Naming Makary loyalist CDER head will prompt staff departures, ease restraints on FDA leaders

Like a wild roller-coaster ride, FDA seemed to stabilize for a few moments following the appointment of Richard Pazdur as CDER director. The sense of equilibrium turned out to be an illusion. With Pazdur’s decision to retire and the selection of Tracy Beth Høeg to serve as acting center director, the agency has again taken a sharp plunge.

Unlike a real amusement park ride, FDA staff can exit at any moment. Departures from the agency are likely to be announced in the coming days and weeks, according to agency officials. They expect Mike Davis, who joined FDA as deputy director of CDER in June, to be among the departures. Davis is highly regarded by FDA staff and industry executives who have interacted with him.  ...