it's crucial when standard are set that they essentially use science-based approaches and risk-based approach toes come up with the standards. they can't be arbitrary. most of these systems in looking at different countries should participate in international cooperative activities and harmonization. so that instead of focusing on very small differences within specific areas, these are harmonized and people are working toward the same goal. decisions should be ethical and when something occurs, that information should be rapidly transmitted to prevent it spreading throughout the system. the federal and medical product regulatory system really should look at product safety through good manufacturer processes, good clinical, laboratory and agricultural processes. staff training and development should occur, monitoring, laboratory inspection and surveillance of product, risk

assessment analysis and emergency response. we go into a lot of detail in this report on those specifics as to what a regulatory system encompasses. when we looked at those, we've identified and ground together nine main gaps in developing country systems. first falls into a classification of adherence to standard. in order for a system to function, there has to be some standard which allows export from a country and import into another country, those standard must be met. it can range from specific tolerance of chemicals, absence of specific microbial contaminants or drugs at a specific concentration in a product. another aspect we found significant is controlling supply chain. so the supply chain is when the chemical or the food is initially produced to when it in the finished product and actually imported. what is that supply chain and

some of the problems we dealt with this week, again last month, a couple years ago really has to do with supply chain integrity and how can we monitor that. this is a gap in many systems we looked at. there are infrastructure deficits. in order to implement supply chain control, in order to adhere to standard, there has to be a system in place. there has to be people trained to know that those standard exist. there has to be laboratories in place and there's infrastructure deficits at various levels in both the food and drug systems. there needs to be a legal foundation for regulating drugs. there needs to be a legal foundation for indicating and imposing safety standards on a product, not just the manufacturing aspect and a manufacturing drive to actually develop these. we notice a number of different workforce problems at multiple levels and we go into a lot of details on this within the report.

essentially what this relates to in many cases is a lack of adequately trained individuals in regulatory science. there's lack of stability within regulatory agencies of those people who are trained. there's turnover and in some smaller countries there's rapid and continuous turnover. in order for the fda to communicate with some of these individual in individual countries, they all need to be talking and speaking the same language. no surprise to anyone, a lot of the regulatory systems are fragmented. they're fragmented politically, they're housed in different ministries, they're housed in health ministries, agricultural ministries and in some cases trade ministries. those organizations have different end points. so when you look at another regulatory system, you really need to start dissecting out where those components exist. and, again, the report goes into detail on those. many countries suffer from a poor surveillance system. and a surveillance system is not just the finished products being

exported but in a lot of the quality control points throughout the production of either food or drugs. there needs to be a way of measuring what's happening, there needs to be a way of determining whether or not specific standards are being met. another gap we found is communication. the communication gap can be within a ministry or an agency to the top to the bottom of the ministry where the work is handled, between different ministries and regulatory systems, between a regulator and regulated industry, between the regulator, regulated industry and consumers of that products, between different countries and regional countries and globally. it just a lot of individuals are just not talking with one another and sharing specific information. and finally in developing a system that guarantees safe food and product, there needs to be a political well to actually do

this. so the committee strategy on addressing this, we came up with 13 recommendations, which again i'm going to briefly overview but what we're looking for is we realize we cannot inspect our way out of this. we cannot demand that only safe products and foods come into the united states. we need to offer a series of carrots and sticks and we need to look at activities that essentially hit a sweet spot in this diagram and that is if we're looking at product safety, we need to build a system that by improving product safety, then the export from these countries can occur and trade can build up in those countries. as we increase product safety, this should have a direct impact short term on public health but long term on public health because we're building up the awareness and building up the workforce and practices within those countries to actually try to produce safe product.

and this should also then impact on aspects of development. and we're going to address this in some of our specific areas. i guess the best way to look at this is if you are trying to assess that only safe products come into this country and there's no systems in place to ensure the safe products can actually be produced and manufactured in these countries, no matter how much inspection, you're always going to find flawed products. what we really need to work on is a system through cooperation and through hitting mutually reenforceable goals we can build a regulatory system and build products in countries that generate safe products. by doing that, they are allowed to increase the exports in those areas and by doing that, the economic activity is in line with what the safety end points are. this is a problem that essentially if someone is trying to generate and you're being

