Transcripts For CSPAN2 Hearing Looks At Changes To Over-the-Counter Drug Regulation 20170915

A group of industry stakeholders spoke and outlined recommendations for lawmakers. This is about two hours, 40 minutes. We will come to order. I recognize myself for five minutes. Opening statement. Todays hearing marks the health of subsidy public discussion on modernizing the Current System of the United States fda to review, approve and update. This hearing provides us in the American Public with the opportunity to better understand the fda regulatory frame work for overthecounter drugs and consider a proposal to reform the monograph system. I would like to commend all for their efforts in offering their insight to the committee. Theyve set a strong record of bipartisanship on Public Health issues such as 21st century cures, the fda reauthorization act and i hope to add to that record of success with todays hearing. Overthecounter drug products provide a wide variety of ailments. Pain relievers, eyedrops, cough drops as a firstline treatment option before going to see the dr. And get a prescriptions. It also includes antibacterial soap, hand sanitizer, sunscreen and the sunscreen commonly used by many families in the United States. Currently, there are more than 300,000 overthecounter products on the market according to the food and drug administration. They go through one of two approval processes to reach the store shelf. Manufacturers can submit a new drug application similar to new Prescription Drugs or they may conform to an otc drug monograph which is a set of specific standards created by the fda that ensures the products active ingredients are generally recognized as safe and effective. The vast majority of overthecounter products rely on the overthecounter drug system. Unfortunately, the Current System does not have a significant update since the fda first establish this in 1972. That is well over 40 years. In addition it requires a burden some rulemaking process that could take years to resolve. All of this has led to a lack of innovation and inability for timely updates to address safety issues and much work left unfinished at the fda. Most of us feel that is unacceptable. The good news is there is broad support from the fda, from stakeholders in patient groups for significant reform to regulate overthecounter products. The subcommittee will examine the safety, innovation and reform act of 2017. The discussion was recently released. The bipartisan proposal establishes the overthecounter user program and makes a number of meaningful modifications to the process. The goal is to create a system that is more flexible and more efficient, that reflects scientific innovations so that patients and consumers have greater access to better and safer overthecounter drug products. Again i want to welcome and thank her witnesses for being here this morning. We look forward to your testimony before yield to the raking member, one housekeeping detail, although this is the premier committee technology, some of our systems are not working this morning. I understand there was a series of slides and those will be made available to you in paper form. We require our doctors to go paperless but here we can still deal with paper. The clock is working but only i can see it. The red green and yellow lights are not working. I will give a brief to click when we are getting down into the yellow zone so you will know the time is to wrap up and we will do that for everyone on the committee as a general reminder that were coming to the end. With that i yield back and recognize the Ranking Member of the subcommittee, mr. Green of texas. Thank you mr. Chairman. Thank you. The overthecounter otc drugs are routinely used during a wide variety of ailments. We go to our local walgreens or other retailer and dont even think about that bottle of ibuprofen or sunscreen like we do with this Prescription Drug. Otc drugs provide a lowcost way to take care of every day lowcost needs and we have a number of choices. According to the fda and the Consumer Healthcare product association, the otc market includes more than 300,000 products with annual sales of 32 billion. Fda monitors most of these drugs. The active ingredients in these products are considered safe and effective when consumers follow instructions on the label without direction from healthcare provider. That is largely true in theory, many contain ingredients that the fda has not yet evaluated or have been misused for labels that have not been modified to warn consumers of potential harm. The Current System also poses challenges for consumer access for better, safer, Innovative Products. The framework for fda oversight are put into place in 1972 and has not been updated despite an increasingly diverse large market. The need for reform was brought into focus when they worked on the sunscreen innovation act in the 113th congress. Under the Current System, the monitor is established through a threestep process. This antiquity system is burdened some and timeconsuming and doesnt work very well. Its unable to respond quickly to safety concerns and keep. [inaudible] it slows development of new drugs. The fda has 88 rulemakings and 26 therapeutic categories that cover over 100,000 otc products. Its one of the largest and most complex regulatory schemes and dramatically under resourced. The agency has 30 fulltime employees and a budget of roughly 8 million. In context, 18 fulltime employees are devoted to the review of one novel drug application. The otc market now includes for the 300,000 products with annual sales of 32 billion. Recognizing the resource and process challenges that the program and beginning to think about how can work better. The congressman and i have been working on a bill that would establish an otc. [inaudible] today we have a discussion drafted that reflects the work of the staff stakeholders. We should consider doing the same with cosmetics. There is a parallel. [inaudible] it will help foster growth and the availability of these medicines. Policy reforms could make the system even more flexible, responsive and accommodating about potential harms of misuse. Ultimately modernizing the system to ensure the industry can update products, broad and Consumer Choice and ensure the fda has the resources. I look forward to hearing from the witnesses about this. I yield the remaining of my time. [inaudible] i dont think your microphone is on. [inaudible] [inaudible] it does not respond too. [inaudible] in 2006 the fda learn that common cough medicines medicines medicine for ten years the fda has been trying to provide the cough and cold industry to warn parents about cough medicine in children but it was unsuccessful. What this would do is give new tools overthecounter medicine. Im extremely glad you are with us again today to give us the same kind of guidance you gave us in 21st century. We really have a great opportunity to upgrade our railway process in a way that benefits everybody. The American Public, the federal government and the regulated industry. I look forward to continuing to work with our college to support the bill and i thank you very much mr. Chairman for holding this hearing. I yield back. The gentleman from texas is recognized. The gentleman from oregon is recognized for five minutes. Thank you. I appreciate you holding the hearing on these important issues and the longoverdue reforms needed at fda to improve efficiency and update their framework for regular eating overthecounter drug products. Following the successful authorization of several of fdas critical medical device User Fee Programs, theres no better time to continue our work for now. I am pleased with the bipartisan effort thats already begun. From cough and Cold Medicine to antiperspirant and antacid, medicine cabinets are filled with overthecounter otc drugs. Its the regulatory process that we heard. They all agree that significant reform is something we all need to join hands on. Theyve engaged and productive conversation to improve upon the status quo. We now have bipartisan to ensure more timely access to safe and effective medicines. There would no longer have to wait years for inflexible timing to wind its way through the bureaucracy. Id like to thank our colleagues as well as chairman and my colleague and others who have put their shoulder to the wheel on this one. We proven time and again and know how to legislate to get things done for american consumers. We will get things done here. I will yield to the gentleman from ohio the remainder of my time. Thank you for holding todays hearing. I also want to thank our witnesses. Its time to move forward to a more flexible framework. I believe it will achieve these goals and provide predictability to the drug approval process. The safety reform act between myself, the chair of the subcommittee, and significant contributions from the fda and the industry. Id like to thank all those involved for your effort in order to increase Consumer Choice and safety. I appreciate the chairman for allowing the opportunity to discuss the discussion draft today. I look forward to hearing the testimony and receiving input from my colleagues on the subcommittee. I think the chairman and for our witnesses and nailed back. I yield to mr. Jeffrey. Thank you for yielding the chairmans time. I appreciate it. Want to thank you for holding this important hearing today. This important bill would enable greater innovation and foster efficiency within the approval process overthecounter drugs, something that has not been done since the 1970s. I want to specifically thank for their leadership on this issue. Im proud to be a cosponsor with several of my colleagues which industry, fda has worked so hard to move forward. I strongly believe this would help every american as these products are firstline in defense against ailments. I thank you for being here today. If theres no one else wanting the time, i yield back. The chair recognizes the gentleman from new jersey for five minutes for an Opening Statement. Thank you, mr. Chairman. I want to thank you also for holding todays hearing on the overthecounter drug reform and the establishment of overthecounter User Fee Program. I also want to commend Ranking Member green, guthrie and the chairman of the committee for your work in crafting a proposal that will accomplish these goals. The safety and effectiveness is established through the monograph, the socalled rulebook outlining the conditions of use for particular drug ingredient that outlines labeling and warnings and other requirements. This rulebook is established through a threephase rulemaking process that is often time inflexible and timeconsuming, making it difficult for fda to quickly revise update in response of safety or other issues. Weve also heard that the monograph process does not lend itself well to evolving science and technology and may have the unintended effect of discouraging the development of new formulations. There is regula Regulatory Reform needed and its under resourced. The otc Monograph Program receives more than 100,00 100,000 products. The Regulatory Reform and increase resources we can streamline the process. With swift finalization, updates and encouraged innovation wherever possible. We are beginning a process of making improvements in the review of overthecounter products, i had hoped we would begin taking action today on cosmetics. Millions of americans use cosmetic products everyday but fdas Regulatory Authority over cosmetics is woefully inadequate. Millions of women and children have been exposed to shampoos that can cause extraordinary hair loss, lip balm that can cause blistering and rashes, and i shimmer tainted with have. Abscessed us. They do not hold these mannish manufacturers responsible and cant ensure that it doesnt happen. We need to provide adequate resourcing for cosmetics as well i look forward to continuing to work with my colleagues and other