February 5, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff
U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg will step down from her position in March, according to multiple news reports Thursday, with the White House making an official announcement about the matter on Friday.
FDA spokeswoman Stephanie Yao has not commented on the matter.
President Barack Obama nominated Hamburg for FDA commissioner and the U.S. Senate confirmed her in May 2009. Hamburg summarized the FDA’s accomplishments for 2014 yesterday on the FDA web site. In 2014 alone, the FDA approved 51 new drugs and “biologics,” the most in almost 20 years. These included treatments for cancer, hepatitis C and type-2 diabetes. In addition, the number of new drugs approved under the Orphan Drug designation was the most since Congress enacted the Orphan Drug Act in 1983.
“These developments are a testament not just to our expanding understanding of human biology, the biology of disease and the molecular mechanisms that drive the disease process,” Hamburg wrote, “but also to [the] FDA’s innovative approaches to help expedite development and review of medical products that target unmet medical needs, while adhering to the established standards for safety and efficacy.”
But Hamburg’s legacy will most likely always be dogged by the decision to allow Plan B, an emergency contraceptive, to be sold to teenagers as one of her most visible achievements. The decision was first overruled by then Health and Human Services Secretary Kathleen Sebelius. Two years later, however, the decision was approved.
The FDA’s chief scientist, Stephen Ostroff, will take over the reins of the agency during the search for a new commissioner, according to Reuters’ source.
Hamburg’s resignation has not surprised many people. When she appointed Robert Califf as the agency’s deputy commissioner for medical products and tobacco at the end of January, many speculated the FDA was putting in place a succession plan, as BioSpace reported. Califf interviewed twice for the position of FDA commissioner under the Bush Administration.
When Califf’s appointment as deputy commissioner was announced, a former associate director for external relations at the FDA, Peter Pitts, spoke to Reuters about the decision. “He is a guy who could very easily be FDA commissioner under any administration,” Pitts, currently serving as president of the Center for Medicine in the Public Interest, told Reuters. “He is one of the few candidates who could sail through the confirmation process because of his universally recognized talents.”
BioSpace Temperature Poll
Will Hiring Heat Up in 2015? With companies as large as Biogen Idec and as small as ICON upping their hiring across the board, where do you think the biotech job market will go in 2015? BioSpace wants your opinion!
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