Compounding pharmacies are mounting opposition to a Senate bill they say would give the Food and Drug Administration unprecedented authority over their operations, including the power to ban hormones used to treat a wide variety of ailments.
The bill, approved unanimously by the Senate Health, Education, Labor and Pension Committee late last month, would give the FDA increased regulatory power over compounding manufacturers who tailor drugs’ dosages or other properties to fit specific patient needs.
The process has come under heavy scrutiny since ameningitis outbreak linked to the New England Compounding Center killed dozens of people and left hundreds sick.
The bill, approved unanimously by the Senate Health, Education, Labor and Pension Committee late last month, would give the FDA increased regulatory power over compounding manufacturers who tailor drugs’ dosages or other properties to fit specific patient needs.
The process has come under heavy scrutiny since a
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-allsynthetic 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 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
The bill, authored by Sen. Tom Harkin (D-Iowa) moves next to the full Senate.
Read more: http://thehill.com/blogs/regwatch/healthcare/304187-pharmacies-say-harkin-bill-would-give-fda-unprecedented-powers#ixzz2VYt2E8i2
Follow us: @thehill on Twitter | TheHill on Facebook
No comments:
Post a Comment