August 15,2006
Gail Anthony
Investigations and Licensing
Naturopathic Physicians Board of Medical Examiners
State of Arizona
1400 West Washington, Suite 230
Phoenix, AZ 85007
Re: Complaint Case Nos. 06-031 and 06-032
Dear Ms. Anthony:
We have been asked by our client Envita Natural Medical Centers of America (“Envita” or the “Centers”) to respond to the Board in connection with Allegation No.2 in the Notices of Complaint No. 06-031 and 06-032 sent to Drs. E. Eihausen and G. Franco, both naturopathic physicians working at the Centers. In your August I, 2006 letters to the doctors, you outlined the Board’s area of concern as a possible violation of Arizona Revised Statutes (A.R.S.) Section 32-1501(dd).1
The firm Kirkpatrick & Lockhart Nicholson Graham LLP (KLNG) has been working with Envita as regulatory counsel for about two years. We were asked to assist the Centers in assuring that its practices and procedures are in compliance with applicable Food and Drug Administration (FDA) requirements.
Our FDA practice group within KLNG specializes in the law and regulations administered by FDA, including those that cover prescription and non-prescription drugs and biologicals, dietary supplements, medical devices, foods, and personal care products. We are fortunate to have as our practice head a former FDA attorney and several other attorneys with science backgrounds. I have been the chief contact between KLNG and the Centers and have practiced food and drug law for the past 20+ years. Envita was aware of our experience and contacted us for legal and ethical guidance before beginning any work with patients using the natural immunological treatments. We recommended, and Envita also agreed, to bring in a consultant, a former FDA inspector, to go over the Centers’ procedures to be sure that the activities were within the practice of medicine and in compliance with applicable ethical and patient protection standards.
1 (dd) Using experimental forms of diagnosis or treatment without adequate informed consent of the patient or the patient’s legal guardian and without conforming to experimental criteria including protocols, detailed records, periodic analysis ofresults and periodic review by a medical peer review committee as approved by the federal Food and Drug Administration or its successor agency.
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