UPDATE: The FDA has now confirmed that Dr. Margaret Hamburg will step down as commissioner next month.
"This is a very challenging job full of opportunities to make a huge and enduring difference," said Hamburg in a statement. "[B]ut it is 24/7 and there are really really difficult decisions to make." Hamburg also said that she had not expected to remain FDA commissioner for so long (she is reportedly the fifth longest-serving commissioner in the agency's history).
Dive Brief:
- U.S. FDA Commissioner Dr. Margaret Hamburg is reportedly resigning from her position at the end of March, sources told Reuters.
- Hamburg has served as the FDA chief for nearly six years and is one of the longest-serving FDA commissioners. Once she steps down, she will be replaced by chief FDA scientist Dr. Stephen Ostroff until President Barack Obama nominates a replacement (more on that below).
- The official White House announcement of Hamburg's resignation is expected to come on Friday.
Dive Insight:
It's confirmed: Dr. Hamburg will be stepping down after a long tenure at the FDA that's seen a considerable amount of change to the agency, including the advent of major reforms like the Affordable Care Act and the Food Safety Modernization Act, as well as the FDA's recent aggressive drive to approve record numbers of novel and orphan drugs.
There will be plenty of time to mull Hamburg's tenure in the coming days. But the tantalizing question right now is: Who will replace her? Last month, the rumor mill already started churning when Hamburg appointed Duke School of Medicine Vice Chancellor Dr. Robert Califf to a deputy commissioner position. That move is beginning to seem increasingly strategic with today's announcement.