the hearing of the subcommittee is called to order and today we are having a hearing actually the third on the food and drug administration globalization act the draft bill that mr dingell myself missis to pack and others have proposed and that today this hearing is specifically on medical devices and cosmetic provisions as well so i recognize myself for an opening statement over the last few weeks as you know we have discussed the various food and drug related provisions in this draft and the focus today or the idea of having a separate hearing if you will on medical devices and cosmetics was because we do believe that these do need to be seeking basically singled out and some emphasis put on those specific purpose provisions as they apply to those industries in two thousand and six for example one hundred eighty three thousand packages of contact lens solution which is classified as a medical device were recalled as a result of bacterial contamination and this was a product that is classified as low risk and that simply shouldn't be happening while congress set out to address initial safety concerns with these and similar types of products under the medical device user fee and modernization act it's clear to me that more must be done the f d a simply incapable of meeting the requirements of that legislation to inspect domestic and foreign device manufacturing establishments in the do smoke we added a two year inspection requirement for device manufacturing companies however according to g a o findings the f d a inspects these establishment on average only every three years for high risk devices and every five years for medium risk devices and i'd be curious to know what the inspection frequency is for low risk devices perhaps even more disturbing  inspection rates for international manufacturers of medical devices which are estimated to be on average every six years for high risk devices and an incredible twenty seven years for medium risk devices and while the market for these products becomes increasingly global the f d a has no requirement to inspect foreign establishment manufacturing medical devices again a clear gap in authority and it's up to us and congress to act to allow the f d a to do its job and protect the american people of further concern is the f d a as use of a risk based classification system while you understand that there are inherently more risks with class three medically implanted devices as with a class one contact lens solution this classification is based only on the nature of the product and does not take into account information related to the actual manufacturers and this is especially concerning when the f d a peers unable to accurately report information on the number of medical device facilities both in the u s and internationally to databases existed f d a to monitor and track inspections and yet the systems cannot exchange information and are fraught with inaccuracies one system reports that there are nearly five thousand foreign establishment registered registered with the f d a for class two and three products while the other system reports that there were over twenty five thousand such establishment internationally this difference is significant and again illustrates the f d a as inability to meet current and emerging regulatory these concerns were echoed in a two thousand and seven report issued by the f d a science board that found disparities between the f d a has responsibilities and available resources including inadequate inspection of manufacturers an obsolete technology technology infrastructure and insufficient basis to access integrate and analyze data and frequent system failures these weaknesses jeopardize the f d a s ability to fulfill its mission of protecting the american people and must be addressed now turning personal care products are used by americans each and every day and yet these billion dollar industries have gone largely unregulated under current federal law the f d a cannot require companies to test cosmetic products for safety before marketing they cannot review or approve cosmetic products before they're sold to the public they can't regulate cosmetic products until they've been until after they have reached the marketplace and they cannot require product recalls and they can't manuf they can't require manufacturers to register cars medic manufacturers in breeding its information or report cosmetic related injuries instead the f d a has to rely on a voluntary reporting system that clearly lacks the means for a systematic examination of the safety of the cosmetic industry further this voluntary system has been used as a rationale against calls for reform in the industry f d a estimates that over the three decades during which the voluntary cosmetic industry review or c r process has been in existence only eleven percent of the ingredients used in cosmetic products have been reviewed in addition countries in the european union have actually banned the use of certain ingredients in cosmetic products yet there are no restrictions in place in the u s and some studies suggest that there are a vast number of products on the market that contain prohibited chemicals that have been deemed unsafe for use by the industry's own c r review process this is to me the overwhelming evidence that the f d a must be empowered with the authority to regulate this industry to protect the public and i just want to thank all the witnesses for appearing today i know we're going to have a good discussion and i now recognize mr deal the ranking member for five minutes for an opening statement like mr chairman we were each reminded every day on a regular basis of potential holes and f d a is current inch section and safety system as we hear of new threats presented by certain imported products just yesterday i had an interview to discuss the possible lead contamination of dental crowns imported from facilities in china some fear these crowns may have contributed to adverse health vance and patients who unknowingly were receiving a product made in china events like this one highlight the dwindling confidence the american public has and the f d a as ability to ensure the safety of the products it regulates as we discuss these issues at today's hearing we can evaluate whether it is the case that the f d a has adequate authorities but insufficient resources or if the agency does not even have the authorities necessary to protect the american consumer my sense from some of our past hearings is this problem ultimately comes down to insufficient resources at the agency while yours are fees may seem like the only option to some members of this committee these these are only further raise questions about an inappropriate relationship between the regulated industry and the agency just last year this committee significantly increased the fees paid by the device industry for product reviews and it added a facility registration fee not seems we are contemplating even further fee increases well above those negotiated less than a year ago one aspect in particular of a silicate fee structure which is concerned me is the possibility the fees paid by domestic facility would help pay for the inspection of a foreign facility if there must be a fee it seems fair to me that the fee structure would account for the differences in the cost to do the inspections at differing facilities it is also my understanding some device manufacturers have expressed concern about the requirement for a facility inspection prior to marketing approval of certain devices i would hope our witnesses could elaborate further on this particular subject we certainly should be examining  safety issues but also must break our ability to evaluate the effectiveness of the current authorities while the f d a is undermined by their lack of resources to carry out these authorities while user fees may be the only method to provide desponding available to this committee we really must question whether or not our dependence on these from the industry is supplanting money which more rightfully should be provided by appropriations and my time thank you mr deal recognize the gentlewoman from california ms for an opening statement thank you mr chairman i'm very glad that we're having this hearing today i think it's  an important one to address the f d a has oversight of medical devices and cosmetics and i want to thank the witnesses that are here today for being with us to testify medical devices and i've done a lot of legislative work in this whole area on medical devices to reform our practices at the f d a relative to them it was a complicated work but i think that we did important work on it established user fees for people that are a part of this why because that really plays a very important role in health care in our country and i think it's critical that we ensure the safety of the devices as we struggled to do that i don't think we've accomplished everything on it relative to food and and drugs it's also important for us not to overlook the unique nature  of these devices which makes them different from drugs and i think the congress has come some distance on that and that a single singular regulatory scheme might not be suitable for all types of  products we are all painfully aware of what has made its way into the country and how it harms americans the newspapers are full of those stories so we have a ways to go on  this i want to be part of of getting there this legislation mr chairman groups drugs and devices and holds them to the same standard of inspection but i think that we have to look at the components of the device and i think that this is where we need to hone in because even a low risk device has i think some other characteristics to it for a low a low class low risk  that comprise that machine and then go into making that into a device the devices are currently inspected and approved by the f d a is finished products and every component has to work correctly of course otherwise the the the total of the of the device is not going to be effective for the patient now under the globalization act each facility which produces every nut each bolt in the circuit boards to go into a device would require an f d a inspection i think we have to look closer at this i don't know if that's where we want to go i don't have the perfect answer but i think that in the draft of this that we've is is what we intend to do so i think that this is an important journey that we're on i want the highest standards for the american people and i think that that's what we have to keep our eye that's how we want to spend our time so i look forward to working with you i have some questions obviously for the for our witnesses and thank you again for holding this very important to hearing  device and cosmetic provisions in this draft as we found in previous hearings to clear the f t age and i have the resources of the authority to effect of the protect the american people from health risks the f d a is responsible for a medical device safety in the us s and for foreign devices entering the country but as noted in our previous hearing on drug safety f d a does not have the ability to require foreign facilities to allow inspectors even in the facilities the g a o estimates the f d a is inspected for in class two manufactures once every twenty seven years and four in class three manufacturers once every six years clear the f d a does not have as many inspectors it needs to conduct these inspections is not effectively adopted a third party inspection meant while the f d a has some authority while regulating devices they have very limited authority when it comes to regulating cosmetics in fact the f d a does not have the ability to recall cosmetics it can monitor companies issue a recall for a product but if a company is unwilling to recall an unsafe product the f d a only has the ability to issue a written request for recall the f d a does not have the ability to inspect cosmetic manufacturing facilities but does not have the does have the ability and i manufacturer but not have the comprehensive or compatible database of manufacturers or products currently registration for the databases voluntarily this means the f d a does not have not know what products are on the market and what ingredients are even in these products it's astounding of the f d a as your lad on manufacturers and industry to self regulate medical devices and cosmetics for many years the risk based approach the resorted to bring during this time of limited resources and restrictions seems the ranking member of the full committee is here gentleman from texas mr barton thank you mr chairman last evening on the house floor i had a very cordial conversation with full committee chairman dingell in which he strongly encouraged myself and other republicans to work you work with you on the other democrats in the subcommittee to after bipartisan food and drug safety bill really we talked about a food and drug import bill and i told him that i had some concerns but that i would definitely encourage all republicans to engage in a good faith effort to see if we couldn't find a about a partisan bill and i've instructed my staff committee staff to do that so in the spirit of that i want to start off today by saying well it's it is a fact that in the draft it's been out for several months medical devices were a part of that draft so it's it's it's not that there's a surprise there but the focus has been in our hearings in the focus has been in our discussions at least my discussions with chairman dingell we are going to focus first on food safety  then drug safety and we really hadn't discussed medical devices the draft on medical devices in my opinion doesn't even deserve to be a part of the discussion doesn't mean we shouldn't look at medical devices but i think there are such differences that we should we should discuss the medical devices as a standalone issue i would also say that  what's in the draft on medical devices in my opinion seems to be overkill and probably not implementable in the real world there are thirty five and fifty class three medical devices that are approved each year these are complex devices and it might make some sense to require pre approval inspection however there are another thirty five hundred less complex class two medical devices that are approved to require each of those facilities to have a pre approval inspection is a waste of resources you only increase cost to patients that as far as i can tell no dem demonst safety benefit and would needlessly the light pay these therapies getting to the patients the bill would also call for a pre inspection of all device parts this is another example of the draft failing to recognize the difference between drugs and devices a medical device part could be a circuit board it could be a battery could be even a screw a battery is not the same thing is happening finally i want to reiterate a point that i made at the hearing several weeks ago during the debate on medical advice user fee reauthorization last year i expressed and other members of the committee expressed serious concern over the level of user fees being paid by the industry last year the medical device industry doubled its funding commitment to the f d a one hundred fifty million to three hundred million we should pay some close attention to the clear warnings before we make the device before we make the f d a even more reliant on the industry that is supposed to oversee this bill would create in dish and that a new set of user fees for medical devices like to point out to the members of the committee that the congress already has as i just said u for medical devices so i'm not trying to be too critical mr chairman i just if we're