FDA Plans To Extend Its Global Regulatory Reach | Belt, Bruner & Barnett

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FDA Plans To Extend Its Global Regulatory Reach

Jun 29, 2011 | Defective Products

Every year, tens of thousands of people are injured or killed by unsafe or faulty products, including faulty medical devices, and pharmaceutical drugs, Alabama product liability attorney Keith T. Belt says.

The US Food and Drug Administration (FDA) plans to take a more global approach to ensure the safety and quality of regulated drugs and medical devices, the agency’s commissioner announced.

One prong of the new 4-pronged approach will involve partnering with counterparts worldwide and creating global coalitions of regulators intent on ensuring and improving global product safety and quality, said FDA Commissioner Margaret Hamburg, MD. This is a long-term strategy, which cannot be accomplished immediately and will probably take many years to implement, depending upon resources.

One part of the new approach will mean regulators no longer regard borders the same way. Borders can no longer serve as the nation’s primary line of defense against unsafe imported products. Instead, the border must serve as a final checkpoint on preventive controls throughout the supply chain. An FDA report, Pathway to Global Product Safety and Quality, describes the new strategy. Most notably, it calls for the agency to change how it conducts business and to take a more global approach to promote and protect the health of US consumers. Highlights of the report include 3 other prongs of the 4-pronged approach:

  • 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 more information gathering and analysis, 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.

Such coalition-type models do not exist in the world of FDA-regulated products and they do not already have a coalition in place. However, many peer regulators have expressed interest in working more closely together to ensure the safety and integrity of products moving through the global supply chain.

If you’ve been injured by a defective product, contact our product injury lawyers at Belt and Bruner online or call (205) 933-1500 today.