A group of industry stakeholders spoke and outlined recommendations for lawmakers. This is about two hours, 40 minutes. We will come to order. I recognize myself for five minutes. Opening statement. Todays hearing marks the health of subsidy public discussion on modernizing the Current System of the United States fda to review, approve and update. This hearing provides us in the American Public with the opportunity to better understand the fda regulatory frame work for overthecounter drugs and consider a proposal to reform the monograph system. I would like to commend all for their efforts in offering their insight to the committee. Theyve set a strong record of bipartisanship on Public Health issues such as 21st century cures, the fda reauthorization act and i hope to add to that record of success with todays hearing. Overthecounter drug products provide a wide variety of ailments. Pain relievers, eyedrops, cough drops as a firstline treatment option before going to see the dr. And get a prescriptions. It also includes antibacterial soap, hand sanitizer, sunscreen and the sunscreen commonly used by many families in the United States. Currently, there are more than 300,000 overthecounter products on the market according to the food and drug administration. They go through one of two approval processes to reach the store shelf. Manufacturers can submit a new drug application similar to new Prescription Drugs or they may conform to an otc drug monograph which is a set of specific standards created by the fda that ensures the products active ingredients are generally recognized as safe and effective. The vast majority of overthecounter products rely on the overthecounter drug system. Unfortunately, the Current System does not have a significant update since the fda first establish this in 1972. That is well over 40 years. In addition it requires a burden some rulemaking process that could take years to resolve. All of this has led to a lack of innovation and inability for timely updates to address safety issues and much work left unfinished at the fda. Most of us feel that is unacceptable. The good news is there is broad support from the fda, from stakeholders in patient groups for significant reform to regulate overthecounter products. The subcommittee will examine the safety, innovation and reform act of 2017. The discussion was recently released. The bipartisan proposal establishes the overthecounter user program and makes a number of meaningful modifications to the process. The goal is to create a system that is more flexible and more efficient, that reflects scientific innovations so that patients and consumers have greater access to better and safer overthecounter drug products. Again i want to welcome and thank her witnesses for being here this morning. We look forward to your testimony before yield to the raking member, one housekeeping detail, although this is the premier committee technology, some of our systems are not working this morning. I understand there was a series of slides and those will be made available to you in paper form. We require our doctors to go paperless but here we can still deal with paper. The clock is working but only i can see it. The red green and yellow lights are not working. I will give a brief to click when we are getting down into the yellow zone so you will know the time is to wrap up and we will do that for everyone on the committee as a general reminder that were coming to the end. With that i yield back and recognize the Ranking Member of the subcommittee, mr. Green of texas. Thank you mr. Chairman. Thank you. The overthecounter otc drugs are routinely used during a wide variety of ailments. We go to our local walgreens or other retailer and dont even think about that bottle of ibuprofen or sunscreen like we do with this Prescription Drug. Otc drugs provide a lowcost way to take care of every day lowcost needs and we have a number of choices. According to the fda and the Consumer Healthcare product association, the otc market includes more than 300,000 products with annual sales of 32 billion. Fda monitors most of these drugs. The active ingredients in these products are considered safe and effective when consumers follow instructions on the label without direction from healthcare provider. That is largely true in theory, many contain ingredients that the fda has not yet evaluated or have been misused for labels that have not been modified to warn consumers of potential harm. The Current System also poses challenges for consumer access for better, safer, Innovative Products. The framework for fda oversight are put into place in 1972 and has not been updated despite an increasingly diverse large market. The need for reform was brought into focus when they worked on the sunscreen innovation act in the 113th congress. Under the Current System, the monitor is established through a threestep process. This antiquity system is burdened some and timeconsuming and doesnt work very well. Its unable to respond quickly to safety concerns and keep. [inaudible] it slows development of new drugs. The fda has 88 rulemakings and 26 therapeutic categories that cover over 100,000 otc products. Its one of the largest and most complex regulatory schemes and dramatically under resourced. The agency has 30 fulltime employees and a budget of roughly 8 million. In context, 18 fulltime employees are devoted to the review of one novel drug application. The otc market now includes for the 300,000 products with annual sales of 32 billion. Recognizing the resource and process challenges that the program and beginning to think about how can work better. The congressman and i have been working on a bill that would establish an otc. [inaudible] today we have a discussion drafted that reflects the work of the staff stakeholders. We should consider doing the same with cosmetics. There is a