does the f.d.a. encounter adverse events with o.t.c. medicines? dr. woodcock: i would say fairly frequently. to rise to a serious level, maybe once every several years. mr. butterfield: frequently or infrequently? dr. woodcock: fairly frequently. given what they are and the exposure of the population to them but once perhaps every two years we're facing an issue that we would like to get out rapidly to the public to notify them and our hands are really tied and we have to use this guidance process. mr. butterfield: all right. two other examples you highlighted in your written testimony related to pediatric issues with certain medicines. would you say that a dispr portionate number of safety concerns with o.t.c. medicines are related to pediatrics? dr. woodcock: i would say in the last decade that is true, a decade or so, and the reason is starting in the late 1990's i think everyone became aware that you should study children and not just treat them as tiny adults and just scale down the medicines. and so with that realization came the realization that children may be being harmed because back in the 1970's, the doses for children were just scaled down adult doses. and so we have been going on a whole campaign, as you know, under bbci and pria to study children. with drugs. here it's going back and looking at these medicines, particularly, say, the cough and cold and some of the other medicines and saying really, is this appropriate for children and what do we need to do about this? mr. butterfield: can you can you provide any examples of safety improvements that have been made to existing monographs and how long those changes have taken to be implemented? i know we touched on that rlier, but can you illuminate? dr. woodcock: let me consult with my colleague. well, most recently it took seven years for us to get the iver warnings on asit minute fin. it's the number one cost of number one drug induced liver failure in the united states. when we strengthened the warnings on acetaminophen we were able to rapidly do the n.d.a. acetaminophen and change those warnings very fast. in contrast it took us seven years. of course, for the monograph and of course a lot of the acetaminophen use is monograph use. mr. butterfield: and finally, how do you envision the mechanism for rapidly responding to urgent safety issues? how do you envision that working? dr. woodcock: we envision that we could have interim final order that could be issued very rapidly. all right. and that order would be in place and therefore manufacturers would have to conform to it so they would have whatever labeling statement they had to put on but subsequent issuing that interim final order, there would be an administrative process that people could comment and there could be discussions and it could be modified. however, we could put the interim final order in place very rapidly. thus keeping people safe while we were discussing the issue. mr. butterfield: thank you. dr. woodcock, there was a suggestion earlier that perhaps the f.d.a. has not been proactive enough to seek legislation to remedy some of these issues. it appears you are the director for center for drug evaluation and research of f.d.a. dr. woodcock: that's correct. mr. butterfield: are you permitted under your rules to pick up the phone and call the chairman of the energy and commerce and ask for legislation? dr. woodcock: no. mr. butterfield: that would be unacceptable in your agency or any other agency in the federal government? dr. woodcock: your not allowed to lobby congress, is my understanding. mr. butterfield: that's what i learned in my 13 years. thank you so very much. i yield back. mr. burgess: the chair thanks the gentleman. the gentleman yields back. the chair recognizes the gentleman from virginia, mr. griffith, for five minutes for questions, please. mr. griffith: all right. thanks very much, mr. chairman. all right. it seems we have a problem. everyone agrees we need to change things. we have a discussion draft in front of us. i looked through it. but i would ask you as our expert who always gives us good counsel -- we don't always take it but we always like to hear your opinion. are there things in the bill that concern you, things we ought to take a look at changing the language on? i know some of it is not finalized yet. as the bill currently exists, is there anything that causes you concern? dr. woodcock: no, not serious concern. i think we would like to give technical assistance because you know the devil's in the details. mr. griffith: always. dr. woodcock: we believe the broad outlines are what we need to be. mr. griffith: and likewise, is there anything you would like to see in the discussion draft that's not currently in there? dr. woodcock: i don't have a role in this, as i told this committee before, but i recognize that there are many folks who want to talk about exclusivity. i don't believe that f.d.a. has a role in those tradeoffs. those societal tradeoffs. but i believe that's something that needs for resolved. mr. griffith: ok. and i appreciate that. and not asking your opinion, per se, but have you anticipated or have you felt any or heard any comments about the user fee portions of this