stakeholders to accomplish both of these goals and ensure that continued availability and safety. I would like to yield the time i have left to mr. Dingell. I think my colleague for yielding. Americans deserve peace of mind in knowing that all drugs they take are safe and effective, whether its a Prescription Drug or an overthecounter drug. There are over 300,000 overthecounter products on the market today which americans use in everyday life. Fdas regulatory system for otcs is completely broken. The agency has a meager budget of 8 million which all of us keep saying over and over, and a cumbersome process that hinders their ability to let new and innovation products come to market. It creates a new user fee system for the otc product to give fda resources it needs to do its job of insuranc ensuring patient safety. The agency can move quickly to update and revise the system thread ministry of orders rather than rulemaking which are similar to the reforms made under the innovation act. We see the benefits the user fees have brought to the regulation of Prescription Drugs and medical devices and its time to bring the system to otc space as well. While im pleased that we are holding this hearing and moving forward, i want to commend them for the same comments made about the cosmetic industry which is also desperately benefit from reform and help the community will soon move forward with legislation establishing a user program for these products. Thank you for working with me on this draft legislation. I look forward to continuing our work to reach consensus on this important issue. Ill back the balance of my time. And i yield back mr. Chairman. The gentleman from new jersey moves back. This can include statements. Pursuant Committee Rules, it will be made part of the record. We do want to thank our witnesses for being here with us to take the time to test testify. Each witness to have the opportunity to give an Opening Statement followed by questions from members. We will start with our first panel. The director for research. We appreciate you being here this morning. You are recognized for five minutes for your Opening Statement. Thank you. We are here to talk about modernizing monograph system for otc darlings. Probably everyone in this room has used an otc drug at one time or another. I know i have. This medicine allows us to manage minor Health Problems without going to consult a health professional. Millions of americans use these products everyday. They are wide spread and theres more exposure to these drugs and there are two Prescription Drugs. The monograph system allows manufacturers to come on the market without the burden some. Product application process that we use for generics or for new drugs. Its a much simplified system. Why the push for reform . As the members have already said, the monograph process is put in place a long time ago to deal with the hundreds of thousands of products on the market after Congress Passed the 62 amendments to the food drug cosmetic act requiring them to show they were effective. and his safety issues would not come up for these products that were marketed but that is not the case and we have been hampered responding rapidly and this could be if opec into a liability. So it does not apply to anything more than that since this is still trying to do with those products that were on the market at that time so theres really nothing for innovation with this entire process. The reform that we are proposing is what works well about prospects that could still be marketed without approval for Market Conditions it is a public process it is open and transparent. But it streamlines to replace the rule making with the administrative orders it is very similar to or generic drugs it is appropriate for scientific decision making. To provide due process with that appeal and hearing process to the fda decision but there are fewer requirements rulemaking to be this accomplished in a much speedier manner also to encourage innovation by expanding eligibility and no longer with a knit to that type of product so they could submit to new kinds of product and what we envision allows for those confidential meetings with the fda before removing to the public process for the innovation to be explored also to quickly respond to urgent safety issues and definitively get that safety information. That could be subject to further Public Comment and discussion but people could be protected that is something we are missing right now to reduce that backlog by transferring these pending regulations by statute that would allow us to deal with an orderly and effective manner that is not finalized up to this point. With Public Health to require certain types of packaging that can protect people from taking too many pills and for the elderly and children that they could overdose so that packaging is very important and with this clarification to complement the cpsc that can require child resistant closures so all is in all this modernization m proposal along with the user fee would benefit the Public Safety and the industry and the fda has been talking to many stakeholders over the last three or four years with those proposals letter of the table. Thank you very much. Now we go into the question the answer port part of the hearing. Youre recognized for five minutes. I appreciate the chairman for yielding and dr. Woodcock think he for being here with your testimony. But what first with a safe packaging over the counter drugs so then you are talking those that are intended for adults with sufficient authority to be granted with modern reform with Public Safety committee touched that . First we believe the language that the administrative order has packaging of day job and negative a drug to use in accordance with labeling and that requirement to include unit dose packaging by children and other appropriate requirements and we believe that provides enough authority to request safe packaging the. Would get the dates from 1970 to when they begin evaluating those therapeutic categories could you go into the system which is slow or antiquated . And with administrative order process to get the drugs out there. Certainly what occurs now to talk about talks about a single roll with that analgesic drug product it shows the steps to move single rulemaking along that require a very large administrative effort that are publishing and the federal register and going through extensive clearance. Is to be substituted by a new process that would take less than two years with a defined time line with the user fee part of the program so to commit to finishing things in a timely manner. So what we would do for the old ones, as some good transitioned to legally marketed drugs that overtime go through a process where the industry would submit data, said the current data and have time lines to read you the published draft. The reason we dont just go to lou in approval is that this is a public process set to publish a draft that allows anyone that is interested to comment and participate to comment before we finalize so there is a slightly additional step because once the order is titled and they can flow to that condition is set of through current regulations. I wish it was working right now with the slides because what you have given us with the rule making the december 4th 197922 different dates down to november 19, 1994, we have to get this speed up and we appreciate the work youre doing i yield back. Said gentleman and from texas. In queue dr. Woodcock you are always good and we appreciate the work you have done for many years. Talking about the Current System the committee learned how the system worked where does it work but was a was clear then and now that those activities are needed to better serve those patients in the industry. Is said rulemaking takes too long it is a process for scientific decisions with the lack of speed and flexibility to make a scientific determination through that administrative order process. I brought a visual aid with me as an example as this relates to the fact with the rulemaking we have to get that out there to patients we realize acetaminophen a common paid read douceur people are allergic with a lifethreatening action we wanted to put a warning label on so what we did play could not modify the rule quickly so we put out day drug safety communication august 2013 of 91 cases resulting in 12 deaths and the alert for civil your skin reaction. If you look at tylenol and the label it does have an allergy statement and warning on their so people go. But if you look at others will or not aware they may need guidance but still did not have it. We issued a funnel and draft guidance 2014 final guidance january 2017. Regional me ask for them to voluntarily comply. This is the case for many products problematic is that pediatric cold. But we know and Congress Holland passed under pediatric drugs that children are of little adults that they can just be extrapolated so to change all that could take 10 years or more. And to streamline the process for what the agency faces in with your testimony and to keep pace with the science is to have that in a timely fashion for current resource. It with a 32 billion industry. So can you elaborate how that is not workable . We do have some reform from a few years ago even now our resources from the innovation act which said that line and we have to Pay Attention to that in the safety issues and were dealing with. We literally have no other resources so even with Additional Authority or ways of implementing we have trouble of bringing that about without additional resources. Know that they worked together on this with an example since 1992 . To have this funding ability battle the had the authority but to regulate and i yield back my time. Hell long have you been at the fda . 30 years. How many have been approved . Currently seven . May be. That would be a reasonable ballpark. Youre not personally responsible but i graduated a college 1972 to lives, for children. [laughter] six grandchildren then approached 17 times to be a member of congress and disapproved wants to be a senator. [laughter] once it is acceptable . Obviously there is a great deal of activity. Im glad it has activity but have trouble passing a lot. It is not your personal problem that i was not aware of this until i read the briefing that the system is broken which obviously was just pointed out. My gosh. Does it take 45 years to say we need help . When you try to find a cure for cancer i dont know of this is the most important priority but improving the monograph for manufacturing drugs should not take a moonshot. I do agree with that if it is under the new proposals of our proposed we could do this and more timely manner but just going through regulations. But somebody in your agency has known for a long time this is a problem. En long long time. I did share the full committee over 32 years nobody ever came to me from the fda to say we have a problem in to approve a specific new drug we have those reviewers to do all of these monographs and all these people reviewing them so dont you think as some point somebody could say we need a few more people were to change the rules . Maybe we dont need that 27 step process. I would assume. Thats true we held a Public Meeting three years ago to discuss the problem and we were very clear this was becoming more unworkable and were difficult to get the regulations through. Now the industry is very concerned about the safety problems because all the drugs remain on the market and it wasnt such a problem in the industry but i do believe the industry supports the us. What is a reasonable time to get these improved . It should be done within two years. Is that the guideline in the bill . If not i will put it in the bill. You cannot do every single one we have touche build up the staff and so forth. I appreciate your willingness to testify hopefully it will not take as 45 years and