Badbugs
Issue Background

Antimicrobial Resistance

Faces of Antimicrobial Resistance Report

Antimicrobial resistance (AMR) is a growing threat to the United States health care system. From the 2016 discovery of the highly resistant mcr-1 gene in the US to the 2017 death of a Nevada woman due to an infection resistant to all available antibiotics, the AMR crisis is receiving increasing public attention, and for good reason.

This Faces of Antimicrobial Resistance report highlights some of these individuals, whose stories demonstrate the urgent need to combat AMR.

IDSA advocates for federal policies to revitalize antimicrobial drug research and development (R&D) because more and more patients are contracting and succumbing to drug resistant infections and there are far too few, in some cases no, safe and effective therapies to treat them.

IDSA strongly supports the establishment of a new limited population antibacterial and antifungal drug approval pathway for antibacterial and antifungal drugs to treat serious or life-threatening infections where there exists an unmet medical need –as called for in the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, H.R. 3742. The ADAPT Act of 2013 is an important successor to the Generating Antibiotic Incentives Now (GAIN) Act, reducing regulatory barriers to antibiotic development with a new Food and Drug Administration (FDA) approval pathway for antibiotics and antifungals that permits the agency to approve drugs to treat serious or life-threatening infections for which there is an unmet medical need in limited populations. This will accelerate development of life-saving new treatments. ADAPT also strengthens Centers for Disease Control and Prevention (CDC) monitoring of resistance and use of antibiotics, and makes these data publically available. Finally, ADAPT streamlines the process by which the FDA updates susceptibility test interpretive criteria (breakpoints) so that up-to-date data are available to health care providers in a timely fashion.

IDSA also supports efforts to address economic obstacles to investment in research and development for new antimicrobials and rapid infectious diseases diagnostics. IDSA supports the Developing an Innovative Strategy for the Antimicrobial Resistant Microorganisms (DISARM) Act, H.R. 4187, and is working with bill sponsors and key stakeholders to strengthen the bill. The DISARM Act would provide a new supplemental payment for certain antimicrobial drugs that treat serious or life-threatening infections for which there is an unmet medical need.. IDSA also supports tax credits for antibiotics and antifungals, modeled after the successful Orphan Drug Tax Credit, which would provide a credit of 50 percent of the qualified clinical testing expenses for the taxable year. Notably, IDSA’s tax credit proposal would add an estimated 5-7 new antibiotics or antifungals to treat serious or life-threatening infections to the pipeline every year.