Yesterday, H. Con. Res. 342 was introduced in the U.S. House of Representatives opposing the Food and Drug Administration's (FDA) decision to restrict Estriol (a form of Estrogen), a compounded hormone preparation used by women to alleviate the symptoms of menopause. The bill counters that the new FDA policy restricting women's access to medications containing estriol “does not serve the public interest" and calls on the FDA to "reverse its policy."  The resolution also calls on the need of FDA to “respect the physician-patient relationship” and recognizes that doctors, not the FDA, are in the best position to “determine which medications are appropriate for their patients.”

Reps. Mike Ross (D-Ark.), Jo Ann Emerson (R-Mo.), Sam Farr (D-Calif.), Tammy Baldwin (D-Wisc.), Michael Burgess (R-Texas), John Carter (R-Texas) and Gabrielle Giffords (D-Ariz.) introduced the resolution in the House of Representatives.

The action was taken after the FDA sent letters to seven pharmacies in January asking them to cease and desist with the use of estriol.  This is a HUGE step in the right direction! We applaud the thousands who have written letters to your members of Congress on this issue and encourage you to keep writing.

“Estriol helps women manage the menopause process and has been proven safe and effective. FDA's decision is not predicated on evidence, therefore questioning their interference in the states' jurisdiction over drug compounding,” said Bruce Roberts, RPh, executive vice president and CEO of the National Community Pharmacists Association (NCPA).

Since FDA announced its estriol policy in January, the agency has since attempted to allay the concerns of thousands of women by stating that doctors may prescribe compounded hormones containing estriol if they complete an Investigational New Drug Application (IND). Unfortunately, this process is unworkable.

For decades, doctors have prescribed compounded hormones containing estriol to women suffering from the painful symptoms of menopause.  The International Academy of Compounding Pharmacists (IACP) estimates that hundreds of thousands of women are prescribed these drugs today.  FDA's policy would force these women to discontinue the hormone treatments that their doctors have determined is appropriate for them.

Pharmaceutical giant Wyeth petitioned the FDA in October 2005 to prohibit compounding pharmacists from preparing hormones that contain estriol on the grounds that doing so posed a "serious threat to public health."  At the same time, though, Wyeth was marketing drugs containing estriol as "an ideal therapy" across Europe.

Wyeth's petition generated more than 70,000 responses, the overwhelming majority of which from women and doctors opposed to Wyeth's request. Unfortunately, FDA fulfilled Wyeth's request earlier this year when it announced that it would "halt" the compounding of compounded hormones containing estriol.

Compounded hormones containing estriol are lawfully prescribed, prepared and dispensed in all 50 states and their use is accepted by the United States Pharmacopeia and the Pharmacy Compounding Accreditation Board.  The FDA has acknowledged that it is unaware of any adverse events associated with the use of these drugs.  Estriol is a component of a multiple sclerosis treatment undergoing Phase II clinical trials; in compounded form it is prescribed by doctors to treat both multiple sclerosis and symptoms of menopause.

Pharmacy compounding is a long-standing, state-regulated and medically vital practice.  Millions of Americans have unique health needs that off-the-shelf prescription medications cannot meet.  For them, customized, compounded medications -- prescribed or ordered by licensed physicians and mixed safely by trained, licensed compounding pharmacists -- are the only way to better health.

We Wish You Well!

C.W. Randolph, Jr., M.D. and Genie James, M.M.Sc.
Co-Authors of From Belly Fat to Belly Flat &
Co-Founders of The Natural Hormone Institute of America

Dr. Randolph is a practicing gynecologist and an internationally recognized expert in the field of in bio-identical hormone replacement. He is the Medical Director for the The Natural Hormone Institute of America and is also the author of From Hormone Hell to Hormone Well as well as From Belly Fat to Belly Flat.

* Please Note: Because legally we are unable to provide prescriptions for telephone consultation patients unless they have been previously seen in my office, should you require a prescription for a more comprehensive panel of bio-identical hormone replacement, my nurse practitioner will advise you how to locate a physician and compounding pharmacy in your area.