A crisis has arisen from the simultaneous decrease in the number of pharmaceutical companies developing antibiotics and the dramatic increase in the prevalence of infections and deaths caused by antibiotic resistant pathogens. Due to the genetic promiscuity of bacteria, the same genetic markers that give rise to antibiotic resistance in hospital acquired infections can be transferred to biothreat pathogens (e.g. Y. pestis, B. anthracis, F. tularensis, B. mallei and/or B. pseudomallei).
Therefore, the threat of naturally-occurring or intentionally-engineered antibiotic-resistant biothreat pathogens potentially impacts the effectiveness of the current stockpile of antibiotic medical countermeasures (MCMs) to treat these threats.
The year-over-year increase in hospital and community acquired bacterial infections due to antibiotic resistant bacteria and the transmissibility of these resistant markers to sensitive bacteria represents a serious threat to the national health security of the United States. These health challenges also place a substantial health and economic burden on our society and will continue to do so if not adequately addressed.
Using Project BioShield funds, the Biomedical Advanced Research and Development Authority (BARDA) seeks to develop candidate antibiotics which have received marketing authorization from the U.S. Food and Drug Administration (FDA) for a pulmonary indication or are in Phase 3 clinical development for a pulmonary indication, and eligible for Emergency Use Authorization (EUA) pre-approval by FDA for a biothreat indication. If the antibiotic does not have FDA marketing authorization for a pulmonary indication, the Offeror must seek development and FDA marketing authorization for a pulmonary indication that could support EUA pre-approval or marketing authorization for a biothreat indication.
BARDA will also support the necessary late-stage development to complete the regulatory pathway for a biothreat indication for the antibiotics being procured (if applicable) and efforts related to post-marketing commitments.
Supporting the development and stockpiling of medical countermeasures that treat antibiotic resistant bacteria including biothreats will augment the U.S. response to any biothreat agent or public health emergency.
Additional details are available via Solicitation Number: 19-100-SOL-00011.