FDA Whistleblowers Help Congress - Feb 13, 2007

Scientists who have worked at the U.S. Food and Drug Administration and criticized agency decisions are now helping Congress fashion legislation to tighten product-safety rules.

The scientists include David Ross, who said in an interview that FDA supervisors forced him to retract a recommendation that the antibiotic Ketek, made by Sanofi-Aventis SA, was probably too dangerous to be used for treating two common respiratory infections. The drug was approved in 2004 and had $148 million in sales in 2005.

Ross is one of four current or former employees of the FDA who are working with Congress on bills intended to create more stringent drug safety rules.

Be prepared for tougher FDA inspections as a result of actions like this.

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