For Immediate Release:
February 17, 2009
Tami L. Wahl, Legislative Liaison
FDA RULING PUTS WOMEN’S HEALTH AT RISK
Health Freedom Organization Urges Action to Lift Estriol Ban
The American Association for Health Freedom (AAHF) is requesting Congressional support to have the FDA-imposed ban on estriol lifted. Estriol is a hormone naturally produced by the body that has been prescribed for decades to address menopausal symptoms.
Last year, the US Food and Drug Administration (FDA) responded to a petition filed by Wyeth Pharmaceuticals asking FDA to change its policy on estriol—claiming, in part, that estriol posed “a serious threat to public health.” FDA ruled that physicians must now obtain an approved investigational new drug (IND) application before pharmacists can fill a prescription with the hormone estriol in compounded medications. According to AAHF, due to the complexity in completing an IND, the FDA has in effect banned the use of estriol.
Today, AAHF hand delivered letters and a White Paper to key political figures in an attempt to force FDA to reverse its policy change on estriol. FDA has already admitted they could not identify a single adverse event from the use of estriol in the decades it has been prescribed to women in the US, and have not yet disclosed any research that would back up its reasoning for designating estriol as a “new investigational drug.”
According to AAHF, the FDA is ignoring the realistic implications of its ruling. Gretchen DuBeau, AAHF’s executive director, stated, “The IND process could cost more than $50,000 and take a minimum of six months to complete. Doctors simply do not have the time, resources, or research expertise to complete this unnecessary, burdensome, and costly procedure to prescribe a natural hormone.”
The public outcry over FDA’s action has been significant. FDA received over 70,000 comments from patients, doctors, and pharmacists in response to Wyeth’s petition, and over 10,000 comments since the ruling.
AAHF Legislative Liaison Tami Wahl said, “Not only has the ruling deprived thousands of women from access to estriol, but two bigger concerns now loom. The first is the impact on the physician-patient relationship. Physicians have the right—and the ethical duty—to practice medicine in a manner that meets a patient’s particular needs. And the right of millions of women to choose their method of healthcare has been significantly compromised. The second concern is that this may be the first of many policies by the FDA to restrict a physician’s ability to prescribe compounded bioidentical hormone replacement therapy (BHRT).
”Senator John Cornyn (R–TX) and Representative Mike Ross (D–AR), along with the support of sixty other members of Congress, introduced a concurrent resolution last session for the FDA to “reverse its policy that aims to eliminate patients’ access to compounded medications containing estriol,” citing physicians as being in the best position to determine which medications are most appropriate for their patients.
Executive Director DuBeau continued, “Pharmacy compounding is a legal, long-standing practice that allows for customized medication to treat a patient’s specific needs. Thousands of women benefit from physician-prescribed bioidentical hormone replacement therapy. For the FDA to issue this ruling without any evidence of adverse effects is a clear indication of abuse and mishandling of the IND process.”
Additional side effects of the ruling include insurers now denying reimbursement for compounded medications containing estriol, and extensive litigation between pharmacies and the FDA questioning FDA’s jurisdiction to issue such a ruling. The 5th and 9th Circuit Courts are now split—frustrating the application of the law—which leaves the legality of compounding in a very precarious situation. The FDA is not the regulatory authority for this traditional pharmacy practice, yet this ruling has the same effect.
AAHF is also investigating the possibility of improper influence in issuing the policy change. A Freedom of Information Act request was submitted to track communication and financial ties between Wyeth and FDA. As Legislative Liaison Tami Wahl pointed out, “Wyeth Pharmaceuticals is a giant drug manufacturer and was the only entity to request that estriol be removed from the market. Wyeth alleged that estriol posed ‘a serious threat to public health’ despite the fact that Wyeth itself markets estriol products in Europe. Perhaps Wyeth’s bottom line from the sale of synthetic hormones was being affected by women’s use of estriol, the natural hormone?”
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NOTES TO THE EDITOR:
About the American Association for Health Freedom (AAHF): www.healthfreedom.net. The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant coalitions.