Medicine Lessons and articles

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