going to do a food safety bill let's do a food safety bill if we want to do drugs let's do a drug safety  think you can combine those i do not think medical devices should be a part of the bill if we're going to really look at medical devices i think you should split it out and do that as a standalone bill and with th thank you next to recognize in the full committee mr dingell courtesy and i commend you for your dodges in holding this series of legislative hearings they have focused on what resources and authorities the food and drug administration needs to adequately protect the public health the third and final hearing today will discuss and focus on the device and cosmetic industry safety in the discussion draft i want to indicate that the discussion draft has been produced to afford us the opportunity to receive the comments and understand the concerns and feelings of everyone who would be affected by this legislation from consumers to manufacturers to importers and i am very anxious as i have indicated to my good friend the ranking minority member of my friend mr barton that we are anxious to work with him to address this problem which is a very real one and one which offers real threat and peril to the american people the same issues that challenge f d a is ability to properly oversee food drugs in an increasingly global marketplace also plagued the agency's ability to regulate medical devices and cosmetics and i want to point out that it is not the intention of the officers of the draft to create a new burdens on american industry but rather to see to it that foreigners meet the same standards in terms of safety and efficacy to american consumers that do domestic producers and i would point out as far as that food drugs total inability to investigate the behavior of foreigners manufactured goods elsewhere is a matter which hurts american manufacturers by showing that american manufacturers face unfair dangerous competitive should and they face the importation of substances and devices which offer a real threat not just to consumers but quite frankly to the goodwill that our manufacturers have been trying to build for so long and i would point out that  we're not for the simple fact that that our commitments under get and b t o force us to treat all marketed commodities in this country whether they're domestic or otherwise alike we might perhaps be able to address this a little more focused on foreign misbehavior it should be noted that the f d a science board in two thousand and seven reported that f d a as ability to carry out its mission in the case of medical devices is grossly inadequate and that due to constrain resources lack of adequate staff a is engaged in reactive regulatory priority setting or a fire fighting regulatory posture is state of pursuing a culture of productive regulatory science in other words people should be concerned about the inadequacies of food drug to carry out its mission to protect american consumers and parents articulate protect american industry from unfair competition by people who are not be regulated by f d a which unfortunately ofttimes doesn't even know where the people abroad that they're supposed to be looking at might happen to be located or indeed who they are this fortunate news has been confirmed in recent testimony the government accountability office office o before the subcommittee on oversight investigations which found that the f d a was not able to make the required inspection every two years of domestic facilities where the highest risk medical devices are manufactured and i would point out is that in the hearings of this committee in times past we found that things like her valves were not being properly and safely manufactured and the result with the failure of that kind of device was an instant heart attack with total fatality being the result to the person who happened to have that particular device implanted so we need to address this we need to understand that currently f d a is only able to inspect medium risk medical devices so these once every five years and high risk device facilities only once every three years american consumers be aware and the number of inspections for producers is much worse g a o estimated that f d a had specs for manufacturers of class two devices only once every twenty seven years and four in class three manufacturers only every six years despite the fact that there are more registered device manufacturers in china than in any foreign country chinese firms can expect f d a to visit them only once every fifty years and was medics currently represent nine percent of f d a regulated products imported of the united states the number of these imports is growing and in spite of small budget increases last year f d a offices cosmetics and colors has been unable to keep pace with the increasing numbers of foreign cosmetic products and i would remind all that we are not talking just about finished products but we're talking about raw materials and components which could offer us greater risk as can the finished products to american consumers with this effort we will hear from two f d a officials today why i hope will be forthright in their testimony about the needs of the agency we want to help the ages in we look forward to the agency helping us to help them when congress could do a better job for american consumers if we receive frank truthful testimony for the people vested with regulatory responsibility i want to commend those in the device and in the cosmetic industry  stepped forward and voiced our willingness to work with us to strengthen f d a and i want to make it plain that we understand their problems and we're desirous of coming up with something with which they can live and which will enable them to compete fairly in a difficult mark and as we start this effort we must all keep in mind that the dire straits in which f d a is and how they impact upon american consumers and we need to understand that the federal budget alone cannot support the growing demands of the agency and we could find time after time where the heads of the agency have come in to tell us what a good job they were going to do and how we could hope in some distant future that they would have a new and wonderful device and methodology for addressing these problems we have been disappointed not only in in their feathers but also in them industries that here that benefit from global marketplace also must share the responsibility of the safety products that they sell to american consumers and they must face the same situation and the same regulatory impact that american manufacturers confront lastly i want to thank the consumer groups and other stakeholders who recognize the crisis at f d a and who've committed to work with us on this effort following the conclusion of today's hearings i intend to begin to work immediately with my good friend mr barton and other members of the committee to try and build a strong bipartisan piece of legislation using the discussion draft that we are considering at this particular time mr chairman i commend you for this i thank you for your courtesy i yield back the balance of my time legislation i do wish that there could have been more him put from the minority side i understand i'm relatively new but it seems like if we could be present while you're drafting the draft it would be easier to to get to a bipartisan a true bipartisan compromise but nevertheless and a year where process regular order seem to be jettisoned so easily i am grateful for this comment to review period we've got a lot of work to do but i about the legislation that will transform the system this year some critics energy and commerce have had hearing after hearing after hearing on the regarding the resources or lack thereof the food and drug administration we've also had many important investigations what is the heparin issue the melamine issue the ongoing investigation led in dental devices but while i sit on the health subcommittee oversight investigations committee congress train consumer protection i cannot recall any discussions or any investigation regarding the cosmetic industry so i'm sure that there are some reforms that need to be made within the office of cosmetics and colors in the center for food safety and applied nutrition but i would urge this committee this subcommittee to move methodically and deliberately we shouldn't just be passing legislation because we happen to be here i would like to address the issue of resources i respect the fact that this bill attempts to garner more resources for the agency but i do question some of the some of the attempts we all know the food and drug administration which should be the premier federal agency has been underfunded for decades many administrations both republican and democratic it's mostly many congresses both republican and democratic that bear responsibility for this problem but this bill seeks to solve that by imposing a pass through tax consumer disguised in the form of user fees so mr chairman i call the leadership of this committee the leadership of the appropriations committee the speaker of the house to come together and develop a plan to get the critical resources to this important agency this is an authorization bill under the best of circumstances when do we expect to see one dime delivered to the food and drug administration yet we can do that through the appropriations process this year we will simply pay attention to the process this committee doesn't appropriate money but every single member of this committee knows that this year we'll be lucky to pass one appropriations bill chances are most appropriations will be passed through on a continuing resolution and so the agency will receive level funding yet for another year consequently unless we take immediate steps to work within the appropriations process the food and drug administration will continue to be under funded regardless regardless of the number of hearings that we mr chairman i appreciate the opportunity to have this hearing today on such an important issue keeping our devices and cosmetics safe for american consumers i applaud your leadership on these issues as well as other issues and concerns addressed in your draft food and drug administration globalization act today i'd like to address some of my concerns about the regulation of cosmetic products at f d a or rather the lack of regulation it is under the food drug and cosmetic the act that f receives its authority to regulate drugs devices cosmetics and other products but what many americans don't no and in fact came as a surprise to me is that f d a has little or little to no authority to actually regulate the personal a does have the authority to require such a safety substantiations labeling requirements and facility inspections but without the resources to do so cosmetics remain widely untested and unregulated for example tests for safety are done by the manufacturers themselves and are not overseen by the f d a additionally without an actual standard for what is considered safe it is hard to imagine what exactly is passing for safe and arriving on shelves across unfortunately even when f d a does find a deficiency or a violation it doesn't possess the authority to issue a mandatory recall and often does not pursue legal action because the burden of proof rests on the f d a which has no resources to carry out investigations or studies of its own so think about it how many personal care products does each of us use every day ten twenty five my concern is that more and more studies are coming out on the hazards of these products and we simply don't know enough about them and their long term effects we are just told that they are save trust that the industry's voluntary reporting program works and assume that the f d a has sufficient authority to act if necessary yet according to a letter sent by the environmental working group to f d a commissioner von eschenbach last september well over twenty two thousand products that's ninety eight percent of all products contain one or more ingredients that has never been publicly assessed for safety not by the f d a not by the cosmetic industry review which is the industry self regulation panel and not by any other publicly accountable u s institution by contrast the european union has required cosmetic companies to remove reproductive toxins mutagens and carcinogens from personal care products and it now bans more than eleven hundred chemicals from personal care products due to risks associated with cancer birth defects or reproductive problems in stark contrast just nine chemicals are banned from cosmetics in the united states that to me is unacceptable and i am so very grateful to the chair for the chairman's efforts to rein in the sun you regulate it industry by requiring manufacturers to register their facilities their products and their ingredients with the f d a and to submit serious adverse events relating to the use of its cosmetics to a registry the stratfor legislation law would also establish good manufacturing practices a big step in the right direction so i look forward to working with you mr chairman as well as the rest of my colleagues on the committee to strengthen these provisions further i think that the improving authority oversight authority of cosmetics is long overdue and i look forward to hearing from our witnesses today thank you and you'll back thank you next is the gentlewoman from tennessee miss blackburn thank you mr chairman for having this hearing to discuss the device and cosmetic provisions contained in the draft the drug administration globalization act i do appreciate the goal of the legislation which is to increase consumer safety in the u s import system and i continue to support increased transparency and enhanced public safety to reduce future incidences of tainted products that are in a ring the country and of course we have heard debated listen to quite a bit of evidence on that issue in this committee this year and as this committee has learned through those numerous hearings what we have is the f d a is a broken agency what we have learned is there seems to be very little in or agency communication that there are too few inspectors that there are insufficient resources to complete its core mission that there are in adequate i t systems and as far as we know since we have not heard differently  there seems to be a lack of best practices within the agency it seems somewhat out of order for this committee to legislate new requirements for f d a without fixing what appears to be their fundamental  structural underpinning which is causing problems within the agency and my hope is that by the time we get around to the final bill that what we will do is prioritize consumer safety with a balanced approach for consumers and for manufacturers when legislating in the name of increased consumer safety it's critical that this legislation achieve its desired effect and not severely restrict the entry of life saving medical technology into the u s health care system this legislation should not limit patients access to important preventative screenings and diagnostic procedures it is well known that the f d a is in need of resources we've heard they need hundreds of millions of dollars in additional funding to increase inspections on both domestic and foreign manufacturing facilities and to do those in a timely and orderly manner last year user fees which are taxes and they all get the consumer user fees re increased under the medical device the user fee and modernization act which was reauthorized to help defray f d a review cost concurrently some on this committee complained that increase again rain that is taxes are further increase and appear to unfairly