they behave in ways that will significantly reduce the ability to crush and inhale or liquefy for injection these products and we need to see it scientifically in the laboratory context and also in terms of actual clinical experience. >> we want to be sure the same standards are applied to generics and others has was applied to of the content. >> absolutely. >> i'm sure you agree with that. >> it is very important that just because the company claims it is abused deterrent doesn't mean it is. it is in everybody's best interests that we try to have standards so that we can really achieve the goal. we don't want the standards to

be so high that nobody can actually need them. we want to in some demise industry to work on these products. >> you are doing good work in this regard because the centers for disease control calls disease abuse epidemic ended is killing more people than car wrecks, especially young people. so your decision will save lives. let me ask you about rescheduling hydro could own combination drugs. in late january the fda drug safety and risk-management advisor recommit the voted to tighten restrictions for prescribing these combination drugs, you don't have to follow their recommendation but i'm trying to figure out whether or not you will.

i hope you do. emergency room visits involving hydro co don't rose from 38,000 in 2004 to 115,000 in 2010. these drugs are often taken in combination with other drugs and/or alcohol, the most popular being called the holy trinity, combination of hydro cogon with a sedative and muscle relaxant. the current schedule for reclassification for hydro could don't project a false sense among some patients and doctors that they are less potent or less habit forming and less dangerous than paco own

painkillers, prescriptions for reschedule can't be called in. you need to see a doctor to get a new prescription after 90 days, no automatic refill. as a result, almost every painkiller is considered a schedule 2 drug for carefully regulated. the most abused narcotics, hydro code known, is missing from that list. we have made -- i am wondering when you will decide this issue and where you think it is going. >> it is an ongoing process. we have an advisory committee sox and important information is discussed and they made a recommendation to us.

we are looking at the information presented in that committee and other information that has come from a range of stakeholders with different perfection on this issue trying to address the importance of the issue of balance of access to critical medicines for legitimate medical needs and potential as you know for abuse and misuse, we will be making recommendations soon. i can release speak to the direction that we are going with specifics of timing but i can assure you that when a decision is made as i did with other abuse deterrent issues i will reach out to you. >> i thank you and i thank you for reaching out to me. mr. chairman, on the matter of labeling of the narcotics which

up until now is moderate to severe pain has misled doctors and patients and is not as addictive drug, we have been pleading with the fda for ten years to restrict the labeling of foxy, the drugs to just severe pain which it was intended in the first place, it is a great drug for people who have horrible pain, terminally ill patients but it has been thrown out for a tow aches and toothaches and everything else. not misleading people that it is difficult to kick as it really is. can you tell me when we might get some sort of indication what they have on changing the labeling to strike moderates?

>> as you know, we are in a process of consideration of these important issues and what is the appropriate management of acute and chronic pain with respect to this class of drugs and had a public meeting to hear presentations and get public comment on these issues, we are reviewing that we take the issue very seriously, we believe fda labeling, indications of use is an important comment of a multifaceted strategy to address this critical lander urgent public health problem and we are actively engaged. i want to commend you for the leadership you have taken on this issue and the this in terms of making sure adequate

attention is paid and there's a sense of urgency. we do feel that and working hard to address it in that meaningful, scientifically based way. >> it should be of very difficult decision. i can imagine why we would want to keep moderate pain labeling for such a dangerous drug that is proven a killer around the country. congressman frank wolf and i ten years ago came up to the fda about this very issue removing from the label which invites doctors and patients to use it for less than severe pain and nothing happened. that was ten years ago. we have been sort of the lone

wolf out there in the forest crying for help but now we have some help. we are not alone anymore. as soon as it is submitted to the fda this summer, clinicians, researchers, health officials call of them asking fda to change the way these narcotics may be prescribed. they argue with the proper labels on prescription painkillers physicians would be more aware of the safety concerns and effectiveness of certain of peaceful foreign necessarily prescribing highly addictive narcotics for pain. so there's a growing consensus to do this and do it now. >> we heard you in your concerns and take them very seriously and though the mother stakeholders as well. we have taken steps with respect to some aspects of labeling of