bill? are there groups out there that have told you they really oppose this and this would be an impediment to bringing certain over-the-counter medicines, particularly in rural areas? dr. woodcock: i have not heard that. all right. i recognize some of the contract manufacturers, because this proposed fee right now is facility fee which is the most straightforward and simple way to do this if you're producing an o.t.c. drug under the monograph. the issues have been raised about the contract manufacturers and their obligation to pay a fee. i think that is one of the more controversial areas. we feel there's tremendous mert in maintaining -- merit in maintaining a simple, uniform fee, a large number of the o.t.c. manufacturers are small business. and so everybody is -- there's lots of small businesses involved here. mr. griffith: right. i wouldn't want to price them out. the others have been highly successful, isn't that fairly much accepted? dr. woodcock: yes. i believe they have been beneficial to industry as well or they wouldn't have been re-authorized as they have been. mr. griffith: yes, ma'am. thank you very much. i appreciate your testimony here today. with that, mr. chairman, i yield back. >> the gentleman yields back. mr. schrader is recognized for five minutes for questions. mr. schrader: i appreciate you having you here, dr. woodcock. how many steps are we anticipate removing as a result of the process? dr. woodcock: i would say practically all. all right. we want to put this behind us basically so part of this proposed legislation would put all the monograph stuff behind us, transfer all these into a new status. start not over but start fresh and have a timeline and plans for moving forward. mr. schrader: so would you be able to establish timelines? s there a rough timeline template, what mr. barton said, to give us benchmark performance measures between you start, you get down the road a little bit and ultimately get to a decision? dr. woodcock: there are goals and they phase in because as i said, we're talking about managed growth. and in the first two years of this program, the plan would be to build a new system. we also have to deal with those legislatively and court mandated projects, the sunscreen innovation act, and other -- some court mandated things we have to finish. but we have to -- we'd have to hire people. we'd need to create new standards and processes. we need to create a new i.t. system. we don't have any i.t. system. mr. schrader: i appreciate that. there's probably a timeline you can give us for all that to occur. that would help us judge the progress to help you with resources and whatever. but once that's all established, it would be interesting to know -- i heard a two-year rough from start to finish. it would be helpful for the committee and for you to see if we're hitting those timelines. i am sure there is a new program and have to make adjustments as we go forward here. dr. woodcock: we had proposed or planned to have goals, ok, for everything. there would be a goal when we do this and when we get that done, just like we do for the other user fee programs. so there would be a structured set of goals and timelines and percentage like, here's the timeline and we would -- our goal would be to do 70% in this time frame. this year and next year it goes up to 80% and so on. it's pretty complicated, and i can't go through it in five minutes. but for the existing monographs, what we planned to do is put forth a dash board that would be in advance. and that would -- because the industry is going to have to submit for the existing, what are now existing monographs. they have to resubmit something, and then we'd have a timeline of when we expected that to come in and then there would be an orderly process with timelines for accomplishing that. mr. schrader: can you share that with us? dr. woodcock: absolutely. mr. schrader: i am sure the industry understands they have to resubmit? dr. woodcock: that is the plan because right now we have this giant sort of mulch of documents that have been sent in over the years. we want to use the current scientific information to make the judgment. mr. schrader: last question. you're about 30 f.t.e. or something like that in this program. with the new revenue coming in, what's your initial expectation to gear up to and where do you hope to be as a more level employee work force? dr. woodcock: right. ultimately we would hire 105 new employees. mr. schrader: wow. great. dr. woodcock: wee would have 135 doing this scientific work. mr. schrader: good work. thank you very much. i yield back. burj the chair thanks the gentleman. the gentleman yields back. the chair recognizes -- there you could be -- >> buddy came in to block me. mr. burgess: the chair recognizes the gentleman from missouri for five minutes for questions, please. >> thank you, mr. chairman. doctor, the over-the-counter monograph program is the key regulatory framework at the f.d.a. for the oversight of o.t.c. medicines which count for the bulk of medications consumed by americans. i understand the user fee program you're setting up is still relatively small, particularly when compared to some of the much larger programs that