i made mention of the canada book drug investigations of the ninety's as well and i might let mr nielsen just recounted his efforts to improve the f d a investigation of of imported counterfeit drugs which which was most likely at least in my opinion quashed at some point in the agency in fact when mr nielsen left o c i i'm going to tell a story on him and  doesn't know i'm going to do it but when he left o c i and eventually reported to his job as the director of the division of import operations and policy he indicated to his supervisor his new supervisor that he was looking forward to getting back to finding ways to prevent counterfeit drugs from other countries into this country to which a supervisor asked what kind of a drugs this separate incident apparently occurred because of some human error in deciding whether an inspection had already been conducted or should be conducted i believe that were on the brink of a series of these events and that waiting for half days timeline will be a mistake the time for developing strip strategies has long passed as i said months ago on the president and to your staff mr chairman this recent case appears to be the close cousin of the  t drug cases discovered nearly two years ago two decades ago scuse me at that time the illegal conduct was discovered through intensive and smart facility inspections and by the efforts of forward thinking forensic scientists and investigators this occurred only because of the intellectual connection between certain domestic inspections at u s facilities by a keen f d a investigator who had previously conducted the for an inspection of the bulk supplier coupled with follow up inspections at the foreign supplier which were themselves targeted with knowledge of where evidence of illegal conduct was likely to be found it's no different today except that we now have available to us significantly improve technological solutions that may prove more useful to more precisely and efficiently identify target and intercept safety risks prior to the realisation in the marketplace will provide now just a summary of six of my recommendations and at this stage i believe that they are basically in the order of priority i would put them out one it's axiomatic that f d a is data systems operational i management systems alike have become the breeding grounds for potential disasters let me be clear that's not to say that all the products being imported distributed into the us are dangerous or even high risk rather the relative risk of any of them is not known by the f d a the agency can barely manage to do more on a daily basis than to check for registration numbers listing numbers and on a very good day some establishment evaluation data when it turning whether imported drugs should enter the country the system maintained remains badly stovepipe siloed and f d a proposals will take at least another five years to correct them f d a solutions appear primarily to be to lay a common portal over the systems which will not actually integrate the legacy systems over to f d a does not conduct in the foreign g m p surveillance inspections that constitute a regulatory force in the world even though the prize market for such articles is here in the united states the agency should be required to conduct foreign good manufacturing practices factions at the same frequency as domestic inspections even without additional funding this would level the relevant risk between domestic and foreign sources of drugs and would force the agency to balance those risks risks against the two sources the c g m p surveillance inspection when conducted by competent investigators who have at their disposal integrated account based information covering the lifecycle of products manufactured by the facility remains the single most effective means for detecting the kinds of activity that have been prevalent in the counterfeiting of drugs the production of articles using unapproved sources of materials and products substitution without a rigorous foreign inspection program f d a will never prevent the next product contamination before it causes illness or death three throwing more without requiring the resources to be used to produce different outcomes will produce diminishing returns in my opinion i believe the most critical area for increasing funding is an f d a s i t systems f d a systems must be far smarter and must be capable of taking data from a variety of sources both internal and external for comparison against legacy data its operational system systems must utilize risk based algorithms designed to predict where an exertion of agency effort will yield positive and measurable product safety and security results without a major reinvention of f days i t systems even the hundreds of poses that were in the two thousand and three imports or change of plan are of limited value and following that it would dramatically increase the resources in the field inspection force to include dedicated for inspection cause funding to increase laboratory capacity findings for leveraging state inspections for f days domestic operations and enhancement of those few headquarters components that are capable of actually assisting the field operations for in order to take the most advantage of enhanced i t systems the agency should begin moving and mainly to an account based regulatory approach that enables the interconnectivity of regulatory processes along the entire lifecycle of its products to encompass all steps from application approval  required to the consumer impact f d a learn a lot by understanding how left out customs has moved from a transaction only approach to an account based approach that evaluates the transaction in the context of the account customs accomplish much of this by requiring each submission of data to be connected to a unique numerical