we can have a bill signing ceremony and hold them to their word and i yield back. Im not trying to denigrate over how many years we have a better year but we are doing but i do think part of the problem is youre not allowed to initiate that you cannot say you need more resources that is our oversight obligation so we do still have to do more oversight that is not for you to come to us . One of the most serious constraints in bed to ruby emerging safety issues so that is why the safety changes take so long. So to briefly discuss how those are currently and then to address the safety issues our thinking has devolved to save the regulation so it was clear and children should be specifically studied so he eventually what we do now is issued the Safety Communications and guidance on labeling even though it is different than what might be in the draft regulation so we can do that that requires voluntary participation so everyone would prefer those safety changes are dealt with promptly and definitively so we can take care of the problem as we get the information. We are considering that process as a transition from rulemaking and efta as would be the expedited authority in the serious adverse event how can we help to respond these issues . The expedited safety where the fda could put out the order rapidly that most orders would have and then it would be binding to notify the public that there would have to conform their label then we could have comments after that to discuss it more but that safety issue is dealt with more definitively say right now it may take eight years or more to get a rule change in the of regulation. What lessons were incorporated . How does that benefit the otc program . Some of the things that we learned for this program is called managed growth where those expectations are clear growing over tom demarco over time. So we learned that where we change those that once to have a simple feast structure as possible because this is a very large industry with a lot of players maybe it will start to look like the tax code. [laughter] the gentleman from kentucky. Thanks for being here today i have heard stories from manufacturers trying to do the right thing to look a labeling in current time for that change currently to make that bureaucratic system red tape for us working together could you tell the committee how those ensure that due process is maintained . There will be be administrative ordinance there is a Comment Period because it is a public issue but other manufacturers were consumers so with that public process if we get substantive comment we can do that in many ways but that is a public process someone that has been proposed for the administrative decisions through the appeal process within the center for drugs and in the administrative appeal before that that is selected to hold a hearing to adjudicate any substantive issue so there are layers of administrative appeal and recourse. You mention the sunscreens how does this fit in my former colleague it just seems with the rise of skin cancer is seems that is difficult to have that in the marketplace. The sunscreen innovation act will continue so what was stipulated by congress is the time frames those that are subjects then folded into the order so to monetized old process is to have confidential meetings and the ability to do that. So that could be put into conform that act once a monograph reform has passed. I appreciate the. I yield back my time. I would like to thank you to give us your testimony today im interested in the benefits your testimony highlighted very similar examples of how they were handled by your agency how frequently does the fda encounter Adverse Reactions . Frequently to was serious trouble once every several years that is fairly frequently but with the exposure to the population but once every two years to face an issue we would like to get out rapidly to notify them better hands are tied. To of the examples you highlighted word related to pediatric issues which is a disproportionate numbers are related to pediatrics . I would say in the last decade that is true because starting in the late 90s every betty became aware you should not steady you should study children not just treat them as tiny adults so with that realization that children could be harmed. This does is for children were just scaled down so we have been on a campaign to study children hear it is going back to looking at these medicines to say is this appropriate for children and what do we need to do about this . Can you provide any examples of safety improvements made to the existing monographs and how long that has taken to be implemented . Let me consult. Most recently it took seven years to get the liver warding on acetaminophen the number one of drug induced liver failure in the United States so we strengthen the zero boardings so we could rapidly to change those very fast in contrast it took us seven years for the monograph and a lot of that acetaminophen use is monograph use. Have you looked at that special mechanism to urgent safety issues . To have that interim final order that could be issued rapidly to be in place there for manufacturers would have to conform but subsequent there would be the administrative process and it could be modified however to put that final order in place while we were discussing the issue there was a suggestion earlier perhaps if the fda had been proactive enough to seek legislation so you are the director for the center of drug evaluation and research. Are you permitted and year rules to call the chairman and ask for legislation . No. That would be unacceptable. We are not allowed to lobby congress. [laughter] that is what i have learned in my 13 years. Five minutes for questions. It seems we have a problem everybody agrees we need to change things we have a discussion draft in front of us but i would ask has our expert who gives good counsel we always listen even though we dont take it are there things in the bill that concern you that we should look at death language but as it sits anything that causes concern . No. We would like to continue because the devils in the details but we believe the of broad outline is where we need to be. Likewise is there anything you would like to see that is not currently in their . I dont want to talk about exclusivity i do not believe the fda has a role that is something that needs to be resolved. Not asking your opinion but have you participated or heard any comments of the user fee portion as this to be an impediment to takeitorleaveit in rural areas . I have not heard that i have heard from the contract manufacturers because the proposed fee is the of facility fee the in church he controversial area of the contract he we feel there is tremendous merit to maintain a large number of those that our Small Business so there is a lot of Small Businesses. But those that have been highly successful. In day have been beneficial as well or they would not have been reauthorize. We appreciate your testimony. I depreciate you being here in and how many of these steps are we anticipating removing . I would say practically all. We want to put it at put this behind us so pardon the proposed legislation would put all of the monograph stuff behind us to transfer into a new status to start fresh and have a time for moving forward. So what about establishing a time line . Is there a template that you could give us a benchmark performance measure when you start forget down the road and then get to a decision . So to talk about managed growth the plan would be to do have a new system to be court mandated project but we have to hire people created due process said the new id system. I appreciate that. And there is a time line you can give us that i heard two years from start to finish to see if we are hitting those time lines . We had proposed to have a goal for everything so there would be a goal when we do this or get that done so there would be a structured set of goals so here is the timeline to be 70 in this timeframe is pretty complicated soviets will put forth a dashboard in a trance in the industry would have to submit to resubmit something with at tie line when we expect that to come in then there will be an orderly process. Can you share that with us . Absolutely. In the week need to resubmit in general. Also to have a giant document that has been sent in an over the years and to use that current scientific information and where do you hope to be . Also alternately 105 new employees and then we would have 135 doing this scientific work. I yield back. The chair recognizes you. How can imus you . [laughter] so this is the Regulatory Framework for oversight of otc medicines and it in the User Fee Program and with those larger programs and wire those user fees needed . We simply do not have enough staff to finalize these coming forward. In to deal with 100,000 products. And with this burdensome of rulemaking process. And that was the staff could not make substantive progress against that in the next five years. How were the fees collected . So for any facility with a monograph is flat. And then to capture the facilities. With more or less as they participate. So that process is one of the most complex regulatory programs ever undertaken by the fda. Can you discuss how the otc monograph reform can address the regulatory challenges . By simplifying that process to finalize to finish with to be in order of the new processes tremendously simpler than with the monograph. And then with those user fees. And to be clear this is not large enough and to get the program set up. And then to be dealing properly with safety issues to be finished with every single one in to take a fair amount of scientific work. We will never finish the process of we dont change your modernize. So can you discuss the fda engagement during the process . Search of a. There was a Public Meeting in 2014. Two o not to the fact that the process is broken although some said otherwise but we did ask the public to advocate and eugene j. And modernize the up process and since that time and also public stakeholders and with professional groups in this is the obscure program. Is to have several public web and are said to also talk extensively into have a particular stake in this especially the American Academy of pediatrics. And with that otc Monograph Program remains . In with that assessment to have cochlear goals and objectives to put forth that we expect timeliness it to its us against that. I want to commend the author to address something that evidently has been overlooked so i want to start with a question what she can or cannot do. You cannot come to congress to lobby for money. Is to have something printed out to say this bill needs to be introduced. I have never heard in 25 years that anyone from any agency cannot meet with members to discuss a shortcoming or policy or surrounded with they had mentioned so could you clarify . I think that changes the complexion of this entire issue. It is just stunning to me so could you clarify . The different administration. You need to be more specific so where is the agency precluded and then we need to Work Together to address this little thing that is the administration that is just the work of the agency and congress. We did hold Public Meetings and write papers youre talking about internal to the agency and not the relationship with the agency and congress. Is there any statute that prohibits the fda from meeting with any members or subcommittees . That it is troubling to the agencies so we need to Work Together . To put together that legislation. The net is more fda then the congress im glad to see this is taken up so wanted to percent of the user fees with bowls that there are goals . We currently have funding i know that. 105 additional. With the risks they pose does that affect the pediatric population . Yes. With pediatric cough and cold in the early 2000s to recognize with the pediatric cough and Cold Medicine and that monograph statement is that they were effective. Not fully. Not yet but in this area. In there for a bad example in deferred everyone that voluntarily changes the label. Because that regulations on the books is safe and effective. Recognizing the gentleman from new jersey. So before i ask questions and want to indicate to examine the cosmetics issue. Into the full committee. N. V. Have been working in that capacity to have that Regulatory Framework. With manufacturers and Small Businesses so that the products they using are safe 21st century fda as these ideas are being developed to govern cosmetics has been unchanged over 70 years and this is where they should break ground to find a bipartisan solution on the issue we are discussing i have a of a letter of reply to submit from the head of all love the american is from Glaxo Smithkline and requests that is putting the record so dr. Woodcock off topic but the issue of the accrued interest right now with their right to try legislation . Ion interested in hearing your perspective. First of all, my personal opinion that i have testified before is the federal government should not stand between somebody who was dying and was to try a medication. If i was that person or a relative i would want to know the last several people who had taken that survive door died quickly so i think so it is the transparency of the outcome if something were to pass now the fda approves about 99. 