we've approved earlier this year. mr. long: can you discuss why the user fees are needd? dr. woodcock: certainly. user fees are needed because we simply don't have enough staff to finalize all these and then deal with innovation coming forward. we have 30 staff to deal with more than 100,000 products that are on the market and currently this burdensome rulemaking process, even if we were to move toon order process that was streamlined in a very efficient effective, the 30 staff could not make substantive progress against that in the next five years. mr. long: how are you -- how are the user frees structured and how is it collected? dr. woodcock: the fees are going to be an -- for any facility that manufacturers a monograph drug. we have a flat fee. how much it would be depends how many registered. we're going to use our drug registration and listing system which is an existing system to capture all of the facilities. it might be between like $14,000 or a little less or a little more depending how many facilities participate. mr. long: you mentioned that the o.t.c. monograph process is one of the largest and most complex regulatory programs ever undertaken by the f.d.a. could you discuss how o.t.c. monograph reform can address these regulatory challenges? dr. woodcock: certainly. by simplifying the process that we have to go through to to ize a -- you know, finish -- in this case it would be an order with the new process is tremendously simpler than what we have to do with the monograph and orders can be amended over time through a simple process. so we can keep up with the science. and hopefully with the user fees we will have enough people to do that. but i have to be clear. this user fee program is not large enough to get all this done in the first five years. we will get the program set up and we will begin to work against it and we will be accepting innovation and that will all be good and we'll be dealing promptly with safety issues but we won't be finished with every single one of these because they do take a fair amount of scientific work. but we would never be finished with them. we will never finish this process if we do not change, do not modernize it. mr. long: speaking of process, can you discuss the f.d.a.'s engagement with stakeholders during the process? dr. woodcock: certainly. as i said, in 2014, we had a public meeting about this. representative barton's point, we did own up to the fact that the process was broken. although some people came and told us it was simply because we were lazy or whatever. but we did ask the public, including advocates, consumer groups and others, you know, how -- and the industry how we could change and modernize this process and we pointed out the different problems. since that time, as we've been talking to industry about how we might change the process, we've also talked to public stakeholders, advocacy groups, consumer groups, professional groups and so forth to keep people in the loop. although i would admit, this is a rather obscure program. and many people are unaware of how this program operated and the problems that it had. we had several public webinars and we also talked extensively to special stakeholders who have a particular stake in this. for example, the american academy of pediatrics. mr. long: excuse me. how will f.d.a. address emerging challenges to ensure that the o.t.c. monograph program remains effective? dr. woodcock: well, i think one of the things we need to build in, which we built into every single other user fee program that we have, are assessments. as i said earlier, we're going to have goals and objectives and so we will have put forth what we expect our timeliness to be, how much we expect to get done and then we will assess against that. and if we're failing on those measures, we will own up to it. mr. long: ok. thank you. with that, mr. chairman, i yield back. mr. burgess: the gentleman yields back. the chair thanks the gentleman. the chair recognizes the gentlelady from california, ms. eshoo, for five minutes for questions, please. ms. eshoo: thank you, mr. chairman. and i want to commend the authors of the legislation for addressing something that evidently has been overlooked for decades. want to start with a question about what you can and cannot do. i know that you cannot come to congress and lobby for money. i know that you can't come to congress and have something printed out and say, this bill needs to be introduced. but i've never heard in 25 years that anyone from any agency can't meet with members to discuss a shortcoming within he agency policy-wise or anything surrounding what i just mentioned. so would you clarify this because i think it changes -- for me, the complexion of this entire issue. not that it doesn't need to be addressed, but it's just stunning to me that it hasn't clarify, ld you please? dr. woodcock: different administrations have different priorities. administrations, basically, decide how the interactions with congress are. ms. eshoo: well, you need to be more specific about that, though. i really want to understand this. ecause it's important. where is the agency precluded from essentially putting a spotlight on something that obviously