Transcripts For CSPAN3 Hearing Looks At Changes To Over-the-Counter Drug Regulation 20170914

The Current System at the United States food and Drug Administration to review, approve and update over the counter drugs. This hearing provides us and the American Public with an opportunity to better understand the food and Drug Administration regulatory pram work to regulate over the counter drugs and consider a proposal to reform the monograph system. Today we will convene two panels of witnesses. First i want to welcome dr. Woodcock back to the subcommittee this morning. Later well hear from representatives of other key stake holders. And 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 full committee have a strong record of by partisan ship on Public Health issues. Such as cures. The fda reauthorizization act and i hope to add to the record of success with todays hearing. Over the counter drug products treat a wide variety of ailments. Time and again consumers seek antacids, cough products as a first line treatment option before seeing their doctor and getting a prescription. These products also include antibacterial soap. Hand sanitizer, sunscreen, and the sunscreen commonly used by many families in the United States. Currently, there are more than 300,000 over the counter products on the market according to 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 a drug monograph. Which is a set of specific standards created by the food and Drug Administration that ensure the product active ingredients are generally recognized as safe and effective. The vast majority of over the counter products rely on the over the counter drug monograph system. Unfortunately the Current System hasnt had a significant update since the food and Drug Administration first established this in 1972. So thats well over 40 years. In addition, the system requires a burdensome multistep rule making process that can take years to resolve. All of this has led to a lack of innovation and inability for timely updates to address safety issues. And much work left unfinished. We feel that is unacceptable. Theres broad support from the food and Drug Administration from industry stake holders, patient groups for significant reform to regulate over the counter product. The Health Subcommittee will examine the over the counter monograph safety innovation and reform act of 2017. The discussion draft was recently leased by representatives latta, deget, and myself. Establishes the program and makes a number of meaningful modifications to the monograph process. The goal is to create a system that is more flexible and efficient. That reflects scientific innovation. So that patients and consumers have greater access to better and safer over the counter drug products. Again i want to welcome and thank the witnesses for being here this morning. Certainly look forward to your testimony. Before i yield to the Ranking Member, one detail. This is the premier committee for technology in the United States congress, some of the systems are not working this morning. So i understand dr. Woodcock had a series of slides. Those will be made available to you in paper form. We require our doctors to go paperless. Here on the committee we can deal with paper. And the clock is working but only i can see it. So the red, green and yellow lights are not working. I will give a brief two click when were getting down into the yellow zone. So youll know the time is wrap up. And well do that obviously for everyone on the committee. Just as a general reminder. With that, i yield back and recognize the Ranking Member of the subcommittee. Mr. Green of texas. Thank you all the witnesses here this morning. The over the counter drugs are routinely used to treat a wide variety of ailments. We go the walgreens or retailer and dont even think about that bottle of sunscreen. Like we do with a Prescription Drug. Otc drugs provide a low cost convenient way to take care of every day healthcare needs. We have a growing number of choices in the local drugstores. According to to the fdai and the Consumer Health product association, the otc market now include more than 300,000 products with annual sales of 32 billion. The Items Available over the counter are diverse, ranging from cough and cold medication and pain reliever. To sunscreen and soon hearing aids. Fda regulates most of the drugs on the store shelves under the monograph system. The active ingredients in the products are considered safe and effective and consumers follow their instructions on the label. Without direction from a healthcare provider. That is largely true in here ri, many contain ingredients the fda hasnt evaluated or known to be misused for labels havent been modified to warn consumers of harm. The Current System also poses the challenges for consumer access to better, safer and Innovative Products. Regulatory frame work for over sight of most over the counter products are put into place in 1972. And hasnt been updated despite an increaseingly diverse and large market. The need for reform was brought into focus when the committee worked on sunscreen innovation act in the 113th congress. Under the Current System. Monograph is established through a three step public ruling process. With each step requiring publication and federal reng ster and Public Comment person. This system is overly burdensome and time consuming and doesnt work very well. Its unable to respond quickly to safe concerns and keep pace with scientific discovery. Which places consumers at risk and slows the development of new drugs. Today the fda has estimated 88 rule makings and 26 therapeutic categories. Its one of the largest and most complex regulatory schemes and also dramatically under resourced. The agency has 30 fulltime employees for the entire program. And budget of roughly 8 million. For context, 18 fulltime employees are devoted to the review of one novel drug application. Again the otc market include more than 300,000 products with annual sales of 32 billion. Recognizing the resource and process challenges the otc Monograph Program, stake holders think about how it would work better and value the establishing of the User Fee Program. We have been working on a by partisan fashion to put together a bill that would establish an otc User Fee Program and reform the monograph system. Today we have a discussion draft that reflects the work of the stake holders. Fda and congress. Im happy to see the committee moving forward. I want to note we should be considering doing the same with cosmetics. There are parallels between kosz mettic and otc products. In also the challenges fda faces in over seeing the kate goirs of every day items that impact our health. Monograph perform will foster growth and the availability of the medicines. Policy reform could make the system more flexible. Responsive and accommodating to innovation and knowledge about potential harm from misuse. Modernizing the otc monograph system or ensure the industry can update products with safe effective ingredients. And ensure the fda has resources to i look forward to hearing from my witness about this. And id like to yield the rest of my time to congressman deget. 40 seconds. I dont think your mike is on. The green light is on. As a result the system doesnt adequately respond to emerging safety issues which create Serious Problems for consumers. In 2006 for example the fda learned that common cough medication tragically caused several toddlers to die. For ten years. Fda has been trying to revise the cough and cold monograph to warn parents about risk for young children. Efforts have been unsuccessful due to the process the fda last used to update and change monographs. What this bill would do is give the fda new tools to protect consumers and streamline how fda reviews over the counter medicine. Im extremely glad youre with us again today to give us the same kind of guidance you gaf us in 21 century cures and other issues. We have a great opportunity to upgrade the regulatory process in a way that benefits all everybody. The American Public, the federal government, and the regulated industry alike. I look forward to continuing to work with my colleague to support this bill. I thank you very much for holding this hearing. The gentlemen from texas yields back. The chair recognizes the gentleman from oregon. Appreciate your holding the hearing on these important issues and the long over due reforms needed. To improve efficiency and update the frame work for regulating over of the counter drug products. Following the reauthorizization of the critical medicine device programs. Theres no better time to continue the work than now and in this space. Im pleased with the by partisan effort thats begun. From cough and Cold Medicine to antipercent pent. Cabinets are filled with over the counter drugs that American Consumers rely upon daily. Unfortunately the process has been the same since the 70s. And while bell bottom ton pants are coming back, we need to innovate in the sector. And safety related change often take years to implement. Fortunately fda agree thats significant reform is something we all need to join hands on. For several years now, they have engaged in productive conversations about how to substantially approve upon the status quo. We now have by partisan resolution before us today that will ensure americans have more timely access to safe and effective atc medicine. Consumers will no longer have to wait years for a rule making process to winds its way through before benefitting from product improvement. I want to thank colleagues mr. Latta, guthrie, dingle. As well