ELLEN JENKINS

-Signed a letter in support of H.R. 3584, The Laboratory Access for Beneficiaries (LAB) Act.

-The Alliance for Aging Research submitted a letter in support of Dr. Stephen Hahn as Commissioner of the U.S. Food and Drug Administration (FDA). -The Alliance for Aging Research submitted a letter to the House of Representatives on our recommendations for policies to be included in a proposed "21st Century Cures 2.0." The letter recommended harmonization of CMS coverage, coding, and payment processes for FDA-approved digital health products to avoid coverage gaps for digital technologies, CMS layout milestones and targeted end dates for Coverage with Evidence Development, CMS/CMMI should develop models to encourage treatments choices that coincide with clinical outcomes/patient-centered outcomes, and total cost of care system, CMS should be accepted FDA approved clinical trials, unfettered access to registry data, public reporting of site-specific health outcomes that are collected by specialty societies as part of the CED process.

-Signed an Ad Hoc Group for Medical Research letter calling for the House and Senate Appropriations Committees to prioritize funding for the National Institutes of Health. -Signed letter to House and Senate regarding 2020 funding legislation for domestic and global programs to address antimicrobial resistance. Below are the funding requests in the letter. Centers for Disease Control and Prevention Our organizations are deeply appreciative of funding at the Centers for Disease Control and Prevention (CDC) to address AMR. We strongly support $186 million in funding for the Antibiotic Resistance Solutions Initiative as appropriated in the House LHHS bill to reduce the emergence and spread of AMR pathogens and to improve appropriate antibiotic use through antimicrobial stewardship. A report released in April 2018 by CDC demonstrated that AMR is an increasingly dangerous threat, but that CDC containment strategies are effective in preventing its spread. For example, the report found 221 instances of unusual resistance genes in just one of the most-deadly bacteria (carbapenem-resistant Enterobacteriaceae or CRE) in the US in 2017. CDC further estimated that its aggressive containment strategy could prevent 1600 cases of CRE in a single state in a three-year period. We also advocate for $12 million for funding for the CDC Healthcare-Associated Infections (HAIs) activities, $22.75 million for the National Healthcare Safety Network, and $32.5 million for the Advanced Molecular Detection Initiative (AMD) as provided in the House LHHS bill. The NHSN increase will be essential to help more hospitals report data on antibiotic use and resistance, to help the CDC and other scientists evaluate our efforts to combat AMR and track emerging threats. The additional funding for the AMD Initiative will allow CDC to more rapidly determine where emerging diseases come from, whether microbes are resistant to antibiotics, and how microbes are moving through a population. Each of these steps is essential to the prevention of patient morbidity and mortality. Our organizations urge funding of $595.84 million for the agencys Global Health Program including $208.2 million for the CDC Center for Global Health global public health protection program as provided in the Senate LHHS bill. The CDC is a key implementor of the Global Health Security Agenda (GHSA), which includes preventing AMR as its first action package. GHSA focuses on improving surveillance and laboratory capacity and promoting judicious use of antibiotics. Without sustained funding for activities to prevent, detect and respond to AMR threats globally, Americans will be left more vulnerable. Assistant Secretary for Preparedness and Response (ASPR) We call for $567 million in funding for BARDA, as provided in the House LHHS bill to further help the federal effort to combat antibiotic�resistant bacteria. The BARDA Broad Spectrum Antimicrobials Program leverages partnerships with public and private partners to develop products that directly support the government�wide National Action Plan for Combating Antibiotic�Resistant Bacteria. CARB-X, supported by BARDA, NIH, and other partners, supports the worlds largest pre-clinical and early development pipeline of antibiotics and other therapeutics, diagnostics, and vaccines to prevent, diagnose and treat resistant infections. Despite progress in the development of new products, antibiotic research and development continue to face steep economic hurdles. While the first BARDA-supported new antibiotic secured FDA approval in 2017, one of the few small antibiotics companies went bankrupt in 2019 and two others laid-off significant numbers of staff. If more companies are allowed to go bankrupt, the antibiotic pipeline will collapse, depriving patients of lifesaving new antibiotics and putting modern medicine and national security at risk. More, not stagnant, investment in antibiotic research and development through BARDA is essential. National Institutes of Health The National Institute of Allergy and Infectious Diseases (NIAID) is a world leader on research related to AMR. We recommend funding of $5.937 billion as provided in the Senate LHHS bill to support this work, including $600 