Today Sponge

1
Today Sponge

• Charles J. Ganley, M.D.
• Director, Division of Over-the-Counter Drug
  Products

2
Regulatory Status

• Today Sponge is an approved drug product
• Change in manufacturing facility for the drug
  product
• There are outstanding chemistry issues
  (manufacturing) to be resolved
• GMP essential to the designation of safe and
  effective
• Labeling of the product is at issue today

3
Safety

• TSS has been reported with the use of the product
• TSS will likely be reported with use after
  re-marketing
• Adequate labeling is important
• inform the user of the risks, signs and symptoms,
  measures to decrease risk
• consumer can decide to purchase product

4
Labeling

• Divergent opinion on the adequacy of the current
  label
• Since 1991, efforts to improve OTC labeling so
  that it is more legible and readable (culminated
  in OTC Label Rule)
• There are substantial changes proposed in the
  labeling that justify converting to the Drug
  Facts format at this time

5
Questions
6
Safety Information

• Given the material provided in your briefing
  packages and presented today, does the revised
  labeling adequately convey the risks associated
  with the use of the product?

7
Efficacy Information

• The current carton label does not include
  information on the efficacy of this product.
  Should the carton label include efficacy
  information so that the consumer will have this
  information available at the point of purchase?
• If yes, should this kind of information be
  required of all OTC contraceptive products?

8
Other Revisions

• Are there other aspects of the labeling that
  should be revised?

9
Post-Marketing Surveillance

• Please provide comments on the type of
  post-marketing surveillance for adverse events
  the sponsor should conduct (e.g. active
  collection, follow-up reporting and analysis of
  cases of difficult sponge removal, provisions in
  place to facilitate adequate adverse event
  reporting)?