as chairman burges. Ranking member green and others. Who have put their shoulder to the wheel on this. We proven time and again in the committee. We know how to legislate and fwet god things done for the american consumer. Well do it again here. Ill yield to the gentleman from ohio. I think the chairman for yielding. And i thank chairman burges for holding todays hearing. On this important issue. I thank the witnesses for being with us to provide the insight on this topic and legislation. Already been said over the counter medicine are nearly every household across the nation. Yet despite widespread utilization. The system in place to regulate the drugs has been out dated for decades. Its teem to move forward to a flexible frame work. I believe the discussion today will achieve these goals and provide predictability to the drug approval process. The otc monograph safety act is the product of the collaboration between myself, the chairman of the subcommittee mr. Burges. And ms. Dingle. As well as significant contributions from the fda and the industry. Id like to thank those involved who worked tirelessly on this effort in order to increase Consumer Choice and safety. I appreciate the chairman for allowing the opportunity to discuss the monograph reform and improve upon the in the cushion draft today. I look forward to hearing todays testimony. Receiving input from my colleagues. I thank the chairman for holding the hearing and for witnesses and i yield back. I yield to mr. Guthrie. Thank you. I appreciate it. Mr. Chairman i thank you for holding this important hearing today. And examine the review protsds of over the counter drugs. This important bill will enable greater innovation and foster inefficiency within the approve process. Something that hasnt been done since the 1970s i want to specifically thank the kopg congressman latta for his leadership on this issue. Im proud to be a cosponsor. Of this important bill which industry fda and the Committee Staff worked so hard to move forward. I strongly believe this legislation will help every american. As products are the first in line of defense against common ailments. Dr. Woodcock i appreciate you being here. And the other witness as well. Theres no one else wanting chairmans time. Ill yield back. Chair now recognize the gentlemen from new jersey. Thank you, mr. Chairman. I want to thank you for holding todays hearing. On the the over the counter reform. I also want to commend our Ranking Member green, representative deget, latta, guthrie and dingle. As well as the chairman of the full committee for work in crafting a proposal that will accomplish the goals. The safety and effectiveness of over the counter drugs is established today through conform with the monograph. This so called rule book out lines the conditions of use for a particular drug ingreed ent that out lines the dosage form, patient population, labeling and warnings and requirements. This is established with three faze rule making process thats oftentimes inflexible and time consuming. We have heard from fda and industry that the monograph process doesnt lend itself well to evolving science and technology. And may have the unintended effect of discouraging the of but the Current Program is drastically under resourced. So today the Monograph Program over sees more than 100,000 products with a staff of 30 people and a budget of just over 8 million. Its my hope that through Regulatory Reform and increase predictable resources we can streamline the over the counter process to allow for swift finalization of current monographs. Timely updates and encourage innovation where possible. Wile were beginning the process of making significant improvement in the review of over the counter products i had hoped that we would be begin taking action on cosmetics. Millions of americans use cosmetic products every day. Regulatory authority is willfully inadequate. In the last year millions of women and children have been exposed to shampoos that can cause hair loss. Lip balm can cause blisters and rashes. And eye shimmer tainted by asbestos. Unfortunately fda doesnt have the authority to hold the manufacturers responsible and has little ability to ensure the cosmetics are safe. This cant continue. As we move forward we should provide adequate resourcing and authority for cosmetics as well. I look forward to continuing to work with my colleagues and other stake holders to accomplish both of these goals and ensure that continued availability and safety of the means of drug products and personal Care Products people use every day. So id like to yield the time that i have left to ms. Dingle. I thank my colleague for yielding. Americans deserve peace of mind in knowing all drugs they take are safe and effective. Whether its a Prescription Drug or over the counter. There are over 300,000 over the counter products on the market today. Which americans use in every day life. Fda regulatory system is completely broken. The agency has a meager budget of 8 million. And a process that hinders the agencies ability to both address safety risk and let new and innovate i have products come to market. The legislation creates a new user fee system for the products to give fda the resources it needs to do its job. Of ininsuring Patient Safety. It allows the agency to move quickly to update and advice the system. Which are similar to the reforms made under lt sunscreen act. We have seen the benefits ha user fees have brought to the medical devices in its time to bring the system to the otc space as well. Wile im pleased were holding this hear and moving forward, i want to commend mr. For the same comments made about the cosmetic industry. Which is also desperately benefit from reform and hope the committee will soon move forward with legislation establishing a User Fee Program for the products. I want to thank any colleagues, for working with me on this draft legislation. And look forward to continuing our Work Together to reach consensus on this important issue. And as always our chairman and ranking minority member. I yield back, mr. Chairman. This concludes member Opening Statements. Per sunt to committee rules, all members Opening Statements will be made part of the record. We want to thank our witnesses for being here with us this morning. Taking the time to testify. Each witness will have the opportunity to give an opening statement. Followed by questions from members. Today we will start with our first panel. And hear from dr. Woodcock. Director of food and Drug Administration center for drug evaluation and research. We appreciate you being here this morning. Youre recognized for five minutes. Thank you. Were here to talk about modernizing the monograph system for otc drugs. Probably everyone in this room has used an over the counter drug. One time or another. Monograph drug in fact. I know i have. These medicines allow us to manage minor Health Problems without going and consulting a health professional. To manage them on our own. And millions of americans use these products every day. Theyre widespread. I believe theres more exposure of americans to these drugs than there are to Prescription Drugs. In this country. The monograph system allows manufacturers to come on the market without the burdensome per product application process. That we use for generic or new drugs. This is a much simplified system. Why the push for reform . Well, as the members have already said, the monograph process was put in place a long time ago. To deal with hundreds of thousands of products on the market after Congress Passed the 62 amendment to the food drug and cosmetic act. Requiring drugs on the market to show they were effective. So fda had to deal with that in some way. Since many of the otc products were different version of the same basic ingredients, fda decided to deal with them in groups. In it was found that x at y dose and was effective for z condition. These facts would be put in a regulation and any manufacturer can come on the market as long as they conform to the conditions. Also subject to inspection and gmp. That is still the case. But problems emerged as members have said. The rule making process it was put in place is become long and burdensome and huge delays. 