Human and Animal Health. This is about an hour 40 minutes. [inaudible conversations] good morning. The Senate Health education and labor subcommission on primary health and Retirement Security will come to order. Thank you for joining us today for the primary health and retirement subcommittee hearing, superbugs the impact of Antimicrobial Resistance on modern medicine. Thank you especially to Ranking Member marshall, to you, your staff shared commitment to preparing for preparing. This is a type of partnership that drives results ultimately in congress. More than 100 years ago the discovery of antibiotics revolutionized modern medicine. Some experts consider penicillin to be the single most important drug ever created. Antibiotics alone have extended our average lifespan by 23 years. But the rise in Antimicrobial Resistance threatens to undo 100 years of medical progress. Minor infections could become incurable bleeding patients with chronic illnesses like Cystic Fibrosis most at risk. Routine surgeries could turn into deadly procedures. A paper cut could become lethal. But with the benefit of a century of scientific advancement on our side this does not have to be our fate. Our scientists and medical leaders already know what needs to be done. They know that the only medicine better than an antibiotic is prevention. They know we must use antibiotics responsibly. They know that keeping people healthy and out of the hospital is critical to reducing Antimicrobial Resistance. Yet more than 100 million americans lack access to primary care. But we here in congress can do something about that. We can invest in our Community Health centers and Public Health infrastructure. We can build worldclass Health System that reaches every person in every community from kansas to massachusetts, and invest in our workforce empowering a legion of medical professionals to prevent infections from turning into pandemics. And we can keep our people healthy by keeping our planet healthy. Last week we saw the four hottest days on planet earth ever recorded. While the planet will turn our coastlines and waterways into petri dishes, diseases will spread faster and new strains will spread farther. Our Climate Crisis feeds the Antimicrobial Resistance crisis, and the only answer is to act now. We need a whole of government approach to prevent the next Public Health emergency. And as we saw with covid19 pandemic, when crisis strikes, it doesnt strike in a vacuum. And Antimicrobial Resistance crisis will disproportionately threatened the people who interact the most with the medical system. It will threaten our health care workers, our friends and family who have disabilities, who are pregnant or who are elderly. It will worsen and sulfuric all. Epidemic and strike in every Community Whether or not have the resources to respond. It will bankrupt our working class and strained a system plagued by inequality. What with the wisdom of hindsight we can improve our pandemic preparedness. We can build a resilient Healthcare System design with people at the very center, decide to take care of all americans. We can deliver the ingenuity of American Innovation but it will only save us from crisis if the treatment is accessible for everyone. Just as a patient without funding is an hallucination, innovation without access is a fantasy. We can and must create a different future, one that does not repeat the sins of the past. The witnesses here today, doctors on the frontlines, haitians living with the risk of Antimicrobial Resistance, Companies Developing new medications and research connecting the health of our people and our environment where light our path forward. They are fighting for a better future, and Congress Must listen and respond. It is time we guarantee a prepared and equitable whole of government plan to prevent a crisis. With that i will now turn to our Ranking Member, senator marshall, for his opening statement. Well, thank you, mr. Chairman for queen told a cheering on Antimicrobial Resistance. I got to chile i could barely sleep last night, i was so excited to get here. This is why we came to congress, was to fix problems like the best. And ill tell you why this is near injured to my heart. Certainly since the secondyear medical student, try to understand bacteria and yeast infections and fungus, but the story that i remember issuing up for my ob gyn residency program. We were delivering 15 15 to 0 babies at a working 36 hour shifts. But the story that haunted everybody was a young lady that had a csection and had died maybe three months before i got there, and she died from a resistant bacteria from sepsis, a complication from a csection. Very few days or weeks went by what we didnt talk or they didnt talk about that case. Was there a month or two and were having a very high infection rates, higher than i was comfortable with with postoperative patients. So i started culturing patients and that something you typically dont do when you have a multibacteria, grampositive gramnegative causing this type of infection but i cultured several people and headache methicillinresistant staph aureus. I had never even seen the patient with it. I had read about it, is that i started to go why all these patients having a methicillin resistance . I looked in the further end of using wimax and called guerrilla selling as a prophylactic and were treating common urinary Tract Infections. They were treating everything with it. And obviously this do i suppose was a third of fourth generation was inducing Drug Resistance. So here we are today, and why is this important . 3 million americans this you will get some type of an antimicrobial resistant superbug this year. 100 americans will die today. When hundred will die tomorrow. And every day this year from some type of a resistant bug. And i see the need for this rising as diabetes and obesity overwhelm our society, those are set up for more resistant organisms. And again in my field of obstetrics, our csection rates are going up for the same reasons and were going to have more infections and more resistant bugs. And then of course sexually transmitted diseases. For years without penicillin resistant gonorrhea but now its resistant to others so its certainly something us everyday in my practice. Those industries are using today compared to 2017 when we pass legislation i bet dr. Apley will talk about that as well. So im proud what weve done in agriculture will need to look in the mirror. We many physicians, Nurse Practitioners and p. A. S you to look at the mirror. Half of the antibiotics we prescribed are probably not indicated. I wish i could tell you which hath it is but certainly my profession needs to look in the mirror. We start need to do more cultures and pay more attention to this as well. Heres the challenge before us. I talked about this one there are people dying every day from some type of resistant organism. Thats probably caused by 20 or 30 different bacteria. Its not that youre going to develop one antibiotic thats going to take care of all of these. You develop an antibiotic and maybe its specific to an infection from a kidney infection and another antibiotic could be specific for a pneumonia and another antibiotic for pelvic infection. So thats what its so costly. Thats what is so costly to develop these. Realizing we need 20 or 30 new antibiotics to take on these key infections. As opposed to, say, a diabetic drug is going to be able to give that to tens of millions of patients or even alzheimers drug, its developed, it will probably be given to 1 million patients. When we develop these types of antibiotics we are hopefully only to use them each a handful of times and just makes the economics of it next to impossible. We have many professional friends and colleagues have asked me to have this patient centered hearing so im so proud of the Allstar Group of witnesses we have. I know its going to be a great hearing. And again i want to emphasize, thank you to your staff as well, chairman, at the Committee Staff working together to bring this to light. This is an issue that this committee can literally make a difference today. People asking why i left Practice Medicine to cover and i would tell them look him in medicine i could impact 30, 40, 50 people a day. Here you and i can impact the lives of thousands of people. Certainly one of people to death at a may and i from antimicrobial resistant bacteria. So proud to be on the 40 hearing from her witnesses. Thank you. And i would ask senator marshall for you to introduce our first witness if you would. You bet. [inaudible] the last six years in congress. Dr. Apley of course is a veterinarian with a phd in pharmacology at the college of veterinary medicine at the kansas state university, home of the fighting wildcats. He teaches multiple courses with iterative food animal medicine, clinical pharmacology come Antimicrobial Resistance. His Research Interests include Infectious Disease, antibiotic efficacy, resistance, antibiotics stewardship which is an issue here today, drug residues that will be interesting in applications of drugs in food animals. Dr. Apley is a nationally recognized for his work and is among the most influential veterinarians in cattle industry. He recognizes the value of his work dr. Apley was appointed a voting them of the president ial Advisory Council in combating antibiotic resistant bacteria. He completed to terms on the council