FDA Switches Up Senior Staff

Oct 03, 2007
By Pharmaceutical Executive Editors

FDA announced last week that it is mixing up its senior brass—at least for the short term.

Steven Galson, head of FDA's Center for Drug Evaluation and Research (CDER), was named acting surgeon general, and his former post will be helmed by former CDER director Janet Woodcock.

"Galson is a real 21st century public health official who is aware of the politics of public health from a regulatory fashion," said Peter Pitts, cofounder of Center for Medicine in the Public Interest. "He is also very pharmaceutical savvy, which is important since so much of the debate right now about healthcare issues circles around the value and the future of pharmaceuticals. He clearly understands the role that government has relative to bringing new drugs to market and overall safety."

However, Galson is not expected to sit in the seat for long. In May, President Bush nominated James W. Holsinger for the job, but the appointment has been slow in coming as Democrats in Senate berate Holsinger for his writings against homosexual behavior.

In the meantime, Woodcock and Galson are treating their positions as anything but temporary. Woodcock is especially familiar with her job description. She was head of CDER before Galson and leads FDA's Critical Path program that's intended to define drug regulation.

"The thing that impresses me the most with Woodcock is that she really changed CDER and brought it into the 21st century," said Lou Morris, president of consulting firm Louis A. Morris & Associates. "Her perspectives are so much more realistic about how people use drugs and what FDA's role is."

Morris explained that Woodcock was largely responsible for bringing the whole risk-management perspective to FDA and changing the culture at CDER. "When I first came to FDA, the medical offices would say, 'We put a label on the drug, what else can we do?' Woodcock realized that FDA's job is not just to put labels on packages but to make sure that drugs are used safely. She had a very broad view, and I give her credit for making FDA see things from a realistic point of view."

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