actually communicate. people need to work together, talk together and start learning and developing a common science base. we found in some developing countries in certain areas in africa especially that even representatives to standard setting bodies do not have the requisite training to actively participate in these bodies. so we freed to maneed to make se types of approaches become implemented and standards are implemented that those standards can actually be handled within those countries. another common thread is supply chain security. obviously, end-to-end supply chain visibility is an important goal. if we could snap our fingers and find out instantly what's occurring in a supply chain, we'd all be happy. that's not going to happen immediately. we freed to work towards this. the food modernization act has a one up, one down approach, where if you are in the middle of a chain you need to know where it came from and where it's going

to so you can then re-create what that supply chain is. we think this needs to be applied towards other fda regulated products. accountability is important. we obviously can control and reject products but there has to be incentives. market access it be a reward for product safety. we need other approaches and engage the private sector and food and drug producers in trying to work out improving the overall quality of the system. fraud and detecting counterfeit products is a crucial problem, but we freed to get some of the systems that may be operative in very large multi-national organizations to be able to work on the smaller scale. some of these are not scaleable. and we need to develop technologies that can actually get closer to the point of origins where the problem is, and eliminate the problem before it goes all wait through the system, and it gets too spread out throughout the system. and another approach on accountability is product liability.

and to try to work out a system that if something is imported into the u.s., this some type of liability fathered back into the supply chain. so specific recommendations. there's 13 recommendations. the first recommendation on we break into international and domestic aspects. we feel it's crucial that regulatory structure, infrastructure in developing countries be strengthened. it's impossible for one agency to do everything. fda cannot protect and guarantee food and product safety around the world and what comes into the u.s. in order to interact and develop surveillance systems, have trained personnel, there needs to be regulatory systems and we feel this should be added to the g-20 agenda so when development and health projects come forward, specifically you're also looking to build the

regulatory system so that there's longer term effects of whatever those funds are being spent on. second recommendation -- in emerging economies national regulatory agencies really need to engage in open and regular dialogue. there needs to be communication. in some of the groups we met with, in certain regulated individuals, talking to the regulators, they never met one another. they had never been in the same room together. they never knew that they existed. they may have known they existed, but what were they doing? communication from the national agencies promulgating a safety standard down to a prevental or state level, just by promulgating a regulation doesn't mean that people at the next level actually understand what that regulation is and how it can be implemented. same again with the communication to the regulated industry. there needs to be regional forums. this is on not and fda activity.

they can participate, but if they didn't call it, this is not what we want to do. get professional associations, national academy, universities that essentially can provide a non-biased format and forum to discuss what these issues, to communicate, to ensure that a standard or a technique that's actually implemented is actually implement nabil a country you're looking at. for the product you're looking at. another recommendation, these are shorter terms. that countries with stranger regulatory agencies should within the next 18 months convene technical working groups to really accelerate the process of sharing inspections. so if you look at the number of lines coming in and if you look at the number of industries in some developing countries producing food and then even to some extent drugs and devices, there is no way possible even by increasing inspectors on the basis that's done with the food

modernization act projected that you will be able to inspect all of these industries literally around the world. we need to start getting to about approach that if a stringent regulatory agency like the european union, canada, australia, switzerland, japan, the u.s., inspects one industry, they share those inspections and let the resources of those countries be spread around to inspect other agencies. it doesn't help us by having the eu and u.s. inspect one specific manufacturer and then not look at another manufacturer. so this is an area that we think some rapid progress has already started but progress could really be accelerated. on a similar vein, our thrust is that regulatory agencies alone cannot solve this problem. so industry associations should over the next three years work out a way of sharing supply chain information. basically, work out a way to find out that what are the good supplies? what are the issues coming up?

what are the problems coming up? what should they be looking at? now, realize, this is tricking. there's trade secrets. we're aware of this, but there has been progress in the line. the group rx360 working on this on pharmaceutics. the beef safety industry held meetings yearly to share off how can supply chains of some of these products actually and the information be shared. so we are not prescribing what needs to be done, but we strongly feel that we need to get private industry involved in how to essentially do this on their own and share those results. starting in the next five years, usa fdic and agencies within usda need to focus on technical assistance. what i've been saying to this point independents case that regulatory agencies need to increase and get infrastructure, some training, but there needs

