Transcripts For CSPAN2 Hearing Looks At Changes To Over-the-Counter Drug Regulation 20170918

Minutes. Subcommittee on health will now come to order. Ill recognize myself five minutes for an Opening Statement. Todays hearing marks the Health Subcommittees first public discussion on modernizing the Current System at the United States food and Drug Administration to review, approve and update overthecounter drugs. This hearing provides us and the American Public with an opportunity to better understand the food and Drug Administrations Regulatory Framework to regulate overthecounter drugs and to consider a proposal to reform the monograph system. Today we will convene two panels of witnesses. First i want to welcome dr. Woodcome back to our subcommittee woodcock back to our subcommittee. Later we will hear from other key stakeholders, and i would like to commend all for their efforts throughout the negotiation process and for offering their insight to the committee. Both the energy and Commerce Health subcommittee and the full committee have a strong record of bipartisanship on important Public Health issues such as 2 19th century 21st century cures, and i hope to add to that record of success with todays hearing. Overthecounter drug products treat a wide varian tiff of ailments, time and again consumers seek antacids, pain relievers, cough products as a firstline treatment option before going to see their doctor and getting a prescription. These products also include antibacterial soaps, hand sanitizers, sunscreens, and the sunscreens 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. These products go through one of two approval processes to reach the store shelf. Manufacturers can, one, 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 food and Drug Administration that insures the products active ingredients are generally recognized as safe and effective. The vast majority of overthecounter products rely on the overthecounter drug monograph system. Unfortunately, the Current System has not had a significant update since the food and Drug Administration first established this in 1972, so thats well other 40 years. In addition, this system requires a burdensome, multistep rulemaking process that can take years to resf. All of this has led to a lack of innovation and an inability for timely updates to address safety issues and much work left unfinished at the food and Drug Administration. Most of us on the committee feel that is unacceptable. The good news is that there is broad support from the food and Drug Administration, from industry stake molders stakeholders, from patient groups for significant reform to regulate overthecounter products. The Health Subcommittee will examine the overthecounter reform act of 2017. The discussion draft was recently released by representatives degette, guthrie, ding get, green and myself. This bipartisan establishes the Monograph User Fee Program and makes a number of meaningful modifications to the monograph 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 all of our witnesses for being here this morning, certainly look forward to your testimony. Before i yield to the Ranking Member, one housekeeping detail. Although this is the premier committee for technology in the United States congress, some of our systems are not working this morning. [laughter] so i understand dr. Woodcock had a series of slides, so those will be made available to you in paper form. We require our doctors to go paperless, but here on the committee we can still deal with paper. And the clock is working but only i can see it, dr. Woodcock. So the red, green and yellow lights are not working. I will give a brief click when were getting down into the yellow zone so youll know that the time is to wrap with up, and well do that, obviously, for everyone on the Committee Just as a genre minder were coming to the end. So with that, ill yield back and recognize the Ranking Member of the subcommittee, mr. Green of texas. With annual sales of 32 billion. The Items Available with a diverse range of medications and pain relievers, screen sentencing hearing name. It regulates most of these drugs under the otc system. The active ingredients of these nonprescription products are considered safe and effective when consumers follow the instructions without direction from a health care provider. While that is largely true, many containing ingredients the fda has not yet evaluated are known to be for labels to warn consumers of potential harms. The Current System also poses the challenge is for consumer access to potentially better, safer, Innovative Products. Fda oversight of products are put into place in 1972 and has not been updated despite increasingly diverse large market to the need for reform brought into sharper focus on the innovation i peered under the Current System the drug apparatus established directory step of the grueling process with publication in the federal register and Public Commentary. This antiquity that system is overly burdensome and frankly doesnt work very well. Its unable to respond quickly to safety concerns and keep pace with scientific discovery which puts consumers at risk and slows the drug previously has an has an estimated 80 april makings and 26 therapeutic categories that cover over 100,000 products. Its one of the largest and most complex regulatory schemes and also dramatically underresourced. The agency is 30 fulltime employees of roughly 8 million for contacts 18 fulltime employees devoted to the rule of one novel drug application in the otc market now include products with annual sales of 32 billion spirit recognizing the resource process challenge of the Acoustic Monitoring Program stakeholders and fda begin to think about how it can work for veteran values establishing the User Fee Program. Representative dingell, and burgess have been working on a bipartisan fashion to put together a bill that would establish an otc User Fee Program and perform the system. Today we have a discussion that reflects the work of stakeholders the fda cameras and im happy to see the committee moving forward. I know we should consider doing the same with cosmetics. Many parallels between cosmetics and otc products in the way consumers use and think about cosmetics and otc products and also the challenges fda faces and overseeing the categories of everyday items that attacker health. Otc will help foster growth in the availability of these medicines. Policy reforms make the system even more flexible and accommodating to innovation and knowledge about potential harms from the use, ultimately modernizing the otc system to ensure the industry except it was safe ingredients for Consumers Choice and ensure the fda has resources to improve safety changes come innovation in the otc market. I look forward to hearing from witnesses about this and id like to get the remainder of my time to congresswoman to get. [inaudible] 40 seconds. [inaudible] yeah, i dont think your mic is on. [inaudible] [inaudible] to warn parents about risks for Young Children but the effort to convince unsuccessful extremely burdensome process to update and change. What this bill would do is protect consumers another review overthecounter medicines. Youre with us today to get the same kind and to so many other issues. We had a great opportunity to upgrade the regulatory process in a way that benefits everybody, the American Public, federal government. I look forward to continuing to work with my colleagues to support themselves in a thank you very much, mr. Chairman. I yield back. The gentleman from texas field back to the chair recognizes the gentleman from organ, chairman of the committee for five minutes. Thank you, mr. Chairman. Appreciate you holding a hearing on these issues and the fda to improve efficiency and update their framework for regulating overthecounter drug products. The following the successful reauthorization of several fda critical programs, no better time to continue our work there now in the space and includes a bipartisan effort to 30 begun. Cough and Cold Medicine come in a purse rents, if noncitizens, and they are filled with overthecounter or otc drugs and American Consumers rely upon daily. Unfortunately the process weve heard has been the theme since the 70s and i see her coming back. We need to innovate in this sector and safety changes take years to implement, simply unacceptable. Fortunately, fda, regulated industry, all agree significant reform is something we all need to join hands on. Several years now been engaged productive conversation on this substantially improve the status quo in owned by the ongoing dialogue we have a bipartisan resolution before us today that will insure americans have more timely access to safe and affect the otc medicines. Consumers no longer have to wait years for them luck symbol rulemaking process to wind its way through bureaucracy before benefiting product improvements. I want to thank our colleagues, and mr. Latta, ministering for, guthrie, burgess, mr. Pallone another is to have put their shoulder to the wheel on this when we proven time and again in this committee we know how the legislative bipartisan way to get things done for the American Consumers. With auto yield to the gentleman from ohio for the remainder of my time. I thank the chairman for yielding that i also think chairman burgess for holding todays hearing. They also want to think or witnesses for being with us today. Its argued that overthecounter medicine in every household across our nation despite the widespread utilization to regulate these drugs has been out needed for decades. The more flexible framework of Consumer Choice and better address a potential in safety. It will achieve these goals and provide predictability to the drug approval process. The otc safety innovation reform act is a bipartisan collaboration between lack of health. The chairman of the subcommittee, mr. Burgess, Ranking Member green, ministering for current vice chairman guthrie and ms. Dingo as well a significant contributions from the fda in the industry. Id like to thank those involved to work tirelessly on the effort in order to increase Consumer Choice and safety. Appreciate the chairman for allowing the opportunity to improve upon the discussion draft today. Look forward to hearing todays testimony and seen them put her my colleagues on the subcommittee. I thank the chairman for holding todays hearing and i yield act. And i yield to mr. Guthrie. Thank you for yielding, mr. Chairman. I want to thank you for holding this hearing today and examine the review process of overthecounter drugs. This would enable greater integration and inefficiencies within the approval process of overthecounter drugs, something not been done since the 1970s and i want to specifically thank congressman latta for his leadership on this issue. Im proud to be a cosponsor for several of my colleagues supported the bipartisan bill with industry and the Committee Staff worked so hard to move forward. I strongly believe the legislation would help every american has these products are the first in line. I always appreciate you being here and i think our other witnesses will follow and if theres no one else, i will yield back. The gentleman yells back. The chair now recognizes the gentleman from new jersey, mr. Pallone for five minutes for an Opening Statement. Thank you, mr. Chairman. I want to thank you for holding todays hearing on the overthecounter drug monograph reforming the establishment of the Monograph User Fee Program. I also want to commend Ranking Member green, representatives degette, latta commenting proposing will accomplish these goals for the safety and effectiveness of overthecounter drugs established through the monograph in the rule book outlines the conditions of use for particular ingredient outlines the dosage of the population labeling and requirements. The rulebook establishes the threephase rulemaking process often times and flexible and timeconsuming, making it difficult for actually two quickly up date safety of other issues. Well sue. Well sue you for nifty industries at the monograph process does not limit the flow to evolving science and technology and may have discouraging the development and formulation. Not only is it clear that Regulatory Reform is needed that the Current Program is drastically underresourced. Today the otc Monograph Program oversees more than 100,000 products in the budget of just over 8 million. The Regulatory Reform increases the resources we can streamline overthecounter process to allow the finalization of current monograph, timely updates and encourage innovation where possible. While we began to cross significant improvements of the review of overthecounter products, i hoped would begin taking action on cosmetics that millions of americans use cosmetic products, but is woefully inadequate in in just the lash of millions of women and children have been exposed to shampoos that cause extraordinary hair loss, lip balm that can cause blistering and rashes and i shimmers tainted by asbestos. Unfortunately, fda does not have the authority to hold these manufacturers want the bulk and very little ability ensure these cosmetics are safe. This cant continue and as we move forward, we should provide adequate researching an authority than i look forward to continuing to work with my colleagues the fda industry and other stakeholders to accomplish these goals and ensure the continued availability of safety to the millions of drug products and personal Care Products people use everyday. I would like to yield the time how blessed to ms. Dingell. I thank my colleagues for yielding. Americans deserve peace of mind in knowing that all drug are effective, whether Prescription Drugs or overthecounter drugs. Over 300,000 overthecounter products on the market today with everyday life. Give fda regulatory is completely broken did the budget of 8 billion from which all of us say over and over in a cumbersome process that the agencys ability of drug safety risks with new and Innovative Products to market. The legislation creates a new user fee system for products to give the resources it needs to ensure Patient Safety and also allows the agency to a data and revised the monograph