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IPQ Inside the global regulatory dialogue

FDA to Partner with State Agencies on Recalls and Regulatory Actions

May 25th, 2010

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FDA is developing national procedures for engaging state agencies in the follow-up to recalls and moving toward partnerships with state agencies to allow the use of state data to support other regulatory actions.

Part of FDA’s obligation is to make sure recalled products are removed from the market promptly.  Doing that is “an enormous job,”   FDA Office of Regulatory Affairs Acting Associate Commissioner Michael Chappell stressed at the FDLI Annual Conference in late April.

FDA has “spent an incredible amount” of its valuable resources on product recalls, Chappell noted, and the agency is looking for other partners and other processes to ensure that products are removed in a more timely manner with fewer resources devoted to the effort.

In addition, FDA is modifying its regulatory procedures manual to specifically permit the use of state data for compliance actions such as warning letters and untitled letters.  “What is important about that,” Chappell emphasized, is that the evaluation of the state data to support those actions will “follow the same process as if it was FDA data.”

In the past, the FDA official admitted, there has been some reluctance to use state data to support FDA’s enforcement actions.  “I think this is the first in what will probably be continued efforts to better integrate states and FDA as we look at trying to regulate both the domestic and to some extent the international environment.”

[Editor’s Note:  The June issue of IPQ will provide an in-depth report on the changing inspection and GMP enforcement landscape in the US, EU, and globally.]

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