burden domestic medical imaging manufacturers i look forward to discussing the rationale for increase shoes or face without creating further dependence on the f know we're going to have quite a discussion on this i've got more to say but mr chairman i'm going to yield back the balance of my time and look forward to the continuing conversation on the legislation leadership on this very important issue as a public health nurse i believe there is no greater goal than protecting the public's health and well being and of course as part of its mission the f d a is responsible for regulating all medical devices that are marketed in the united states including including those manufactured on foreign soil inspections are probably the most powerful tool that the f d a has to ensure that these devices are safe and effective yet growing demands on the food and drug administration have limited the resources it has available to adequately fulfill its mission as a result inspections are far too infrequent and unsafe devices have the potential of entering the market undetected but device manufacturers also need to be part of this process we need to form a working partnership in order to guarantee a safe supply i'm pleased that will have an opportunity here today from both the f d a and the medical device industry about how to make such a partnership work it's abundantly clear that the food and drug administration is in desperate need of an additional resources this fact has been acknowledged by colleagues on both sides the aisle and it was confirmed by f d a officials testifying before this committee just this month medical devices are not the only products that may be compromised by such limitations the f d a has authority to regulate the cosmetic industry has been historically limited but cosmetic produce products in ingredients are not currently subject to rigorous rigorous pre market f inspection and approval it is left to the cosmetic industry to verify the safety of their products this limited oversight combined with a lack of product recall authority greatly constrain the f d a as ability to protect consumers from potential consumers from potential toxins hidden in cosmetic products without sufficient resources adequate staff and robust regulatory authority the f d a has been relegated to a reactionary role instead of taking preventive and proactive measures this is no way to protect the public's health and safety changes do need to be made and in order to do this we must make a strong commitment to invest in the food and drug administration something i've supported throughout my tenure in congress so i thank the witnesses for taking the time to join us today and i look forward to a productive discussion thank you and i yield back thank you recognize the gentleman from pennsylvania mr pitts thank you mr chairman and thank you for convening this hearing today on the device and cosmetic provisions of the food and drug safety discussion draft i have to admit i am a bit confused as to why drugs and devices have been included in the same title of the discussion draft the f d a amendments act of two thousand and seven recognized the distinct differences between drugs and devices and addressed the two separately yet several provisions in the draft before us apply the same requirements to both sectors i would like to welcome all of the witnesses particularly those from miten m d m a i look forward to all of your comments on this draft legislation i think it is important to point out that foreign medical device manufacturing facilities are already subject to international quality and safety inspections at least annually as part of the international standards organization one three four eight five standard a standard virtually identical to the f d a quality system regulations meeting this i s o standard is a requirement for medical device manufacturers and forty seven countries worldwide the f d a should make use of the valuable information gained from these already required inspections also the discussion draft requires an inspection every time a change is made to a medical device and requires inspections of all component parts medical imaging devices for example are updated or improved on average once every eighteen months the device may have be updated software the device may have an added functionality or it may be able to image another part of the body i do not believe that these updates t already approved products warrant an entirely new facility inspection we've all heard about f d a s lack of resources and the lack of inspectors we can't wait until an f d a inspector comes to a facility to complete the new assessment to give the go ahead to a product that has what is effectively an eighteen month shelf life patients here in the us need those technologies it is also important to note that the f d a classifies medical imaging devices as class two which are considered low risk the f d a inspection approves medical imaging devices as finished products i fail to see how inspecting every single component down to the screws used to hold the device together is an efficient use of f t s time resources every screw circuit board and screen must work correctly for the completed device to function properly and pass it's rigorous inspections examining component parts individually would be duplicative and not be a prudent use of funds these new inspection requirements could ultimately end up slowing down the delivery of improved and updated technology to the us market and ultimately to patients finally medical device manufacturers currently pay officially registration fee of seven hundred dollars per facility per year to the f d a they also pay fees for i s o inspections however this discussion draft includes additional annual facility registration fees as well as an annual ten thousand dollar importer registration fee let's remember that device manufacturers voluntarily agreed to almost double the amount of fees they paid f d a last year these new fees are duplicative and do not provide a direct benefit to the manufacturer i believe we need to be careful not to cross from valid user fees into new taxes on these manufacturers i would like to thank all of our witnesses for testifying today i look forward to your statements and i yield back the balance of my time thank you the other gentleman from pennsylvania mr murphy mr chairman it seems as some life much of what can be said has been said and some of my friends say one thing is some another and i agree with my friends on this but nonetheless i want to emphasize here too and thank you for this  hearing and hope that part of what we get out of this and shaping a bill is one that recognizes we do need to have a more effective system of inspections not just for the its own sake but on devices and on these other products want to make sure we're simply not adding more to the cost  burden of these products without yielding results in particular some of the areas that i hope our witnesses will talk about is in the areas of finding those who may manufacture or bypass or violate some of these rules when we're dealing with foreign companies that it's not hard for them to simply close that company and shop is another name and therefore say under the radar screen with this one of the great things about america is we are able to still be seen as a leader in inspection having product safety however we want to make sure that we maintain that position and not give it up to other countries who are able to bring other products in here that don't have that so i look forward to hearing it here and finding how we can carefully balance this issue of making sure that we are able to maintain product safety and not simply overburdened system with regulations that are not leading that and i yield back thank you i believe that concludes our opening statements i will now turn to our first panel i'd ask  witnesses from the f d a in the g a o to come forward at this time help us in that respect and then next is doc marcia cross who is director of health care for the general accounting office you know the drill we hear five minute opening statements and they become part of the hearing record but each witness may in the discretion of the committee submit additional statements in writing for inclusion in the record and i'll start with dr sunlight for five minutes thank you for being here thank you mr chairman and members of the sub committee i am dr steven sun loft director of the center for food safety and applied nutrition of the u s food and drug administration and as you indicated with me today is dr lillian gill senior associate director center for devices and radiological health  a thank you for the opportunity to discuss the challenges posed by imported medical products and components and of cosmetics we commend the members of this subcommittee and their staff for developing the discussion draft entitle the food and drug administration globalization act of two thousand and eight we recognize and appreciate the committee's efforts to include new authorities requested by the administration in support of the action plan for import safety foreign manufactured medical devices must meet f d a regulatory requirements in order to be imported into the united states or its territories these requirements include stashing registration device listing manufacturing in accordance with quality systems regulation reporting of adverse events and pre market notification or pre market approval initial importers must register with the f d a foreign manufacturers must designate a u s agent to among other things facilitate interactions co operatively works with customs and border protection in regulating imported products products that do not meet f d a as regulatory requirements may be detained at the border cosmetics firms are responsible for substantiating the safety of their products and ingredients before marketing in general except for color additives and ingredients specifically prohibited or restricted by regulation a manufacturer may use any ingredient in the formulation of a cosmetic provided that the ingredient does not adulterate the finish cosmetic and the finish cosmetic is properly labeled cosmetic manufacturers are encouraged to register their establishments and file cosmetic product ingredients statements with the with f d a as voluntary cosmetic registration program this program provides f d a with the best information available about the locations business trade names and types of activities of these talismans that participate in this program if manufacturers do not remove dangerous products from the market the agency has can pursue enforcement actions against violent products or against firms or individuals who violate the law f d a works closely with its with all of its partners including the international regulatory authorities a wide variety of issues important on a wide variety of issues important to the cosmetics safety including ingredient usage and labeling marketing surveillance and areas of emerging science the administration's action plan for import safety presented broad recommendations and specific actions steps to promote the safety of imported products under the organizing principles of prevention intervention and response one of the plans promise s that the u s must transition from outdated snapshot approach to import safety in which decisions are made at the border into a cost effective preventive focus models that identifies an targets critical points in the imports  lifecycle where the risk of the product is greater greatest and verifies that the safety of products at those verify the safety of products at those important phases under the auspices of the administration's action plan for import safety f has many initiatives underway to further protect them from most public health for example f d a is beyond our borders initiatives a multi pronged approach to promote and verify compliance of imported foods cosmetics and medical devices with the a requirements prior to importation this initiative includes increased f d a presence overseas increased f d a inspections greater sharing and use of foreign confident authority inspection reports and other information use of third party certification and increased capacity building with countries that have less developed regulatory systems to ensure product safety in order to target our intervention efforts related to foreign firms f d a has several plans to enhan its i t systems in ways that will improve databases and hansen or operator interoperability of systems within the agency and among other regulatory agencies and provide better analytical function to assess and control risk finally when a health threat emerges with a regular regulated product f d a must have the tools to facilitate the timely recovery of the violative product reduce the opportunity for harm and secure the integrity of the supply f working with is working to facilitate the adoption by industry of track and trace technologies to identify and track the product along the products lifecycle back to the point of origin under the food and drug administration amendments act of two thousand and seven a is working to develop a recognized unique identifiers which may support product identification technologies under new authorities the action plan for import safety calls for providing a number of new authorities in order to enhance the safety of imported products it requests authority to establish import certification programs using accredited third parties to compliance of foreign products with u s standards the plan recommends authorizing f d a to refuse admission of foreign manufacturers products when access to the foreign manufacturing site is hampered the plan also request authority to expedite destruction of refuse medical products which will prevent unsafe medical products for personal use from entering the u s market finally asset forfeiture remedies for certain criminal offenses involving fraudulent or counterfeit products would allow the forfeiture of all vessels vehicles aircraft and other equipment used  in the importing exploiting transporting selling receiving acquiring and purchasing of violated products we are in the process of reviewing the f d a globalization act discussion draft in detail and we look forward to working with you on this legislation let me reiterate some general principles that guided the development of the action plan for important to the senate of why i hate to stop the f d a witness in your case but you're about a minute and a half over but mr chairman and members of the subcommittee i'm pleased to be here today as you examine f d a as oversight of medical devices at the request of the full committee we have been reviewing a number of issues related to f d a for an inspection programs a variety of medical devices are manufactured in other countries including high risk devices designed to be implanted or used in invasive procedures our work points to one conclusion f d a programs have not kept up with the globalization of manufacturing and the products that f d a regulates f d a inspections of foreign establishment are infrequent the agency's data systems have been rife with errors and law fundamental capabilities needed to manage the programs and the agency has faced several challenges unique to conducting foreign inspections since i first testified about these problems f d a has announced a number of initiatives to address these concerns as we have heard today from dr some off f d a as initiatives have the potential to strengthen f d a s four and device inspection program but they do not fully address the weaknesses f d a is required to inspect every two years all domestic establishments manufacturing medical device classified