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)?