2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC7494
Submitter : Ms. Sharon O'Malley Date & Time: 03/06/2006 04:03:55
Organization : Consumer
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I want to strongly urge you to DENY Wythe's attempt to keep compounding pharmacies from providing bioidentical hormones to women. I cannot take premarin & deseperately need 'natural hormones'. I suffer from Lichen Sclerosis (LS) and only natural hormones help me. To deny people access to 'natural hormones' & other compounded medications simply so a company can have a monopoly is immoral, and I believe, 'illegal'. This country is supposed to have free enterprise. The FDA is responsible for protecting us from harmful drugs. Premarin can be very harmful to me and other women who have a high rate of cancer in their families. Please do not cave in to the pressures of Wythe and its money. Think about the numerous people in this country that depend on 'natural hormones' to live a healthier and more normal life. The FDA is supposed to protect us. Protect us from a self-serving company when their only real concern appears to be their profit margin and not the health of the women in this country. Bioidentical hormones are natural and have the same chemical structure as those produced naturally by human females. I am a human being, a woman with a clear understanding of what is and is not good for me. I am not a horse and do not want my only option to be a derivative of mare's urine. As I stated previously, I cannot use it. It causes problems for me. Thus, for me and many others like me, if the FDA sides with Wythe, you are condemning us to being ill, having flare ups with Lichen Sclerosis, not being able to live as 'normal' a life as we can w/natural hormones; not to mention the increased risks of cancer. It is imperative that you deny Wythe's flagrant attempt to deprive women and their doctors of the ability to choose what is right for us. The only 'moral' issue here is one of honesty. Compounding pharmacies have been providing women with beneficial & safe bioidentical hormones, and other patients with medications only available to them through compounding pharmacies. The doctors & pharmacists know what they're doing as do the patients using compounding pharmacies. I am sure many of the people making these decisions know someone who uses medication(s) that are compounded. Do not let Wythe take that choice away from us. I implore you, do what is right for the citizens of this country and do not give in to money. Thank you for your consideration. Very truly yours, Sharon O'Malley, Wisconsin, USA