The FDA Attempts to Limit Access to Compounded Bioidentical Hormone Replacement Therapy
The FDA’s Recent Memorandum of Understanding
In May 2020, the FDA released its Memorandum of Understanding (MOU) about proposed regulations on distributing cBHRT drugs out of state. According to the MOU, the FDA will limit pharmacies to distributing only 5% of their compounded drugs out of state if they do not sign the document.
The FDA will allow pharmacies who do sign the MOU to distribute up to 50% of compounded drugs. Any failure to adhere to these regulations results in a state investigation and mandatory reporting to the FDA. Not only will these regulations impact cBHRT, but they will impact all compounded medication.
To advocate for patients, pharmacy groups, such as the Alliance for Pharmacy Compounding (APC) , voiced concerns about revising the MOU so that states and the government can reach an agreement. Until then, numerous states refused to sign the MOU.
The FDA Commissions The NASEM To Study cBHRT
In the spring of 2020, the FDA commissioned the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a study on cBHRT and its overall effectiveness. To no surprise, the report was basically an extension of the FDA’s biased hypothesis towards cBHRT.
Here are a few facts about the report that show the FDA’s bias:
- The committee for the NASEM study did not include any professionals with patient-facing experience.
- The committee included one former FDA employee who is an outspoken compounding opponent.
- The NASEM defined the study’s recommendations based on the literature review. However, the literature review only included 13 sources among the hundreds of sources available.
- The NASEM report fails to address that many FDA approved treatment plans do not meet patients’ dosage requirements.
Although the report includes valuable information, the FDA should involve other federal and state agencies instead of solely relying on the NASEM. This will improve the validity of these studies in the future. Also, involving other agencies would be a more fair use of taxpayer dollars.
Overall, the APC is working diligently to hold the FDA accountable for a more holistic, balanced review process of cBHRT.
The Impact on Patients
What does this mean for you? The FDA’s MOU, biased studies, and proposed regulations severely limit your access to cBHRT. In addition, these regulations further delay you from getting the compounded drugs when you need them.
Compounded Bioidentical Hormone Therapy is a treatment plan that pharmacists use to create customized individual hormone therapy for patients. In this process, pharmacists use plants or animals to create hormones with an identical molecular structure to hormones that the body naturally creates.
Natural Hormone Therapy helps patients across the country restore their natural hormone levels and improve their quality of life. If the FDA passes their proposed regulations, then patients may not have access to the medical treatment that they need.
Help Protect Natural Hormone Therapy
Now, the APC needs your help. Have you used cBHRT? If so, we’d love to hear from you. What positive impacts have you seen in your life based on your experience with cBHRT?
Share your experiences on the Alliance for Pharmacy Compounding’s website to help protect access to Bioidentical Hormone Therapy. You can also get involved by joining the grassroots organization Partnership for Personalized Prescriptions.