Pharma types 'nervous' about Sharfstein

For months we've been speculating and wondering about President Obama's FDA picks. Now that we know who they are--Margaret Hamburg as commish, Joshua Sharfstein (photo) as chief deputy--what's the word? Well, within the pharma industry, the word is "worried."

Industry insiders tell Government Executive that pharma is "cautiously optimistic" about Hamburg. But Sharfstein is another story. "Hamburg will be focused on the food supply and creating regulation of tobacco, and to some degree it's expected Sharfstein will have a certain amount of autonomy on pharmaceuticals and medical devices," one pharma lobbyist said. "Companies are clearly going to get more scrutiny."

Industry types are "shuddering" at the thought of a former Henry Waxman acolyte--Sharfstein served on the tough Congressman's committee staff for several years--having power over the drugs business. Sharfstein was Waxman's go-to guy on many public health issues, including off-label drug marketing and pharma gifts to physicians. As Baltimore Health Commissioner, he pressed the FDA to re-evaluate the safety of cough and cold meds for kids.

"I think companies are really nervous based on his track record," an industry insider said. Until Sharfstein has a track record at the FDA, however, we won't know for sure.

- read the story in Government Executive

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