Transcripts For CSPAN2 Hearing Looks At Changes To Over-the-

CSPAN2 Hearing Looks At Changes To Over-the-Counter Drug Regulation September 18, 2017

Minutes. Subcommittee on health will now come to order. Ill recognize myself five minutes for an Opening Statement. Todays hearing marks the Health Subcommittees first public discussion on modernizing the Current System at the United States food and Drug Administration to review, approve and update overthecounter drugs. This hearing provides us and the American Public with an opportunity to better understand the food and Drug Administrations Regulatory Framework to regulate overthecounter drugs and to consider a proposal to reform the monograph system. Today we will convene two panels of witnesses. First i want to welcome dr. Woodcome back to our subcommittee woodcock back to our subcommittee. Later we will hear from other key stakeholders, and i would like to commend all for their efforts throughout the negotiation process and for offering their insight to the committee. Both the energy and Commerce Health subcommittee and the full committee have a strong record of bipartisanship on important Public Health issues such as 2 19th century 21st century cures, and i hope to add to that record of success with todays hearing. Overthecounter drug products treat a wide varian tiff of ailments, time and again consumers seek antacids, pain relievers, cough products as a firstline treatment option before going to see their doctor and getting a prescription. These products also include antibacterial soaps, hand sanitizers, sunscreens, and the sunscreens commonly used by many families in the United States. Currently there are more than 300,000 overthecounter products on the market according to the food and Drug Administration. These products go through one of two approval processes to reach the store shelf. Manufacturers can, one, submit a new drug application similar to new Prescription Drugs or they may conform to an otc drug monograph which is a set of specific standards created by the food and Drug Administration that insures the products active ingredients are generally recognized as safe and effective. The vast majority of overthecounter products rely on the overthecounter drug monograph system. Unfortunately, the Current System has not had a significant update since the food and Drug Administration first established this in 1972, so thats well other 40 years. In addition, this system requires a burdensome, multistep rulemaking process that can take years to resf. All of this has led to a lack of innovation and an inability for timely updates to address safety issues and much work left unfinished at the food and Drug Administration. Most of us on the committee feel that is unacceptable. The good news is that there is broad support from the food and Drug Administration, from industry stake molders stakeholders, from patient groups for significant reform to regulate overthecounter products. The Health Subcommittee will examine the overthecounter reform act of 2017. The discussion draft was recently released by representatives degette, guthrie, ding get, green and myself. This bipartisan establishes the Monograph User Fee Program and makes a number of meaningful modifications to the monograph process. The goal is to create a system that is more flexible and more efficient, that reflects scientific innovations so that patients and consumers have greater access to better and safer overthecounter drug products. Again i want to welcome and thank all of our witnesses for being here this morning, certainly look forward to your testimony. Before i yield to the Ranking Member, one housekeeping detail. Although this is the premier committee for technology in the United States congress, some of our systems are not working this morning. [laughter] so i understand dr. Woodcock had a series of slides, so those will be made available to you in paper form. We require our doctors to go paperless, but here on the committee we can still deal with paper. And the clock is working but only i can see it, dr. Woodcock. So the red, green and yellow lights are not working. I will give a brief click when were getting down into the yellow zone so youll know that the time is to wrap with up, and well do that, obviously, for everyone on the Committee Just as a genre minder were coming to the end. So with that, ill yield back and recognize the Ranking Member of the subcommittee, mr. Green of texas. With annual sales of 32 billion. The Items Available with a diverse range of medications and pain relievers, screen sentencing hearing name. It regulates most of these drugs under the otc system. The active ingredients of these nonprescription products are considered safe and effective when consumers follow the instructions without direction from a health care provider. While that is largely true, many containing ingredients the fda has not yet evaluated are known to be for labels to warn consumers of potential harms. The Current System also poses the challenge is for consumer access to potentially better, safer, Innovative Products. Fda oversight of products are put into place in 1972 and has not been updated despite increasingly diverse large market to the need for reform brought into sharper focus on the innovation i peered under the Current System the drug apparatus established directory step of the grueling process with publication in the federal register and Public Commentary. This antiquity that system is overly burdensome and frankly