system to administrative order rather than noticing comment rulemaking similar to the reform made under the immigration act. Weve seen the benefit user fees on Prescription Drugs and medical devices and into the otc space as well and while we are pleased we have this hearing, i want to commend ms. Pallone for the cosmetic also a desperately benefit to reform and hope the committee will soon move forward with legislation establishing the User Fee Program for these products. I want to thank my colleagues, congressman latta, degette, green for working on this legislation and continuing our Work Together to reach consensus on this important issue and is always her chairman and ranking minority member. I yield back the balance of my time. And i yield back tears that gentleman from new jersey yields back. This concludes the number of pending statements. Pursuant to committee rules, all members Opening Statements will be made part of the record. We want to thank her witnesses for being here with us this morning, taking the time to testify before the subcommittee have the opportunity for drug evaluation and research. Dr. Woodcock come you recognize woodcock come your recognize for your Opening Statement. Thank you here we are here to talk about modernizing otc drugs. Everyone in this room has used an otc drug at one time or another. I know i have. These medicines allow us to manage minor Health Problems without going on the road. Millions of americans use these products every day. They are widespread and i believe theres more exposure of American Cities than there used to Prescription Drugs. In this tree. The monograph system allows manufacturers to come on the market without the burden some product application process that we use for generic surgery drugs. Its a much simplified system. And so why the push for reform . The monograph process put in place a long time ago to deal with the hundreds of thousands of products on the market after Congress Passed the 52 amendments to the act, requiring the drug markets to show. Is since many of the otc products were different of the basic ingredients, fda decided to deal with them in groups. They were effective for the condition, these facts would be put in regulation in any manufacturer could come in the market as long as he can on to those conditions. Of course, these manufacturers were also sub check to inspection for the manufacturing and that is still the case. But their problems emerged as members of ernie said. The rulemaking process has put in place has become lengthy and burdensome in their immediate monographs and it also means that we cant respond rapidly to safety issues. Perhaps a naive thought at the time that science would need understanding wouldnt involve a new safety issues would come up for these products already marketed. But that is by no means the case and we have really been hammered in responding rapidly to safety problems. Sometimes this means consumers unprotected. Any of these manufacturers open to liability. This process prison in 1972, so it doesnt apply to anything later. So this is only still trying to deal with the products on the market at that time. So there is really nothing for innovation in this entire process. The reform that we are proposing on the monograph system and follow the condition will be marketed without prior fda approval conformed to the commission for marketing. Its a public process, so the public has is streamlining process by replacing rulemaking with administrative orders. Using an order system is very more to what we do for new drugs are generic drugs it is quite appropriate. We would issue a proposed order rendered the discussion and allow Public Comment and issue a finer order that provides new process to healing appeal in hearing process to the decision so that processes in place. But there are fewer requirements that have to do with rulemaking so this will be accomplished in a much speedier manner. It also would encourage innovation by claiming eligibility that no longer is limiting to appease 72 type of process. Industry can request we amend the monograph or even submit new kinds of products. What we envision allows for confidential meetings early in the process between industry and the fda before removing the public trust us to allow for the innovation to be explored. It also would allow very important the fda to quickly respond to urgent safety issues. We could issue an interim final rule and definitively get that Safety Information out. That role would then be subject to further Public Comment and discussion and so forth, but would be in place during that time so people could be protected quickly. And that is something we are really missing right now. It would reduce the backlog of unfinished monographs by transferring the pending regulations and so forth and this would allow us to deal in an orderly and affect his manner with all the pending work that has not been finalized up until this point. I think also deserve the provision to clarify authority to require certain types of packaging such as unit dose packaging. This can stop people from taking too many pills and we know that for elderly and children especially, they may mistake medicines for candy. They can overdose and not packaging is very important in this clarification would complement the authority of the Consumer Product Safety Commission which can require child resistant closures on different packages and we conform to their standards. All in all the modernization proposal along with the user fees to enable to do what i think would really benefit both the public most importantly, public state the inuit benefit the industry. The fda has been talking to many stakeholders about this over the last three or four years and we feel the proposals on the table would really serve the public well. Thank you very much. The chair thanks doc durer woodcock for your testimony and move into the questionandanswer portion of the hearing. I will begin to yield the nighttime to the principal author of the bill, mr. Trained to recognize for five minutes for questions. Thank you. I appreciate the chairman for yielding a doctor woodcock, we appreciate your testimony and the work you have been doing at fda. If i can start with the first question you were just discussing, as they work to draft this legislation, we are very mindful to ensure fda has the authority they need to regulate the safe packaging of overthecounter drugs to prevent unintended consequences as you were talking with children that ingest drugs intended for adults. The discussion goes back into the draft provides sufficient authority in which you also discuss the authority would be granted if it becomes law. Back into that, please. Certainly. We believe the language that said requirements for the packaging of a drug which may include requirements per unit dose packaging to encourage these important labeling. Such packaging requirements that we can have could include unit dose packaging, special requirements for products intended for use by children and other appropriate requirements and we believe the language provides just enough authority to require a safe packaging. Thank you. Also, we look at the date we are looking at in some cases 1972 and it began evaluating the therapeutic categories and monographs for each of them. Could you go into again the system that we are looking not with the review of the otc, that it is antiquated and again speaking before us today, how the administrative order process and procedure would be speeded up to get drugs out there. Certainly. What occurs now, which you have in front of you, the first slide talks about a single role and this is an important one. It shows many of the steps weve gone through, simply to try and move it on. Each one of those required to very large administrative password, many of them publish in the federal register on notice, going through extensive clearances. This could be substituted by a new process that would take less than two years and would have defined timelines under the user fee part of the program. So we would commit to finishing things in a timely manner. What we would do for these old ones, some of them would transition to legally marketed drugs that would over time go through a process for the individual would commit data, the old monograph issues to be taken off the table and submit a current beta we would have a timeline within which we would reveal that publish draft and then finalized an order. The reason we wouldnt just go to an approval is for a new drug or a generic drug, if we published the draft that allows anyone to participate in that to comment before we finalize that there is a difference at the additional step to the new drug is once the order is final, any manufacturer who wishes may enter the market and foreign to those conditions. But we do it directly instead of through publishing regulations in the current regulations would go off the books. I wish the slides were working right now because what youve given us is a process in the rulemaking. We are looking at december 4th , 1979 and theres 22 different dates on here. We get down to november 19, 1997. So weve got to get this sped up and we appreciate the work youve been doing and we look forward to getting the bill passed. Mr. Chairman, thank you for yielding and i yield back. Thank you very much. The chair recognizes the gentleman from texas for questions. Thank you, mr. Chairman. Thank you, dr. Woodcock. Always good to see you and we appreciate the good work youve done. I want to start by asking about the current otc system. The committee learned how the system works or doesnt work during our consideration. It was clear then and even more clear now that reforms of the modernizing fund, fda, otc are needed to better serve patients, consumers in the industry. Is we need to get that out there. We found out that acetominophen. Some people are allergic and have life threatening skin reaction and we wanted to put a warning on. So, what we did, we couldnt modify the rules quickly. So, what we did, we put out drug safety communication in august 2013 discussing 91 cases that had associated with 12 deaths and the allergy alert for severe skin reaction was, we put march, 2014. So, now, if you look at tylenol, okay . And you look at the label of it. It has this allergy statement on there and warning so people know. If you look at others that you can get, perhaps smaller manufacturers, who are arent aware of this, they we issued guidance how to do this labeling, but this still does not have a safety label on it and we issued a final guidance, draft in 2014, and final guide guidance, and its different than the regulation, if you follow me. This is an otc. And this is a drug without a warning and thats the case for many products, problematicall why. Y. And congress has studied pediatric drugs and yet, the monograph assumes that children are like little adults and they can can be extrapolated. To change that could take ten years or more in regulation. Thank you, the monograph wont address the resource challenges that the agency faces. The fda struggles to meet Public Health needs for mono graph products for Current Resource levels. The fda has a putting of about 8 million and 30 fulltime employees to oversee a 32 billion industry, one of the most complex regulatory frame works that they have. Can you say how its unworkable . We have had some regulation that Congress Passed several years ago and even right now our resources are completely taken up by implementing the sunscreen innovation act. Were under court order for certain deadlines for other monographs and we have to Pay Attention to that and we literally have no other resources so even were we given additional authorities for ways of implementing, you would have a great deal of trouble bringing that about without additional resources. Mr. Chairman, i only have 12 seconds left. I know the fda stake holders and the members Work Together on this and i think we had a good example of this it committee and subcommittee over the years since what, 1992 and to have the funding ability for the fda to be able not only to have the authority, but to actually regulate and oversee it. Ill yield back my time. Thanks the gentleman. The chair recognizes the gentleman from texas. Thank you. The subcommittee chairman. Dr. Woodcock, how long have you been at fda . 30 years. 