judged on economic activity, product safety falls to a lower priority. we have to change that. we have some common threads as to what we think needs to be done and i just want to go through these four areas that you will see coming through our specific recommendations. first is the concept of enterpri enterprise risk management. we're using this as a broad-based concept that a regulatory agency and specifically in this case fda needs to look at all of its operations. it needs to assume that with 80% of aprs not produced in the u.s., with 20 million import lines coming, in essentially you can't differentiate between domestic and international and therefore you need to start thinking about how you regulate resources. and resources are not just inspectors in a foreign country or the number of inspections but it also has to do with budget specific training dollars, where

is that money being spent, how is this being spread to the risks that are occurring. one needs to really look at the agency that was created and existed for an era where there was domestic production and there was domestic consumption. there's been a lot of changes over the last 40, 50 years. but now to get to a point to be adaptable. it has to be responsive to current problems. another aspect we realize in developing countries is the whole concept of professionalism and credentialing. is that regulatory science and working and developing regulatory agencies and end points in those agencies are not specifically addressed in training programs. there are sporadic training programs around the world. the eu puts on programs, the fda puts on programs, they may cover one topic this year, another topic next year. somebody joins a regulatory agency when they miss the first topic. there's no standing ability to actually communicate. there needs to be a lot more venues where essentially people

can work together, talk together and start learning and developing a common sign base. we found in some developing countries in certain areas, africa especially, that even representatives to standard vetting bodies do not have the requisite training to actively participate in these bodies. so we need to make sure that as those types of approaches become implemented and standards are implemented that those standards can actually be handled within those countries. >> another is the supply chain security. nd-to-end supply chain visibility is an important goal. if we could snap our fingers and find out instantly what's happening in a supply chain is not going to happen. the food act as a one up/one down,you're in a chain you need

to know where it's going to to recreate where that supply chain is. accountability is important. we obviously can control and reject products coming in, but there has to be incentives to do this. market access to be a reward for product safety. we need to get other approa approaches,in gauge the private sector and engage food producers to improve the overall system. fraud technology. there's a crucial problem but we need to get systems that may be opera difficult in a very large multi-national organization to be able to work on a smaller scale. some of these are not scaleable. we need to develop technologies that can get closer to the point of origin and eliminate the problem before it goes all the way through the system and gets too spread out throughout the system. another approach on accountability is product liability and try to work out a system that if something is

imported into the u.s., there's some type of liability farther back into the supply chain. so specific recommendations. there's 13 recommendations. the first recommendation on 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, in order to have trained personnel, there needs to be in tact regulatory systems and we feel this should be added to the g20 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 at. second recommendation, in emergent 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 srn regulated individuals talking to the regulators, they never met one another. they had never been in the same room together. they never knew they existed. they may have known they existed but what were they doing? communication from a national agency promulgating a safety standard to a professional or state level doesn't mean the 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 not an fda activity and the fact that the fda can

participate if fda called it, this is not what we want to do. get neutral venues, professional association, university, that can provide a non-bias format and forum to discuss what these issues are, to communicate, to ensure a standard or technique that's implemented is actually implementability for the country you're looking at or for the product you're looking at. another recommendation, and these are shorter term, that countries with stringent regulatory agencies should within the next 18 months convene technical working groups to really accelerate the process of sharing inspection. so if you look at the number of lines coming in and you look at the number of industries in some developing countries producing food and then even to some, tent drugs and deep vice, there is no way possible even by increasing inspectors on the basis that's done with the food modernization act that's being projected that you will be able to inspect all

of these industries literally around the world. we need to start getting to an 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 trusted 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 what are the supplies, what are the issues coming up, what are the problems coming up, what should they be looking at?

now i realize this is tricky, there are trade secrets, we're aware of this but there has been some progress in this line. the group rx 360 has been working on, this the beef safety industry has been working on this so the information can be shared. so we are not prescribing what needs to be done but we strongly field 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 agencies within usda need to focus on technical assistance and strength yening of surveillance. so what i've been saying is regulatory agencies need to increase and get infrastructure and get training, but there needs to be the laboratory

facilities and 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 as supply chains can get defined we shall ned defin defined, we need to look at how that can be handled. >> i talked about risk management. what this really comes to is the agency has very specific mandate and has to follow very specific approaches for approving drugs for testing, food safety. but what needs to be happening is where are the problems and 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. these problems aren't going to disappear. if you look at the drug safety kind of issues we've had, we've

had heparin, avastin. those are vastly different supply chains. 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 a lot more flexibility on allocation of those resources. the fda should facilitate trainers of regulators in countries and need to be focused to work with ongoing regulatory agencies to provide ongoing standard curriculums so if individual 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 that. in addition to that, we should be looking at the same concept on economic development to build a regulatory agency. we talked about what

