Table 2.
Summary of Funding Recommendations for Congress
| Agency/Program | Funds Needed | Purpose | Section(s) |
| Congressionally-enacted economic incentives most likely overseen by ASPR or FDA | Depends on which economic incentives are enacted and their scope and size | Entice companies to reengage in antibiotic (and related diagnostics) R&D though the use of a combination of “push” and “pull” mechanisms (grants, exclusivity, tax credits, etc.) | I.1, VII.2 |
| *ASPR's BARDA | ≥$1.7 billion annually of multi-year funding | Support development of therapeutics, diagnostics, and vaccines, including antibiotics and diagnostics that specifically target antibiotic-resistant pathogens | I.2 |
| *ASPR's Proposed Independent Strategic Investment Firm | ≥$200 million annually | Smaller innovative companies with promising antibiotics in development would leverage public funds to obtain additional private venture capital | I.2 |
| *Proposed PPP most likely overseen by ASPR or BARDA | Depends on scope of the effort and availability of private capital | Advance development of promising lead compounds toward approved products targeting the highest priority unmet medical needs where market challenges are most extreme | I.2 |
| FDA's Center for Drug Evaluation and Research (CDER) | Additional $40 million annually | Expand staff to develop clinical trial guidance and Critical Path initiatives ($15 million) and new antibiotic R&D under regulatory science initiative ($25 million) | II |
| Existing Interagency Task Force on Antimicrobial Resistance and the STAAR Act's HHS ARO and PHAAB | $30 million in FY2012 to HHS for the task force; and then $44 million in FY2013 and $80 million in FY2014 for the work of all three | Strengthen coordination and expansion of federal antimicrobial resistance efforts and permit ongoing input from non-government medical and public health experts to enhance federal priority-setting and assure greater accountability | III |
| *US Centers for Disease Control and Prevention (CDC) | $50 million annually beginning in FY2012 | Enable enhanced antimicrobial resistance surveillance, data collection and publication, prevention and control strategies, related research, education of providers and patients, and expansion of antimicrobial stewardship* efforts nationally | IV, V, VI, VII |
| National Institute of Allergy and Infectious Diseases | Additional $500 million annually | Support expansion of antibiotic resistance and development (drug, diagnostics, etc.) research portfolios | V.5, VI, VII |
| FDA's Center for Veterinary Medicine (CVM) | Additional $5 million immediately of multi-year funding | Complete/publish safety reviews of antibiotics of importance to human medicine that are approved for non-therapeutic purposes in food-producing animals | VIII |
| National Antimicrobial Resistance Monitoring System (NARMS) Program (US Department of Agriculture [USDA], CDC, FDA's CVM) | Additional $3 million annually | Increase surveillance (additional bacterial species and numbers and/or types of samples); more sensitive methods; farm-level surveillance of antibiotic-resistant bacteria | IV.2 |
| USDA, Agency for Healthcare Research and Quality, US Agency for International Development, US Department of Veterans Affairs and other members of the Interagency Task Force | Increases specific to each agency's antimicrobial resistance programs, as necessary | Support US efforts to limit and control the development and spread of antimicrobial-resistant infections in humans and animals in the US and abroad. | III |
*Funding for these activities could be supported through the establishment of the AIC Fee described in recommendation I.2 and V.6