30 years . And how many monographs have been approved in the time youve been there . Probably seven, maybe. We dont know, but we would that would be a reasonable ballpark. I know youre not personally responsible for this, but i graduated from college in 1972, 45 years, ive had two wives, four children, six grandchildren, been approved 17 times to be a member of congress and disapproved once to be a senator. Do you think that seven monographs in 45 years is acceptable . No, for each theres been a great deal of activity. And yell and scream and stir and have a lot of activity, but that doesnt pass a law. I know its not your personal problem. I didnt i wasnt aware of this until the read the briefing, but, you know, if the system is broken, which obviously as the congressman just pointed out, my gosh, does it take 45 years for the fda to say, help, we need help . I mean, this when youre trying to find a cure for cancer and the other great things, i dont know that this is the most important priority at the fda, i wouldnt say that, but approving a monograph for perfect of overthecounter drugs shouldnt take a moon shot. Agree with that . I agree with that and we could do it under the new proposals that have been proposed, we could do this in a more timely manner. Its simply going through regulations and doing regulations, its. Well, but i mean, again, somebody in your agency has known for a long, long time this is a problem. A long, long time. I mean, i never chaired the Health Subcommittee, but i did chair the full committee. Ive been on the committee for 32 years, nobody ever came to me from the fda and said, hey, weve got a problem here. I mean, dont you mr. Latta says that to approve a specific new drug, you have an average of 18 fte reviewers working on that, but to do all of these monographs youve only got 18 people reviewing them. Thats right. Dont you think that somebody at some point in time, in your position, or somebody reports to you, could of sahaved maybe we need a few more people, maybe we need a lot of people. Maybe we change the rules, maybe you dont need 27step processes. I would assume that the fda supports the latta, degette, green bill is that thats true. We held a Public Meeting three years ago to discuss the problem and we were very clear that the system was progressively becoming more unworkable, as it was more and more difficult to get regulations through. Now, the industry is very concerned about the safety problems, but earlier, because all of these drugs remain on the market until the monograph was finalized and prepped and some would be taken off, it wasnt such a problem for the industry. But in the modern world, it is industry, i believe, supports this. Well, what, in your mind, is a reasonable time to get these monographs approved . I believe for a public process several years and should be done. Two years . Yes. Is that guideline in the bill, two years, do we know, anybo anybody. If its not ill put it in the bill. Were not going to be able to do it at the same time. Well have to build up our staff and infrastructure and i. T. I appreciate your willingness to testify on this and i commend the subcommittee chairman and sponsors of the bill and hopefully it doesnt take us 45 years to move the bill and we have a bill signing and hold them to are their word. With that ill yield back. The chair recognizes the gentleman from new jersey, five minutes. Thank you, mr. Chairman, im not trying to denigrate you, dr. Woodcock or mr. Barton and not how many years weve been here and what weve been doing, but i think that part of the problem is, youre not allowed to initiate that. You cant write us letters and say you need more resources, you want to change the law. Thats our oversight obligation and whether its democrats or republicans in power we have to do a lot more oversight, its not up to you to come to us, it doesnt work that way i understand it. One of the current constraints of the monograph system is the process requires to make any revisions or updates and thats why the safety changes take so long if they happen at all. So, i just, i want you if you could, briefly discuss how emerging safety issues are addressed currently through the otc monitor grab process and what has prevented the agency to move swiftly to address those issues such as those associated with the cough and cold products for children you mentioned, actually. Its evolved since the cough and cold first came up. The thought was well, the regulation says these are generally recognized as safe and effective even for children and thats in government regulation, what could we see . Its clear that the its changed for children and needed to be evaluated. Now we issue draft Safety Communications and issue guidance on labeling, even though its somewhat different than what might be in the regulation, or the draft regulation or whatever state the tentative final monograph, whatever state its in. The and that requires voluntary, as i said, participation by the industry, its not binding on industry because its guidance. So i think that everyone would prefer that safety problems are dealt with promptly and very definitively not in guidance or something thats voluntary so we can take care of the problem, keep people safe rapidly as we get the information. Well, thank you. In the discussion draft that were considering, the monograph process would be transitioned from rule making to an administrative order process and fda given expedited authority to update safety, and could you tell how the expedited to safety labeling will help to respond to the emerging safety issues . Well, the same expedited safety labeling would be say an interim order whereby the fda could put it out rapidly not subject to the comment that those orders would have. All right. And once its out, it would be binding, interim final, binding. So we would notify the public and manufacturers would have to change their label and conform their label to the safety problem. Then, you could have comments after that, and we could discuss it more. But, the safety issue would have been dealt with more definitively so people are protected, right now, it may take eight years or more for us to get a rule change for that we could have new safety statements in the regulation. All right, thanks. I wanted to ask you, what lessons have we learned that were incorporated into the overthecounter monograph drug and how will user fees benefit the patients, for example . Well, some of the things we learned, for this program were going to have what we call managed growth is what were have been discussing with everyone where the programs starts are small, expectations are clear for everyone and user fees grow so we can absorb and lay down the foundation. We learned that from the Generic Program where we had to change like a huge number of things at once. We also have learned that we should have the simple a Fee Structure as possible, with as few exceptions and tiers and all because this is a very large industry, there are a very large number of players here, and have all kind of different status and the more exceptions and tiers and everything, maybe it will start looking like the tax code. [laughter]. All right. Thank you. Thank you, mr. Chairman. Chairman yields back. The gentleman from kentucky, five minutes. Thank you, dr. Woodcock. Ive heard stories of manufacturers trying to do the right thing and having a misbranded product, labeling realtime and the current process can take years as mr. Barton described. In order for a label or a packaging change currently must go through, can make years. And thank you for bringing this together to try to move this forward. Could you tell me, tell the committee. How the administrative orders would make sure that doo you process is obtained if there are differing opinions since this is a public process . Well, therele be an administrative order first and then a Comment Period and thats because this is a public issue, other manufacturers may not have been participating, but may want to get into that space or in the public, the consumers, advocates may want to comment on the order so theres that public process whereby comment. If we get substantive comments on the proposed order, then, this time of finalization may be delayed, but thats a public process. And then there is a process that has been proposed for administrative appeal of decisions through an appeal process within the center for drugs, all right. And then appeal, administrative appeal above that to a party who is a third party who is selected to hold a sort of hearing on it. And adjudicate any substantive issue thats a material difference that might occur. So, there are layers of administrative appeal and recourse for people. Okay. Thank you, you mentioned sunscreens earlier. Can you please expand how sunscreens will fit, can fit into this overthecounter drug report. My good friend whitfield, colleague from kentucky, former kentucky no longer in congress, did a lot of work in this space and talked about it and it seems with the rise of skin cancer is seems difficult to get improved sunscreens in the marketplace. My understanding of the current draft, what, the sunscreen innovation act will continue to operate, all right . What was stipulated by congress there and we have met all the time frames that were required under the sunscreen innovation act. We have exceeded those time frames. Once those sunscreens have been processed they will be ordered so we will have a common system. And a question, one of the innovations or improvements thats being proposed in this discussion for modernizing the whole monograph process is to have confidential meetings with manufacturers and an ability to do that. Thats not part of the sunscreen innovation act, so that could be put in to conform, conform that act with if monograph reform is passed. Was i clear . Or is this i believe so, i appreciate that and those are all my questions and i yield back my time. Chair. Thank you. The court recognizes thank you, id like to thank you for coming back again and giving us your testimony today. Im very interested in the potential Public Health benefits of reforming the otc medicine regulations. Your testimony today highlighted several examples of safety concerns with otc medicines and how they were handled by your agency. How frequently, how frequently does the fda encounter adverse events with otc medicines . I would say fairly frequently. To rise to a serious level maybe with uns once over frequently or infrequently. Once exposed to the population, but perhaps once every two years were facing an issue we would like to get out rapidly to the public and notify them and our hands are tied and we have to use this guidance process. All right, two of the examples that you highlighted in your written testimony were related to pediatric issues, with certain medicines. Would you say that a disproportionate number of safety concerns with otc medicines are related to pediatrics . I would say in the last decade, that is true, decade or so. And the reason is, starting in the late 90s, i think everyone became aware that you should study children and not just treat them as tiny adults and just scale down the medicines w that realization came the realization that children may be being harmed. Back in the 70s when this was started the doses were children were scaled down adult doses and so, we have been going on a whole campaign, as you know, under bpca and priya to study children with drugs. Here, its going back and looking at these medicines, particularly say the cough and cold and some of the other medicines and saying, really, this appropriate for children . And what do we need to do about this . Can you provide can you provide any safety improvements made to existing monographs and how long its taken to be i mplementeimplemen i know you touched on that earlier. Let me consult. Yes, most recently it took seven years for us to get the liver warnings on acetominoph acetominophen. Its the number one cause of drug induced liver failure in the United States. When we put on the warning labels, we were able to do the fda acetominophens. In contrast it took seven years for the monographs and a lot of acetominophen is monograph use. How could you look at the special medicine for how do you envision this. A final order that could be issued rapidly and that order would be in place and therefore, manufacturers would have to conform to it and they would have without labeling statement that they have to put on. But subsequent to issuing that interim final order, there would be an administrative process that people could comment and there could be discussions and it could be modified. However, we could put the interim final order in place rapidly, thus, keeping people safe while we were discussing the issue. Thank you, doctor woodcock, there was a suggestion earlier that perhaps the fda has not been proactive enough to seek legislation to remedies some of these issues, it appears that you are the director for the center for drug evaluation and research are fda. Thats correct. Are you permitted under the rules to pick up the phone and ask for legislation . No. That would be unacceptable in your agency or any other agency in the federal government. Were not allowed to Lobby Congress is my understanding. Thats what ive learned in my 13 years. Thank you, thank you very much. Ill yield back. Chairman thanks the gentleman yield back. Chair recognizes the gentleman from virginia. Thank you very much, mr. Chairman. All right, it seems that we have a problem, everybody agrees we need to change things. We have discussion drafts in front of us, ive looked through it, but i would ask you, as our expert who always gives us good counsel, we dont always take it, but we always like to hear your opinion, are there things in the bill that concern you . Things that we ought to take a look at changing the language on . I know some of its not finalized yet, but as it currently exists, is there anything in there that causes you concern . No, not serious concern. I think that we would like to continue to give Technical Assistance because the devil is in the details. Always. And we believe that broad jut lines is where we need to be. Likewise is there something not currently in there that you would like to see in there. I dont have a role in this as ive told this committee before, but i recognize there are many folks who want to talk about exclusivity. I dont believe that the fda has a role in the societal tradeoffs. I believe that thats something that needs to be resolved. I appreciate that. And not asking your opinion, per se, but have you anticipated or have you felt a any heard any comments about the user fee portions of this bill . Are there groups out that that have told you that they really oppose this and this would be an impediment to bringing certain overthecounter medicines, particularly in rural areas . I have not heard that. All right . I recognize that from the contract manufacturers, because this proposed fee right now is the facility fee, straight forward and simple way to do this if youre producing an otc drug under the monograph, that the issues have been raised about the contract manufacturers and their obligation to pay a fee and i think thats one of the more controversial areas. We feel that theres tremendous merit in maintaining a simple uniform fee, a large number of the otc manufacturers are Small Business and so everybody is theres lots of Small Businesses involved here. Right. I wouldnt want to price them out, but at the same time the others have been successful isnt that fairly much accepted . Yes, and i believe that they have been beneficial to industry as well or they wouldnt have been reauthorized as they have been. Yes, maam. Thank you, i appreciate your testimony today. With that i yield back. The gentleman yields back. Mr. Schrader is recognized for five minutes for questioning. Thank you, mr. Chairman. I appreciate having you here, dr. Woodcock. How many steps are we anticipating removing as a result of the new process. I would say practically all, all right. We want to put