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# Analysis Hits National Academy cBHT Report
- URL: https://www.fdaweb.com/analysis-hits-national-academy-cbht-report/
- Published: 2021-04-28T12:00:00.000Z
- Updated: 2026-09-14T16:56:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149209

An independent analysis funded by the Pharmacy Compounding Foundation and conducted by Berkeley Research Group says FDA should not rely on or consider a 2020 FDA-funded report published by the National Academies of Science, Engineering, and Medicine (NASEM) on the safety and utility of compounded bioidentical hormone therapy (cBHT). The [report](https://media.thinkbrg.com/wp-content/uploads/2021/04/19201541/BRG-NASEM%5FReport-Analysis%5F2021-V1.pdf?ref=fdaweb.com) says the NASEM report “is compromised by potential bias, conflicts of interest, and bad science.”

Berkeley says FDA commissioned NASEM in 2019 to undertake an objective review of the safety and effectiveness of compounded hormones. After the NASEM report was released 7/1/20 with a recommendation for across-the-board restrictions on compounded hormones, FDA issued a public statement that the agency would base its next steps on compounded hormones on the NASEM report, it says.

The Pharmacy Compounding Foundation says FDA failed to say that it had exerted inappropriate influence and bias in almost every phase of the commissioned report, even recommending study committee appointees who had no expertise in prescribing or compounding hormones.

“This white paper shows how FDA inappropriately meddled in the composition of the NASEM committee, fed the committee selective research for its consideration, and even advised the committee on its final recommendations for restricting compounded hormones,” said foundation CEO **Scott Brunner**. “And all so FDA could have a report that reflected its existing negative view of compounded hormone therapy. The white paper reveals an FDA much more interested in documenting its own biases than in actual objective science. And it was apparently willing to spend $1.3 million in taxpayer dollars to do it.”

The BRG white paper says that instead of relying on the NASEM report, FDA should work to ensure that prescribers, patients, and pharmacists may continue to collaborate on treatment options that work best for individual patients in a manner that is safe and effective. The report makes these specific recommendations: 

- FDA should work collaboratively with medical and pharmacy compounding industries to address concerns around labeling and adverse event reporting for compounded therapies;
- FDA should sponsor or encourage sponsorship of educational campaigns directed to medical providers, pharmacists, and/or patients on the benefits and risks of cBHT compared to commercially available hormone therapies;
- FDA should develop and/or improve upon systems to encourage adherence to Code of Ethics for providers and pharmacists, and appropriate use of cBHT should be encouraged; and
- compounding pharmacies should be expected to comply with USP standards related to the preparation of compounded prescriptions and state boards of pharmacy should assess their current requirements and monitoring and enforcement efforts around compliance with USP standards.