FOOD AND
DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
(CDER)
Nonprescription Drugs Advisory Committee (NDAC)
Hilton Hotel - The
Ballrooms
QUESTIONS FOR THE COMMITTEE
1. Please
discuss the use of surrogate markers for the assessment of the effectiveness of
healthcare antiseptics.
2. Has
compelling evidence been provided to change the currently used threshold log
reduction standard? Please vote on each product
category separately.
|
|
Industry Bacterial Reduction (log10) |
FDA TFM Bacterial Reduction (log10) |
|
|
Healthcare Personnel Handwash |
Wash 1 |
1.5 |
2 |
|
Wash 10 |
---- |
3 |
|
|
Surgical Hand Scrub* |
Wash 1 |
1 |
1 |
|
Wash 2 |
--- |
2 |
|
|
Wash 11 |
--- |
3 |
|
|
Patient Preoperative Skin Preparation* |
Preinjection |
1 |
1 |
|
Abdomen |
1 |
2 |
|
|
Groin |
2 |
3 |
|
* Industry has recommended removal
of the 6-hour persistence criteria for these products.
3. Given
current standards using surrogate markers to demonstrate efficacy, how should
the analysis be conducted?
i.
How should we define “meeting the threshold” (e.g., mean
log reduction, median log reduction, % of subjects meeting the threshold)?
ii.
How should we evaluate the variability in the data?
iii.
How do we evaluate the variability in the test method?
4. Current
labeling for healthcare antiseptics consists of class labeling that does not
include product performance information.
What labeling information would be helpful for clinicians to fully
understand product efficacy?