international organizations need to do. fda needs to be pro active to make sure that food safety and drug safety objectives are actually built into their development activities. the fda needs to and continue the development and information strategy that allows risk safety. 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 instan takenious use of credit card. it's a mobile, completely electronic system. in order -- not today but in order in five years to start increasing the speed that this information can work through a global regulatory system, we need to start defining very specific 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 collected and those metrics be interchangeable between agencies. by doing that we can start developing 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 that 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. the fda is not going to have 20 million inspectors to follow each of those lines. so essential litsly we need to using modern technology, which is available now at relatively cost effective approaches to start implementing these types of systems. we need and we strongly suggest and in some legislation being proposed by fda that the supply chains of drug manufacturers and device manufacturers start getting defined and nailed down.

we think applying the one up/one back approach in food, to begin to develop that toward drugs would be a good to make sure s chain integrity can be assured. next recommendation is we need to make sure that fda can develop the proper mix of incentives in order to promote safe product delivery and some of those are market access. there's 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 they handle. there needs to be an incentive to some of these aspects. 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 on other programs within private industry and research funding to encourage businesses to develop

and universities simply public football 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 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 it be liable for that. we have a number of discussions within the report 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 on

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 many 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 which allows export from those countries. what would we like to see that will be happening ten years from now is if we look at the list of an tour regulatory countries that i mentioned to you that there was double the number of countries on that list. then tuck start focusing on areas because the problem starts becoming more manageable. training and education must be collaborative. we're looking at multisectoral recommendations and there's a

lot of people that can help implement this, but they have to be coordinated. in looking at this, it's crucial that regulatory system, the from structure 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 three of my member whom are here who worked on this traveled around and debated and debated on what these recommendations could work and the outstanding it staff at iom that has determined the facts and tried to work us forward. so thank you, and i guess we're open for questions. >> microphone please. >> okay. my name's ellen ferguson within congressional quarterly. 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 provided some exactly what needs to be done. >> you say it. >> they're essentially what needs to be done is ask congress negotiates trade agreements as congress interacts and produces legislation that interacts in areas that relate to in that this is high on a priority list to develop a system and a regulatory system in that line. in addition to that, congress has to realize that regulator products of fda cannot be broken down into domestic and international alone. 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 need 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, also help to increase surveillance within those countries so that instead of just inspecting you're actually helping to build the system. >> just a couple of other -- i'm tom b o bowlbbollyky. they could grant fda the ability to share data on inspection reports with other regulators that will allow them top cooperate internationally. this is something i think the

fda has been pushing for for a long time particularly in this austere budgetary environment. i think it's crucial for fda's ability to have this interoperability with other regulatory authorities. i know there's a -- i'm sorry? >> u.s. or international? >> their ability to share u.s. proprietary data from the u.s.-based companies with other regulators so that they can then receive the same. they need to be able to do this in order to have an interoperable regulatory system. there's also in the current drug safety bill pending before congress, there's a provision for end to end supply chain visibility. as a committee we recommended traceability and having adequate one-step back, one step forward and that's a version of that. fda has been starved for

resources in its international programs department to engage in this type of regulatory activities in the past. i think that's crucial. as jim mentioned, you right now the 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 whaernl trade officials do is promoting high standard food and drugs and also on the same part what are fda does is cognizant of the benefits for development and for trade of the countries involved to adopt these high consistent international standards, as well.

>> and from outside. >> our first question will come from emily walker. >> hi, thanks for taking my question. just one quick clarifying question, then another question. is it true now that a country, you know, such as japan i guess will go and inspect a food or drug facility but then the u.s. might send an inspector to inspect that same facility? is that how it happens now? >> yes. >> my other question is, would you say it's a fair assessment, called on more inspections. would you say that this report is saying that more inspections is not necessarily the answer because it's deeper than that and the kind of reform of regulatory systems in these countries needs to happen first? >> yes, we're not saying to cut back on inspections but more might be important. but all resources can't be just spent on inspections. resources have to be spent on integrating more and trying to change the nature and work with the regulatory infrastructure in

other countries. >> and we did also discuss sharing inspection reports so it's not just the u.s. ramping up in inspections, have the ability to rely on the inspections of other very well resourced regulatory agencies. >> and also shift the burden to industry to do showing 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 it's improving capacity. it's much more cost effective if we improve the capacity in the developing countries to actually test and not send the product down the supply chain because it's very costly to get something to the end point and have it rejected. so capacity building is really important. >> tis