The landscape for developing new antibiotics is precarious, posing scientific and financial obstacles for drug companies. The formula involving the difficulty finding novel mechanisms to combat bacterial pathogens plus clinical trials and regulatory approval process and then provider delays in actually using new antibiotics, equals extremely expensive, complex and risk-prone conditions for new antibiotic development.
University of Wisconsin conducted a study to determine exactly how long providers (e.g. hospitals, health systems, etc.) are delaying the use of new antibiotic drugs, reported University of Minnesota’s CIDRP news.
Published in Diagnostic Microbiology and Infectious Disease, the Wisconsin team found that providers on average wait more than one year prior to prescribing any of the new six antibiotics approved by the FDA within the past five years.
The UW team examined a clinical administrative database of US medical centers from 2014 through 2018 to determine the first use of six new antimicrobials that had received qualified infectious disease product (QIDP) designation from the FDA—they included:
- Isavuconazole (antifungal)
Congress created, in 2012, the Generating Antibiotic Incentives Now (GAIN) Act, to spur the development of new antibiotics for difficult-to-treat infections by granting companies an additional 5 years of marketing exclusivity as well as eligibility for fast-track approval.
The team questions the sustainability of this federal incentive given what they have learned from their analysis. Among the 132 hospitals that reported prescribing one of the six QIDP agents, the median number of days to use any of them was 398, with some hospitals using the new drugs within 2 weeks and others waiting 4 years or more.
Those providers with a sicker population were prone to use the new antimicrobials faster. Large hospitals (400+ beds) and academic centers were more likely to use any of the QIDP agents than smaller hospitals and non-academic medical centers.
Hospitals in the South used the antimicrobial (median 733 days) while the Northeast providers took the longest (median 1,370 days).
Follow the source University of Minnesota Center for Infectious Disease Research and Policy (CIDRP) for more details.
Lead Research/InvestigatorSource: Center for Infectious Disease Research and Policy