has an effect on the population in the country to say there's a shortcoming here and we need to work together to address this? i don't think that's -- i don't think that that is something that changes with administrations. i think that's part of the ongoing work of the agency and the congress. dr. woodcock: we certainly can, as we did, hold public meetings. we can write papers. we can do many things, depending on -- ms. eshoo: you are talking about internal to the agency and what you do there. i'm talking about the relationship between the agency and congress. let me ask this. is there any statute or rules that's written that prohibits the f.d.a. from meeting with any members or chairs of committees or subcommittees to point out that there's a shortcoming somewhere, it's troubling to the agency and that we need to work together on whatever the issue might be? dr. woodcock: not to my knowledge. we wish to put forth a legislative proposal, that's put forward through the a-19 process by the administration. ms. eshoo: well, clearly this has been overlooked and my sense is that it rests more with the f.d.a. than the congress. but i'm glad that this is being taken up. now, on the user fees, there is does 100% of the user fees coming in fully fund the 130 positions that you have goals for? dr. woodcock: we currently have funding. e currently fund 30 positions. ms. eshoo: i know but you are anticipating 130. dr. woodcock: 105 additional would be fully funded by user fees, fully. s. eshoo: on the risks relative to the incomplete monograph, the risks that they pose, does that affect the pediatric population? dr. woodcock: yes. ms. eshoo: it does. and can you give us an example? dr. woodcock: well, in pediatric, cough and cold and the early -- in the early 2000's, we recognized that there was harm, significant harm to children, ok, due to use of pediatric cough and cold medicines. but the monograph statements were they were safe and effective. so difficult. ms. eshoo: were they ever corrected? dr. woodcock: we have not fully, not yet. hat we have done is -- . eshoo: in bcpa and pria -- dr. woodcock: it doesn't apply. they changed their labeling but as i showed for the acetaminophen example, not every -- every manufacture voluntarily changes their label. -- manufacturer voluntarily changes their label and we don't have the tools right now because the regulation is on the books or the tentative final regulation says safe and effective. ms. eshoo: my time has expired. thank you. mr. burgess: the chair thanks the gentlelady. the gentlelady yields back. the chair recognizes mr. lance for five minutes for questions. mr. lance: thank you. good morning. it's always a pleasure to be with you, dr. woodcock. before i ask questions i do want toined indicate it's my hope that the committee will examine the cozz mitt metics issue. this has been discussed in opening statements by others. i'm involved in that issue with mr. pallone, the ranking member of the full committee. many americans use these products and i have been working in a bipartisan capacity to advance consumer safety and provide a regulatory framework that furthers growth and innovation for american cosmetics manufacturers and small businesses. consumers need to know that the products they are using are safe and businesses need a 21st century f.d.a. that responds as quickly as new great ideas are being developed. statutory scheme governing cosmetics has been unchanged virtually for 70 years. in is an area where the committee should break ground and find a bipartisan solution for consumers and stakeholders. mr. chairman, on the issue we're discussing this morning, i have a letter that i would like to submit into the record from colin mckenzie who is the head for all of the americas from glaxosmithkline consumer health care. i respectfully request that be put in the record. thank you very much. dr. woodcock, off topic but an issue of acute interest on the hill right now, right to try legislation. i've been involved in this. i'm interested in hearing your perspective on the proposal that recently passed in the senate. dr. woodcock: well, first of all, my personal opinion, which i have testified on before, is that the federal government should not stand between someone who's dying and wants to try a medication. however, i feel if i were that person or relative of that person, i would want to know if the last several people that had taken that medication had survived or had died quickly or whatever. so i think for protecting people, it's important that there be some transparency about the outcomes of these uses. if something were to pass. now, the f.d.a., as you know, approves about 99% or 99.9% of ll requests for uses of drugs. however, we are aware that certainly not all firms are willing to give out medicines because they may have short supply or they may be concerned about the situation or even the safety of the treatment for that particular individual. o i believe it's a complicated scenario. we should consider not only the rights of patients but their safety. mr. lance: thank you. the o.t.c. monograph reform bill we are considering provides for significant expansion of f.d.a.'s o.t.c. drug review and oversight