88 monographs that are not finalized. And it also means that we cant respond rapidly to safety issues. Perhaps a naive thought at the time that science wouldnt evolve. Science wouldnt evolve and safety issues wouldnt come up. Thats by no means the case. We have really been hampered in responding rapidly to safety problems. And sometimes this leaves consumers unprotected and may leave manufacturers open to liability. Then this process is frozen in 1972, and before. So it doesnt apply to anything later than that. So this is only still trying to dole with those products that were on the market at that time. Theres really nothing for innovation. In this entire process. So the reform that were proposing keeps the features of the monograph system that work well. Products that follow the conditions could still be marketed without prior fda approval. If they conform to the conditions. For marketing. Its a public process. So the public has input and itself an open and transparent process. Its streamlines the process by replacing rule making with administrative orders. So using an order system is very similar what we do for new drugs or generic chl its quote appropriate for scientific decision making. We would issue a proposed order under the discussion draft allow Public Comment and issue a final order. It provides due process, appeal and hearing process. To permit challenges to fda decision. So that process is in place. There are fewer requirements that have to do with rule making. So that this can be a accomplished in a much speedier manner. It also would encourage innovation by expanding eligibility. And the no longer limiting it to pre72 products. So industry can question we amend a monograph or even submit new kinds of products. And what we envision allows for confidential meetings early in the process between industry and the fda before we move into the public process. To allow for that innovation to be explored. It also would allow very importantly fda to quickly respond to urgent safety issues. We could issue an interim final rule. And definitively get the Safety Information out. That rule then would be subject to further Public Comment and discussion and so forth. But it would be in place during that time. So that people could be protected quickly. And thats something were really missing right now. It would reduce the backlog of unfinished monographs by transferring these pending regulations and so forth by statute. And this would allow us to deal in an orderly and effective manner with all the pending work that has not been finalized up until to point. The Public Health i think would be served if there provision to clarify the authority to require certain types of packaging. Such as unit dose packaging. This can protect people from taking too many pills. And we know that for our elderly and children especially, they may mistake medicines for candy. They can over dose. That protective packaging is very important. This clarification would compliment the authority of. Which can prior child resistance closures on different packages and we conform to their standard for that. So all in all, this modernization proposal along with the user fees that would provide the staff to enable to do it, i think would benefit both the public most importantly, public safety, and would benefit the industry. And the fda has been talking to many stake holders about this over the last three or four years. And we feel the proposals that are on the table would serve the public well. Thanks for your testimony. And we will move into the question and answer portion of the hearing. Im going to begin by yielding my time to the principle author of the bill. Mr. Latta. Thank you, very much. I appreciate the chairman for yielding. And dr. Woodcock thanks for being with us today. We appreciate your testimony and the work you have been doing. If i could start with the first question. Touching on what you were discussing. As we Work Together to draft the legislation, we were mindful to ensure that fda has the authority they need to regulate the safe packaging of over the counter drugs to prevent unintended consequences. Children that accidently would ingest drugs intended for adults. Does the discussion draft provide fda with sufficient authority and would you also discuss the authority you would be granted when the monograph reform becomes law and benefits to public safety. Touch back into that, please . Certainly. First we believe the language that said an administrative order may include requirements for the packaging of a drug. Would make requirements for unit dose packaging to encourage yis. Such packaging requirements that we could have could include unit dose packaging and special requirements for products intended for use by children and other appropriate requirements. And we believe that language provides us enough authority to require safe packaging. Okay. Thank you. Also, when you look at the dates that were looking at in some cases, back to 1972. And the fda began evaluating 26 therapeutic categories and has yet to finalize monographs pr them. Could you go into, again the system that were looking at, especially with the review of the otc, that its. Speaking to the proposal. Especially urn the administrative order process and procedure that would be speeded up to get the drugs out there . Certainly. What occurs now what you have in front of you the first slide talks about a single role. And this is an important one. External drug product. All right. It shows many of the steps that we have gone through simply to try and move a single rule making along. And each one of those requires very large administrative effort writing many of them publishing in the federal register notice going through extensive clearance. This would be substituted by a new process. That would take less than two years. And would have defined time lines under the user fee part of the program. So we would commit to finishing things in a timely manner. And what we would do for the old ones, some of them would transition to legally marketed drugs. And that would over time go through a process where the industry would submit data. The old monograph issues would be taken off the table. Submit current data. And we would have time lines within which we would review that, publish a draft and then finalize an order. And the reason we wouldnt just go to an approval like we do for a new drug, or this is a public process. If we publish a draft, that allows anyone who might be interested nd commenting and participating in that to comment. Before we finalize. So theres a different slightly additional step compared to approving a new drug. Once that order is final, then any manufacturer who wishes may enter the market. If they conform to the conditions. But we do it directly. And would do it directly instead of through publishing regulation. And the current regulations would go off the books. I wish that this slides were working right now. What you have given us on the you have the multistep process in the rule making. Were looking at the first as december 4, 1979. Theres 22 different dates on here. We get down to november 19, 1997. So we have to get this sped up. And we appreciate the work and we look forward to getting this bill passed. I thank you for yielding and i yield back. Mr. Green five minutes for questions please. Thank you, chairman. And thank you dr. Woodcock. Always good to see you. We appreciate the good work u you have done for many years. I want to start by asking about the current otc monograph system. The committee learned a bit about how the system works or doesnt work during our consideration to the sunscreen innovation act. Clear then and even more clear now that reforms to modernize and Fund Activities are needed to better serve patients, consumers and the industry. You just elaborated on how rule making takes too long. And inefficient process for scientific decisions. And how the lack of speed and flexibility poses harm to Patient Safety. How will allowing the fda to make scientific determine n through the administrative order process improve over all Patient Safety and allow for new innovation . I brought a little visual aid with me as an example. Sometime ago this relates the fact that with the rule making you assume something is fixed. Theres always new scientific knowledge with drugs. We need to get that out there to patients. We discovered that a a. Some people are allergic and have life threatening skin reactions. We wanted to put a warning on. So what we did, we couldnt modify the rule quickly. Right . So what we did we put out a drug safety communication in august of 2013. Discussing 91 cases that had associated with 12 deaths. And the allergy alert for severe skin reaction. We put march 2014. So now if you look at tylenol, 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 arent aware of this, they we issued guidance on how to do this labeling. But they this doesnt have it still doesnt have the safety label on it. And we issued a final guidance a draft guidance in november 2014. A final guidance in january of 2017. Most sponsors voluntarily complied. Thats all we could ask. Its different than the regulation. If you regulation, if you follow me. So this is an otc nda drug there are say monograph drug and it still is out there without the warning. And that is the case for many products, most problematically i think are the pediatric cough and cold where the manufactures weve had to get them to voluntarily comply. We know and congress has passed several lawyers arous around st pediatric drugs. And yet the monograph system and all those old rules we made assume that children are like little adults and that the dosing should just be extrapolated. And so to change all that could take ten years or more in regulation. Thank you. The monograph reform cannon will streamline the process but it wont address the resource challenges that the agency faces. You know in your testimony the fda struggles to meet the requirements of congressional mandates, keep pace with the science and meet Public Health needs for monograph products in a timely fashion for Current Resource levels. The fda has a budget of about 8. 30 fulltime employees to over see a 32 billion industry, one of the most complex remembering laer to frameworks the agency has. You can elaborate on how a reform without user fees is utterly unworkable . Weve had some reform in the sun screen innovation act that Congress Passed several years ago. Even right now our resources are completely taken up by implementing the sun screen innovation act. We are under court order for certain deadlines for other monographs and we have to Pay Attention to that. And then acute safety issues that were dealing with. We literally have no other resources. So even were we given additional authorities or different ways of implement, we would have a great deal of trouble bringing that about without additional resources. I only have 12 seconds left, but i know the fda stakeholders and the members Work Together on this and i think we had a good example of this committee, subcommittee doing over the years, its 1992, and to have this funding ability for the fda to be able to not only have the authority but can actually regulate and oversee it. And so i yield back my time. Gentleman yields back. Chair thanks the gentleman. Chair recognizes the gentleman from texas mr. Barton five minutes for questions, please. Thank you, the subcommittee chairman. Dr. Woodcock, how long have you been at the fda . 