identifier is it a fires can be related to one another and able in cross linking of companies to demonstrate in relationships under the current regime the lack of integration of data accounts means a human must notice slight differences and company names to assess whether a foreign drug facility has ever been inspected and in this regard a unified registration system could quite easily have prevented some of the desks as well the five i believe the organization of the agency contributes to his inefficiencies i recommend again establishing with an f d a an organization that reports to the commissioner with a mission of focusing on enhancing the safety of foreign made products all products i continue to believe fixing f d a is important for an inspection problem requires it to be broken free from the domestic operation which produces much of the bureaucratic inertia against change in this area this new organization will be responsible for all important international focus work planning activities conducting facility inspections of foreign processors and importers overseeing and conducting border operations conducting foreign government industry assessments and training and support trade negotiations negotiations in a manner to enhance safety of imported products and to accomplish this a new organization should be directly funded rather than receiving its funding through the product centers of basic persistent infrastructure to manage risk associated with all important commodities must be maintained regardless of the year to year changes that may or properly occur and program directions and six and finally perhaps an unpopular solution to some involves the use of some third parties in my opinion f d a should begin in obtaining as much information as it can from as many reliable sources as the agency can find regarding the c g m p compliance status and supply chain security programs o foreign drug facilities that are not inspected by f d a are not ever going to be inspected by the f d a additional risk data could come in the form of third party inspection and certification companies accompanied by a robust auditing process on both sides of the border all such data should be connected to the firm's unique identifier in a corporation and account data to permit its assessment in the light of other legacy and other agency data this recommendation would permit the agency to focus its import inspection and examination efforts on shipments representing known and unknown risks and i thank the subcommittee chairman the members for the opportunity to discuss these important issues again thank you and thank you to everyone for your testimony today mr hubbard mr mr england i believe you were here when the commissioner testified what would each of you just give me quickly what would you each do if you were the commissioner how would you come to address this issue give me the top three a functional organizational structure to deal with the issues at hand you know i do concur with what ben said that there does need to be a separate and i also recommended that in my written statement an organization with the responsibility in funded and and empowered will provide solutions that will work and certainly funding is still a big issue but the funding needs to be attached to very specific events with articulated outcomes or expected outcomes mr england i think is two levels one is what do you do in the instant event and i think that i'd f d a is doing probably the best they can in trying to figure out where this product came from this and heparin doing it right to the specific heparin situation when it when it comes i mean i disagree entirely with the theory that the inspection couldn't have had a significant impact in preventing this i mean i think i think if we keep in mind that the inspection that we have now seen the forty three four occurred after the adverse events and we still saw the conditions we saw all i mean if f d a had been there prior to the adverse events during a approval inspection i'm inclined to believe that they would have seen as a facility in even worse condition and which case they would not have been in a position to be a source for this product so i think i think that the that the for inspection component is absolutely critical foreign market where it doesn't have the mandate and that it tries to do the best it can most of the four inspections in ri and reaction to the idea that well even some for inspections were conducted and yet there was still contaminated product that came from perhaps those facilities those inspections probably were today preapproval inspections we just saw at this facility regarding heparin was probably a five day i believe inspection far more deep in the united states that would have been a ten to twelve to sixteen day inspection and maybe that's not necessary to find the appearance of violation and prevent that product come in but i would agree that a two day inspection may not be able to produce this to be able to find these kinds of problems so i think it's passions but if we don't have the it really doesn't matter what you do you can't put together a space program and even customs work the integration with international trade data systems f d a still has to have data to balance that data against and without integration on the side you can go one place to get plant was never inspected but baxter did inspect it where is the corporate responsibility year or why would baxter inspected that we still have all these problems that were highlighted in document that you indicated with the f d a inspection information very very much information about it our understanding yesterday after we submitted this statement is that it's now been pushed off but that they do still intend to move forward in trying to establish some program it's not clear to us what