capacity. how will it boost -- how will the boost in personnel -- which we all favor -- enable the f.d.a. to resolve the o.t.c. drug review backlog and timely consideration of applications for new innovative products? dr. woodcock: well, what we have envisioned is -- envisioned in what's been written down so far is sort of a staged improvement where first infrastructure and hiring and training and so forth take place. then innovation begins to be taken up as well as early cases f finalizing these pending proceedings and those will go over time with time frames. so what we envision is we would start with the innovation along with dealing with the, quote, so-called backlog, and the safety, of course, immediately upon having this new program we would be able to deal with safety problems much quicker and we would. mr. lance: well. thank you and i wish you well in that and certainly we want to be involved to the greatest extent possible. mr. chairman, i yield back 32 seconds. mr. burgess: the chair thanks the gentleman. the chair now recognizes the gentlelady from colorado, ms. degette, for five minutes for questions, please. ms. degette: thank you, mr. chairman. i really want to thank you for going through regular order with this bill because i think that this is one of those issues that has really being a bug-a-boo for a long time. the agency has tried to deal with it. congress has tried to deal with it. dr. woodcock, i want to ask you a couple of questions. the first is about the process we have used to come up with the discussion draft on which e're having the hearing today. all of the group that the committee mentioned, the republicans and democrats, we have been working with your agency for over a year on that, is that correct? dr. woodcock: yes. ms. degette: and maybe you can talk a little bit more about some of the steps that the f.d.a. took to get input for us on this o.t.c. monograph reform bill from the various stakeholders. dr. woodcock: certainty sernl. -- certainly. well, we had a public meeting on this in 2014. at that time pointed out the fact that the monographs were not getting finished and the difficulties we were having. the difficulty of safety and also the problem with innovation. and there was a great deal of support for doing something. subsequently with that we -- and that was the industry numerous times, a large number of times trying to work out what such program would look like. so congress would have something to work with and getting through a lot of the technical issues. so there were numerous meetings about both the policy changes, the legislative changes that would enable -- enable us to have orders and so forth as well as what a user fee program might look like. at the same time we had public -- we posted meeting minutes of those meetings and we had various public interactions at different times. and we met with some of the more involved stakeholders, some of whom will testify today, as well. ms. degette: in addition, as the bill was being drafted, i assume your staff gave technical assistance to the committee staff on this? dr. woodcock: that's exactly right. ms. degette: so really the draft we are looking at today is sort of all of those processes that we had up until today. i want to ask you about a specific provision of the discussion draft that allows the f.d.a. to include requirements for the packaging of a drug to help protect children from harm such as horough doses -- through doses unity pack ging a -- unit packaging. does the packaging language in the draft give the f.d.a. sufficient authority to require packaging information to protect children from risk or is there more that needs to be done? dr. woodcock: no. we believe this language is adequate. ms. degette: and why do you believe that? dr. woodcock: because it says -- it says other appropriate requirements so it gives us fairly wide scope. ms. degette: thank you very much. and thank you for all of your efforts and your agency's efforts. i yield back, mr. chairman. mr. burgess: the chair thanks the gentlelady. the gentlelady yields back. the chair recognizes the gentleman from florida, mr. bilirakis, five minutes for questions. mr. bilirakis: thank you, mr. chairman. appreciate it. dr. woodcock, in your testimony you mentioned 1/3 of the monographs started decades ago are still not being finished. can you give us a sense of the size of this backlog? how big is it? how long do you think it will take to clear the backlog? what types of submissions are in the backlog? dr. woodcock: well, first of all, you have to understand this backlog is a little different than, say, what you used to talk about the generic backlog which we have dealt with. these products are still on the market. all these products are on the market, and the process of finalizing the monograph would perhaps remove some of those from the market. and establish the conditions under which they can be marketed. and perhaps limit those. so there are about 100 ingredients, i think, several hundred ingredients left out of 100 that haven't been finalized. d there are about maybe many uses, more than several hundred uses of those ingredient us because many ingredients are used for multiple