Tell Congress: Protect Bioidentical Hormones

The FDA has accepted nominations to its "Difficult to Compound" (DDC) list, which is supposed to identify drugs that cannot safely be compounded because of their complexity. Included on this list are certain kinds of safe, bioidentical hormones such as progesterone (including progesterone with estradiol) and estriol.

This is extremely disconcerting. Compounding pharmacists say these bioidentical hormones are not difficult to compound and are not dangerous. A review of the clinical literature concluded that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more effective than synthetic or animal-derived hormones.

Compounded hormones are used by millions of women to manage menopause or fertility changes. Pharmacies can make hormone medications that are tailored to a patient's individual needs, as determined by a doctor. Compounded bioidentical hormones have been used safely for decades; there is no reason for the FDA or its Pharmacy Compounding Advisory Committee (PCAC) to eliminate consumer access to these medications--particularly estriol, for which there is no commercially available drug.

Write to Congress and the FDA, telling them to protect patient access to compounded bioidentical hormones.

Recipients

  • Your Senators
  • Your Representative
  • Food and Drug Administration

Contact

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Message

Please protect bioidentical hormones

Dear [Decision Maker],

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]
[Your Email]