as being of high risk or class three such as pacemakers and to federal later or medium risk or class two such as syringes and hearing aids there is no comparable required time requirement for inspecting for an establishment but f d a is responsible for ensuring that they meet the same standards required of domestic establishments we found that f d a has not met the statutory requirement for domestic inspections of medical devices stablish ment's and foreign medical devices stablish months are inspected less frequently about every six years for class three devices or twenty seven years for class two devices as of september two thousand and seven there were about five thousand class two and three foreign devices stablish ment's registered with f d a of which fewer than three hundred words inspected last year f d a has faced particular challenges in managing it foreign inspection program f d a databases contain inaccurate information about fat medics foreign medical devices stablish months and the products they manufacture are recent changed to f d a as medical device registration process could improve the accuracy of the registration data the new process includes electronic registration with an annual registration fee current currently set at about seven hundred dollars there's another initiative aimed at reducing duplication in its import database is a proposal that f d a has supported to change the date it receives from customs and border protection on products entering the united states however the implementation of this proposal is not certain and would require action from multiple federal agencies in addition inspections of foreign devices stablish months post challenges to f d a in human resources and logistics f d a depends upon volunteer inspectors lacks independent translators associated with this an issue dave 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 chinese nationals to provide translation and other support however the impact that these offices will have on the foreign device inspection program is unknown because the staff would be responsible for all f d a regulated products finally over the years there has been interested in using third parties to supplement f d a s inspection resources we found however that few inspections have been conducted through f d a as to accredited third party inspection programs in the four years since a first cleared an accredited organization to conduct independent medical device inspections a total of eleven inspections have been conducted six of foreign establishment and five of domestic establishments in conclusion given the growth in foreign device manufacturing for the us 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 rate of inspections the agency has recently taken some positive steps to improve its foreign inspection program including announcing plans to increase its presence overseas however it is too early to tell whether these steps will ultimately enhance the agency's ability to ensure the safety and effectiveness of medical devices marketed in the united states mr chairman this concludes my prepared remarks i'd be happy to answer any questions that you or other members of the subcommittee may have thank you dr cross and i'm going to start the questioning by of the written there's been industry interest in the international harmonization of standards for device inspection specifically we've heard that industry would like f d a to adopt international standards organization while the standards of they'd like them to adopt international standards organization standards that sounds a little weird but that's what it is are there any substantive differences between the f d a standards and those of the international standards organization and what is your opinion on asking the f d a to move to those standards thank you mr chairman we have worked for quite a while the center for devices with the global harmonization task force in fact we chaired that task force this year we have been working to harmonize our quality system regulation with many of the standards on the g h t f task force we find that their quality system or their iso inspection thirteen four eighty five is pretty close very similar to ours and the most recent f d a modernization act allowed us to evaluate foreign inspection reports thirteen for eighty five iso inspection reports so we find them to be very similar we certainly are developing the criteria under which we could get the reports in look at them determine whether or not they have met the foreign standard requirements and to see if they're similar to ours and we look forward in the future to figuring out how we can use these in lieu of an inspection ok thank you and then i want to ask  across in your testimony you mention the third party inspection programs that are currently in place in the fact that very few companies have taken advantage of those programs even after improvements were made can you explain why this is and make any recommendations is how to put in place more incentives for companies to actually partake in those programs and then does the f d a need additional authorities or basically are there ways to make this work and how would you go about it thank you yes we did take a look at the accredited inspection programs and one of the issues that we hear from industry is that it's not clear at this point that a single inspection to meet the requirements of both the f d a and other foreign governments is really that feasible a few of the companies ahead explored using this program had determined from the uncredited inspectors that they would actually conduct separate inspections to meet the u s requirement from that that they would conduct for for example the european union and so at this point i think there are still some issues to be art out there also is a concern i think on the part of some industry organizations that if you're hiring uncredited inspector you are insuring then that someone is  coming coming to your door and exposing you to possible regulatory action right now f d a doesn't come that often and so if you just sit back and wait for f d a to show up it could be many years so that has worked also with a disincentive for organizations to hire an uncredited inspector to pay for that inspection right now an f d a inspection does not cost them any money and then to face possible penalties that that might be incurred so i think it's too soon to know whether the changes that were made in the bill last year or going to modify that but at this point under that a credit inspection program only one additional inspection has been conducted since we testified in january on this  at self has undertaken a separate pilot program with with canada to try to determine if they can iron out some of these problems thank you let me it's one cosmetic question dr sun love you mentioned several areas  concern with the rapidly growing nature of the cosmetics industry including increasingly sophisticated technology and more complex ingredients well the provisions included in the discussion draft and i'm referencing you know the mandatory registration mandatory adverse event reporting g m p regulations where they assist f d a into filling its regulatory mission concerning cosmetics in terms of requiring that the firms register and report all of the ingredients of at least alert us to the fact that there there may be new ingredients that we may not otherwise have been aware of were in these cosmetics so in that respect yes comment except rather than you know they the other ones i don't think would particularly address that issue of the widely emerging new products that are coming out in terms of for inspections i don't have that number with me i'd be happy to provide that but we do know that those that are in the european union recognize that is does china recognize those or do they participate china is a has attended the last global harmonization test fourth meeting they are scheduled according to discussions we've had to attend the next set of g h t f meetings but i would assume it takes action on the part of the country to incorporate the i s o inspection standards in to their way of doing business in their own country they have to  is that correct that's my understanding how long do you anticipate is going to take to determine whether or not if the standards can be harmonized with i s o standards we are currently working through looking at the standards now looking at the differences and preparing to have a public announcement of our adoption of how ready i heard you to do that as quickly as possible the next question is in the event you determine that i s o standards are sufficient to cover the f d a responsibilities would it require legislation to allow you to use the i s o inspections inspections i think it's there harmonize inspections and we find that there are are very equivalent to our ours i'm not sure the legislative changes are absolutely necessary i would have spelled out we would look at that because i personally think that's the direction we need to go in so i can question is do other countries require our own side inspections of american manufacturing facilities and other words that the reverse of what we do and overseas inspections yes agreement between the third party inspector and the manufacturers in order for that to be accomplished the reverse of what we normally think of here would it require formal action on the part of the united states  one of the one of the issues that was mentioned was the beyond our borders an issue that if da has undertaken i think it's going to be increasingly important for us to try as best we can to harmonize with other countries that are trying to do the right thing and be able to work while particularly in that effort and i think it's also going to require that we continue to apply pressure for those countries that do not move in that direction and in that regard reference was made to mr dingell's opening statement that we could not we have to be careful i guess underdone b t o that we do not differentiate between domestic and foreign inspection cost etc but isn't it true that it is significantly more expensive to do overseas inspections on our current system than it is to do domestic inspections i do believe there are costs associated with travel and foreign inspections that we don't have to pay for domestic inspections but we do try to cover at least three inspections while we're there to minimize that travel costs one of the things that the administration ask us under their safety plan is ask congress to grant the f d a the authority to refuse to admit for import products that were manufactured in facilities that denied  inspectors are hampered their ability to do inspections is it true that we that you do not have that authority to that there is no authority to do to discriminate against those countries and products where you have been denied or hampered in your inspections that we don't have any authority to discriminate against them currently allowing an f d a investigator into a facility a foreign facility is voluntary so we're not talking about on our end what i read is that apparently you're asking congress to give you the authority to discriminate against those products from those countries or from those plants that have interfered with your ability to inspect their products is that something that needs statutory changes yes i believe it is and right now we we can we can detain product if we have reason to believe that it's adulterated but we have to establish at the port of entry that it is it is adulterated then we can issue an import of lurkers and and that prevents it but just we we don't have that authority just on the basis we can initiate imported on the basis that their country of origin refused our inspection like these are selling products to the american people yes you kno producing bipartisan legislation this concern it would it would be very helpful to have the committee have the agency's plan of action for improving its device information system both its funding needs and timelines  would cost an additional hundred million can you to tell us how much you need to meet the required frequency for don't mistake device inspections that also could be provided fully submit that for the  record i'm told her cording to dr cross f d a had specs relatively few foreign medical devices stablish woods despite the fact that over forty two hundred foreign facilities been registered so the medium and high risk devices to american consumers is that accurate could you repeat that question f d a expects relatively few forn device establishment supported dr krause despite the fact that over facilities we will certainly make that part of the answer we supply to you now have you seen the g a o study yes we have i want you to to submit any criticisms to this committee you have regard to the factual and other questions associated with this study of and i'll ask that the record be kept open so that that may be done now according to the report all right they went on to say this you inspections of foreign device manufacturing stablish france a been conducted through and through f d a as to programs for inspections by accredited third parties is that statement true according to the report yes we've responded all right now in this they further say this f d a faces challenges conducting it is correct then they go out and say f d a officials told us it has been difficult to reduce rather to recruit investigators to voluntary travel to foreign countries  however they added that if the agency could not find that individual to volunteer for a for an inspection trip it would mandate to travel logistically foreign medical devices stablish this is fiction as are difficult to extend even if problems are identified because it trips are scheduled in advance is that true yes they are pre announced inspection no what what are you doing about that well we're certainly cleaning up the database and finding yours is a great agency and regrettably you are crippled by or inability to carry out your responsibilities like a driver thank you and without objection so would have to submit those questions we we do have a vote eleven minutes left i was going to ask confused about medical devices being included in this particular bill we've had major problems with food imports from china and we've had major problems with drug imports from china but i'm not aware that we've had major problems from medical device imports from china dr gil are you aware of any major medical device issues in terms of medical devices that are manufactured in china and sent to the united states well the most recent  china on certain medical devices that have been manufactured in china has been used to coat certain that if we solve the heparin problem the device itself is not that was all i says that's correct ok now on overseas as it does in the united states that we have a law that allows the company to ask for a third party but many companies don't do that because they say well if the f not inspected me why should i ask for a third party inspection that then may result in an f d a inspection what if we reverse that and allow the f d a to direct a third party inspection as a well certainly in the import safety action plan we are we we looked at what would help us to get more information about foreign for still a tease and certainly asking for those foreign inspections reports would give us that information but currently f d a directed third party inspection it has to be done at the request of the facility is not correct it is all voluntary so if we changed it you could still ask for the voluntary but if you gave the f d a the authority because of whatever reason the limited resources limited to