Don’t Empower the FDA to Take Away Your Access to Compounded MedicationsMay 7, 2013
This new legislation is a wish list for Big Pharma.Action Alert!
On April 26, the Senate Committee on Health, Education, Labor, and Pensions (HELP) released draft legislation that would “clarify” the FDA’s ability to regulate both compounding pharmacies and the compounded medications themselves.
It’s our understanding that the draft bill was written with the specific intent of giving the FDA broad authority to remove compounded medications from the market in one of two ways: either by putting bulk ingredients on a list of “banned” compounded drugs, or by redefining compounded variations of approved drugs as illegal “copies.”
The way the bill is written, a compounded medication—like the low-cost pregnancy medicine 17P (similar to KV Pharmaceutical’s hugely expensive drug Makena), or a bioidentical estriol that can be used instead of Pfizer’s dangerous (and not bioidentical) Prempro—could be banned.
We don’t yet know who is pushing the specific language of this bill, but it is interesting to note that Pfizer gave campaign contributions to eight out of the twenty-two members of the HELP Committee.
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