million in funding to address AMR. Funding at this level enables NIAID to continue its role as a lead funder of research to discover novel antimicrobials, diagnostics and vaccines that are urgently needed to address multi-drug resistant organisms. This funding also supports the Antibacterial Resistance Leadership Group (ARLG), a scientific team that manages and implements a strategic research agenda by building transformational trials that will change clinical practice and reduce the burden of AMR. Current ARLG efforts aim to support the research and development of urgently needed new diagnostics and antibiotics, assess the impact of stewardship interventions, and optimize dosing of existing antibiotics to maximize effectiveness and limit the development of resistance Agriculture and Related Agencies Antibiotics in Agriculture Experts agree that a One Health approach, addressing both human and animal health, is essential for combating antimicrobial resistance. We urge robust FY2020 funding to enable the Center for Veterinary Medicine (CVM) at the US Food and Drug Administration (FDA) to continue to make progress on the Agencys five-year Action Plan for Antibiotic Stewardship in Animal Agriculture. FDA recently announced its proposed Guidance for Industry (GFI) 263 to incorporate veterinary oversight for all remaining medically important antimicrobial drugs administered to animals, but additional funding is needed to enable FDA to advance these and other important priorities identified in the Action Plan, including updating labels for medically important antimicrobials that lack targeted durations of use, the finalization of a biomass adjustment methodology to enhance sales data reporting, updating FDAs list of medically important antimicrobials associated with GFI 152, as well as FDAs commitment to develop a functional and efficient system for collecting antimicrobial use data in food animals. Funding these activities will help ensure that animal antibiotic drug labels reflect judicious use principles and veterinary stewardship while enhancing the quality and granularity of antibiotic data available to producers, veterinarians and public health stakeholders interested in promoting antibiotic stewardship in agriculture. We also urge full funding for AMR activities at the US Department of Agriculture (USDA). Funding for the Departments AMR activities would provide continued support for important research in the area of antimicrobials in agriculture, the emergence of resistance and the search for effective antibiotic alternatives. Additional funding would strengthen USDA efforts to promote antibiotic stewardship and support voluntary, on-farm surveillance through the USDAs Animal and Plant Health Inspection Service (APHIS) (we acknowledge and support the increase reflected in the House bill for this work), and essential intramural and extramural research activities underway at the Agricultural Research Service (ARS) and the National Institute of Food and Agriculture (NIFA), as well as training and technical assistance on good stewardship practices provided through USDAs Cooperative Extension Service. State and Foreign Operations Appropriations US Agency for International Development We urge funding of $1.56 billion for the Global Fund to Fight AIDS, Tuberculosis, and Malaria, as provided in the House and Senate bills. Further, we recommend funding $310 million for the tuberculosis program through the US Agency for International Development as proposed in the House and Senate bills. Support for the Global Fund and USAIDs TB program will drive reductions in the growth of drug-resistant forms of this disease. Funding for these efforts would support high-quality screening, diagnosis and treatment services for patients affected by multidrug-resistant TB. USAID also leads efforts to expand treatment to more patients infected with MDR-TB in the 10 highest-burden countries, strengthen diagnostic and surveillance capacities globally, and accelerate basic and applied research and development to combat MDR-TB. Additionally, we call on Congress to sustain adequate funding for USAID implementation of the Global Health Security Agenda (GHSA). Between 2014 and 2019, USAID has supported GHSA global AMR activities, including training health providers to prevent healthcare-associated infections - which are often resistant to antibiotics - and expanding surveillance of drug-resistant bacteria. Department of Defense (DoD) We urge funding of $33.495 billion provided for the DoDs Defense Health Program in the Senate FY2020 DoD Appropriations bill. The Defense Health Program and the Research, Development, Test & Evaluation (RDT&E) budgets support R&D to address key medical challenges to the military including antibiotic resistance. For example, in recent years, projects have been supported to develop strategies to prevent, mitigate, and treat antibiotic-resistant bacteria in wounds. The Defense Health Program also supports a Multi-Drug Resistant Surveillance Network (MRSN) program that includes development projects for Army service level support. Specifically, the MRSN is the Enterprise effort to collect and characterize bacterial isolates to inform best practice, such as patient management and antibiotic selection