9 request survey all firms are not willing in that short supply even the safety of the treatment for that individual. So with their safety. The otc bill has significant expansion how will that boost of personnel to resolve that backlog with applications . What we had envisioned is a staged improvement with that infrastructure and hiring and training take place as well as early cases with those proceedings. So what we envision is dealing with the backlog and of the safety immediately upon having this new program i wish you well into the various extent possible. The chair recognizes the gentlelady from colorado. I really want to do take you for regular order this is an issue it has been the bugaboo as they try to deal with it as an agency and congress by just a couple of questions, but but all of the group with republicans in democrats on this committee to work through this so can you talk about the steps the fda took the from those various stakeholders said to have a Public Meeting on this in 2014 to point out the fact the monographs for not getting finished and there was a great deal of support. Subsequently members times trying to work out the programs so to enable them to have orders. At the same time so to have those interactions a different time with the more involved staplers stakeholders. So in addition to what is being drafted you work with the Committee Staff . So with that process so to include requirements to help protect children so it does say packaging. Thank you for all of your efforts in your agencys efforts, i yield back. Chair recognizes the gentleman from florida. Thank you mr. Chairman. I appreciate it. In your testimony, you mentioned that roughly one third of the monographs started decades ago are still not been finished and can you give us a sense of the size of this and how big is it . How long will it take to clear the backlog . What type of commissions are in the backlog . Well, first of all you have to understand that this backlog is a little different then say what you use to talk about the generic backlog, which we have dealt with. These products are still on the market. All of these products are on the market and the process of finalizing the monographs would perhaps remove some of those the market. It would establish the conditions under which they could be marketed and perhaps limit those. So, there are about 100 ingredients, i think, several hundred ingredients last out of 800 that havent been finalized and they are about maybe many uses more than several hundred users of those ingredients because many ingredients are used for multiple uses. It is difficult to have a count because until we get to the final monographs we dont know whether it will be in or out in each one of those but that is the ballpark. Its about one third. And how long do you think it will take to clear the backlog . Deftly we believe it will take well beyond the fiveyear period. Okay, your testimony shows that finding for fda monograph products is fairly flat. Somewhere roughly between seven and 8 million annually. Have submissions been fairly flat figure two year or are they increasing . The activity has increased because of all the new scientific knowledge and as i showed you this chart earlier the turn that happens with any given monographs, as we learn more scientific information. This was fixed really a 1972 and so we dont have any new submissions at all to this, in the sense that new ingredients added or whatever except a few that might be for and it could come within the time and extent pathway which was what the sunscreen and activation dealt with. Next question. In your testimony you talk about the slow timeline for changes to the monograph. You use the example of liver injury for generic tylenol taking seven years to update the warning. My goodness. How would monogamy perform and shorten the time frame substantially question what changes will be required by statute and what can fda do to administratively help . Yes, the goal would be that we could have issued an interim final rule on safety, on specific safety changes. And we could issue that rather quickly and then it would be binding. Then the discussion about it and any further adjudications could occur after that and we go to a final rule after we get Public Comments. Say we find a safety problem can be dealt with labeling and we issue an interim finding rule and all the labels change that people are protected and then we can have further scientific discussion and go to a final rule that would, you know, have that chance for people to have discussion. Okay. Very good. Thank you. I yield back. The gentleman yields back. In the chair recognize the lady from illinois. Thank you very much. Let me just say personally, for small, how much i appreciate what you do and your testimony here. I thank you are always transparent and candid and informed and i thank you very much for that. You know, we can all look back and think we should have moved ahead further or faster on this issue but here we are today and i know that you will be working with us to make sure that we deal with overthecounter drugs. I wanted to reaffirm something that has been said a number of times and that is that i am very hoping very much that the Committee Moves forward on cosmetics. I have a bill of cosmetic safety act that ive been working on for a long time but, you know, when we have shampoos that cause people to lose their hair or a child who lost all her hair or a teens eye shadow is tainted by asbestos and the fda right now is unable to ask for it never let it be said that we ignored the issue of cosmetics and i think that is another thing we need to move forward on. But back to otc. We have talked a lot about the administrative problems about how long it takes to regulate the cumbersome of the process but i wonder if you could physically list the safety issues that we need to address that arent being addressed right now. Well, we could start with the skin reactions to acetaminophen and we could start with an ad the safety problems with pediatric cough and cold medication. We can is that in part of the sweet gummy kind of things that might attract children . That is a different safety issue related to the dosage form and overdoses in children. Thats another issue that we would be dealing with. You know, there are quite a few. We finally finished the liver warning for acetaminophen but there are other overthecounter drugs that need probably need to move on the safety. Do you think that once this process is in place that there will be overthecounter drugs that will be removed and you alluded to that in the last set of questions. Well, the monograph system itself envisions removing when we have a final monographs certain ingredients out of the monograph and that is how it works. They are all on the market to start with and as we go through this process they get removed. As we finalize the monograph, certain ingredients, will no longer be permissible to be marketed in the United States. Most of them dont have serious safety issues and some of them dont simply have any data that show they work. Is a somewhat have to have more warnings . They might have to have more warnings or simply have to withdraw because they cant produce any data that shows they are effective. So, this new process would be a before the fact look at these drugs or no question what they sold on the market anyway contract. No drugs supposedly since 1972 have gone on the market. This process now only deals with drugs that were on the market in 1972 or before. So, what we are planning to put in place, if congress, you know, 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 and for products that are otc products where multiple parties can market them. Let me ask one more thing. As you know, the Consumer Product Safety Commission is charged with implementing and enforcing special packaging and child resistant package apartments. I wondered how you work the fda and work and interact with the Consumer Product Safety Commission on these packaging requirements . Certainly, we work very closely with them. We recognize their standards. They set the standard for Child Resistant Packaging, safer bottles and how you test for that. For this to forward we could have a memory of understanding with them on how we would notify them about anything we were doing on packaging to make sure that they were aware if we were making some safety packaging or whatever and we let them know. Thank you. I yield back. Chair thanks the gentle lady. Chair recognizes the gentle lady from. [inaudible] thank you, mr. Chairman. I also want to thank doctor woodcock for becoming for this committee again and explain to us why it is so necessary to take these long, what im learning are overdue steps to update our overthecounter monograph process. I appreciate that 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 of how the inefficiencies in the existing otc drug monograph system had exposed americans from potentially unsafe, would you just talked about or possibly ineffective drug products. Are there any specific examples that you would like to provide . Until we get the monograph finalize, as far as to call them ineffective until theyre approved a Current System, or their shown regulations is published saying they are ineffective so, that is one of our conundrums. It sits very well with your question. We arent officially ineffective until theyre found ineffective in a final regulation. That is what has been so problematic. Yes, it is very difficult to get to that point. Yes, and you know people can always submit data in these types of things that we propose them as ineffective and then they are back and forth. It can be prolonged very long. Thank you. We know that american patients provides have benefited greatly from Congress Previous authorization for authorization of the user fees, Prescription Drugs, generic drug, biologic and bio similar drugs, animal drugs, and we know that otc drugs have products lacked behind. How do you believe that the user fees authorized in this legislation combined with congressional appropriations will give you the necessary resources to bring the otc drug regulation on par with other drug and medical products . Secondly, in addition to the personnel increases, which you have talked about going from 30335, what resources will this legislation provide fda to improve the system . We plan to spend about 26 million on investing in an it system so this becomes paperless instead of a