to be the laboratory facilities and the trained people somewhere actually assessing whether this is happening. and we think it's crucial that this happen in the countries of origin or closer to the places of production, rather than after the finished product is starting to work its way into the u.s. so a supply chain can get defined, we need to look at how that can be handled. domestic action. i talked about enterprise risk management, and what this really comes to is -- is the agency has very specific mandates, and it has to follow very specific approaches for approving drugs, for testing food safety, but what needs to be happening is, where are the problems? there needs to be resources allocated to fda, but there needs to be an ability within fda to determine where those resources best need to be put. we've talked about a lot of aspects of keeping track of things. this is a developing problem. okay? these problems aren't going to

disappear. if you look at the drug safety issues we've had. heparin, vastly different supply chains and so we need to be able to sort of keep track of what's actually happening in that line, and we need to be able to have that flexibility on allocation of those resources. fda should facilitate training of regulators in developing countries and this really needs to be focused on an ongoing basis to work with its other regulatory agencies and stringent regulatory agencies to provide ongoing standard curriculums. so that if individuals in a specific agency are appointed to a position, they can within a relatively short time frame start getting to know what the other regulators are doing and start getting to know what those end points should be and what actually pertains to them. in addition to that, we should be looking at the same concept on economic development to build

the regulatory agencies. we talked about what international organizations need to do. fda needs to be proactive to make sure that food safety and drug safety objectives are actually built into their development activities. the fda needs to and continue in development and information on strategy that allows this risk based system to actually be implemented. so if you look at where we are in the 21st century, we have twitter. we have google. we have instantaneous transfers of financial transactions and instantaneous use of credit cards. it's a mobile completely electronic system. in order not today but in order in five years to start increasing this speed of this information that can work through global regulatory systems we need to start defines very speck metrics. we need to make sure that as new

agreements come into place between countries that fda and other stringent agencies absolutely demand that very specific metrics be clollected and those metrics interchangeable between agencies. by doing that we can develop much more rapid information systems to get an idea on where the potential problems might be occurring and where the risk might be occurring. it's a different approach than what's been done relative to the structure of the existing systems, but with 20 million import lines coming in, we have to be realistic. fda is not going to have 20 million inspectors to follow each of those lines. so essentially, we need to start using modern technology which is available now, at relatively cost-effective approaches to actually start implementing these types of systems. we need and we strongly suggest and in some legislation tweeg prosed by fda that the supply chain of drug manufacturers and as device manufacturers start

getting defined and nailed down. we think that initially applying to one backup approach in food to begin to develop that towards drugs would be a good beginning on this. but we freneed to make sure sup chain integrity can be assured. next recommendation is, we freed need to make sure that fda can develop the proper nix of incentives in order to promote safe product delivery and some are market access. an fda secure supply chain pilot program that is currently in effect. fda really needs to look at how this is working and if this looks like it's working well, to really push and expand that to other aspects that they handle. there needs to be an incentive to some of these aspects. it just cannot be a negative and a regulatory impact. final two items of domestic action is, fda should encourage through cooperative research and development agreements and other

programs within private industry and research funding to encourage businesses to develop universities simply applicable surveillance-type tools. technology that is easily implementable, relatively cheap to use, but can essentially carry surveillance down to deeper levels within the supply chain. large companies have this worked out, but a lot of very large company systems are not scaleable down to smaller systems. and finally, over the next 15 years, u.s. government agencies should really work to strengthen the ability of those harmed by unsafe foods to actually be liable for that. and we have a number of discussions within the report as to how that might actually work. so in conclusion, the overall goal is that fda cannot do this alone. it's just impossible. and everyone has to realize that the globalization is not going to reverse to any great extent.

with the rates of increase in product imports, and even domestic products that have international components, that we need to address this. and we need to create a regulatory system that interfaces with partners of similar abilities and desires to work together to try to develop a larger regulatory system in terms of maintaining what's happening. if countries have well-developed regulatory systems, then in that line, food safety and those product safety should be increased allows exports from those countries. what would we like to see that would actually be happening in ten years from now is if we look at the lift u of the regulatory agencies i next the to you, there was double the number of countries on that list. if that happened, then you can start looking at inspection and you can start focusing on areas because of problems starting to become more manageable. training and education must be collaborative.

