Thursday, January 15, 2009

FDA Commissioner Update

It looks as if the Race to White Oak is almost over. We know at least one commissioner candidate was informed of the decision yesterday.

As we said previously, a decision was likely to be made yesterday with an announcement coming later this week or soon thereafter. To read our previous post, click here.

We also understand that David Dorsey could be named FDA Chief Counsel and Bill Schultz could be named HHS General Counsel. Both picks would make a lot of sense.

Dorsey previously worked in the FDA Office of the Chief Counsel before leaving temporarily to join the staff of Senate Health, Education, Labor and Pensions Committee Chairman Ted Kennedy. Dorsey returned to the agency last week.

Schultz, if named HHS General Counsel, would be the second former staffer of House Energy & Commerce Chairman Henry Waxman to ascend to a top position in the health department. Schultz previously served as counsel to Waxman on food and health care issues.

He was also deputy commissioner for policy at FDA and a former assistant deputy attorney general. Schultz most recently involved in negotiations over an abbreviated approval pathway for follow-on biologics. As a partner with Zuckerman Spaeder, he was one of four principal negotiators of compromise legislation and represented the generic drug industry in those talks. To read our coverage of FOBs, click here.

Dorsey was also heavily involved in the FOBs negotiations on the Senate side as a staffer to Kennedy.

We'll let you know when we find out more.

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