probable cause you name it to direct a third party inspector with that would that help address this issue of lack of frequency of f d a inspections that's my question i think we would want to make sure that the third parties are trained to conduct them so that we get the same quality in the inspection that we get with our own f d a inspections might help i would just add that at the current time there aren't enough to fill the gap there are not enough trained accredited inspectors to be able to fill the gap to to get inspections up to the level that's required and also you would be asking the company then to bear the cost of that inspection a credit inspection program requires the company to pay but the concept on the face of it doesn't seem  unworkable the accredited inspection program is set up with the goal that that inspection is equivalent to an inspection by f d a and we wouldn't change then that's all my questions mr chairman thank you mr bar and we'll take a recess is only one vote so we should be back fairly quickly and then we can take the rest of the questions for this panel subcommittee stands in recess pathway for inspections and how we operate today and where we want to go obviously the legislation put forth the way what i'd like to examine with inspections of devices being sent into our country is it better to inspect in the facilities abroad how effective is your inspection here and so i 'd like to examine that area because most frankly i'm not so sure how it works how well it works and what you think of it what i want to say this is a just a general observation and we don't have very many members here so i'm going to be speaking to like three other people most frankly i think if i were the f d a commissioner i would bring forward a list of the congress in this committee and say these are all of the responsibilities that you have charged us with in order to protect the american people we have the resources to do the following you know that we may have given the f d a seventy nine things to do all very very important at the agency and not having the resources to carry the rest out i have said consistently here we cannot remain content with user fees there they are important i help to establish some but having said that i don't believe the congress is funding the agency the way it needs to be funded in order to carry out these all important mandates including the ones that we're looking at in this legislation so can you take us iso iso standard that is very similar in that in the thirteen forty five that looks at many of the same components that are quality system inspection look that where i think the major differences lie in what is what is covered in the f d a inspection we include not only g n p is a higher standard it in alludes many more elements to and some of the differences also in the the the depth of our inspection we inspect to the regulation we of course look at whether or not they have and how often do you do that we do the f d a inspection every time we go  have two levels of inspection we have in the breviary a good quality system inspection and we have a full inspection is one products are coming into the united states this is the inspection technique process that we use regardless we use the in foreign manufacturers we use that in the mystic manufacturers we don't inspect product at the border if it's coming in we inspect the manufacturing facility and how often do you do that  the report says we are doing domestic conducting domestic inspections for class three devices about once every three years and clay you're satisfied with that five it is according to our risk bas area covering our most critical high risk issues ok let me just get another question and i still think this needs some more exploration i raised in my opening statements the whole issue of  the component parts for medical devices circuitboard software except for a do you want to comment on that i mean i don't think f d a knows how to inspect those things that our our our current law requires the manufacturers to be responsible devices as you dated are made up of multiple components and we have in our in our law said the manufacturers are responsible for inspect whether or not they have looked at all components for their products i say to make sure that they were acceptable according to the standard ok thank you and my time is up thank you mr chairman thank you gentleman from indiana if you i'd like to do some follow up on the questions mr deal had asked earlier just for clarity for clarity purposes to the f d a when during during these inspections and you you have a a foreign government that will not cooperate where you have a company in a foreign country that doesn't cooperate with an inspection are you asking us for specific statutory authority so that you could prevent those products from entering into the united states market yes or the import safety action plan specifically ask for increase for authorities to seek to deny  importation of products if we are denied access to those foreign firms and this committee were to take affirmative action include that in this bill that's a provision for which you would support then could you repeat the question w we took x if we took that and put this in the bill obviously that's something you would support the administration has for now obviously would have to see exactly what the language said but you don't so you don't want to dance i suppose you know we try to help you right ok or don't you don't have to do that kind of answer with regard to are you aware of any trade agreement issues that might arise from the bills ten thousand dollars for import  registration fee on how that can be interpreted i don't have the answer to that we can we can get your answer in writing there's i think the kind of trade agreement concerns that we had was that says specifically looked at having higher standards for imported products than we do for our domestic products and that we need to make sure that any any legislative language would not interfere with our trade agreements well that would be my hope also all right to be helpful to us and to the g a o if you have a nickname if you in cooperation with other departments or agencies recognize that if we were to actually put a ten thousand dollar import registration fee and it's it's against any of our trade agreements we need to know about about that supplies that the committee know in writing  i have some some concerns that if we if there are approximately thirty eight hundred premarket notifications a year in the majority are class two devices given your testimony  the drug side of this bill and how much effort it's going to take for you to do staffing and resources necessary to inspect on the drug provisions of this bill what are your concerns with them i believe that with all of the new authorities that this bill would offer we would need additional resources to be able to accomplish all of the accomplish all of the new authorities that we have  and exactly what that is the dollar amount i can't say i mean one of the things that we we say in our import safety action plan and that has been addressed in this bill as well is the use of third parties  and depending upon how extensively we took advantage of those third parties would have a major impact on what we need to staff in other words f d a inspectors versus what we would be relying on third parties to accomplish without i thank the gentleman for yielding i understand that there was a letter written to the committee by the european union do you have that here i'm trying to get staff to to get it for us apparently i'm not aware of that issue i think it's a concern that we need to be looking at dr cross no i'm not aware of that issue either there currently is a registration fee that is being charged to all medical device firms and i had earlier ask of foreign countries we're also coming in and charging fees of our manufacturers and i've had several people during the break to assure me that they are and that the fees that they are charging to american manufacturers are significantly more than they are charging to their own domestic manufacturers so i would simply request hopefully i'll have that copy of the letter will put in the record perhaps before the end of the hearing i would ask al if you would take a look at that issue we don't need to we don't need to do something that's going to provoke a devotee oh fight in retaliation and all the things that we know go along with those kind of disputes if there is a way we can achieve our purposes short of that then i would think we would all hopefully work toward that and i would i would follow up to mr boyer on that line of questioning as to your action plan as it relates to the statutory language i have not personally seen any suggested language on that this would be the appropriate place in my opinion for us to try to get that statutory authorization that you say that you think is appropriate and i would  make that available to us or soon as possible because i assume we're going to be marking this bill up sometime in the very near future and this committee appreciate the gentleman over i would i will get a check on that and get back to you according to the registration according to the registration date certain types of catheters used balloon catheters used an angioplasty are among the top devices imported from foreign countries the there's a supreme there was a supreme court case regal vs medtronic where the regal sued the medical device company for injuries that mr regal sustained when the balloon catheter that was used by his physician versed in angio plasti and they the supreme court ruled in favor medtronic and found that f d a regulations preempted state civil matters and my concern is this of if we're doing an adequate job of inspecting of a ring the safety of these devices and yet any other actions either state actions or court actions are precluded because the f d a is the final authority then it seems to me were leaving people without options and at an at risk an unimportant ability for states and individuals who are private right of action that might be an incentive for these products to be safer or is precluded i just wondered if anybody had a comment on you know whether or not the ultimate authority if consumers can really depends now on the f to be the ultimate authority on the safety of these products i'm i don't have any current comment on that i think many of many of our products are safe we do have a reporting system that lets us know from all users as well as consumers when there are problems with products and for the most part we're finding devices are safe and we are actively investigating those that are not well would you argue dr cross that the g a o report would that assessment i think we have concerns about the current level of oversight that f d a is able to employ both for medical devices and for drugs right let me ask  a about cosmetics it is not i understanding dr sun loss that in response to the an environmental working group petition in two thousand and five that the f d a responded quote the food drug and cosmetic to again contains no provision that requires demonstration to f d a of the safety of ingredients of cosmetic products prior to the marketing of the product is that correct that is correct there is no pre market review of cosmetics but you do have a requirement that manufacturers adequately substantiate their products for safety is that not correct yes that's correct are you able to provide our subcommittee with f d a is definition of safe i can provide that to you in writing my understanding is that there is no f d a definition of safe in the area of cosmetics i will have to go back and look into that there certainly is definitions of safe for foods and medical products check that i'd be interested because i am told that there is no definition for say for these cosmetics that the agency developed guidelines for industry and what should be done on their part to substantiate safety sorry could you repeat their guidelines developed by the f d a to substantiate safety that manufacturers have to follow certain kinds of safety and those have been in effect for a number of years and when the companies substantiate their products before they're sold who did they submit the data to the f d a they're not required to submit data to the f if it turns out that there is a safety issue associated with a particular cosmetic the f d a has the authority to inspect that facility and determine whether or not the company has done an adequate job of demonstrating the safety before they entered the product in the market thank you mr chairman may i ask one more question it's my understanding that the industry funded safety panel the cosmetic ingredient review panel has only reviewed eleven percent of the over twelve thousand and greedy ants in personal care products over its thirty year history so i'm concerned that this panel might not be up to the job and in your testimony you state that f d a estimates that within their voluntary registration system there is product information from just a third of all domestic manufacturers so what do you think it would take to review all ingredients used in personal care products what kind of data does f d a currently have on chemical and greeting its most commonly used in personal care products and i guess finally do you think that the work that is being done to guarantee safety currently is sufficient certainly there that the law as it currently is written allows virtually anything to be incorporated into cosmetics with with certain exceptions that are specifically prohibited under under the act  there the remainder of your questions i think we would need to go back and we can provide you with an answer in writing ok and i just wonder dr krause if i haven't read the whole report if you deal with that in your report you know i'm sorry we do not look at cosmetics at all ok thank you thank you mr chairman thank you and they had concludes our questions of the first panel i want to thank you very much for answering the questions and for your testimony and as you know we we do intend to move towards the marking of this bill at some time in the near future so we'll continue to get back to thank you and if the next panel could come forward at this time well welcome again i'm going to introduce each of you starting on i left some of you i don't know maybe all of you but certainly a lot of you've been here before you know strangers to the committee first oh i see you doing both ok and then we have ms amy guy dia with the consumers union she's the policy counsel she was here recently and then we have elizabeth george who's vice president for quality and regulatory affairs at philips health care and pamela bailey who is president and c e o of personal care products council and jane who hand who's vice president for research of the environmental working group here in d c thank you all for being here you know the rules five minutes opening statements they become part of the record and we may submit additional questions in writing that we've asked you to get back to us about and i'll start out with  that on it's on now ok good morning mr chairman ranking member deal pre shared the opportunity to share our views on the discussion draft of the f d a globalization act of two thousand and eight that ickle technology is one of the few manufacturing industries where the remains a strong vibrant balance of trade every day our member companies export more medical devices that are imported to the u s in fact more than three and a half times more exports than imports in two thousand and seven medical device exports were approximately four point seven billion and imports were