Placebo or Panacea: The FDA's Rejection of ImClone's Erbitux Licensing Application

This paper draws upon the media reports, congressional hearing testimony, and company press releases to recount events surrounding the FDA’s refusal to issue a license to ImClone’s cancer drug Erbitux, late in 2001. Erbitux was granted fast-track status by FDA, and was evaluated under the agency’s accelerated approval process. Despite hype about the drug’s effectiveness in fighting certain types of cancer, the FDA found numerous and considerable problems with the licensing application, and in particular with the conduct and documentation of the main registration trial. The paper discusses the possibility that ImClone’s public statements may have misled investors, and the ability of the FDA and the SEC to oversee these disclosures. Finally, recent changes in the FDA approval process are addressed, as well as the current state of ImClone’s continuing attempts to gain licensing approval for Erbitux.