FDA Attempts to Make E3 Illegal,Supreme Court Not Yet Ruled

The E3 vs.Wyeth battle masked as FDA ruling continues. (The FDA site no longer posts their ruling).  Wyeth is the drug manufacturer of Premarin having petitioned the FDA to make compounding of E3 illegal.  Their first and foremost motivation is due to all the money they have lost from Premarin sales since the Women’s Health Initiative Study has shown Premarin to be unsafe.

Although E3 (Estriol) has been deemed as FDA unapproved (as a result of the Wyeth petition) and sources of Estriol are now limited, Compounding Pharmacists are continuing to dispense it, physicians are continuing to prescribe it and ruling by the Supreme Court is likely favorable yet will take 2-3 years.  The first attachment summarizes it well… where the American Pharmacy Association supports a compounders right to dispense various compounds and the state’s Boards of Pharmacy to be the most appropriate agency of oversite and rule of law. Meanwhile the Oregon Board of Pharmacy and Naturopathic Board of Examiners have not made a ruling.  The other attached articles help to justify continued prescribing of E3 on many levels as well.  Feel free to talk to me personally about any questions or concerns.

The best online resource is the Int. Academy of Compounding Pharmacists www.iacprx.org. and another great consumer advocate group is www.savemymedicine.org I will be talking with the Executive Director of IACP to clarify further documentation to make available to patients at the time of prescribing E3.

Recall the basic biochemistry of E1 (Estrone) which metabolises into E2 (Estradiol).  E 2 metabolizes both back into E1 and into E3.  E3 does NOT metabolize back into anything.  E1 <=> E2 -> E3 The carcinogenic estrogens are E1 metabolites only (4 and 16 hydroxy estrone).  This basic estrogen biochemistry is enough science to verify its safety.

Furthermore, Estriol has been a part of the US Pharmacopia for over 40 years and pharmacists have been mixing and dispensing it safely for those many years.  Wyeth and the FDA are wanting all compounded drugs to be manufactured drugs.  Estriol is not available in any manufactured drug form.

If a compound is deemed in the best interest of the pharmacist and the physician yet is not available as a manufactured drug the FDA is attempting to make it illegal for a compounder to dispense.  This is pretty obviously unconstitutional, has no reasonable precident and the US Supreme Court will be ruling on it in the next 2-3 years.