30 years. 30 years. Yes. 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 seven monographs in 45 years is acceptable . No. I mean, obviously for each monograph theres been a great deal of activity, all right. Scientific i can go outside and yell and scream and cause a stir and have a lot of activity, but that doesnt pass a law. Yes. I know its not your personal problem. Right. I didnt i wasnt aware of this until i read the briefing, but if the system is broken, which obviously is congressman latta 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 all the other great things, i dont know that this is the most important priority at the fda. It wouldnt say that. But approving a monograph for manufacture of overthecounter drugs shouldnt take a moon shot. Do you agree with that . I agree with that. And we could do it under the new proposals that have been proposed, we can, i think, do this in a more timely manner. Its simply going through regulations and doing regulations is 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 house subcommittee but did i chair the full committee. Ive been on the committee for 32 years. Nobody ever came to me from the fda and said, hey, we 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 these monographs, youve only got 18 people reviewing them. Thats right. Dont you think somebody at some point in time in your position or somebody reports to you could have said, maybe we need a few more people . Maybe we need a lot of people . Maybe we need to change the rules . Maybe you dont need 27step processes. I mean, i would assume that the fda supports the latta, degette, green bill, is that thats true. And 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 these drugs remained on the market until monograph was finalized and perhaps some of them would be taken off, it wasnt such a problem for the industry. But in the modern world, it is an industry, i believe, supports this. Well, what what, in your mind, is a reasonable time to get these monographs approved . Right. I believe for a public process several years it should be zblun two years . Yes. Does the bill, is that is that the cat line in the bill . Two years . Do we know . Anybody. We do. Okay. Well if its not ill put it in the bill. But we arent going to be able to do every single one at the same time in two years, okay. I understand that. Were going to have to and we can talk about that. We will have to build up our staff, our infrastructure, our i. T. Systems and so forth. Well, i appreciate your willingness to testify on this and i commend the subcommittee chairman and the sponsors of the bill. Hopefully it wont take us 45 years to move the bill, mr. Chairman, and we can have a bill signing ceremony and then hold them to their word that theyll start approving these in two years. With that i yield back. Chair thanks the gentleman. Chair would recognize the gentleman from new jersey, mr. Pallone. Five minutes for questions, please. Thank you, mr. Chairman. Im not trying to denigrate you, dr. Woodcock or mr. Barton and im certainly not going to get into how many years weve been here and what weve been doing. But i think part of the prosch lem is th problem is you cant initiate that. With you cant write us letters saying you need more resources you want to change the law. Thats our oversight obligation. Whether its democrats or republicans in power, we need to do a lot more oversight, its not up to you to come to us, it doesnt work that way, the way i understand it. But in any case, the one of the most serious constraints of the current monograph system is the ability to move quickly to revise the monograph to addressee merging safety issues and the current multistep monograph process requires fda to make any revisionors updates through a rulemake process. Thats why these 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 drug monograph process and what has prevented the agency thus far moving swiftly to address safety issues such as those associated with the use of cough and cold products in children, which you mentioned actually . Well, i believe our thinking has evolved on that since the cough and cold issue first came up. Because when it first came up, the thought was, well, the regulation says these are generally recognized as safe and effective, including for children. Thats what it said in a government regulation, so what could we say . But it was clear that thinking had changed on children and that children should be specifically studied and the safety evaluated in children. Eventually what we do now is we issue draft Safety Communications and issue guidance on labeling and so forth even though its somewhat different than what might be in the in the regulation or the draft regulation or whatever state the teniative final monograph, whatever state it is in. So we can do that, and that requires voluntary, as i said, participation by the industry. Its not binding on industry, its guidance. And so i think everyone would prefer that safety changes we deal with 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. Now, in the discussion draft that were considering, the monograph process would be transitioned from rule making to an administrative order process and fda would be given expedited authority to update label Safety Information in light of adverse events. Will you explain how the administration to order and extra safety labeling will help to respond to these emerging safety issues . Well, the expedited safety lalg would be an interim order whereby the fda would colorado put out an order rapidly, not subject to some of the Public Comment requirements and so forth that most orders would have, all right. And once that was out, 2 would be binding, it would be interim final, so it would be binding. So we would know the fight public and the 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 changed so that we can have new safety statements in the regulation. All right. Thanks. I wanted to ask you, what lessons have been learned from fa dufa that were incorporated into the overthecounter monograph user fee act and how will user fees benefit the otc Program Industry in patients, for example . Well, some of the things we learned is for this program were going to have what we call managed growth is what were have been discussing with everyone where the Program Starts sort of small, expectations are clear for everyone and it grows oversiem and user fees grow so that we can absorb and lay down the foundation. And we learned that from the generics program where we had to change a huge number of things at once. We also have learned that we should have a simple a Fee Structure as possible, with a few exceptions and tiers and all. Because this is a very large industry, there are 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. All right. Thanks a lot. Thank you, mr. Chairman. Gentleman yields back. Chair recognizes the gentleman from kentucky, mr. Guthrie five minutes for questions, please. Thank you mr. Chairman and dr. Woodcock. Thanks for being here discussing this important matter. Ive heard stories from manufacturers trying to do the right thing, have risked having a misbranded product as the current process can take years as mr. Martin described. In order for a label or pack abling change currently manufacturers must go through notice and comment role make and bureaucrat tick system of red tape that can take years. Thanks to bricking this to us and us working together to try to move this forward. But could you tell me, or could you tell the committee how the administrative orders will ensure due process is maintained if there are differences of opinions since this is a public process . Right. Well, there will be the administrative order thats not final comes out first, then there will be a comment period. And thats because since this is a public issue, other manufacturers who may not have been participating but may want to get into that space or the public consumers, advocates, whatever, may want to comment on the order. And so theres that public process whereby to comment. If we get substantive comments on the proposed order, then the time of finalization may be somewhat delayed as we deal with those issues and we can do that in many ways. But thats a public process. And then there is a process that has been proposed for administrative appeal of decisions, right, through an appeal process within the center for drugs, all right. And then appeal, administrative appeal above that to a party who is third party who is selected to hold a sort of hearing on it and adjudicate any substantive issue thats a material different that might occur. So there are layers of administrative appeal and recourse for people. Okay. Thank you. And you mentioned sun screens earlier. Could you please expand on how sun screens will and can night this overthecounter drug reform . I many a good friend at whitfield whose a member of this committee, and a former colleague whos no longary i member of congress who did a lot of work in this space and talked about him with it some tabbed seems with