-Signed a letter in support of H.R. 3584, The Laboratory Access for Beneficiaries (LAB) Act.

-Signed an Ad Hoc Group for Medical Research letter calling for the House and Senate Appropriations Committees to prioritize funding for the National Institutes of Health. -Signed letter to House and Senate regarding 2020 funding legislation for domestic and global programs to address antimicrobial resistance. Below are the funding requests in the letter. Centers for Disease Control and Prevention Our organizations are deeply appreciative of funding at the Centers for Disease Control and Prevention (CDC) to address AMR. We strongly support $186 million in funding for the Antibiotic Resistance Solutions Initiative as appropriated in the House LHHS bill to reduce the emergence and spread of AMR pathogens and to improve appropriate antibiotic use through antimicrobial stewardship. A report released in April 2018 by CDC demonstrated that AMR is an increasingly dangerous threat, but that CDC containment strategies are effective in preventing its spread. For example, the report found 221 instances of unusual resistance genes in just one of the most-deadly bacteria (carbapenem-resistant Enterobacteriaceae or CRE) in the US in 2017. CDC further estimated that its aggressive containment strategy could prevent 1600 cases of CRE in a single state in a three-year period. We also advocate for $12 million for funding for the CDC Healthcare-Associated Infections (HAIs) activities, $22.75 million for the National Healthcare Safety Network, and $32.5 million for the Advanced Molecular Detection Initiative (AMD) as provided in the House LHHS bill. The NHSN increase will be essential to help more hospitals report data on antibiotic use and resistance, to help the CDC and other scientists evaluate our efforts to combat AMR and track emerging threats. The additional funding for the AMD Initiative will allow CDC to more rapidly determine where emerging diseases come from, whether microbes are resistant to antibiotics, and how microbes are moving through a population. Each of these steps is essential to the prevention of patient morbidity and mortality. Our organizations urge funding of $595.84 million for the agencys Global Health Program including $208.2 million for the CDC Center for Global Health global public health protection program as provided in the Senate LHHS bill. The CDC is a key implementor of the Global Health Security Agenda (GHSA), which includes preventing AMR as its first action package. GHSA focuses on improving surveillance and laboratory capacity and promoting judicious use of antibiotics. Without sustained funding for activities to prevent, detect and respond to AMR threats globally, Americans will be left more vulnerable. Assistant Secretary for Preparedness and Response (ASPR) We call for $567 million in funding for BARDA, as provided in the House LHHS bill to further help the federal effort to combat antibiotic�resistant bacteria. The BARDA Broad Spectrum Antimicrobials Program leverages partnerships with public and private partners to develop products that directly support the government�wide National Action Plan for Combating Antibiotic�Resistant Bacteria. CARB-X, supported by BARDA, NIH, and other partners, supports the worlds largest pre-clinical and early development pipeline of antibiotics and other therapeutics, diagnostics, and vaccines to prevent, diagnose and treat resistant infections. Despite progress in the development of new products, antibiotic research and development continue to face steep economic hurdles. While the first BARDA-supported new antibiotic secured FDA approval in 2017, one of the few small antibiotics companies went bankrupt in 2019 and two others laid-off significant numbers of staff. If more companies are allowed to go bankrupt, the antibiotic pipeline will collapse, depriving patients of lifesaving new antibiotics and putting modern medicine and national security at risk. More, not stagnant, investment in antibiotic research and development through BARDA is essential. National Institutes of Health The National Institute of Allergy and Infectious Diseases (NIAID) is a world leader on research related to AMR. We recommend funding of $5.937 billion as provided in the Senate LHHS bill to support this work, including $600 million in funding to address AMR. Funding at this level enables NIAID to continue its role as a lead funder of research to discover novel antimicrobials, diagnostics and vaccines that are urgently needed to address multi-drug resistant organisms. This funding also supports the Antibacterial Resistance Leadership Group (ARLG), a scientific team that manages and implements a strategic research agenda by building transformational trials that will change clinical practice and reduce