we're looking at multisectorial regulations but have to be coordinating. in looking at this it's crucial that regulatory system, the infrastructure and the communication, fda, the eu, japan, canada, cannot do this alone. we need to work together to increase that capacity. i thank the excellent committee through my members whom are here who worked on this, traveled around and debated and debated and debated on what these recommendations actually could work, and the outstanding staff at iom that really has dug into this and determined the facts and tried to work this forward. so thank you and i guess we're open forequestions. for questions. >> my name's ellen ferguson. >> microphone, please. >> okay. my name's ellen ferguson with congressional quarterly so my

focus is on congress. what role would congress have in any of this in terms of either facilitating things for fda or directing the state department and other federal agencies to focus and make this a priority in terms of the negotiating trade agreements or, you know, other international -- >> you actually provided what needs to be done. no. essentially have what needs to be done is as congress negotiates trade agreements, congress interacts and produces legislation that interacts in areas that relate to this, that this is high on a priority list to develop a system and develop a regulatory system and outline. in addition to that, congress has to realize that, that regular products of fda cannot be broken down into domestic and international. that, that worked 20, 30 years ago. it does not work now. from the opening slide i showed you. so that authority has to be

granted to fda to have flexibility in moving resources. they need resources. a lot of these agreements are unfunded mandates, but what we need to essentially do is not just throw money at the problem. we freneed to give fda the flexibility to put the money into areas that would actually have impact. for example, it may not be important just to throw more inspectors in a country. it may be important to throw inspectors in a country but also put training in place. help to increase surveillance in those countries so instead of just inspecting you're actually leping to build the system. >> just a couple of other -- tom boiky one of the committee members. a couple other things to add that could certainly do. certainly they could grant fda the ability to share data on inspection reports with other regulators that will allow them

to cooperate internationally. this is something i think the fda has been pushing for for a long time and particularly in this austere budgetary environment. it's crucial for fda's ability to have this inner opper ability with other regulatory agencies. >> [ inaudible ]. >> i'm sorry? >> u.s. or international -- >> their ability to share u.s. proprietary data with other regulators toe they can then receive the same. they need to be able to do this no order to have an inner operable reg la story system. there's a bill pending before congress. end-to-end supply chain visibili visibility. that's crucial. as a committee we recommended traceability and having adequate one step back, one step forward. that's a version of that.

fda has been starved for resources in its international programs department. to engage in this type of laeger to activities in the past, i think that's crucial. as jim mentioned, you right now see a balkanization of what trade development and regulatory agencies do around food and drug safety. there needs to be an integration of that and i think congress has a big role to play to ensure that what trade officials do is promoting high standard food and drugs and also on the same with what fda does is cognizant of the benefits for development and for trade of the countries involved in adopt these high, consistent international standards as well.

>> some from outside. >> first question will come from emily walker. >> hi. thanks for taking my question. one clay firing a question then another question. is it true now that a country such it's a japan, i guess, will go and inspect a food or drug fast then the u.s. might sent an inspector to inspect that same fast? is that how it happens now? >> yes. >> okay. and then my other question is, would you say it's kind of a fair assessment, a lot of previous reports on the saum issue have call and more inspections. i feel like i read that a lot. would you say that this report is saying that more inspections is not necessarily the answer, because it's deeper than that and that kind of reform of regulatory systems needs to occur first? >> yes. we're not saying cut back on inspections. saying more inspections might be important, but all resources can't just be spent on resources. they have to change the nature

of the, and work with the regulatory infrastructure of the countries. >> and, of course, on that, we did also discuss sharing discuss sharing inspection reports so it's not just the u.s. ramping up in inspections that have the ability to rely on the inspections. there are other well resourced regulatory agencies. >> and shift the burden to industry, to do sharing amongst themselves. to basically -- if we can get higher quality products being generated throughout the whole system, then the inspection resources may ultimately catch up with what it's trying to capture. >> and a big part is actually we stress in the report is improving capacity. it is much more cost effective in the developing countries to actually test and not send the product down the supply chain because it's very costly, the logistics of getting something to the end point to have it rejected. so capacity is really important.

