Anonymous - Comment

In response to Question 1 (considerations as they relate to implementation of revised product labeling): Recalls imposed by the FDA for significant safety issues costs additional resources. It would be useful if the FDA could define or provide examples of such scenarios. In response to Question 4 (alternative labeling mechanisms): Gilead agrees with the suggestion by the FDA that corporate websites with labeling should be updated within 10 days. Gilead would also like to see electronic compendiums become available (where labeling can be uploaded externally) as they are in the UK. In response to Question 5 (relative seriousness of new safety information): Gilead believes within 10 days on a corporate website and within 6 months for printed labeling is reasonable. As stated above, guidance from the FDA on examples requiring a recall would be helpful. In response to Question 6 (implementation considerations): Gilead does not see any with respect to safety data provided. In recall scenarios patient perceptions could be adversely affected and there could be increased anxiety. In response to Question 7 (reasonable time frame): Gilead believes that within 6 months of approval by the FDA to be in new packaging is reasonable.