2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC1686
Submitter : Dr. Sharon Turnbull Date & Time: 02/13/2006 01:02:24
Organization : http://www.goddessgift.com
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
As a woman, a health professional, a patient and consumer of bioidentical hormones, I urge that you not entertain the suggestion to limit their availability. There is a valuable place for them in our clinical armamentarium and suitable safeguards (prescription by physician, compounding by licensed physicians) in place and sufficient evidence of their safety and efficacy. Current law and policy is adequate and changes not needed...should an individual pharmacy be in flagrant violation of the law its activity should be curtailed using existing standards and mechanisms for enforcement. This effort by a major pharmaceutical company to restrict the choices available for patients and their physicians looks suspiciously like restraint of trade. Please do not erase the progress that has been made during the previous decades in our attention to the unique health care concerns of women.