Patients, Doctors, Pharmacists Praise Bipartisan House Resolution On Compounded Hormones Containing Estriol

Main Category: Menopause
Also Included In: Pharmacy / Pharmacist
Article Date: 08 May 2008 - 13:00 PDT

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The International Academy of Compounding Pharmacists joined hundreds of thousands of women and doctors in applauding the introduction of H. Con. Res. 342, a bipartisan resolution stating that "the Food and Drug Administration's (FDA) new policy restricting women's access to medications containing estriol does not serve the public interest" and calling on the FDA to "reverse its policy."

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.

"We commend all of the sponsors for standing up for women and introducing H. Con. Res. 342," said L.D. King. "Women with menopause suffer enough. Fortunately, this resolution aims to provide them with some relief."

For decades, doctors have prescribed compounded hormones containing estriol to women suffering from the painful symptoms of menopause. 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.

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.

"FDA ignored the comments of tens of thousands of women and instead listened to Wyeth," continued Mr. King. "Removing this drug from the market robs patients of a long-standing, vital and legal menopause treatment alternative to Wyeth's products. FDA's policy is an unwelcome intrusion of federal bureaucrats into thousands of doctors' offices."

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.

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.

"FDA is trying to fit a square peg in a round hole," concluded Mr. King. "FDA is setting doctors up to fail, leaving them in the same position are they are in now - unable to treat women with the medication of their choice."

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 or veterinarians and mixed safely by trained, licensed compounding pharmacists - are the only way to better health.

About IACP

The International Academy of Compounding Pharmacists (IACP) is a non-profit association founded in 1991 to protect and promote the art and skill of the compounding pharmacy profession. We represent more than 2,000 pharmacists, physicians, technicians and patients who are committed to the safe practice of pharmacy compounding. We are committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and of patients to take customized medications that meet their unique, individual needs.

International Academy of Compounding Pharmacists