serving as vice chair. He currently serves as a diplomat at the American College of veterinary clinical pharmacology and is in the American Veterinary Medical Association. Dr. Apley thank you so much for agreeing to be here and to testify. We look forward to your information. Should a introduce the next one . Dr. Apley, go ahead. Whenever you feel comfortable please begin. Thank you. Chairman markey, Ranking Member marshall, members of the subcommittee and my esteemed colleagues, good morning. My name is mike aptly, a veterinarian and also serve as an alternate member on the American Veterinary Medical Association committee on antimicrobials. Clinical use of antibiotics and research into the optimal use has been my focus since 1987. Today we are addressing the issue of antibiotic resistance. More specifically, the issue of acquired antibiotic resistance were antibiotics that were previous effective against the bacterial pathogen have lost the ability to have an impact on the outcome of disease caused by the pathogen in humans or animals. We can think of worse resistance as the worstcase scenario of there being no possible treatment for a bacterial disease. Or resistance can mean that our initial animatic choice doesnt work and it is later in the disease process went and effective antibiotic is used. This delayed effective intervention can result in a more prolonged disease course, an increased chance of debilitation, or an eventual failure of antibiotic therapy. Resistance to our initial antibiotic choice can also mean the remaining options have undesirable side effects which complicate recovery. Acquired animatic resistance may occur due to a mutation in bacterial dna which is passed down through the subsequent generation, but the other more alarming route for acquiring resistance occurs through the horizontal transfer of resistance genes between different bacteria by means of transferable genetic elements which encode for resistance mechanism, a method of transfer and the means to be incorporated into the dna of the bacteria receiving the genetic elements. These transferable genetic elements may contain the genetic codes of more than one resistance mechanism. With many of these mechanisms encoding resistance to multiple antibiotics. This is to multiple Drug Resistance, or mdr. The conditions leading to a acquired antibiotic resistance reached a point where this resistance has an impact on the use of an antibiotic include frequently applied antibiotic selection pressure, a highly mutable population of bacteria with a short generation time here this selection pressure may result in a higher proportion of the pathogen population being resistance as will as of the expansion of an already resistant bacterial population i reducing the numbers of other bacteria competing for the same resources. The latter situation highlights the importance of the Health Impact of our normal bacteria. To be clear this is a generalized account of the nature of acquired antibiotic resistance. Discussions should be held in relation to specific combinations of antibiotic exposure, the bacteria of interest, and invited to which of the antibiotic bacterial interaction occurs. We have pathogens which of acquired resistance to most and in some cases all of our antibiotic options and we have pathogens which maintain susceptibility to our most basic firstline antibiotic choices. The severity of the antibiotic resistant challenge to our health is illustrated is a characterization of the major resistance threats to human health by the centers for Disease Control and prevention, or the cdc. More specifically their 2019 209 antibiotic resistant threats report identifies 18 bacteria and fungi as might be involved in more than 2. 8 million antibiotic resistant infections each year, resulting in 35,000 deaths. When severe and potentially fatal diarrhea caused by with her to antibiotic use is considered, this raises estimates to 3 million infections and 48,000 deaths. The complex relationship of animatic resistance to our Healthcare System is reflected in a 2022 special report by the cdc on the impact of covid19 on antibiotic resistance. The American Veterinary Medical Association has also published a document identifying antibiotic resistance challenges encountered in veterinary species. Consideration of a challenge of antibiotic resistance has led to the National Action plan for combating antibiotic resistant bacteria, carb. An important component of carbon is the one Health Approach which recognizes relationships between the help with humans, animals, plants in the environment. Consistent with this one Health Approach the fda center for veterinary medicine is in the last year of the current five year action plan for supporting antimicrobial stewardship in veterinary studies. With the recent progress report. I would also like to highlight a resource on antibiotic resistance within the u. S. Department of health and human services. The president ial Advisory Council on combating antibiotic resistant bacteria, or at carb. Pat carb produce a first of 11 reports in 2016 with the most recent report of 2023. I suggest this resource is the only way to her from experts but also as a bridge to meet Additional Resources in the field. Thank you very much for the opportunity to be at this morning and forward to our discussion. Thank you, doctor come so much. And now im going to introduce doctor helen boucher. Dr. Boucher is the dean as well as professor of medicine at Tufts University school of medicine and the chief academic officer of tufts medicine Health System in boston, massachusetts. She is a practicing Infectious Disease physician, and not a wildcat but a jumbo. She also served as director of stuart a levy center for integrated management of Antimicrobial Resistance. In 2015 dr. Boucher was appointed to the president ial Advisory Council on combating antibiotic resistance bacteria. Dr. Boucher, you may proceed. Thank you, chairman markey, it Ranking Member marshall and distinguished member of the subcommittee. Thank you for holding a hearing on at the microbial resistance and for inviting me to test my behalf of Diseases Society of america and in my capacity as a dean at the Tufts University school of medicine. As an id physician i see firsthand how amr in the birth of new antimicrobials is harming patients. Amr is everyones crisis and everyones responsibility. I will briefly outline key drivers of amr, what amr is one of the Significant Health crises of our time and urgently needed solutions. As doctor albert pointed out the beautifully amr pathogens ability to evolve to resist antibiotics, making those drugs ineffective. One resistance occurs in nature, antimicrobial overuse in humans, animals and the environment speech resistance. Antimicrobials are unique in that used in one individual can impact efficacy and the rest of the population. Despite some progress, antibiotics continue to be misused. In 2016 about half of hospitalized patients were present at antibiotics and 3o 50 were inappropriate. Environmental factors are accelerating amr. Climate change, pollution, wildfires and into population settings can all facilitate the spread of amr through waterborne pathogen, infected birds and increases in respiratory infections. In 2019 an estimated 1. 27 Million Deaths worldwide were directly caused by amr, and amr played a part in nearly 5,000,000 deaths. U. S. Healthcare costs links to infections from six of the biggest amr threats total more than 4. 6 billion annually with 1. 9 billion of these costs borne by medicare. Antimicrobials and dental modern medicine. Advances like cancer chemotherapy, Organ Transplants, hip replacement, csections and of the complex care character risk of infection and only possible with antibiotic support. Amr puts all these therapies to which americans are entitled at risk due to our lack of novel antimicrobials. I specialize in caring for patients undergoing Organ Transplantation 50 stations must be on immunosuppressive medicines to prevent rejection. Individually to eradicate or control an infection precludes transplantation and an infection following transplant is a leading cause of death in the speculation. Ive had the said duty of caring for a person with an infection caused by resistant bacteria for which we had no effective antibiotic. He was unable to proceed to the transplant he needed and had to go home on austin. Ultimately leading his two young sons fatherless. Amr is impacting healthy individuals in our communities. I have cared for otherwise healthy women with resistant urinary Tract Infections that are delivered treatable with oral antibiotics. This has required two weeks of intravenous antibiotic therapy often stored in the hospital and prolonged time away from work and school. The Opioid Epidemic is also fueling amr. Individuals who inject drugs are 16 times more likely to experience an invasive infection. Amr just proposed ethics communities of color and other marginalized populations. Amr sachse Security Threat is bioterror agents may be engineered to resist antimicrobials in military Service People are at heightened risk for infected wounds. Idsa appreciates the h. E. L. P. Committee leadership on amr. We think Ranking Member marshall and senator blumenthal for spearheading an annual letter urging congress to provide funding to support improved amr survey was, prevention and research but we must address gaps. The