A bi-partisan group of Congressional reps have introduced a resolution* criticizing the FDA for its recent move to warn compounders about their use ofestriol in their bioidentical versions of hormone replacement treatments.
Last January, the agency questioned the safety and effectiveness of BHRT products, citing unsupported medical evidence, and false and misleading claims. The agency accused seven compounders of claiming their products are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat such diseases as Alzheimer’s, stroke, and various forms of cancer, according to the FDA.
And last month, US Senator Tom Coburn, a Republican from Oklahoma, wrote a letter to FDA commish Andy von Eschenbach seeking agency data on actual adverse events and and to demand the agency reconsider its decision, because some insurers are supposedly no longer covering the products.
The issue has pitted compounding pharmacies, among others, against Wyeth, which in 2005 filed a citizen's petition with the FDA in an effort to stop compounders from making bioidentical versions of Prempro, its controversial hormone replacement therapy. In lawsuits, some women claim Prempro has caused them to develop breast cancer.
* To view the resolution, go to Thomas.gov, click the little button that instructs you to search for bill number and type in H. Con. Res. 342.