paper intensive process. That would require about 3 million a year ongoing maintenance once it is built. The 26 million would be spread out over the first four years or so as the program. We would also invest in the training of our people and developing processes and different matters like that. This level of program, as i said, will not result in the monograph all of being in the new order system and having all final orders at the end of five years. It wont be that fast. I appreciate that and you certainly let us know that. And you set the expectations. Are you saying right now the Current System relies on a paper process . To a great extent. And so the building of an appropriate it system, which doesnt exist right now, would be credibly humbled . Yes, and since we are going to put what i call the mulch behind all this past documentation that we have is all over the place, we can have an electronic gateway like we do for the other user programs submissions, electronic, standardized formats, many things that help everybody in a modern system the efficient. And just out of curiosity, you talk about additional training that would be needed besides the 30 staff that are currently on board. Have they been involved in this system or in this process in a significant way contract. Yes. Yes. They are bracing themselves if they have to train other people and try to complete some of the work at the same time. Thank you. I yield back. Chair thanks the gentle lady. Chair recognizes the gentle lady from michigan for five minutes questions. Thank you, mr. Chairman. Doctor, i think everyone here is a fan and we are grateful for all the work you are doing is sitting through these questions, many of which sound the same. I think we are all saying that we think of the otc system is working for patients, doctors, for people in industry who are making Innovative Products and your testimony said this and the questions and answers keep reaffirming. Just for the record, again, it is true that there are far more otc monograph products than a brand of Prescription Drug products. That is true. And despite this fact fda got only 7. 9 million last year to review otc products while Prescription Drugs ending totaled 1. 1 billion when user fees were included. Is that correct . That is correct. So, i do have this question because when youre talking about the five years and youre talking about creating an it system that doesnt exist can money help accelerate that five years contract will getting you more money we can always do more with more. We can move faster with more. So, at some point, you could give us so much how to create that it system which will tolerate it and maybe give us and thats not in a plane question by think its a question thats popular. The draft legislation we are considering today will give fda the resources and agency needs to do a more effective job . Definitely a more effective job. Absolutely. Especially we need the authority to do more effective job. We cant use the authority. As you just said, the lack of funding is not the only issue but the draft legislation were continuing today is also gives fda the authority to use the administering of orders to make changes to otc and monograph rather than current. [inaudible] which is a many monograph on finalized in critical safety issues unaddressed. Does fda believe that these changes in the draft legislation will make it easier to allow Innovative Products to make it to the market . While also allowing the agency to address the safety issues faster. Yes, there is a specific innovation pathway that has been built in with timelines and deliverables and so forth and we definitely can inflate that innovation is to be had in the space. Thank you. I think this goes a long way but i want to take a step back and give context into 14, congress came together unanimously to pass the sunscreen innovation acts because our nation spacing a skin cancer epidemic in the last time a new otc sunscreen ingredient was approved in the 1990s, what you know. This is a symptom of how broken the otc is overall but it is more pressing and more urgent because 5 million americans being treated for skin cancer every year and the rate of melanoma is on the rise. While otc reform will make it easier for all Innovative Products to safely and quickly get to market, we cannot forget the urgent need to ensure that there constituents have access to sunscreen products avenue safely for decades overseas. This is where the frustration comes from all of us. That is the work our congress is concerned about about the skin cancer academic and can we work with you in other stakeholders to ensure americans have access to the latest sunscreen ingredients and what do we need to do to make sure that thats here in short. We have met, as i said, all the stipulations have exceeded them in sunscreen innovation. What we are waiting for is dated for the safety data to be submitted. What the sunscreen innovation act did not do is lower the standards for safety for otc medicine and so, when we receive those data we will be able to review them promptly because, as i said, the sunscreen innovation act is one of our highest priorities. How long will it take to get that data . What is the hold up . Why is this account get a . Under most of the fda regulates we dont do that research. The research is done by the sponsors because they have the medicine, drugs, formulations and a summit that research to us. We wait for them to conduct the research and we give them parameters about what the research should look like to meet the standards and then we it is on their timeframe. Doing other time . We certainly are in contact with them about their activiti activities. I personally have met with him recently. Thank you. I yield back the bill for my time. Chair recognizes the gentleman from georgia. Five minutes for questions, please. Thank you. You for being here and help me to understand something understand here. I have been in between subcommittee hearing so please excuse me if i have missed this. When you come up with a profile for a certain ingredients, it doesnt apply to every product and every manufacturer that has a product out there. For instance ibuprofen, if you come up with a profile for ibuprofen and then you say if you have ibuprofen in your product you have to have this on your monograph . The monograph identifies the ingredients and then it specifies the ingredients and it specifies the dosages that can be used and it specifies in the regimen and it specifies what condition can be advertised for, right . If you then market using those parameters then you dont have to send in an application. If you market so, tell me if you find out something and you find out that ibuprofen over in a certain dosage causes toxicity or eating your stomach up and you want to get it so you go to every product out there that has a certain amount of ibuprofen in and you say you need to add this to your monograph . Know, the monograph is in fda regulation. Okay. And so we would have to change but if you change it do they have to does every product out there have to change . That is correct but they would have to have morning. That seems simple enough. Only if you got the slide and we for small, we have to have a final monograph in place and then we have to change it to rulemaking and through noticing how long does the process take the smart. Sixeight years. Oh please. Here is one. Heres the external i have seen that. Why does it take a long . Because. Doesnt take that long for prescription medications. Oh yeah, we get them off the market licketysplit if they are dangerous. Here the issue is say we have a final monograph in place and the government has a regulation in the regulation states that this drug is recognized as safe and effective and now were saying oh, it is not safe but we have a regulation that says it is safe. So, for the lawyers in the room they understand the problem. Okay . We have to then what we do now because of that is the issue safety alerts and we look for voluntary changes to the label but we cant mandate changes why not . Because its regulation. Because of the legislatio ren legislatively contract. Rules that we promulgate and we have to propagate a new rule. Thats how the new roles work. Let me ask you something. Let me ask for off the label uses. I practice pharmacy for over 30 years and i did that regularly. Do you ever address that. We address that in the sense that if an off label use is leading harm then we will send out safety alerts and help people and so forth. So, if a product has been on the market for years and lets just take, for example,. [inaudible] for many years it was an antihistamine that was used for bee stings or Something Like that and i always recommended it to help somebody sleep and now youve got benadryl p. M. And you got products and the art marketing for that. How long does that take to get that new indication their question. They are already partners, right . They are already part of the sleep aids. They are now but initially they werent. They always were, right . Im not sure about that. Nevertheless,. Okay, get a new one. Thats what youre asking about. [inaudible conversations] at one time when i was in school, which was just a few years ago, but one time, it was a side effect. Right. But that is what we used it for so, if the new indication comes out and how long does it take you to get that new indication for them to be able to market it that way. Under the monograph there is no way to do that. Unless it was marketed for that purpose 41972 then it is ineligible for the monograph. They could file an nda. Before 1972 . Yes, this whole system is fixed in 1972. I think we have discovered the problem. Thank you, doctor what. Chairman yield back. Doctor woodcock, i deferred my questions until the end and i just have a couple. First off, you mentioned that the start you had a pending monograph and does the committee have that list and are you able to share that . We certainly can provide that. It would provide context of what we are working on. With mr. Carters line of questions, there used to be an overthecounter asthma inhaler and there is not and that was part of the 1972 that that product was available. So, let me just ask the question because i know im going to get it from other people is where do we stand with providing that active pharmaceutical ingredient that was in overthecounter asthma inhaler prior to 1972 . Right. I cant comment on pending applications but that was not a monograph products for that was a new drug application product. A new drug explication . Product yes. There are products overthecounter like, say, federal antifungal and those were all switched from Prescription Drugs and they are still have a new drug application they are not monograph products. I see. Well, let me just make a plea that asthmatics do need an overthecounter preparation and they shouldnt have to incur an emergency room charge in the middle of the night just because to get relief. With the gentleman yield . Briefly. Im sorry. What you do in situations like pseudoephedrine which has been a proof but is being abused and do you do anything in that situation . Congress took the step of moving that and restricting why would Congress Need to press what i wouldve thought that was your job. I dont think we have the authority to do that. So if you see that a drug that has been approved in 1972 act is now being abused, you dont have the authority to do something about that . We can move against things on safety grounds. But that was being used as an ingredient in manufacturing and abuse drug. Is not enough to start. I would not like to give a legal opinion here. Is a gentleman, could take my time and there have been various states regulations that have been applied and that is why in different states theres a different requirement as to whether or not you need to show a drivers license to purchase those products however, when