ISSUES

Legal Analysis and Comments About the NASEM Study

To Whom It May Concern:

We hereby submit this comment to the U.S. Food & Drug Administration (“FDA” or “Agency”) on behalf of a coalition of traditional compounding pharmacies and FDA-registered outsourcing facilities (the “Coalition”) and request that FDA reject the conclusions and recommendations published by The National Academies of Sciences, Engineering, and Medicine (“NASEM”) in its report titled The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use (the “Report”). FDA cannot adopt the Report or rely on it in any way, because the Report patently fails to represent an independent perspective and is rooted in striking biases. As such, the adoption thereof not only threatens to violate the statutory requirements for federal advisory committees set forth in the Federal Advisory Committee Act (“FACA”), but will also prohibit millions of men and women across the U.S. from receiving the treatment they need.

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