The Food and Drug Administration on Tuesday released draft guidelines that should make it easier to develop new antibiotics and antifungal drugs, one facet of a multi-pronged approach to limiting antimicrobial infections in long-term care settings and elsewhere.
“We must tackle this issue on all fronts and seek new approaches to this persistent and potentially deadly problem,” FDA Commissioner Scott Gottlieb said in announcing details of the Limited Population Pathway for Antibacterial and Antifungal Drugs.
The development program was established as part of the 21st Century Cures Act. The FDA will consider expediting development of certain medications based on severity, rarity or prevalence of the infection the drug is intended to treat and lack of alternative treatments.
Gottlieb reiterated that new drugs aren’t the only solution to a problem that plagues some 2 million Americans each, killing about 23,000 of them.
“The global effort to educate patients and providers about the importance of reducing the unnecessary and overuse of antibiotics is a crucially important means to slowing the rate of resistance,” he said. “However, we must acknowledge that these essential antimicrobial stewardship programs do have an impact — as they should and aim to do — on the use of antibiotics and thus the amount of product sold.”
In addition to the new pathway, the FDA is giving incentives for qualified infectious disease products, including fast-track designation, and possible exclusivity extensions.
Gottlieb’s comments came as the Association for Professionals in Infection Control and Epidemiology met in Minneapolis for its annual conference.
APIC on Wednesday unveiled new research that shows how critical nurses are to successful antimicrobial stewardship programs.
A study conducted at Jefferson Health in New Jersey shows such programs are stronger when nurses are educated about antimicrobial stewardship and buy into it.
A 10-question quiz on antibiotic usage found nurses were generally not comfortable using microbiology reports or familiar with the unique features of different antibiotics. Just half checked susceptibility results of cultures before administering antibiotics, and just under two-thirds of clinical nurses notified physicians if cultures showed resistance.
“Changing the culture and empowering nurses to speak up about antimicrobial stewardship leads to closer team coordination and cross-discipline collaboration, which ultimately saves lives,” said Jefferson Health New Jersey Infection Control Officer Cindy Hou, DO, MA, MBA, FACOI, the study’s lead author.