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The following is a statement from William G. Powderly, MD, FIDSA, president of the Infectious Disease Society of America (IDSA):
"The Infectious Diseases Society of America (IDSA) applauds the Senate for passing the 21st Century Cures Act earlier today. The soon-to-be law makes regulatory changes and new investments that will undoubtedly save lives in the years ahead. IDSA is particularly pleased that the legislation contains provisions that help combat antibiotic resistance as well as the opioid epidemic that is spurring a surge in new HIV and hepatitis C infections. The bill also recognizes that our ability to address future public health threats is enhanced by acting now to support young biomedical researchers.
"Antibiotic resistance is one of the critically important public health threats addressed by the 21st Century Cures Act. Across the globe, at least 700,000 individuals die annually from drug-resistant infections. Increased research and development for new antibiotics is a central part of the broader strategy to combat drug resistance.
"IDSA has long advocated for the creation of a limited population approval pathway at the FDA for antibacterials and antifungals that treat serious or life-threatening infections with an unmet medical need. The new pathway is essential to reinvigorating R&D in this area as the population of individuals who have a specific antibiotic-resistant infection at any given time is relatively small, which is often an obstacle to populating a traditional large-scale clinical trial. We are pleased that the Cures Act creates this approval pathway and gives hope to future patients suffering from antibiotic-resistant infections.
"IDSA also commends Congress for creating the Next Generation Researchers Initiative within the National Institutes of Health as part of the Cures Act. This new effort joined with an increase in the NIH loan repayment maximum, also included in Cures, will help make certain that we have the workforce necessary to combat existing and emerging infectious diseases.
"While the next Congress will need to build on the 21st Century Cures Act to realize its goals, the new law is a tremendous contribution to public health and national security."