A new bill in the U.S. House of Representatives focuses on stimulating antibiotic and related diagnostic development. The Generating Antibiotics Incentives Now (GAIN) Act (H.R. 6331) would, among other steps:
- extend the exclusivity period for new qualified ID products, including certain antibiotics or diagnostic tests by 5 years
- give priority regulatory review to applications for these kinds of products
- require on-going review of Food and Drug Administration (FDA) guidelines for conducting clinical trials for antibiotics
U.S. Rep. Phil Gingrey (R-Ga.), a former obstetrician, is the bipartisan bill’s lead sponsor. Co-sponsors include Reps. Gene Green (D-Texas), Mike Rogers (R-Mich.), Diana DeGette (D-Colo.), and Ed Whitfield (R-Ky.). The bill was introduced Sept. 29. IDSA provided input to the bill’s drafters prior to its introduction and continues to work with House members to strengthen the bill. For more information about the Society’s continuing support for a broad strategy to address antibiotic resistance and the lack of new antibiotic drugs, visit the Society’s website.
Other recent IDSA advocacy efforts include:
- During a Sept. 29 congressional hearing, Andrew Pavia, MD, FIDSA, testified on IDSA’s behalf to underscore the importance of continued investment in product research and development to ensure the country is protected against biological threats, such as pandemic influenza, biologic weapons, and emerging infections, including antimicrobial-resistant infections. Chair of IDSA’s Pandemic Influenza Task Force, Dr. Pavia testified before a Senate appropriations subcommittee hearing focused on the medical countermeasures plan announced by the Department of Health and Human Services in August. Testimonies and video from the hearing are available online.
- Earlier this month, a coalition of physician specialty societies, including IDSA, asked members of Congress to join Sen. Arlen Specter’s (D-Pa.) sign-on letter urging Medicare to reinstate the consultation service codes. The agency eliminated these codes as covered services effective Jan. 1, 2010.
- In a recent comment letter, IDSA, the Society for Healthcare Epidemiology of America (SHEA), and the Pediatric Infectious Diseases Society (PIDS) commended the inclusion of ambulatory surgical centers and end-stage renal disease facilities in a draft action plan developed by the Department of Health and Human Services to prevent health care-associated infections. The groups also supported the draft plan’s inclusion of influenza vaccination of health care workers. The full comment letter is available on IDSA’s website.
- IDSA urged the Agency for Healthcare Research and Quality (AHRQ) to prioritize the development of performance measures for hospital-based physicians and home infusion therapy in the National Health Care Quality Strategy and Plan. Click here to download IDSA’s Oct. 15 comments in response to AHRQ’s request for feedback.
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