1. In the Best Interests of the Public Health... Janice Soreth, M.D. Acting Director Division of Anti-Infective Drug Products CDER/FDA

2. April 26, 2001 …On Resistance Encourage development of new drugs to treat patients infected with resistant bacteria Use antimicrobials prudently to preserve their usefulness

3. April 26, 2001 …On Safety Clinical trials are powered to address efficacy questions, not safety If safety concerns arise, there are three options: –Stop. –Do additional pre-marketing studies to define risk management. –Make post-marketing inquiry, with labeling to speak to careful use.

4. April 26, 2001 …On Safety/Lessons Learned Once prescribing patterns are established for a new drug, they are very difficult to change.

5. April 26, 2001 …In the Best Interest of the Public Health We need to do it right the first time

6. April 26, 2001 Dr Temple/JAMA “…the possibility of using more rigorous methods, namely, large simple trials, to detect such risks should be considered in some cases (e.g., where very wide exposure is expected).”

7. April 26, 2001...In the Best Interests of the Public Health “If a question is important, answering it may well be worth the cost and effort.”