opioids, the rim that was applied to the class of of the drugs, voluntary requirements, part of that on physician education which is absolutely key. we are hoping there will be legislation that will manage part of the licensing for physicians who use these products because they are so powerful treatments when indicated but also potential for abuse and we will be coming forward with a specific response to your question very soon. >> thank you for being here. >> we are joined by the ranking member of the appropriations committee and i will recognize you for any opening statement any questions you might have at this time. >> thank you, mr. chairman, welcome. we are fortunate to have a person of your caliber in this

position, thank you very much. this week there has been a lot of attention paid to the damaging effects of the sequester and the faa and commercial air travel. flight delays are an inconvenience and represent real economic losses to individuals, families and businesses in new york and across the country but we can't ignore the real dangerous effects of the sequester in other areas of the budget especially when they have a profound consequences for public health. from frozen tv dinners to medical countermeasures to addressing nuclear threats to new drugs to treat major causes of death by cancer and heart disease the american people rely on fda and its expertise, review and approve products they use every single day. the repercussions of congressional inaction are clear that the fda. the agency will undertake 2100

fewer inspections which is at an 18% decline compared to last year. the implementation of the 2011 food safety modernization act will be further delayed meaning we can continue to expect an estimated cost of $75 billion annually in lost productivity and medical expenses and new drugs that reduce pain and sustain life will take longer to review and approve robbing 6 americans of improved quality of life and more time with the loved ones, by cutting services and decreasing investments critical to our economic competitiveness fees across the board budget cuts having a severe impact across all sectors of the economy. we must replace reckless, indiscriminate cuts with a renewed focus on jobs, economic growth and a balanced fiscal package that creates long-term deficit reduction.

i just want to say i look forward to a day soon when chairman rogers and i can work together in a bipartisan way and really address serious issues as a result of sequestration, bring about regular order into a budget that makes sense to the american people. we know that the discretionary budget for is at its lowest level in the last 45 years as a percentage of gdp. i made my message clear. let me ask you a few questions. first of all, millions of americans with clinton tolerance have been waiting for the fda to finalize the standards for gluten free labeling. it took five years to get bipartisan support to put labels on food which is food allergies. in 2004 the food halogen

labeling and consumer protection act that i offered became law. one of the provisions requiring the fda to created gluten free labeling standard by august of 2008, nearly five years past the deadline and nine years since the law was signed, i am still waiting for the administration to finalize the rules. i know the rulemaking process is complicated. fda must work with omb and others but when will rule be finalized which will give those people the peace of mind the food they purchase are truly clinton free? no matter who i speak to everyone seems to be going on a gluten free diet. it would be really helpful if we could be assured that it is gluten free? >> it is an important development and turns out as we learn more about celiac disease

and broader nutritional concerns that a gluten free diet is benefiting more and more americans and it is critical that people have that information about the nature of their products and i had hoped i might have been able at a hearing at this moment in time to be able to fa speak to the rule actually having been issued. it is in the final stages of administrative review and i do leave that you will see it soon. >> i promised congressman rogers on another matter, the first call i make will be to you. >> release 4. another area i have been concerned with is we all have a drug compounds. this safety of products sold by compound pharmacies following last year after deadly meningitis outbreak is a serious

concern. in an effort to crack down on unsafe facilities the fda has recently conducted a number of inspections of these pharmacies. could you share with us your findings? >> we did recently undertake a fairly aggressive effort to about 31 surveillance inspections of facilities that we consider potentially high risk because they were making sterile, injecting will products and we knew about them either because of past from rooms, states telling us they thought they could be on the high-risk list or in some cases what we learned from the public and the media. and we also did another such of inspections in relation to reports of actual concern about products. i would have to say those

inspections were very concerning because we did find real stability concerns at many of the sites. underscore these are facilities that are not required register with the fda because they are, pounding pharmacies so they are not routinely inspected by us but when we went in and looked at the standards for sterile processing there were very real reasons for concern. we actually under took a number of recalls of products the we thought represented a more imminent risk and we certainly believe that underscore is the importance of a stronger, clearer regulatory and legal framework for oversight of these kinds of facilities and also really striking that even in light of recent events we had real trouble with the number of these inspections going in, having our authority questioned, in two cases we had to go to the