exactly is going to be done under this contract whether they're going to perform on site inspections of a certain proportion of facility how they're going to select those facilities volved in the verification what information they're going to get beyond just is there a building there build into this also would not i mean if you need to know about a custom needs to know what's coming in and what's coming in could probably get the information quicker by going to customs because at least they know what's coming into this country it's not clear how there's not yet agreement that the unique identifier that would be used with customs is going to move forward because it requires the agreement of a large number of federal agencies and they all have to fund the changes to their systems to make this work board and said here's what we're trying to do help us implement here's our recommendations to implement your human blueprint on how to fix things have they work with you to try to get it implemented or to say here's our priorities what does happen after you s have not gotten back to the science board i'm only one member of the science or they could have talked to others to to share with us the civically how they would propose to implement the recommendations i'm aware however that they have begun the review of all our and in c t r that we recommended and i am aware that you know the scientist has been appointed although that was not in relationship to our recommendation but rather it seems that the due for legislation that also recommended the chief scientific officer outside of those three things i'm not aware of other activities that are that are ongoing and as  now when someone goes through and hold this up that we haven't done this i like into this to one of our my other responsibilities was telecommunications and and interoperability for first responders we've had katrina we've had september eleventh law and loving their neighbor and not want to steal we wouldn't have this problem but we live in a sinful world but the folks that are producing illicit drugs to enter our consumer market you know we ought to identify and they ought to be punished to the full extent why can't we just say you don't comply with our inspection regime you don't sell in our country well that's one of the things that i think it's been mentioned in german english bill that the concept is for both food and drugs is if someone can show that they're meeting our standards they ought not to be sending us food and f d a ought to have the ability to put borders say this company demonstrate that it met the standards and if the answer is no it doesn't come yet and then you shifted the burden from f d a to find the problem back to the producer to show he's doing a good job i'm not a big i'm not well received by the trial lawyers so i'm thinking if they had some good ones in there's a couple parts of the testimony that we found compelling and talk about one of the questions just deals with if we don't have institutional reform of the are selected for example i don't think it's just an issue of getting more resources but there has to be a hard look as to how existing resources are also used even if the entire domestic industries are being in yeah i mean i think that i think that to a certain extent i give a couple examples and i wish i'd brought flies with me because if you look at the organizational structure of the f and and similarly as time went on to the one thousand hundreds you know there was some functionality in f d a for managing import issues but most of what was coming in was bulk ingredients that was for the manufacturing in those circumstances f d a would ensure that there was inspection quarantining that was happening on the domestic side and that they were qualifying they're properly qualifying the vendors and and so they would use a domestic inspection now we have a whole lot of that now in the drug industry is actually still very much like that which is an example for instance with happen which is why you still have to do inspections of those bolt facilities but so so now you've got you've got a situation where where f d a has a division of import operations and policy the coral is a director over and he's responsible for managing oasis the i t system he has absolutely no authority over anybody in the field he cannot tell them to do anything so he i have all the great ideas in the world to fix a situation but he lacks the power to make f d a move and those are the kinds of organizational structures that exist such an appendage diop as an appendage let me follow up because you all sat in here the commissioner and his testimony in my opening statements talked about how well intentioned the vigils going to the bureaucracy trying to slay the dragon and really walk away not being able to do so i think there's more examples of that occurring than really transforming because some of the terminology we talked about stovepipe and silos i mean  my opening statement comments is if you are just rebuild i mean stop and restart the process how would we how would we go about getting to that area of where we need to be so the question is based on listening to the commissioner did you get a feeling that there was an understanding of the transformational nature that the f d a has to change or did you get a feeling and i think the frustration is that it's not a hundred percent commitment mr england i know i well know that i don't want to characterize a commitment level i think though however part of it is that we are at a stage i think now where the agency has is saying what a number of us have been saying for literally a decade as far as this risk and these kinds of things that are that are out there and there they are starting to say but i also think that that f d a has lost a fair number of people who actually would