FDA Needs to Bolster Quality, Safety With Increase of Imported Products

'Manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,' says FDA.

The FDA is being called upon to transform the way it conducts business in order to better protect the health of U.S. consumers. A report, "Pathway to Global Product Safety and Quality," released on June 20 calls for a new way of doing business.

"Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. "There has been a perfect storm -- more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented."

The FDA points out that currently a typical U.S. manufacturing company relies on more than 35 different contract manufacturers around the world. This trend will continue as Western economies "increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes," the report says.

The report includes four key elements needed to make the change:

  • The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.
  • The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.
  • The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
  • The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

"FDA regulated imports have quadrupled since 2000," Hamburg said. "The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources."

The FDA has begon working on this issue and has increased the number of foreign drug manufacturing inspections by 27% between 2007 and 2009. It opened a series of international offices in key locations and iss collaborating with its counterparts in the European Union and Australia on drug inspection. It has joined the Pharmaceutical Inspection Cooperation/Scheme which is an organization of the drug manufacturing inspectorates from 39 countries. The FDA and other global leaders are also creating an expanded global regulators forum for medical devices.

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