doesnt work very well. Its unable to respond quickly to safety concerns and keep pace with scientific discovery which puts consumers at risk and slows the drug previously has an has an estimated 80 april makings and 26 therapeutic categories that cover over 100,000 products. Its one of the largest and most complex regulatory schemes and also dramatically underresourced. The agency is 30 fulltime employees of roughly 8 million for contacts 18 fulltime employees devoted to the rule of one novel drug application in the otc market now include products with annual sales of 32 billion spirit recognizing the resource process challenge of the Acoustic Monitoring Program stakeholders and fda begin to think about how it can work for veteran values establishing the User Fee Program. Representative dingell, and burgess have been working on a bipartisan fashion to put together a bill that would establish an otc User Fee Program and perform the system. Today we have a discussion that reflects the work of stakeholders the fda cameras and im happy to see the committee moving forward. I know we should consider doing the same with cosmetics. Many parallels between cosmetics and otc products in the way consumers use and think about cosmetics and otc products and also the challenges fda faces and overseeing the categories of everyday items that attacker health. Otc will help foster growth in the availability of these medicines. Policy reforms make the system even more flexible and accommodating to innovation and knowledge about potential harms from the use, ultimately modernizing the otc system to ensure the industry except it was safe ingredients for Consumers Choice and ensure the fda has resources to improve safety changes come innovation in the otc market. I look forward to hearing from witnesses about this and id like to get the remainder of my time to congresswoman to get. [inaudible] 40 seconds. [inaudible] yeah, i dont think your mic is on. [inaudible] [inaudible] to warn parents about risks for Young Children but the effort to convince unsuccessful extremely burdensome process to update and change. What this bill would do is protect consumers another review overthecounter medicines. Youre with us today to get the same kind and to so many other issues. We had a great opportunity to upgrade the regulatory process in a way that benefits everybody, the American Public, federal government. I look forward to continuing to work with my colleagues to support themselves in a thank you very much, mr. Chairman. I yield back. The gentleman from texas field back to the chair recognizes the gentleman from organ, chairman of the committee for five minutes. Thank you, mr. Chairman. Appreciate you holding a hearing on these issues and the fda to improve efficiency and update their framework for regulating overthecounter drug products. The following the successful reauthorization of several fda critical programs, no better time to continue our work there now in the space and includes a bipartisan effort to 30 begun. Cough and Cold Medicine come in a purse rents, if noncitizens, and they are filled with overthecounter or otc drugs and American Consumers rely upon daily. Unfortunately the process weve heard has been the theme since the 70s and i see her coming back. We need to innovate in this sector and safety changes take years to implement, simply unacceptable. Fortunately, fda, regulated industry, all agree significant reform is something we all need to join hands on. Several years now been engaged productive conversation on this substantially improve the status quo in owned by the ongoing dialogue we have a bipartisan resolution before us today that will insure americans have more timely access to safe and affect the otc medicines. Consumers no longer have to wait years for them luck symbol rulemaking process to wind its way through bureaucracy before benefiting product improvements. I want to thank our colleagues, and mr. Latta, ministering for, guthrie, burgess, mr. Pallone another is to have put their shoulder to the wheel on this when we proven time and again in this committee we know how the legislative bipartisan way to get things done for the American Consumers. With auto yield to the gentleman from ohio for the remainder of my time. I thank the chairman for yielding that i also think chairman burgess for holding todays hearing. They also want to think or witnesses for being with us today. Its argued that overthecounter medicine in every household across our nation despite the widespread utilization to regulate these drugs has been out needed for decades. The more flexible framework of Consumer Choice and better address a potential in safety. It will achieve these goals and provide predictability to the drug approval process. The otc safety innovation reform act is a bipartisan collaboration between lack of health. The chairman of the subcommittee, mr. Burgess, Ranking Member green, ministering for current vice chairman guthrie and ms. Dingo as well a significant contributions from the fda in the industry. Id like to thank those involved to work tirelessly on the effort in order to increase Consumer Choice and safety. Appreciate the chairman for allowing the opportunity to improve upon the discussion draft today. Look forward to hearing todays testimony and seen them put her my colleagues on the subcommittee. I thank the chairman for holding todays hearing and i yield act. And i yield to mr. Guthrie. Thank you for yielding, mr. Chairman. I want to thank you