the rise of skin cancer its difficult to get approved sun screens on the marketplace. How would this work for sun screens . My understanding of the current draft is what the sun screen innovation act will continue to operate, all right. So what was stipulated by congress there, and we have met all the time frames that were required under the sun screen innovation act, we have exceeded those time frames. Those will continue to operate. Once those sun screens that are subject to that are done and through the process, then they will be folded into the order so that then we have a common system. Now, one thing that remains 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 ability do that. Thats not part of the sun screen 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 my questions and i yield back my time. Chair thanks the gentleman. Gentleman yields back. Chair recognizes the gentleman from north carolina, mr. Butterfield, five minutes for questions. Thank you. Dr. Woodcock 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 encountered adverse events with otc medicines . Id say fairly frequently. To rise to a serious level maybe once every several years. Infrequently. Fairly frequently, but given what they are in exposure of the population to them. But once perhaps every two years were facing an issue that we would like to get out rapidly to the public to notify them and our hands are really tied and we have to use this guidance process. 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, or 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. And so with that realization came the realization that children may be being harmed because back in the 70s when all this was started, the doses for children were just scaled down adult doses. And so we have been going on a whole campaign, as you know, under bpca and prea 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 is this appropriate for children and what we need to do about this. All right. You can provide theres one thing in here. You can provide any examples of safety improvements that have been made to existing monographs and how long those changes have taken to be implemented . I know we touched on that earlier, but can you illuminate on that . Let me consult my colleague. Yes. Yes. Well, most recently it took seven years for us to get the liver warnings on asit men fin. Thats the number one cause of drug induced liver failure in the United States. When we strengthen the warnings on it, we were able to rapidly do the nda and change those warnings very fast. In contrast it took us seven years in the and of course for the monograph. And of course a lot of the acetaminophen use is monograph use. And finally how do you envision the special mechanism for rapidly responding to urgent safety issues . How do you envision that working . We envision that we could have an interim final order that could be issued very rapidly, all right. And that order would be in place and manufacturers would have to conform to it. So they would have whatever labeling statement they had to put on. But subsequent to issuing that interrup final order, there would be an administrative process that people could comment and there could be discussions and it could be modified. However, we could put the interim final order in place very rapidly thus keeping people safe while we were discussion the issue. Thank you. Dr. Woodcock, there was a suggestion earlier that perhaps the fda has not been proactive enough to seek legislation to recommend dip some of these issues. It appears that youre the director for the center for drug evaluation and research of fda. Thats correct. Are you permitted under your rules to pick up the telephone and call the chairman of the committee on energy and commerce and ask for legislation . No. That would be unacceptable in your agency or any other agency of the federal government . Were not allowed to lobby congress, thats my understanding. Thats what ive learned in my 13 years. Thank you. Thank you so very much. I yield back. Chair, thanks the gentleman. Gentleman jeelds back. Chair recognizes the gentleman from virginia. Mr. Griffith, five minutes for questions, please. Thank you very much, mr. Chairman. It seems that we have a problem, everybody agrees that we need to change things. We have a discussion draft 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 we ought to look at changing the lang wamg on . I know some of its not finalized. But as the bill exists is there anything in there that causes you concern . Not serious concern. We would like to continue to give Technical Assistance on it because the devils in the details. Always. But we believe the broad outlines of this are where we need to be. And likewise is there anything that would you like to see in the discussion draft thats not currently in there . I dont have a role in this, as ive told this committee before, but i recognize that there are many folks who want to talk about exclusivity. I dont believe that fda has a role in those tradeoffs, those societal tradeoffs. But i believe thats something that needs to be resolved. Okay. And i appreciate that. And not asking your opinion, per se, but have you anticipated or have you felt any or heard any comments about the user fee portions of this bill . Are there groups out there the that have told you they really oppose this and that would be an impediment to bringing certain overthecounter medicines particularly in rural areas . I have not heard that, all right. I recognize that some of the contract manufacturers, because this proposed fee right now is a facility fee which is the most straightforward and simplest way do this if youre producing an otc drug under the monograph, that the issues have been raised about contract manufacturers and their obligation to pay a fee. Okay. And i think that is 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 theres lots of Small Businesses involved here. Right. I wouldnt want to price them out, but at the same time the other ones have been highly successful, isnt that fairly much accepted . Yes. And i believe they have been beneficial to industry as well, or they swroebt been reauthorized as they have been. Yes, maam. Thank you very much. I appreciate your testimony here today and with that mr. Chairman i yield back. The gentleman yields back. Mr. Shader schrader is remembering ny ford five minutes for questions. Thank you. I appreciate having you here very much. How many of these steps are we anticipating removing as a result of the new process . What would you expect . Id say practically all, all right. Thats a welcome. We want to put this behind us, basically, so part of this proposed legislation would put all the monograph stuff behind us, transfer all these into a new status, kind of start not over but start afresh and have a timelines and plans for moving forward. So would you be able to establish a timelines is there a rough timeline template to mr. Bartons earlier question that you would give us and maybe some benchmark Performance Measures between you start, you get down the road a little bit and then hopefully ultimately get to a decision . Well, there are 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 courtmandated projects, the sun screen innovation act and other some courtmandated things that we have to finish, all right. But we have to would have to hire people. Wed need to create new standards and processes, wed need to create a new i. T. System. We dont have any i. T. System for this. I appreciate that. Yes. And theres probably a timeline you can give us for all of that to occur. Right. That would help us judge the progress and help with you resources and whatever. But once thats all established it would be interesting to know what is the expect i heard a twoyear roughout from start to finish and its interesting and helpful i think for the committee and four to see if were hitting those timelines. Im sure as a new program were going to have to make adjustments as we go forward here. We had proposed to have plans and goals for everything. So there would be a goal for when we do this and when we get that done just like we do for the other User Fee Programs. So there would be a structured set of goals and timelines and percentage like heres the timeline and we would our goal would be to do 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 planned to do is put forth a dashboard that would be in advance and that would because the industry is going to have to submit for the existing what are now existing monographs. Theyre going to have to resubmit something and wed have a timeline of when we expected that to come in and then there would be an orderly process with timelines for accomplishing that. You can share that with us . Absolutely. 