different uses. it's difficult to have a count because until we get to the final monograph we don't know what will be in or out of each one. that's the ballpark, about a third. mr. bilirakis: about a third. how long do you think it will take to clear the backlog? dr. woodcock: we think it will definitely think it will take well beyond the five-year period. mr. bilirakis: ok. your testimony shows that funding for f.d.a.'s monograph products is fairly flat. somewhere roughly between $7 million and $8 million annually. have submissions being fairly flat year to year or are they increasing? dr. woodcock: well, the activity has increased because of all the new scientific knowledge, and as i showed you this chart earlier, the churn that happens with any given monograph as we learn more scientific information. but this was fixed really in 1972, and so we don't have any new submissions at all to this in the sense of new ingredients added or whatever except a few that might be four ingredients that could come with the time and extent pathway which was what the sunscreen innovation act dealt with. mr. bilirakis: ok. next question. in your testimony you talked about the slow timeline for changes to the monograph. you used the example of liver injury for generic tylenol taking seven years to update the warning. my goodness. how would monography reform shorten the time frame substantially? what changes would be required by statute, and what can f.d.a. do -- what can they do administratively? dr. woodcock: yes. the goal would be that we could have an issue an interim final rule on safety, on specific kind of safety changes. and we could issue that rather quickly. and then it would be binding. and then the discussion about it and any further adjudication could occur after that and we'd go to a final rule after we gut public comment. but say we find out a safety problem, a serious safety problem can be dealt with with labeling. we issue an interim final rule, all the labels change so people are protected and then we can have further scientific discussions and go to a final rule that would, you know, have -- had that chance for people to have a lot of discussion. mr. bilirakis: ok. very good. thank you, doctor. i yield back, mr. chairman. burj the chair thanks the gentleman. the gentleman yields back. the chair recognizes the gentlelady from illinois, ms. schakowsky, for five minutes for questions. ms. schakowsky: let me say how much i appreciate what you do and your testimony here. i think you are always transparent and candid and informed and i thank you very, very much for that. and, you know, we can all look back and think, well, maybe we should have moved ahead further or faster on this issue but here we are today and i know that you'll be working with us to make sure we deal with over-the-counter drugs. i wanted to reaffirm something that's been said a number of times and that is that i am very hoping -- hoping very much that the committee moves cosmetics. i have a bill, the cosmetics safety act, that i have been working on for a long time. but, you know, when we have shampoos that cause people to lose their hair, a child who lost all her hair, or a teen's eye shadow is tainted by asbestos, the f.d.a. right now is unable to act. so never let it be said that we ignored the issue of cosmetics and i think that's another thing we need to move forward on. but back to o.t.c., we've talked a lot about the administrative problems, about how long it takes to regulate the cumbersomeness of the process but i wonder if you could succinctly list the safety issues that we need to address that aren't being addressed right now. dr. woodcock: ok. we could start with the skin reactions to acetaminophen. we can add the safety problems with pediatric cough and cold medications. we can -- ms. schakowsky: is that in part using the sweet gummy kinds of things that might attract children? dr. woodcock: that's a different -- that's a safety issue related to the dosage form and overdoses in children. that's another issue that we would be dealing with. there are quite a few. we finally finished the liver warning for acetaminophen but there are other over-the-counter drugs that we probably need to move on safety. ms. schakowsky: so do you think that once this process is in place that there will be over-the-counter drugs that will be removed? you eluded to that in the last set of questions. dr. woodcock: well, the monograph system itself envisions removing when we have a final monograph certain ingredients out of the monograph. that's first. they are all on the market. when we start this process it gets removed. as we finalize these monographs, certain ingredient also no longer be permissible or marketed in the united states. most don't have serious safety issues. some don't have any data to show they work. ms. schakowsky: so some would have to have more warnings? dr. woodcock: they may have to have more warnings or they might have to withdraw because they can't produce any data to show it's effective. ms. schakowsky: so this would be a before the look of these drugs or, no, would they gone the market anyway? dr. woodcock: no. no drugs supposedly since 1972 have gone on market. this process