courts to get at the history of warrants and have access to the records pleaded to assess what they were making and their business practices and really understand the risk, so we have indicated a very serious and urgent desire to work with congress, to create new, stronger, clearer legislation to provide the oversight of these facilities that the american people deserve and expect. >> i certainly hope we can continue to work together to resolve this huge shallow image. i have been told in talking with some people since last year's deadly out for a, reports of additional inspections, cases of reported blindness, loss of the

i associated with off label treatments, macular degeneration so as a clinician i would assume you would agree that certain areas of the body such as the eye, the brain, this fire mccollum are least able to defend against infections and any package will compound products which are injected into these areas. if they have compromised sterility, a higher likelihood of resulting, causing injury or even death, so i would hope and i will conclude, mr. chairman that the fda would consider prioritizing its oversight while we are working on regulations and enforcement activities to focus on those repackaged products that pose the most significant risk to patients based on risk factors and would

all patients benefit from a single quality standard relating to sterile in injectables? >> we definitely believe that there needs to be clear, explicit standards for sterile practices in a uniform way. in terms of fda regulatory oversight we think we can provide the greatest benefit in terms of where the risks are 5 really addressing as you know sterile injectable products, those facilities that are making sterile injectables in advance without a prescription and selling across state lines, we think represent the category that presents the highest risk to the american public so we think clearly any sterile products should be made in accordance with sterile procedures. >> it seems so obvious to me that this is such a huge issue

out there and is costing people their eyes, in some cases their life. thank you very much. >> thank you, mr. chairman, thanks for being here today. we had a discussion how to properly handle the sequester and budget reductions you are facing. interesting to note the federal government continues to grow. pretty significant rates this year. more tax dollars than at any time in history yet we are still running record deficits. so i think we all know as you endeavor to figure out how to do more with less you're getting greater and greater requirements put upon you based upon implementation of the obama health care bill, a new law passed by congress, those are additional requirements that you didn't have some time ago. that is what the private sector

had to deal with. i know you get that but in context, think about how we have to handle these reductions, promote the american people, they had to do a bunch more than this, they had hours cut and salaries cut. i talked to constituent about having her hours cuts because her employer doesn't want her to have over 30 hours to qualify for the health care bill. huge problems in the economy some of which have been created by policies pursued by congress over the past years that increase mandates on businesses, increase the cost of doing business and i want to talk about some particular set have a few questions for you. one of the impact on the economy is $1 trillion in taxes, the health care law, if those burdens weren't enough, we now have federal food labeling mandates which you're engaged in a local grocers and storeowners.

and those are bed for the economy, job creation and the cost of doing business so one of the mandates was to try to help those requirements coming from the health care law, affordable way to be implemented to. where are we on the labeling requirements. are we working hand-in-hand with grocers and convenience store owners to make sure these health care mandates are required by law to come down the pike and costs beneficial and responsible and do we know what the impact is in terms of the office of what they have to pay? >> the health care reform act did include many labeling, for change of 20 or more when there are 20 or more by the same motor and we have been doing rulemaking on that and it has

been an extended process, and we are now working the through all the comments we have gotten in that process to put forward the final rule. one of the challenges to the franc has been defining what is a restaurant like establishment? what arrest drug is seen as very straightforward and i initially thought implementing this was going to be one of the easier tasks but it has been enormously complicated and the issues about convenience stores, box stores, movie theaters, different kinds of facilities that still prepared foods have all been part of the discussion and we attempted to look at the public health impact and economic analyses and requirements for implementation, trying not to

make excessively burdensome, but one that will have meaning and reflect on the legislation so we will be by the end of the calendar year putting out the final rule on new labeling. >> do we know what the cost of compliance is up to $1 billion on groceries and convenience stores? does your agency have an idea what this will come up for small business understand how can this reduce cost? >> there are very estimates as people have thought about different models for how the condors might be defined in terms of the broad array of restaurants like establishments. the final determinations have not been made in terms of which kinds of facilities will be and which won't be but we are looking at economic analyses as

well as public health implications for with respect to the overall consideration of -- >> since the question about user fees for this. when those fees are sequestered to those fees go back to the same entity or are they allowed to be spent at a later date by the fda? is there it a delay in expenditures or is it a cut and if it is a cut then do the fees the back to paying entities? >> that is a question that is still being resolved at higher levels than i. the user fees are being subject to the same levels of cuts as budget authority dollars. those fees cecil being collected from industry but they are not going to support the fda programs that were negotiated with industry as part of the collection of those user fees.

