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 applicat