Protect Women's Access To Compounded Bioidentical Hormones

Over 2.5 million women rely on estriol and other natural bioidentical hormones to manage fertility, menopause, and other hormone imbalances, but the FDA is trying to take them away!

Estriol is at the greatest risk, as there is no FDA-approved estriol product—meaning if the FDA bans compounded estriol, patients would lose all access to this essential hormone.

Estriol is a critical component of compounded bioidentical hormone replacement therapy. Many doctors and patients prefer using estriol as opposed to other estrogens because it is safer and has many health benefits. Studies suggest that estriol:

• benefits both bone and urinary tract health;
• improves cardiovascular risk factors;
• reduces brain lesions of multiple sclerosis; and
• is NOT associated with increased cancer risk, like some other hormone products are.

Despite being compounded safely for decades, estriol and other customized bioidentical hormones have been nominated to the FDA's "Demonstrably Difficult to Compound" list. When completed, the items that appear on this list can no longer be compounded.

This means that millions of women would lose complete access to estriol and customized dosages of other important bioidentical hormones such as progesterone.

Patients, in consultation with their physicians, have a right to choose the medications that are best for them. Please act now and tell FDA and Congress to protect patient access to these important hormones.
Dear [Decisionmaker],

I'm writing you on behalf of the 2.5 million women who rely on estriol and other compounded bioidentical hormones to urge the Food and Drug Administration (FDA) and its Compounding Pharmacy Advisory Committee (PCAC) to ensure continued access to these safe and effective medications.

In implementing the Drug Quality and Security Act of 2013, the FDA allowed open nominations for the Difficult to Compound List, without regard for the nominator's qualifications, potential conflicts of interests, or the validity of said nomination. When finalized, the items that appear on this list can no longer be compounded. Despite being compounded safely for decades, the bioidentical hormones estriol, estradiol, progesterone, and testosterone have been nominated to the list.

Bioidentical estriol, estradiol, and progesterone are crucial hormones women need when going through menopause, fertility challenges, or other hormonal imbalances. In the case of compounded bioidentical estriol, which has no FDA-approved alternative, consumer access would be eliminated if it were not allowed to be compounded.

Estriol is at the greatest risk, as there is no FDA-approved estriol product—meaning if the FDA bans compounded estriol, patients would lose all access to this essential hormone.

Estriol is a critical component of compounded bioidentical hormone replacement therapy. Many doctors and patients prefer using estriol as opposed to other estrogens because it is safer and has many health benefits. Studies suggest that estriol:


• benefits both bone and urinary tract health;

• improves cardiovascular risk factors;

• reduces brain lesions of multiple sclerosis; and

• is NOT associated with increased cancer risk, like some other hormone products are.


Unlike conventional hormone therapy that uses synthetic and animal-derived hormones that are slightly different from a woman's own hormones, bioidentical hormones are biochemically identical to those made by the ovaries during a woman's reproductive years. Formulations of these hormones can relieve and control the symptoms of menopause as well as other hormonal imbalances.

Congress did not intend for the DQSA to remove patient access to compounded hormones such as estriol, estradiol, and progesterone, which have been safely compounded for decades and that many Americans rely upon for their health.

We urge the FDA and the PCAC to remove estriol, estradiol, progesterone, and testosterone from consideration for the Difficult to Compound List.

Sincerely,

[Your Name]
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