barely a third of that at one point five billion before i address our specific comments on the discussion draft i'd like to first emphasize the broad range of medical devices and the risk based approach currently used by the f d a to effectively regulate devices as you know f d a classifies devices in the three risk categories ranging from low risk products and class one to hike risk devices in class three since its inception in one nine hundred seventy six the legislative framework the medical device law has been to regulate based on risk f d a is regulatory regime whether it's the approval process or setting of inspection of priorities are based on the level of risk associated with the device we believe is risk based approach effectively focuses the agency and its resources on the right areas to ensure public health and safety i'd like to now address three primary issues with regard to the discussion draft first we have concerns with the proposed new broad based industry fee but we are open to exploring a more targeted approach to inspections our view is that inspections are a core function of the f d a and funding should come from the appropriations process not industry fees as has been mentioned earlier last year's f d a and them in fact resulted in a ninety one percent increase in industry user fees including the establishment of the first ever facility registration fee a new broad based user fee would impose a potentially significant  burden on top of the increased user fees and accidental or last year we also believe there could be unintended consequences with a broad based user fee many of our members particularly small companies do not even have foreign facilities yet through their fees they would effectively subsidize inspections of foreign companies exporting their products to the u s consider that high risk medical device imports overwhelmingly come from countries with established regulatory systems according to our analysis of u s customs data from two thousand and seven ninety three point seven percent of imported medical device implants come from the highly developed countries of the european union canada australia and japan in this category of devices zero point zero one percent come from china i want to emphasize that we're willing to explore a targeted funding mechanism for inspections of foreign facilities that are located in countries with less developed regulatory systems and actually export products to the u s our second issue is with the proposed preapproval inspections for class two and class three devices as you know f d a already conducts pre approval inspections of all new class three medical devices has been mentioned with regard to class two devices there are more than three thousand six hundred approved each year simply put the f d a approval process would come to a screeching halt if this proposal were implemented requiring a pre approval inspection for this number of products before they are permitted to be marketed could inhibit the availability of lifesaving and life and hansen devices the third issue is with the catch up inspections for all class two and class three facilities according to the g a o there are ten thousand six hundred facilities manufacturing class two in class three devices having f d a inspect all of these facilities within the next two years is an unrealistic expectation we support f d a as risk based approach in determining its inspection priorities moreover for the purpose of setting those priorities the recently enacted f d a and then once act permits f d a to accept submissions from companies of certifications to internationally accepted quality system standards set by the international organization for standardization or i a so to explain i s o is an international standard setting independent organization consisting of technical ask experts including f d a f d a personnel are active participants in the iso technical committees developing these important standards we support a change in law that would go one step further by allowing f d a to accept iso quality system standard is equivalent to f d a s current quality systems regulation doing so would allow f d a to use a company's compliance with the iso standards in place of an f d a inspection this also would bring f d a and harmonization with the intentional internationally recognized and accepted quality systems regulations in closing we support a strong f d a and appreciate the committee's leadership in offering the discussion draft under consideration our members are committed to providing safe and effective products and we look forward to working with you the medical and devices manufacturing association thank you is that right thank you for that in our president very nervous when you made that announcement chairman flown and ranking member deal thank you for having me here today to testify many of my comments echo those of mr uble we appreciate the opportunity to comment on this draft legislation we recognize and acknowledge the sincerity of concerns that motivate this legislation and we really do support additional appropriations for f d a to accomplish their assigned mission but i'd like to spend my five minutes focusing on a few concerns about the draft legislation as was mentioned my name is calvin cullen when i am the president's chief executive officer of dinah tronics corporation which is a small publicly traded medical device company headquartered in cottonwood heights utah we also have manufacturing facilities in tennessee today i'm here to testify on behalf of the m d m a medical device manufacturers association which is a national or it is ation w more than one hundred eighty member companies representing the innovative entrepreneurial sector of the medical technology industry m d m a his mission is to ensure that patients have access to the latest advancements in medical technology most of wh developed by small research driven medical device companies m d m a was actually founded in one thousand nine hundred two to oppose attempts by congress and large manufacturers to institute a device user fee program while m d m a recognize the appropriate role of government include important provisions to ensure the smaller companies receive fee relief it did start the slippery slope of government reliance on industry fees in two thousand and seven this committee led effor the result was fees paid by industry almost doubled from one hundred fifty million under the new one to three hundred million under movement to their authorization also expanded fees beyond just a device applications to include annual registration fees of seventeen hundred dollars a plausible to every registered manufacturer and fees for filing of annual reports if we continue to add more and more fees it will create a significant financial burden for the majority of small medical device companies that could literally m the difference between success and failure for those companies in light of the doubling of the medical device user fees under maduka reauthorization last year the current draft legislation is proposals to see even more fees from industry is very alarming while these fees may not be viewed as a hardship for multibillion dollar drug and device companies i can say for certain that it would be a hardship for the thousands of small medical device companies in this country which are responsible for much of the medical device innovation levying additional fees will further from congressional appropriations not additional user fees particularly given the proposed paradigm that requires domestic and non importing manufacturers to subsidize such efforts when i testified before this committee last year concerns were raised about a becoming to rely on an industry user fees for funding i share these concerns and strongly advocate for additional congressional appropriations to fund this proposed legislation i'd like to take a moment discuss the bill's provisions dealings with inspections congress  have recognized the importance of the status and risk based classifications for medical devices based upon the level of f d a control necessary to establish an assert the safety and effectiveness of the medical device however section two o two of the draft legislation ignores the important distinctions between class two and three medical devices and proposes the subject all of these medical devices to equal pre approval and pre clearance inspection regardless of risks the proposed section two zero two appears to require f conduct pre clearance inspections of all five hundred k pre market notifications such a requirement would create a logistical nightmare for f d a and would effectively impose additional indeterminant delays on the applicant all waiting for an f d a inspection regardless of whether f d a determined such a pre clearance inspection was necessary it could also result in manufacturers being inspected multiple times per year adding an additional waiting period for an f d a pre clearance inspection would result in unacceptable unnecessary delays for both patients and manufacturers not to mention the untold pressure on f d a resources to conduct thousands of additional inspections each year finally let me briefly address the issue of the proposed civil monetary penalties outlined in the draft bill in particular is currently dry this section suits and could be read as mandating the imposition of penalties for any violation this section would appear to impose penalties and situations where f d a and manufacturers have historically work cooperatively to remedy minor and technical violations the legislation should permit f d a the flexibility and discretion to determine when civil penalties should be imposed and should specifically clarify the penalties would not be imposed for violations that can be addressed by the cooperative efforts of f d a in the industry thank you for providing me with the opportunity to testify today before the committee we look forward to working with you and your staff to improve the current f d a inspection process and in the fashion and effective manner thank you mr cohen ms got you good afternoon s ranking member deal and members of the subcommittee my name is a media and i am policy counsel with consumers union the nonprofit publisher of consumer reports magazine i'm here today to testify about the medical device and cosmetic safety provisions of the discussion draft of the f d a globalization act consumers union applauds chairman dingell for his leadership on the proposed legislation and commend members of the energy and commerce committee for holding today's hearing on this critical consumer safety issue some of the more high profile failures of our medical device and cosmetics regulatory system are well known at this point the two thousand and six recall of one hundred eighty three thousand packages of contact lens solution manufactured in china because of bacterial contamination and  june two thousand and seven import all or about toothpaste made in china that contained a very dangerous chemical dye ethylene glycol which is used in antifreeze and as a solvent other frightening stories of recalls of medical devices include that could fail to deflate and cause a heart attack and happier unlock flush syringes that were contaminated with bacteria f d a is charged with overseeing these products but due to a lack of resources and political will the agency has dropped the ball there have not been enough inspections enough authority or and often foresman of existing regulations and consumers are paying the price consumers union believes that the discussion draft of the f d a globalization bill contains a number of strong provisions that will help make consumers safer with regards to medical devices see you supports the provisions of the bill that would require mandatory inspection of both domestic and foreign medical device that hillary's every two years this inspection provision if implemented with protections against conflicts of interest should help improve compliance with existing f d a safety regulations we would respectfully recommend that this inspection occur annually and more often if there are problems given the host of serious public health risks that have emerged from foreign facilities in particular with regards to cosmetics c u is in support of the provisions addressed in the f d a is cosmetic adverse event reporting system ca ers in addition to mandatory reporting of adverse events by manufacturers it is important that f d a is processing and publicizing of these events occur and occurs in a timely manner with regards to both device and cosmetic safety we are pleased that under the draft legislation f d a would track all registered establishment and at least with regards to medical devices have a firm number of establishments subject to inspection currently the number of establishments the f d a should be inspecting is a ballpark figure with many establishments completely is radar the discussion draft would require destruction of adulterated misbranded or counterfeit drugs that a company attempts to import to import into the united states however a similar safeguard does not exist for unsafe medical devices and we would recommend that it be added we also support the provisions in the bill creating a fee requirement for importers of cosmetics it is not sufficient for f t s inspection resources to stay at their current extremely inadequate level with regard to imported cosmetics this importer fee requirement is one step towards addressing this problem there are however some provisions in the discussion draft affecting both medical devices and cosmetics that consumers union would encourage the committee to consider strengthening we would recommend shortening the time frames for implementation it appears at the effective date of a number of the bill's provisions are too far out in the future sometimes two or three years out the should be short we support the we support the provision creating a user fees schedule for various new f d a functions however we urge the committee to ensure that the user fees do not turn into a pay for play scenario we would not want to see regulated entities have the ability to exert undue influence over the f d a and its decision making or other functions in addition like the user fees for food safety importation the fees pertaining to device and cosmetic safety should be indexed for inflation consumers union also believes that the monetary civil penalties for violations of the medical device protections in the bill are set too low for him large manufacturer producer or other multinational a penalty of one hundred thousand dollars is simply a cost of doing business or a few hours worth of profit for the penalties deserves a true deterrent against illegal actions they should be set higher f d a must also have the ability to perform unannounced inspections of foreign facilities because of advanced warning these foreign manufacturers unlike domestic companies are able to clean up to pat to ensure that they pass inspection even if they are out of compliance every other day of the year in addition any provisions in the final bill that permit to outsource any agency tasks to a third party should include protections against such tasks being performed by entities with a conflict of interest we have a number of other concerns and recommendations about the draft bill that we would also like to bring to the committee's attention these particular concerns are presented presented in detailed in my written testimony we wholeheartedly support providing f d a with new authority and resources we are pleased that this discussion draft gives f d a a number of new and very necessary powers to better ensure the safety of our medical devices and cosmetics