Top FDA Regulatory Official Stepping Down, Will Assume New Duties

Posted 22 August 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) top regulatory affairs official, Dara Corrigan, is giving up her duties and assuming a position as director of FDA's Europe Office and as senior advisor for global operations, sources tell Regulatory Focus.

Corrigan had served as the associate commissioner for regulatory affairs since September 2010, where she was in charge of more than 4,000 staff focused on ensuring regulatory compliance in import, export and manufacturing operations for products overseen by FDA.

A Public Face for Global Regulation

As one of FDA's top officials, Corrigan has been a public face for the agency, often testifying before Congress on the importance of regulatory initiatives.

In a March 2012 hearing before the House Committee on the Judiciary's Subcommittee on Crime, Terrorism and Homeland Security, Corrigan testified that FDA is transforming from a domestic agency to one with a global focus, "fully prepared for an environment in which product safety and quality know no borders."

"The agency is developing a new, more global operating model that relies on strengthened collaboration, improved information sharing and gathering, data-driven risk analytics and the smart allocation of resources, leveraging the combined efforts of government, industry, and public- and private-sector third parties," said Corrigan.

"When governments collaborate to strengthen safety standards, the results are safer, higher-quality products and enhanced economic development through a productive industry and a strong, reliable export market," Corrigan continued. "To a large extent, our success or failure in this effort will be contingent on the relationships we establish with our foreign partners."

Corrigan will likely have the opportunity to put these words into direct practice, with her new role putting her in close contact with EU regulators and placing her in a more general oversight role over FDA's global operations. Sources tell Regulatory Focus that Corrigan will be physically stationed in Brussels, Belgium-the capital of the European Union.

New Acting Associate Commissioner Steps Up

Filling Corrigan's shoes until a permanent replacement can be found will be Melinda Plaisier. Plasier has previously served as the Office of Regulatory Affairs' (ORA) US central region director.

Before ORA, Plasier served for 13 years in the Office of the Commissioner (OC) as the associate commissioner for international programs and then the associate commissioner for legislation.

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