February 18, 2022

FDA doubles down on NASEM report

Lest you think FDA’s threat to restrict compounded hormones based on the deeply flawed NASEM report was idle talk, consider this letter the agency sent last week to 22 members of Congress.

The letter was in response to those representatives’ December 14 letter to Acting Commissioner Janet Woodcock — a letter expressing concern the agency’s implicit threat to restrict compounded hormones.

Based on the response, FDA appears to be doubling down on its earlier statement that it would base its next steps on the NASEM report, despite that report’s documented bias, conflicts of interest, and lack of scientific rigor.

To be clear, this is bad news. With FDA leaning in to the NASEM report as basis for restrictions on compounded hormones, our effort to engage patients, prescribers, and more members of Congress is even more urgent.

APC’s goal is to raise $850,000 in 2022 for the Campaign to Save Compounded Hormones to pay for stakeholder outreach, to engage practitioners in the effort, to expand compounding.com, and to help spread information through a variety of media channels. Thus far, we’ve raised about $300,000 toward that goal.

Help protect your patients’ access to cBHT — help stop FDA’s misguided effort. Support the Campaign to Save Compounded Hormones. And remember, through the month of February Topi-Click will match any new contribution, dollar for dollar, up to $10,000.

Give to Save cBHT