this behind us, basically, so part of this proposed legislation would put all the monograph stuff behind us, and transfer all of these into a new status and start not over, but start afresh and have the timelines and plans for moving forward. So, would you be able to establish the time lines . Is there a rough time line dem plate to mr. Bartons earlier question that you would give us and maybe some benchmark Performance Measures in between you start, you get down the road little bit and hopefully ultimately get to a decision . Well, there are goals and they phase in, because as i said, were talking about managed growth. And in the first two years of this program, the plan would be to build a new system. We also have to deal with those legislatively and court mandated projects. The sunscreen innovation act and other some court mandated things that we have to finish, all right . But wed have to hire people, we need to create new standards and processes, create a new i. T. System. We dont have an i. T. System. Once thats all in i appreciate that and theres probably a timeline to get all that to occur, that would help us judge the process and resources. Once thats established, its interesting to know, i heard two year rough out from start to finish and it will be interesting and helpful, i think, for the committee and for you to see if were hitting those time license. Im sure its a new program well have to make adjustments as we go forward here. Well, we had proposed or planned to have goals, okay, for everything and so there would be a goal for when you could when we do this and when we get that done, just like for the other user free programs. So there would be a structured set of goals and time license and percentage, like here is the timeline and we would our goal would be 70 in this time frame this year and the next year it goes up to 80 and so on. Its pretty complicated, i cant go through it in five minutes, but for the existing monographs, what we plan to do is put forth a dashboard that would be in advance, and that would cause the industry is going to have to submit for the existing, what are now existing monographs. Theyre going to have to resubmit something and we have a timeline, when we expected that to come in, and that would be an orderly process with time lines for accomplishing that. Can you share that with us . Absolutely. And i assume the industry understands they have to resubmit and in general, theyre okay with that process . Thats the plan because right now, we have this giant sort of mulch of documents that have been sent in over the years and if we we want to use the current scientific information that makes judgments. Sure. And the last question, youre about 30 fte. With this new one, your initial expectations to get up to and a more level Employee Work force. Ultimately we would hire 105 new employees, so we would have 135 doing the scientific work. Thank you very much, good luck and i yield back. Thank you. Thank the gentleman. The gentleman yields back. Chair recognizes i think me. Oh, there you are. How could i miss you . Somebody came in to block me, i had to move here. Recognize the gentleman from missouri. Thank you, dr. Woodcock, the overthecounter Monograph Program is the key work for oversight for medications, the bulk consumed by americansment i understand the user free pra many your a setting up is he will rtively small, particularly compared to the much larger programs that weve approved earlier this year, could you discuss why the user fees are needed . Certainly, user fees are needed because we simply do not have enough staff to finalize these and deal with innovation coming forward. We have 30 staff to deal with more than 100,000 products that are on the market and currently this burdensome rule making process. Even if we were to move to an order process that would streamline in an efficient, effective, 30 staff could not make substantive progress against that. How are these user fees structured and collected . The fees are going to be for any facility that manufactures a monograph drug would have a flat fee. How much it would be depends on how many registered. Well use our drug registry, an existing system, to capture all the facilities. It might be between like 14,000 and or a little less or a little more, depending how many facilities participate per annum. You mentioned the otc process is one of the most complex regulatory programs taken by the fda. Can you discuss how they look at challenges. Ap simply going through and we have to finalize, you know, to finish. In this case, there would be an order with the new process is tremendously simpler than what we have to do with the monograph and orders can be amended over time to keep up with science and hope the user fees have enough people to do that. I have to be clear this user free program is not large enough to get this all done in the first five years, were just we will get the program set up and begin to work against this and accepted innovation and that will be good and well be dealing promptly with safety issues, but we wont be finished with every single one of these because they do take a fair amount of scientific work, but we would never be finished with them, we will never finish this process if we do know the change, do not modernize it. Speaking of process, can you discuss the fdas engagement with stake holders during the process . Certainly. As i said, i think in 2014, we had a Public Meeting about this. And to representative burrtons point, we did own up to the fact that the process was broken, although some people came and told us it was because we were lazy or whatever. But we did ask the public, including advocates, consumer groups, and others, you know, how in the industry, how we could change and modernize this process and we pointed out the different problems. Since that time, as we have been talking to industry about how we might change the process, weve also talked to public stake holders, advocacy groups and so forth to keep people in the loop. Although i would admit, this is a rather obscure program and many people are unaware how it operated and the problems if had. Weve had several public web nweb webinars. Excuse me, how will the fda address challenges to assure that the ot c. Monograph Program Remains effective . I think that one of the things we need to build in which weve build into every single User Fee Program we have are assessments. As i said earlier, we are going to have goals and objectives and so we will have put forth what we expect our timeliness to be, how much we expect to get done and then we will assess against that. And if were failing on those measures, well own up to it. Okay. Thank you, mr. Chairman, i kneeled back. Thanks, gentleman. The chair recognizes the gentleman from california. Thank you, mr. Chairman. Five minutes, please. And i want to commend the authors of the legislation for addressing something that evidently has been overlooked for decades. Id want to start with a question about what you can and cannot do. I know that you cannot come to congress and lobby for money. I know that you cant come to congress and have something printed out and say this bill needs to be introduced, but ive never heard in 25 years that anyone from any agency cant meet with members to discuss a short coming within the agency policywise or anything surrounding what i just mentioned. So would you clarify this . Because i think it changes for me, the complexion of this entire issue, not that it doesnt need to be addressed, but its just stunning to me that it hasnt been. So would you clarify, please . Well, different administrations have different priorities. Administrations, basically, decide how the interactions with congress are. Well, you need to be more specific about that though. I really want to understand this because its its important. Where is the agency precluded from essentially putting a spot night on something that obviously has a fen effect on t population in the country to say theres had a shortcoming here and we need to Work Together to address this. I dont think that thats i dont think that that is something that changes with administrations. I think thats just part of the ongoing work of the agency and the congress. We certainly can as we did, hold Public Meetings. We can write papers, we can do many things, depending on so youre talking about internal to the agency and what you do there. Right. Im talking about the relationship between the agency and congress. Is there any statute or rule thats written that prohibits the fda from meeting with any members or chairs of committees or subcommittees to point out that theres a shortcoming somewhere . Its troubling to the agency . And that we need to Work Together on whatever the issue might be . Not to my knowledge. I mean, if you wish to put forth legislative proposal thats put forward through by the a19 process. This clearly has been overlooked and my sense is it rests more with the fda than the congress. Im glad its taken up. On the user fees, the 100 fully fund with the 130 positions that you have goals more . We currently have funding, we currently fund 30 positions. And up to 130. 135. 105 would be funded by user fees. Fully . Fully. On the risks of relative to the incomplete monograph, the risks that they pose, does that affect the pediatric population . Yes. It does . And can you give us an example . Well, in pediatric cough and cold in the early 90 in the early 2000s, we recognized there was harm, significant harm to children, 0 being, due to use of pediatric cough and Cold Medicines, right, and, but the monograph statements were that they were safe and effective. So, its difficult. Were they ever corrected . Not fully, not yet. What weve done is work with the pria, but in this area. It doesnt apply. It doesnt apply. So what we did, we worked with the industry and they voluntarily changed their labelling, as ive shown for the acetominophen example not every manufacturer voluntarily changes their label and we dont have the tools right now because the regulation thats on the books or the tentative final regulations says safe and effective. My time has expired. Thank you. Thanks, gentle lady. Yields back. Recognize the gentleman from new jersey, five minutes for questions, please. Thank you very much. Good morning to you. Its always a pleasure to be with you, dr. Woodcock. Before i ask any questions, its my hope that the committee will examine the cosmetics issues. This has been discussed in Opening Statements by others. Im involved in that issue with mr. Pallone. And weve been working to advance consumer safety and provide a regulatory frame work that furthers growth and innovation for american cosmetics, manufacturers and Small Businesses. Consumers need to know that the products they are using are safe. And businesses need a 21st century fda that responds as quickly as new great ideas are being developed. Statutory governing cosmetic has been unchanging in 70 years. Its been there should be a bipartisan effort for consumers and stakeholders. Mr. Chairman, on the issue were discussing this morning, i have a letter that i would like to submit into the record from colin mckenzie, who is the head for all the americans from Glaxosmithkline Consumer health care and i requested that be put in the record. Thank you very much. Dr. Woodcock, off topic, but an issue of acute interest on the hill right now. Right to try legislation. Ive been involved in in and im interested in hearing your perspective on whats recently passed in the senate. First of all, my personal opinion, that ive testified on before, is that the federal government should not be in between someone who is dying and wants to try a medication. If i were the person or the relative of the person, id want to know if the last people taking that medication had survived or died quickly or whatever. I think for protecting people, its important that there be some transparency about the outcomes of these uses. If, if something were to pass. Now, the fda, as you know, approves about 99 or 99. 9 of all requests for uses of drugs. However, if were aware that not all firms are willing to give out medicine because they might have a short supply or they may be concerned about the situation or even the safety of the treatment for that particular individual. So, i believe its a complicated scenario and i believe for most, we should consider not only the rights of patients, but their safety. Thank you. The otc monograph reform bill were considering provides for significant expansion of the otc drug review and oversight capacity. How will it boost how will the boost in personnel which we all favor, enable the fta to and look for applications for new Innovative Products. What weve written town is sort of a an aged improvement with infrastructure and training take place. Then innovation begins to be taken up, as well early cases of finalizing these pending proceedings and those will go over time with time frames. What we envision, we would start with the innovation along with dealing with the quote, socalled backlog and the safety, of course, immediately upon having this new program, we would be able to deal with safety problems much quicker and we would. Well, thank you, and i wish you well in that and certainly, we want to be involved to the greatest extent possible. Mr. Chairman, i yield back 32 seconds. Thanks the gentlemen. Recognize the gentle lady from colorado, five minutes for questions. Thank you, mr. Chairman. I really want to thank you for going through regular order with this bill because i think that this is one of those issues that has really been a bugaboo for a long time. The agency has tried to deal with it. The congress has tried to deal with it. Dr. Woodcock, i want to ask you a few questions. The first is the discussion draft on which were having the hearing today. All of the group that everybody mentioned, the republicans and democrats on this committee who have been trying to work through this, weve been working with your agency for over a year on that, is that correct . Yes, and maybe you can talk a little bit more about some of the steps that the fda took to get inabout ut for us on this otc monograph reform bill from the various