parallel. [inaudible] it will help foster growth and the availability of these medicines. Policy reforms could make the system even more flexible, responsive and accommodating about potential harms of misuse. Ultimately modernizing the system to ensure the industry can update products, broad and Consumer Choice and ensure the fda has the resources. I look forward to hearing from the witnesses about this. I yield the remaining of my time. [inaudible] i dont think your microphone is on. [inaudible] [inaudible] it does not respond too. [inaudible] in 2006 the fda learn that common cough medicines medicines medicine for ten years the fda has been trying to provide the cough and cold industry to warn parents about cough medicine in children but it was unsuccessful. What this would do is give new tools overthecounter medicine. Im extremely glad you are with us again today to give us the same kind of guidance you gave us in 21st century. We really have a great opportunity to upgrade our railway process in a way that benefits everybody. The American Public, the federal government and the regulated industry. I look forward to continuing to work with our college to support the bill and i thank you very much mr. Chairman for holding this hearing. I yield back. The gentleman from texas is recognized. The gentleman from oregon is recognized for five minutes. Thank you. I appreciate you holding the hearing on these important issues and the longoverdue reforms needed at fda to improve efficiency and update their framework for regular eating overthecounter drug products. Following the successful authorization of several of fdas critical medical device User Fee Programs, theres no better time to continue our work for now. I am pleased with the bipartisan effort thats already begun. From cough and Cold Medicine to antiperspirant and antacid, medicine cabinets are filled with overthecounter otc drugs. Its the regulatory process that we heard. They all agree that significant reform is something we all need to join hands on. Theyve engaged and productive conversation to improve upon the status quo. We now have bipartisan to ensure more timely access to safe and effective medicines. There would no longer have to wait years for inflexible timing to wind its way through the bureaucracy. Id like to thank our colleagues as well as chairman and my colleague and others who have put their shoulder to the wheel on this one. We proven time and again and know how to legislate to get things done for american consumers. We will get things done here. I will yield to the gentleman from ohio the remainder of my time. Thank you for holding todays hearing. I also want to thank our witnesses. Its time to move forward to a more flexible framework. I believe it will achieve these goals and provide predictability to the drug approval process. The safety reform act between myself, the chair of the subcommittee, and significant contributions from the fda and the industry. Id like to thank all those involved for your effort in order to increase Consumer Choice and safety. I appreciate the chairman for allowing the opportunity to discuss the discussion draft today. I look forward to hearing the testimony and receiving input from my colleagues on the subcommittee. I think the chairman and for our witnesses and nailed back. I yield to mr. Jeffrey. Thank you for yielding the chairmans time. I appreciate it. Want to thank you for holding this important hearing today. This important bill would enable greater innovation and foster efficiency within the approval process overthecounter drugs, something that has not been done since the 1970s. I want to specifically thank for their leadership on this issue. Im proud to be a cosponsor with several of my colleagues which industry, fda has worked so hard to move forward. I strongly believe this would help every american as these products are firstline in defense against ailments. I thank you for being here today. If theres no one else wanting the time, i yield back. The chair recognizes the gentleman from new jersey for five minutes for an Opening Statement. Thank you, mr. Chairman. I want to thank you also for holding todays hearing on the overthecounter drug reform and the establishment of overthecounter User Fee Program. I also want to commend Ranking Member green, guthrie and the chairman of the committee for your work in crafting a proposal that will accomplish these goals. The safety and effectiveness is established through the monograph, the socalled rulebook outlining the conditions of use for particular drug ingredient that outlines labeling and warnings and other requirements. This rulebook is established through a threephase rulemaking process that is often time inflexible and timeconsuming, making it difficult for fda to quickly revise update in response of safety or other issues. Weve also heard that the monograph process does not lend itself well to evolving science and technology and may have the unintended effect of discouraging the development of new formulations. There is regula Regulatory Reform needed and its under resourced. The otc Monograph Program receives more than 100,00 100,000 products. The Regulatory Reform and increase resources we can streamline the process. With swift finalization, updates and encouraged innovation wherever possible. We are beginning a process of making improvements in the review of overthecounter products, i had hoped we would begin taking action today on cosmetics. Millions of americans use cosmetic products everyday but fdas Regulatory Authority over cosmetics is woefully inadequate. Millions of women and children have been exposed to shampoos that can cause extraordinary hair loss, lip balm that can cause blistering and rashes, and i shimmer tainted with have. Abscessed us. They do not hold these mannish manufacturers responsible and cant ensure that it doesnt