Article
Rheumatologist Prominent on FDA Oversight Panel for Compounding Firms
Among five physicians on a new panel responsible for monitoring compounding pharmacies, the industry representative has a long history in rheumatology.
Responding to a Congressional mandate in the wake of deaths from contaminated epidural injections in 2012, the US Food and Drug Administration has formed an expert panel to oversee compounding pharmacies that create such products.
The industry representative on the panel, which includes four other physicians, is rheumatologist Ned Braunstein MD of Regeneron Pharmaceuticals, which markets injecteable rilonacept (Arcalyst), approved for the treatment of cryptopyrin-associated periodic syndromes (CAPS).
Braunstein, who is vice president and head of regulatory affairs at Regeneron, was formerly head of the lupus and arthritis clinic at New York-Presbyterian Hospital.
The chairperson is pharmacologist Jurgen Venitz MD PhD of Virginia Commonwealth University. The consumer representative, another physician, is Michael Carome MD, director of Public Citizen's Health Research Group, a public-health advocacy organization co-founded in 1971 by Ralph Nader.
Other physicians on the panel are dermatologist John DiGiovanna MD of the National Cancer Institute's DNA Repair Section and Padma Gulur MD, an anesthesiologist and professor at University of California, Irvine.