we also urge that manufacturers and others who profit from the sale of medical devices and cosmetics to american consumers fairly short shoulder their full responsibility for improving the safety and quality of the p that they sell i thank the committee for the opportunity to testify today and we consumers union look forward to working with the committee to help move forward on the strongest f d a reform bill possible thank you  mr chairman ranking member deal and members of the committee thank you for the opportunity to testify today my name is elizabeth george vice president of quality regulatory sustainability and product security at philips health care i'm testifying today on behalf of medical imaging and technology alliance my idea where i serve as a member of the board of directors might understands and has a record of supporting the committee's desire to ensure that f d a is well funded and that medical devices imported into the united states are safe for us patients might it is the collective voice of medical imaging equipment manufacturers innovators and product developers who sales comprise more than ninety five percent of the global market medical imaging encompasses x ray c t scans radiation therapy ultrasound pet and m r i our members make the products that detect and treat serious illnesses such as heart disease cancer stroke and osteoporosis the equipment our member companies manufacture and come empowers doctors and medical professionals to view the human body with stunning and ever increasing clarity and accuracy this enables better diagnosis and more effect of medical care for patients often reducing the need for costly medical services and invasive surgical procedures in fact it's not an exaggeration at all to say the term exploratory surgery will become obsolete in medicine due to the power of medical imaging medical imaging industry is a net exporter an economic engine and employs tens of thousands of skilled workers here in the us the research and development that led to the innovative technologies were invented right here in the communities across america as we continue working together to reduce health care spending improve patient care and outcomes might appreciates the support from leadership and members of this committee to protect medical imaging from further medicare reimbursement cuts we understand that there are concerns significant concerns about drug ingredients and food that have been imported from foreign countries however we believe the device industry a highly regulated industry globally is vastly different medical devices are classified into class one two and three based on the level of risk medical imaging devices are classed to our members foreign and domestic the facilities are subject to international quality and safety inspections at least annually as a part of the international standards organization i s o thirteen four eighty five standard this inspection is virtually identical to the f d a quality system regulation inspections meeting the iso thirteen four eighty five standard is a requirement for medical imaging manufacturers in forty seven countries might a believe that the f d a should have veil itself of the valuable information gained from these inspections that are required by every other industrialized nation i'd like to turn to the discussion draft before us today we believe the discussion draft places new unnecessarily regulatory burdens on our products without taking into account the unique nature of how devices are manufactured and extensively regulated for example the draft would require an f d a inspection for nearly every modification of the device might have believed this inspection requirement and duly stalled delivery of improve technology that benefits patients on average each medical imaging device is updated with improved technology once every eighteen months for example a manufacturer may submit a device change to the f d a based on the fact that we can image another part of the body we've updated the software or added new functionality these updates do not warrant a new facility inspection which will halt production of already approved products until an f d a inspector completes a new assessment secondly we are concerned that requiring registration and inspection of component parts may be duplicative and imprudent medical imaging devices are inspected and approved by the f d a as finished products components including screw circuit boards monitors and so forth must work correctly for the device to function properly finally we believe significant new fees are duplicative n n r a necessary last year f d a act the industry agreed to ninety percent increase in user fees in order to provide stability to the agency and ensure that life saving medical devices would proceed to market medical device manufacturers currently pay fees for i inspections as well as for f d a mandated facility registration fees however the draft includes additional annual facility registration and importer fees these new fees unfairly burden domestic medical imaging manufacturers might understands the need to fund the f d a but any fees should be targeted at funding the actual inspection of the foreign facilities in conclusion medical imaging has become integral to best practices across so many disease states and plays a critical role in providing high quality patient care it is critical that patients have access to innovative medical imaging technology to help fight serious illnesses again thank you for the opportunity to testify of today's hearing and i welcome your questions later thank you bailey thank you chairman polonca ranking member deal i'm pleased to be able to testify today on behalf of the personal care products council and to discuss the longstanding safety record of our personal care products companies the council is a leading national trade association representing the global cosmetic and personal care products industry in our six hundred member companies are the manufacturers suppliers and distributors of the vast majority of finished personal care products marketed in the united states we would like to state up front that we appreciate and support the goal of this committee in the cosmetics section in the pending legislation to ensure that f d a has the authority to provide strong oversight so that american consumers can be assured that imported products are safe i also appreciate the opportunity today to provide additional information to the committee on the existing nature of the regulatory framework governing personal care products consumer safety has always been the number one priority of our company under the federal food drug and cosmetic act it is a crime to market an unsafe cosmetic product in the united states cosmetic products imported into the u s are subject to the same stub substantive standards as those produced in the u s and face an even higher regulatory threshold upon entry in that in appearance of adulteration or misbranding may subject them to detention at the border they must be safe  contain no prohibited ingredients in all labeling and packaging must be in compliance with u s regulations in addition all colors must be listed and are pre approved by f d a and in amber of color additives in addition must be pre approved batch tested before they can be added to a personal care product either within the united states or outside in addition if a product is in contains an active ingredient that qualifies it for regulation under our o t c drugs rules they are subjected to the stricter drug review standards that govern drugs in the us what this means mr chairman is that if a product is a sunscreen in and i personally went in a dandruff shampoo toothpaste mouthwash it must go through the pre approval standards of the o t c program in addition any colors added to products must be pre approved so a product as simple as a lipstick will review that has s p f in it will be subject to pre approval standards both for the colors and for the s product safety in a global marketplace is not only a matter of law for our members it is the primary commitment for each of them and for our association for forty years our companies have invested millions of dollars through our trade association in safety programs to enhance the regulatory regulatory responsibilities at f d a including our consumer commitment code the cosmetic ingredient review panel our f d a company registration program the international cosmetic ingredient dictionary our consumer information website in our import safety committee the result of these safety practices and initiatives cosmetics and personal care products are the safest category of products regulated by f this means for example that of the eleven billion individual personal care products sold in the u s each year less than two hundred instances of product adverse events are reported to f d a it means that between the years of two thousand  two thousand and five of the warning letters issued by sistan some fourteen hundred of them related to food and only three related to cosmetics we recognize that ours is now a global industry and that our products and our ingredients are manufactured and source throughout the world we agree with the committee that f d a needs basic information about the safety of products and where and how they are manufactured that's why three years ago when we wrote  consumer commitment code we required member companies signing the code to register their cosmetic facilities with f d a and to report serious and on it unexpected adverse events to f d a we are proud that in the first sixteen months of its implementation eighty percent of all u s annual sales are covered by our board member companies who have certified to the code and are registered with f d a and have agreed to report their adverse events to f d a we're proud that our industry helped craft global manufacturing standards and have worked with international regulatory agencies to encourage each nation to adopt those g m p standards and we have encouraged f d a to issue guidance incorporating iso g m p standards into current practice in the u s the committee in the draft bill challenge us to take the next step exactly how that is done is important we have been working with the bipartisan staff to provide technical details on the draft regulatory provisions and we appreciate the opportunity to continue those discussions we believe the most effective way to enhance cosmetic safety is to provide additional resources to a the budget for f d a for cosmetics in one thousand nine hundred seventy four was two point seven million dollars in real dollar terms that would be fourteen point five million dollars today in reality it was three point five million dollar it was last year before we successfully lobbied for an additional one million dollars in appropriations we are going to continue those efforts and urge the committee to support additional appropriations mr chairman i want to close with a note on the registration and import fees our industry has never been subject to these this is a topic of significant discussion we are continuing discuss we're going to continue to discuss it with the committee but we're going to do more time on that in other issues in conclusion we want to thank the committee for the opportunity to work on this legislation our industry has always put safety first we have always been aware of the necessity to take additional steps whenever that may be and we look forward to discussing with the committee the most effective way to take the next step so that we can continue to assure the american consumer that our products are safe thank you thank you very much this who him loan and ranking member deal thank you for the opportunity to testify my name is jane houlihan i'm vice president for research at the environmental working group or a nonprofit research and advocacy organization based in washington d c we appreciate the interest of the in addressing the regulation of cosmetics for the first time in a long time cosmetics or personal care products are essentially unregulated under the federal food drug and cosmetic act f d a can't require companies to test products and can't review or approve products or ingredients before they're sold f d a can't require product recalls they must go to court to remove misbranded in adulterated products from the market f d a can't require manufacturers to register cosmetic establishments file data on ingredients or report cosmetic related injuries instead they rely on voluntary reporting for this data and in the absence of government authority the same a fee of personal care product ingredients is evaluated through a voluntary industry programs a cosmetic ingredient review this absence of accountability to a responsible government agency has created a culture of ignorance far too little is known about ingredient safety and the  industry maintain that everything is safe even without full knowledge in the committee discussion drafter taking vital steps that we support to close some of these gaps requiring that companies register and report their facilities products ingredients and cosmetic related injuries to the f d a and follow good manufacturing processes we look forward to working with you on additional efforts as well i want to tell you about seven major gaps in cosmetic safety that show why it's important to act first of all the vast majority of ingredients have not been assessed for safety by any publicly accountable body through three decades the c i r has reviewed only eleven percent of ingredients and products and at this pace it will require another two and a half centuries to complete reviews for all ingredients second companies are free to use almost any ingredient they choose in personal care products f d a is prohibited are restricted only nine ingredients in personal care products in contrast two hundred forty four ingredients are restricted in prohibited in japan more than six hundred and canada more than eleven hundred in the e u and a third major gap in cosmetic safety these ingredients can penetrate the skin they can pose health risks particularly for children americans use an average of nine products every day with one hundred twenty six unique ingredients cosmetic ingredients are found in blood urine breastmilk even in breast tumor tissue these ingredients are linked to birth defects allergies thyroid problems and more in children are particularly at risk their skin a standard than an adult their exposures are higher their bodies are more vulnerable the fourth gap in cosmetic safety despite these potential health risks f d a doesn't even know how many ingredients are used in cosmetics they have records of forty one hundred product ingredients we found an additional five thousand in gradients not on record of f d a at all in our survey of products on the market the fifth major gap in cosmetic safety f d a doesn't know where and how many companies making distribute personal care products facility inspections are f d a is primary enforcement tool for overseeing this industry according to g a o and yet the f d a doesn't even know where all these facilities are and they can't mandate registration the six major gaps on cosmetic safety is that f d a doesn't know the extent of health impacts from harmful ingredients and cosmetics companies are required to report adverse events and companies that have experienced major problems may be least likely to report them voluntarily the seventh gap in cosmetic safety consumers right to know is hampered by a lack of standards and labeling loopholes not all ingredients appear on labels like ingredients in fragrance and companies can use terms like natural and hypo allergenic to mean anything or nothing at all more than a