happen. We need to provide adequate resourcing for cosmetics as well i look forward to continuing to work with my colleagues and other stakeholders to accomplish both of these goals and ensure that continued availability and safety. I would like to yield the time i have left to mr. Dingell. I think my colleague for yielding. Americans deserve peace of mind in knowing that all drugs they take are safe and effective, whether its a Prescription Drug or an overthecounter drug. There are over 300,000 overthecounter products on the market today which americans use in everyday life. Fdas regulatory system for otcs is completely broken. The agency has a meager budget of 8 million which all of us keep saying over and over, and a cumbersome process that hinders their ability to let new and innovation products come to market. It creates a new user fee system for the otc product to give fda resources it needs to do its job of insuranc ensuring patient safety. The agency can move quickly to update and revise the system thread ministry of orders rather than rulemaking which are similar to the reforms made under the innovation act. We see the benefits the user fees have brought to the regulation of Prescription Drugs and medical devices and its time to bring the system to otc space as well. While im pleased that we are holding this hearing and moving forward, i want to commend them for the same comments made about the cosmetic industry which is also desperately benefit from reform and help the community will soon move forward with legislation establishing a user program for these products. Thank you for working with me on this draft legislation. I look forward to continuing our work to reach consensus on this important issue. Ill back the balance of my time. And i yield back mr. Chairman. The gentleman from new jersey moves back. This can include statements. Pursuant Committee Rules, it will be made part of the record. We do want to thank our witnesses for being here with us to take the time to test testify. Each witness to have the opportunity to give an Opening Statement followed by questions from members. We will start with our first panel. The director for research. We appreciate you being here this morning. You are recognized for five minutes for your Opening Statement. Thank you. We are here to talk about modernizing monograph system for otc darlings. Probably everyone in this room has used an otc drug at one time or another. I know i have. This medicine allows us to manage minor Health Problems without going to consult a health professional. Millions of americans use these products everyday. They are wide spread and theres more exposure to these drugs and there are two Prescription Drugs. The monograph system allows manufacturers to come on the market without the burden some. Product application process that we use for generics or for new drugs. Its a much simplified system. Why the push for reform . As the members have already said, the monograph process is put in place a long time ago to deal with the hundreds of thousands of products on the market after Congress Passed the 62 amendments to the food drug cosmetic act requiring them to show they were effective. and his safety issues would not come up for these products that were marketed but that is not the case and we have been hampered responding rapidly and this could be if opec into a liability. So it does not apply to anything more than that since this is still trying to do with those products that were on the market at that time so theres really nothing for innovation with this entire process. The reform that we are proposing is what works well about prospects that could still be marketed without approval for Market Conditions it is a public process it is open and transparent. But it streamlines to replace the rule making with the administrative orders it is very similar to or generic drugs it is appropriate for scientific decision making. To provide due process with that appeal and hearing process to the fda decision but there are fewer requirements rulemaking to be this accomplished in a much speedier manner also to encourage innovation by expanding eligibility and no longer with a knit to that type of product so they could submit to new kinds of product and what we envision allows for those confidential meetings with the fda before removing to the public process for the innovation to be explored also to quickly respond to urgent safety issues and definitively get that safety information. That could be subject to further Public Comment and discussion but people could be protected that is something we are missing right now to reduce that backlog by transferring these pending regulations by statute that would allow us to deal with an orderly and effective manner that is not finalized up to this point. With Public Health to require certain types of packaging that can protect people from taking too many pills and for the elderly and children that they could overdose so that packaging is very important and with this clarification to complement the cpsc that can require child resistant closures so all is in all this modernization m proposal along with the user fee would benefit the Public Safety and the industry and the fda has been talking to many stakeholders over the last three or four years with those proposals letter of the table. Thank you very much. Now we go into the question the answer port part of the hearing. Youre recognized for five minutes. I appreciate the chairman for yielding and dr. Woodcock think he for being here with your testimony. But what first with a safe packaging over the counter drugs so then you are talking those that are intended for adults with sufficient authority to be granted with modern reform with Public Safety committee touched that . First we believe the language that the administrative order has packaging of day job and n