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The following is a statement from IDSA president Barbara Murray, MD, FIDSA:
"I am grateful to the House Energy and Commerce Subcommittee on Health for inviting me to testify on behalf of the Infectious Diseases Society of America (IDSA) on the ever-growing public health crisis of antibiotic resistance and urgent need for new antibiotics and diagnostics. IDSA remains deeply concerned about the increasing number of patients with multi-drug resistant infections.
"The report from the President’s Council of Advisors on Science and Technology (PCAST) on antibiotic resistance and the White House’s National Strategy on Antibiotic Resistance and accompanying executive order adds to an impressive chorus of experts clamoring for substantial policies to address antibiotic resistance. Now it is time for action, and we are pleased to see the White House take critical initial steps to implement a well-coordinated plan, with clear timelines and benchmarks to measure progress, to address antibiotic resistance.
"The antibiotics our patients need are not being developed due to many significant barriers facing antibiotic research and development (R&D). Passing the bipartisan Antibiotic Development to Advance Patient Treatment (ADAPT) Act is one important step Congress can take right away to reduce a key regulatory barrier to antibiotic R&D.
"Some of the most deadly, highly drug-resistant pathogens are to date infecting a relatively small number of patients, making it difficult or impossible to populate traditional, large clinical trials to study drugs to treat these infections. It is essential to develop new antibiotics for these infections before they sicken more people. ADAPT would allow companies to utilize smaller clinical trials to study new antibiotics that treat serious or life-threatening infections where there is unmet medical need. ADAPT drugs would be approved only for a limited population. ADAPT contains safeguards to help ensure these drugs would be used appropriately. It is important that the labeling of ADAPT drugs make clear that these drugs are different from traditional antibiotics.
"In addition to ADAPT, we must continue the progress Congress made when it passed the GAIN Act. There need to be more economic incentives for antibiotic R&D, including tax credits, public private partnerships, and stronger funding for federal agencies such as the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). The economic barriers are so significant, we must do more to generate life-saving new antibiotics.
"It is equally critical to stem the rise of resistance rates and the spread of resistant infections through careful oversight of our current antibiotics. IDSA is calling for a requirement that all healthcare facilities implement an antibiotic stewardship program as a condition of participation in Medicare. Stewardship programs are a key tool in limiting the overuse and misuse of antibiotics that drives resistance. IDSA also supports funding for the Centers for Disease Control and Prevention (CDC) Detect and Protect Against Antibiotic Resistance Initiative, which would strengthen surveillance capabilities and improve antibiotic prescribing practices. We also support increased funding for CDC’s National Healthcare Safety Network to improve data collection and reporting on antibiotic use and resistance patterns.
"Finally, we need to be able to understand more quickly what diseases we are facing when treating patients. That means we need to promote the development and clinical integration of new diagnostics. Rapid, point-of-care diagnostics can reduce inappropriate antibiotic use by lessening the need for empiric therapy. IDSA recommends increased investment in diagnostics research, regulatory approval pathways, strengthening reimbursement, and supporting outcomes research to demonstrate the impact of diagnostics on patient care.
"IDSA looks forward to working with the Administration and Congress to provide economic and regulatory incentives for the development of new antimicrobial drugs, diagnostics and vaccines; establish antibiotic stewardship programs in all healthcare facilities; and fully fund research and public health interventions to most effectively detect and control resistance, prevent infection, and optimize antibiotic use. Patients are continuing to die from multi-drug resistant infections, and they are depending on federal government leadership to address this public health crisis."