Pharmacies say Harkin bill would give FDA unprecedented powers
States are currently charged with overseeing compounding operations and a group representing a coalition of pharmacies associations and other groups is balking at the proposed shift.
The group, My Meds Matter, is circulating a petition to protest the bill.
Specifically opponents warn that the FDA, if given the authority, could move to ban custom compounded bio-identical hormones used to treat imbalances. The hormones are used to treat low testosterone in men, as well as menopausal and PMS symptoms in women.
Imbalances can cause depression, insomnia, low libido and headaches.
“Bio-Identical hormones are a critical necessity,” said Dr. Mila McManus of The Woodlands Institute for Health & Wellness. “An FDA ban on compounded hormones would make doctors dependent upon one-size-fits-all synthetic hormones. But one size does not fit all, and I am very concerned for my patients that this legislation has made it to the Senate.”
The bill, authored by Sen. Tom Harkin (D-Iowa) moves next to the full Senate.