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FDA Report: Agency Moving to Engage Globally to Meet Realities of Supply Chain

Posted 23 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) Commissioner Margaret Hamburg released a new report that aims to show how the regulatory agency is revamping itself from a domestic agency to one with a "global public health focus".

"As our world transforms and becomes increasingly globalized, we must come together in new, unprecedented, even unexpected, ways to build a public health safety net for consumers around the world," said Hamburg in a statement.

FDA's Global Engagement Report outlines seven areas where the agency says it is making strides:

  • establishing foreign posts
  • strengthening regulatory systems capacity
  • harmonizing science based-standards
  • leveraging knowledge and resources
  • conducting risk-based monitoring and inspections
  • preparing and responding to public health crises
  • advancing regulatory science

"FDA recognizes that it must transform itself from a largely domestically-focused agency reacting to a globalized world, to one that proactively engages in a regulatory environment in which product safety and quality know no borders," wrote Mary Lou Valdez, associate commissioner for international programs and Director of FDA's Office of International Programs.

Valdez's statement coincides with the launch of a new FDA "Global Initiative" webpage containing all of FDA's global regulatory initiatives.

Valdez said the report, along with the FDA's other intellectual and physical initiatives, are a part of "a critical transformation" of FDA.

"The globalization of commerce presents an incredible challenge to FDA," explained Valdez. "We are being asked to do more than ever before and consumers expect us to ensure the safety and quality of FDA-regulated products."

The numbers are striking: FDA oversees products from 150 countries, 130,000 importers and 300,000 foreign facilities. Pharmaceutical products being imported have increased by 13% per year on average, while medical devices have increased 10% per year on average. Forty percent of drugs consumed in the US, says FDA, are now manufactured abroad.

"[W]e recognize that to successfully protect US public health, we must think, act, and engage globally," concluded Hamburg in a statement. "Our interests must be broader than simply those within our own borders."

Read more:

FDA - Mary Lou Valdez: Global Engagement

FDA - FDA strengthens international collaboration to ensure quality, safety of imported products

FDA - It's a Small World, After All

FDA - Global Initiative

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