most important thing this subcommittee can do is advance policy to establish a whole incentive such as a subscription model to spur the discovery and velvet of antimicrobe is. A subscription model would pay for these based on the value instead of volume to try private investment in antimicrobial r d. The president s budget request propose such a model and over 200 organizations support this approach. Rnd incentives must be paired with resources for stewardship stewardship programs optimized antimicrobial use, improve Patient Outcomes and lower healthcare costs. Unfortunately many Healthcare Facilities lacked the resources necessary for stewardship. The id workforce that is needed to confront amr is in crisis. Patients with serious infections do better when theyre treated by an idea physician. Nearly 80 of u. S. Counties lack an idea physician and only 56 of idea physician Training Programs fill the positions in 2023. Financial barriers hinder recruitment come something i personally grapple with as a dean. Id physicians are among the lowest paid specialist. Congress must help ensure the availability of the i. T. Workforce by breeding reimbursement, addressing student debt and providing resources for training and early career development. Thank you so much for your attention to the critical issue of amr. Yep, thank you, doctor come so much. The next where going to from this melanie lawrence. Ms. Lawrence is a a massachuss resident and healthcare advocate living with Cystic Fibrosis. Ms. Lawrence serves on committees for the Cystic Fibrosis foundation, boston childers hospital and Cystic Fibrosis learning network. Shes also a recipient of the alex award, the highest award that cf edition gives for her volunteer work to help and support people with Cystic Fibrosis. Whenever you feel comfortable with begin, ms. Lawrence. Thank you so much. Good morning faq chairman markey, Ranking Member marshall and distinguished member of the subcommittee for inviting me here to testify. My name is melanie lawrence. I am 43 living with Cystic Fibrosis. While i didnt speak you about my expense with infection, drugresistant bugs are not a problem exclusive to People Living with cf. This is human issue and last i checked we are all human. They are a problem that all americans will face if we dont find a solution to jumpstart innovation in Antimicrobial Development. Cf is a rare genetic disease affecting nearly 40,000 people in the u. S. That causes the body to produce sticky mucus in the lungs heightening the risk of infection. When i was diagnosed my parents were told that my Life Expectancy would be 16 years old. Today the meeting Life Expectancy of people with cf has increased to 56, but there is still no cure. Cf is only a part of who i am though. It does not define me. I am a single mother to a most amazing 12yearold son. I am a daughter, a sister, a friend, a proud and and im passionate about making sure that patients like me and others have access to treatment they need to have fulfilling lives as well as a Healthcare System that is rooted in humanity. Every day i spent i was taking medications, doing physical therapy, exercise, meditation, breath work all while raising a very active 12 year old trying to as many meaningful memories with him as i can. Despite being proactive, infections due to drugresistant impacts my health and have relied heavily on antibiotics my whole life. Earlier i could trust that he to eat antibiotic course of oral antibiotics would do the trick. This meant as that kerry in my lungs began outsmarting the antibiotics, i also needed iv antibiotics to keep my infections under control. This meant a two week stay in in the hospital and i would have to antibiotics administered to our pic line through it up the vein in my arm. By 18 i needed a larger dose of iv antibiotics for up to five weeks at a time. Losing hope, i pitch is spent in a for iv compromise in which ended up causing chronic tendinitis, or severe kidney damage and ultimately removed from the study because of it. Over the next two decades antibiotic resistance became a bigger threat to my health, as to the subsequent side effects of more potent antibiotics. My airways became so dems i began having bleeding in my lungs. I also begin developing blood clots. Because of that my own option for iv antibiotics became a temporary iv line placed to my jugular vein. It was no longer possible to eradicate the bacteria so the goal was to keep my head above water. Now in my 40s that kerry in my lungs are resistant to nearly every antibiotic except for tobramycin which a candidate because it is a toxic to my already damaged kidneys and hearing. My focus is to manage my symptoms and maintain the best quality of life possible. Without the security of effective antibiotics to i find myself living with chronic fear and anxiety about when the bacteria residing in my lungs will act out or when another infection will take me away from on on a deeper level, i an navigating a humbling loss of control, loss of autonomy, and the deep subconscious fear of death. Im leaving my son without his primary caregiver, the person who knows and best in motion without abandon, his mom. My body is both my biggest ally keeping me alive and fighting off these infections what also being my biggest threat trying to kill me from the inside. And yet living with cf has been a gift, not a curse. It is open my eyes to the fragility of time and the importance of connection, and that is a gift we should all be so lucky to receive while we are healthy and able to appreciate it rather than when its too late. My story is not an uncommon experience in the cf community nor is it unique to people with cf. Bacteria are abundant and it is inevitable that more americans will encounter infection. Set a question of if you can catch them, it is a question of win. Without new antibiotics the bacteria will win this war. I think the subcommittee for giving me the opportunity to share my story, and after that you Work Together to find Innovative Policy Solutions for patients like me and for all americans like the pastore act. Me personally, i would love to my son graduate college or even to become a grandparent come something that ive never even allowed myself to imagine because it feels so out of reach with that new antibiotics. Time is ticking and we need your help. Thank you. Beautiful, thank you. Senator marshall, would you introduce our next what is . Thank you, mr. Chairman. I want to introduce ms. Christine miller who is testify on behalf of the Antimicrobials Working Group and the biotechnology innovation organization. Ms. Miller is the ceo of the Melinta Therapeutics, a Biopharmaceutical Company that specializes in novel broadspectrum antibiotics to help patients in hospital and community settings. With that background in chemical engineer, ms. Miller has spent over 20 years championing Life Sciences innovations working for Small Companies to some of the leading innovators in the world. Ms. Miller will shed light on why the commercial marketplace for and about x in the United States is at serious risk of collapsing. Something my colleagues tell me over and over again. That its a risk of collapsing with ongoing reimbursement challenges and supply chain shortages. Again my friends back home tell me this everyday copacabana talk to my friends still practicing. Shes going to show westlaw companies are not responsible for over 95 of global novel Antimicrobial Development and even then face bankruptcy in the coming years. They do so much for agreeing to testify and share your story. Ms. Christine miller. Thank you, chairman markey, Ranking Member marshall, and, ad distinguished members of the site pity. Thank you for the opportunity the subcommittee. My name is christine miller, a presidency on Melinta Therapeutics and melinta as a small biotech providing innovative therapies to people impacted by a cute and lifethreatening illnesses. My story begins in new york with two amazing parents who immigrated here from jamaica. The women in my family dedicated their careers to helping patients. My mother a registered dietitian worked at a hospital. As a child i remember visiting her at the hospital watching her salt patients problems. I was inspired to pursue a career in pharmaceuticals when i realized i could use my education, like the women of my family, to help patients. This is why being here today is so important to me. I want help identify the unmet need of patients, address the issues of availability and access to lifesaving antimicrobial medicines. Antimicrobial drugs are the cornerstone of modern medicine. These drugs are critical to effectively deliver medical care for patients receiving chemotherapy, Organ Transplants, and patients undergoing routine surgical procedures like hip replacement and csections. However, bacteria and fungi are living organisms that adapt and evolve over time and become resistant to antimicrobials. A phenomenon known as antimicrobial resistant, or amr. In the United States amr is the third leading cause of death behind Heart Disease and cancer. Things have gotten worse since the pandemic. In 2020, hospital acquired drugresistant infections and deaths jumped 15 as covid erased use of progress in the fight against superbugs. While drafting my testimony i was reminded of a story from a patient sue paxton. Sue who was recipient of a successful liver transplant who also vanish at a severe