Earlier this week, APC submitted a letter signed by nearly 2,000 prescribers of compounded hormones to FDA Commissioner Robert Califf, urging FDA to assure continued patient access to compounded hormone therapy.

“This letter is an extraordinary demonstration of support for APC’s efforts to protect access to compounded hormones, and it’s all thanks to the APC members and partners who reached out to prescribers they worked with and urged them to sign the letter,” said APC CEO Scott Brunner. “Thank you, thank you, thank you to those members who answered our call for help on this project.”

The letter addressed the flawed 2020 report FDA commissioned from the National Academies of Sciences, Engineering, and Medicine (NASEM), and what the repercussions would be should FDA use that report as the basis for restricting access to compounded hormones

The prescribers also noted that access to compounded medications provides the ability for them to uniquely tailor and personalize medications to meet the needs of individual patients for whom, in the prescriber’s judgment, commercially available drugs are not suited. Therefore, by implementing across-the-board restrictions on compounded hormones, the letter stated that that these would interfere with the practice of medicine and prevent them from treating their patients.

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