Law and Legislation

Urgent Action Needed to Protect Your Right to Choose Bio-Identical Hormones!

Your right to use human (bio-identical) hormones and other medications prepared by compounding pharmacies is under attack again. Contact your U.S. Senator and Congressman today to ensure that you keep your freedom to choose natural, human (bio-identical) hormones and other medications prescribed by your physician and prepared by your pharmacist.

Together we were able to stop the so-called “Safe Drug Compounding Act of 2007” in Congress last year.  Now the Food and Drug Administration (FDA), working in concert with Wyeth, the maker of Premarin and Prempro, is trying to eliminate your access to estriol, a human estrogen hormone, and other human (bio-identical) hormones.  Their goal is to force you to use manufactured, “one-size-fits-all” counterfeit hormone replacement therapy, not the human (bio-identical) hormones which your physician and you choose. Instead, the bureaucrats at the FDA would dictate which pharmaceutical drug is best for you. 

In a series of warning letters to compounding pharmacies nationwide, the FDA is threatening to seize any compounded human (bio-identical) hormones that include estriol, substituting the FDA’s judgment for that of patients and doctors. By targeting estriol and indicating that it is planning to ban its importation, the use of natural, human (bio-identical hormones for women will be jeopardized because 80% of all bio-identical hormone therapy uses estriol.
 
In a Consumer Health Information flyer, the FDA says they have not approved any drug containing estriol so therefore the safety and effectiveness of estriol are unknown. Compounded preparations have never been under the jurisdiction of the FDA rather their use is determined by your physician based upon his clinical experience and judgment.

The fact is women produce natural estriol in adequate amounts until they approach menopause when estriol and the other naturally occurring estrogens decline. This declines leads to the symptoms associated with perimenopause and menopause.  Nearly forty drugs containing estriol have been approved in other countries, including Switzerland, Germany and England. Even Wyeth, the manufacturer of counterfeit hormones, produces an estriol product that is sold in Europe. Wyeth is the pharmaceutical manufacturer that filed a complaint with the FDA in 2005 requesting that the FDA stop compounding pharmacies from preparing human (bio-identical) hormones.

Wyeth wants to destroy the competition from compounding pharmacies. Its profits plummeted when its products, Premarin and Prempro, were shown to cause increased heart attacks, blood clots and strokes in the Women’s Health Initiative. Many women switched to human (bio-identical hormones) purchased from compounding pharmacies.

You and your physician have the right to choose safe, effective and natural human (bio-identical) hormones. Do not let the bureaucrats at the FDA be used as a hammer by Wyeth to deny your freedom for access to natural solutions.

You need to act immediately to protect your rights!

Take Action - Contact your U.S. Senators and Congressmen by e-mail, phone and fax today.

Ask your senators and congressmen to protect your right to choose bio-identical hormones and other compounded medications by defeating Senator Kennedy’s misguided bill on compounding pharmacy.

See a sample letter.

Steven F. Hotze M.D., is the president of PROJECT: F.A.N.S. and the founder of the Hotze Health & Wellness Center in Houston, TX. Since 1989 he has focused his practice on helping women and men obtain and maintain heath and wellness naturally.