Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC6977
Submitter : Mrs. Catherine Rollins
Date & Time: 03/06/2006 09:03:03
Organization: Natural-Progesterone-Advisory-Network.com
Category: International Consumer Group Issue Areas/Comments
GENERAL
Women in Australia have been accessing human-identical hormones via a doctor’s prescription since 1998 when over-the-counter & MLM cream distribution was outlawed.
The Therapeutic Goods Administration (TGA) across all members of the British Commonwealth of Nations (for example Australia, New Zealand, UK, Canada) enforced a strict code of practice that now requires women to hold, at all times, a current doctor’s prescription when accessing bioidentical hormones such as progesterone.
We have choices in where we buy our cream, and whether it’s compounded locally or mass produced by a pharmaceutical company.
I’ve been using progesterone cream for over a decade, and I’ve certainly “sampled” a number of cream preparations. I require bio-identical progesterone to maintain hormone balance, and I opt to purchase a cream provided by Australia’s own Lawley Pharmaceuticals. It’s a personal choice I make based on what is best for “me” in terms of selecting a premium cream that’s easy to get access to on prescription, and entitles me to a refund through my healthcare fund. Should I require a cocktail of hormones further down the track (for example testosterone, cortisol and progesterone) then my compounding pharmacist can individualize treatment to meet my specific needs, in consultation with my GP.
I’m pleased to report that the number of compounding pharmacists competent in formulating quality BHRT has grown across the country in line with demand. So too has the number of GPs competent in clinical management and treatment protocols.
Compounding pharmacists in this country provide:
- a choice of individualized BHRT or synthetic HRT treatment protocols, in adherence to a doctor!|s prescription
- a referral service for women looking for a GP prescribing BHRT in their area
- medication advice to patients and their physicians
- advise on health insurance reimbursement process
Can I say that after applying counterfeit HRT for a mere 18 months in my mid 30s, I went from a not unwell female experiencing the odd hot flash to a woman in crisis, requiring hospitalization to treat thickening of the endomentrium, cervical erosion, and a lump in my right breast that required further investigation.
The switch to BHRT, on evidence, possibly saved my life.
Women like me - “lab rats” no less - are entitled to certain freedoms that leave room for healthy choices. If you allow Wyeth to cross your palms with silver, if you decide to prevent doctors from prescribing, and compounding pharmacists from filling BHRT prescriptions, you effectively close the door on women’s right to choose the most appropriate treatment for herself. And the next woman denied access could be your mother, your wife, your daughter, your granddaughter.
Did I mention a large number of ageing MEN are receiving bio-identical testosterone and progesterone replacement therapy supplied by the local pharmacists?
I urge you, please DO NOT sell us out. Hasn’t the last 20 years taught us anything?
Catherine Rollins
Director, Natural-Progesterone-Advisory-Network.com
“Advocating Women’s Right to a More Natural Approach of HRT”
Source - www.fda.gov
