Throughout 2008, IDSA has continued the work outlined in the “Bad Bugs No Drugs” campaign by advocating for advancements in antimicrobial research and development. Medicare and vaccine financing also were key areas of focus.
Much of the Bad Bugs, No Drugs action this year took place at the Food and Drug Administration (FDA). Following urging from IDSA and other organizations, FDA updated breakpoints for vancomycin and penicillin this spring. FDA raised the breakpoints at which S. pneumoniae is considered susceptible to penicillin and, due to growing resistance, lowered the breakpoints for vancomycin in the treatment of Staphylococcus aureus.
The Society held a joint scientific workshop with FDA in November to address uncertainty about the appropriateness of non-inferiority trials for treating skin and soft tissue infections (SSSI). Brad Spellberg, MD, FIDSA, a member of IDSA’s Antimicrobial Availability Task Force, introduced IDSA’s recommendations for reversing the trend of reduced development of antimicrobials.
Proceedings from a January 2008 IDSA/FDA workshop, which addressed the design and conduct of clinical trials of antibacterial drugs in the treatment of community-acquired pneumonia (CAP), are published in a supplement to the December 1, 2008 issue of Clinical Infectious Diseases.
In addition to antimicrobial research and development, the Society championed its views on Medicare by joining the American Medical Association (AMA) and more than a dozen specialty societies in endorsing the Medicare Improvement Act (H.R. 4992). The bill would shift all preventive vaccines into Medicare Part B.
IDSA also joined a coalition of home infusion pharmacists, pharmaceutical companies, and patient groups urging Congress to enact the Medicare Home Infusion Therapy Coverage Act (H.R. 2567), which would provide Medicare beneficiaries with access to home infusion therapy services. This bill and the Medicare Improvement Act did not pass this session, but are likely to be re-introduced next session.
IDSA endorsed two pieces of legislation regarding vaccine financing. The Vaccines for Children Access Act of 2008 (H.R. 4990) would expand the category of children eligible for the Vaccines for Children (VFC) program to include the under-insured vaccinated at any public health clinic. The VFC program is federally funded, providing vaccines to eligible children who cannot otherwise pay.
The Vaccines for the Uninsured Adult Act of 2008 (H.R. 4993) would establish a Vaccines for Uninsured Adults Program (VFUA), providing recommended vaccines to eligible adults, and would be modeled on the successful VFC program. Though neither bill passed, they are expected to be reintroduced next year.
At a National Vaccine Advisory Committee (NVAC) meeting, IDSA presented testimony concerning draft recommendations by NVAC’s Vaccine Financing Workgroup regarding public and private financing of childhood vaccinations. IDSA asserted that the private and public sectors must support the purchase of vaccines and that health care providers must be adequately reimbursed for vaccinating children and adolescents regardless of insurance status. NVAC provides recommendations for vaccine policy to the Department of Health and Human Services.
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