Regulatory Focus™ > News Articles > Corrigan: FDA Transforming to a Global Agency, Success Depends on Partnerships

Corrigan: FDA Transforming to a Global Agency, Success Depends on Partnerships

Posted 29 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration's (FDA) Associate Commissioner for Regulatory Affairs, Dara Corrigan, testified Wednesday (28 March) before a House subcommittee investigating drug counterfeiting, saying she believes FDA is moving to become an agency with a global focus built upon global partnerships.

Speaking before the House Committee on the Judiciary's Subcommittee on Crime, Terrorism and Homeland Security, Corrigan said FDA "intend[s] to further transform FDA over the next decade from a predominantly domestically focused Agency, operating in a globalized world, to an Agency fully prepared for an environment in which product safety and quality know no borders."

Corrigan noted FDA now has permanent posts in Beijing, Shanghai, and Guangzhou, China; New Delhi and Mumbai, India; San Jose, Costa Rica; Mexico City, Mexico; Santiago, Chile; Brussels, Belgium; London, England; and Parma, Italy. FDA also opened two temporary posts in Amman, Jordan and Pretoria, South Africa in 2011.

"These offices enable us to have a regional presence around the world and serve as important hubs for improved coordination with regulatory authorities and industry in other nations," remarked Corrigan.

Corrigan noted FDA's recent report, entitled Pathway to Global Product Safety and Quality, which lays out the agency's global strategic plans.

"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.

Corrigan's remarks also touched on supply chain issues, which she noted were increasing "despite [FDA's] successes."

"FDA has undertaken a wide range of activities aimed at addressing the challenges and opportunities of globalization, including efforts to harmonize scientifically rigorous standards internationally consistent with FDA's high standards for safety and effectiveness; to share scientific and technical expertise with our fellow regulators; to provide training around the world in crucial regulatory disciplines; to strengthen detection, surveillance, and assessment systems; and to design innovative risk-modeling systems."

"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," said Corrigan. "To a large extent, our success or failure in this effort will be contingent on the relationships we establish with our foreign partners."

Read more:

FDA Testimony - Hearing on H.R. 4223, the "Safe Doses Act"; H.R. 3668, the "Counterfeit Drug Penalty Enhancement Act of 2011"; and H.R. 4216, the "Foreign Counterfeit Prevention Act"

FDA - Pathway to Global Product Safety and Quality


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