third of all children's products marked as natural in fact contain artificial preservatives linked to allergic reactions and nervous system problems we support the committee's discussion draft with mandatory reporting and manufacturing standards but we also support safety standards for cosmetics and authority enforcement authority for f d a this should be brought up to par with f d a has authority over past decides and food and color additives which meet a safety standard under the act because american gradients are found in cord blood they pollute the bodies of almost everyone in the population and they should be as safe as pesticides food and color additives f d a needs the mandate to ensure that ingredients are safe and the authority to demand the study it needs to make this finding thank you very much actually several of you mentioned that you mentioned in your testimony can you elaborate a bit on the c r for example how was the panel determined the conflict of interest considerations how were the conflict of interest considerations made how are decisions disseminated sure thank you mr chairman the panel was set up in one thousand nine hundred seventy six and at that time it was designed to mirror the same standards applied for o t c drug reviews that f d a in fact my understanding it was set up by the industry because f d a did not then have the resources to do it itself the conflict of interest standards are indeed as strict if not stricter nobody on the expert panel can have any tie whatsoever to the industry the panel most or all chair are all chosen by existing panelists the chair when the dr wilmut berg feld is considered the first lady if you will of dermatology and chairs the department of dermatology at the cleveland clinic response from the cosmetic industry in reaction to those restriction recommendations both from the c r as well as the f d a and those ingredients found in products on the market today i'm sorry are those ingredients found on the market today in products that are on the market to y in ingredient that is unsafe mr chairman should not be in any cosmetic product because a company cannot substantiate the safety of it so the ingredients that f d a has found to be unsafe should not be in any product nor should the ones that c dominated by dermatologists who are primarily interested in allergic reactions and irritations with ingredients and that means that a huge wealth of health impacts doesn't get proper consideration by that panel and it's one reason in addition to many others that we feel like the authority for assessing ingredient safety needs to be mandatory needs to belong with f d a so we have a consistent national standard and f d a authority over cosmetic safety did you want anything i would con is growing rapidly i do and we support the provisions in the discussion draft that would make mandatory the registration of facilities in gradients products and adverse effects i think it's a great first step to get f d a that very basic data that it needs to determine the range of unsafe products that might be on the market and to take action with regarding reading and how many ingredients to estimate are currently being used in cosmetic products currently being used by american consumers in other words of those ingredients how many would you say have been tested by f d a or other independent bodies for safety there's no mandatory reporting of ingredients to f d a so it's not known the full range of ingredients that are on the market f d a has estimated twelve thousand five hundred but cosmetic industry officials have estimated it's only between two thousand and four thousand when we surveyed products on the market we found eighty eight hundred unique and gradients it's an open question and that's one reason that mandatory and gradient porting needs to happen so that f d a has an understanding of what's on the market we do know that the estimated twelve thousand five hundred ingredients that f d a thinks are on the market the industry has reviewed only about fourteen hundred eleven percent  in the cosmetic dictionary that we in fact publish not all of those ingredients are used by custom that includes many products by eric can't fifty five hundred ingredients are commonly used in u s products of them some three thousand are ingredients such as botanicals they would not reach the threshold of risk for the full peer reviewed study that leaves twenty five hundred by the end of this year two thousand and eight  reviewed two thousand they are chosen by level of risk and complexity and by use on the common use so that would leave some five hundred that would be of lower risk and c understand it is now reviewing how the best way would be to review those ingredients but they're now reviewing them at the rate of two hundred a year if i if i could add the issue of how many ingredients and what's commonly in use is also a reflection of the database problem that f d a has because until two thousand and five all of these files were made by paper and they have yet been able to to complete the transfer of the paper filings into their new electronic system ok i had a medical device question but let me let us hear from the other two members and then we'll see if we have time mr deal i'll try to go quickly i'll do the  same going down the list of all of you there are do any of you disagree with the proposition that f d a needs greater resources in order to carry out the responsibilities that currently have and would particularly need more resources if they were given the responsibilities under this proposed legislation anybody disagree with the concept that they need more money or not let me go down the list though what should be the source of that revenue should it be further appropriations back congress or should it be user fees or some combination thereof mr you will i'll start with you we believe inspections are core function the agency and as a result should be funded by appropriated dollars in addition i think f d a is risk based approach together with greater reliance or leveraging of the iso standard that's been discussed is our preferred approach for addressing a legitimate gap that's been raised as a result of primarily appropriation to come or we agree appropriations of the way to do it we feel that user fees have the risk of undermining a very essential element and regulatory and that is fiscal restraint when there's no fiscal restraint the regulatory prioritization is much more difficult to do and another misguided some combination of appropriations and user fees with conflict of interest protections would be passed in our judgment i think one of the first ways better would be to leverage all of the iso certificate reports that we're already paying for as an industry and get annually and that would be a significant amount of information and data to the f d a to help them make that risk determination and determine whether they need to do further inspections of us and i have pointed out we have a long way to go on the federal side of consent that it be admitted for the record without objection so let me go back to the proposition that several of you looted to and ask questions about now size so first of all i understand there are forty seven countries and china is not one of them as i understand those forty seven countries that already require are each of you to comply with i associate anders assume that they in many instances if you are exporting they send inspectors to your facilities here in the united states and charge fees associated with that is that true yes yes yes yes all right how do we harmonize what f d a is trying to do with what i s o regulations are already doing that would be very helpful that seems to me to be a great way of saving a lot of mud any on both sides of the ocean so to speak  in terms of what it cost to get products to the consumer now ms george your country your company has a lot of experience with dealing with this and you indicated that you participate in the i s o standard making process is that correct yes we do we have members that are on the committees that actually help define those as well as our members are on the global harmonization task force along with the f d a as well as other country members it is also participating in that process already yes they are all right i would just hope that all of us would work toward trying to achieve this purpose i think it would save a lot of money the other last thing i want to make mention of  that is am i pronouncing correctly you indicated that you felt like that everybody ought to be inspected at least once every two years if there are eleven thousand of those and i don't think that even includes what this bill would contemplate on component manufacturers that will be added to that list is that a realistic thing that we can achieve or is it just pie in this god i think we could inspect them all within a two year period something that is in my written testimony but for time purposes i could not fit in my o testimony we recognize that there are a lot of differing devices out there a lot of things are classified as devices we would support an approach that differentiates between say tongue depressors and how often those facilities are inspected versus say you know cardiac pacemakers we recognize that there is a difference in the risk level don't know if i would go as far as saying a risk assessment basis but we recognize the differences in different types of device says ok my time's up i was told you said something like billions i mean the there's a lot i use a lot of myself and and you said that of that number only two hundred adverse events were reported for so where would they be report your i'm talking about two f d a and this is a number that's remained fairly consistent over a number of years do you really think that that's the extent of adverse facts do you think it's representative of a true number we do because in fact adverse events are very rare with these products because they are inherently safe and let me also point out that t c cosmetics for example we that have an active ingredient are regulated it's over the counter drugs are and those adverse event reactions would be reported to the drug side of s d a on a mandatory well i mean none of the research anybody else want to comment on that that the two hundred represents in fact a reasonable assessment of adverse reactions so i can't thank you representative it's an absolute underestimate because adverse event reporting is not mandatory and the g a o found that companies that experience the most serious effects from their products may be disinclined to report  voluntarily and until we have mandatory reporting we won't see the full scope i'll just give you one example is that fragrance and personal care products is considered one of the top allergens in the world and we're certainly not seeing all of their chick reactions to fragrance  personal care products reported to f t s database yeah i really would caution against using that number i mean just even when there are adverse effects so few people actually on the reporting at all but are you israeli of any studies that have been done on the lifetime of facts of your company's products do we know how safe it is to use any one personal care product over the course of a person's life every single day in fact companies are obligated to substantiate the safety of individual ingredients and the safety of the product before it is marketed in those assessments taken to a can't the knowledge that these products are used in combination with other products and may be used over industry you're only eleven percent of the ingredients or one thousand four hundred out of the twelve thousand five hundred and you go on to say that at this pace it will require two and a half centuries  review all the products assuming nothing new is it is introduced so what can we do to reduce this timeframe of two and a half centuries for reviewing the safety of these ingredients well clearly one thing we need is a consistent safety standard in the law that would mandate pre market safety testing of cosmetic ingredients and products before they go on the market and that testing could be done by manufacturers it should be public it should be reviewed by f and with so many ingredients on the market one thing that can be considered is a prioritization system that would target first ingredients that might pose the highest risk that would cross the placenta would be a risk to develop children that are known or suspected hazardous chemicals but we certainly need to see the pace picked up to have an assurance that products on the market are safe and i wonder if anybody wants to comment on this the e u the european union has required cosmetics companies true move reproductive toxins mutagens and carcinogens from personal care products and now bans eleven hundred chemicals from the personal care products due to serious adverse affects cancer birth defects reproductive problems and just nine chemicals not nine hundred or ninety year but nine chemicals are banned from cosmetics in the united states how do we account for this difference and does that mean that women in the united personal care products consumers are at risk in the united states why have the you banned eleven hundred and we only nine how do we explain that well in fact the list of chemicals that you're referring to includes many ingredients that aren't even used in cosmetics either in europe or in the u s the reality is in the u s and europe there is the same principle that a company must substantiate the safety of its product be substantiated for safety it cannot be included in a finished product an f d a has the authority to ban certain ingredients any time it wants to it has a list the c findings are peer reviewed published peer reviewed journals and there is a substantial body of science in the us behind every ingredient that is included in a finished product but how do we get that big for instance i may want to speak to the i mean it would seem like even even if we don't use all those that it's not explained sufficiently what's happened in the us is that for the past three decades we've had a voluntary industry system for evaluating ingredient safety and f d a has stepped back and let that be the defacto safety standard in the us and one of the major problems is yes there's a requirement in the law that ingredients in products be substantiated for safety but there is no definition our guidance that f d a has provided to industry for what that means and so when we look at angry ends that are on the market here in the u s we see one in five products containing gradients and chemicals linked to cancer we see sixty percent of all products contain estrogenic chemicals that can cause hormone problems we find lead contamination in let's stick and cancer causing impurities in baby products and in natural products so companies are making distant the different decisions about what's safe enough to sell because they don't have f d a guidance on the issue thank you my time is more than expired thank you thank you and the bells have rung for our vote so i guess we just finished up in time to go to the floor and i just wanted to thank all of you again as you know and i said before we are a discussion draft and it's still a work in progress and so you know we may very well get back to you with additional questions or comments as we move forward to markup if we get additional questions to be submitted in writing will be submitted within the next ten days and then we'll get back to you so that you can hopefully answer them but thank you again this is a very important issue in this concludes our third and final hearing on on the discussion draft and without objection