FDA Dings Drugmakers Over Missing Pediatric Studies

By Jeff Overley (December 5, 2013, 6:47 PM EST) -- The U.S. Food and Administration is widening its criticism of pharmaceutical companies that haven't completed mandatory post-approval studies of their products' safety and effectiveness in children, although Pfizer Inc. and others being targeted are describing good-faith efforts to comply.

FDA's admonishments — the latest of which was disclosed Wednesday — came in the form of noncompliance letters sent to drugmakers and posted on the agency's website. They allege a failure to analyze products in accordance with the Pediatric Research Equity Act, which passed in 2003 and requires certain new prescription medicines to be studied in children.

Congress in last year's user-fee...

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