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 id
'/>"/>

SOURCE International Academy of Compounding Pharmacists
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

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:8/31/2014)... August 31, 2014 This September, ... California State Library, celebrates 30 years of changing ... Since its inception, California’s Library Literacy Services has ... learn to read and write. , To mark ... the state is launching a month-long awareness campaign ...
(Date:8/31/2014)... Sunday 31 August 2014: Renal denervation seems to ... with resistant hypertension when it includes accessory renal arteries, ... Dr Linda Schmiedel from Germany. , Dr Schmiedel said: ... hypertension, which is defined as blood pressure (BP) greater ... from resistant hypertension (rHTN) and are unable to reduce ...
(Date:8/30/2014)... August 2014: A new method to predict the ... was presented at ESC Congress today by Dr Benjamin ... needs 350 AEDs located in public places for optimal ... Dr Dahan said: "Out of hospital cardiac arrest is ... ranging between 50 and 100 per 100 000 in ...
(Date:8/30/2014)... Walking-Canes.Net has released several articles related ... can help in making gait problems easier. The new ... website that contains all of the news articles that were ... articles deal with diseases that make walking a problem and ... help in making life easier for the patient. The articles ...
(Date:8/30/2014)... Cokato, MN (PRWEB) August 31, 2014 ... renewed in home renovation, especially spa style bathrooms and ... (NASS) has observed an increase in interest not ... understanding the history, culture and health benefits of sauna. ... Finnleo , the North American Sauna Society provides ...
Breaking Medicine News(10 mins):Health News:California Library Literacy Services Celebrates 30th Anniversary 2Health News:California Library Literacy Services Celebrates 30th Anniversary 3Health News:Renal denervation more successful when it includes accessory arteries 2Health News:New method predicts optimal number and location of AEDs 2Health News:Information Articles on Gait Problems from Walking-Canes.Net 2Health News:As Interest in Saunas Increases, the North American Sauna Society Increases Outreach to Provide Education on History, Design, and Culture 2
... compared to kids without disorder , MONDAY, Oct. 19 ... in blood mercury levels between children who are developing ... disorders. , The findings, appearing online Oct. 19 in ... some of the debate surrounding mercury and autism. , ...
... not trained in skin cancer examinations, nor have they ever ... the October issue of Archives of Dermatology , one ... that can be detected early for which U.S. death rates ... Although melanoma remains the second most common cause of cancer ...
... WASHINGTON, D.C., October 19, 2009 With chronic diseases ... solutions to improve care and outcomes for these often ... today announced a new initiative funded with a grant ... will allow pediatricians across the country to pilot a ...
... a joint letter to the Centers for Medicare and ... fluorodeoxyglucose (FDG) positron emission tomography (PET) scans for a ... only one FDG-PET study during initial treatmenta limitation that ... under certain circumstances. "It is absolutely critical for ...
... ... Assara Laser Cosmetic Services Centers and Park Avenue Laser Vision ... dedication to providing exemplary care in the cutting-edge laser cosmetics field. ... laser spider vein removal and laser facials. Park Avenue Laser Vision ...
... ... Access, Choice, and Flexibility. , ... Albany, NY (Vocus) October 19, 2009 -- In a continuous effort to develop products and ... benefits, CDPHP ® announces several enhancements to take effect in 2010 pending New York ...
Cached Medicine News:Health News:Mercury Levels Not Abnormal in Autistic Children 2Health News:Mercury Levels Not Abnormal in Autistic Children 3Health News:Resident physicians seldom trained in skin cancer examination 2Health News:Pediatricians put proven treatment strategies to work against childhood asthma 2Health News:1 scan per patient is not always enough 2Health News:Assara Laser Announces Strategic Alliance with Park Avenue Laser Vision 2Health News:Assara Laser Announces Strategic Alliance with Park Avenue Laser Vision 3Health News:CDPHP Launches National Network and Three-In-One Plan, and Expands Member Incentives 2Health News:CDPHP Launches National Network and Three-In-One Plan, and Expands Member Incentives 3Health News:CDPHP Launches National Network and Three-In-One Plan, and Expands Member Incentives 4
(Date:8/29/2014)... , Aug. 29, 2014  BC Technical, the nation,s ... Polaris Medical Imaging, a leader in sales, service and ... acquisition allows BC Technical to continue to expand their ... MR and CT modalities. "We are ... Mark Alvarez , president and CEO of BC ...
(Date:8/29/2014)... DENVER , Aug. 29, 2014 Does your ... date, nearly 800 doctors have recommended marijuana to the over ... Amendment 20. But the majority of the other roughly 20,300+ ... still know very little about it – even though a ... adults say they have tried it. ...
(Date:8/29/2014)... Diseases largely eradicated in the ... Measles was declared eliminated in 2000, yet the CDC ... 15—the highest incidence in 20 years. In July, ... cough a problem of "epidemic proportions." ... from these preventable diseases—in part because some parents (more ...
Breaking Medicine Technology:BC Technical Acquires Polaris Medical Imaging 2Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 2Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 3Medical Rules Marijuana Sales in Colorado But Most Doctors Still in the Dark 4Vaccines at the Crossroads: Outbreaks On the Rise Across America 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 3
... WESTON, Fla. , June 15 DHL Global Mail ... of mail-order pharmacies. DHL SMARTMAIL PHARMA SELECT ™ incorporates best ... the pharmaceutical industry. Thanks to this expertise and Global Mail,s nationwide ... accountability and value. , , ...
... Perrigo Company (Nasdaq: PRGO;TASE) today announced that Perrigo Executive Vice President ... Goldman Sachs Global Healthcare Conference on Tuesday, June 15 , at ... in Los Angeles .  The presentation will be webcast on the ... , , ...
Cached Medicine Technology:DHL Global Mail Launches Specialized Shipping Service for Mail-Order Pharmacies 2
Comfor™ Cast Boot - Rocker Sole - Closed Toe...
The Multi-Purpose Medical-Surgical Shoe...
... assay for the qualitative and ... to Gliadin in human serum. ... be used as an aid ... disorders, mainly Coeliac Disease. This ...
... For use as a non-reactive quality assurance reagent ... Toxoplasma gondii (TOXO IgG and TOXO IgM), IgG ... and rubella IgM), IgG and IgM antibodies to ... IgM antibodies to herpes simplex virus types 1 ...
Medicine Products: