Compounding Pharmacists Group Urges Practitioner Comments on NASEM Study
United Pharmacies for Patient Access to Medications
The FDA Sponsored NASEM Study
A Time Sensitive Call to Action
The Study
The FDA is funding a study by the National Academies of Science, Engineering, and Medicine (NASEM) on the Clinical Utility of Treating Patients with Compounded “Bioidentical” Hormone Therapy (BHT).
The goal of the FDA sponsored NASEM study is to “examine the clinical utility of treating patients with compounded BHT products. NASEM will provide a report evaluating the available scientific evidence relating to the safety and effectiveness of these products and discussing whether the available evidence supports use of compounded BHT products to treat patients.” (NASEM Website)
Why This is Important to You
Industry leaders and associations believe that the information presented to NASEM thus far may be one-sided favoring commercially available HRT, possibly with predetermined outcomes in mind. The FDA does not understand why compounded forms of estradiol, progesterone, and testosterone are prescribed for patients instead of FDA-approved drug products. Big Pharma cannot fill the gap that customized compounded hormones provide our patients. It is important that NASEM hears from providers because the outcome of this FDA report will be the basis for future FDA regulation and could affect the way you practice medicine and restrict access to compounded bHRT for your patients for years to come.
Call to Action by Commenting on the NASEM Website
It is of utmost importance that NASEM hears from practitioners about the “clinical need” and “effectiveness” of compounded bHRT. This information can only come from the practitioners who write the prescriptions for their patients who need the customized dose, dosage form or unique combination that compounded bHRT provides.
Comments to NASEM should be sent before Sept 30th.
Click below to Comment to NASEM on the clinical need for compounded bHRT and your patients. (or copy & paste link into browser)
https://www8.nationalacademies.org/pa/feedback.aspx?key=51373&type=project