The Alliance for Pharmacy Compounding (APC) recently reported that 1,957 prescribers of compounded hormones signed a letter submitted to FDA Commissioner Robert Califf urging that he protect continued patient access to compounded hormone therapy.

The letter stated, “We are deeply concerned that the FDA may consider restricting access to compounded hormones—life-enhancing therapies that patients have relied on for years—and that it may do so based on a flawed 2020 report it commissioned from the National Academies of Sciences, Engineering, and Medicine.”

According to Scott Brunner, CEO of APC, the prescriber letter to Commissioner Califf follows comparable input to the FDA from pharmacy associations, members of Congress, and patient organizations communicating concern about bias, conflicts of interest, and a lack of scientific rigor in the FDA-funded National Academies of Sciences, Engineering, and Medicine (NASEM) report on compounded hormones.

“This threat to patient access and care is one that concerns not only compounding pharmacists, but also prescribers, who stand to be deprived of certain longstanding therapies that are benefitting their patients if FDA restricts compounded hormones,” stated Mr. Brunner. “This letter is an expression by prescribers of that concern.”

In the letter, the prescribers stated that the NASEM report’s recommendations for across-the-board restrictions on compounded hormones—therapies millions of American women and other patient populations undoubtedly benefit from and have come to rely on—“would interfere with the practice of medicine and prevent us as practitioners from treating our patients with therapies that in our medical judgment are best for those patients.”

The letter mentioned that access to compounded medications provides the ability for a prescribing physician to individually tailor and personalize medications to meet the needs of individual patients for whom, in the prescriber’s judgment, commercially available drugs are not appropriate.

The signers advocated expanded education on the use of bioidentical hormones for all healthcare practitioners involved in caring for patients, as well as establishment of a reasonable, consistent framework for adverse event reporting for compounded medications.

Mr. Brunner stated, “APC stands ready to work with FDA in collecting and assessing patient-reported outcome data related to compounded hormone therapy, because we believe that data validates that compounded hormone therapy is helping patients live healthier, fuller lives. We’re also willing to work with FDA to develop a state-based adverse events reporting regime for compounded medications.”

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