Drug Development

Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.

The market for antimicrobial (AM) drugs is unique in that it is associated with a positive externality (public health) as well as a negative externality (antimicrobial resistance, or AMR) (Mossialos, et al., 2010). AMR occurs when microbes change over time and no longer respond to available medicine.

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.

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