there was a product that was marketed that contained some derivative of ephedrine i thank you all did move pretty quickly to remove that from the market. We did. That was the safety related to that. Well, i want to thank you for being here today and just to address the comments that were made on both sides of the dais, where has the committee been and where has the agency been and i have just been through my third reauthorization of the user Fee Agreement. This concept was brought to me late in the spring and we were pretty far down the road on the user Fee Agreement and i made the decision that nothing would deter us from getting the user Fee Agreements across the finish line and we did. We recognize that there would be some serious personal repercussions at the agency, if we did not do our work. We did. I also committed that we would tackle this problem quickly after we got the user Fee Agreement put together and delivered and here we are today. I know i personally have made through trips to your physical campus and you received myself and staff one time when we are worried about the drug shortages, a few years ago. I think i was there on doctor hamburgs first day. They were kind enough to have me out in the previous iteration of your headquarters so, the agency i have always found it to be welcoming to Committee Members and there has never been that i have detected any reluctance of the agency to talk to members of the committee. Now, maybe there are rules that prohibit the direct patient, as far as what would be considered a lobbying, but generally the flow of information from the agency to, at least myself as member of congress, i found the door to be opened. Im grateful for that. Grateful for your test money here today and i thank you have helped this process and clearly it is something that needs to be addressed in fixed and we will continue to pursue it and get it done. We will conclude this panel. I will not recess in the interest of time but we do have another panel to follow. Again, thank you doctor woodcock and we look forward to your next adventure here. Wha[inaudible conversations] we will now hear from our second panel of witnesses. Again, we do want to thank our witnesses for being here today and taking the time to testify before the subcommittee each witness will have the opportunity to give an Opening Statement followed by questions from members. Our second panel will hear from mr. Scott melville, president and ceo of Consumer Products association. Mr. Kristin moore, project wrap for Healthcare Products, mr. Michael warner, partner on behalf of the Public Access to sunscreens coalition. Doctor Bridget Jones, chair committee on drugs American Academy of pediatrics and mr. Gil ross, president and Pharma Bio Pharma outsourcing association. We do appreciate you being here today. Mr. Melville, you are recognized for five minutes for an opening, please. Please use the microphone. Thank you for the opportunity to provide this money today on the overthecounter monograph system. And the importance of modernizing regulation to enhance the Public Health. My name is Scott Melville and im president and ceo of the Consumer Healthcare products association. Since 1881, the hpa has served as the Industry Association representing leading manufacturers and marketers of overthecounter medicines in the United States. See hpa members produce the mass majority of medicines in our country and provide millions of americans with safe, effective and affordable therapies to treat, prevent and many Common Elements and conditions. The availability of selfcare Treatment Options saves money, reduces burdens on the health care system, and keeps consumers active and productive. Given the importance of otc medicines to consumers in our nations healthcare system, its essential that the regulatory structure that oversees these medicines is one that is modern, efficient, transparent and accommodating to innovation. The vast majority of otc medicines in our homes today are regulated under the otc monograph system and our member strongly support the system. It oversees over 300 active ingredients and more than 100,000 nonprescription products ranging from antacids to diaper rash creams, from pain relievers to coffin will products. While the otc system was created over 40 years ago, as we heard earlier today from several speakers, the process is still not complete. Movement on unfinished items has ground to a halt, largely because of the system is based on noticing comment rulemaking. A thorough but extremely timeconsuming process that has slowed across all Government Agencies and partners in recent years. Change is needed to have a regular system that accounts for advances in science. It accommodates innovation, permits timely updates to safety information, creates a workable process for completing unfinished monographs. See hpa has therefore worked with fda and members of the congress to provide recommendations for a modernized monograph process by which fda can make scientific determinations for these ingredients through administrative order process rather than notice and comment rulemaking with necessary due process protections for dispute resolution and issue escalation. These impairments would empower the fda to ask more quickly when needed to address safety issues for other monograph changes while preserving the existing monograph structure. A structure that does not require unnecessary free market review, provided manufacturers utilizing agreement that have been determined to be generally recognized as safe and effective by the fda. We understand that this new system is enacted by congress, will require more effort on fdas part which is why our industry is willing to supplement Government Resources with a modest User Fee Program. We believe that the agreement strikes the right balance and will help achieve a more nimble regulatory structure for monograph drugs that would be a win, win, win for consumers, manufacturers and regulators. In summary, the draft legislation we are discussing today is incredibly important and, if enacted, will impact the health of nearly every american for decades to come. It is the product of months and years of consideration in demise between stakeholders, including see hpas manufacturer members. See hpa has some important technical comments on the discussion draft and we look forward to continuing to work with members of the committee to finalize the text and supported instruction and consideration in the near future. Thank you. Thank you. You are recognized for five minutes for questions, please. Thank you. Thank you for holding the hearing and for the invitation to testify. My name is Kirsten Moore and i direct the trust Healthcare Products the product. It is a nonpartisan, nonprofit and Advocacy Center and im here in strong support of this legislation that would help update fdas regulation over the counter products. By streamlining fda process you have the opportunity to improve consumer safety and promote innovation. My remarks will focus on the problems of the outdated otc monograph system, its Public Health implications and the benefits of the proposed legislation. Each year more than 240 million americans use otc products in this market places vast and diverse with up to 300,000 products ranging from cough and cold, to sunscreens, to pain relievers, and in theory the active ingredients in these products are considered safe and effective when consumers follow the instructors on the label without direction from health care provider. In practice, however, many contain ingredients that the fda has not yet evaluated. There is no deadline by which fdas ingredients must be finalized in several of these reviews have lasted decades. Two main problems lead us to this point. First, fda is favored by a cumbersome and inefficient regulatory system in evaluating these products. It is a system that is not been updated since its introduction in 1972. Second, fda has only 30 fulltime employees in approximately eightpoint to Million Dollars to oversee this growing marketplace. Fda evaluates safety and efficacy of otc radiance for monograph system which is described in greater detail in my written testimony but important to note that the changing a paragraph is a multistep process involving reviews by fda, the chairman of health and human services, and often the White House Office of management and budget. In contrast, fda review of Prescription Drugs relies solely within fdas jurisdiction. The additional steps for review for otc products at considerable time and do not add the key determinations of safety and efficacy. Let me provide one example of the Current Systems effects of Public Health. This april, fda required the companies add the strongest form of warning labels to childrens prescription cough and pain medication containing coding. The drug can cause potentially fatal breathing problems, especially in children under 12. These safety concerns lead Advisory Committee to recommend that fda remove coding from otc products in 2015 but fda has not yet made this change yet because of the inefficient monograph system. When patients are in harms way, we need action, not bureaucracy. This spring, few other stakeholders issued a set up as most for overthecounter monograph perform. These principles are probably reflective in both the house and the Senate Language and the Bipartisan Legislation that you are considering would produce a winwin reducing revelatory burdens and protecting consumers in four key ways. First, by driving efficiency. The proposed reforms will replace cumbersome rulemaking with an administrative process aligning fdas Decisionmaking Authority for otc products with authority for Prescription Drugs. Legislation also would expedite the review process by giving the secretary Additional Authority for data collections. Second, improving safety. The proposal will ensure that fda has reason to believe a product is a safe, it can take swift action. Currently products remain on the market when fda has insufficient information about whether or not they are safe and effective because they cannot be removed before final monograph is issued. Third, helping innovation. Under this legislation fda can more quickly, accommodate products for many new ingredients as well as new indications and formulations on existing ingredients. Lastly, providing resources. The proposed agreement would provide fda with the resources required to clear out the fdas review backlog, address safety concerns for product currents on the market, in review future applications for Innovative Products in a more timely manner. What it supports to it strikes a sensible balance of reflexive couple compromise between stakeholders. The current monograph system has had detrimental effects on consumers in theaters fdas ability to ensure that the effectiveness of the overthecounter products. We applaud the subcommittee for the bipartisan proposal and urged congress to capitalize on this momentum and pass this legislation as soon as possible. Thank you. Thank you. Mr. Warner, your recognized for five minutes. Opening statement. [inaudible] thank you for inviting me to testify today regarding efforts to improve and strengthen the approval process for overthecounter otc products, including sunscreen ingredient. The past coalition is a multi Stakeholder Coalition is a Public Health groups, dermatologist, sunscreen and lectures in leading advocates for skin cancer patients. The past coalition was formed to ensure americans have access to the latest sunscreen technology to curb the skin cancer epidemic in the United States. To address this problem, congress led by the subcommittee the fda, coalition and other stakeholders came together to enact the bipartisan sunscreen innovation act, the sia in 2014 to ensure that americans get access to new sunscreen. Working together, we identified regulatory barriers to the consideration of otc sunscreen ingredients and