Medical Product Development

Antibiotic Resistance continues to pose a significant threat to our Nation’s public health. To coordinate and enhance the public health response to this threat, the U.S. Government developed the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). The CARB Task Force is co-chaired by HHS, USDA, and DOD.

In February 2007, the Eastern Research Group (ERG) submitted to the Office of the Assistant Secretary for Planning and Evaluation (ASPE) Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IG

Antibacterial resistance is responsible for excess morbidity, mortality, and medical costs around the globe. Estimates vary widely, but the economic cost of antibacterial resistance in the United States could be as high as $20 billion and $35 billion a year in excess direct healthcare costs and lost productivity costs, respectively. CDC’s most recent report on U.S.

Antibiotic Resistance continues to pose a significant threat to our Nation’s public health. To coordinate and enhance the public health response to this threat, the U.S. Government developed the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). The CARB Task Force is co-chaired by HHS, USDA, and DOD.

Antibiotic resistance (AR) poses a significant threat to our Nation’s public health. To coordinate and enhance the public health response to the AR threat, the U.S. Government developed the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). The CARB Task Force is co-chaired by HHS, the U.S. Department of Agriculture, and the U.S. Department of Defense.

Partnerships involving public sector organizations, academia, non-profits, and pharmaceutical companies have demonstrated their potential for addressing unmet needs in medical product research and development (R&D). Effective partnerships can enhance access to innovation, reduce risk, manage costs, and may provide a means for steering R&D investment to address societal objectives.

Pharmaceutical companies conduct clinical trials for many reasons. The most obvious goal of clinical trials is to demonstrate safety and efficacy to gain Food and Drug Administration (FDA) approval. FDA provides guidance to developers about what constitutes acceptable clinical trials and appropriate outcomes.

Antibacterial resistance is a growing global problem. At least 2 million people in the U.S. acquire serious infections with bacteria that are resistant to one or more of antibacterial drugs designed to treat it.

ASPE ISSUE BRIEF Health Care Cost Containment and Medical Innovation May 2012 By: Amber Jessup, Ph.D.

Contract HHSP23320045017XI Task Order HHSP233200700003T Prepared for: Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation Prepared by: