Drug Development

In 2017, at least 2.8 million people in the U.S. acquired serious infections with bacteria that are resistant to one or more antimicrobial drugs and 35,000 have died as a result. Resistance to antimicrobials is viewed as a global threat with antimicrobial drug use in human and animal health driving resistance.

This issue brief provides a primer on FDA user fees, presents findings of how user fees affect the cost of medical product development, and summarizes the research literature on user fees, most notably in expediting medical product development and approval.Related Products:

Department of Health and Human Services Secretary Alex Azar and Inspector General Daniel Levinson have issued a proposed rule, “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in

Despite the increasing investment and interest in drug development, the amount of time and resources needed to develop a new drug continues to rise. Biomarkers are an important tool with the potential to decrease the time, cost, and failure rate of drug development.

   

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

  ASPE ISSUE BRIEF Expanding the Use of Generic Drugs By: ASPE Staff December 1, 2010

U.S. Department of Health and Human Services

U.S. Department of Health and Human Services

Contents IGIV Supply and Distribution - Key Findings IGIV Demand - Key Fundings IGIV Access Problems- Key Fundings Immune globulin intravenous (IGIV), also referred to as intravenous immune globulin (IVIG), is a valuable treatment for many seriously ill patients. Although the U.S.