In the Best Interests of the Public Health...

1
In the Best Interests of the Public Health...

• Janice Soreth, M.D.
• Acting Director
• Division of Anti-Infective Drug Products
• CDER/FDA

2
On Resistance

• Encourage development of new drugs to treat
  patients infected with resistant bacteria
• Use antimicrobials prudently to preserve their
  usefulness

3
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
On Safety/Lessons Learned

• Once prescribing patterns are established for a
  new drug, they are very difficult to change.

5
In the Best Interest of the Public Health

• We need to do it right the first time

6
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
...In the Best Interests of the Public Health

• If a question is important, answering it may
  well be worth the cost and effort.