Monday, November 20, 1995
Interneuron Pharmaceuticals Inc. last week provided a primer for biotech companies on how to retain one's cool when confronted with a hostile (and not very well-informed) FDA advisory panel. After being blind-sided at its first panel on Sept. 28, when questions neither the company nor the upper echelons of the FDA had expected were raised about the neurotoxicity of IPIC's obesity drug, Redux dexfenfluramine, the company came back and did it all again (see BioCentury Extra, Nov. 17).
They were prepared, they were professional, they didn't let their frustration show, they never raised their voices, and they stuck to the data, with no more than the kinds of minor pushing of the boundaries that a partisan may be allowed. Other first-timers at the FDA should take note.