have known how to do it so there are some ways a little bit perplexed as to what the steps ought to be also i also feel that they feel pressure from congress and from others from this committee and other committees for perhaps that that they should be doing certain things because it was mandated even if maybe those aren't the best things to and so i so i think they've they're a little bit in iraq in our place but i also would add that that that it does take not directed name by whoever wants to chime in address the frequency debate both obviously we came to our frequency if we're not inspecting overseas but if we were what would be the frequency there versus the frequency here you're talking about mr england just mentioned mandated things that we have to do in my previous with the commissioner talking about you know if a manufacturing facility has year record of man inspect every two years with defects should we consider frequency evaluation in that venue anyone chime in real quick mr hubbard well i think as a start you do need the same frequency but i think commission one issue about was correct in that over time you do want to move toward a response system if you've got a facility as you say that's been done doing very well and makes a relatively low risk drug then maybe that gets a pass really two years and someone is not doing a good job or makes a high risk drug gets inspected every year but they can't even that raises a whole nother issue because they're having difficulty finding enough people willing to go to these countries i think the agency would like to create a foreign inspector of people for that purpose posted in these countries and in sufficient numbers to do the coverage and  think that's a good idea personally go ahead miss nelson i would also say that that is another scenario where the integrated function is critical you can gather all of this information but you just as well not have it if you can't get access to it that's right and then and i wanted to move mr england i just want clarification because i think it ties in with you propose what's called the accounting system approach can you just again for the most elaborate just for someone who's simple minded how is that a change i mean it can account bas account based approach as opposed to a transactional right now if you look at the way f d a manages its import program for instance everything is on a line by line basis now sometimes they will make some decisions based upon history of a processor for instance i would presume based upon the warning letter that this manufacturer heparin is now an important lurd now whether that works or not is a completely different question because i think the important words don't work anyway to park too many cases but that ordinarily the agency is doing transaction by transaction and the and the inspector or the evaluators trying to figure out whether to let this one in rather than for instance on a registration basis someone registers they if there's a user fee there's a user fee you think the f d a can do that now doesn't need legislative authority can they can that be part of the change in dynamics i think they could do it now i think i would be surprised if they didn't have the authority to to move to that system they would they probably have the resources  inspectors that money was taken and then used other places i've heard rumors of that and i don't know what the best example is after nine eleven secretary thompson was very concerned about foreign products in general from a bioterrorism point of view and with a lot of pushback from the white house he demanded the hiring of new inspectors for the ports and f d a very rapidly hard six hundred fifty new inspectors in two thousand and three at a few years ago was to to say that if a country or given product from a country was repeatedly problematic then that would trigger a regulation so that that country would then have to come to the f d a and say would fix whatever problem you have found future shipments to the united states will meet your standards and demonstrate that and that would mean that countries that don't have a problem don't stay in bad products would not to do anything different but countries with a problem they have to step up food what have we done and we just slap the wrist well the way the way the law works now is f d a has to catch each shipment find a problem and say you can't come in and since they only inspect six tenths of one percent very little gets caught so you need to shift to the other way and say they need to once again once they're caught they need to do something more because you know it's just going to keep on happening until they fix the problem in other words if you start in bargain figure out as those goods come to the united states which ones are the ones that are subject to the ban you're still in that which is still an i t issue it seems to me that there that if the f d a were to be able to do more for inspections they would be able to better distinguish segments of industries and segments of our kinds of industries in contrast to others and actually and actually incentivize for instance in china industries that are doing it right in order to create examples even in china and there's and i think i think that's i think it's a kind of a policy that that that that encourage is holding up those that are meeting our standards rather than just trying to catch i think we're still trying to catch at the border and i don't think it's going to be as effective establish is to have an affirmative process for that compliance is the european union having similar problems or countries within the union like we're having with imports come in and train well certainly they i think i would just add also that the e u doesn't do as many inspections of the active pharmaceutical on greedy and