stakeholders . Certainly, as ive said, weve had a Public Meeting on this in 2014 and at that time pointed out the fact that the monographs were not getting finished and the difficulties we were having, the difficulties of safety and also the problem with innovation. And there was a great deal of support for doing something. Subsequently with that, we met with the industry numerous times, a large number of times, trying to work out what such prm would look like, so, Congress Wave Something Congress would have something to dork with, and there were numerous meetings about both the policy changes, the legislative changes that would enable, enable us to have order and so forth and what a user would look like. And at the same time we posted minutes meetings of those various meetings and various public interactions at different times and weve met with some of the more involved stakeholders some of whom will testify today as well. So, and in addition as to the bilk dra bill being drafted, your staff gave to that. Right. So really the draft were looking at today is an amalgam of all of those. I want to ask you about a specific provision of the fda requiring packaging of a drug to help protect children from harm such as unit dosage packaging or other requirements. Does the packaging language include in the discussion draft, give the fda sufficient authority to require packaging information to protect children from risk, or is there more that needs to be done . No, we believe that this language is adequate. And why do you believe that . Because it says in it says are there appropriate requirements. It gives us fairly wide scope. Thank you very much and thank you for your efforts and your agencys efforts, i yield back. Chair recognizes the gentleman from florida, five minutes for questions. Thank you, mr. Chairman, appreciate it. Dr. Woodcock, in your testimony you mentioned one third of the monographs started decades ago are still not finished. Can you give us an idea of the size of the backlog, how long do you think it would take to clear the backlog. And what types of submissions are in the backlog . Federal, you have to understand that this backlog is different than awhat you used to talk about the generic backlog, which we have dealt with. These products are still on market, all right . All of these products are on the market and the process of finalizing the monograph would perhaps remove some of those from the market, right . And establish the conditions under which they can be marketed. And perhaps limit those. So there are about 100 ingredients, i think, several hundred ingredients left out of 800 that havent been finalized. And there are about, maybe many uses, more than several hundred uses of those ingredients because many ingredients are used for multiple different uses. Its difficult to have a count because until we get to the final monograph, we dont know whether it will be in or out in each one of those, but thats the ballpark. Its about a third. A third and how long would you think it will take to clear the backlog . Well, definitely, it will take well beyond the five year period. Okay. Your testimony shows that fighting for fda Monograph Programs is fairly flat. Between 7 and 8 million annually. Have submissions been fairly flat year to year or are they increasing . Well, the activity has increased because of the new scientific knowledge and i showed you the chart earlier, the churn that happens with any given monograph. But this was fixed in 1972 so we dont have any new submissions at all to this, in the sense of new ingredients added or whatever, except a few that might be foreign ingredients that could come within the time and extent path way, which is what the sunscreen dealt with. The next question, in your testimony you talked about the slow timeline for changes to the monograph. You used example liver injury for generic tylenol, seven years it update the warning. My goodness. How would monography reform and shorten the time frame substantially and what changes required by statute and what can the fda do administratively . Yes, the goal would be that we could have issue an interim final rule on safety, on specific kind of safety changes. Had and we could issue that rather quickly and then it would be binding. And then the discussion about it ap any further adjudication could occur after that and wed go to a final rule after wed get Public Comment, but on the safety problem, a serious safety problem can be dealt with with labeling. We issue a final rule and all the labels are changed toe people are protected and we could have further scientific discussions and go to a final rule that would, you know, have had that chance for people to have a lot of discussion. Okay. Very good. Thank you, dr. Woodcock. I yield back. Thank you, the gentleman yield back, and the chair recognizes, gentle woman. Let me say, first of all, how much i appreciate what you do and your testimony here. I think youre always transparent and candid, and informed, and i thank you very, very much for that and you know, we can all look back and think, well, maybe we should have moved ahead further or faster on this issue and here we are today and i know youll be working with us to make sure that we deal with overthecounter drugs. I wanted to reaffirm something thats been said a number of times and that is that i am very hoping hoping very much that the Committee Moves forward on cosmetics. I have a bill of cosmetic safety act ive been working on for a long time, but, you know, when we have shampoos that cause people to lose their hair. A child that lost her hair or a teens eye shadow is tainted by asbestos, the fda is not able to act. Never let it be said that we ignore the issue of cosmetics and i think thats another thing we need to move forward on, but back to otc. Weve talked a lot about the administrative problems, how long it takes to regulate the cumbersomeness of the process. But i wonder if you could just suscinctly list the safety issues that we need to address that arent being addressed right now. We could start with the skin reactions to acetominophen. Add the safety problems with pediatric cough and cold medications. We can does that in part, using the sweet gummy kind of things that attract children . Thats a different, a safety issue related to, you know, the dose age form and overdoses, and those are the safety issues, there are quite a few. Weve finally finished the liver warning for acetominophen, but there are other overthecounter construction that we probably need to move on safety. So do you think that once this process is in place that there will be overthecounter drugs that will be removed . You alluded to that in the last set of questions. Well, the monograph system itself envisions, removing, when you have a monograph, certain ingredients out of the monograph. Theyre all on the market to start with and as we go through this process they get removed. So, as we finalize these monographs, certain ingredients will no longer be permissible, to be marketed in the United States. Most dont have serious safety issues, some of them simply dont have any data to show they work. Some would have to have more warnings . They might have to have more warnings or simply withdraw because they cant produce any data that show theyre effective. So this new process would be before the fact, look at these drugs or no . Would they still go on the market anyway . No drugs supposedly since 1972, have gone on the market. This process only deals with drugs on the market in 1972 or before. So, any what were planning to put in place as congress, you know, puts agrees with this, is a process where we could move new ingredients into this process and have this regulated this week which is much less burdensome for the industry for products that are otc products, multiple parties can market them. Let me ask you one more thing. As you know, the Consumer Product Safety Commission is charged with implementing and enforcing special packages and child resistent package requirements. Im wondering how you work the fda, work and interact with the Consumer Product Safety Commission on packaging requirements . Certainly, we work very closely with them. We recognize their standards. They set the standard for child resistent packaging, say for bottles and so forth. And were this to move forward we could have an understanding with them on how we would notify them about anything we were doing on packaging to make sure that they were aware of, you know, if we were making some safety unit of use packaging, wed let them know. Thank you, i yield back. Appreciate you. Chair, thanks the gentle lady. The gentle lady yields back and the chair recognizes the gentle lady. Thank you, mr. Chairman and i also want to thank dr. Woodcock coming before this committee again and explaining why its necessary to take im learning are long steps or the mon store process. I appreciate that youve 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 and the existing otc drug monograph system were potentially unsafe or possibly ineffective drug products. Are there any specific examples youd like to provide . Welcome, until we get the monographs finalized its hard to call them ineffective until theyre improved until regulation is published staying theyre ineffective. That have benefited greatly from congresses authorization of fda user fee for animal drugs, medical devices and other drugs but otc drugs have lagged behin behind. How can you ensure this will give you the necessary resources to bring the otc drug regulation on par with other drug and medical products and secondly, in addition to the personnel increases, which youve talked about going from 30 to 135, what resources will this provide fda to improve the system question. We plan to spend about 26 million on investing in it systems so this becomes paperless instead of a paper intensive process. That would require about 3 million a year ongoing for maintenance once its built. 26million would be spread out over the first four years of the program. We would also invest in training of our people, developing processes and different matters like that. This level of program, as i said, will not result in the monograph all being in the new order system, having all final orders at the end of five years. It wont be that fast. Appreciate that and you certainly let us know that and have set the expectations. Are you saying that right now the Current System relies on a paper process. To a great extent. And so the building of an appropriate it system which doesnt exist right now would be incredibly helpful. Yes, and since we are going to put all this past documentation behind, its all over the place, we can have electronic gateway like we do for the other User Fee Programs so submissions are electronic and their standardized formats. Theres many things that help everybody be efficient. 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 were in this process in a significant way. Yes. Thank you. I yield back. The chair thanks the gentle lady. The chair recognizes the gentle lady from michiga michigan for five minutes. Thank you. Like everyone here we are a famine really grateful for being here. I think we are all saying the otc system is broken. Its not working for patients, doctors, people in the industry who are making Innovative Products, and your testimony said this in the question and answers keep reaffirming that. Just for the record, i can, it is true that there are far more otc products than Prescription Drug product. Thats true. Despite this fact, they got only 7. 9 million last year to review otc products while Prescription Drugs total 1. 1 million when user fees were included. Is that correct. Thats correct. I do have this question, when youre talking about the five years and youre talking about creating an it system that doesnt exist, is it, can money help accelerate that five years . Will getting you more money. We can always do more with more. We can move faster with more. Maybe at some point you could give us how much you need to create the it system which will accelerate it. The draft legislation we are considering today give fda the resources the agency needs to do a more effective job. Definitely a more effective job, absolutely. Especially combined, we need the authority to do more effective job. We cant use these authorities. As you just said, its not the only issue. The draft legislation were considering gives them the authority to use the administrative order rather than the current notice which will make many on finalized in critical safety issues unaddressed. Does the fda believe these changes would make it easier to allow Innovative Products to make it to the market while also allowing the agency to address the safety issue factor. Yes, there is a specific pathway thats been built in the timeline and deliverable and so forth so we definitely contemplate that there is innovation to be had in this space. Thank you. I think this goes a long way. I want to take a step back and give some context. In 214 congress came together to pass the sunscreen innovation act because we are facing a skin cancer epidemic in the last time a new otc sunscreen ingredient within the 1990s. This is a symptom of how broken the ot system is overall, but its more pressing and more urgent because there are 5 million americans being treated for skin cancer every year. The rate of melanoma is on the rise. While otc reform will make it easier for Innovative Products to safely and get to market, we cannot forget the urgent need to ensure they have access to sunscreen products that have been used safely for decades overseas. This is where the frustration comes from all of us. Congress seems concerned. Can we work with you and other stakeholders to ensure americans have access to the way this ingredients and what we need to do. We have met all of the stipulations, actually exceeded them in the sunscreen innovation act. What we are waiting for is the safety data. What it 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 the sunscreen innovation act is one of our highest priorities. How long will it take to get this aid . Why is this so complicated. Under most of the things that fda regulates, we dont do that research. The