created historical forms to address them. The act was enacted by the house and senate unanimously. The past Coalition Supports the efforts of the many to extend full reforms to other otc product categories. We also support the establishment of the User Fee Program to provide fda with the resources they need to implement these reforms. Based on our experience over the last three years with limitation of the sia and our productive conversations with fda leadership, including doctor woodcock, we believe there are several improvements needed to continue to enhance the review process for printing and new screening ratings. The otc reform legislation being considered by the committee provides the opportunity to codify these improvements and achieve the promise of the sia. Mr. Chairman, and cancer remains a Public Health crisis in the United States. According to the Surgeon General over 5 million americans are treated with cancer every year. Each year there are more new cases of skin cancer than breast cancer, prostate cancer, lung cancer and colon cancer tonight. In the us a person is diagnosed with melanoma every eight minutes in an american loses her life every hour from the disease. Clearly, americans need access to all available safe and effective sunscreen products. The last time a new otc sunscreen was approved in the us was decades ago and 2002, eight new sunscreen ingredients have been submitted for review under the fdas socalled time and extent process. These ingredients have been widely available in europe, asia, and elsewhere for decades. Clearing the backlog of applications will ensure that americans have greater access to Broad Spectrum sunscreen and get better protection against both uva and uvb rates. As you heard this morning, fda has met all the timelines provided by the act but unfortunately none of the eight pending sunscreen ingredient has yet received a final decision and they are not available in the United States. Based on recent conversations with fda, there is an agreement that some changes to the sia for the eight pending agreements are needed and that a new otc pathway should accommodate screening ratings. So, as Congress Considers otc reform legislation the past coalition respectfully met the following principles for consideration first, the eight sunscreen ingredients party received proposed administrative orders to continue to be considered under the sia. New sunscreen ingredients should go through the otc reform framework. Second, any new otc approval pathway should be flexible enough to accommodate new sunscreen ingredients us or International Market experience and not require sponsor to file a new drug application for its active ingredient to be considered for an otc administrative order. Third, any otc with legislation should authorize fda to meet individually on a confidential basis with sponsors of sunscreen ingredients to allow for open discussion of commercial, confidential information and trade secrets. Finally, the fda testing standards for these products should be periodically reviewed and assessed. Inclusion of provisions that incorporate the balls will ensure americans have access to safe and effective sunscreen ingredients that are available across the world. The draft legislation that we have seen contains many of these provisions and we look forward to continuing the subcommittee. Thank you for the opportunity to buy. I look forward to your questio questions. The chair organizes doctor jones for five minutes for your Opening Statement. Thank you. Good morning. Thank you for the opportunity to speak here for the importance of modernizing the regulation of overthecounter drugs for americas children. My name is doctor Bridget Jones and im a practicing allergy, allergy immunologist in kansas city maggiore. I also conduct Clinical Research provide the safety and efficacy for drugs of children. Im here today to represent the American Academy of pediatrics or the aap. In my practice, i frequently need to discuss with parents the risk and benefits of using otc medicines to treat common pediatric illnesses such as allergies and asthma. As a pediatrician, advising parents i want to know that the products i recommend have been tested to ensure that they are safe, effective and labeled appropriately for their use. Therefore, we must have a process to regulate them that is responsive to the most recent medical science. The current otc regulation process at the fda is not able to adapt an emerging evidence based on concerns or products innovation. For the regulatory process is caused unnecessary delays in the otc monograph was in large part developed based on evidence from 50 years ago. Some of these drugs continue to be mainstays of pediatric practice but others, we know from more recent evidence, provide little or no benefit to children. Put simply, the Current System does not serve the need for children. The only way to ensure reliable in safe otc medicines for families is to change how the monograph system works and provide significant new resources for the endeavor. Therefore, the aap strongly supports the effort of congress to reform the process and create a User Fee Program to fund fdas monograph work. The monograph regulating cough and Cold Medicine for children is a good example of how the process does not work. The data that led fda to label these medicines for children does not meet todays standard and data gathered since then clearly shows cough and cold products to be completely ineffective for children. Nevertheless, these products are still commonly marketed to children despite safety risk. While fda does agree to revise these more than a decade ago today they have yet to publish draft changes despite evidence that these products result in thousands of pediatric overdose related emergency visits each year. It is our hope that through reform the monograph system the fda will act at long last to modernize the cough and cold monograph. We also must ensure that innovation made possible by otc reform does not have unintended negative consequences. One area where we it is be greater in the is in the development of nonfarm relations for otc products. It is possible that industry may work dummy formulations much like. [inaudible] dummy formulations of ot drugs whether intended for children or adults have greatly concerned beauticians that we know when a product looks and taste like candy, children will eat it. If a child consumes gummy acetaminophen for instance outside the watchful eye appearance it could lead to a trip to the emergency room or worse. Therefore fda must have Clear Authority to regulate the packaging of otc drugs including requirements for unit dose packaging such as packs that will prevent abuse and protects against unsupervised ingestion. While the Consumer Product Safety Commission has existing authority to require the drugs coming Child Resistant Packaging tested to ensure that it is difficult for children to open, cpsc cannot require specific types of packaging. Therefore, fda must be able to do so and since the pfd only requires a small handful of monograph drugs to be sold in Child Resistant Packaging greater collaboration between fda and cpsc is critically important. Mr. Chairman, the latest discussion draft is largely reflective of the aaps principal for otc monograph form. We strongly support the packaging language. Additionally, we look forward to continuing to work with the committee to ensure that the fda and the bsd established process for notifications when the fda takes action that might warrant cpsc reevaluation of its own packaging regulations. Thank you for the opportunity to speak here today about this important issue. Thank you. Mr. Ross, he recognized for five minutes for Opening Statement. Thank you. Thank you for the opportunity to submit as many about the proposed overthecounter monograph safety, innovation and reform act of 2017. I am gil ross, president of the bio pharma outsourcing or pb oa. P boa is a leading trade association for Contract Manufacturing organizations and Contract Development and organizations known as cmos and cdm owes. P boa core mission is to advance regulatory general business interests of the cmo and cdm o sector. I am here today to express the support for the newly released draft to urge this committee and the congress to advance the strapped into express my thanks for ensuring that the strap takes into account the unique needs of the cmo, cdm o community. Their willingness to ensure our seat at the table is greatly appreciated and pb oa strongly believes resulted in a release of a better draft to serving bipartisan support. You may wonder what is cmo and cdm o is and how these companies contribute to the development of drugs or in this case, over the counter drugs. Cmos, cdm owes are the true experts in manufacturing and members are predominantly domestic provide manufacturing from information technology, packaging and other services that enable Drug Companies to develop and commercialize medicine. They help make more than one third of all doses dispensed to patients in america, producing both innovative drugs in generics, small molecules and biologics, pills to eject bubbles, otcs and file similars. Cmo, cdm owes empower their customers to bring lifesaving costeffective, quality medicines to patients. Ive been involved in the cmo sector since 1999 and when is the industrys rapid growth and the key role it plays in the American Health care system. Id like to commend the committee for your continued focus on the important issues we will examine today. The fda has long outstanding commitments to produce and finalize overthecounter monograph with began year after i was born and has been noted the current physical year the fda has allocated 8 million to such efforts. Some that can only yield minimal dedicated staff and little progress. The industry, the fda in the congress can agree that the monograph process overall is outdated and further, there is recognition that monograph you cannot expand without additional resources. The legislation under consideration should help resolve those issues. It will provide resources to fda to finalize long unfinished monograph giving manufactures a degree of certainty. As with other User Fee Programs, the transparency and goals dictated by the commitment should provide industry with tractability. A roof was passed is overdue and can benefit manufacturers and marketers alike. Including cmos specializing in unique dosage forms. Although p boa does not include negotiations between industry and fda it would please the legislative tax discussion under. [inaudible] it provides a degree of lease funds overall and we are very appreciative of this role the stakeholder voices were heard as we develop this draft. We hope the p boa and cdm o businesses that represents will be included in future fda user fee negotiations. Particularly, ones that are considering contributions from the Manufacturing Sector in the form of facility fees. We look forward to continuing to participate in the legislative process relating to. [inaudible] and to the day when this good legislation is signed into law. Thank you again for the opportunity and im available for questions we think the gentleman. We think all of our witnesses for your testimony and we move into the member question portion of the hearing and i will yield to mr. Guthrie of kentucky for five minutes for your question, please. Thank you. [inaudible] i have worked on the sunscreen innovation act in the past and work to ensure that in this package we work to further addressing the needs of the continued hold up we see on these products that the fda. Can you outline the positive benefits that you see in monograph proposal for sunscreen products . [inaudible] [inaudible] as science has evolved over the years, new ingredients have been available elsewhere in the United States. There hasnt been a process, as doctor woodcock mentioned, to innovate under the monograph