Estrio Resolutions (H.342/S.88)
The American Association for Health Freedom has been very disappointed with the Food and Drug Administration’s (FDA) actions towards bio-identical hormones this year.
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on compounders, patients, and physicians because until then NO compounded drug component with a USP monograph had been withdrawn from circulation unless there had been evidence of harm to patients. (Click here to read more information.)
U.S. Congress is taking a key first step toward reigning in the FDA’s astounding actions against women’s health and we need your support!
Congress has introduced House Concurrent Resolution 342 and Senate Concurrent Resolution 88. This resolution calls upon the FDA to stop their new policy of restricting women’s access to prescriptions containing estriol.
This is one of our best courses of action to restore estriol’s availability to the market.
The resolution also calls on the need of FDA to respect the physician-patient relationship and recognizes 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.
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NOTE: This alert is for both the Senate and the House. If you have already written your House Representative, click here to contact your Senators. If you have already written your Senators, click here to write your House Representative.
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Talking Points
To have the FDA decide to take away this protective estrogen in response to a ‘citizen’s petition’ from a drug company, whose drugs for post-menopausal women were removed from an NIH study because they caused strokes and breast cancer, is just unbelievable! Apparently the FDA is siding with that company to try to force women to go back to using their horse estrogens instead of safe human bio-identical hormones.
In all other hormone replacement therapies, like insulin and thyroid therapies, medicine has moved toward bio-identical human hormones to prevent side-effects. Thus to see the FDA moving away from bio-identical estrogens is contrary to other trends in medical treatment.”
Congress has never given the FDA the right to dictate the practice of medicine and if this action stands they will have usurped fundamental rights from our nation’s women and their physicians. We understand that the FDA has briefed the Congress that their action is not a problem for women. A physician who wishes to prescribe an estriol containing compound simply needs to file an Investigational New Drug application. They fail to mention the complexity involved nor the application fees that goes with it. The fact that estriol cannot be patented as a drug because it is a bio-identical compound precludes such action. Never has the FDA taken any compound off of the market unless there were reports of serious adverse events like death. They have admitted that there have been no adverse events reports for any use of estriol in medications. Therefore their action should be reversed!
Dear [ Decision Maker ],
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Sincerely,
[Your name]
[Your address]
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