Two years ago, Dr. Margaret Hamburg stepped down as commissioner of the Food and Drug Administration. During her six-year tenure, she weathered various political and regulatory storms, such as a fracas over whether to sell a contraceptive pill over the counter, controversies over drugs made in India and China, and the safety of compounded medicines. An FDA commissioner confronts a lot, after all. So we asked Hamburg for her thoughts on Dr. Scott Gottlieb, who was nominated to lead the FDA, and some of the issues the agency faces. This is an edited version of our conversation …
Pharmalot: So what do you think about Scott Gottlieb? His nomination has sparked concern about his ties to industry, but he worked at FDA, knows the industry …
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Scott’s greatest asset is that, unlike Obama and Hamburg he is not a product of the Harvard System, so he will not be prone to academic perambulations and fuzzy thinking.