the a p i manufacturers like the facility in china so they're less likely to be doing specials i would also point out that it's not a simple matter to just say this country's products that are coming to the u s could be problematic because those products go other places and they come to the u s for example china shipped many products to the e u to be in court finished products that are i think it can help but what's more important is delinquent the registration process a requirement to provide affirmative information that they can make the product in distributed somewhere else in the globe and they ultimately there could be some utility but the bottom line is we need much more information than just who they are we need to know what the conditions are can they make safe product that's kind of one of the point is what do we do to make them know upfront that we're going to be checking or that we want we're going to be on top of it i mean there's any specific recommendation i would i would modify the registration process the current registration process and has been a universal process for all of the  the operations are they capable even if it's the basics and i think the registration process should be more of a submission of more information or develop some kind of process general quired any of these folks that register or do the importing to this country if i'm an insurance company and i've got to write a bond for you i want to know damn well that would you ship in that country i'm not going to have to pay off on that do protein and an awful culture coming out of china those are country wide importance and the agency does them now i think part of the question i mean the question about whether they just started refusing to do with whether or not if someone delayed or denied and then section who's running policy at dyess now and they've got five people i think i mean the people who are responsible for oasis are responsible for reviewing important they've got there's five people doing it and we're talking about seventeen million lines of  entry that these folks are responsible for that goes to resources that goes it also goes to theory and policy and where do you put the resources and and i don't think many people are really thinking about inside the agency because they're just trying to do what they've always been doing and question i would just like to say that to me it all goes back not only to the resources in priority setting but people and one of them and the quality of of individuals not that we don't have good people there we mentioned in an external peer review so this review that's ongoing right now it's the first time daryn knowledge that's ever occurred i think a lot of these problems would have occurred had those processes been in place to bring to the attention of everybody that i think the issue of the critical getting the right people recruiting them retaining them whether it be the scientists or information technology specialists which they seem to have a hard time recruiting are absolutely critical to the everything we're talking about today institutional knowledge about how to how to think through these situations like like the kind of above drug investigations where you know just a keen investigator knew how to do investigations and he was an inspector and he put two and three together came up with the number five tools they have the training and they have the time to be in the facilities they can do it with the second round questions but go back to the key to the cia's were doing their job and they were asked to do their investigation and they were denied the opportunity and they got frustrated and basically are leaving the agency because not allowed to do their work in some cases more of a structural thing and you know we're talking about issues of mandates that the f b i we this committee job and to help reconfigure the f d a so we can get at this issue which is going to be a growing problem along those lines on our legislation mr roberts mentioned a couple of the others mentioned that if you have some suggestions on things we should improve ahead of the curve i think in some respects it's almost mind boggling when you think about the degree of the complexity of the products increasing and especially in terms of safety as it relates to biologic they're not as easily manufactured we all know and appreciate a small molecules so i think again it goes back to  that we have the latest scientific evidence for the seasons that would be made the best people making those decision the technologies in place to improve upon our inspections we mentioned in  our testimony i think in some of the discussion on the twenty ninth of january that the department of defense department of homeland security has invested millions of dollars in their information technology for doing data mining a  lot of different topics particularly as it were laid the biological weapons and they've also developed very good methodology for detection in the field of both chemicals and biologicals the same  methodology could be applied i believe to inspection in terms of quality control as far as potential chemical and biological contamination of our products i don't know to what extent you know the f d a has tried to leverage those technologies and apply them are bring them online but i think we have to begin to apply newer better technology as well as just be sure that the individuals that are are performing these functions are up to date in brought up the fact that it was could have been for criminal or deviant mind but whether it's melamine or heparin i don't think we see that it really economic pressures putting pressure on to find a cheaper substitute as a melamine you know believe me they don't get it for that is that common i mean we make substitutions to a formula that when you do that you