>> yeah? >> marcia brohmfield from the committee. we have to be mindful of the flip side of the issue. we were asked what congress needs to undertake, but one thing that was very important to this committee is that this is not a u.s. problem. this is a global problem. so even simple things like sharing inspection reports, they may be laws in european countries and canada and japan that prevent sharing. so there needs to be a mechanism to influence the regulators in other countries to make this a two-way dialogue. >> which is why our first recommendation is to bring this to the g-20 agenda, to get everyone on the same page on that. >> and to build on both jim and martha's and claire's good point on this, this is why this committee took such great efforts to emphasize that there is an intersection of global health, trade and development on these issues. that operates both

internationally and why this should be important at the g-20. it's not just about public health. also, should operate domestically as well and we're hopeful that that allows the ability to bring together all the necessary partners that you need to bring to bear on this problem. >> caller: thank you very much. once again, if you want to ask a question -- >> yes? >> hi. i'm lauren becker with the global health technologies. for the u.s. government, there were clear actors and for some of the first set there were as well, but i'm curious because as we all know the challenges in developing countries they're not waiting for an iom report to tell them they should communicate more with each other, but they clearly need to. i'm wondering who you see as a driving force, particularly for that recommendation. but for the other international

recommendations as well. >> essentially what we're looking at is, again, the agenda is bringing on the g-20 agenda is to get the u.s. and other areas into the development organizations and the world bank and various other groups to essentially put strength and regulatory infrastructure as a part of going forward. to start getting that message out. with the domestic regulations at fda, it brings this forward. the question with congress, bring this forward, as new approaches to public health go forward. there's a realization that for that to last and have a multiplier effect within those countries that essentially the regulatory infrastructure needs attention. >> i think that's right. i mean, we call for basically the g-20 to endorse this as an intersection of global health trade and development and with that endorsement what we'd like to do next is what we recommend doing next is that this then

filter down to the various international agencies that are dedicated to those issues. and, you know, of course there's wto and its network on the issues. there's codex. we think supporting strong regulatory systems again achieves global trade and outcomes and we have activities as well. we're looking for an endorsement hopefully at the next meeting of the g-20 which will be in mexico, of the intersection of these issues and then to start to build down from there to these topic specific international organizations. >> it's martha brohmfield. if i can add on to tom's points. my experience and if others disagree, please speak up, was that the regulators with whom we were interacting in the

countries were very enthusiastic about this initiative and are anxiously awaiting the report. so i think there is a lot of receptivity on the part of many of these regulatory agencies. so it's not just for g-20 to push it. although i think that's incredible important. but i think there can be other mechanisms, maybe softer. one-on-one types of approaches, where there would be a lot of receptivity with the agencies in the developing countries. >> i think we -- one of the things we recommend here again is international standards to make it easy for them. one of the things we found, we did as jim mentioned a lot of field visits as part of this committee, and we often found strong regulatory systems in the areas that support products for export. that don't necessarily extend to the population at large. and there is a lot we can do both the u.s. specifically by doing more to support international standards and the participation of developing country agencies and their development. but also internationally to make

this easier for those countries to adopt internationally compatible high standards. >> ultimately, you'd want spillover effects so it wouldn't be towards the export department. so you'd be improving the health and safety of food in the developing countries. i think there is a clear desire for the people we have been talking to in the developing countries that that's what they're interested in. >> any more questions? >> ellen ferguson, congressional quarterly. all right, you talked about your goal is to have this adopted, the idea of having food and

medical device product, safety is an integral part at the g-20 meeting. what other things are you looking to happen let's say in the next three, six, 12 months as a result of your report? >> i think that the immediate short term is the sharing of inspection approaches and really a push to get agreement amongst fda and its partner regulators that this really is an important activity for everyone involved. secondly, to push on the industrial sharing in both the food and drug groups to share resources and not duplicate resources in that light. and i think a third one begins a training, a training aspect and educational aspect could have immediate impact within a year or two.

for even fda domestic regulators to realize what is happening internationally to get communication and to start sharing that with other regulators. so to essentially share that information and the spillover on that in every level is dramatic. once individuals go back to their countries, even on food production on both sides the quality of both should increase. >> the only thing i would add to that is per your training, one of the things we mentioned in the report that we think is helpful and that's a short term thing that the fda can do is adoption of an fda version of cdc's epidemiological service. which has been successful in that context and applying expertise on epidemiology to other countries as well as building capacity into the countries and building an international community that engages in international surveillance around disease control.

how we see that working in the fda context is of course there's both in terms of bringing foreign regulators over here to potentially work with fda, to encourage that kind of information sharing and mutual understanding, but also to send junior staff level fda regulators abroad to work in other regulatory agencies and we see this as a way of building a high profile program as you have in the context and starring to filter out a common regulatory approach to the same persistent challenges on food and drug safety that we face and other countries face. >> i just want to stress -- one other thing that we talked about, the metrics, it's important that we start gaining the base line information so that we can do -- understand the impact and evaluate that later on to see are these training programs and are these things really wng