Fungal Infection when hospitalized, after multiple rounds of antifungals and further deterioration of her condition, sue and her doctoral able to gain early access to a novel antifungal developed by said dara therapeutics that melinta will launch later this month. Within days sue school on sue was on path to recovery. Unfortunately what happens to sue happens all too often in hospitals, and the only way to combat these lifethreatening infections is to continually innovate newer, safer antimicrobials, and ensure that patients have access to these innovations. Its important to understand that we do not have an innovation problem. The u. S. Government recognized the need and has taken action to support research and Development Needs to address resistant infections. Programs like carfax had done an amazing job at reinvigorating the preclinical pipeline. Also programs through barda have been vital to combat a market melinta as a partner in a publicprivate collaboration with the barda to advance two fda approved antibiotics used in pediatric patients and for use against biothreat pathogens. We also do not have an approval problem. Congress already enacted a policy to streamline Regulatory Approval for antimicrobials, companies are getting Innovative Products approved but are failing after launch. What we do have is a commercial marketplace problem that is fundamentally unique to antimicrobials, driven by reimbursement and access challenges. As a result, many Biotech Companies run out of money in the rush to provide patients to access with lifesaving therapies. Unless we see changes to the postapproval side of the equation, the ability to bring these products to patients remain in jeopardy. The good news is that congress and the federal government are in the position to solve this problem. Policies to increase access to new antimicrobials through reforms to antimicrobial reimbursement and novel payment mechanisms called pull incentives that the comp payment from the volume of antimicrobials used are urgently needed now. Without changes to the system, we will continue to see access challenges and further deterioration of the innovation pipeline. And patients, our family members, our neighbors will continue to die. My hope for today is that this Committee Views all of todays testimony as a call to action to fix the commercial marketplace. Amr remains a silent killer in hospitals every day every year we went to address this crisis is another year more patients are at risk of losing their lives. Thank you for your attention to this Public Health crisis, and i look forward to your question. Thank you, ms. Miller. Thanks to this great panel. I will turn to questions from the subcommittee. Ms. Lawrence, as a Cystic Fibrosis patients, patient, you know more than anyone, patients are more prone to infection and most be able to rely on antibiotics that are effective, and that you also have to be able to access and afford this on top of what can be dozens of pills a day for a cf patient. So can you talk about the importance of developing new antibiotics . Ms. Miller just talked about that. And making sure those antibiotics are available and affordable for people like you. Yes. Thank you for the question, chairman markey. I think that antibiotics are not the most expensive of all of the drugs that i take. They are probably the most affordable. I i am a very avid participant n Clinical Research to try to bring new drugs and therapies to market, and of all the studies ive done over the decades ive only done one new antibiotic trial. And even though it did result in lasting permanent side effects, i would do another one in the heartbeat. Its just, they are not, we dont have the opportunities to find that antibiotics, so it doesnt, its so, so much as a cost issue as it is as an availability and development issue. Thank you. Dr. Boucher, you are treating patients in boston every single day. Using how bad the Opioid Crisis has become. Tufts is right there at the center of it in Downtown Boston and it puts people at risk of Antimicrobial Resistance. So can you explain to us why people with opioid use disorder and are at risk, and how can we mitigate that risk . Thank you for the question, chairman markey. Yes, sadly we saw daily released about a week ago that in massachusetts the open epidemic is at its worst. We are seeing increased number of patients with infections. The way these individuals get sick, it starts often with a very simple thing, interruption of the skin. Some injection interrupts the protective layer of the skin gives our body, and people are colonized. The skin is colonized with the stuff back to the gates into the system. What happens in these individuals is that they become sick or many of them are also malnourished, have other underlying diseases, hepatitis c, of the things consist treating them as complicated. Many of them express homelessness comes to following through on treatment is complicated. They go into environments where they can spread the infection, that propagates the problem so gets into more social problems as well as medical problems. In a hospital these patients are greater care. They need to be isolated in private rooms. We have to protect ourselves so we dont spread the infection to other patients. It adds greatly to kos come to morbidity and mortality for the station. Great, thank you. And it is no silver bullet. Dr. Apley, could us about the orchestra of different entities that will be needed to Work Together in order to prevent this crisis from spreading further . Thank you, chairman markey. When i look at that, the combination, its Infection Prevention which is very, very, very important. A huge part of our efforts. Diagnostics. We have challenges with having access to rapid diagnostic tests, and as i understand from my de son packet card we somehow times have challenges in reverse for the test would do have that we able to put in accurate test and then are antimicrobial susceptibility testing, interpretation and continue to develop breakpoints and more rapid test for pathogen identification and determining which antibiotics might be the best. Those are really the main components. The other thing is both human and veterinary sides are very, very focused initiatives on antimicrobial stewardship. And this also gets into the realm of behavior as it relates to antimicrobial. Okay, thank you. In between the doctor and their patient . Well, thank you for the question. Companies like ours, melinta, focused on creating access anytime we can for patients. When we are working with hospitals and hospital systems, it definitely is quite complicated to get a new product on formulary. There is a bit of a red tape, but our Organization Works tirelessly to make sure that hospitals are aware of the latest therapies and provide them all the information that they need in order to get our products onto hospital formul formularies. What we do know is that theyre disincentivized for formularies and having their use because of the cost. Its definitely more of an incentive because of the way reimbursement works in the hospital or hospitals to use older, cheaper generic drugs line versus using newer Innovative Products. Thank you. Senator marshall. Ill yield to senator betts. Thank you for you and the panel for being here today. Ms. Miller you look at development to launch as valley of death, tens of years, before a new antibiotic can come to the market. So, as i mentioned before, carb x has been really great at reinvigorating the pipeline. Unfortunately some of those products are, you know, far from actually coming to market, but barta has other programs, other publicprivate partnerships that are helping to bring innovation to the marketplace faster than if companies were trying to do that on their own. We Just Announced a recent partnership with barta for a privatepublic partnership and what that will allow us to do is bring innovation for pediatric patients to market faster. Thank you for that. When i go on their website or carb x, it shows a little over 300 million, a little under 400 million thats been invested. What attracted those dollars and how do we make that more if its a good program . Well, i think the first thing is focusing on where is there unmet medical need, right . So we see the trends. We see where infections are higher, where resistance is higher and so when companies can bring forward ideas to carb x for funding, theres opportunity there for collaboration and the need to focus on preparedness, not just the infections that were battling today, but what could be the infections in the future, the pathogens that we need to be most concerned about from a biothreat perspective. Theres opportunities to collaborate there as well. Thank you, now you also mentioned a Second Valley of death when the f. D. A. Approves a new drug, but patience cant access it because hospitals keep physicians from prescribing the newest therapy. Can you go into detail about the reverse incentives that keep the new therapies on the shelves and then what reforms to the gain act congress should pursue to make sure that they have access to the drugs. I want to make sure that its clear that we support antimicrobial stewardship, that its important to use the right drug at the right time for the right bug and stewardship is important. As a result antibiotics and antifungals are going to be used more sparingly than you would see a typical product