Bioidentical Hormones - U.S. Senate Special Committee on Aging

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visory warning, as required for FDA-approved hormones. This is a
serious concern for women and their doctors.
Compounding pharmacies are not required to adhere to the strict
manufacturing processes governing FDA-monitored facilities, raising
concerns about purity, potency and quality.
In one FDA-conducted post-market survey, 4 out of 11 compounded
hormones failed tests for potency and/or uniformity.
Our concerns are shared by the broader medical community, including
multiple other professional medical organizations. The
AMA recently adopted a policy in support of our society's positions.
In conclusion, the society supports legislative action to standardize
regulation of compounded hormones to include requirements
for: (1) surveys for purity and potency; (2) mandatory reporting of
adverse events; (3) a registry of these events; (4) inclusion of uniform
patient information in the packaging; and finally and (5) limits
on the use of this term, "bioidentical hormones." The fact is that
scientific evidence is lacking at this time to either negate or support
claims that bioidentical hormones are safer and more effective
than other commonly prescribed hormones. Until conclusions are
based on science, the Federal Government must ensure patients receive
safe and effective drugs with accurate information.
That concludes my personal remarks, Senator. I would be happy
to answer any questions.
[The prepared statement of Dr. Wartofsky follows:]