system. With the exception of a process called time and extend applications that has never proven to be a very effective approach to market and very timeconsuming and therefore, the monograph performs being discussed today it would open up a new opportunity to go to the monograph system and not using those that has been sufficiently used but use the administrative order process which would be a much more effective and efficient process. Monograph drugs that are sunscreen you have two choices today under this law. You could continue, as mr. Warner said, to operate under the sunscreen innovation act that Congress Passed in implanted four years ago or you could elect to operate under the new monograph structure, and i think longterm gradients would be utilized the new structure. Its very positive for sunscreen. Thank you. We didnt hear your test paper you mentioned to be over the counter the view process to be flexible to accommodate sunscreen and how active agreements are slightly different then say advil or tylenol. Can you explain that . Sure, thank you. So, for small, yes, the new overthecounter process has to be flexible enough to accommodate sunscreen and a couple of the big reasons that those are different is because number one, the new drug application process isnt really feasible for sunscreen products for any number of reasons not the least of which is that would give you an approval for final product and final formulation and sunscreens, sunscreen ingredients are used in lots of different products. Number one and number two is sunscreens change with the seasons for they might change their scent and they might change their lives and et cetera. The process has to provide for an alternative pathway to approval and the otc space, besides the new drug application in draft legislation certainly does that. The other thing is just like current law sunscreen many lectures should be able to use their safety and efficacy data from elsewhere around the world where the products are being used and as part of their application process to demonstrate safety and effectiveness for the fda purpose and thats another way that the products are slightly different and its another way that it accommodates both products. Okay. Thank you. Mr. Roth, in your money you talk about how they specialize in unique dosage forms. Can you please explain this process further and explain how the process would be affected by overthecounter monograph for . Some cmos essentially work informational dosage form models and a great portion of the market is comprised by those but other ones do work in unique dosage forms and in semisolid and other topical Delivery Systems et cetera. For some of those types of dosages, it is possible that innovation in the monograph might lead to products that they would then be open to manufacturing where just changing the type of the pill might not be as big and innovation. For this Technology Provider like some of our Member Companies this could open the door to new otc monograph products if they would produce for their customers. Thank you. I yield that my time. Gentleman yields back in the gentleman from texas is recognized. Ms. Moore, and mr. Melville, some of the benefits of the reform has been potential for streamlining innovation in the otc drug market and it is also proposes an Additional Market of incentive that would provide 24 months of exclusivity to an innovative overthecounter product and many support targeted exclusivity and certain product areas to create a market where one does exist such as antibiotics or areas where we want to give their greater competition such as with the generic drug products. I think that issue exclusivity is part of this legislation and we appreciate the different roles and benefits to be under different legislation. Wed to legislate for overthecounter products we want innovation in the marketplace, it would be worthwhile for a the industry and other stakeholders to reach a time table to evaluate if that is striking the right balance and improving patients access. I heard a cry of your members with the exclusivity about paying the user fees that regardless of the streamlining that the executive order to set aside if that was then what about that product to have that long of day period to block access to increase patient utilization . Y n of the great benefits of the industry it gives consumers a choice with the branded product or a store brand product. The prices under 8 they are very affordable. One of those systems currently enforced has spent in the market since 1972 and has not been a lot of innovation but to spur that a manufacturer has to come to the table with data that the drug will work on humans. That is very costly and if you dont have that exclusivity the next day there could be a private label version of the market. Our association represents branded manufacturers and the chairman right now for the Largest Store brand any fracture in the United States is a strong supporter of exclusivity to recognize that investment to innovate and part of the future pipeline. Also to encourage that Regulatory Reform also to see that marco of exclusivity to see that issue with the subcommittee to make sure that doesnt overtake the for that patient access. So working closely with the Contract Manufacturing organizations and day are tailored to those companies so kid you elaborate with that value of the otc products . So internally with the industry the much lower margins when it comes to working with b otc products with the prescription and generic products that they manufacture so working with Industry Partners to have a model that would reflect those respective values from the up products and this product overall. Does that answer your question . You are out of time. 8q very much for being here today. I will open it up to whoever wants to open this up is there anything we have been in the discussion draft that would cause concern . Who wants to jump in first . No. We strongly support having explicit authority for packaging that is in the statute of how that can be applied is still being discussed. There are three ways fda than under the statute in to move very quickly and then there is an interim authority to update that labeling and we strongly support that. So with the gray enhancement over current law with a public discussion before it takes effect. That requires that tight of discussion. So that is limited to the administrative order process. That is why i asked the questions. Is there something you think we ought to have in their . Does anybody else have something we should put on the table to discuss . It sounds like there is a bipartisan agreement to make sure we cover all bases. As we said in our testimony we do think it would be useful to incorporate some way to assess that standard the fda has published guidance and certainly it goes a long way with the agreement of the appropriate standards. Uphill on reauthorization to evaluate how bad is going. And i appreciate what you do with an 11 yearold has all kinds of issues cents four months old and appreciating your comments and every kid is a little bit different as i am sure you are aware. Because you could not find Something Else that would work. Is that correct . Yes. There are significant strides over those last several years that 50 or 60 percent of the drugs that are used off label. We dont have that dosage and if they are effective but it if they have some evidence that it could work then you are forced to use of medication in the off label situation. But we are making significant strides. It is good information. In to do Due Diligence to comb of literature and to make as a difficult decision with off label medication. More information is better than and less . Yes. And appreciating your testimony to three years ago us difficulty with the acetaminophen to be given a childs dose of the infinite concentration that the youth preparation was more potent for concentrated than what was labeled for children and there were some therapeutic misadventures with acetaminophen because of that. Correct. One of the things you strive to avoid in the of future from one apparent mighting counter with that child stowes of intent is not appropriate. The acetaminophen in the correct dose for that medication dose the limitations that we cannot put that information on the packaging or the labeling so they are less than two years of age to say contactor Health Provider how to dose that medication. If you are a parent to the middle of the night and your baby has a fever less in two years of age you do not have the instruction is there to tell you how to dose of medication so that is the safety issue if they cannot contact the health care provider. So hopefully those will be addressed with legislation. That is my hope as well and with cross jurisdiction as dr. Woodcock mentioned as well one of the things taken into account i have now id even consider the dispensing mechanism like the dummy bears is a special challenge as far as packaging is concerned. So one of the reasons to be nimble to be much more agile and is currently capable. And acetaminophen is a great example that the fda could not move forward quickly on that. Because of the requirement under the Current System of today the industry did move forward and as dr. Jones referred to was both permit it the industry voluntarily did that these are real world there was some confusion so today there is only one concentration and it is more diluted we also voluntarily had florey stricter so of the children did get into a bottle they could not get a full dose so the industry has moved forward to innovate to improve the safety it is a work in progress to work with them with these improvements for all participants in the industry. You brought up activity of the structure we are in now so it makes me wonder in the future will there be an app for that . [laughter] in the future uses of technology have different labels for a hologram with different languages. I think the options are led the list for using technology for the safe use and we will work with fda on those issues. Frequently there is a you to the video how to provide the instructions that you need. [laughter] error is things to the witnesses before be here today and your testimony know for their members want to ask questions pursuant to Committee Rules to have 10 Business Days to submit additional questions for the record and ask the witnesses to recede submit within 10 Business Days of receiving those questions. We are adjourned. [inaudible conversations] [inaudible conversations]. You had a pretty violent temper. Can you explain . Yes. I think it was because i was thinking about me. House somebody took my things are in there in my space. One day when i was 14 i tried to stab him with a kid the knife luckily he had a large belt buckle and is struck with such force that a broken he was terrified but i was more terrified because i was going to take somebodys life over nothing in that had a profound effect on me. A lot myself in the bathroom in it turned things around academically went from a terrible student to the top of the class. I realize they could never become a doctor with a temper like that would be jailed or Reform School or the grave and that was not an option so i just prayed there was a bible i picked it up there all these verses about in your like proverbs 19. Nineteen. Also proverbs 16, 32. Is over three hours they stayed in there praying and reading and contemplating with the understanding that to react violently was not a sign of strength and but a sign of weakness that means you can easily be manipulated by your environment so i decided i would doubt be manipulated. Good afternoon. Of a leg to repaid a statement bin from u. K. And france spent the u. S. Condemned the attacks in london today that targeted innocent civilians during their commute on the subway. We are grateful dolan was killed and our thoughts and prayers go with th