the burden of AMR. Current ARLG efforts aim to support the research and development of urgently needed new diagnostics and antibiotics, assess the impact of stewardship interventions, and optimize dosing of existing antibiotics to maximize effectiveness and limit the development of resistance Agriculture and Related Agencies Antibiotics in Agriculture Experts agree that a One Health approach, addressing both human and animal health, is essential for combating antimicrobial resistance. We urge robust FY2020 funding to enable the Center for Veterinary Medicine (CVM) at the US Food and Drug Administration (FDA) to continue to make progress on the Agencys five-year Action Plan for Antibiotic Stewardship in Animal Agriculture. FDA recently announced its proposed Guidance for Industry (GFI) 263 to incorporate veterinary oversight for all remaining medically important antimicrobial drugs administered to animals, but additional funding is needed to enable FDA to advance these and other important priorities identified in the Action Plan, including updating labels for medically important antimicrobials that lack targeted durations of use, the finalization of a biomass adjustment methodology to enhance sales data reporting, updating FDAs list of medically important antimicrobials associated with GFI 152, as well as FDAs commitment to develop a functional and efficient system for collecting antimicrobial use data in food animals. Funding these activities will help ensure that animal antibiotic drug labels reflect judicious use principles and veterinary stewardship while enhancing the quality and granularity of antibiotic data available to producers, veterinarians and public health stakeholders interested in promoting antibiotic stewardship in agriculture. We also urge full funding for AMR activities at the US Department of Agriculture (USDA). Funding for the Departments AMR activities would provide continued support for important research in the area of antimicrobials in agriculture, the emergence of resistance and the search for effective antibiotic alternatives. Additional funding would strengthen USDA efforts to promote antibiotic stewardship and support voluntary, on-farm surveillance through the USDAs Animal and Plant Health Inspection Service (APHIS) (we acknowledge and support the increase reflected in the House bill for this work), and essential intramural and extramural research activities underway at the Agricultural Research Service (ARS) and the National Institute of Food and Agriculture (NIFA), as well as training and technical assistance on good stewardship practices provided through USDAs Cooperative Extension Service. State and Foreign Operations Appropriations US Agency for International Development We urge funding of $1.56 billion for the Global Fund to Fight AIDS, Tuberculosis, and Malaria, as provided in the House and Senate bills. Further, we recommend funding $310 million for the tuberculosis program through the US Agency for International Development as proposed in the House and Senate bills. Support for the Global Fund and USAIDs TB program will drive reductions in the growth of drug-resistant forms of this disease. Funding for these efforts would support high-quality screening, diagnosis and treatment services for patients affected by multidrug-resistant TB. USAID also leads efforts to expand treatment to more patients infected with MDR-TB in the 10 highest-burden countries, strengthen diagnostic and surveillance capacities globally, and accelerate basic and applied research and development to combat MDR-TB. Additionally, we call on Congress to sustain adequate funding for USAID implementation of the Global Health Security Agenda (GHSA). Between 2014 and 2019, USAID has supported GHSA global AMR activities, including training health providers to prevent healthcare-associated infections - which are often resistant to antibiotics - and expanding surveillance of drug-resistant bacteria. Department of Defense (DoD) We urge funding of $33.495 billion provided for the DoDs Defense Health Program in the Senate FY2020 DoD Appropriations bill. The Defense Health Program and the Research, Development, Test & Evaluation (RDT&E) budgets support R&D to address key medical challenges to the military including antibiotic resistance. For example, in recent years, projects have been supported to develop strategies to prevent, mitigate, and treat antibiotic-resistant bacteria in wounds. The Defense Health Program also supports a Multi-Drug Resistant Surveillance Network (MRSN) program that includes development projects for Army service level support. Specifically, the MRSN is the Enterprise effort to collect and characterize bacterial isolates to inform best practice, such as patient management and antibiotic selection

