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FDA transparency committee set up under Obama openness pledge

03-Jun-2009

Related topics: Industry Drivers

New US FDA Commissioner Margaret Hamburg has created a transparency taskforce to better explain the agency’s decision making processes.

Key areas of review for the taskforce will include how the US Food and Drug Administration (FDA) evaluates drugs and enforces regulations, as well as how it handles unpublished trial data submitted to it by pharmaceutical manufacturers.

Hamburg explained that: “President Obama has pledged to strengthen our democracy by creating an unprecedented level of openness and public participation in government, and the FDA looks forward to participating in this process."

I have asked the Transparency Task Force to deliver recommendations to me for ways to make more information available and foster better understanding of decision-making,” she continued

The taskforce, which will be lead by Deputy FDA Commissioner Joshua Sharfstein will spend the next six months consulting with the drug industry and physicians to formulate a progress plan.