Docket Management
Docket: 02N-0445 - FDA Regulation of Combination Products
Comment Number: EC -10

Accepted - Volume 4

Comment Record
Commentor Ms. Wendy Wells Date/Time 2003-01-14 12:43:40
Organization Optimal Women's Wellness
Category Health Professional

Comments for FDA General
1. General Comments I received a letter from Wyeth yesterday indicating that you are urging other HRT producers to place the same warnings on their PI that Wyeth is doing as a result of the WHI findings. I am insulted to think that Wyeth as well as the FDA expects me to think that conjugated equine estrogens and MPA have the same biochemical effect on a woman's body as other formulas, doses, and delivery systems. This is in direct contradiction with the information provided by the WHI researchers who indicated that the study results DID NOT apply to other formulations, doses or delivery systems. How did Wyeth talk you into such a thing? Do you forget that we went to school and studied biochemistry and pharmacology? Just because we are still not clear as to why some women develop these side effects doesn't mean we need to create widespread panic. Can you imagine this great country if women were all taken off their hormones? It would not be a pretty sight. My question for you is did the FDA start this or did Wyeth?

EC -10