research is done by the sponsors if they have medicines and drugs in formulations and they submit that research to us. We wait for them to conduct the research. We give them parameters about what the research should look like to meet the standards and then its on their timeframe. Do we know their timeframe . We certainly are in contact with them about their activities. I personally have met with them very recently. Thank you. I yield back the balance of my time. The chair recognizes the gentleman from georgia. Thank you. Thank you for being here. Helping understand something. Ive been in between subcommittee meeting so please excuse me if ive missed this. When you come up with a profile for a certain ingredient, does it apply to every product, every manufacturer that has that product out there. For instance, ibuprofen. If you come up with a profile for ibuprofen and you say if you have ibuprofen in your product, you have to have this on your monograph. The monographs ssi ingredients ibuprofen, it specifies ingredient, it specifies the dosages that can be used, and then it specifies what conditions it can be advertised for. If you then market using those parameters, then you dont have to send in an application. So tell me, if you find out something, if you find out ibuprofen in a certain dosage causes toxicity or is eating the stomach up, see you go to every product out there that has a certain amount of ibuprofen and it and you say you need to add this to your monograph. No, its a fda regulation, and so we would have to change, if you change it, does every product out there have to change. They would have to add the warning, thats correct. That seems simple enough. And only if, first of all we have to have a final monograph in place and then we have to change it through the rulemakin rulemaking. How long does that process take. Six or eight years. Oh please. Heres one. Ive seen that. Why does it take that long. It doesnt take that long with prescription medication. They get them off the market quicker than that. We get them off the market liquid licketysplit. Here the issue is, if we have a final monogram in place, the government has a regulation that states this drug is generally recognized as safe and effective. Oh, its not safe, but we have a regulation that says it safe. For the lawyers in the room that understand the problem, we have to then, what we do now, because of that we issue safety alerts and we look for volunteering changes to the label, but we cant mandate changes. Why not. Because its a regulation. Its a regulation legislatively. Rules that we propagated. And we have to promulgate a new role. Thats how the rules work. Let me ask you something. What about off label uses. Ive practice pharmacy for over 30 years and i dig that regularly. Do you ever address that . We address it in the sense that if off label use, we will send out safety of alerts and tell people, and so forth. If a product has been on the market for year, lets take for example diphenhydramine. For years it was just antihistamine you used for bee stings and i always recommended it to help somebody sleep. Now youve got benadryl p. M. Youve got products in the marketing for that. How long did that take to get that new indication. They are already part of the sleep aid. They are now, but initially they werent. They always were. Im not sure about that. Get a new one is what youre saying. Rate, and antihistamine for sinus drainage, at one time when i was in school it was a side effect, but thats what we used it for so if a new indication comes out, 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 before 1972. Then it is in eligible for the monograph. They could file an nda. Before 1972. This whole system is fixed in 1972 and in the past. I think we have discovered the problem. Thank you. The i deferred my questions to the end and i just have a couple. First, you mentioned at the start that you have 88 pending monographs. Is that correct. Yes. Does the committee have that list . Are you able to share that. We can certainly provide that. That would provide some context of what were working on. And with mr. Carters line of questions, there used to be an overthecounter asthma inhaler and there is not. That was part of 1972 that that product was available. So let me just ask the question because i know im going to get it from other people. Where do we stand with providing that active pharmaceutical ingredient that was in an overthecounter asthma inhaler prior to 1972. I cant comment on pending applications. That was not a monograph product. That was a new drug application product. So there are products, overthecounter like chordate or antifungals, those were all switched from Prescription Drugs and they still have a new drug application. They are not monograph products. I see. Well let me just make the pulley that asthmatics do need an overthecounter option. They shouldnt incur an emergency room charge in the middle of the night to get some relief. What you do in situations with pseudoephedrine that has been approved but is being abused. You do anything in that situation. The Congress Took the step of moving that, restricting that. Why would Congress Need too. I thought that was your job. That we have the authority to do that. So if you see that a drug that has been approved in a 1972 act is now being abused, you dont have the authority to do something about it . We can move against things on safety grounds, but that was actually being used as an ingredient in manufacturing and abuse drugs. I would not like to give a legal opinion here. I think there have been various state regulations that have been applied and thats why in different states theres different requirements as to whether or not you need to show a drivers license purchase those products. However, when there was a product that was marketed a weight loss product, i think you moved pretty quickly to remove it from the market. We did. That was due to safety events related to that. I want to thank you for being here today, and just to address the comments that were made on both sides, where has the committee been, where has the agency been, ive just been through my third reauthorization of the user Fee Agreements. This concept was brought to me late in the spring. We were pretty far down the road on the user Fee Agreements, and i made the decision that nothing would deter us from getting user Fee Agreements across the finish line, and we did, recognizing there would be some serious repercussions if we did not do our work, but we did. I also committed that we would tackle this problem quickly after we got the user Fee Agreements put together and delivered so here we are today. I know i personally have made three trips to the fda, your physical campus and you received myself and staff when we were 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 in the previous iteration of your headquarters so the agency, ive always found has been very welcoming to Committee Members and theres never been any reluctance of the agency to talk to members of the committee. Now maybe there are rules that prohibit the direct communication as far as what would be considered lobbying, but generally the flow of information from the agency to myself as a member of congress, ive always found the door to be open and ive been grateful for that. Im grateful for your testimony here today. I think youve helped this process. Its clearly something that needs to be addressed and be fixed. We will continue to pursue it and get it done. We will conclude this panel. We do have another panel to follow but thank you doctor woodcock and we look forward to your next adventure here. [inaudible conversations] we will now hear from our second panel of witnesses. 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, the president and ceo of Consumer Products association. Ms. Kirsten more, healthCare Products, michael warner, partner on behalf of Public Access to sunscreen coalition , bishop jones, chair committee on drugs, American Academy of pediatrics and mr. Gill, president , bio Pharma Association. We do appreciate you being here today. You are recognized five minutes front Opening Statement. Thank you for the opportunity to provide testimony today on the overthecounter monograph system and the importance of modernizing regulation to enhance the Public Health. My name is scott and i am president and ceo of the consumer healthCare Products association. Since 1881, chp a has served as the Industry Association representing leading marketers of overthecounter medicines in the United States. The Member Companies produced a vast majority of otc medicines in our country and provide millions of americans with safe, effective and affordable therapies to treat and prevent many common ailments and conditions. The availability of self care treatment option saves money, reduces burdens on the Healthcare System and keeps consumers active and productive. Given the importance of otc medicines to consumers and 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. Vast majority of otc medicines in our homes today are regulated under the otc monograph system and our members strongly support the system. It oversees over 300 active ingredients and more than 100,000 nonprescription products ranging from antacids to diaper rash creams, pain relievers and cough and cold products. While the otc system was created over 40 years ago, as we heard earlier today, the process is still not complete. Movement on unfinished items has grip come to a halt largely because the system is based on rulemaking. A thorough but extremely timeconsuming process that has slowed across all Government Agencies and departments in recent years. Changes needed to have a regulatory system that accounts for advances in science, accommodates innovation and permits timely updates for Safety Information and creates a workable process for creating unfinished monographs. The hpa has worked with fda and members of congress to provide recommendations for modernized monograph process. With necessary due process protections for dispute resolution and issue escalation, these improvements would empower the fda to act more quickly when needed to address safety issues or other monograph changes while preserving the existing monograph structure. A structure that does not require unnecessary premarket review, provided manufacturers utilizing ingredients have been determined to be generally recognized as safe and effective i the fda. We understand this new system , if 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 free program. We believe the Fee Agreement strikes the right balance and will help achieve a more nimble, regulatory structure for monograph drugs which would be a win win win for consumers, manufacturers and regulators. In summary, the draft legislation we are discussing today is incredibly important, in as if enacted will impact the health of nearly every american for decades come. Its the product of months and even years of consideration and compromise between many stakeholders including chp a manufacture members. See hpa has some important technical comments on the discussion draft and we look forward to continuing to work with members of this committee to finalize the text and support this introduction and consideration by the congress in the very new future. Thank you. I look forward to addressing any questions you may have. Thank you. Ms. Moore, you are recognized for five minutes for questions. Thank you very much. Members of the subcommittee, thank you for holding a hearing and for the invitation to testify. My name is Kristen Moore and i direct the healthcare project. Its a nonpartisan, Nonprofit Research and Advocacy Center and i am here today and strong support of this legislation that would help update fdas regulation of overthecounter products. By streamlining fdas 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 in the benefits of proposed legislation. Each year more than 240 million americans use otc products. Its marketplaces vast and diverse with up to 300,000 products ranging from cough and cold to sunscreen and pain relievers. In theory, the active ingredients are considered safe and effective when consumers follow the instructions on the label without direction from Healthcare Provider. In practice, however many contain ingredients that the fda has not yet evaluated there is no timeline to when reviews must be finalized. They are hampered by a number some system in evaluating these products. Its a system that has not been updated since 1972. To have only 30 fulltime employees. They evaluate safety and efficacy of ingredients for monograph system which will be described in greater detail in my written testimony when its important to note that changing monograph is a multi step Program Involving several offices. In contrast, fda review of Prescription Drugs is solely within the jurisdiction. The additional step for review for otc products at considerable time and does not add key determinations of safety and efficacy. Let me provide one example of the effect on Public Health. This april, fda required that companies had the strongest form of warning labels to cost medicine containing coding. It can cause potentially fatal breathing problems, especially in children under 12. These safety concerns lead an Advisory Committee to recommend they remove it from products in 2015 but they have not made the change yet because of the inefficient monograph system. When patients are in harms way, we need action, not bureaucracy. This spring. You and several other stakeholders issued a set of principles for reform. They are probably reflected in the house and senate language. The Bipartisan Legislation that you are considering would produce a winwin, reduced Regulatory Burden and protect consumers in four key ways. First by driving efficiency. The proposed reforms will replace cumbersome rulemaking with the administrative rule process aligning fdas decisionmaking with its authority for Prescription Drugs. The legislation would also expedite the review process by giving additional review authority for data collection. Second, improving safety. The proposal will ensure that if fda has reason to believe a product is unsafe 