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“The FDA as a Global Actor”: a Summary Report

October 2, 2012

On Monday morning this week, the Center for Strategic and International Studies (CSIS) held an event “The FDA as a Global Actor,” which featured a conversation between FDA Commissioner Margaret Hamburg and event moderator Stephen Morrison, CSIS Senior Vice President and Director, Global Health Policy Center.

Commissioner Hamburg’s remarks focused on her experiences at FDA as the agency is increasing efforts to expand its capacities and partnerships outside U.S. borders to protect Americans’ health and safety in the complex, globalized marketplace for both food and drugs. Commissioner Hamburg also had an important focus on resources.

Below is a recap of the highlights of the event.

Commissioner Hamburg described how there has been a fundamental transformation of FDA’s responsibilities from almost one of a primarily domestic focus to one that is becoming predominantly global in nature. The Commissioner provided several statistics to highlight the FDA’s growing international workload, including:

  • 80% of pharmaceutical ingredients are now made in other countries.
  • Nearly two-thirds of the fruits and vegetables — and 80% of seafood — eaten domestically come from outside the U.S.
  • The number of imported, FDA-regulated products has quadrupled in the last decade.

Commissioner Hamburg stated that these developments have caused the FDA to re-think about concepts such as supply chain safety and integrity and have forced FDA to develop a whole new strategy to address the global complex public health issues.

Major Priorities at FDA in the New Global Environment. Commissioner Hamburg outlined the FDA’s major priorities relating to its increased global responsibilities:

  1. Create a global coalition of regulators. FDA should work with its regulatory counterparts around the world to achieve common goals.
  2. Need to strengthen and enhance FDA’s informational and data systems. Sharing of information with all stakeholders will be key to addressing new, complicated challenges.
  3. Use risk-based approaches. FDA needs to be strategic in solving problems and use its resources to target the highest risk problems. Increased use of information technologies will allow FDA to better conduct these risk-based analyses.
  4. Increase partnerships with all stakeholders. FDA must collaborate more and better with all stakeholders, including industry.

Role of Resources. Commissioner Hamburg explained how resources at FDA must be increased on a sustained basis for the agency to succeed in its ever-increasing global role. According to the Commissioner:

  • FDA’s resources and responsibilities are dramatically out of sync. The FDA needs sustained and continued budget increases to help carry out its growing international responsibilities.
  • New investments are needed because FDA has a very unique role to play in these important issues. Helping to ensure the health and well-being of the public is inherently a national security as well as an economic developmental mission.
  • FDA’s role as the protector of public health has a significant impact on economic development as increased regulatory capacities are needed to support stable, growing industries.

FDA Reorganization.Commissioner Hamburg briefly described how the FDA is carrying out a re-organization of its internal structure to allow it to respond to and reflect the globalization of iuts responsibilities. In particular, she noted that:

  • In 2011 FDA established a new office to help address FDA’s increasing global responsibilities (the
    Office of Global Regulatory Operations and Policy also known as “GO” or “Global Operations”), and created a new position, Deputy Commissioner for Global Regulatory Operations and Policy.
  • A global focus must be integrated across all of FDA’s programs with a systematic approach for international regulatory compliance.

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