2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC1573
Submitter : Mrs. Sue Olson Date & Time: 02/13/2006 11:02:51
Organization : Mrs. Sue Olson
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
As a woman currently benefiting from prescription strength bioidentical hormones I take exception to the fact Wyeth is accusing the Compounding Pharmacy industry of unsafe practices. I am currently using the lowest effective dose of bioidentical hormones, as prescribed by my physician. I welcome the day when these hormones are as accessible, standardized, and well-studied as the synthetic forms. In the meantime, I wish to continue with the use of these hormones especially since these medications have been available and effective, without notorious side effects, for decades. 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