# Presentation: 007641

## Infectious Disease Society of America

- Andrew T. Pavia M.D.
- University of Utah

## Background

- IDSA identified several key public policy priorities for action
- Based on importance, potential role of IDSA in bringing stakeholders together and influencing policy
- Antimicrobial Availability Task Force
- Pandemic Influenza Task Force

## www.idsociety.org/badbugsnodrugs

## Bad Bugs, No Drugs

- Targets
- Scientific and medical community
- Industry
- Public
- Policymakers
- Premise: Crisis is here, responses must be initiated now.
- Lays out menu of specific remedies

## Recommendations in Bad Bugs, No Drugs

- Recommendations for Congress
- Recommendations for FDA
- Recommendations for NIAID
- New funding needed

## Recommendations for Congress

- Commission to develop priorities
- Statutory incentives
- Supplemental intellectual property protection for investment in R and D
- Provide tax incentives for R and D
- Provide FDA with statutory flexibility to deal with targeted pathogen rather than type of infection
- Create guaranteed market

## Additional recommendations for Congress 

- Statutory incentives for small biotech companies entering field
- Incentives for companies that develop needed diagnostics
- Liability protections for companies that receive FDA approval for antibiotics that treat targeted pathogens
- Limited antitrust exemptions for companies that seek to work together to expedite research on targeted antibiotics

## Recommendations for FDA

- Publish updated guidelines for clinical trials of anti-infectives
- Encourage imaginative clinical trial designs that focus on efficacy against resistant pathogens
- Develop and clearly define acceptable surrogate markers in trials for resistant pathogens
- Work with NIAID to accelerate bench to bedside process for new anti infectives
- Grant accelerated approval status to products targeted for resistant pathogens

## Recommendations for NIAID

- More aggressively expand bench to bedside development research
- Increase number and size of grants for development of agents for resistant pathogens
- Explore programs similar to those between NCI and FDA to expedite drug development and deployment

## New Funding Needed

- Increase funding to CDC for monitoring epidemiology of resistant pathogens
- Increase funding for NIAID on translational research on treatment of resistant pathogens
- Increase funding to FDA to support development and review of targeted antimicrobials

## Concrete goals 

- Report card on the first meeting
- What deliverables will go on the report card for this meeting?
- Specific
- Pathway
- Menu
- Opportunities
- Bioshield 2
- S.B. 3 Preparedness Act of 2005

## Opportunities for recommendations

- Regulatory process
- Funding for CBER
- Identify legislative and diplomatic ways to speed harmonization
- Facilitate communication
- Stockpiles
- Revenue recognition
- Liability issues
- Strengthen VCIP
- Tort reform – standards of scientific evidence

## Incentives
Valuation of vaccines
Market
Education
Legislative incentives
Facilitate new entrants
Encourage R and D
Maintain existing players
Improve inter agency coordination

- Valuation of vaccines
- Market
- Education
- Legislative incentives
- Facilitate new entrants
- Encourage R and D
- Maintain existing players
- Improve inter agency coordination

- Opportunities for recommendations

## Vaccine supply issues are cross cutting
Overlap with:
Antiviral and Antibiotic supply
Emerging infections and other Public Health
Biodefense
Pandemic preparedness
Changes most often introduced in response to crisis

- Overlap with:
- Antiviral and Antibiotic supply
- Emerging infections and other Public Health
- Biodefense
- Pandemic preparedness
- Changes most often introduced in response to crisis