Drug Development Challenges

Antibiotic drug development by pharmaceutical companies is extremely challenging. There are exceptional drug discovery challenges, regulatory complications and commercial issues. Discovering new antibiotics is inherently difficult and finding novel agents that successfully target bacteria is scientifically challenging. There are regulatory complexities specific to antibiotics. For example, late stage clinical trials investigating antibiotics against resistant infections require an excess number of trial participants, as not all those enrolled with be infected with the resistant strain of bacteria being targeted. There is a low return on investment for antimicrobials compared to other medicines. This limits the feasibility of antibiotic development for the pharmaceutical manufacturers. New antibiotics are used sparingly – only when patients have failed to respond to existing therapies. This significantly limits the commercial return that is needed to encourage investment in antimicrobial research and development and to fund it into the future.

There are exceptional drug discovery challenges, regulatory complications and commercial issues.

“Drug choices for the treatment of common infections are becoming increasingly limited and expensive – and, in some cases, nonexistent.”

—”A Public Health Action Plan to Combat Antimicrobial Resistance,”
Interagency Task Force on Antimicrobial Resistance, co-chaired by the
Centers for Disease Control and Prevention, the U.S. Food and Drug
Administration, and the National Institutes of Health. March 2011.