US Republicans attack "too lenient" FDA

Republican members of the US House of Representatives' Energy and Commerce Committee have launched an attack on the Food and Drug Administration's enforcement measures against persons and companies that have been convicted of a federal felony. Rep Joe Barton (Texas), the ranking Member of the Committee who presented the report, said that congressional hearings concerning the antibiotic Ketek (telithromycin), marketed by France's Sanofi-Aventis, had prompted his investigation.

Rep Barton argued that the criminal conviction of Anne Kirkman-Campbell, a clinical researcher for misconduct in a safety trial for the drug, ought to have led to debarment by the FDA from working in the drug industry. Instead of acting promptly, he claimed the agency waited three years after Dr Kirkman-Campbell had been jailed. He said the "FDA's failure to take action in a timely manner increases the risks of criminals continuing to operate in, and undermine, the drug regulatory process."

In the 15 years since legislation was introduced to provide the FDA with debarment powers for firms and individuals, the report compiled by Republican staffers found that only nine cases have led to such action. For the fiscal years 2003-2005, researchers hired by the Republican group identified 40 individuals the FDA ought, allegedly, to have acted against, but who escaped enforcement action despite being convicted of serious criminal acts.