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Capitol Health Call
October 10, 2007

FDA Under Scrutiny

JAMA. 2007;298(14):1631. doi:10.1001/jama.298.14.1631-c

The Food and Drug Administration's (FDA’s) handling of manufacturing quality violations by the maker of a drug-eluting coronary stent is being questioned by leadership of the House Energy and Commerce Committee.

In letters sent August 13 to the FDA and Johnson & Johnson (New Brunswick, NJ), committee chairman Rep John Dingell (D, Mich) and Rep Bart Stupak (D, Mich), chairman of the Subcommittee on Oversight and Investigations, requested documents as part of an inquiry examining regulatory activities and decisions made by FDA officials. In the letter sent to FDA Commissioner Andrew von Eschenbach, the representatives said the committee is investigating the FDA's ability to protect the US public from excessive risks associated with products regulated by the agency.