do you want to speak? >> the only other thing i would have to add is fda and user fees regarding sequestration, the understanding that those dollars are held basically in fda's account, the only way they have the authority to spend them with the if they appropriate them. >> the money is still there, cutting the delay in spending and congress gave them permission. >> i don't know that for sure. >> mr. laurel. >> thank you, welcome, thank you for the great job that you do with in the navy portfolio which includes food, drugs, devices, tobacco. it really is extraordinary and to that i want to make a note about user fees if i can quickly to get to my question. fda budget without user fees is

$2.5 trillion for 2013, contracts, request for nasa is $17 billion for 2014. move back to 2013, $2.3 billion, nasa got $17 billion, 7.3 times larger than the fda. review the portfolio of this agency and what it does. we are not talking about hardware, we are not talking about, talking about life and death at the food and drug demonstration. if we are serious, let us provide the fda with the budget authority that it needs commensurate with the job that it does and let's start in fact putting our money and dollars where our mouths are. i would rather have budget authority than user fees any day of the weekend and willing to vote to give this agency the money it needs to get there. before i start i am glad to hear

is that the fda has moved forward on reclassifying tanning beds to their appropriate risk category and long overdue. we will wait to see where we are. i hope to see if -- i often the new labeling rules and it became part of the ac a and it was to include movie theaters, chains, talking about chains, chain grocery stores and all similar retailer establishments. at just want you to go and this is about those who claim they are not in the food business. i take pictures when i go. chicken tenders, chicken tender, though, hot dogs and fries, mozzarella sticks and funnel cake. we are not talking popcorn and soda at any longer at movie theaters. we are talking about a k hat,

special bytes, go to the movie theater, take pictures and find out what the movie theaters are in these days. this is a key part of their marketing. they ought to be required to label in the same way the restaurant association agrees, and we work closely with the restaurant association to put the calories on the board. let me talk about -- i want to ask -- the trade agreement, those negotiations that are underway. some segments of the food industry are strongly advocating for binding dispute resolution. what are your perspectives to making the provision subject to binding dispute settlement? >> as you know these are ongoing discussions that involve very

important issues. we are a partner across government in these discussions with our role is obviously to make sure important issues of public health and public safety are adequately addressed in the agreements that are ultimately reach. we do think there's a very clear role for incorporating technical consultation of cooperation if as part of dispute resolution mechanism. our concern is we want decisions about the safety of imported products, the appropriateness of bringing certain products in for the american people, that those questions are adjudicated with of the right subject matter, based on the best possible science and knowledge about public health and medical implications so i think the

issue of whether it is a binding dispute mechanism if we would never want to be locked into a situation where the best subject and expertise necessary to best serve the health of the american people and one needs to think through, what are the unintended consequences of various approaches that can be undertaken? >> there's a danger in my view about the integrity of the standards that are imperative to consumers for. the substance ranging from the inspection process to microbiological standards are zero tolerance for the most dangerous pathogens can be put

in harm's way if we move in this direction. i will continue to follow this with you and i am hopeful and that another point i want to know about your seat at the table in those trade negotiations and the weight of your felice in that effort. thank you, mr. chair. >> let me just say we're going to stay as close as possible, at this time i want to recognize mr. validere. >> hispanic women can have permanently disabling birth defect, 70% of these can be prevented if women of childbearing age had adequate levels of b vitamin. before end in early pregnancy. for over a decade our nation has mandated folic acid be added to

cereal graiproducts. this does not include a staple of many hispanic women's diets. scientists and if the petition was filed with the fda over a year ago the proposal to allow the addition of folic acid to products like corn and tortilla. what is the status of fda's review of this position and does little ridge you to a short expedient and reasonable review the petition and be mindful that these things continue to occur while the fda delivery to the >> this is an important public health issue and i have been briefed on it and where of it. i am not up to speed on the timing of the review and define a i would like to get back to you with information on that but it is certainly an issue that is on our radar screen and being worked on and i will give you more specific information if i

