Pharmaceutical & Drug Policy
Comments on Medicare Drug Price Negotiation Program’s Section 30.2 and Part B high spend drugs
As part of ongoing cooperative work with the U.S. Food and Drug Administration, the Engelberg Center for Health Care Reform has formed a council to bring together expert perspectives on the challenges facing antibacterial drug development. Designed to include representatives from academia, patient advocacy groups, industry, providers, and government agencies, the Brookings Council on Antibacterial Drug Development (BCADD), will convene twice a year to discuss pressing issues in the treatment of infectious diseases and potential steps to address them.
The first BCADD meeting, held on August 30, 2012, brought stakeholders together to discuss the following:
- Ongoing antibacterial initiatives at FDA and the Clinical Trials Transformation Initiative
- Statistical and methodological approaches that could be harnessed to improve the efficiency of antibacterial drug development
- Balancing benefit-risk and uncertainty considerations with public health needs
- Next steps for council action
For more information on FDA’s Antibacterial Drug Development Task Force, click here.
Agenda
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August 30
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Welcome, Introduction, Charge to the Council, and Meeting Objectives
9:00 am - 9:45 am
JWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration -
Session I: Addressing Statistical Challenges in Antibacterial Drug Development
9:45 am - 10:45 am
LLLisa LaVange Director, Office of Biostatistics, Center for Drug Evaluation and Research - U.S. Food and Drug Administration -
Session II: Council Discussion on Data and Statistical Issues
11:00 am - 12:00 pm
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Session III: Risk-Benefit and Uncertainty in Antibacterial Drug Development and its Impact on Addressing Public Health Needs
12:30 pm - 1:45 pm
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