Congress Finds FDA Wanting

Abstract

Food and Drug Administration (FDA) internal documents released this month by a House subcommittee allege that Eli Lilly and Company, which recently suspended sales of the anti-arthritis drug benoxaprofen, has repeatedly failed to report adverse effects of drugs it was testing or marketing. Charges against the company include incomplete and delayed reporting of data, improper record maintenance, and failure to follow clinical protocols. The FDA memoranda mention the possibility of prosecution. An Eli Lilly statement at the subcommittee hearings denied the allegations. (KIE abstract)