especially in a hospital setting. However, the way reimbursement is set up in the hospital, the hospitals are intersent advised to incentivized to use cheaper than newer or potentially more costly innovation. What wed like to see is a reform to reimburse that so that hospitals are not incentivized to put our new, newer antibiotics on the shelves in reserve, but to use them when its appropriate. They need to do the right testing, of course, but when they see that a bug is susceptible to a newer antibiotic or antifungal, they shouldnt be prohibited from using that because of cost. At the end of the day, the cost of inaction of not using the right product sooner costs the Health Care System money and of course, it costs lives. Thank you for that. Again, thank you all. I yield. Thank you, senator. Senator hassan. Well, thank you, chairman markey and Ranking Member marshall for this hearing and i want to thank all the witnesses for your participation and testimony and miss lawrence, im especially grateful for your testimony its hard to talk about personal experience in a large setting like this, but its really, really important so thank you. I want to start with a question to you, ms. Miller. Youve just been having some of this discussion with senator bud, but antibiotic resistance is obviously a serious and emerging threat to Global Health and we need to Work Together to encourage the development of new products that can treat with antibiotics. Thats the whole point of our discussion today. What im standing is that many large Drug Companies used sorry, used to develop antibiotics, but over the last decade this field has narrowed to aened had aful of small Biotech Companies, right . So youve just been talking with senator bud about some of the obstacles for investment here, but for these smaller operations that are now driving the research, are there any obstacles you havent discussed to antibiotic innovation and bringing new antimicrobial drugs to market . Thank you. The crux of it is the commercial marketplace problem. If there were a sound commercial marketplace youd see Larger Companies and investors willing to invest in the space. Bus of the broken marketplace, this is why you have only a few companies actually doing development in the space. Fortunately, we do have collaborations with barta and other private Public Partnerships that are helping and assisting, but its not enough. We need to fix reimbursement. We need to have incentives that will help address the commercial marketplace and make it possible for companies to be sustainable in the space. Well, thank you for that. One of the things that i think we could do in addition to pursuing government investments in boosting the demand for new antibiotics is look at ways we could leverage the tax code to provide incentives to startups to engage in this research. Doctor, while drug innovation is central antimicrobials are some of the issues. And they need to mitigate the drug resistant infections. Can you speak to the area, such as antimicrobial surfaces in hospitals . Thank you, senator hassan. This problem is a wicked problem and requires a multipronged approach. Infection prevention is vitally important, washing our hands and making sure every procedure is done on the patient to prevent infection as much as possible. And importantly were in a situation where we have the science that brought us Incredible Technology for diagnostics. But the way that theyre approved by the food and Drug Administration and the payer in the hospitals. In my role as a dean i have the privilege to help educate the work force of tomorrow, its not just physicians its all other health professionals, we need experts to do this work and you heard from the doctor how complicated it is to choose the right drug, the right patient. We need to be able to attract people to do this work so our children and their children will be protected. Thank you for that. That takes me to the last question which is to dr. Apply. Youve written extensively in the use of antibiotics in animals. How do we promote medically responsible. And i work for veterinary side. Weve put stewardships in action and we spend a lot of Time Starting right at the start with case definitions, diagnostics and the applications and reasonable choices so its a complication effort between everyone on our side of caring for animals and the weve had one whole meeting at that was based on communication and that communication aspect and aiding in that communication is the basics of all of it. Well, thank you, and i will yield back and may follow up in terms with all of you in terms of what resources and guidance for practitioners making sure they have the best information readily available. Thank you. Thank you. Thank you, mr. Chairman. Ms. Lawrence, youre a living breathing miracle and we want you to know that we want you to see your son graduate from high school. We want to see you have grandchildren some day as well and i remember my first patient, with Cystic Fibrosis. There was once upon a time no Cystic Fibrosis patient would think about conceiving and an incredibly tough pregnancy if they did. And in one way the innovation is working, with the innovative drugs. And what does your doctor say your future looks like . Thank you for the question, Ranking Member marshall, there have been so many medical advances, especially with the highly effective mod ulators. Theyve offered a level of stability which has been really nice. Is that the gene therapy . The highly effective modulaters, and i could explain more. Thats okay. It stabilizes the experience. It stabilizes for many patients it raises pulmonary function tests and decreases infections. I have been in Clinical Trials for every generation of these modulaters, its made a difference, but not stopping me from getting infections and thats my biggest threat and also, like the infection breeds pneumonia, its just a vicious cycle. So thats my biggest threat by far. And if i may, ranking chairman markey, i wanted to add to my answer about your question about new antibiotics. Theres also a timing factor and while i have very good access to health care and affordable insurance, in order for them to cover a new antibiotic, it make it very hard and hoops to jump through and cultures to get back and my mine is progressing to pneumonia. A prior authorization that you have through . You have to submit a culture and prove the antibiotics are resistant and requires often inpatient hospital stays so they definitely do not make it easy to access a new antibiotic. Thank you. Doctor boucher, im going to get a premedical consult from you here. Most of your patients you see are probably people that survive Organ Transplants that maybe theyve taken Cancer Therapy recently and then we lose them to infection. What would the message of hope you give to a cyst fibrosis patient like ms. Lawrence, so she can see her grandchild. The treatment before and after transplants with cancer and Cystic Fibrosis. We need drugs to treat the infections that still happen. Its not js one, as pointed out earlier, we need a pipeline thats robust and we know that resistance will march on. Really finding a solution to that, thats the idea of this subscription model is a way to focus on value, not volume of antibiotics, to use them well through stewardship, but to have them be developed and delivered to our patients in ways that are predictable and reproducible so that the drugs that the government invest in will be on the shelves in my pharmacy when theres an infection. Doctor boucher, not many people have watched somebody die. Whats it like to watch your patients die because you dont have the right antibiotic . It starts off as a kidney infection, starts off with pneumonia. Whats it like to watch them die and not have them have the antibiotic that you they need . Ill start by saying i chose the field of infection 30 years ago and curative, life saving drugs so i came into this field to cure people of infections and send them home and enjoy their lives and with the transplant that they get. And to sit with the woman who sit through rounds of lukemia and watch her going from sicker and sicker to dead in a number of days is heartbreaking. Its a privilege to treat patients at this point in their life, but thank you. Dr. Apley, speak a bit about what agriculture, protein production, what weve done to decrease the use of antibiotics and to address these issues and specifically talk about how the 2017 law has impacted your world. Thank you, senator marshall. If you go back to 2017 and look at the f. D. A. Sales data for antibiotics following that and 2017 was the start of the transition to all medically important antibiotics used in feed to the veterinary feed directive and any use in water to under veterinary control and the next year we saw at the time tetracycline, and with their patients and the principles. The last time a new antibiotic group was approved that weve used in food animals was 1978, that a new group was approved. So were using tried and trued older compound groups and we get new numbers of them. Also if you look at our veterinary organizations we ascribe to the avma stewardship definition and the ways that we go through to look at those. And the other thing that just happened july 1 of 2023 was that all of our antimicrobials that were previously overthecounter are under veterinary control. Veterinarians are involved in decisions