Hamburg Confirmed as FDA Commissioner

New FDA chief is only the second woman in 100 years to hold the post.

By: Michael Barbella

Managing Editor

TheU.S. Senate confirmed President Barack Obama’s choice to oversee food and drug safety, supporting a bioterrorism expert who has vowed to restore consumer confidence in the government’s ability to protect public health.

Dr. Margaret Hamburg, 53, will be sworn in as the 21st commissioner of the U.S. Food and Drug Administration (FDA). She is only the second woman in 100 years to hold the post (the first was Dr. Jane Henney, who served from November 1998 to Jan. 19, 2001).

The Senate confirmed Hamburg’s nomination in a voice vote.

Hamburg’s first priority as FDA chief will be to help direct development of a vaccine for the H1N1 virus, better known as the “swine flu.” Since the outbreak was first reporter earlier this spring, the disease has sickened 9,830 people worldwide and caused 79 deaths, mostly in Mexico.

Hamburg also faces a laundry list of other issues when she assumes the position, including improving food, drug and medical device safety, reviewing food labeling standards, and creating a “culture at the FDA that would enable all voices to be heard.”

The last issue may be difficult, depending on what those voices say. Earlier this year, a group of employees at the Center for Devices and Radiological Health accused managers of corrupting the scientific review process to speed medical device clearances. Hamburg told senators at her confirmation hearing that she would put science first and run an open and accountable operation.

“The American people place a huge amount of trust in the FDA,”Hamburg said at her May 7 confirmation hearing. “It is critical that we take steps to boost their confidence, particularly when it comes to the safety of drugs and food.”

Hamburg’s claims during the confirmation hearing convinced officials with the Advanced Medical Technology Association (AdvaMed) that she is ready to confront the challenges currently facing the FDA. In a statement released after the Senate’s confirmation vote, AdvaMed President and CEOStephen J. Ubl said Hamburg’s record will help her promote and protect public health.

“We applaud Dr. Hamburg’s expressed priorities of fostering innovation and further advancing the safety of medical products and we look forward to working with her to ensure the continued safety and effectiveness of medical technologies,”Ubl stated. “Her record of successfully managing large, complex organizations will help ensure FDA will continue to fill its mission of protecting and promoting the public health.”

Hamburg’s record includes stints as an assistant health secretary under President Bill Clinton and head of the New York City health department.


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