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 a final monograph is issued. Third, helping innovation. Under this they can more quickly accommodate innovation with new indications on existing ingredients. And lastly, providing resources, the proposed agreement would provide fda the ability to clear up backlog and address concerns for products on the market and accept applications in a more timely manner. They support the proposed legislation because it will lead to improvements in consumer safety and administrative efficiency. It strikes a sensible balance and reflects thoughtful compromise between stakeholders. We applaud the subcommittee for the bipartisan proposal and encourage you to pass this legislation as soon as possible. Thank you. Thank you for inviting me to testify today regarding efforts to improve and strengthen the approval process for overthecounter otc products including sunscreen ingredients. The past coalition is a multi Stakeholder Coalition composed of Public Health groups, dermatologist, sunscreen manufactures and leading advocates for skin cancer patients. It was built to ensure americans have the latest technology to sunscreen and to address the problem, congress, led by the subcommittee, the coalition and other stakeholders came together to enact the bipartisan sunscreen act in 2014 to ensure americans get access to new sunscreens. In 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 subcommittee to extend similar reform to other product categories. We also support the establishment of the User Fee Program to provide fda with the resources it needs to implement these. Based on our experience over the past three years with implementation 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 pending use on sunscreen ingredients. The otc reform legislation being considered by the subcommittee provides the opportunity to codify these improvements and achieve the promise of the fia. Mr. Chairman, skin cancer remains a Public Health crisis in the United States. According to the surgeon general, 5 million americans are treated every year. Each year there are more new cases of skin cancer than breast cancer, prostate cancer, lung cancer and colon cancer combined. In the u. S. Patient is diagnosed every eight minutes and 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 ingredient was approved in the u. S. Was decades ago. Since 2028 new sunscreen ingredients have been submitted for review. These ingredients have been widely available in europe, asia and elsewhere for decades. Clearing this backlog of applications will ensure they have greater access to broadspectrum sunscreen to get better protection against both uva and uvb rays. They have met all the timelines required by the act but none of the eight pending sunscreen ingredients have received final decision and they are not available in the u. S. Based on recent conversations with fda, there is agreement that some changes to the fia for the eight pending ingredients are needed and any new pathway should accommodate sunscreen ingredients. As Congress Considers otc reform legislation they respectively submit the following principles for consideration. First the sunscreen ingredients that have already received proposed administrative orders should be considered under the fia. New sunscreen ingredients should go through the otc reform framework. Second, any new otc drug approval pathway shall be flexible enough to accommodate new sunscreen ingredients with u. S. Or International Market experience and should not require the sponsor to file a new drug application for its active ingredient. Third, any otc form legislation should authorize them to meet individually on the confidential basis to allow for open discussion of commercial confidential information and trade secrets. Finally, the fdas testing standards for these products should be periodically reviewed and assessed. Inclusion of provisions that incorporate these principles will ensure americans have access to safe and effective sunscreen ingredients that are available across the world and draft legislation that we could see in many of these provisions and we look forward to continuing to working with the subcommittee. Thank you for the opportunity to testify. The chair thanks the gentleman. Five minutes for your Opening Statement. Good morning. Thank you for the opportunity to speak here today about the importance of modernizing the regulation of overthecounter drugs for americas children. My name is doctor bridget jones. I am a practicing at kansas city missouri. I also conduct Clinical Research to improve the safety of drugs for children. Im here today to represent the American Academy of pediatrics. In my practice, i frequently meet to discuss with parents the risks and benefits of using otc medicines to treat common pediatric ailments such as allergies and asthma. As a pediatrician advising parents, i want to know the products recommend have been tested to ensure they are safe, effective and labeled properly 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 is not nimble to adopt. Burden some processes cause unnecessary delay. Some of these drugs continue to be mainstays of pediatric practice but others provide little or no benefit to children. Put simply, the Current System does not serve the needs of children. The only way to ensure reliable and safe otc medicines for families is to change how the monograph system works and provide significant new resources for the endeavor. Therefore they strongly support the efforts of congress to reform the process and create a User Fee Program to fund the 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 medicine for children does not meet todays standards and data gathered since then clearly show certain cough and cold products to be completely ineffective for children. Nevertheless, these rocks are still commonly marketed to children despite safety risks. What fda agreed to revise the monograph more than a decade ago, today fda has yet to publish even draft changes despite that they relate in thousands of overdose visits each year. It is our hope that through reform the fda will act 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 anticipate greater Industry Innovation is in the development of formulation for otc product. Its possible that the industry may work on developing gummi formulations of drugs much like supplement manufacturers have done in recent years with their marketing of gummy vitamins. Gummi formulations of otc drugs, whether intended for children or adults would greatly concerned pediatricians because we know when a product looked and taste like candy, children will eat it. If a child consumed gummi acetaminophen outside the watchful eye of parents, it would be a trip to the emergency room or worse. Fda must have Clear Authority to regulate the packaging of otc drugs including requirements for unit dose packaging to prevent abuse or misuse and protect against unsupervised ingestion. They have existing authority for child resistant packaging, its difficult for children to open, they cannot require specific types of packaging. Therefore fda must be able to do so since they only require a small handful of otc drugs to be sold in childproof packaging, greater cooperation is critically and wharton. Mr. Chairman, the latest discussion draft is largely reflective of the ap principal for monograph reform. We strongly support the packaging language. Additionally we look forward to continuing to work with the committee to ensure the fda and cps the establishes processes for when they take action that might want reevaluation of its own packaging regulation. Thank you for the opportunity to speak here today about this important issue. The chair thanks doctor john. Mr. Ross you are recognized for five minutes for an Opening Statement. Ranking member greene, members of the subcommittee, thank you for the opportunity to submit testimony about the proposed overthecounter safety, innovation and reform act of 2017. I am president of the pharma and bio Pharma Association or pb away. Pb away is a leading trade association for Contract Manufacturing organizations and Contract Development organizations known as cmo and cmo. The core mission is to advance regulatory legislative business in the sector. Im here today to express their support for the newly released draft to urge this committee and the congress and to express my thanks for ensuring that this drafting into account the unique needs of the cmo, cdl community. Your willingness to ensure our seat at the table is greatly appreciated and they strongly believe its resulted in bipartisan support. You may be wondering what that actually is and how these companies contribute to the development of drugs or in this case overthecounter drugs. Cmo are the true experts in manufacturing. Members were predominantly domestic provide manufacturing, packaging and other services and enable Drug Companies to develop commercialized medicine. They help make more than one third of all those who dispense to patients in america, producing innovator drugs and generics, small molecules and biologics, pills and injectable injectables, otc and bio similars. Cmo empower their customers to bring lifesaving, costeffective quality medicines to patients. Ive been involved in the sector since 1999 and have witnessed the rapid growth and the key role it plays in the american Healthcare System. I would like to commend the committee for their continued focus on the important issues we will examine today. The fda has long outstanding commitments to produce and finalize overthecounter monographs which began the year after i was born and has been noted, the current fiscal year the have allocated 8 million. Industry, the fda and the congress can agree that the monograph process overall is outdated and further there is recognition that monograph cannot expand without additional resources. The legislation, under consideration should help solve those issues. It will provide resources to finalize long unfinished monographs giving them a degree of certainty. As with other User Fee Programs, the transparency and goals dictated by the commitment letter should provide industry with increase predictability. This path for innovation to establish ingredients is overdue and could benefit manufacturers and marketers alike including cmos that specialize in unique dosage forms. Although is not included in the negotiations between industries in fda, we are pleased that the legislative discussion includes a fee model that has. [inaudible] that provides relief from the facility fees proposed overall. We are very appreciative of this committees role in ensuring that all stakeholder voices were heard as you develop this draft. We hope the pb away and the cmo business is that it represent will be included in future user fee negotiations, particularly ones that are considering contributions in the form of facility fees. We look forward to continuing the process. Thank you again for the opportunity and we are available for questions. Thank you to all of our witnesses for their testimony. We will move in to the member question portion of the hearing and will take five minutes for your questions. I have worked on sunscreen innovation in the past have worked to ensure this passage that we work on the continued holdup we see at the fda. Can you outline the positive benefits that you see in proposal for sunscreen products. [inaudible] [inaudible] science has evolved over the years, new ingredients have been available elsewhere in the United States. With the exception with a process called time and extent applications. That has never proven to be a very effective approach to market, very timeconsuming, and there for the monograph or forms being discussed today would open up a new opportunity and bring new ingredients to the market through the monograph system, not using those in rulemaking as has been traditional used but using the administrative order process which would be a much more effective and much more efficient process. I think for monographs drugs that are sunscreens, you would have two choices today under this law. You will continue as mr. Warner said to operate under the sunscreen innovation act that Congress Passed and implemented four years ago, or you can elect to operate under the new monograph structure. I think longterm, new ingredients would all be utilized in the new structure. Its very positive for sunscreen. He mentioned the need for new overthecounter review process to be flexible, enough to accommodate sunscreen and how sunscreen active ingredients are slightly different than advil or tylenol. Could you explain that . Sure. Thank you. So first of all, yes, the new overthecounter process has to be flexible enough to accommodate sunscreens and a couple of big reasons those are different is, number one, the new drug application process isnt really feasible for sunscreen products for any number of reasons, but not the least of which is that would give you an approval for final product and final formulation and sunscreens ingredients are used in lots of different products. Number one, number two sunscreens typically change with seasons. They might change their center their lotion, et cetera. The process has to provide for an alternative pathway to approval in the otc space and draft legislation certainly does that. The other thing is, just like current law, sunscreen manufacturers should be able to use their safety net of data from elsewhere around the world where the products are being used as part of their application package to demonstrate safety and effectiveness for the fda purpose. Thats another way that the products are slightly different and its another way that this legislation absolutely accommodates those products. Thank you. In your testimony, you mention the Contract Manufacturing organization may specialize in unique dosage forms. Can you explain this process further and explain how that process would be affected by overthecounter monograph or form . Some cmos essentially work in traditional dosage models. Others do work in unique dosage forms and semisolid and other topical delivery systems. For some of those types of dosages, it is possible that innovations might lead to products that