and frank and candid discussions what we should and should not be doing and discuss prevention control, animal movement, et cetera. Thats great. By the way, we have some agriculture initiatives with food supplements, feed supplements that would also decrease a lot of the bacteria as well. And ms. Norman finish with several questions as well. Big picture, how many failures does your company have before they get a get one across the finish line . Well, i mean, this space you probably have a 1 chance of getting a product from initial idea conception to approval. Its a pretty high failure rate when it comes to development and a pretty costly one. Yeah, i used to help run a hospital and you try to keep your formulary tight from a Cost Management standpoint and some of the antibiotics that you would use maybe 5, 10, 20 times a year as well and no way that my hospital could afford to keep that in stock. And we think about the drg reimbursement. Were going to get a lump sum of money, whether we get ampicillin or a drug. I know there are exceptions to that. Can you walk us through what your solution would look like for that type of patient that probably is going to be resistant. Now, theyre got copd and theyve been in isu for three days already and not Getting Better you know its a drug resistant antibiotic. What would it look like for reimbursement model . I think its important to look at the big picture. Theres a drg and we need to reform reimbursement and look at entap, for example, a framework already in place and make reforms to it so that antimicrobials are better suited for use in the ntap construct. However, we have to look at what does it cost to have that patient hospitalized for extended period of time . I can tell you every day a patient is in a hospital, not getting the care that they need, further deteriorating costs the hospital and costs health care much more than okay, 5 or 10,000 a day literally. Exactly. So we really have to consider that the products that we have developed that we have made available or were making available to patients are curative. Right . This is invaluable. I appreciate the answer and being respectful, i need to move on. I do appreciate everybody coming to your testimony today, i need to go to another hearing. Id like to come back and circle back, that drug. Not all hospitals could keep every one in stock, but how to share those as well so that they can get it tomorrow and then the Regional Hospital can get it as well. Thank you, mr. Chairman. Thank you, senator marshall and thank you for your partnership on this issue. Senator hickenlooper. Thank you, mr. Chair. Thank you all for your time. Im trying to come up the stair and barely have caught my breath coming up the four floors here. Obviously microbially weakened somehow. On a more serious note, i first learned i learned firsthand the importance of what were talking about today. My father passed away in 1960 after a long battle with Colorectal Cancer and a big part of his challenge they pretty much only had penicillin in those days and after a couple of years, several operations, he would get infections and they were unable to treat. And my mother would tell stories about waking up in the middle of night several times and having to he would have had cold sweat and have to roll him over and get a clean sheet under him and roll back and get the rest of the sheet put down and what a trial that was for him every night. And its amazing that weve come so far and yet, we still havent progressed as further as one would hope in this issue. So, ill start with dr. Boucher. The development of new antimicrobial drugs hasnt kept pace with the increasing rate with the pathogens becoming Drug Resistance due to not much in the space. Weve cosponsored the pasture act, which we referred to and enter into subscription contracts with antimicrobials. How would the subscription mechanism incentivize the development of new antimicrobialals . Thank you for your question, and your support of the pasture act. The pasture act valued for it focuses on the most needed antibiotic, the most needed infections. There are clear criteria that the developer needs to met to get the subscription reimbursement, guaranteed reimbursement and its linked to stewardship to use it in the best way possible so its preserved as much as possible. And this is a much needed first step getting us back to a healthy Economic Framework for antibiotics. And i want to come back to the comment about carb x made earlier. Its probably the most successful partner with sparta and today over a dozen products and Clinical Trials in patients and if we dont see progress in Something Like the pasture act all of that will go to waste and those medicines. Thank you for your support. Thank you for all of your work. Ms. Miller, a lot of the Drug Research and development is obviously, its been discussed by all your hard work and doesnt often have many victories. Many of the skilled professionals behind this research, you know, the creators of these innovations are often lured away from the uncertain antimicrobial drug market for more commercially viable pursuits. The pasture act is designed to help with some of that uncertainty and improve the viability of the market. So in your opinion how would the stability of the pasteur act, help with not just recruitment, but retention in this for these drugs. Thank you, senator for the question. Absolutely, there has been a brain drain, we call it in the ib space. You have talent within the industry who really have concerns how much theres been an underinvestment in antimicrobials and so people have left and gone to other pursuits like oncology and other chronic diseases where the marketplace is more certain. What pasteur does and incentives, it creates the possibility of stability in the marketplace. Knowing that there would be a sustainable marketplace to bring people back into the space, not just from a Development Point of view, but investors as well. All right, i see im out of time. If i dont ill make sure my additional questions and you get to see it in writing. Thank you for your great public service. Thank you, senator. Senator braun. Thank you, mr. Chairman. Interesting discussion because it looks like were up against a foe that so easily outmaneuvers us. You know, the more you use something thats effective temporarily, the more youre giving it the chance to change and require something different. I got interested in this and i think its called the spiokeet and then you find out an old drug is the only thing that could knock them out. Are we in a never ending battle where we can never get ahead of it, youre saying only 1 of any investment in something to, you know, way lay any new malady hits pay dirt. Where does this dynamic end . Because it looks like the dynamic generally favors the microorganism. My question would be, start with dr. Boucher, where is the recent example theres been something so bad, so widespread where a current antibiotic wasnt working, how long did it take to marshal the resources when you knew that you needed to to actually get something to the marketplace . Thank you for your question, senator braun. I think we have to look at the example of covid, right . Its a virus, not a bacteria, but we marshalled, right, and got a vaccine into arms in less than a year, right, and drugs into patients very quickly remdesivir, et cetera. We can do this, the science exists. There are numbers of candidate drugs, vaccines, diagnostics, that have advanced, theres no derth of science. The issue is really this economic problem and the multipronged approach of surveillance, diagnostic tests, everything required to combat this wicked problem, we live in a country where its advanced. We transplant, heart transplant is normal business in a hospital today. We did that in a Matter Research was building toward it and finally applied. What would you say if that urgency is there . Because sooner or later, it will be either another virus or a bacteria or even like an spirokeet where there are other diseases, tick borne, and what would you say when it comes to an antibacteria, not an antiviral, unless theyre completely analogous in terms of how youd get there . Was there anything recently when its come to something that had to have an antibiotic and how long did it take . Yeah, i guess i would say, if we look at the most recent antibiotic approvals, drill back to met with approve and the bacteriaer infections, less than 10 years and that was thats an infection that we know is coming, its multidrug resistant. This is a game where there needs to be planning in advance for the threats we know and some we dont know. Someone mentioned candida infections, it was not on the threat list in 2015, it is in 2019. Is it one of the biggest concerns . Its a big concern. So we need infrastructure and we need Something Like the pasteur act, one thing you all can do, advance that bipartisan act. Were not doing it ad hoc based upon the very urgent need. Some day that may not be quick enough. Correct. Ms. Miller, would you want to weigh in . So, definitely theres a cost in action and we do need to be planful, we do need to prepare. Theres a great science out there, its just waiting to have a stable home to land in and so, if there is one thing that i would ask be done today, we need to reform the commercial marketplace. We need reforms to reim reimbursement. We need to fix the