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. We want to use the current scientific information to make the judgment. Sure. And the last question. Youre about 30 fte with this program. With the new revenue coming in, whats your initial expectation to gear up to and where do you hope to be as a more level Employee Workforce . Right. Ultimately we would hire 105 new employees. Wow, great. So we would have then 135 doing this scientific work. Very good. Thank you very much. Good luck and i yield back, mr. Chairman. Thank you. Chair thanks the gentleman. Gentleman yields back. Chair recognizes thank me. There you are. How could you miss. You buddy came in to block me. Chair recognizes the gentleman from missouri. Five minutes for questions please. Thank you, mir chairman. Dr. Woodcock, the overthecounter Monograph Program is the key regular lagger to framework at fda which account for the bulk of medication consumed by americans. I understand that the User Fee Program youre setting up is still relatively small. Particularly when compared to some of the much larger programs that weve approved earlier this year. Could you discuss the user fee why the user fees are needed . Certainly. User fees are needed because we simply do not have enough staff to finalize all these and then deal with innovation coming forward. We have 30 staff to deal with more than 100,000 products that are on the market and currently this burdensome rule making process. Even if we were to move to an order process that was streamlined in a very efficient, effective, 30 staff could not make substantive progress against that in the next five years. How are the user fees structured and how are these fees collected . The fees are going to be for any facility that manufacturers a monograph drug would have a flat fee. How much it would be depends on how many registered were going to use our drug registration enlisting system, which is an existing system to capture all the facilities. It might be between like 14,000 and or a little lessor a little more depending on how many facilities participate per annum. Okay. Well you mentioned your testimony that the otc monograph process is one of the largest and most complex regulatory programs ever undertaken by the fda. Could you discuss how otc monograph reform can address these regulatory challenges . Certainly. By simplifying the process that we have go through to finalize a you know, to finish in this case would be an order with the new process, is tremendously simpler than what we have do with the monograph. And orders can be amended over time through a simple process. So we can keep up with the science and hopefully with the user fees well have enough people to do that. But i have to be clear, this User Fee Program is not large enough to get all this done in the first five years. Were just we will get the program set up and well begin to work against it and we will be accepting innovation and that will all 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 not change do not modernize it. You can discuss the fdas engagement been stakeholders during the process . Certainly. As i said, i think in 2014 we had a Public Meeting about this. And representative bartons point we do own up to the fact that the process was broken, although some people came and told us it was simply because we were lazy or whatever. But we did ask the public, including advocates, consumer groups, and others, you know, how in the industry how we could change and modernize this process. And we pointed out the different problems. Since that time, as weve been talking to industry about how we might change the process, weve also talked to public stakeholders, add video sais casey groups, consumer groups, professional groups and so forth to keep people in the loop. Although i will admit, this is a rather obscure program and many people are unaware of how this program operated and the problems that it had. Weve had several public webinars and weve also talked extensively to special stakeholders who have a particular stake in this, for example, the American Academy of pediatrics. How will fda addressee merging challenges to ensure that the otc Monograph Program remains effective . Well, i think one of the things we need to build in, which weve built into every single other User Fee Program that we have are assessments. As i said earlier, were going to have goals and objectives and so we will have put forth what we expect our timeliness to be, how much weapon expect to get done, and then we will assess against that. If were failing on those measures, we will own up to it. Okay. Thank you. With that, mr. Chairman, i yield back. Gentleman yields back. Chair thanks the gentleman. Chair recognizes the gentleman from california, ms. Eshoo, five minutes for questions, please. Thank you, mr. Chairman. And i want to commend the authors of the legislation for addressing something that evidently has been overlooked for decades. I 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 policiwise 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 spotlight on something that obviously has an effect on on the population in the country to say theres a short coming here and we need to Work Together to address that . 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 and tgency and the congress we certainly can, as we did, hold Public Meetings, we can write papers, we can do many things depending on the priorities but youre talking about internal to the agency and what you do there. Right. Im talking about the relationship between the agency and congress. Uhhuh. Let me ask this. Is there any statute or rule thats written that prohibits the fda from meeting with any members or chairs of committees or subcommittees to to point out that theres a short coming 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, we wish to put forth a legislative proposals thats put forward through the a 19 process by the administration, right. Well clearly this is this has really been overlooked and my sense is that it rests more with the fda than the congress. But im glad that this is being taken up. Now, on the user fees, does 100 of the user fees that would be coming in fully fund the 130 positions that you have goals for . We currently have funding. We currently fund 30 positions. I know that, but your anticipating 130. Yes. So will the user fees the 05 additional would be funded by the user fees. Fully. Uhhuh. On the risks relative to the incomplete monographs, you know 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 2000s, we recognized that there were there was harm, significant harm to children, okay, due to use of pediatric cough and Cold Medicines, right. But the monograph statements were that they were safe and effective, okay. So its dult difficult were they ever corrected . Well, we have not fully, not yet. We have what weve done is worked with the industry. Did i bpca, pria, but in this area. It doesnt apply. It doesnt azblie so what we did, we worked with the industry, they voluntarily change thard labeling. B but as i showed for the asee the minute fin not every manufacturer changes their label. And we dont have the tools right now because the regulation thats on the books says safe and effective. My time has expired. Thank you. Chair thanks the gentle lady, chair recognizes the gentleman five minutes for questions, please. Thank you very much. Its a pleasure to be with us dr. Woodcock. Thank you. I do want to indicate that its my hope that the committee will examine the cos met ticks issue. This has been discussed in Opening Statements by others. Im involved in that issue with mr. Pallone, the Ranking Member of the full committee. Millions of americans use thee pro dubts and i have been working in a bipartisan capacity to advance consumer safety and provide a Regulatory Framework that provides growth in safety in cosmetics, and Small Business. Consumers need to know the products theyre using are safe and businesses need an fda that responds as quickly as new great ideas are being developed. The statutory scheme governing cosmetics has been unchanged virtually for 70 years. This san area where the committee should break ground and find a bipartisan solution 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 Collin Mckenzie who is the head for all of the americas from glassco, smith, klein and i respectfully request that be put in the record. Thank you very much. Dr. Woodcock, off topic but an issue of acute interest on the hill right now, right to try legislation. Ive been involved in this and im interested in hearing your perspective on the proposal that recently passed in the senate. Well, first of all, my personal opinion, which i have testified on before, is that the federal government should not stand between someone whos dying and wants to try a medication. However, i feel if i were that person or a relative of that person wroir want person, i would want to know if the last person who had taken than medication had survived or died quickly or whatever. So 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, we are aware that certainly not all firms are willing to give out medicines because they may have short a short supply or they may be concerned about the situation or even the safety of the treatment for that particular individual. So it is, i believe, a complicated scenario, but i believe foremost 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 fdas otc drug review and oversight capacity. How will it boost how will the boost in personnel, which we all favor, enable the fda to resolve the otc drug review backlog and timely consideration of applications for new Innovative Products . Well, what we have envisioned, and envisioned in what has been written down so far is sort of a staged improvement where first infrastructure and hiring and training so faorth take place. Then inany vatinovation begins taken up as well as early cases of finalizing these pending proceedings. And those will go over time with time frames. So we what we envision is that 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 could 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. Chair thanks the gentleman. Chair now recognizes the general lady from colorado, ms. Degette. Five minutes for questions, please. 