Placebo or Panacea: The FDA's Rejection of ImClone's Erbitux Licensing Application
Hron, Benjamin M.
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CitationPlacebo or Panacea: The FDA's Rejection of ImClone's Erbitux Licensing Application (2003 Third Year Paper)
AbstractThis paper draws upon the media reports, congressional hearing testimony, and company press releases to recount events surrounding the FDAâ€™s refusal to issue a license to ImCloneâ€™s cancer drug Erbitux, late in 2001. Erbitux was granted fast-track status by FDA, and was evaluated under the agencyâ€™s accelerated approval process. Despite hype about the drugâ€™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 ImCloneâ€™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 ImCloneâ€™s continuing attempts to gain licensing approval for Erbitux.
Citable link to this pagehttp://nrs.harvard.edu/urn-3:HUL.InstRepos:8889445
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