may. >> thank you. >> thank you very much for being with us here today, fascinating to hear the wide-ranging level of information you have to cover and there's a tremendous responsibility that rests with your organization so thank you for your hard work. i hear about the fda from my constituents in a variety of ways and want to take on one of the issues you talk about which is the food safety modernization act and the implementation you are going through. i want to start by saying we all want our food to be safe and every day we hear about a concern people have in making sure our food is safe. i represent a lot of farmers and small farmers and i know i can say i never met a farmer who does not take very seriously the responsibility to produce good, safe food for consumers. i want to commend my colleague who works carefully to produce a

bill that produce ensur food safety for consumers. from the consumer side she has been working extremely hard as so many members of congress have. during the debate on the food safety modernization act congress had a healthy discussion about 1-size-fits-all regulation and how best to assess where risk actually comes from. i was in courage in the senate hearings, reminding everyone he had included a provision, final food safety bill that works for making regulations more workable for small and mid-size farms involved in low risk supply chains and while i am encouraged that that is in there i remain very concerned about the impact of the final rules on diversified small food producers. and fortunately for my first four years in congress i have heard almost nothing from the farmers in my district the fear, frustration, confusion about how the food safety rules are going to be implemented. they want to know how the rules

will impact them and how they will fit into the system. they're very concerned about the cost and administrative burden that will put on them and whether they will be able to stay in business. i have often talked frequently from this committee about the growing role of local food and agriculture and how people are very interested in buying food from small retail outlets, local foods, farmers markets, i want to make sure and i know you have a lot of work left to do and this is kind of long but it is the deep concern of mine. want to make sure you are looking at diversified operations, that you have those farmers in mind who worked to improve and scaling regulation to the size of the farm and the amount of risk. the fact the difference supply chains go to different levels of risk in the food supply must be part of the guiding principles the fda works with. i don't think we want something that looks like a repeat of what happened with the meat processing rule long time ago which had the unintended

consequence of shutting down hundreds of small processors of meat processors because they could no longer afford to do business. in my opinion hasn't provided the consumer with all say for all perfect food. some of the fda estimates have said the cost to comply with this proposed truce pull for farms of less than $250,000 of annual revenue face $22,000 in compliance costs. for many farmers who are just getting a start or starting to grow, small farmers in my district, that their profit for the year. i hope you are looking carefully at how these rules will be imposed, really understanding the aggregation of, the the par with the agriculture on the one hand is promoting and finding great success in making sure as you look at how these are implemented that there isn't an onerous burden and it makes our food safer but doesn't cut off the small, medium-sized farmers. >> i could give you a very quick

answer to a very important question which is we are very mindful, we take this very seriously, we tried as we were shaping the proposed rules to do a lot about reach, meet with the divers from our community and go on too many of these different kinds of farms to get a better understanding of their issues and concerns. the original food safety modernization act did have an amendment that excluded certain size farms and was limited distribution areas altogether but as we think about the rules going forward and as we get feedback on the proposed rules that are out there, we are very much recognizing this set of issues. no matter who is growing the food at the end of the day everybody wants a food but we do need to recognize the approaches

need to be tailored to the unique and differing needs including the approaches and phase in to and able and support farmers who are trying to make a living and trying to produce safe, high-quality food. >> thank you very much. i am out of time but i just want to say i am looking forward to working closely with the fda. this is an issue the have heard as much about anything from farmers and food processors and i hope we can continue to have a conversation. >> thank you, mr. chairman, thank you for appearing today. is our imported food safe? >> we're very fortunate to have one of the safest food supplies in the world. as the world has become more

globalized the volume of imported food has increased dramatically and many of the foods that are being imported into this country are coming from places with much less sophisticated regulatory oversight and our commodities that are vulnerable, intrinsically. and i did see a survey recently that showed that 61% of the american people are very concerned about the safety of imported food and it is a concern that i share and we are making aggressive efforts to respond to the growing volume of food safety imports, doing it in the number of different ways but we feel we have to strengthen oversight of these products in order to assure is that the food americans get in the grocery store and in other settings is