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 bugga boo for a long time, the agency has tried to deal with it, congresses that tried to deal with it. Dr. Woodcock i just want to ask you a couple of questions. The first one is about the process that weve used to come up with 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 input for us on this otc monograph reform bill from the various stakeholders. Certainly. Well, as i said, we 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 is safety and also the problem with innovation. And there 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 program would look like so that congress would have something to work with, right, and getting through a lot of the technical issues. So there were numerous meetings about both the policy changes, the legislative changes that would enable enable us to have orders and so forth, as well as what a User Fee Program might look like. At the same time, we had public we posted Meeting Minutes of those meetings and we had various public interactions at different times. And we met with some of the more involved stakeholders, some of whom will testify today as well. So and in addition, as the bill was being drafted i assume that your staff gave Technical Assistance to the committees staff on this . Thats exactly right, uhhuh. So so really the draft were looking at today is sort of all of those processes that weve had up until today. Uhhuh. I want to ask you about a specific provision of the discussion draft of that allows the fda to include requirements for the packaging of a drug to help protect children from harm such as thorough unit dosing packaging or through unit dosage packaging or other requirements. Does the packaging language include in the discussion draft give the fda sufficient authority to, i packaging information to protect children from risks or is there more that needs to be done . We believe this language is adequate. And why do you believe that . Because it says in it says other appropriate requirements. So it gives us fairly wide scope. Thank you very much. And thank you for all of your efforts and your agencys efforts. I yield back, mr. Chairman. Chair thanks the general lady. General lady yields back. Chair recognize the gentleman from florida, mr. Bilirakis, five minutes for questions. Thank you mr. Chairman, appreciate it. Dr. Woodcock in your testimony you mentioned that roughly onethird of the monograph dollas started decades ago are still not being finished. You can give us the sides of this backlog . How long do you think it will take to clear the backlog . Whoa types of submissions are in the backlog . Well, first of all, you have to understand this back slog a little different than the generic backlog which we have dealt with. These products are still on the market, right. All these products are on the market. And the process of finalizing the monograph would perhaps remove some of those from the market and establish the conditions under when they can be marketed and perhaps limit those. S. P. O. So there are about several hundred ingredients left out of 800 that hnt havent be 800 that havent been finalizesed. And there are many uses, more than several hundred uses of those ingredients, because many of the ingredients are used for multiple uses. Its difficult to have a count because until we get to the final monograph we dont know what will be in or out in each one of those. But thats the ballpark, its about a third. About a third. And how long will you think it will take to clear the backlog . Well, definitely we believe it will take well beyond the fiveyear period. Okay. Your testimony shows that finding for fdas monograph products is fairly flat. Somewhere roughly between 7,000,008 million annually. Have submissions been fairly flat year to year or are they increasing . The activity has increased because of all the new scientific knowledge. And as i showed you this chart earlier, the churn that happens with any given monograph as we learn more scientific information. But this was fixed, really, in 1972, and 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 pathway, which is what the sun screen innovation act dealt with. Okay. Next question. In your testimony you talked about the slow timeline for changes to the monograph. You used the example of liver injury for generic tie lel lyle taking seven years to update the level. How with it affect the timeline substantially, what changes can be required by statute and what can fda do administratively . Yes, the goal would be that we could have an issue an interim final rule on safety, on specific kind of safety changes. And we could issue that rather quickly. And then it would be binding. And then the discussion about it and any further adjudication could occur after that and we would go to a final rule after we get Public Comment. But say we fooinld fiind out a safety problem can be dealt with labeling, we issue an interim final rule, all the labels are change sod people are protected and then we can have further scientific discussions and go to a final rule that would, you know, have have had that chance for people to have a lot of discussion. Okay. Very good. Thank you, dr. Woodcock. I yield back, mr. Chairman. Thank you. Chair thanktz gentleman. Chair recognizes the general lady from illinois, ms. Cha kows sky, five minutes for questions, please. Thank you very much. Let me just 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, but here we are today and i know that youll be work 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 that ive been working on for a long time, but, you know, when we have shampoos that cause people to lose their hair, a child who lost all her hair or a teens eye shadow is tainted by asbestos, the fda right now is unable to act. So never threat be said that we ignored 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, about how long it takes to regulate, the cumbersomeness of the process, but i wonder if you could just succinctly lift the safety issues that we need to address that arent being addressed right now. We could start with the skin reactions to asee the minute fin. We can add the safety problems with pediatric cough and cold medications. We can is that in part using the sweet gummy kinds of things that might attract children . Thats a different thats a safety issue related to, you know, the dosage form and overdoses in children. Thats another issue that we would be dealing with. There, you know, there are quite a few. We finally finished the liver warning for accede minute fin, but there are other overthecounter drugs 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 we have a final monograph certain ingredients out of the monograph. Thats kind of how it works. Theyre all on the market to start with and as we go through this process they get removed. So as we finalize these monographs, certainly ingredients will no longer be permissible in the United States. Some of them dont have safety issues, some of them dont have any data to show they work. So some would have to have more warnings. They might have to have more warnings or they simply might have to withdraw because they cant produce any data that show that theyre effective. So this new process would be a before the fact look at these drugs or no . Would they still go on the market anyway right away . No. No drugs supposedly since 1972 have gone on market. Had this process now only deals with drugs that are on the market in 1972 or before. So any what were planning to put in place, if congress, you know, puts agrees with this, is a process where we could move new ingredients into this process and have them regulated this way, which is much less burdensome for the industry. For products that are otc products where 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 packaging. Yes. And child resistant package requirements. Im just wondering how you work the fda work and interact with the Consumer Product Safety Commission on these packaging requirements. Certainly. Were we work very closely with them. We recognize their standards. They set the standard for Child Resistant Packaging say for bottles and how you test for that and so forth. And were this to move forward, we could have an understanding with them of 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 or whatever. Wed let them know. Thank you. I yield back. Appreciate you. Chair thanks the gentle lady, chair recognizes the gentle lady ms. Brooks, please. Thank you. I want to also thank dr. Woodcock for coming before this committee again and explaining to us why its so necessary to take these long, what im learning, are overdue steps to update our yournlt monograph progress. I appreciate that youve talked about some of the challenges and you just went some specific problems but wondered if there were any other examples of how the inefficiencies in the existing otc drug monograph system have exposed americans to risk from potentially unsafe, which you just talked about, i believe, or possibly ineffective drug products. Are there any any specific examples youd like to provide . Well, until we get the monographs finalized its hard to call them ineffective until theyre in the Current System until theyre shown by a regulation is published saying theyre in effective. So thats one of our ka none drums that fits very well with your question. We arent officially ineffective until theyre found ineffective in a final regulation. Thats whats been so problematic is getting to that point. Its very difficult to get to that point. And people can always submit more data and all these types of things. We propose them as ineffective and back and forth. So it can be prolonged very long. Thank you. We know that american patients