2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC4830
Submitter : Ms. Lynn Allard Date & Time: 02/23/2006 08:02:33
Organization : Ms. Lynn Allard
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I will be starting to take prescription bioidentical estradiol as a result of saliva test results that indicated my estradiol was low. In addition,I will continue to use bioidentical progesterone cream. As an American citizen, currently living in Canada,I take exception to the fact Wyeth is accusing the Compounding Pharmacy industry of unsafe practices. As a citizen of the United States I expect the FDA to stand up for my rights and the rights of all women who have found consistent, safe and effective treatment with bioidentical hormones. Eliminating options by bowing to a large pharmaceutical company like Wyeth is not in the public interest and would deprive hundreds of thousands of American women from access to bioidentical hormones. Synthetic hormone replacement has been proven unequivocally unsafe in a government sponsored study and should not be forced as the sole treatment option for women. I hereby request the FDA rule against Wyeth's request and ask for more information on the safety of the Wyeth synthetic hormone