FDA Considers Reinstating Warning Oversight to Boost Quality

Contact: Jeff Grizzel
Phone: 703-538-7668

WASHINGTON DC, USA -- PHARMA UPDATE NEWS SERVICE™ -- AUGUST 31, 2010: Last summer, FDA Commissioner Margaret Hamburg ended an agency policy requiring prior legal review of all untitled and warning letters. To speed up enforcement action, she instructed that the Office of Chief Counsel would review only warning letters that have "significant legal issues."

Since then, warning letter quality has declined, drugmakers say, prompting the agency to evaluate the policy change.

"I have noticed what appears to be a diminution in the quality of warning letters -- issues ranging from typographical errors to lack of legal support for assertions," Jennifer Bragg, partner at Skadden, Arps, Slate, Meagher & Flom, told DGR.

In line with Hamburg's commitment to ensure that the FDA's work is factually and legally correct, the agency is evaluating the impact of the change, spokeswoman Karen Mahoney told DGR. That evaluation should be completed by the end of September.

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