now only deals with drugs that are on the market in 1972 or before. so any -- what we're planning to put in place, if congress, you know, puts -- agrees with this, is a process where we could move new ingredients into this process and have them regulated this way which is much less burdensome for the industry for products that are o.t.c. products, where multiple parties can market them. ms. schakowsky: let me ask you one more thing. as you know the consumer product safety commission is charged with implementing and enforcing special packaging and child resistant package requirements. i'm just wondering how you work the f.d.a. work and interact with the consumer product safety commission on these packaging requirements? dr. woodcock: certainly. we work very closely with them. we recognize there are standards. they set the standard for child resistant packaging, say, for bottles and how you test for that and so forth. were this to move forward, we could have a memorandum of understanding with them on how we notify them about anything we were doing on packaging to make sure that they were aware of, you know, if we were making some safety packaging or whatever, we'd let them know. ms. schakowsky: thank you. i yield back. i appreciate you. mr. burgess: the chair thanks the gentlelady. the gentlelady yields back. the chair recognizes the gentlelady from indiana, mrs. brooks, for five minutes for questions, please. mrs. brooks: thank you, mr. chairman. want to also thank dr. woodcaulk for coming to this committee -- woodcock for coming to this committee again and take what i'm learning are long overdue steps to update our over-the-counter monograph process. i appreciate you talked about some of the challenges and you just went through some of the specific problems but wondered if there were any other examples how the inefficiencies in the existing o.t.c. drug monograph system have exposed americans to risks from potentially unsafe, what you just talked about, i believe, or possibly ineffective drug products. are there any specific examples you'd like to provide? dr. woodcock: well, until we get the monographs finalized, it's hard to call them ineffective until they're shown by a regulation is published saying they're ineffective. that's one of our conundrums that fits very well with your question. we aren't -- they aren't officially ineffective until they're found ineffective in final regulation. mrs. brooks: that's what's been so problematic. dr. woodcock: yes, it's very difficult to get to that point, yes. more can always submit data. back and forth. so it can be prolonged very long. mrs. brooks: thank you. we know that american patients, providers and manufacturers have benefited greatly from congress' previous authorization of f.d.a. user fees for prescription drugs, generic drugs, bilogic, animal drugs, medical devices, but we know o.t.c. drugs, products have lagged behind. how do you believe the user fees authorized in this legislation combined with congressional appropriations will give you the necessary resources to bring the o.t.c. drug regulation on par with other drug and medical products? and then secondly, in addition to the personnel increases, which you've talked about going from 30 to 135, what resources will this legislation provide f.d.a. to improve the system? dr. woodcock: well, we plan to spend about $26 million on investing in i.t. system so this becomes paperless instead of a paper-intensive process, and that would require about $3 million a year ongoing for maintenance once it's built. so $26 million will be spread out over the first four years or so of the program. we'd also invest in training of our people developing processes and different matters like that. but this level of program, as i said, will not result in the monographs all being in the new order system and having all final orders at the end of five years. it's not going to be that fast. mrs. brooks: no, i appreciate that, and you certainly let us know that and have set the expectations. are you saying that right now the current system relies on a paper process? dr. woodcock: to a great extent. mrs. brooks: and so the building of an appropriate i.t. system which doesn't exist right now would be incredibly helpful? dr. woodcock: yes. since we are going to put what i call the mulch behind this past documentation that's all over the place, we can have an electronic gateway like we do for the other user fee programs so submissions are electronic. there are standardized formats. many things that help everybody in the modern system be efficient. mrs. brooks: and just out of curiosity, you talked about additional training that would be needed besides the 30 staff that are currently onboard. have they been involved in this system -- in this process in a significant way? dr. woodcock: yes. yes. and are bracing themselves if they need to train new people and try to complete some of the work at the same time. mrs brooks: thank you. thanks. i yield back. mr. burgess: the chair thanks the gentlelady. the gentlelady yields back. the chair recognizes the gentlelady from michigan, mrs. dingell, five minutes for questions, please. mrs. dingell: thank you, mr. chairman. doctor, like