Friday, October 5, 2012

FDA as a Global Actor

At the Center for Strategic and International Studies earlier this week, U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg, in a discussion with J. Stephen Morrison, stressed the need for the FDA to take on more of a global approach to regulation and to collaborate with scientists, industry, and stakeholders to strengthen supply chain integrities and overall food safety.
Nothing stresses the necessity for a global approach more than these startling numbers:
  • 25 cents of every dollar spent in the U.S. goes to products regulated by FDA.
  • 80 percent of active pharmaceutical ingredients are manufactured abroad.
  • 40 percent of all drugs taken by Americans come from abroad.
  • 85 percent of seafood and close to 50 percent of fruit is imported.
  • Global production of FDA-regulated products has quadrupled over the last decade.
At the event, Hamburg noted that while “the FDA remains the gold standard for regulation, minimum thresholds for standards must be established globally” to effectively regulate today’s intertwined system of supply chains and international competitiveness.
To restructure the system effectively and build capacity, Hamburg underscored the need to:
  • move toward a global coalition of regulators;
  • create new data systems for sharing information;
  • find a strategic risk-based approach and use the best science and experts to target high-risk products and identify vulnerabilities within them; and
  • establish new partnerships with all stakeholders, including industry.
By developing new models, standards will be raised, information can be shared, and regulatory capacity will be built to underline the harmony of interests between the FDA, development agencies, and stakeholders. Embracing our global reality will enable key sector leaders to better work toward the goals of stronger economics, improved infrastructure, a stronger regulatory capacity, and, most importantly, improved health and safety regulations that impact the everyday lives of citizens worldwide.

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