FDA Warns Pharmacies That Wyeth is Annoyed

| 1 Comment
Cut Rate Drugs

When I read this article's opening paragraphs, I turned and said to my partner, "Sounds like a major pharmaceutical company placed a couple calls to their lackeys at the FDA." Bioidenticals are big business, but not for Wyeth.

The Food and Drug Administration is cracking down on pharmacies that sell customized hormone mixtures as antidotes for menopause symptoms such as hot flashes, saying they are being promoted with false claims about their benefits and contain an ingredient the agency hadn't approved.

The regulator's move ramps up a contentious debate over growing use of the customized hormone products, which have surged in popularity since a government study in 2002 raised questions about the health risks associated with traditional menopause hormone drugs. They were also boosted by actress Suzanne Somers, who promoted use of them in her books.

[From FDA Warns Pharmacies On Hormone Claims - WSJ.com]
Seems as if I was right (thought the FDA denies it of course):
Drug maker Wyeth, which sells hormone drugs for the same uses, had complained to the agency about pharmacies' practices. Wyeth reported $791 million in revenue from hormone products for the first nine months of 2007. In a sign of the issue's high profile, the FDA got more than 70,000 comments from patients, pharmacists and others about the company's petition, many defending the pharmacies. The controversy comes as millions of women born at the peak of the postwar baby boom are entering their 50s. The North American Menopause Society said an estimated 6,000 U.S. women reach menopause every day, or over two million a year.

In letters, the agency warned seven individual pharmacies to stop using certain promotional language, including the popular descriptive phrase "bio-identical." The FDA also told the pharmacies that they couldn't sell hormone mixtures containing the ingredient estriol, which the regulator views as a new drug that hasn't won agency approval. The special hormone combinations, known as "compounded" products, must be prescribed by a physician.

A Wyeth spokesman, Doug Petkus, said the company supports the FDA's action against the pharmacies. Mr. Petkus said Wyeth was "pleased" with the FDA's formal response to its petition, a document the FDA also released yesterday.
70,000 folks take the time to write in, but one phone call from Wyeth trumps the will of the people. Profits Über Alles!

(Digg-enabled full access to complete article here)

1 Comment

It is obvious that the FDA has been waging a war
against bioidentical hormones because of a citizen's petition from Wyeth.

Wyeth makes the synthetic hormone, prempro, a drug found to cause cancer and heart disease in the WHI study published in JAMA July 2002.

Wyeth has lost 2 billion in sales since millions of women have switched away from the Wyeth product to compounded bioidentical hormones, a safer and more effective alternative.

Wyeth wants to use the FDA to eliminate its competition.

The problem is that the FDA does not regulate compounded bioidentical hormones, the states do the regulation.

And the FDA's actions have only demonstrated that the agency is completely inept and corrupted by special interest groups in the drug industry.

To read more about this click here,
FDA Declares War on BioIdentical Hormones by Jeffrey Dach MD

Jeffrey Dach MD

About this Entry

This page contains a single entry by swanksalot published on January 10, 2008 4:34 PM.

Rocket Man was the previous entry in this blog.

FBI Wiretaps Dropped Due to Unpaid Bills is the next entry in this blog.

Find recent content on the main index or look in the archives to find all content.


Powered by Movable Type 4.37