Medical Product Development

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:

Contents Background and Purpose Methodology Summary of Key Findings and Stakeholder Suggestions Conclusions and Policy Implications A.

Health Care in Transition: Technology Assessment in the Private Sector Prepared by: Richard Rettig of the RAND Corporation Office of the Assistant Secretary of Planning and Evaluation Agency for Health Care Policy and Research. July, 1996.