have to at least what depends on the severity of the change if it's very great change you have to get f d a approval if it's a minor change you have to at least tail f d a so they can object i mean one of the things to keep in mind even on the counterfeit like the carbon is a p it has to pass the test even if it's nominal it has to pass the detect mr england you mention the import of lurton fact as we were this panel see that we've had three imported lurks just come out from the f d a on some foods and other issues here you're not a big fan of it they don't work you said number of different seafood and alerts reporter rather quickly found two hundred some odd shipments that have gotten through the system and never been tested by the f d a and never been stopped even though they were subject to the criteria you know and so when carl was asked in the press as to whether or not that surprised of course the in these country wide alerts and so you know if congress wants f d a to have that they that's something they might want to consider clarifying but in many respects you know the important is supposed to be just guidance to the field and it really ends up acting as a regulation and i think that's where the agency begins to run into some particular potential liability they've been challenging number times and i don't think they've got these one yet when they've been challenged on them but i learned as to whether it's legitimate i mean to fix that those problems i think f d a in fact will have or when he was when he was in the agency and along with us we went through a process of trying to establish what we called attention without physical examination rule to basically describe these are the are the the kinds of evidence a might rely on to issue an import a large here's the kinds of evidence we might rely it might seek in order to overcome it and at least to create a regulatory regime to manage it and then your guidance could be your alerts that are just applying the reg but but there is a number of those kinds of situations both i t and i think also the way that the authority is structured that the agency is vulnerable and it's not as effective let me just and one can jump in on this one but me mr hubbard more directed you i'm not a big fan of the use fee to get your drugs approved with the new drug applications but from a practical point of view has worked i mean you've given the money the drugs are approved by such and such a timeline i'm not talking focus area or go back to regulation wherever it might be as long as resources are there and they can and they attract the science people that we need to do the job in this country i think absolutely i think the programs and well funded is probably a small amount and we can attract the science and the inspector we need to provide it we have a dedicated funding source because i don't want to see an example like this panel's pointed out where homeland security had a six hundred fifty inspectors got him right away  after nine eleven got him training within two or three years are all gone because it was not a dedicated funding source that seems the dr cassell you want jump in on that i think you're right to be concerned about that i like mr hubbard the believe that given the resources with emphasis upon the right people not just warm hotties i think they can absolutely do the job the other thing that i would just encourage assault to think about again though is to encourage putting in place this extra peer review if you will process because to me that would also help ensure accountability and in the long run i know it's just one more committee  a to deal with but if you look at the n i look at c d c now that they have these extra review committees implies the peer pressure does apply an important role in keeping things on track my i think this legislation would have a much better success it was a dingell poll lone stupid barton deal shimkus may we'll get there because there's a lot of things that we i mean we agree upon and hopefully that  series of unfortunate events and we don't want this to continue to be a series of unfortunate events every it does go back to leadership i mean from the military school of of training and someone at the top that has to drive transformational change in and and in that we're all skeptical and it goes back it's not one you know my commission or vanishing box only been there two and a half years now there's two and a half years to really make substantial changes but there's guys you form the only folks after and there's other administrations and we've always fall into a dilemma that a lot of us don't want to see we want to see it fixed and i think you've got some great great comments talked about chairman stupak talked about if other countries start coming into the system i wish legislatively we could stop you know if you're in a in a hole the best way to get out of it is stop digging new entries into this maybe that's where we start a regime but then you have not being favorably inclined to mr england you want to chime in on that just quickly because it's actually got up earlier and  comes from canada or mexico or comes through canada mexico and they're right here there are nafta neighbors we have access to we have we have ways to put together risk based programs that we can actually verify at  feeling is is that if we were to focus where we could apply risk based principles and be able to have some verification trust but verify and then you take the resources and you put them where you really don't have any basis to trust or verify  n i think i think you i think you start creating incentives for countries to want to be those countries and they want to be like those countries in the you throw in registration pieces and the expenses of that of that and where that money goes i think is important i think you know you he money and how that's how it's applied is a management decision but when it comes to this how you address trying to versus other places i think we've got we actually have the ability to show some leadership in in markets where we have access to show it prove it and then and then begin to create incentives for other countries to come into it and i want to go back to the account based with a question have you or anyone might be i think you're by understand the premise is there anything that the f d a is doing right now that gives you hope that they are understand that are moving in that direction i'd have to see what the current proposals are my  recollection of the proposals as i left in the ones i saw from november were mostly was a portal overlaying existing systems which means you still have your silos you have him in one basket now let me let me jump predict that we've all been waiting and told is that would that if that was taken hold of and move would that be move in that direction predict would require integration to be the most effective but predict itself is not an integration system what it does do though is take data from multiple sources and it does think about that data using evolutionary algorithms but also uses it with rules based looking at the agencies are storing all data so it's hard to go from seafood into other products without already having being able to do some that risk analysis to think about how you're going to wait you know these these different characteristics so it will not do the integration but it i think it should be at the front end of their inspection program as well i mean i think it just makes the most sense if i can jump in that the government gets hands are all this one we got i think seven different databases we're dealing with with the f d a on food and drug safety why is this insurmountable task that we can't seem to get through to from my observation a good portion of the existing legacy system is based on the need of a particular product center and not directly funded and and i not directly fund and that's position doing a good portion of the post market surveillance work from information from each of those legacy systems it has to be integrated  investigators and either at the border or doing and facility inspections need information they're going to go from one industry to another they may do a drug inspection device inspection or biologic and so you've never had that commitment to fixing the systems so you have these one nine hundred seventy s and eighty's systems limping along totally unaffected i would agree and just remind you that in  heard this week that's very disturbing is that while we were well on their way to developing a new system for adverse event reporting apparently the backup system that we pointed out that didn't exist actually doesn't exist it was last year six weeks behind in terms of implementation in the problem still hadn't been resolved so i think again this is one area that is urgent it's critical that that it be fixed  quick examples one because i think some of this responsibility happened actually happens because congress sometimes tries to fix problems one piece at a time prior notice for example f d a mandated mandated to do prior notice where they were given no money to do it to support the id system together so all the money they were going to use for oasis enhanced once all went into prior notice which quite frankly i think didn't really accomplish very much now if we as we think about the idea of proposing a registration system where people pay money for registration some of that money will go into what and i t system and it will be a stovepipe system just like the rest of them so as this as these solutions come up if they're not if they're not thought across the it actually aggravates the problem they started using that money to create so pipe solutions to manage the new mandate and that's one of the issues of the whole institution and if you would rebuild it from the ground up and we've got to break down these barriers i'm going throughout three phrases for the sake of time and just have comment the apparent standard for kicking off an import and then also the debate on extra tours extraterritorial jurisdiction on our stop that product now and then and the courts tend to defer to the agency as to what the appearance is and is that is that right well i represent other people who don't like that but you can see why judges do it as far as extraterritorial power you're not really reaching into those foreign governments with that standard all you do as per se you're just saying not in my backyard not here i know that the question is should that be something that we legislatively consider what  penalize ing well i understand i mean we're going to talk about having a lot but if there's criminality i mean the united states government already has power to prosecute foreign nationals that commit the kinds of crimes they've done before they did it in the kind of a drug well thank you to this panel it's always a very very good panel we enjoy and that's why just like members just to go on and ask the questions i mentioned the three recall just while this panel was invented we had from china snow fungus which is mushrooms from vietnam ginger and from china dried lily bulbs those were the three recall just came in or alerts i just came and not my clients just give you a heads up trying to figure out what do we do with consent that the hearing record will remain open for thirty days for additional questions for the record that objection the record will remain open i ask unanimous consent that the contents of our document binder be entered in the record not objection documents will be entered into the record that concludes our hearing without objection this meeting of the subcommittee is a