TAKE ACTION: Oppose FDA's Restriction on BHRT

Washington, DC - In January, the FDA decided to restrict women's access to estriol and bio-identical hormone replacement therapy (BHRT). Take action and preserve your right to make your own health decisions.

Washington, DC - An attack is under way against a woman's right to know as well as her access to bio-identical hormone replacement therapy (BHRT), and the information women need to make their own health decisions is in jeopardy.

On January 9, 2008, the FDA sent numerous pharmacies an order to stop using estriol as well as banning the use of the term “bio-identical.” This was an unprecedented attack on compounders, patients, and physicians because until then NO compounded drug component with a USP monograph had been withdrawn from circulation unless there had been evidence of harm to patients.

The U.S. Congress has taken a critical first step toward reining in the FDA’s actions, and is acting to preserve woman’s right to make her own health and wellness decisions. Congressman Mike Ross (D-AR), together with other members of the House of Representatives, has introduced House Concurrent Resolution 342. This Resolution calls upon the FDA to reverse the change in its policy that would restrict women’s access to prescriptions containing estriol.

Click the "Take Action" link and urge your Representative to Preserve Access to Estriol and BHRT!

House Resolution 342 also calls on the FDA to respect the physician-patient relationship and states that doctors, not the FDA, are in the best position to determine which medications are appropriate for their patients. It also points out that the FDA has acknowledged that it is unaware of any adverse events associated with the use of estriol over the past three decades. In fact, the FDA's own policy, stating that bio-identical hormones are natural and, therefore, can't be patented, seems to run counter to its actions earlier this year.

In addition, the FDA has never taken any compound off the market unless there were reports of serious adverse health events. Since the FDA itself has admitted that there have been no adverse events reported for any use of estriol in medications the only apparent motivation for its restriction of estriol is a citizen's petition filed by Wyeth Pharmaceuticals in 2005 intended to undermine women's access to BHRT.

So, why this policy change by the FDA, and why now?

On October 6, 2005 Wyeth filed a Citizen Petition with the FDA that appears to be the primaray motivation for the FDA's actions, rather than protecting women's health. (Again, protecting women from what - a substance the FDA itself admits has caused no adverse health events?)

It is illuminating to note that a 2002 study by the National Institutes of Health linked Premarin® and Prempro®, synthetic hormone drugs manufactured by none other than Wyeth, to increased risk of stroke, breast cancer, heart attacks and circulatory disease. In fact, Wyeth took a hit financially as a result of the study, and sales of the drugs plummeted from $1.3 billion in 2002, to $880 million in 2004. While we aren't psychic, and cannot know for sure what the motivation is behind Wyeth's petition and the subsequent restrictions on BHRT, Citizens for Health believes the timing, and motive, for Wyeth's attempt to bury BHRT has nothing to do with concerns for women's health or the safety and effectiveness of bioidentical hormones. Rather, we believe it has everything to do with protecting Wyeth's revenue and profit.

Click the "Take Action" link above to urge Congress to put your interests ahead of corporate profits!

This is nothing new. Corporations often try to exploit for their own economic ends the methods developed to allow citizens the opportunity to seek redress for governmental wrongs - for example, see our article on GlaxoSmithKline's petition to the FDA seeking to reclassify weight loss claims by supplement manufacturers as disease claims: http://www.citizens.org/action-alerts/take-action-gsk-threatens-access-to-weight-loss-supplements.

As long as the FDA encourages such actions by putting corporate profits ahead of the concerns of the consumers it is supposed to protect, corporations will grow more and more confident that they can circumvent their responsibilities to public safety. This will mean more of the same, and business as usual.

Show them they're wrong, and that the collective voice of tens of thousands of angry consumers - and voters - can speak more loudly than pharmaceutical industry influence at the FDA.

Send your comments today and preserve your freedoms tomorrow!