everybody here, we are a fan and really grateful for all the work you're doing, sitting here through all these questions, many of which sound the same. but i think we're all saying that we think the o.t.c. system is broken. we don't think it's working for patients, for doctors, for people in the industry who are making innovative products. your testimony said this in the and the questions and answers keep reaffirming this. for the record, i again want to -- it is true there are far more o.t.c. monograph products than brand of prescription drug products? dr. woodcock: that is true. mrs. dingell: despite this fact, f.d.a. got $7.9 million to review o.t.c. products while prescription drugs spending totaled $1.1 billion when user fees were included, is that correct? dr. woodcock: that's correct. mrs. dingell: so i do have this question because when you're talking about the five years and you're talking about cruiserweight an i.t. system that doesn't exist, is it going to -- can money help accelerate that five years? will getting you more money -- dr. woodcock: well, we can always do more with more. we can move faster with more. mrs. dingell: so it's maybe at some point you could give us how much you need to create that i.t. system which will accelerate it and maybe give us the little -- that's not in any of the plan questions but i think it's a question that's popping here. will the draft legislation we're considering today give f.d.a. the resources the agency needs to do a more effective job? dr. woodcock: definitely a more effective job, absolutely. especially combined. we need the authorities to do more effective job. we can't use these authorities. mrs. dingell: so as you just said, the lack of funding is not the only issue. the draft legislation we're considering today also gives f.d.a. the authority to use administrative orders to make changes to o.t.c. monographs rather than the current notice and comment rulemaking process which has left many monographs not finalized. does the f.d.a. believe this would make innovative markets make it to the market while also allowing the agency to address the safety issues faster? dr. woodcock: yes. there is a specific innovation pathway that's been built in with timelines and deliverables and so forth and we definitely contemplate there's innovation to be had in this space. mrs. dingell: so thank you. i think this draft bill goes a long way. i want to take a step back a bit and give some context. in 2014 congress came together unanimously to pass the sunscreen innovation act because our nation is facing a skin cancer epidemic. the last time a new u. oo.t.c. sunscreen ingreed went was approved was in the 1990's which you know. this is a symptom how broken the o.t.c. system is overall. it's more pressing and more urgent because there are five million americans being treated for skin cancer every year. and the rate of melanoma is on the rise. so while o.t.c. reform is going to make it easier for all innovative products to safely and quickly get to market, we cannot forget the urgent need to ensure that americans have access to sunscreen products that have been used safely for decades overseas. this is where the frustration comes from all of us, doctor, congress remains concerned about the skin cancer epidemic. can we work with you and other stakeholders to ensure americans have access to the latest sunscreen ingredients? what do we need to do to make sure that's here now? dr. woodcock: well, we have met, as i said, all of the stipulations. actually exceeded them in the sunscreen innovation act. what we're waiting for is data, the safety data to be submitted. what the sunscreen innovation act did not do is lower the standards for safety for o.t.c. medicines. and so when we receive those data we will be able to review them promptly. as i said the sunscreen innovation act is one of our highest priorities. mrs. dingell: so how long is it going to take to get that data? what's the holdup? why is this so complicated? dr. woodcock: under most of the things the f.d.a. regulates, we don't do that research. the research is done by the sponsors because they have the medicines, the drugs, the formulations and they submit that research to us. so we wait for them to conduct their research. we give them parameters about what the research should look like. to meet the standards and then we -- it's on their time frames. mrs. dingell: do we know their time frame? dr. woodcock: certainly are in contact with them about their activities. i personally have met with them fairly recently. mrs. dingell: thank you. i yield back the balance of my time, mr. chairman. mr. burgess: the chair thanks the gentlelady. the chair recognizes the gentleman from georgia, mr. carter, for five minutes for questions, please. mr. carter: thank you, mr. chairman. dr. woodcock, thank you for being here. help me understand something here, and i have been in between subcommittee meetings so please excuse me if i missed this. did you -- when you come up with a profile for a certain ingredient, does it apply -- >> you can continue to watch this hearing online. we're streaming it live at c-span.org. we'll leave here. the u.s. house gaveling in for legislative