September 22, 2020
A joint letter to protect cBHT access
Three major pharmacy associations — APC, NCPA, and NASPA — have submitted a joint letter today to the FDA, expressing concern about the NASEM study of cBHT and FDA’s stated intention of considering restrictions based on that study.
The letter points out deficiencies in the NASEM committee (e.g., the lack of anyone with expertise in either compounding or hormone therapy), how the committee overreached its assignment (notably by recommending that most cBHT hormones be considered for FDA’s difficult to compound list), and how the committee somehow recommended limits on cBHT despite never identifying “any pattern or significant quantity of adverse events that warrant such aggressive and punitive recommendations.”
The letter is part of a multi-pronged approach APC and our partners have been taking since the NASEM study was released in May, aimed at ensuring that millions of Americans do not lose access to these critical compounded medication.