-The Alliance for Aging Research submitted a letter in support of Dr. Stephen Hahn as Commissioner of the U.S. Food and Drug Administration (FDA). -The Alliance for Aging Research submitted a letter to the House of Representatives on our recommendations for policies to be included in a proposed "21st Century Cures 2.0." The letter recommended harmonization of CMS coverage, coding, and payment processes for FDA-approved digital health products to avoid coverage gaps for digital technologies, CMS layout milestones and targeted end dates for Coverage with Evidence Development, CMS/CMMI should develop models to encourage treatments choices that coincide with clinical outcomes/patient-centered outcomes, and total cost of care system, CMS should be accepted FDA approved clinical trials, unfettered access to registry data, public reporting of site-specific health outcomes that are collected by specialty societies as part of the CED process.

-Signed letter requesting the delay of Protecting Access to Medicare Data Act (PAMA) data reporting period and supporting H.R. 3584, The Laboratory Access for Beneficiaries (LAB) Act. -Submitted meeting summary document to the Hill that found widespread support for an out-of-pocket cap for Medicare Part D, allowing for installment paying for Part D prescription drugs, and consideration of realigning incentives in the Part D program that may currently prefer higher-cost products. -Signed a Medicare Access for Patients Rx (MAPRx) letter that supported the out-of-pocket cap in Medicare Part D in the Prescription Drug Pricing Act of 2019. -Signed letter supporting Improving Seniors Timely Access to Care Act of 2019 (H.R. 3107) -Submitted letter thanking Sen. Menendez and Sen. Cassidy for working on introducing legislative language to allow for Medicare Part D beneficiaries to pay for their medications in installments. -Signed letter supporting an extension of a Centers for Medicare & Medicaid Services (CMS) program to provide equitable relief for select individuals enrolled in a Marketplace plan who delayed Medicare enrollment during their Initial Enrollment Period. -Signed letter to waive out-of-pocket costs for seniors on Medicare who have precancerous polyps removed during a colonoscopy. -Submitted letter regarding a CMS proposed rule Medicare and Medicaid Programs; Requirements for Long-Term Care Facilities: Regulatory Provisions To Promote Efficiency, and Transparency calling for changes to prescribing practices and the rating system for antipsychotics in long-term care facilities. -Ryne and Missy had meetings with Congressional staff to discuss allow the Medicare Part D program to allow for installment payments for prescription medication

-Signed letter expressing concern regarding two National Institutes of Health (NIH) guidances titled Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research and Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions Regarding Proposed Human Fetal Tissue Research. Our organization was concerned about proposed restrictions regarding federal research requiring the use of fetal tissue. -Signed letter opposing Section 207 of S. 1895 the Lower Health Care Costs Act. --Signed letter supporting the appointment of Dr. Norman E. Sharpless as the Commissioner of the Food and Drug Administration

-Ryne and Ellen met with Congressional staff to advocate for the reauthorization of the Patient-Centered Outcomes Research Institute (PCORI) -Ellen met with Senate staff to discuss reauthorization of the Elder Justice Act

-Signed letter calling for advancements, new investment, and policies to stabilize the antimicrobial market, ensure a robust and diverse antibiotic pipeline, and reduce antimicrobial resistance. The letter supported universal hospital reporting of antibiotic use and resistance data to the CDC National Healthcare Safety Network (NHSN) and for HHS to provide funding for hospitals that may require initial support to establish stewardship programs and to begin reporting to NHSN. The letter also supported the U.S. Food and Drug Administration (FDA) five-year roadmap to enhance stewardship in veterinary settings and food-animal production.