for holding this hearing today and examine the review process of overthecounter drugs. This would enable greater integration and inefficiencies within the approval process of overthecounter drugs, something not been done since the 1970s and i want to specifically thank congressman latta for his leadership on this issue. Im proud to be a cosponsor for several of my colleagues supported the bipartisan bill with industry and the Committee Staff worked so hard to move forward. I strongly believe the legislation would help every american has these products are the first in line. I always appreciate you being here and i think our other witnesses will follow and if theres no one else, i will yield back. The gentleman yells back. The chair now recognizes the gentleman from new jersey, mr. Pallone for five minutes for an Opening Statement. Thank you, mr. Chairman. I want to thank you for holding todays hearing on the overthecounter drug monograph reforming the establishment of the Monograph User Fee Program. I also want to commend Ranking Member green, representatives degette, latta commenting proposing will accomplish these goals for the safety and effectiveness of overthecounter drugs established through the monograph in the rule book outlines the conditions of use for particular ingredient outlines the dosage of the population labeling and requirements. The rulebook establishes the threephase rulemaking process often times and flexible and timeconsuming, making it difficult for actually two quickly up date safety of other issues. Well sue. Well sue you for nifty industries at the monograph process does not limit the flow to evolving science and technology and may have discouraging the development and formulation. Not only is it clear that Regulatory Reform is needed that the Current Program is drastically underresourced. Today the otc Monograph Program oversees more than 100,000 products in the budget of just over 8 million. The Regulatory Reform increases the resources we can streamline overthecounter process to allow the finalization of current monograph, timely updates and encourage innovation where possible. While we began to cross significant improvements of the review of overthecounter products, i hoped would begin taking action on cosmetics that millions of americans use cosmetic products, but is woefully inadequate in in just the lash of millions of women and children have been exposed to shampoos that cause extraordinary hair loss, lip balm that can cause blistering and rashes and i shimmers tainted by asbestos. Unfortunately, fda does not have the authority to hold these manufacturers want the bulk and very little ability ensure these cosmetics are safe. This cant continue and as we move forward, we should provide adequate researching an authority than i look forward to continuing to work with my colleagues the fda industry and other stakeholders to accomplish these goals and ensure the continued availability of safety to the millions of drug products and personal Care Products people use everyday. I would like to yield the time how blessed to ms. Dingell. I thank my colleagues for yielding. Americans deserve peace of mind in knowing that all drug are effective, whether Prescription Drugs or overthecounter drugs. Over 300,000 overthecounter products on the market today with everyday life. Give fda regulatory is completely broken did the budget of 8 billion from which all of us say over and over in a cumbersome process that the agencys ability of drug safety risks with new and Innovative Products to market. The legislation creates a new user fee system for products to give the resources it needs to ensure Patient Safety and also allows the agency to a data and revised the monograph system to administrative order rather than noticing comment rulemaking similar to the reform made under the immigration act. Weve seen the benefit user fees on Prescription Drugs and medical devices and into the otc space as well and while we are pleased we have this hearing, i want to commend ms. Pallone for the cosmetic also a desperately benefit to reform and hope the committee will soon move forward with legislation establishing the User Fee Program for these products. I want to thank my colleagues, congressman latta, degette, green for working on this legislation and continuing our Work Together to reach consensus on this important issue and is always her chairman and ranking minority member. I yield back the balance of my time. And i yield back tears that gentleman from new jersey yields back. This concludes the number of pending statements. Pursuant to committee rules, all members Opening Statements will be made part of the record. We want to thank her witnesses for being here with us this morning, taking the time to testify before the subcommittee have the opportunity for drug evaluation and research. Dr. Woodcock come you recognize woodcock come your recognize for your Opening Statement. Thank you here we are here to talk about modernizing otc drugs. Everyone in this room has used an otc drug at one time or another. I know i have. These medicines allow us to manage minor Health Problems without going on the road. Millions of americans use these products every day. They are widespread and i believe theres more exposure of American Cities than there used to Prescription Drugs. In this tree. The monograph system allows manufacturers to come on the market without the burden some product application proc

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