Navigation Links
FDA Asserts New Policy to Restrict Women's Access to Bioidentical Hormones
Date:1/9/2008

Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone Treatments, Use the Term "Bio-identical"

MISSOURI CITY, Texas, Jan. 9 /PRNewswire-USNewswire/ -- In a series of warning letters to compounding pharmacies across the country, the Food and Drug Administration (FDA) has asserted a policy that would deny hundreds of thousands of women access to many compounded bioidentical hormones commonly, substituting its judgment for that of doctors. Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned the FDA to do so in October 2005. More than 66,000 doctors, patients, and pharmacists filed comments with the FDA opposing Wyeth's petition.

"Under this policy, patients will suffer while Wyeth profits," said L.D. King, executive director of the International Academy of Compounding Pharmacists (IACP). "Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate, sometimes because Wyeth's products are found to be ineffective or produce side effects. This is a decision that should be left to doctors."

In the letters, the FDA states that it will "halt" compounding of medications containing estriol, an estrogen produced by the human body. Estriol is one of the most widely prescribed hormones and is regularly compounded with other bio-identical hormones pursuant to doctors' prescriptions for women suffering from symptoms of menopause. Like many commonly prescribed drugs (e.g, Phenobarbital, quinine, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded.

The FDA also stated in its letters that pharmacies may not use the term "bio-identical" to characterize compounded hormone therapies, even though the chemicals used in such compounds are chemically identical to what is produced by the human body. Furthermore, manufacturers of drugs containing the same bio-identical hormones commonly use the term to characterize their products. The chemical structure of these drugs is indisputable.

Pharmacy compounding is a long-standing, state-regulated and medically vital practice. Millions of Americans have unique health needs that off-the-shelf prescription medicines 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.


'/>"/>
SOURCE International Academy of Compounding Pharmacists
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Donde West Death Highlights Unnecessary Risk of General Anesthesia for Cosmetic Surgery, Asserts Dr. Friedberg
2. GPhAs 2007 Annual Policy Conference Features Top Generic Industry CEOs; FDA, Government Officials; Wall Street Analysts
3. Chinas 1-child policy could backfire on its elderly
4. Education Key Focus of Michigan Policy Summit
5. Consumer Group: Hillary Clintons Mandatory Health Insurance Purchase Plan is an Act of War on the Middle Class Family That Cant Afford $12k Policy
6. SATELLITE BROADCAST: Consumer Group Says Hillary Clintons Mandatory Health Insurance Plan is an Act of War on the Middle Class that Cant Afford $12k Policy
7. First-in-the-Nation Health Care Billing Policy Announced in Minnesota
8. Statement by Robert Greenstein, Executive Director of the Center on Budget and Policy Priorities, on the New Congressional SCHIP Agreement
9. Global Leaders Converge for Special Olympics Global Policy Summit
10. Wellpoint NextRx Receives TIPPS Certification from the HR Policy Association
11. National Medical Association Selects New Director of Health Policy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/6/2016)... ... , ... Shark Finds and Kevin Harrington, along with the Product ... with Belly Bands. , Having a dog is great—except when it wets every couch, ... nothing works, get Belly Bands, the easiest way to stop dogs from wetting ...
(Date:2/5/2016)... ... February 05, 2016 , ... VeloReality ... lighter, sleeker next generation LYNX VR Indoor Trainer with multi-rider capability to an ... and manufacturing not only reduce the weight of the unit, they also enhance ...
(Date:2/5/2016)... ... 2016 , ... The Muscular Dystrophy Association and Sailormen Inc., ... 14th annual “Appetite for a Cure” campaign on Feb. 1 to raise critical ... diseases that severely limit strength and mobility. , Now through March 20, ...
(Date:2/5/2016)... ... February 05, 2016 , ... After years as an ... Burn Unit, plastic and cosmetic surgeon Dr. Wayne Carman transitioned to chief of the ... successfully completed his first three-year term as chief and began a second three-year term ...
(Date:2/5/2016)... ... February 05, 2016 , ... The American public tends ... water may be safer than regular municipal or well water. The recent experience with ... Sharon Kleyne, could go a long way toward increasing public acceptance of recycled waste ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... Wegener Polyangiitis - Pipeline Review, H2 ... Polyangiitis - Pipeline Review, H2 2015, provides an ... This report provides comprehensive information on the therapeutic ... at various stages, therapeutics assessment by drug target, ... and molecule type, along with latest updates, and ...
(Date:2/4/2016)... -- Summary Breast cancer, a malignant neoplasm, is ... cancer in women worldwide, accounting for 16% of all ... of women diagnosed with breast cancer has increased over ... has declined due to earlier diagnosis and better treatment ... the past four decades, especially with increasing usage of ...
(Date:2/4/2016)... Feb. 4, 2016 Frontier Pharma: Chronic ... First-in-Class Innovation Chronic Obstructive Pulmonary ... chronic inflammation of the airways and lungs. Persistent ... make the disease one of the leading causes ... in the world. COPD is linked to cumulative ...
Breaking Medicine Technology: