FDA NEWS RELEASE

FDA Takes Next Step in Transformation of its Center for Drug Evaluation and Research
Effort Part of Agency's Response to Institute of Medicine Recommendations

The U.S. Food and Drug Administration today announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.

The award to Oakland, Calif.-based CPD is part of the FDA's ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER's organizational effectiveness and reaffirm its mission of advancing and protecting the public health.

"This transformative program will provide CDER with the tools and expertise necessary to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer and acting center director.

The IOM report, The Future of Drug Safety — Promoting and Protecting the Health of the Public, identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them. Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER's senior management team and a cross-sectional working group of CDER employees to assess the center's organizational culture, identify characteristics and a vision for CDER's desired culture, and develop a plan for implementation and follow-up.

The CPD contract runs through Sept. 20, 2009.

For more information

• The Future of Drug Safety — Promoting and Protecting the Health of the Public
• FDA's Response to the Institute of Medicine's 2006 Report http://www.fda.gov/oc/reports/iom013007.html#intro

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