BIO-IDENTICAL HORMONES/ REFUTATION OF FDA's POINT OF VIEW

[Guest guest]

Refuting what the FDA is claiming in their response about bio-identical hormones,

Myths vs. Facts.

From P2C2 Patients and Professionals for Customized Care (P2C2)

Dee

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FDA Response on Bio-identical Hormones:

Myths vs. Facts

P2C2 members who have written FDA about the agency’s recent action on bio-identical

hormones may have received a standardized response containing some misleading

statements about the issue.

While FDA is right that it’s inappropriate for pharmacists to claim that bio-identical

hormones are safer or more effective than other drugs, there are a number of myths

being spread by the Agency. Here is the truth.

FDA Myth #1:

“Many pharmacies also use the term ‘bio-identical’ to suggest that

their products are natural or identical to hormones made by the

body. We know of no valid scientific evidence to support any of

these claims, and we are concerned that these claims may mislead

patients and healthcare providers.”

FACT: The chemical structure of the hormones estradiol, estrone, estriol

and progesterone are identical to that of a woman’s body, hence

the term “bio-identical” appropriately describes them. This is

indisputable.

And it’s not just pharmacies who use the term “bioidentical;”

drug companies who manufacture FDA-approved

bioidentical hormones use that term, too.

FDA Myth #2: “Unless a pharmacist is preparing BHRT drugs pursuant to an

investigational new drug application, he or she may not prepare

those drugs using ingredients that are not part of FDA-approved

drugs.”

FACT: Like all compounded drugs, BHRT IS legal. Many drugs are

commonly compounded and prescribed even if they are not

components of FDA-approved drugs. Aspirin and Phenobarbital

are just a few examples.

FDA Myth #3: “FDA’s action was in no way designed to interfere with the doctor/patient

relationship” and the agency “support(s) traditional pharmacy compounding: when a pharmacist prepares a drug according to a valid prescription to meet a patient’s special medical needs.”

FACT: BHRT falls squarely into the category of “traditional pharmacy

compounding,” as defined by FDA. Pharmacists only compound

bio-identical hormones pursuant to a valid prescription from a

physician who has determined a need for a specific patient. With

this new policy, FDA is inserting itself into your doctor’s examining

room. Tell them to get out!

For more information, visit www.SaveMyBHRT.org or

talk to your pharmacist today!

SOURCE:

http://iacprx.convio.net/site/DocServer/FDAresponse_Myth_Fact.pdf?docID=3461 & JServSessionIdr004=i0e7iswxs2.app14b