they would then be open to manufacturing, where just changing the type of pill might not be as big and innovation. For Niche Technology provider like some of our Member Companies, this could open the door to new otc monograph products they were produced for the customer. Thank you. Mr. Chairman, i yield back my time. The gentleman yields back. We recognize the gentleman from texas for five minutes. Ms. Moore, one of the discussed benefits of the monograph reform has been potential for streamlined regulatory process to encourage innovation and otc drug market. This draft also proposes an Additional Market incentive that would provide 24 months to an innovative over the counter product. They have targeted it exclusively as a way to create a market where one doesnt exist such as in antibiotics. Whether or not this incentive was the right incentives in this example, it was crafted with a public goal in mind. The question that i mentioned, the discussion draft would propose a warning to innovative overthecounter products, a vastly longer. Then 180 days awarded to the first market insurance for the six months provided by the pharmaceutical manufacturers to complete the necessary studies. In considering overthecounter products, what Public Health considerations could congress have in mind to ensure there is a proper balance between innovation and Public Health . Its a very long question. First, the current draft is a really well thought through compromise on many of the parties and we appreciate that. I think the issue is always one of the more sensitive issues and legislation and we appreciate the fact that different goals and different benefits have been evaluated under different types of legislation. I think in this case, for overthecounter products, because we are hoping to have a fair amount of innovation in the marketplace, it would be worthwhile, we understand congress in industry and other stakeholders have agreed to a certain timetable but it would be worthwhile to evaluate whether that timetable really is striking the right balance between spurring innovation and actually improving Patient Access. Thank you. I heard from members in your industry that is warranted in order to justify paying user fees or alternatively that streamlining as a monograph process, that through executive order is still not sufficient for countries to innovate. Setting aside whether or not exclusivity, what is the Public Health justification for a awarding 24 months to an overthecounter product. It seems to me that this long time has potential for blocking Patient Access to new formulations. Mr. Green, i think one of the great benefits of the overthecounter drug is that it gives consumers a choice. They can choose a branded product or a store brand product. Many of them are under 8. The monograph system has been set since 1972. There hasnt been a lot of innovation. The manufacturer would have to come to the table with human data and will be safe and effective on humans. Thats very costly for the next day there could be a private label version of that product on the market. Mr. Chairman, our association represents branded and private. Our chairman is the business had for the Largest Store brand manufactured in the United States. They are strongly supportive because they recognize what it takes to innovate and they recognize their future pipeline and they will benefit from that. Thank you. My colleagues also want to encourage Regulatory Reform. Its almost like an issue in our subcommittee and we need to make sure it doesnt overtake Patient Access. We work closely with Contract Manufacturing organizations and Contract Development organizations. Can you discuss how this reflects the value of otc products with the cmo and cdl. Certainly. Its an industry that reflects the much lower market that cmo has especially when working with otc products. In working with our industry partners, we developed a model that we think would better reflect from the products in this program overall. Thank you, mr. Chairman. The chair recognizes the gentleman from virginia. Thank you very much. I open it up for whoever wants to jump in. The first question is, is there anything we have in the discussion draft that causes concern to you. Whoevers passionate wants jump in first. Anybody have any comments. We strongly support having explicit authority for fda and that is in the statute. The specific language and how it can be acquired is still being discussed. There are three ways they can apply the new authorities they get. It can act under an eminent hazard and move very quickly to remove a product from market. There is some interim Order Authority that it can used to update labeling. We strongly support that. Then theres the traditional order process which is a great enhancement over current law and allows for a period of public discussion before in order would take effect. We believe packaging decisions, because theyre very complex require that sort of discussion before they would take effect. We think it should be limited to the administrative order process. Thats helpful to know her thats why asked the question. Thank you. The second half of the question is, does anybody else have something we ought to put on the table. It appears as a bipartisan agreement that weve got the substance so lets make sure we cover all the bases that we can. Does anyone have anything we should put in that isnt currently there. As we said in our testimony, we do think it would be useful if we could incorporate some way to assess testing standards, for sunscreens the fda has published guidance on this and certainly the bill goes a long way by guaranteeing meetings, its a long way toward coming to some kind of agreement. Since its such a new area we thought it would be important to have reauthorization of the bill and re author is how its going. Im in a switch gears and turned you in a slightly different vein. I havent asked my two questions on this subject. I appreciate what you do. I have an 11yearold and we have all kinds of issues going on. In a Perfect World weve appreciated your comments making sure things are focused on kids. Every kid is little different as im sure you are aware. Thats correct. Theres been significant strides in the ability to study drugs in children over the past several years. As pediatricians, we still know that 50 or 60 of the drugs we currently have to use in children are used off label. We do not have direct evidence for proper dosage and whether those medications are actually effective. When you see a child with a certain condition and you know that this drug has some evidence that it may work in adults or other populations in your somewhat forced to use those medications in off label situations. But, i think with significant strides, i hope that will continue. Its always good to get more information from whatever source you can to make sure you are using that off label drug when you have to come in the best way that you can. Isnt that also cracked. Yes. I think any medical provider, its your Due Diligence to your patients to ensure that you have combed the literature and do as Much Research when using off label medication. Any information is better than less information. Yes. Thank you. I yield back. The gentleman yields back and recognizes myself for five minutes for questions. I appreciated your testimony. I do seem to recall maybe two or three years ago a difficulty with the labeling of infant preparations of acetaminophen and a child be giving a childs dose of the infant concentratio concentration. The infant preparation was more potent or more concentrated than the label for children and i believe there were some misadventures with acetaminophen because of that. due to limitations of people to add language to the monograph cannot put that information on the packaging and on the labeling so the child is less than two years of age at the places contact your Healthcare Provider to provide how to does that medication. If you are apparent in the middle of the night and your baby has a fever and they are less than two years of age you do not have any instructions to tell you how to those that medication and that is when you get into safety issues where a parent might have to guess the dose, if the not able to contact their Healthcare Provider or may have to take their child out in the middle of the night to an emergency room so they can be dosed. I think those are significant safety concerns that will be addressed with this new legislation. My hope as well. Doctor jones, mr. Melville, you both referenced cross jurisdiction and doctor woodcock mentioned it as well and clearly that is one of the things that will have to be taken into account. I had not even considered that the dispensing mechanism being a gummy bear would pose a special talent, as far as the packaging is concerned. Clearly, it would so that is that gets to the point and one of the reasons we are here today is we have to be nimble and have to be much more agile for our Regulatory Agency needs to be much more agile than it currently is able to be on the monograph. If i could follow up. Doctor jones makes a great point and the medicine is a great example. Fda wasnt able to move forward quickly because of the requirements under the current monograph system so today it does not exist but our industry didnt move forward and the two concentrations of acetaminophen as doctor jones referred to were both permitted under the monograph and the industry voluntarily withdrew one of those because we saw in real world that there was confusion so there is only one consultation today and its a more deluded concentration. We also voluntarily added flow restrictors to pediatric to dominican for the children, if they did get into a bottle that was opened and not sealed properly, would not be able to get a lethal dose of that. The industry has moved forward to innovate and to make sure, to improve the safety of these products and its a work in process and we look forward to the new authority that they would have us we can work with them and get improvements and make sure that they are not applied voluntarily but to all participants in industry. That begs the question that you brought up about commerce and activity of the ruling comment type of structure that we are in now so, in the future will there be an app for that. [laughter] technology is certainly changing things and today consumers have to look at the label to get all the information they need to use the product safely and with technology and advances are there uses of technology that can add a hologram or multiple languages and adoptions are limitless for using technology to enhance the safety of overthecounter medicine. We look forward to working with fda on those initiatives. As every doityourselfer knows there is strictly a Youtube Video on how to provide the instruction that you need. And that concerns us greatly. Im sure that it does. It opens another avenue. It has been a fascinating discussion and i want to thank our witnesses for being here today. Thank you for your testimony. I see no further members wishing to ask questions pursuant to the rules i remind you have ten additional days to submit for questions for the record and please. Committee is adjourned. [inaudible conversations] the Senate Returns today at 3 00 p. M. Eastern to finish work on the fiscal year 2018 Defense Authorization bill. Final passage could come as early as this evening in a series of votes starting at 530 eastern. Watched the senate live here on cspan2 the house is not in session this week. Members returned from a district work. On september 205th when they will take up faa reauthorization and chp, the Childrens Health insurance program. Funding for those programs expires at the end of the month. Watched the house, live on cspan. Hillary clinton gives personal account of the 2016 president ial campaign and election in her memoir what happened. She will talk with what former aides and politic pros and that will be live today starting at 7 00 p. M. Eastern on our companion network cspan. It is that time of year to announce our 2018 student cam video documentary competition. Help spread the word to middle school and High School Students and their teachers. This years theme is the constitution and you. We are asking students to choose a provision of the u. S. Constitution and create a video eliciting why it is important. Our competition is open to all middle school and High School Students grades six through. Students can work alone or in a group of up to three and produce a fiveseven minute documentary on the provision selected. 100,000 will be awarded in cast prices to the grand prize of 5000 will go to the student or team with the best overall entries. The deadline is january 18th, 2018. Mark your calendars and help spread the word. For more information go to our website student cam. Org. Tonight on the communicators. A discussion about Key Technology and tell medication issues surfacing before congress. The fcc and the public with tech reporters lydia, john and tara. Its important to keep an eye on that were headed in a direction where two different versions of Net Neutrality will be very likely litigated. They will be in court. We have the wheeler Net Neutrality rules from 2015 and will have the high Net Neutrality untitled of Net Neutrality. Everyone seems to be watching fcc chairman and hes facing more pressure given that the senate also sold a big public rollcall on his reconfirmation in the fall. This is unheard of for an fcc nominee. Whats interesting is they normally passed by unanimous consent and a bigger package. I think the murder that is at the top of everyones mind both at fcc and in congress and for people who watch this space and for those in the industry is that the merger or acquisition really of Tribune Media company, a broadcasting giant perceived as somewhat conservative leaning and perhaps politically aligned with republicans and the administration and the implications of them growing even bigger. Watched the communicators tonight at eight eastern time act on cspan2. Let me bring on a member of congress his own district was impacted by one of those recent hurricanes by hurricane harvey, Sheila Jackson lee is on the on