The U.S. House of Representatives is considering a wide-reaching 21st Century Cures initiative that provides a platform for IDSA to advocate for effective public policy on antimicrobial resistance, vaccines, ID research, and other priorities. The nearly 400-page draft bill reflects recommendations collected over the past year from multiple organizations, including IDSA.
The draft bill contains multiple promising provisions aimed at stimulating antibiotic research and development (R&D), including Limited Population Antibacterial Drug (LPAD) approval pathway, creation of a public private partnership similar to the European Union’s Innovative Medicines Initiative, improved reimbursement for antibiotics, and a provision to speed the Food and Drug Administration (FDA) process for updating susceptibility breakpoints. The proposed legislation also includes provisions aimed at speeding FDA review of urgently needed new diagnostic tests, and IDSA is seeking inclusion of additional provisions aimed at ID diagnostics.
The Cures draft also contains several provisions related to vaccines. IDSA expressed support for provisions that would direct the FDA to issue final guidance to facilitate the use of accelerated and expedited pathways for the development and licensure of urgently needed vaccines, expand National Institutes of Health (NIH) vaccine R&D programs, and require prompt updates to Medicare upon issuance of recommendations from the Advisory Committee on Immunization Practices (ACIP). IDSA also recommended that the bill require coverage for all ACIP-recommended vaccines through both Medicare Part B and D to ensure comprehensive coverage of these vaccines for all seniors. IDSA also expressed concern for provisions that would micromanage the ACIP process and require CDC to meet with any vaccine manufacturer within 90 days of a request without providing CDC any additional resources to support such activities.
The draft bill contains multiple IDSA-supported provisions pertaining to research, including use of a single institutional review board for multi-site studies, improving access to clinical data registries, and requiring entities that receive NIH funding to release their findings to the public. Congressional staff also indicated to IDSA their intention to add a provision to the bill to make it easier for federal employees to attend scientific conferences, and IDSA highlighted the importance of such participation.
The draft bill contains some provisions that are causing concern among many medical and scientific societies as well as patient groups. Many advocates believe these provisions would allow for inappropriate congressional micromanaging of NIH through such means as establishing term limits for institute directors, requiring detailed strategic plans, and statutorily mandating the percentage of funds to be spent on basic research. IDSA urged that Congress maintain NIH’s authority to be guided by science and not micromanaged by politicians.
For more information, you can view IDSA’s detailed comment letter here. IDSA will continue advocating for ID priorities in 21st Century Cures, which is expected to proceed in the House later this year. The Senate recently launched a similar initiative, and IDSA provided the leading Senators with detailed recommendations.
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