FDA Attacks Bio-identical Hormones
The Food and Drug Administration (FDA) has announced a major assault on compounding medicine and bio-identical hormones. The FDA is using a multi-prong approach that started last year with a Congressional Hearing before the Aging Committee, and continuing with banning estriol, denying the term “bio-identical” to characterize compounded hormones therapies, and encouraging consumers to use drugs instead.
We acted swiftly last year and were able to stop the introduction of the so-called “Safe Drug Compounding Act of 2007” in Congress by powerful Senators. Now we have a new battle.
In a series of warning letters to compounding pharmacies across the country, the FDA is asserting a policy that would deny hundreds of thousands of women access to many compounded bio-identical hormones, substituting the FDA’s judgment for that of doctors. (Remember when Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned the FDA in October 2005 to restrict access to bio-identical hormones? More than 70,000 doctors, patients, and pharmacists filed comments with the FDA opposing Wyeth’s petition.) By targeting estriol and indicating that they are planning on banning its importation, this will effectively end compounded hormones for women because 80% of all bio-identical hormone therapy uses estriol.
The FDA seems particularly upset with “marketing” claims that bio-identical hormones are a better choice than “FDA approved menopausal hormone therapy drug products.”
In a Consumer Health Information flyer, the FDA points out that they have not approved any drug containing estriol so therefore the safety and effectiveness of estriol are unknown. Of course since estriol is a natural ingredient and is therefore unable to be patented, no company has submitted it to the billion dollar pipeline at the FDA. The FDA is ignoring the fact that before Premarin the work on hormone replacement therapy was with “bio-identical” hormones. Additionally, there are several European studies about estriol that are quite impressive.
The FDA also downplays the lack of adverse event reports in relation to bio-identical hormones. Their flyer says, “Unlike commercial drug manufactures, pharmacies aren’t required to report adverse events associated with compounded drugs.” What they are not saying is that consumers can report any AER and furthermore doctors and hospitals are required to report all adverse events.
What You Can Do
Be prepared to contact Congress and the FDA in a few weeks to let them know what you think about bio-identical hormones.
What We’ll Be Doing
Please get involved in this struggle – we can’t do it without you.
This issue is fundamentally about the right of the consumer to choose and the practitioner to practice. It will take a very large grassroots movement to make Congress sit up and hear us. It happened in 1994 with DSHEA and can happen again in 2007! Your voice does count.
Don’t forget to stay updated on this issue. Additional information and action items will be developed shortly. Please check www.healthfreedom.net frequently for more information.