commercial marketplace. Anyone else want to weigh in quickly . Ill just add one thing that there was a report released in march linking pandemic preparedness to amr. This is not if, its when. And this goes through the different aspects that need to be addressed, including the pasteur act. Thank you. Thank you, senator. Senator smith. Thank you, mr. Chair. Thanks for this hearing. I dont know if everyone in this room knows this, but today is senator markeys birthday, i believe. I could not miss this opportunity to embarrass you in front of the whole Committee Staff. Youve been very successful. [laughter] dangerous to go against your committee, your subcommittee or your Committee Chair like this. Happy birthday. Thank you. I really appreciate all of you and appreciate very much this hearing and i am getting clearly this the broad message this have hearing which is that we need to take a comprehensive and holistic approach and we need to improve access to education about prevention measures like vaccines and handwriting and using antimicrobials responsibly in hospitals, agriculture or veterinary medicine and invest in the developing and manufacturing in a new market that isnt broken and that is fixed and working well. So i want to dive into this from the perspective of shortages in antibiotics and what weve seen with this issue and whether or not this question of supply chain is part of the broken part of the market. You know, we saw shortages of antibiotics, in the last year, we know that this is about sometimes it is the antibiotic itself or sometimes its the component of the drug that we dont have. And with this in mind that caused me to team up with senator cassidy on our now bill now law, the onshoring essential antibiotics act which basically helps to expand the the concept is to expand capabilities by allowing hhs to award grants to build or upgrade facilities here in the u. S. To basically on shore our supply chain. So, let me start. Dr. Boucher, could you just talk a little about how you see this shortage affecting patients and your view of this . Thank you, senator smith for the question. Weve seen antibiotic shortages for some years and we see them almost routinely, our hospital pharmacists, you know, send a thing out every week telling us about shortages and we manage them often creatively, thinking about substitutions and ways to manage and sometimes its not easy and sometimes it does affect patients. Im in a very fortunate position to work in supply chain, and hospitals, critical access hospitals its not so easy and the impact is greater. So addressing this is a huge need and thank you for your attention. And i will mention that especially ingestible antibiotics require manufacturing often and its difficult and part of the reason we need robust pipelines and oral antibiotics. We havent had a new oral antibiotics in a decade. One of the things we learned from the pandemic is the threats that we have when we do not have on shored manufacturing of so many things, including antibiotics. So, maybe im wondering, ms. Lawrence, if youd like to comment from your own personal experience whether youve seen issues not being able to get access to an antibiotic that you really needed because it wasnt available. Not about price, its about availability. Yes, thank you for the question, senator smith. I have been impacted by antibiotics shortages and other medical or medicinal shortages as well and i am extremely fortunate to have an amazing care team at boston Childrens Hospital that knows how to work and navigate and a best friend who is a pharmacy manager and can help with the pharmacy side, but i am very lucky to have that and if i didnt have that, if i were elderly and didnt know how to navigate the system or if i, you know, didnt have the connections that i have, i would not know even where to begin to work around that shortage. Thank you for that. I think thats really important and you both are making a comment about how, you know, antibiotic shortages affect different people differently based on where people are and where they live. I just have a few more minutes. Dr. Apley, i want today ask you about the concept of one health. That human health and Animal Health are linked and too often our federal agencies that oversee this work in their silos, rather than thinking about how we need to be thinking again holistically and coprehensively about bugs. I wonder if you could talk about this concept. The one health framework. Senator young and i have worked on this together. And working hard with the department of agriculture get this one framework adopted. Can you tell where you see this path going. And the pat carb, one of the fundamental things as were in this together. If you look at the list of the American Veterinary Medical Association important resistant organisms in veterinary medicine and look at the c. D. C. s list in human medicine youll see pseudomonas salmonella listed in both. And we share a lot of organisms that we have challenges with and we share a lot of the same needs for diagnostics, for helping to get the best information to our practitioners, and together awning our Human Behavior and its interact how we dispense and so many of the same messages, so much of the same information is vital to both physicians and veterinarians that is absolutely wrapped up together. Thank you. I know im out of time, mr. Chair. I appreciate this hearing very much. You can have extra time for wishing me a happy birthday. [laughter] thank you so much, senator smith. Let me ask you, miss lawrence, your disease is one that actually has had enormous progress because of what the families have done. My friend, who i went to Catholic High School with, joe odonnell, his boy joey contracted Cystic Fibrosis and there was no cure, and Companies Really werent doing the research on it. So he, along with the families, each year raised money and then said to Biotech Companies, if you do research in Cystic Fibrosis, well give you our money to do the research and ultimately the families raised hundreds of millions of dollars in order to Incentivize Research and thats where a Company Named vertex got their funding, it was from the families. To give them that incentive and these breakthroughs have all come because of that incredible entrepreneurial activity. My friend ultimately wound up, joe odonnell going to Harvard Middle School and they used the private sector to move. And joey, little joey would be your age today, but he passed away at a very, very young age. But now Life Expectancy has been lengthened dramatically. So we know that it can happen. We know that the breakthroughs are there and we just have to find the methodologies that ensure that were going to have research be medicines field of dreams from which we harvest the findings that give hope to families that they wont suffer unnecessarily for diseases in their familys lives. How, ms. Lawrence, can we better support patients in Antimicrobial Resistance. Thank you, chairman markey, and happy birthday as well. I actually met joe last july at a concerns and hes wonderful and has done so much for the community as has the Cystic Fibrosis foundation. I work with them on several levels and i think that they are one thing that they really do well to drive Community Incentives in working together and funding different things, is that they have a patient centered model of care. So they hear the patient voice. They take into account the Community Needs and where the lack is, and that better directs the science and they have patients like myself have input at a research level, at a grant level, at a needs, like a workshop level. Every level of the process, the patient voice is front and center and thats driven where the money goes and progress. Beautiful, thank you. Dr. Boucher, in your written testimony, you talked about how Climate Change facilitates, the risk of Antimicrobial Resistance. Can you talk about that. Thank you, senator markey, for the question. We know that Climate Change leads to more antimicrobial resistant through wound infections and warmer temperatures, often are infected with antimicrobial organisms. Water borne organisms travel more on we see more Antimicrobial Resistance and pathogens picked unfrom the soil in warm and hot climates so were already seeing the impacts and were doing studies in the tuft center looking at waste water and were seeing changes already with just small incremental changes in temperatures that weve seen. Linked from humans, animals and the environment as we see Climate Change evolve. As temperatures warm, insects, animals, now my migrate to other parts of the planets and those populations are not as protected against. Absolutely, we see migration of vectors of illness, things like animals and we see evolution in places where infection isnt recognized and people havent put two and two together, like moving south with lyme disease, endemic in massachusetts now moved in the countries. Lots of room to act in the positive as well and truly back to the wicked problem. One of the multipronged approaches needs to really be thinking about climate active impacts on amr. And again, wicked is such a massachusetts, boston word as well, so, its bad. So dr. A apley, youre advocat of the one health, and how it impacts the Antimicrobial Resistance . I think we have been able to identify common approaches that supporting them, we advance stewardship in our antibiotic