providers and manufacturers have benefit the greatly from congresss previous authorization of fda user fees for Prescription Drugs, biological, animal drugs, medical devices but we know that otc drugs products have lagged behind. How do you believe that the user fees authorized in this legislation combined with congressional appropriations will give you the necessary resources to bring the otc drug regulation on par with other drug and medical products and then secondly, in addition to the personnel increases which youve talked about going from 30 to 135, what resources will this legislation provide fda tacoma prove the system . Well, we plan to spend about 26 million on investing in an i. T. System so that this becomes paperless instead of a paperintensive process and that would, i about 3 million a year ongoing once its built. So it 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. But this level of program, as i said, will not result in the monographs all being in the new order system and having all final orders at the end of five years. Its not going to be that fast. I appreciate that. And youve 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, uhhuh. And so the building of an appropriate i. T. System which doesnt exist right now would be incredibly helpful. Yes. And since were going put what i call the mulch behind all this past documentation that we have, its all over the place, we can have an electronic gateway like we do for the other User Fee Programs, so submissions are electronic, theyre standardized formats, many things that help everybody in modern system be efficient. And have just out of curiosity, you talked about additional training that would be needed besides the 30 staff that are currently onboard. Have they been involved in this system or in this process in a significant way . Yes. Yes. And bracing themselves if they have to train all these new people and try to complete some of the work at the same time. Thank you. Thanks. I yield back. The gentle lady yields back. Chair recognize the gentle lady from michigan. Five minutes for questions, please. Thank you, mir chairman. Dr. Woodcock, like everybody here were grateful for all the work youre doing sitting here through all these questions some of which sound the same. But i think were all saying that we think the otc systems broke pent we dont think its working for patients, for doctors, for people in the industry who are make innovative product, and your testimony said this and questions and answers were getting were getting keeps reaffirming that. But just for the record again want to it is true that there are far more otc monograph products than brand of Prescription Drug products. That is true. And despite this fact, fda got only 7. 9 million last year to review otc products while Prescription Drug spending totaled 1. 1 billion when user fees were included, is that correct . Thats correct. So i do have this question because when youre talking about the five years. Yes. And youre talking about creating an i. T. System that doesnt exist, is it going to can can money help accelerate the five years . Will getting you more money we can always do more with more, we can move fast we are more, uhhuh. So its maybe for at some point you could give us how much you need to create that i. T. System which will accelerate it and maybe give us a little thats not in any of the planned questions but i think its a question thats really popped in here. Will the draft legislation were 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 authorities to do a more effective job. We cant use these authorities. So as you just said, the lack of fundings not the only issue. The draft legislation were considering today also gives fda the authority to use administrative orders to make changes to otc monographs rather than the current notice and comment rulemaking progress which has left many monographs unfinalized and critical safety issues unaddressed. Does fda believe that these changes in the Draft Administration would make it easier to allow Innovative Products to make it to the market while also allowing the agency to address the safety issues faster . Yes. Theres a specific innovation pathway thats been built in with timelines and deliverables and so forth. And we definitely contemplate that theres innovation to be had in this space. So thank you. I think this goes a long way, but i want to take a step back a bit and give some context. In 2014, congress came together unanimously to pass the sun screen innovation act because our nations facing a skin cancer epidemic and the last time a knew otc sun screen ingredient was approved was in the 1990s, which you know. This is a symptom of how broke n the ot system is overall, but its more pression and more urgent because there are 5 million americans being treated for skin cancer every year and the rate of melanomas on the rise. So while otc reform is going to make it easier for all Innovative Products quickly and safely get to market we cannot forget the urgent need that americans have access to sun screen productsing that have been used for decades overseas. This is where the frustration comes from all of us. Dr. Woodcock, Congress Remains concern about the skin cancer epidemic. Can we work with you and other stakeholders to ensure americans have access to the latest sun screen ingredients and what do we need to do to make sure that its here now . Well, we have, you know, met, as i said, all the stipulations actually exceeded them in the sun screen innovation act. What were waiting for is data, safety data to be submitted. What the sun screen innovation act did not do is lower the standards for safety for otc medicines. So when we receive those data, well be able to review them promptly because, as i said, the sun screen innovation act is one of our highest priorities. So how longs it going to take to get that data . Whats the hold snup why is this so complicated . Under most of the things that fda regular laigts lates, we dont do that research. The research is done by the sponsors because they have the meds sins, drugs, and formulations and they submit that research to us. So we wait for them to conduct the research. We give them parameters about what the research should look like and to meet the standards and then we its on their time frames. Do we know their time frames . We certainly are in contact with them about their activities. I personally have met with them fairly recently. Thank you. I yield back the balance of my time. Chair thanks the lady. Chair recognize the gentleman from georgia. Five minutes for questions, please. Help me to understand something here. And ive been in between subcommittee meetings so please excuse me if ive missed this. Do you 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, ib profen were if you come up with a profile for that and then you say if you have that in your product you have to have this on wrur monograph . The monograph specifies the ingredient ib profen if that were in there which it isnt, but it specifies the ingredient, it specifies the dosages that can be used, and then the regime and it specifies what conditions it can be sort of advertised for, right. And if you then market using those parameters, then you dont have to send in an application. If you market hfts so te s find out something, if you find out that ib profen in a certain dosage causes ha pat tick toxicity sore eating your stomach up and you go to every product out there that has that has a certain amount of i bu profen in it, you say you need add this to your monograph. No, its an fda regulation. Okay is. So we could have to change. But if you change it do they have does everybody product out there that v to change . They would have to add the warning. That seems simple enough. Only if gout this slide, we have to first of all, we have to have a final monograph in place, okay. And then we have to change it through rule making, through notice how long does that process take . Six, eight years. Oh, please. Heres heres one, this is external ive seen that. High does it take that long . Because is it didnt taoesnt take t with Prescription Medications quicker than that. We get them off the market licketysplit if theyre dangerous. Absolutely. Here the issue is especially say we have a final monograph in place. The government has a regulation, the regulation states this drug is generally recognized as safe and effective. And now were saying, oh, its not safe, okay. But we have a regulation that says its safe. So for the lawyers in the room, they understand the tproblem. What we do now because of that, we issue safety alerts and we look for voluntary changes to the labels. But we cant mandate changes until we why not. Because its a regulation. Its a regulation legislatively or through your rules that you prom mule gated. Rules that we promulgate and we have to promulgate a new rule before it gets changed. Let me ask you something, what about offlabel uses, you know that happens. I practice pharmacy for over 30 years and i did that regularly. Do up ever address that . Well, we address it in the sense that if an offlabel use is leading to harm, we will send out safety alerts and tell people and so forth. So if a product has been on the market for years, lets just take for example dive fen hydromean. For many years that was just an ant histamine that you use ford bee stings for Something Like that and i always recommend today to help somebody sleep, you know, and now youve got youve got benadryl pm. And theyre kmaergtd for that now. 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