as safe as it can possibly be whether it comes from an imported source or domestic source. >> interesting article in the new york times last year talking about how there's a significant lack of business ethics and distrust among chinese people of their own food supply. i don't know what the percentage of food we import comes from china on medical devices. another category that you have pointed out that 80% of it comes from china or india so i don't know how that correlates to food imports but i assume it is a significant percentage and 80% of our seafood is coming from overseas. i don't know how that correlates to china but the larger generality here is given the

aggressive expansion of food imports there is reason to be concerned. >> we are very focused on a set of critical products and our working relationship with critical regions of the world that are importing products to us. china is the major partner in our efforts to improve food safety. >> would you unpack that statement and explain what that means? >> it means we get a large volume of products, food and medical products from china including active pharmaceutical ingredients and drugs used here. it means we do need to really have a robust regulatory framework to address concerns, both known, existing concerns and also ones we can anticipate in the future.

we now have three offices in china, beijing, shanghai, dissent in our ability to be on the ground working with industry and regulators in china at and doing more inspections. >> what do we inspect? >> the percentage of facilities overseas that we are able to actually inspected is not very large. i don't know what the number is. we are doing many more for an inspection that we have ever done in the past but we are not going to be able to inspect our way out of the realities of the modern world and the challenges we face. we also have to put in place new systems that involve cooperative arrangements with regulatory authorities, more sharing of information, sharing of the workload in terms of inspections. we need more sophisticated screening methodologies that are based on risk and we need industry to work with us to put in place the kinds of supply

chain protections. >> time is running short. sorry to interrupt. the american taxpayer subsidized the inspection of food imports? what is the mechanism here by which those are paid for? >> our inspection program whether it is domestic or imported comes out of our budget, we in this budget are asking user fees to help to support some of our important imports oversight activities and inspections activities but yes, our activities, whether domestic or international for food safety come from our available budget. >> thank you. >> thank you very much. mr. chairman, thank you very much, dr. hamburg, for being here with your team. i have some questions i would like to explore with regards to

livestock and poultry. i have consistently tried to look out for industry as well as the consumer and try to balance went comes regulation and my analysis is regulation should be based in sound science, receptive to cost-benefit analysis and make common sense. and i appreciate very much as the committee does the fda's efforts to examine the sale status of antibiotics. they you are collecting is flawed because of two things. one is that the data include antibiotics that may be used on non livestock species and also the data includes tracking of this given the mode of action is

extremely different from that of antibiotics and to the best of my knowledge, it does not pose any risk to humans, why does the fda still specify and a force as antibiotics? i ask my second question as we're running short on time, the fact that you monitor and time marco rubio resistance and keep track of trends in the grocery store and on the farm, we heard the program is undergoing changes. i would like for you to share with us why the program is being changed and what you are proposing and particularly what changes with regard to the farm. >> you asked a lot of questions embedded in one on very

important public health issues. the problem of antibiotic resistance for humans and animals is a very serious one and we need to protect our ability to have antibiotics that really work against important infections. the use of antibiotics in animal populations fuse on major contributor to the resistance we have seen evolve over as the years and we are making concerted efforts to understand the nature and scope of the problem and to address that importantly we're taking actions to really achieve judicious use of the antibiotics that we have in animal and human populations but with respect to animal husbandry to make short antibiotics are not appropriately used for growth promotion but are used to treat

infections. >> i appreciate that very much. >> we do feel that our system is very important. >> before you get to that system, and of forbes are different from antibiotics and from my understanding not proven to contribute to any resistance in humans. >> i can give you the best possible answer if we get back to you, part of the record because i am not directly familiar with the data on ionaforbes. >> when you do get that make sure it is based on sound science. >> i will do my best. that is a guiding principle. but we are looking at it, we are trying to get in put from the public and stakeholders about how we could really affect some

enhancements to our data collection systeto better inform our decisionmaking and make sure we have good solid data. >> thank you for that answer but i was struck to find out appears the fda is categorizing its antibiotics, and ionaforbes which have a different way of working in terms of being mixed with feed or livestock and poultry and of course is that again as proposed regulation, understand you are looking at the anti resistance developments, could have a great impact on the meat industry, the poultry industry as it is processed and grow the food that we each. it has got to be balanced but when you regulate, make sure it

is based on sound science, subjected to cost-benefit analysis and makes good common sense. thank you. >> thank you for being here. there were questions about the user fees, analysis of pharmaceuticals. the users are still paying the fees but some of them are being set aside in some suspense accounts that are not being used to evaluate the drug's. is that right? >> this is not an fda policy, this is a decision or determination based on the way in which the user fee dollars

are appropriated, that they are treated like budget authority dollars. in terms of the impact on fda, the user fees are collected from the user fees renegotiated from those fees. they are not available as they stand of the user fee programs. and access to some of the user fees, and at the same but the authorities with respect to sequester. >> what effect on improving life-saving drugs is this suspense account sitting on the side of money? >> we are going to try to do as much as we can to achieve the roles of user fee programs.