decisions across every place we use them. One. Things thats happened in the carb again is we look at the issues of fungi, and we brought in someone on that committee on that counsel, excuse me, thats an experiment in applications of antimicrobials. So we realize that this one health really does involve the environment and anyplace we might be using the antimicrobials and again, involves diagnostic, preventives, new and novel ways of preventing disease. Once you break down the silo personally from seven and a half years, the things i learned from the human side that i take to veterinary medicine and maybe went the other way, too, that having a group thats just really focused on breaking down those silos is important. And youre in the medical Device Coalition on this issue. According to the Government Accountable Office the development of new drugs that could treat bacteria currently resistant to medications is insufficient. How are facilities partnering with the federal government to incentivize drug investment with f. D. A. Pathways and exclusivity periods . And is that Partnership Working . Thank you for the question, happy birthday. So, you know, there are really good and productive publicprivate partnerships to support amr. It isnt enough in the end, right . Because we need to make sure that were continually innovating because the bugs are continually evolving so we need to ensure that we have an ongoing stream of innovation to have newer, safer, antimicrobials over time, but existing relationships, they are working though. Right . And we need to continue that. At the crux of it though, we do need to address the commercial marketplace because i believe if we do do that we will create an incentive for companies and for investors to come back into the states to do more development and to ensure that the relationships that we do have, the partnerships that we do have, these products can actually land in the marketplace effectively. Lets talk about that, the families with Cystic Fibrosis, i can only 35,000 in market, they saw a market inefficiency, they saw where the private sector was not going to respond so they injected themselves into it and raised money to a number of companies and said well do the research and well help to forehand fund you, and it emerged to the one doing the best work. That was market inefficiency just few people are affected. And what do we have to do, dr. Boucher, that such a small number of people benefit from it, but by benefitting it they stop the spread of it potentially. Senator markey, happy birthday, dont want to forget and thanks for asking the question. You hit on the key important criteria for antibiotics. The use in one patient affects a whole community so thats the why we should care, even if this particular infection only impacts a few. And im going to come to something that we havent talked about explicitly, but i think that really important and thats awareness, so its a sad reality that in 2023, we still have awareness problem for this amr in our country and holding this hearing is a good step in that, and thats what many of us at this table spend our time trying to do, but we have to do better, right . We still lack a clear voice and a clear patient voice. The National Action plan has called for a federal champion for amr. In the u. K. You might have seen dame sally davis, shes now a u. N. Ambassador. Shes done more for this world, shes leading. We need more for our country. I hear you loud and clear, were doing more Clinical Trials with patients at the table as we develop questions through the Leadership Group and making progress at looking at quality of life. Lots more to do and lots morallying from the base in terms of patients and families. Well talk a little more about the champion. Who is that person . What are they doing . So, the champion that i have seen is the spokesperson in europe and globally now for the problem. So across the government, across the globe actually speaking for the different stake holders and bringing very practical things to the table with one voice and really being recognized. So we recognized this back in 2015, 2016 and it was incorporated in the National Action plan, if hasnt been implemented, but i think that appointing such an individual would help advance this problem and our response to it. Youre saying that the administration should appoint, name a champion . Yes. A spotlight to continue to keep this issue front and center. Yes, sir, thats the ask. Well try to help you accomplish that goal. I think thats a great idea and we need to have somebody who is in charge to be applying the pressure that all of the families in our country feel on this issue. So lets do this. Lets and thank you all, by the way, for this incredible hearing today. I think you really advancing the cause and you can see the enormous interest which the subcommittee has in the subject. So lets do this, lets give each one of you one minute to summarize what you want the subcommittee to retain from your testimony today, just well go in reverse order of the original testimony so that you can give us your summary to the jury to the subcommittee, in terms of what our agenda should be. What should we remember from todays hearing so well begin with you, ms. Miller. Thank you. And maybe what ill also start by saying, while amr is an issue where sometimes we only have antibiotics or antifun gals to address a few patients, what we do know, there are a number of patients that are affected by amr every day. Theyre dying from infections, they may have cancer and maybe their loved one thinks theyre dying from cancer, but they actually die from infection. So this is an everyday persons problem, its not something thats in the future. To be a problem for families and our loved ones, its a today problem for folks. So what i would definitely like for everyone to walk away from todays discussion is to really understand that amr is a threat to us, to our society, to our medical and Health Care System, that we need to have adequate development and ongoing innovation in the space to ensure that we will be able to save patients lives. We also need to address the commercial marketplace, this is definitely something that you know, really needs the federal government to step in and address. We need to see reforms and reimbursement, we need to see incentives like the pasteur act be put in place so the development, the publicprivate partnerships happening today actually have a place to land and that patients can get the life saving medicines that they need. Thank you. Ms. Lawrence . I hope that i have given a human depiction of what antibiotic resistance looks like so that it becomes more relatable to most and i hope that i brought a sense of humanity to the issue that it is not many of us are not as impacted by something until it happens to us and were personally affected by it and i hope i can shed some light or that the Committee Takes away. This is a global problem that will affect you at some point in time. So how proactive do you want to do and i second the pasteur act before this congress as well. Thank you, and thank you for your powerful testimony here today. Thank you were invaluable putting the human face on this crisis. Dr. Boucher. Thank you, senator markey. I echo the gratitude for being here and emphasizing that this problem is here and now, affects all of us and we need to act immediately. We need to ensure that we have a work force to prepare for and address this problem and we need to advance the pasteur act, and saying over 200 organizations that will provide subscription model for the stewardship and prudent use of those antibiotics. Thank you. Dr. Apley. Two things, i want to make sure that the antibiotics are important, and one of the words we havent used here is risk. When a veterinarian or physician takes a stand on that, i know you want one, were not going to. Theres risk in supporting physicians and veterinarians and undertaking that risk with information and collaboration is important. Thank you, dr. Apley very much. We thank everyone who has participated today, especially our witnesses who would travel here today from massachusetts, kansas, and new york. Each witness here told us loud and clear, if we do not address Antimicrobial Resistance, we will face a growing health care threat to our country and today, we are not only el illustrating the problem, but illuminating the path forward, with the medications available and find a way in which we incentivize the development of new solutions to this problem, and we need a Healthy Planet that doesnt facilitate the spread of these deadly diseases. So ordinarily, at this point i would ask unanimous consent to revise and extend my remarks or the remarks of the Committee Members here, but in this instance im going to ask to revise and delete any references to my birthday from the record and without objection, and i ask unanimous consent to have a statement from stake holders outlining priorities for addressing Antimicrobial Resistance and for any senators who wish to ask additional questions for the record, it will be open for 10 Business Days until july 25th at 5 p. M. And all senators are invited to ask those questions in writing and for the witnesses then to answer them in writing as well. And with that, this very important hearing is adjourned. Thank you. [inaudible conversations] [inaudible conversations] [inaudible conversations]