This is a portion of a letter that I just sent to Senators Hagan and Burr. They may vote on SB 959 tomorrow (July 31). This bill will compromise health care for women and men across the country. It is in response to the tragedy last winter when New England Compounding Company sent out contaminated steroids to physicians across the country. Many people died, even more are still sick. This bill allegedly is an attempt to keep that from ever happening
Unfortunately, it doesn't stop there. The restrictions on neighborhood compounding pharmacies and those from which I get ingredients for IV's that I give to patients and on doctors like me who use and prescribe compounded medications is ridiculous.
Please contact you senators across the country and tell them to vote NO on S.959.
For more information: http://www.anh-usa.org/compounding-bill-vote-possible-tomorrow/
I understand that a substitute bill in the form of an amendment has been
proposed for S.959. The rewritten bill is now 189 pages long, up from its
original 50 pages. While there have been a few positive changes to this new
version, it remains a terrible bill that will, for millions of Americans,
cut off access to the important compounded medications on which they rely.
As your constituent I'm asking you to vote NO on S.959.
Several new provisions in the bill are especially troubling. The first is
the potential loss of estriol (the bioidentical hormone) which has a USP-NF
monograph. Legally, it can be compounded. Estriol is an anti-cancer
estrogen. It is very safe. It's incorporation into HRT prescriptions lowers
the risk of breast and other cancers for women. The bill would allow FDA to
identify bulk ingredients as "drugs not suitable for compounding" even
though they have a monograph as estriol does! This is a huge concern for me
and my patients. In the past, the FDA has attempted to ban bulk bioidentical
estriol at the request of Wyeth, a pharmaceutical company. Wyeth still
promotes Prempro for HRT even after it was proven to increase the risk of
cancer during WHI and up to 10 years later...even after women in the WHI
study stopped the drug. Wyeth even uses estriol in European formulations!
The current language of the bill could allow FDA to regulate away my access
to that critical medication. Let's not forget: the regular prescription
drugs that the FDA promotes as an alternative to bioidentical estriol have
been proven to be very dangerous. This provision is a direct danger for
millions of women who depend on bioidentical estriol.
Another section of S. 959 which directly affects women's health will let
compounded versions of "FDA-approved drugs" be banned as "copies" of the
drugs depending on how strictly that term is interpreted. This could
eliminate access to the much less expensive 17P in favor of the FDA-approved
The pharmaceutical companies and their representatives have a vested
financial interest in this bill. Even though they themselves praise the
safety and efficacy of bioavailable hormones, they bemoan the fact that
compounding pharmacies have the lion's share of the market, and they have
stated quite explicitly that they intend to take that share for themselves.
Their versions of the drugs are wildly more expensive than the compounded
versions and in some cases have been proven to be unsafe. Big Pharma is
trying to control the marketplace through legislation, and that's just not
right. And women will suffer needlessly.
Please don't let FDA or drug companies use the smokescreen of compounding
regulation to seize huge new markets for themselves, leaving consumers with
vastly more expensive and less safe alternatives, or with no alternatives at
all! Please vote NO on S.959, the Compounding Medications Bill!
If you don't act, who will?
Thanks and blessings!