however, dollar amounts of the user fee agreements reflect a careful calculation of what were the critical needs, what did take to achieve them and when those dollars were cut, it means we are not going to be able to fool the achieve the goals and performance targets that were set in conjunction with the user fee process. we are worried will slow operability to put out important guidance and review applications that come before us to do a set of important new hires, stand up new programs and expand others to improve business processes and make regulatory pathways

more effective and efficient and importantly to do the work for new regulatory tools that would make the regulatory system really appropriate for the sophistication of coming before us. the other thing is we know that the system works better when we can work more closely with sponsors of the product to identify what kind of data is going to be needed, studies that will be most important for them to do, and have ongoing communication and this will limit the flexibility to engage in this activity. >> you said this is not fda's making. this was made at a higher level than i. who made the decision?

i might turn to my colleagues in the department of health and human services, a budget expert but i believe -- >> the implementation of execution of the sequester government-wide, led by the office of management and budget so the council is determined what the appropriate application of that sequester would be for user fees in this fiscal year. >> the office of management and budget made the decision to take money that has already been made, set it aside, not do anything with it at your testimony is that it is slowing the approval of potentially life-saving drugs. >> my testimony is we are concerned that the user fees were negotiated at specified with respect to program activities and what they would cost to achieve and if there are cuts to the available dollars it

will likely have meaningful impact. >> this isn't an elective but their determination of the subject. >> thank you, mr. chair. we are approaching a vote and in consideration that we have a series of votes and will be on the floor for some time so i don't anticipate going back and forth 30 to 40 minutes of we're going to wrap up. we do, several of us have questions we want to submit for the record but we would ask to go ahead and the daring some that you are not left to consolida our schedule as well. >> reporter: i appreciate your indulgence. just for the record, with the

compound and drugs and medical projects, i would very much like to have -- get back to me directly to my office about the authorities that you need, specific authority that you need in order to address this issue. i am asking to take a look get the state legislation introduced in this area to tell us whether or not it helps to meet your concerns and how we can mitigate against what has happened. food safety, gdp is investigating an outbreak of salmonella in 18 states associated with it -- imported cucumbers. fda is not going to -- only 1200

planned inspections, 2016, 19,000 for the facility. and for domestic and foreign infections, will they need more inspectors? when do they need to be hired? it helps to meet the requirement and once i would like, and i would like you to submit for the record also directly to the office a detailed breakdown of personnel noting the number of personnel for domestic inspections and the number of international inspections. >> quick question, and answer to your question. we did meet the targets, the numbers as you know in the legislation ramp up, as we think about the real world that we

live and, and other important activities as part of the overall programs, and in the food safety modernization act, information sharing and other countries doing training, technical assistance, foreign suppliers verification program, third party audit could be very important as well to our overall programs that affect food safety and also the new rules, produce safety and senate controls will apply with the you are domestic or foreign manufacturers or grower so there are a number of things beyond inspections alone that will help to strengthen the security supply chain and food

imports. >> i would only add that in fact if there is going to be a trend of pacific partnership agreements that the influx of imported seafood from vietnam, from thailand and malaysia will be extraordinary. my colleague mr. thornberry pointed out 80% of our sea food is imported conlan and we know now the rate of contamination and import alerts that have occurred. that will make your job harder. we need to know on this committee what is required to ensure public health of this country, domestically, internationally, and how overwhelmed york agency may be if this committee doesn't do something about the resources that it supplies. thank you very much. >> this will wrap up our last annual hearing for the budget, i

want to thank staff on both sides of the aisle for their work in this hearing process and thank you for being here and look forward to working with you. thank you. .pulling ..