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

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Now, you have identified in your testimony that 19 of these sites
are still selling hormone products that make unsubstantiated
health-related claims.
I guess what I am asking is, what revisions is the FTC going to
be making to enforce its policies to ensure that this type of egregious
enforcement lapse does not reoccur?
Ms. HARRINGTON. Senator, we, as I said, will be receiving enforcement
recommendations on companies that are not in compliance.
I can't say, in a public setting, precisely when and what the
nature of those will be.
I think we could have moved faster here, and we should have.
Senator SMITH. Well, I don't mean any personal embarrassment
to you. But, I mean, I am just saying that, in this senator's opinion,
the American people are owed better by the FTC than what the
evidence shows by my staff's being able to buy this with these kind
of claims on the Internet; something that may be harmless, it may
be dangerous, but it is unproven and ought not to be out there as
modern-day snake oil.
Ms. HARRINGTON. Point well-taken, Senator.
Senator SMITH. After the early termination of the Women's
Health Initiative study, the FDA issued a black box warning indicating
that estrogens with or without progestin should be prescribed
at the lowest effective doses for the shortest duration.
However, it is my understanding that when the FDA issued the
guidance, there were no studies indicating at what dose women
faced the lowest risk of serious side effects. It seems to me that the
Federal Government is playing a guessing game with women's
health, and I think they deserve better.
So, Dr. Rossouw and Dr. Galson, without studies indicating at
precisely what dose women will see less risk of serious side effects,
why did the FDA take such an extreme position?
Dr. GALSON. Well, let me make a few points.
The first is that, with any area where there is a lot of scientific
information, the data available to physicians and patients changes
month by month with more publications by Dr. Rossouw's group
and others around the country..The challenge we have at FDA is
interpreting this information, deciding which of that information
warrants changing the instructions to patients and physicians.
At any one moment, when we are convening, when we get together
at advisory committees, and we meet internally and we
make a decision about how to change a label and change the instructions,
we base it on the best information that we have available
at that moment.
We are aware, as we were when we most recently changed the
labeling, that there are many ongoing studies on hormone products.
So we anticipate continuing to make changes in these instructions.
But at the point which we put on those warnings, that was the best
information we had.
We do know that the news is not all bad. There are some women,
at some times in their life, depending on their symptoms, who may
benefit from short courses of these hormones. It wouldn't be right
for us to completely shut the door and say they are never indicated,
never appropriate.